Ex parte Baurin, 2024-002920 (August 6, 2026) (designated: August 6, 2026) [finding that separate ownership / anti-harassment is a standalone rationale for obviousness-type double patenting and questioning its continued significance]

Texto completo

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UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE APPEALS REVIEW PANEL OF THE
PATENT TRIAL AND APPEAL BOARD
Ex parte NICOLAS BAURIN, CHRISTIAN BEIL, CARSTEN CORVEY,
CHRISTIAN LANGE, DANXI LI, VINCENT MIKOL,
ANKE STEINMETZ, and ERCOLE RAO
Appeal 2024-002920
Application 17/135,529
Technology Center 1600
Before JOHN A. SQUIRES, Under Secretary of Commerce for Intellectual
Property and Director of the United States Patent and Trademark Office,
KALYAN K. DESHPANDE, Chief Administrative Patent Judge, and
MICHELLE N. ANKENBRAND, Acting Deputy Chief Administrative
Patent Judge.
SQUIRES, Under Secretary of Commerce for Intellectual Property and
Director of the United States Patent and Trademark Office.
DECISION ON SUA SPONTE REHEARING
I. 	INTRODUCTION
This Appeals Review Panel (“ARP”) was convened to review the
Board’s Decision on Appeal (“Dec.” or “Appeal Decision”) and Decision on
Request for Rehearing (“Reh’g Dec.” or “Rehearing Decision”), with
particular focus on the Board’s reversal of the Examiner’s rejections of
claims 1–18 for nonstatutory double patenting, also known as obviousness-

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type double patenting (“OTDP”). We have jurisdiction under 35 U.S.C.
§ 6(b).
On review, we REVERSE.
II. 	BACKGROUND
A. Procedural History
On November 8, 2024, the Board issued an Appeal Decision reversing
the Examiner’s rejections for OTDP.1 On January 3, 2025, the Examiner
filed a Request for Rehearing (“Req. Reh’g”) under MPEP § 1214.04. On
December 18, 2025, the Board issued a Rehearing Decision, which included
a dissenting opinion.
On March 5, 2026, I convened this Appeals Review Panel (“ARP”)2
and granted sua sponte rehearing to review the Board’s Appeal Decision and
Rehearing Decision. See ARP Order, dated Mar. 5, 2026 (“ARP Order”). In
the ARP Order, we authorized further briefing from Appellant. ARP Order
2. 	We also permitted briefing from amici curiae. 	Id.
The ARP Order indicated that Appellant and amici should consider
addressing the following three questions: (1) whether Allergan USA, Inc. v.
1 The Appeal Decision reversed six OTDP rejections based on each of the
following reference patents or patent applications in combination with
US 2009/0162359 A1 (“Klein”): (i) Patent 10,882,922 B2 (“the ’922
patent”), (ii) Patent 11,186,649 B2, (iii) Patent 11,530,268 B2, (iv) Patent
11,613,576 B2, (v) Patent 11,192,960 B2, and (vi) Application 18/183,107
(now Patent 12,227,573 B2). Appeal Dec. 3–4, 11. The Appeal Decision
focused on the rejection involving the combination of Klein and the ’922
patent, and noted that all of the rejections involved the same determinative
issue. Id. at 4. We likewise focus our discussion on the OTDP rejection
involving the combination of Klein and the ’922 patent.
2 See Appeals Review Panel § 1, available at https://www.uspto.gov
/patents/ptab/appeals-review-panel.
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MSN Laboratories Private Ltd., 111 F.4th 1358 (Fed. Cir. 2024), applies to
the facts of this appeal and what constitutes “first-filed” for OTDP purposes
under facts different than presented in Allergan; (2) whether examiners
should determine projected expiration dates when making rejections for
OTDP during prosecution; and (3) whether the risk of separate ownership
and preventing potential harassment by separate owners of claims to obvious
variants of an invention is an independent basis that supports an OTDP
rejection during prosecution. ARP Order 2.
The Office received Appellant’s additional briefing (“ARP Brief” or
“ARP Br.”) on March 27, 2026, and received eleven briefs from amici,
which were entered into the prosecution record on April 1, 2026.
On August 6, 2026, an Order changing the ARP panel was entered.
B. Undisputed Matters
The ’529 Application at issue in this case was filed December 28,
2020. Appeal Dec. 6. The ’529 Application, through intervening
continuation applications, claims the priority benefit of a non-provisional
application (US Application No. 13/433,033) filed March 28, 2012. Id. at 5.
Thus, the term of any patent issued on the ’529 Application will expire on
March 28, 2032—twenty years from the patent term filing date3—absent
other factors that may affect patent term.4 Appeal Dec. 5–7.
3 Patent term filing date refers to the filing date that begins the running of the
term. This date generally is the filing date of the first U.S. application to
which the patent claims priority (i.e., it excludes priority claims to foreign or
provisional applications). 35 U.S.C. § 154(a)(2).
4 Appellant has acknowledged that, in view of existing terminal disclaimers
over two other patents, any patent issuing on the ’529 Application could not
expire later than March 28, 2032, the same as its natural term expiration.
Appeal Br. 10–11.
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The ’922 patent, asserted here as an OTDP reference, has an actual
and patent term filing date of April 13, 2017. The ’922 patent issued
January 5, 2021. Its twenty-year term ends April 13, 2037, and it received
an additional 70 days for patent term adjustment.
The ’529 Application and the ’922 patent are, at present, commonly
owned by Appellant Sanofi and share several common inventors (Christian
Beil, Ercole Rao, Christian Lange, and Carsten Corvey).
The Examiner determined that “[t]here is no dispute regarding
Appellant’s analysis of the patent term filing date.” Ans. 11.
The claims on appeal relate to an antibody-like binding protein with
certain characteristics. Appeal Br. 50 (Claims Appendix). The Examiner
found, with no counterargument from Appellant, that pending claims 1–18
would have been obvious over claims 1–39 of the ’922 patent in further view
of Klein. Ans. 3–4. Appellant argued and the Examiner acknowledged,
however, that the claims of the ’922 patent would not have been obvious
over the ’529 Application’s disclosure (as published). Appeal Br. 16;
Ans. 12.
C. Double Patenting History
To provide additional context for our decision, we first set forth a
history of the prohibition against double patenting, which is grounded in
statutory language extending back to the earliest patent statutes.
1. Statutory Basis of the Prohibition Against Double
Patenting
The prohibition against double patenting is firmly rooted in the text of
the Patent Act. Section 101 of the statute provides that applicants “may
obtain a patent” on their inventions. See 35 U.S.C. § 101 (emphasis added).
Similar language has existed in every patent statute in U.S. history. 	See
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Patent Act of 1790, § 1, 1 Stat. 109, 110 (codifying “that a patent may be
granted” on an applicant’s invention) (emphasis added); Patent Act of 1793,
§ 1, 1 Stat. 318, 320 (same); Patent Act of 1836, § 6, 5 Stat. 117, 119
(authorizing the Commissioner of Patents to “grant a patent” on each new
invention) (emphasis added); Patent Act of 1870, § 24, 18 Stat. 198, 201
(authorizing applicants to “obtain a patent” on an invention) (emphasis
added). The use of the singular—“a patent”—signals that, by statute, only a
single patent is allowed on each invention. Thus, the basic prohibition
against double patenting has long been grounded in the text of our country’s
Patent Acts.
Importantly, the prohibition against double patenting has also long
extended to prohibit multiple patents on trivial variations of the same
invention. As the Supreme Court held in Miller v. Eagle Mfg. Co., 151 U.S.
186, 198 (1894), “no patent can issue for an invention actually covered by a
former patent, especially to the same patentee, although the terms of the
claims may differ.” See also McCreary v. Pa. Canal Co., 141 U.S. 459, 467
(1891) (stating that a second patent containing only a “colorable variation”
from a first would be void because “a patentee cannot take out two patents
for the same invention”). Thus, trivial variations of the claim language do
not remove a patent from the prohibition on double patenting of the same
invention.
That additional rule is, in modern caselaw, frequently and accurately
described as a prohibition on “obviousness-type double patenting.” While
this rule has sometimes been called a judicially-created doctrine, the rule is
also well-grounded in the statute. The statutory language in current § 101 of
the Patent Act states that “a patent” may be awarded to “[w]hoever invents
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or discovers” new technology. 	See 35 U.S.C. §101. Invention and
discovery are expressly defined in the Patent Act to be synonyms, see 35
U.S.C. § 100(a) (defining “invention” to mean “invention or discovery”),
and since at least 1793, some class of trivial variations are not considered to
constitute a patentable invention or discovery. See Patent Act of 1793, § 2, 1
Stat. at 321 (declaring that “simply changing the form or the proportions of
any machine, or composition of matter, in any degree, shall not be deemed a
discovery” for purposes of patent law); see also Hotchkiss v. Greenwood,
52 U.S. 248, 267 (1851) (holding that technological changes reflecting
merely “the skill and ingenuity . . . possessed by an ordinary mechanic
acquainted with the business” lack “that degree of skill and ingenuity which
constitute essential elements of every invention”). Ever since 1952, the class
of trivial variations of existing technology that are not patentable are
described as those “obvious” to a person having ordinary skill in the relevant
art. 	See 35 U.S.C. § 103.
At its core, the longstanding doctrine against double patenting reflects
the basic patent-law bargain: in exchange for a limited right to exclude, the
inventor discloses the invention to the public, and the public receives the
right to practice that invention when the patent expires. 	Singer Mfg. Co. v.
June Mfg. Co., 163 U.S. 169, 185 (1896). Further, as the Supreme Court
explained well over a century ago, “the power to create a monopoly is
exhausted by the first patent, and . . . a new and later patent for the same
invention would operate to extend or prolong the monopoly beyond the
period allowed by law.” 	Miller, 151 U.S. at 198 (emphasis added).
Although the ban on double patenting may have been viewed as
absolute in the nineteenth and early twentieth century, Congress in the 1952
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enacted § 253 of the Patent Act, which included a provision authorizing
patentees to “disclaim” the “terminal” part of a patent term. Patent Act of
1952, § 253 66 Stat. 792, 809 (1952) (second paragraph); see also 35 U.S.C.
§ 253(b) (modern codification). Contemporaneous commentary read that
provision as providing a potential “cure” for some double patenting
problems, and such commentary can provide an indication of the original
public meaning of the statute. Within a dozen years, the Federal Circuit’s
predecessor court, the Court of Customs and Patent Appeals (“CCPA”),
permitted terminal disclaimers to overcome at least some double patenting
objections raised during patent prosecution. 	See In re Robeson, 331 F.2d
610 (CCPA 1964). As the court noted, “when the right to exclude granted
by a patent expires at the end of the patent term, the public shall be free to
use the invention as well as obvious modifications thereof or obvious
improvements thereon.” Id. at 614. A terminal disclaimer could vindicate
that policy by ensuring that any subsequent patents on obvious modifications
of a first-issued patent expired at the same time as the first patent.
Since the early 1970s, to overcome an OTDP rejection, agency
regulations have required a terminal disclaimer both to disclaim any term
extending beyond the expiration of a related patent and to identify and
maintain common ownership. 	See 37 C.F.R. § 1.321(c) (1971). Indeed, a
“terminal disclaimer precludes any extension” of patent term because “the
second patent expires simultaneously with the first, [and] the right to fully
utilize the patented discovery at the expiration date remains unimpaired.”
Robeson, 331 F.2d at 614.
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2. An Important Limitation on the Prohibition against
Double Patenting
The Supreme Court in Miller also set forth a logical limitation on the
prohibition on double patenting. The Court observed “that where the second
patent covers matter described in the prior patent, essentially distinct and
separable from the invention covered thereby, and claims made thereunder,
its validity may be sustained.” 151 U.S. at 198. This passage is correctly
read as vindicating another fundamental part of the Patent Act: Any
patentably distinct inventive “improvement” on basic technology is itself
patentable in a subsequent patent. See 35 U.S.C. § 101 (expressly allowing
patents on any “new and useful improvement”).5 A new patent on a
nonobvious improvement on previously patented technology does not
violate the prohibition against double patenting, and that remains true even if
the inventors and owners of the first and second patents are the same.
Encouraging nonobvious improvements on existing technology is an
important part of the patent system, and the inventors of a basic technology
are often well positioned to develop patentable improvements on that
technology.
3. OTDP Before the Uruguay Round Agreements Act
(URAA)
Before the URAA was enacted in 1994, a patent’s term ran seventeen
years from its issuance. URAA, Pub.L. 103–465, 108 Stat. 4809. Under
that pre-URAA framework, issuance date and expiration date were closely
5 Further to this point on improvements, the statutory definition of “process”
means “process, art or method, and includes a new use of a known process,
machine, manufacture, composition of matter, or material.” 35 U.S.C.
§ 100(b) (emphasis added).
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linked—a later-issued patent generally expired later. Courts, therefore, often
framed OTDP concerns as arising from a “second” or “later-issued” patent
because that “second” patent was ordinarily the one that threatened to extend
the patentee’s term of exclusivity already set by a first or earlier-issued
patent.
The pre-URAA focus on issue date reflected the mechanics of patent
term at the time. A later-issued patent on the same invention or an obvious
variant could prolong the patentee’s right to exclude after the first patent
expired. Thus, the caselaw described OTDP as a doctrine aimed at
preventing an unjustified timewise extension of patent rights due to the grant
of a second-issued patent. For example, in In re Schneller, 397 F.2d 350,
354 (CCPA 1968), the court stated that “[t]he fundamental reason for the
rule [of OTDP] is to prevent unjustified timewise extension of the right to
exclude granted by a patent.” The same rationale informed the Federal
Circuit’s early OTDP cases, where the central concern was an improper
extension of exclusivity through claims that were not patentably distinct.
See, e.g., In re Longi, 759 F.2d 887, 892 (Fed. Cir. 1985).
4. OTDP After URAA
The URAA changed the patent-term framework by setting patent term
to twenty years from the earliest effective filing date. 35 U.S.C. § 154(a)(2).
After that change, issuance date no longer predicted expiration date. That is,
a later-issued patent may expire earlier, and an earlier-issued patent may
expire later. Nonetheless, in Gilead Sciences, Inc. v. Natco Pharma Ltd.,
753 F.3d 1208, 1217 (Fed. Cir. 2014), the court recognized the continued
importance of the OTDP doctrine post-URAA, and held that a later-issued,
but earlier-expiring patent could serve as an OTDP reference against an
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earlier-issued but later-expiring patent. Then, in Abbvie Inc. v. Mathilda &
Terence Kennedy Inst. of Rheumatology Tr., 764 F.3d 1366, 1374 (Fed. Cir.
2014), the court made “explicit what was implicit in Gilead: the doctrine of
[OTDP] continues to apply where two patents that claim the same invention
have different expiration dates.”
5. Modern OTDP Analysis
More recent Federal Circuit decisions show that expiration date plays
a central role in the OTDP analysis, but does not operate as an absolute rule.
The modern OTDP inquiry considers not only which patent expires first, but
also why the patents have different expiration dates. For example, the court
has treated patent term adjustment (“PTA”) and patent term extension
(“PTE”) differently when analyzing OTDP. 	See Novartis AG v. Ezra
Ventures LLC, 909 F.3d 1367, 1373 (Fed. Cir. 2018) (holding OTDP does
not invalidate a validly obtained PTE); In re Cellect, 81 F.4th 1216, 1229
(Fed. Cir. 2023) (holding OTDP is based on patent expiration dates after
PTA is added).
In 2024, the Federal Circuit’s Allergan decision further refined the
expiration-date inquiry behind OTDP, and cautioned against an overly
mechanical analysis. In Allergan, the challenged patent was the first-filed
and first-issued patent in a family, but due to PTA, it would expire after two
later-filed continuation patents that were being asserted against the parent as
OTDP. Allergan, 111 F.4th at 1363. The court held “that a first-filed, first-
issued, later-expiring claim cannot be invalidated by a later-filed, later-
issued, earlier-expiring reference claim having a common priority date.” 	Id.
at 1369. The court reasoned that “the first-filed, first-issued patent in its
family . . . sets the maximum period of exclusivity for the claimed subject
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matter and any patentably indistinct variants.” Id. In other words, the parent
patent received the full term to which it was statutorily entitled—it did not
create an unjustified timewise extension of the monopoly, and the later-filed,
earlier-expiring continuation patents, therefore, were not properly asserted as
OTDP references against the parent patent. 	Id.
6. Two Rationales for OTDP
As discussed above, the primary and historically dominant rationale
for OTDP is preventing unjustified timewise extension of a patent’s term.
Cases such as AbbVie, Gilead, and Allergan focused on whether the
challenged patent improperly extended exclusivity beyond the point at which
the public should be free to practice the invention and obvious variants.
The courts, however, also have recognized a second policy rationale
behind OTDP: preventing harassment from separate lawsuits brought by
multiple assignees asserting patents covering the same invention or obvious
variants thereof (the “anti-harassment rationale”). 	See, e.g., In re Fallaux,
564 F.3d 1313, 1319 (Fed. Cir. 2009) (stating that “there is a second
justification for obviousness-type double patenting—harassment by multiple
assignees”). We discuss this second rationale in more detail below because
it plays a pivotal role in our decision.
The coexistence of the two recognized rationales for OTDP has
produced tension in the doctrine. Some decisions describe prevention of
unjustified term extension as the doctrine’s primary purpose, while others
invoke anti-harassment to sustain OTDP in circumstances where the term-
extension concern is diminished or absent. Compare Allergan, 111 F.4th at
1369 (describing “fundamental purpose[]” of OTDP as avoiding improper
timewise term extension), with Fallaux, 564 F.3d at 1318 (explaining
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“unjustified patent term extension justification . . . has limited force in this
case”). The rationales often point in the same direction when patents are
commonly owned and have different expiration dates: a terminal disclaimer
can align both terms. Yet in cases where there is no unjustified term
extension, there remains a broader (and arguably unsettled) doctrinal
question of whether anti-harassment should serve as an independent basis
for OTDP. Having discussed the history, current application, and rationales
for OTDP, we now turn to the case at hand.
III. 	ANALYSIS
A. Allergan Does not Apply to This Case
We asked Appellant and amici to address whether Allergan applies to
the facts of this appeal and what constitutes “first-filed” for OTDP purposes
under facts different than presented in Allergan. Appellant and most amici
focus on the Federal Circuit’s discussion in Allergan about the fundamental
purpose of OTDP, i.e., to prevent patent applicants from effectively
extending the life of a first patent and the relative filing dates of the patent
applications involved in an OTDP analysis, in urging that Allergan applies
broadly. See, e.g., Response to Order Convening Appeals Review Panel and
Granting Sua Sponte Rehearing, 1–3; Brief of Amicus Curiae Amgen Inc. in
Support of Appellant, 2–5.
Although Appellant and the amici arguments are not without merit,
we determine that the OTDP exception Allergan establishes does not apply
to the facts here. The holding in Allergan was that “a first-filed, first-issued,
later-expiring claim cannot be invalidated by a later-filed, later-issued,
earlier-expiring reference claim having a common priority date.” 	Allergan,
111 F.4th at 1369. The “first-filed” prong refers to actual filing dates, as this
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is the interpretation that makes best sense in view of the facts of Allergan—
the challenged and reference patents had the same patent term filing date and
there was no suggestion that the conflicting claims had different effective
filing dates. 	In the present case, the “first-filed” prong is not satisfied
because the ’529 Application does not have the first actual filing in its
family, as was the case for the challenged patent in Allergan. Nor does the
’529 Application have an earlier actual filing date than the ’922 patent.
With respect to the “first-issued” prong, the claims of the ’529 Application
are not “first-issued” because the ’529 Application is still pending. The
“common priority date” prong refers to patent term filing dates, see id. at
1363 (explaining that each of the two reference patents “will expire on
March 14, 2025, i.e., twenty years from its priority date”), and this prong is
not satisfied because the ’529 Application and the ’922 patent have different
patent term filing dates. Thus, Allergan’s holding does not apply here.
B. The Board’s Decision is Contrary to Binding Federal
Circuit Precedents
We now turn to the Board’s decision that the ’922 patent could not
serve as an OTDP reference against the claims on appeal. Appeal Dec. 9.
The Board reached its decision not because the claims on appeal are
nonobvious over the ’922 patent’s claims—it was undisputed that the
appealed claims covered obvious variants of what is claimed in the ’922
patent. Id. at 4, 9. Instead, the Board considered decisive that any claims
issuing from the ’529 Application on appeal “will have a term that cannot
extend beyond March 28, 2032, which is well before the expiration of the
’922 patent claims [in 2037].” Id. at 6–7. As the Board explained, in typical
OTDP cases, “the reference patent claims ha[ve] an earlier filing date than
the patent against which they were applied,” but here “the Examiner is
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applying . . . [reference] claims from a second, later-filed application that
was earlier-issued, but would be later expiring than claims that would issue
from the application on appeal.” 	Id. at 8.
The Board in effect found the OTDP doctrine inapplicable where
issuance of the claims on appeal would not raise term-extension concerns.
Because it was undisputed that the earlier-filed, earlier-expiring claims on
appeal would not, if issued, extend the life/term of the later-filed and later-
expiring ’922 patent claims, the Board reasoned that the underlying purpose
of the OTDP doctrine was not implicated.6 Id. at 7 (citing Allergan, 111
F.4th at 1369, for the proposition that the “purpose of the non-statutory
double patenting doctrine ‘is to prevent patentees from obtaining a second
patent on a patentably indistinct invention to effectively extend the life of a
first patent to that subject matter’”); see also Reh’g Dec. 9 (same).
According to the Board, the appealed claims will not produce “a second,
later expiring patent for the same invention as the ’922 patent, and as such
do[] not extend a period of exclusivity on the claimed subject matter.”
Appeal Dec. 10. Thus, the Board concluded that “the ’922 patent claims
cannot serve as reference claims against the claims on appeal” and reversed
the Examiner’s OTDP rejection. Id. at 10.
Improper term extension, however, is not the only rationale
underpinning the OTDP doctrine. As discussed above, the anti-harassment
6 The filing dates referred to here by the panel are patent term filing dates
under 35 U.S.C. § 154(a), which the panel also refers to in its decisions as
“effective” filing dates. 	See Appeal Dec. 9; Reh’g Dec. 3–5. Such dates
may be, but are not necessarily, an application’s or patent’s actual filing
dates.
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rationale is a second justification for the doctrine. As the Federal Circuit has
recognized:
There 	are 	two 	justifications for 	obviousness-type double
patenting. The first is “to prevent unjustified timewise extension
of the right to exclude granted by a patent no matter how the
extension is brought about.” Van Ornum, 686 F.2d at 943–44
(quotation and citation omitted). The second rationale is to
prevent multiple infringement suits by 	different assignees
asserting essentially the same patented invention. Fallaux, 564
F.3d 	at 	1319 	(recognizing that 	“harassment by 	multiple
assignees” provides “a second justification for obviousness-type
double patenting”); see also Chisum on Patents § 9.04[2][b][ii]
(“The possibility of 	multiple suits against an infringer by
assignees of related patents has long been recognized as one of
the concerns behind the doctrine of double patenting.”).
In re Hubbell, 709 F.3d 1140, 1145 (Fed. Cir. 2013).
Current Office guidance instructs examiners to consider both
rationales when making OTDP rejections. 	See MPEP § 804(II)(B). As
spelled out in that guidance, “[a] rejection based on nonstatutory double
patenting is based on a judicially created doctrine grounded in public policy
so as to prevent the unjustified or improper timewise extension of the right
to exclude granted by a patent.” 	Id. (citing precedents). Moreover, the
guidance states, “[a] double patenting rejection also serves public policy
interests by preventing the possibility of multiple suits against an accused
infringer by different assignees of patents claiming patentably indistinct
variations of the same invention.” 	Id. (citing precedents).
And, to address both rationales, when an applicant files a terminal
disclaimer to overcome OTDP rejections, the Office’s rules specify that such
disclaimer must also include a common-ownership provision. 37 C.F.R.
§ 1.321(c). More specifically, the Office requires a terminal disclaimer to
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include a provision that any patent granted on the subject application “shall
be enforceable only for and during such period that said patent is commonly
owned with the application or patent which formed the basis for the
judicially created double patenting.” Id. at § 1.321(c)(3); see also In re Van
Ornum, 686 F.2d 937, 944–48 (CCPA 1982) (approving common-ownership
requirement under 37 C.F.R. § 1.321); In re Griswold, 365 F.2d 834, 840 n.5
(CCPA 1966) (noting the common-ownership requirement was “an
imaginative solution to one of the more theoretical objections to double
patenting, split ownership of two patents and potential harassment”).
The Examiner cited the risk of separate ownership and the anti-
harassment rationale as support for the OTDP rejections on appeal, but the
Board dismissed that rationale as immaterial. Final Act. 7–8; Reh’g Req.
10–12. According to the Board, “a risk of separate ownership . . . is
immaterial where the ’922 patent is not a proper nonstatutory double
patenting reference.” Appeal Dec. 10 n.6. In the Board’s view, the anti-
harassment rationale does not independently support an OTDP rejection and
plays, at most, only a supporting role when the first rationale—improper
term extension—is present. Reh’g Dec. 16–22 (rejecting proposition that
the anti-harassment rationale “is a stand-alone justification” for upholding
the OTDP rejections).
To demonstrate the real-world concern associated with the anti-
harassment rationale, consider (for example) a hypothetical licensee to the
’922 patent. Such a licensee might legitimately believe that it has the full
permission of the patent owner to practice the technology disclosed and
claimed in the ’922 patent, but if the ’529 Application should issue as a
patent, such licensee will need to obtain a new license from the patent owner
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of the ’922 patent as that owner would also own the results of the
’529 Application. Worse still, if the current owner of the ’922 patent should
sell the rights to the pending ’529 Application, licensees of the ’922 patent
would have to negotiate with an entirely different entity.
We conclude that the Board erred in dismissing the anti-harassment
rationale as inadequate to support the Examiner’s OTDP rejections. The
Federal Circuit has repeatedly recognized the anti-harassment rationale as a
policy justification underpinning the OTDP doctrine and, applying that law
here, we are compelled to reverse the Board and sustain the rejections for
OTDP on appeal.
The Federal Circuit has invoked the anti-harassment rationale and
endorsed the Office’s rules designed to address it, even where there was no
evident term extension concern. In Fallaux, for example, after remarking
that “[i]t is true that the unjustified patent term extension justification for
obviousness-type double patenting has limited force in this case,” the court
turned to “a second justification for obviousness-type double patenting—
harassment by multiple assignees.” Fallaux, 564 F.3d at 1318–19 (affirming
the Board and OTDP rejections on appeal). Indeed, the court explained, the
“harassment justification . . . is particularly pertinent here because the
Fallaux application and the [reference] patents are not commonly owned,”
noting “this defect was of the applicant’s creation” due to assignments that
split ownership between different entities. Id. at 1319. The appealed claims
in Fallaux had an earlier patent term filing date and earlier expiration date
compared to the reference patent’s respective patent term filing and
expiration dates—much like the claims of the ’529 Application and the
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’922 patent at issue before us. Id. at 1315. Thus, as in this case, improper
timewise extension of patent term was absent in Fallaux.
Four years later, the court revisited and “reaffirmed” the anti-
harassment rationale as underpinning the OTDP doctrine. Hubbell, 709 F.3d
at 1147 (explaining “in Fallaux, this court reaffirmed the multiple assignee
harassment rationale and applied it to a situation where, as here, the patents
were related to the application only by way of a common inventor”).
Although the main dispute in Hubbell was whether OTDP rejections could
be sustained where the application and reference patent were not commonly
owned and shared only partial overlap in named inventors, the court
repeatedly invoked the anti-harassment rationale in affirming the Board. 	Id.
at 1147–48 (finding “if Hubbell’s rejected application claims were to issue,
the potential for harassment by multiple assignees would exist” because an
infringer of the reference claims would also infringe the pending claims and,
thus, “the multiple assignee harassment justification adopted in Van Ornum
and reaffirmed in Fallaux applies here”). And, like Fallaux, improper term
extension was not an identified concern given the respective patent term
filing dates and apparent expiration dates for the appealed and reference
claims. 	See id. at 1142–43 n.1–2.
More recently, in Cellect, the court identified the risk of separate
ownership as a reason to uphold the Office’s OTDP rejections. Indeed, the
court seemingly accepted the Office’s argument that a terminal disclaimer
ensuring continued common ownership would have been required to
overcome OTDP rejections “even if the patents had the same expiration
date.” 	Cellect, 81 F.4th at 1229. Although term extension issues were
manifest in Cellect as the relevant patents did not share expiration dates, the
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court “also agree[d] with the USPTO that the Board did not err in
determining that a risk of separate ownership existed and, even in the
absence of separate ownership, that a terminal disclaimer would have been
required to ensure common ownership.” 	Id. at 1230 (agreeing the risk of
divided ownership and separate lawsuits existed despite patentee’s argument
that it had not and would not split ownership of the patents, explaining
“[p]romises do not substitute for sound applications of rules of law”). Here
again, the court recognized the anti-harassment rationale behind the OTDP
doctrine. 	Id.
Given the foregoing precedents, we disagree with the Board’s
characterization of the anti-harassment rationale as “immaterial” and its
attempt to brush aside decisions applying that rationale as mere “dicta.” 	See
Appeal Dec. 10 n.6; Reh’g Dec. 16–23. As explained above, in at least
Fallaux and Hubbell, there was no apparent term extension concern and no
asserted rationale based on it—the OTDP rejections were premised on later-
filed and later-expiring reference patents.7 Yet the Federal Circuit, citing
7 The Board suggests improper term extension was at issue in Hubbell, but
that is incorrect. Reh’g Dec. 17. According to the Board, “[i]n Hubbell,
there was no dispute that the reference patent [with species claims], which
was filed post-URAA, was filed prior to the application at issue [with genus
claims].” Id. Thus, the Board concluded “there can be no dispute that the
issuance of genus claim of the application would extend the term of the
reference patent species claim.” Id. The Board is mistaken. The flaw in the
Board’s reasoning is its reliance on and comparison of actual filing dates,
not patent term filing dates for determining the terms. Comparing patent
term filing dates, the term of the rejected genus claim (with an earlier patent
term filing date) would end before the term of the reference species claim
(with a later patent term filing date) and, therefore, the species claim’s term
was not extended. 	Hubbell, 709 F.3d at 1142–43 n.1, n.2.
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the anti-harassment rationale, affirmed the Office’s OTDP rejections all the
same. Although we note the Board’s (and Appellant’s) attempts to dismiss
Fallaux and Hubbell, the notion that the court’s discussion of the anti-
harassment rationale in those cases is dicta would mean that the rejections
were affirmed for no underlying OTDP rationale at all. 	See ARP Br. 9–10;
see Brief for Prof. Mark A. Lemley and Prof. Lisa Larrimore Ouellette as
Amici Curiae in Support of Examiner, p. 5, Appeal 2024-002920 (PTAB
Nov. 8, 2024).
If, contrary to our conclusion here, the Federal Circuit’s precedents
should not be read as permitting OTDP rejections based on the anti-
harassment rationale where no term-extension concern is apparent, the
Office would welcome that clarification from the court. Indeed, the issue is
now before the court in In re: Ablynx N.V., Appeal No. 26–1333 (sub nom
Ex parte Baumeister). See Ex parte Baumeister, 2025 WL 3515282 at *10
(PTAB Nov. 20, 2025) (determining that Van Ornum, Fallaux, and related
progeny supported the examiner’s OTDP rejection, and rejecting appellant’s
argument that those precedents were “wrongly decided” because the “Board
is not the proper venue to address this argument”); see also id. at *5
(determining that “Fallaux remains good law” and rejecting appellant’s
argument “that the reference patents do not qualify as [OTDP] references
because they each have a later patent term filing date compared to the instant
application and expires later than any patent issuing from the instant
application”).
C. A Future Framework for OTDP at the USPTO
We reverse the Board’s determination and sustain the Examiner’s
rejections for OTDP for the reasons discussed above, applying existing
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precedents as we understand them. Nonetheless, the ARP also takes this
opportunity to provide our thoughts about the continued significance of
examining for OTDP at the Office, and to propose a possible framework for
an approach to OTDP that is reasonably administrable by examiners and
more predictable to our stakeholders, should the Federal Circuit clarify that
OTDP rejections cannot be based solely on the anti-harassment rationale.
The proposed framework acknowledges the precedents and the policy
justifications behind the OTDP doctrine while endeavoring to apply the
doctrine in a way that avoids harm to existing and future innovation
identified by amici.
1. Whether Examination for OTDP Remains
Necessary
If the primary policy justification for the OTDP doctrine is the
improper timewise extension of a first patent’s term of exclusivity arising
from a later-filed second patent covering obvious variants of the subject
matter claimed in the first patent, it must be acknowledged that this policy
justification plays a diminished role following the passage of the URAA.
That law, effective June 8, 1995, changed patent term from seventeen years
from a patent’s issuance to a twenty-year patent term that begins to run from
the patent’s earliest claimed priority date. See 35 U.S.C. § 154(a). By tying
the putative expiration date of related patents to a single common filing date,
that change in the law curbed abuses in continuation practices where,
previously, related applications claiming essentially the same subject matter
might be filed seriatim with each newly-issued patent getting a new 17-year
term—effectively extending the patent monopoly well beyond the original
life of the first-issued patent. 	Boehringer Ingelheim Int’l GmbH v. Barr
Labs., Inc., 592 F.3d 1340, 1346 (Fed. Cir. 2010) (“The doctrine of
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obviousness-type double patenting is an important check on improper
extension of patent rights through the use of divisional and continuation
applications, at least for patents issued from applications filed prior to the
amendment of 35 U.S.C. § 154 to create twenty-year terms running from the
date of the earliest related application.”).
The Federal Circuit has acknowledged that the URAA mitigated
concerns about improper term extension as forming a basis for the rejection
or invalidation of claims for OTDP. In Fallaux, for example, the court noted
the “limited force” the patent term extension justification holds for post-
URAA patents, explaining “this is surely true of many double patenting
rejections today, in no small part because of the change in the Patent Act
from a patent term of seventeen years from issuance to a term of twenty
years from filing.” Fallaux, 564 F.3d at 1318. So too in Allergan, where the
court noted that “[i]n many cases . . . post-URAA, there is little risk of an
unjustified extension of term subject to [OTDP] because all patents to an
invention that share a priority date are expected to expire on the same day.”
Allergan, 111 F.4th at 1367.
At the same time, the court has also recognized that the OTDP
doctrine is still important, even for post-URAA patents. Abbvie, 764 F.3d at
1373 (“Although this court has recognized that the doctrine of [OTDP] is
less significant in post-URAA patent disputes, we have also recognized its
continued importance.”). OTDP “continues to apply where two patents that
claim the same invention have different expiration dates.” Id. at 1374. This
may happen when the challenged claims and the reference claims are filed as
part of different patent families with different patent term filing dates, such
as in Gilead. See Gilead, 753 F.3d at 1210. There, the court held that an
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earlier-filed and “earlier-expiring patent can qualify as an [OTDP] reference
for a later-expiring patent” regardless of the patents’ respective issue dates.
Id. at 1214–1217 (“Looking instead to the earliest expiration date of all the
patents an inventor has on his invention and its obvious variants best fits and
serves the purpose of the doctrine of double patenting.”).
The court has also held that the OTDP doctrine may apply where a
grant of PTA under 35 U.S.C. § 154(b) causes related patents to have
different expiration dates. Indeed, the court has affirmed rejections for
OTDP when, for instance, two related patents share the same patent term
filing date but a later-issued patent claiming obvious subject matter has, by
reason of awarded PTA, a longer term than an earlier-issued patent with less
or no PTA. 	See Cellect, 81 F.4th at 1219–21 (comparing, e.g., the ’742
patent’s claims with claims of the ’369 reference patent), 1226 (holding a
“crucial purpose of [OTDP] is to prevent an inventor from securing a
second, later-expiring patent for non-distinct claims,” which “purpose
applies equally to situations in which the later patents have received grants
of PTA resulting from examination delays at the USPTO”).8 There are
exceptions, however, as seen in Allergan where a first-filed, first-issued
parent patent that received PTA was not invalidated for OTDP by its later
filed and issued progeny patents that received no PTA. Allergan, 111 F.4th
at 1363–64 (depicting filing, issue, and expiration timeline of related
patents), 1369 (“We therefore hold that a first-filed, first-issued, later-
8 Although OTDP may apply based on different expirations resulting from
the grant of PTA, it cannot be based on different expiration dates arising
from PTE under § 156. 	Novartis, 909 F.3d at 1372 (holding the “judge-
made doctrine” of OTDP should not be used to “cut off a statutorily
authorized time extension” for otherwise validly obtained PTE).
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expiring claim cannot be invalidated by a later-filed, later-issued, earlier-
expiring reference claim having a common priority date.”).
Although improper term extension concerns are less prevalent post-
URAA, we heed the Federal Circuit’s instruction that the OTDP doctrine is
still needed. Accordingly, under the proposed framework, the Office would
continue to review patent applications for potential OTDP. For reasons we
discuss below, however, the ARP is of the view that the Office’s review for
OTDP should be more streamlined, predictable, and, to the extent possible,
aimed at mitigating the term extension issues the court has flagged for post-
URAA patents. Further, and to those ends, the Office’s review should be
based on facts of record known during examination—not speculation about
matters unknown to the Office at that time.
2. Potential Harassment as a Freestanding Rationale
for OTDP Rejections During Examination
Were the Office not bound by the Federal Circuit’s precedents
applying the OTDP anti-harassment rationale, this ARP would clarify that
the risk of separate ownership and hypothetical harassment generally should
not form a standalone basis for OTDP rejections during examination. This is
so because, absent evidence that an applicant/patentee has engaged in
splitting ownership to patents covering obvious variants of the same
invention and that the public has been subject to separate lawsuits on such
patent, the Office is just speculating. And such speculation encumbers
patents with terminal disclaimers including an anti-alienation and anti-
enforcement provision that is premised on contingencies that may never
come to be. As Judge Rich presciently observed nearly sixty-years ago, the
anti-harassment rationale is more theory than real. 	In re Jentoft, 392 F.2d
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633, 641 (CCPA 1968) (remarking “we do not see the courts bogged down
with harassment suits”).
Further, the Office’s grant of a patent without an OTDP rejection or
terminal disclaimer to overcome the rejection would not immunize that
patent from all future challenges. If, in fact, a patentee does split ownership
of multiple patents and facilitate harassment lawsuits, the courts are
empowered to adjudicate validity under the judge-made OTDP doctrine or to
penalize the offending behavior as appropriate. Jentoft, 392 F.2d at 641 (“In
those rare instances where there is a situation which a court can be
persuaded amounts to harassment, it has means for dealing with it by
inflicting the plaintiff with attorney’s fees.”).
There are also policy downsides to sustaining OTDP rejections based
on a freestanding anti-harassment rationale. As many of the amici point out,
allowing later-filed, later-expiring patents to invalidate earlier-filed, earlier-
expiring patents based merely on the possibility of split ownership and
separate infringement lawsuits, discourages follow-on and inter-company
collaborative research and may ultimately harm future innovation. See, e.g.,
Brief for Canon Inc. et al., as Amici Curiae in Support of Appellant, p. 6–10,
Appeal 2024-002920 (PTAB Nov. 8, 2024) (“Canon Br.”); Brief for
Regeneron Pharma., Inc. et al. as Amici Curiae, in Support of Appellant, p.
8–10, Appeal 2024-002920 (PTAB Nov. 8, 2024). Once the OTDP doctrine
is untethered from the term-extension rationale, patents covering
improvements, even if filed years after a foundational patent or application,
might be used to invalidate or reject those foundational innovations—
disincentivizing the discovery and patenting of such improvements. 	See
Canon Br. at 7 (“This creates a backwards-looking OTDP problem that is
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entirely unprecedented” where “the mere act of continuing to innovate by
filing new patent applications that stand on their own could retroactively
threaten the validity of a company’s existing patents.”). If the rule is that
possible harassment is a sufficient rationale on its own, there are few
limiting principles to this OTDP regime. Indeed, where a broad seminal
patent claim is obvious over a “reference” patent claiming an improvement
on that technology (regardless of respective filing or expiration dates), and if
the patents are commonly owned or share even one inventor in common, that
could be enough to reject or invalidate the seminal claim for OTDP.
An example may help illustrate a problem with applying the OTDP
doctrine in this way. Imagine a scenario where inventors Smith, Rogers, and
Jones file a patent application claiming a foundational genus or platform
technology (e.g., nucleic-acid vaccines), which application is assigned to
their employer Acme Corp. Jones then leaves Acme, starts his own
company (Beta Corp.), and two years later with the help of inventor Davis,
develops a method of treating pancreatic cancer with an mRNA vaccine for
which they file a patent application that is assigned to Beta. Assume, for
purposes of this example, that the Acme application is still pending at the
time the Beta application issues as a patent. And further assume the Acme
application claims are obvious over the Beta patent claims, but the Beta
claims are a true improvement and nonobvious over the Acme claims.
Under this example scenario, there is no apparent term-extension
concern if Acme’s patent were to issue—it has an earlier patent term filing
date than Beta’s patent. But, applying the anti-harassment rationale alone,
the Office could properly reject the Acme claims for OTDP. While Acme
may be able to overcome the OTDP rejection by filing a terminal disclaimer,
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the common ownership language in the terminal disclaimer would preclude
Acme from enforcing the patent unless Acme also acquired ownership of the
Beta patent. One might alternatively suggest that Acme could amend its
claims—a paradoxical (if not unfair) position that asks Acme to amend its
foundational discovery to try to avoid a follow-on innovation and, therein, to
give up broader claim scope that it might have otherwise been entitled to had
Beta never filed a patent application on its later-developed technology. In
short, the standalone anti-harassment rationale potentially sets a “trap” with
no viable escape for at least some applicants. See Canon Br. at 8 (explaining
“a later-expiring patent by a co-inventor at a different company could
potentially invalidate an earlier patent, and the earlier patent holder would
have no mechanism to cure the defect”).9
3. 	Rubric for Examination of OTDP at the Office
Under the proposed framework, the Office would continue to examine
for OTDP with an emphasis on the doctrine’s fundamental purpose—
“prevent[ing] an unjustified timewise extension of patent exclusivity beyond
the life of a patent.” Allergan, 111 F.4th at 1367 (describing the avoidance
of improper term extension as the “doctrine’s primary goal”). As discussed
9 This hypothetical scenario is not far removed from the facts of Hubbell,
where four inventors at CalTech filed an application claiming a genus of
proteins with certain domains and two of the inventors subsequently left to
join the faculty at the University of Zurich, where they developed follow-on
technology and filed an application claiming species of the aforementioned
proteins. See Hubbell, 709 F.3d at 1140, 1142–44. The ARP submits that
the dissent in Hubbell seized on something important in recognizing, under
facts such as these, that “[t]his court need not create a new protocol wherein
the contributions of distinct entities and separate ownership are rejected for
‘double patenting’ instead of examined under the established rules.”
Hubbell, 709 F.3d at 1151 (Newman, J., dissenting).
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above, the Federal Circuit has made clear that OTDP can still apply to post-
URAA patents where two patents that claim obvious variants of the same
invention have different expiration dates. 	See, e.g., Abbvie, 764 F.3d at
1374.
Although examiners generally are not instructed to make predictions
about the expiration dates for patents that may issue on the applications they
are reviewing, they need not do so to examine for OTDP consistent with the
doctrine’s primary purpose. 	See Reh’g Req. 6–8 (arguing that predicting
expiration dates involves speculation and is inconsistent with MPEP § 804).
Rather, looking to patent term filing dates, which start the statutory clock on
a patent’s ordinary twenty-year term, can serve as a surrogate for expiration
dates. And examiners already regularly consider and compare patent term
filing dates as part of their review for possible anticipation or obviousness.
The OTDP analysis would thus ask a simple question: Does a putative
OTDP reference have a later patent term filing date than the patent term
filing date of the application under examination? If the answer is “yes,” the
Office’s OTDP analysis under a term-extension rationale for that alleged
reference ends.10 If, alternatively, the reference has an earlier patent term
filing date, the analysis may proceed to a comparison of the claims and, as
appropriate, a rejection for OTDP may be made.
10 In limited instances, such as when the reference’s term is shortened due to
a known terminal disclaimer where the natural twenty-year term of the
claims under examination would extend beyond the reference’s term, the
OTDP inquiry may proceed. When a patent has been granted PTA, thus
extending its known expiration, that may also factor into the analysis. The
focus, however, should be on using known facts of record, not speculation on
unknown matters such as hypothetical future grants of PTA, possible
withdrawal of terminal disclaimers, or potential priority benefit changes.
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The analysis above would be appropriate for applications and/or
patents from different patent families, but does not address what the Office
should do to mitigate term-extension concerns and potential OTDP within a
single family. 	See generally Cellect, 81 F.4th 1216 (affirming OTDP
rejections between members of related family patents). Related patents and
applications that share the same patent term filing date ordinarily should
expire at the same time. However, as cases like Cellect and Allergan make
clear, that is not always true. Applications and patents within the family that
have later actual filing dates can be awarded PTA that extends their term
beyond the term of earlier-filed patents or applications in the family. To the
extent such later-filed applications or patents claim obvious variants of
subject matter claimed in the earlier-filed ancestral applications or patents,
the OTDP policy against improper timewise extension would be implicated.
On the other hand, first- or earlier-filed and issued patents within a
family would not be subject to invalidation or rejection for OTDP by the
later-filed progeny of those patents on the basis of improper term extension.
As the Federal Circuit held in Allergan, “the first-filed, first-issued patent in
its family . . . is the patent that sets the maximum period of exclusivity for
the claimed subject matter and any patentably indistinct variants.” Allergan,
111 F.4th at 1369–70 (citing Novartis, 909 F.3d at 1374 (noting that “the
traditional concern with obviousness-type double patenting” is not raised
where “it is the earlier-filed, earlier issued . . . patent, not the later-filed,
later-issued . . . patent, that has the later expiration date”)). Thus, in keeping
with the Federal Circuit’s reasoning, when examining for OTDP within the
same patent family, the Office would focus on actual filing dates (and issue
dates, if known, as applicable). Applications with later actual filing dates
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can be rejected for OTDP over their earlier-filed parent applications or
patents within the family, but such rejections would not work in reverse.
This approach would better ensure that later-filed patents will not have a
term that extends longer than their parent patents claiming substantially the
same innovation.11
Finally, we suggest that the standalone anti-harassment rationale
should be, if not abandoned as part of examination at the Office as detailed
above, at least circumscribed in some ways to mitigate unfairness to
applicants and downstream harms to innovation. One option would be to
require actual evidence of previous ownership splitting and harassment
resulting from the conduct of a particular applicant before the anti-
harassment rationale could be wielded on its own against that applicant as a
basis for OTDP rejections. That an applicant might get caught facilitating
such conduct and thereby suffer the consequences in future dealings with the
Office would, we expect, act as a deterrent. Another option is requiring the
examiner to establish the obviousness of the challenged claims and reference
claims over each other—essentially a two-way test—before a standalone
anti-harassment rationale could form the basis for OTDP at the Office.
Historically, that test has been reserved for rare circumstances, especially
aimed at pre-URAA patents, where the Office was solely responsible for
delays that caused an applicant’s follow-on patent to be issued before an
earlier-filed application. 	See In re Berg, 140 F.3d 1428, 1437 (Fed. Cir.
11 Absent a change or clarification in the law by the Federal Circuit, if the
anti-harassment rationale is sufficient on its own, the Office will continue to
examine for OTDP across or within families of patents regardless of the
respective actual or patent term filing dates.
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1998). But it could be appropriate to address the departed inventor “trap”
scenario discussed above and circumstances in which the reference claims
and the challenged claims do not stem from common ownership or a
complete overlap in inventors, giving applicants a fairer and more realistic
means of overcoming the rejection. 	See Hubbell, 709 F.3d at 1152
(Newman, J., dissenting) (explaining that although OTDP has evolved, it has
“never departed from the requirement of either common inventorship or
common ownership, and never departed from the available remedy of
terminal disclaimer”). In other words, the Office would ask whether a third-
party application would issue as a patent under the same circumstances and,
if so, would not reject the claims for OTDP. Whether the Office might
pursue such options, however, is contingent on further guidance from the
Federal Circuit about the reach of the anti-harassment rationale.
IV. 	CONCLUSION
For reasons discussed above, we reverse the Board’s Appeal Decision
and Rehearing Decision. The Examiner’s rejections of record for
obviousness-type double patenting, therefore, are affirmed.
V. 	GUIDANCE TO USPTO PERSONNEL ON APPLYING
ALLERGAN
Finally, we take this opportunity to provide guidance to USPTO
personnel on how the Office will apply Allergan at this time. USPTO
personnel should continue to follow existing pre-Allergan OTDP practice
discussed in MPEP § 804 unless a determination is made that the holding of
Allergan applies because (1) the application (or patent under reexamination)
and the OTDP reference are in the same family and have the same patent
term filing date, and (2) the claims under examination are first-filed, first-
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issued, and later-expiring. In this context, consistent with Allergan, a first-
filed, first-issued claim is a claim present in a patent that has the first actual
filing date and the first issue date of all the patents in that family. This can
arise in reexamination of a patent or in an application for reissue. It will
rarely, if ever, arise in original examination because a patent examiner will
rarely, if ever, be in a position to determine that the claims under
examination will be first-filed, first-issued, and later-expiring claims.
32

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1–18 	Nonstatutory Double Patenting: US
Patent 11,192,960, Klein
1–18
1–18 	Provisional Nonstatutory Double
Patenting: US Patent Application
18/183,107, Klein
1–18
Overall
Outcome
1–18
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l.136(a)(l)(iv).
34

OCR transcription for search; preserved printed pages are authoritative

UNITED STATES PATENT AND TRADEMARK OFSI
DEPARTMENT OF COMMERCE

# UNITED STATES PATENT AND TRADEMARK OFFICE

UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov

APPLICATION NO.

FILING DATE

FIRST NAMED INVENTOR

ATTORNEY DOCKET NO.

CONFIRMATION NO.

17/135,529

12/28/2020

Nicolas Baurin

S2325.70000US02

5010

159933

7590

08/10/2026
Sanofi (Bioverativ/Ablynx/Pasteur)/Wolf
c/o Wolf, Greenfield & Sacks, P.C.
600 Atlantic Avenue
Boston, MA 02210-2206

EXAMINER

WU, JULIE ZHEN QIN

ART UNIT

PAPER NUMBER

1643

NOTIFICATION DATE

DELIVERY MODE

08/10/2026

ELECTRONIC

Please find below and/or attached an Office communication concerning this application or proceeding.

The time period for reply, if any, is set in the attached communication.

Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
B1553_eOfficeAction@WolfGreenfield.com
Patents_eOfficeAction@WolfGreenfield.com

SUNT AND TRAINER OF
DEPARTMENT OF COMMERCE

# UNITED STATES PATENT AND TRADEMARK OFFICE

## BEFORE THE APPEALS REVIEW PANEL OF THE PATENT TRIAL AND APPEAL BOARD

Ex parte NICOLAS BAURIN, CHRISTIAN BEIL, CARSTEN CORVEY,
CHRISTIAN LANGE, DANXI LI, VINCENT MIKOL,
ANKE STEINMETZ, and ERCOLE RAO

Appeal 2024-002920
Application 17/135,529
Technology Center 1600

Before JOHN A. SQUIRES, Under Secretary of Commerce for Intellectual
Property and Director of the United States Patent and Trademark Office,
KALYAN K. DESHPANDE, Chief Administrative Patent Judge, and
MICHELLE N. ANKENBRAND, Acting Deputy Chief Administrative
Patent Judge.

SQUIRES, Under Secretary of Commerce for Intellectual Property and
Director of the United States Patent and Trademark Office.

## DECISION ON SUA SPONTE REHEARING

### I. INTRODUCTION

This Appeals Review Panel ("ARP") was convened to review the
Board's Decision on Appeal ("Dec." or "Appeal Decision") and Decision on
Request for Rehearing ("Reh'g Dec." or "Rehearing Decision"), with
particular focus on the Board's reversal of the Examiner's rejections of
claims 1-18 for nonstatutory double patenting, also known as obviousness-

Appeal 2024-002920
Application 17/135,529

type double patenting ("OTDP"). We have jurisdiction under 35 U.S.C.
§ 6(b).

On review, we REVERSE.

### II. BACKGROUND

#### A. Procedural History

On November 8, 2024, the Board issued an Appeal Decision reversing
the Examiner's rejections for OTDP.1 On January 3, 2025, the Examiner
filed a Request for Rehearing ("Req. Reh'g") under MPEP § 1214.04. On
December 18, 2025, the Board issued a Rehearing Decision, which included
a dissenting opinion.

On March 5, 2026, I convened this Appeals Review Panel ("ARP")2
and granted sua sponte rehearing to review the Board's Appeal Decision and
Rehearing Decision. See ARP Order, dated Mar. 5, 2026 ("ARP Order"). In
the ARP Order, we authorized further briefing from Appellant. ARP Order
2. We also permitted briefing from amici curiae. Id.

The ARP Order indicated that Appellant and amici should consider
addressing the following three questions: (1) whether Allergan USA, Inc. v.

1 The Appeal Decision reversed six OTDP rejections based on each of the
following reference patents or patent applications in combination with
US 2009/0162359 A1 ("Klein"): (i) Patent 10,882,922 B2 ("the '922
patent"), (ii) Patent 11,186,649 B2, (iii) Patent 11,530,268 B2, (iv) Patent
11,613,576 B2, (v) Patent 11,192,960 B2, and (vi) Application 18/183,107
(now Patent 12,227,573 B2). Appeal Dec. 3-4, 11. The Appeal Decision
focused on the rejection involving the combination of Klein and the '922
patent, and noted that all of the rejections involved the same determinative
issue. Id. at 4. We likewise focus our discussion on the OTDP rejection
involving the combination of Klein and the '922 patent.

2 See Appeals Review Panel § 1, available at https://www.uspto.gov
/patents/ptab/appeals-review-panel.

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MSN Laboratories Private Ltd., 111 F.4th 1358 (Fed. Cir. 2024), applies to
the facts of this appeal and what constitutes "first-filed" for OTDP purposes
under facts different than presented in Allergan; (2) whether examiners
should determine projected expiration dates when making rejections for
OTDP during prosecution; and (3) whether the risk of separate ownership
and preventing potential harassment by separate owners of claims to obvious
variants of an invention is an independent basis that supports an OTDP
rejection during prosecution. ARP Order 2.

The Office received Appellant's additional briefing ("ARP Brief" or
"ARP Br.") on March 27, 2026, and received eleven briefs from amici,
which were entered into the prosecution record on April 1, 2026.

On August 6, 2026, an Order changing the ARP panel was entered.
B. Undisputed Matters

The '529 Application at issue in this case was filed December 28,
2020. Appeal Dec. 6. The '529 Application, through intervening
continuation applications, claims the priority benefit of a non-provisional
application (US Application No. 13/433,033) filed March 28, 2012. Id. at 5.
Thus, the term of any patent issued on the '529 Application will expire on
March 28, 2032-twenty years from the patent term filing date3-absent
other factors that may affect patent term.4 Appeal Dec. 5-7.

3 Patent term filing date refers to the filing date that begins the running of the
term. This date generally is the filing date of the first U.S. application to
which the patent claims priority (i.e., it excludes priority claims to foreign or
provisional applications). 35 U.S.C. § 154(a)(2).

4 Appellant has acknowledged that, in view of existing terminal disclaimers
over two other patents, any patent issuing on the '529 Application could not
expire later than March 28, 2032, the same as its natural term expiration.
Appeal Br. 10-11.

The '922 patent, asserted here as an OTDP reference, has an actual
and patent term filing date of April 13, 2017. The '922 patent issued
January 5, 2021. Its twenty-year term ends April 13, 2037, and it received
an additional 70 days for patent term adjustment.

The '529 Application and the '922 patent are, at present, commonly
owned by Appellant Sanofi and share several common inventors (Christian
Beil, Ercole Rao, Christian Lange, and Carsten Corvey).

The Examiner determined that "[t]here is no dispute regarding
Appellant's analysis of the patent term filing date." Ans. 11.

The claims on appeal relate to an antibody-like binding protein with
certain characteristics. Appeal Br. 50 (Claims Appendix). The Examiner
found, with no counterargument from Appellant, that pending claims 1-18
would have been obvious over claims 1-39 of the '922 patent in further view
of Klein. Ans. 3-4. Appellant argued and the Examiner acknowledged,
however, that the claims of the '922 patent would not have been obvious
over the '529 Application's disclosure (as published). Appeal Br. 16;
Ans. 12.

#### C. Double Patenting History

To provide additional context for our decision, we first set forth a
history of the prohibition against double patenting, which is grounded in
statutory language extending back to the earliest patent statutes.

##### 1. Statutory Basis of the Prohibition Against Double Patenting

The prohibition against double patenting is firmly rooted in the text of
the Patent Act. Section 101 of the statute provides that applicants "may
obtain a patent"' on their inventions. See 35 U.S.C. § 101 (emphasis added).
Similar language has existed in every patent statute in U.S. history. See

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Patent Act of 1790, § 1, 1 Stat. 109, 110 (codifying "that a patent may be
granted" on an applicant's invention) (emphasis added); Patent Act of 1793,
§ 1, 1 Stat. 318, 320 (same); Patent Act of 1836, § 6, 5 Stat. 117, 119
(authorizing the Commissioner of Patents to "grant a patent" on each new
invention) (emphasis added); Patent Act of 1870, § 24, 18 Stat. 198, 201
(authorizing applicants to "obtain a patent" on an invention) (emphasis
added). The use of the singular-"a patent"-signals that, by statute, only a
single patent is allowed on each invention. Thus, the basic prohibition
against double patenting has long been grounded in the text of our country's
Patent Acts.

Importantly, the prohibition against double patenting has also long
extended to prohibit multiple patents on trivial variations of the same
invention. As the Supreme Court held in Miller v. Eagle Mfg. Co., 151 U.S.
186, 198 (1894), "no patent can issue for an invention actually covered by a
former patent, especially to the same patentee, although the terms of the
claims may differ." See also McCreary v. Pa. Canal Co., 141 U.S. 459, 467
(1891) (stating that a second patent containing only a "colorable variation"
from a first would be void because "a patentee cannot take out two patents
for the same invention"). Thus, trivial variations of the claim language do
not remove a patent from the prohibition on double patenting of the same
invention.

That additional rule is, in modern caselaw, frequently and accurately
described as a prohibition on "obviousness-type double patenting." While
this rule has sometimes been called a judicially-created doctrine, the rule is
also well-grounded in the statute. The statutory language in current § 101 of
the Patent Act states that "a patent" may be awarded to "[w]hoever invents

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or discovers" new technology. See 35 U.S.C. §101. Invention and
discovery are expressly defined in the Patent Act to be synonyms, see 35
U.S.C. § 100(a) (defining "invention" to mean "invention or discovery"),
and since at least 1793, some class of trivial variations are not considered to
constitute a patentable in vention or discovery. See Patent Act of 1793, § 2, 1
Stat. at 321 (declaring that "simply changing the form or the proportions of
any machine, or composition of matter, in any degree, shall not be deemed a
discovery" for purposes of patent law); see also Hotchkiss v. Greenwood,
52 U.S. 248, 267 (1851) (holding that technological changes reflecting
merely "the skill and ingenuity . . . possessed by an ordinary mechanic
acquainted with the business" lack "that degree of skill and ingenuity which
constitute essential elements of every invention"). Ever since 1952, the class
of trivial variations of existing technology that are not patentable are
described as those "obvious" to a person having ordinary skill in the relevant
art. See 35 U.S.C. § 103.

At its core, the longstanding doctrine against double patenting reflects
the basic patent-law bargain: in exchange for a limitedright to exclude, the
inventor discloses the invention to the public, and the public receives the
right to practice that in vention when the patent expires. Singer Mfg. Co. v.
June Mfg. Co., 163 U.S. 169, 185 (1896). Further, as the Supreme Court
explained well over a century ago, "the power to create a monopoly is
exhausted by the first patent, and . . . a new and later patent for the same
invention would operate to extend or prolong the monopoly beyond the
period allowed by law." Miller, 151 U.S. at 198 (emphasis added).

Although the ban on double patenting may have been viewed as
absolute in the nineteenth and early twentieth century, Congress in the 1952

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enacted § 253 of the Patent Act, which included a provision authorizing
patentees to "disclaim" the "terminal" part of a patent term. Patent Act of
1952, § 253 66 Stat. 792, 809 (1952) (second paragraph); see also 35 U.S.C.
§ 253(b) (modern codification). Contemporaneous commentary read that
provision as providing a potential "cure" for some double patenting
problems, and such commentary can provide an indication of the original
public meaning of the statute. Within a dozen years, the Federal Circuit's
predecessor court, the Court of Customs and Patent Appeals ("CCPA"),
permitted terminal disclaimers to overcome at least some double patenting
objections raised during patent prosecution. See In re Robeson, 331 F.2d
610 (CCPA 1964). As the court noted, "when the right to exclude granted
by a patent expires at the end of the patent term, the public shall be free to
use the invention as well as obvious modifications thereof or obvious
improvements thereon." Id. at 614. A terminal disclaimer could vindicate
that policy by ensuring that any subsequent patents on obvious modifications
of a first-issued patent expired at the same time as the first patent.

Since the early 1970s, to overcome an OTDP rejection, agency
regulations have required a terminal disclaimer both to disclaim any term
extending beyond the expiration of a related patent and to identify and
maintain common ownership. See 37 C.F.R. § 1.321(c) (1971). Indeed, a
"terminal disclaimer precludes any extension" of patent term because "the
second patent expires simultaneously with the first, [and] the right to fully
utilize the patented discovery at the expiration date remains unimpaired."
Robeson, 331 F.2d at 614.

##### 2. An Important Limitation on the Prohibition against Double Patenting

The Supreme Court in Miller also set forth a logical limitation on the
prohibition on double patenting. The Court observed "that where the second
patent covers matter described in the prior patent, essentially distinct and
separable from the in vention covered thereby, and claims made thereunder,
its validity may be sustained." 151 U.S. at 198. This passage is correctly
read as vindicating another fundamental part of the Patent Act: Any
patentably distinct inventive "improvement" on basic technology is itself
patentable in a subsequent patent. See 35 U.S.C. § 101 (expressly allowing
patents on any "new and useful improvement").5 A new patent on a
nonobvious improvement on previously patented technology does not
violate the prohibition against double patenting, and that remains true even if
the inventors and owners of the first and second patents are the same.
Encouraging nonobvious improvements on existing technology is an
important part of the patent system, and the inventors of a basic technology
are often well positioned to develop patentable improvements on that
technology.

##### 3. OTDP Before the Uruguay Round Agreements Act (URAA)

Before the URAA was enacted in 1994, a patent's term ran seventeen
years from its issuance. URAA, Pub.L. 103-465, 108 Stat. 4809. Under
that pre-URAA framework, issuance date and expiration date were closely

5 Further to this point on improvements, the statutory definition of "process"
means "process, art or method, and includes a new use of a known process,
machine, manufacture, composition of matter, or material." 35 U.S.C.
§ 100(b) (emphasis added).

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linked-a later-issued patent generally expired later. Courts, therefore, often
framed OTDP concerns as arising from a "second" or "later-issued" patent
because that "second" patent was ordinarily the one that threatened to extend
the patentee's term of exclusivity already set by a first or earlier-issued
patent.

The pre-URAA focus on issue date reflected the mechanics of patent
term at the time. A later-issued patent on the same invention or an obvious
variant could prolong the patentee's right to exclude after the first patent
expired. Thus, the caselaw described OTDP as a doctrine aimed at
preventing an unjustified timewise extension of patent rights due to the grant
of a second-issued patent. For example, in In re Schneller, 397 F.2d 350,
354 (CCPA 1968), the court stated that "[t]he fundamental reason for the
rule [of OTDP] is to prevent unjustified timewise extension of the right to
exclude granted by a patent." The same rationale informed the Federal
Circuit's early OTDP cases, where the central concern was an improper
extension of exclusivity through claims that were not patentably distinct.
See, e.g., In re Longi, 759 F.2d 887, 892 (Fed. Cir. 1985).

### 4. OTDP After URAA

The URAA changed the patent-term framework by setting patent term
to twenty years from the earliest effective filing date. 35 U.S.C. § 154(a)(2).
After that change, issuance date no longer predicted expiration date. That is,
a later-issued patent may expire earlier, and an earlier-issued patent may
expire later. Nonetheless, in Gilead Sciences, Inc. v. Natco Pharma Ltd.,
753 F.3d 1208, 1217 (Fed. Cir. 2014), the court recognized the continued
importance of the OTDP doctrine post-URAA, and held that a later-issued,
but earlier-expiring patent could serve as an OTDP reference against an

earlier-issued but later-expiring patent. Then, in Abbvie Inc. v. Mathilda &
Terence Kennedy Inst. of Rheumatology Tr., 764 F.3d 1366, 1374 (Fed. Cir.
2014), the court made "explicit what was implicit in Gilead: the doctrine of
[OTDP] continues to apply where two patents that claim the same invention
have different expiration dates."

### 5. Modern OTDP Analysis

More recent Federal Circuit decisions show that expiration date plays
a central role in the OTDP analysis, but does not operate as an absolute rule.
The modern OTDP inquiry considers not only which patent expires first, but
also why the patents have different expiration dates. For example, the court
has treated patent term adjustment ("PTA") and patent term extension
("PTE") differently when analyzing OTDP. See Novartis AG v. Ezra
Ventures LLC, 909 F.3d 1367, 1373 (Fed. Cir. 2018) (holding OTDP does
not invalidate a validly obtained PTE); In re Cellect, 81 F.4th 1216, 1229
(Fed. Cir. 2023) (holding OTDP is based on patent expiration dates after
PTA is added).

In 2024, the Federal Circuit's Allergan decision further refined the
expiration-date inquiry behind OTDP, and cautioned against an overly
mechanical analysis. In Allergan, the challenged patent was the first-filed
and first-issued patent in a family, but due to PTA, it would expire after two
later-filed continuation patents that were being asserted against the parent as
OTDP. Allergan, 111 F.4th at 1363. The court held "that a first-filed, first-
issued, later-expiring claim cannot be invalidated by a later-filed, later-
issued, earlier-expiring reference claim having a common priority date." Id.
at 1369. The court reasoned that "the first-filed, first-issued patent in its
family ... sets the maximum period of exclusivity for the claimed subject

matter and any patentably indistinct variants." Id. In other words, the parent
patent received the full term to which it was statutorily entitled-it did not
create an unjustified timewise extension of the monopoly, and the later-filed,
earlier-expiring continuation patents, therefore, were not properly asserted as
OTDP references against the parent patent. Id.

### 6. Two Rationales for OTDP

As discussed above, the primary and historically dominant rationale
for OTDP is preventing unjustified timewise extension of a patent's term.
Cases such as AbbVie, Gilead, and Allergan focused on whether the
challenged patent improperly extended exclusivity beyond the point at which
the public should be free to practice the invention and obvious variants.

The courts, however, also have recognized a second policy rationale
behind OTDP: preventing harassment from separate lawsuits brought by
multiple assignees asserting patents covering the same invention or obvious
variants thereof (the "anti-harassment rationale"). See, e.g., In re Fallaux,
564 F.3d 1313, 1319 (Fed. Cir. 2009) (stating that "there is a second
justification for obviousness-type double patenting- harassment by multiple
assignees"). We discuss this second rationale in more detail below because
it plays a pivotal role in our decision.

The coexistence of the two recognized rationales for OTDP has
produced tension in the doctrine. Some decisions describe prevention of
unjustified term extension as the doctrine's primary purpose, while others
invoke anti-harassment to sustain OTDP in circumstances where the term-
extension concern is diminished or absent. Compare Allergan, 111 F.4th at
1369 (describing "fundamental purpose[]" of OTDP as avoiding improper
timewise term extension), with Fallaux, 564 F.3d at 1318 (explaining

"unjustified patent term extension justification . . . has limited force in this
case"). The rationales often point in the same direction when patents are
commonly owned and have different expiration dates: a terminal disclaimer
can align both terms. Yet in cases where there is no unjustified term
extension, there remains a broader (and arguably unsettled) doctrinal
question of whether anti-harassment should serve as an independent basis
for OTDP. Having discussed the history, current application, and rationales
for OTDP, we now turn to the case at hand.

### III. ANALYSIS A. Allergan Does not Apply to This Case

We asked Appellant and amici to address whether Allergan applies to
the facts of this appeal and what constitutes "first-filed" for OTDP purposes
under facts different than presented in Allergan. Appellant and most amici
focus on the Federal Circuit's discussion in Allergan about the fundamental
purpose of OTDP, i.e., to prevent patent applicants from effectively
extending the life of a first patent and the relative filing dates of the patent
applications involved in an OTDP analysis, in urging that Allergan applies
broadly. See, e.g., Response to Order Convening Appeals Review Panel and
Granting Sua Sponte Rehearing, 1-3; Brief of Amicus Curiae Amgen Inc. in
Support of Appellant, 2-5.

Although Appellant and the amici arguments are not without merit,
we determine that the OTDP exception Allergan establishes does not apply
to the facts here. The holding in Allergan was that "a first-filed, first-issued,
later-expiring claim cannot be invalidated by a later-filed, later-issued,
earlier-expiring reference claim having a common priority date." Allergan,
111 F.4th at 1369. The "first-filed" prong refers to actual filing dates, as this

is the interpretation that makes best sense in view of the facts of Allergan-
the challenged and reference patents had the same patent term filing date and
there was no suggestion that the conflicting claims had different effective
filing dates. In the present case, the "first-filed" prong is not satisfied
because the '529 Application does not have the first actual filing in its
family, as was the case for the challenged patent in Allergan. Nor does the
'529 Application have an earlier actual filing date than the '922 patent.
With respect to the "first-issued" prong, the claims of the '529 Application
are not "first-issued" because the '529 Application is still pending. The
"common priority date" prong refers to patent term filing dates, see id. at
1363 (explaining that each of the two reference patents "will expire on
March 14, 2025, i.e., twenty years from its priority date"), and this prong is
not satisfied because the '529 Application and the '922 patent have different
patent term filing dates. Thus, Allergan's holding does not apply here.

B. The Board's Decision is Contrary to Binding Federal
Circuit Precedents

We now tum to the Board's decision that the '922 patent could not
serve as an OTDP reference against the claims on appeal. Appeal Dec. 9.
The Board reached its decision not because the claims on appeal are
nonobvious over the '922 patent's claims-it was undisputed that the
appealed claims covered obvious variants of what is claimed in the '922
patent. Id. at 4, 9. Instead, the Board considered decisive that any claims
issuing from the '529 Application on appeal "will have a term that cannot
extend beyond March 28, 2032, which is well before the expiration of the
'922 patent claims [in 2037]." Id. at 6-7. As the Board explained, in typical
OTDP cases, "the reference patent claims ha[ve] an earlier filing date than
the patent against which they were applied," but here "the Examiner is

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applying ... [reference] claims from a second, later-filed application that
was earlier-issued, but would be later expiring than claims that would issue
from the application on appeal." Id. at 8.

The Board in effect found the OTDP doctrine inapplicable where
issuance of the claims on appeal would not raise term-extension concerns.
Because it was undisputed that the earlier-filed, earlier-expiring claims on
appeal would not, if issued, extend the life/term of the later-filed and later-
expiring '922 patent claims, the Board reasoned that the underlying purpose
of the OTDP doctrine was not implicated.6 Id. at 7 (citing Allergan, 111
F.4th at 1369, for the proposition that the "purpose of the non-statutory
double patenting doctrine 'is to prevent patentees from obtaining a second
patent on a patentably indistinct invention to effectively extend the life of a
first patent to that subject matter"); see also Reh'g Dec. 9 (same).

According to the Board, the appealed claims will not produce "a second,
later expiring patent for the same invention as the '922 patent, and as such
do[] not extend a period of exclusivity on the claimed subject matter."

Appeal Dec. 10. Thus, the Board concluded that "the '922 patent claims
cannot serve as reference claims against the claims on appeal" and reversed
the Examiner's OTDP rejection. Id. at 10.

Improper term extension, however, is not the only rationale
underpinning the OTDP doctrine. As discussed above, the anti-harassment

6 The filing dates referred to here by the panel are patent term filing dates
under 35 U.S.C. § 154(a), which the panel also refers to in its decisions as
"effective" filing dates. See Appeal Dec. 9; Reh'g Dec. 3-5. Such dates
may be, but are not necessarily, an application's or patent's actual filing
dates.

rationale is a second justification for the doctrine. As the Federal Circuit has
recognized:

There are two justifications for obviousness-type double
patenting. The first is "to prevent unjustified timewise extension
of the right to exclude granted by a patent no matter how the
extension is brought about." Van Ornum, 686 F.2d at 943-44
(quotation and citation omitted). The second rationale is to
prevent multiple infringement suits by different assignees
asserting essentially the same patented invention. Fallaux, 564
F.3d at 1319 (recognizing that "harassment by multiple
assignees" provides "a second justification for obviousness-type
double patenting"); see also Chisum on Patents § 9.04[2][b][ii]
("The possibility of multiple suits against an infringer by
assignees of related patents has long been recognized as one of
the concerns behind the doctrine of double patenting.").

In re Hubbell, 709 F.3d 1140, 1145 (Fed. Cir. 2013).

Current Office guidance instructs examiners to consider both
rationales when making OTDP rejections. See MPEP § 804(II)(B). As
spelled out in that guidance, "[a] rejection based on nonstatutory double
patenting is based on a judicially created doctrine grounded in public policy
so as to prevent the unjustified or improper timewise extension of the right
to exclude granted by a patent." Id. (citing precedents). Moreover, the
guidance states, "[a] double patenting rejection also serves public policy
interests by preventing the possibility of multiple suits against an accused
infringer by different assignees of patents claiming patentably indistinct
variations of the same invention." Id. (citing precedents).

And, to address both rationales, when an applicant files a terminal
disclaimer to overcome OTDP rejections, the Office's rules specify that such
disclaimer must also include a common-ownership provision. 37 C.F.R.
§ 1.321(c). More specifically, the Office requires a terminal disclaimer to

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include a provision that any patent granted on the subject application "shall
be enforceable only for and during such period that said patent is commonly
owned with the application or patent which formed the basis for the
judicially created double patenting." Id. at § 1.321(c)(3); see also In re Van
Ornum, 686 F.2d 937, 944-48 (CCPA 1982) (approving common-ownership
requirement under 37 C.F.R. § 1.321); In re Griswold, 365 F.2d 834, 840 n.5
(CCPA 1966) (noting the common-ownership requirement was “an
imaginative solution to one of the more theoretical objections to double
patenting, split ownership of two patents and potential harassment").

The Examiner cited the risk of separate ownership and the anti-
harassment rationale as support for the OTDP rejections on appeal, but the
Board dismissed that rationale as immaterial. Final Act. 7-8; Reh'g Req.
10-12. According to the Board, "a risk of separate ownership . . . is

immaterial where the '922 patent is not a proper nonstatutory double
patenting reference." Appeal Dec. 10 n.6. In the Board's view, the anti-
harassment rationale does not independently support an OTDP rejection and
plays, at most, only a supporting role when the first rationale-improper
term extension-is present. Reh'g Dec. 16-22 (rejecting proposition that
the anti-harassment rationale "is a stand-alone justification" for upholding
the OTDP rejections).

To demonstrate the real-world concern associated with the anti-
harassment rationale, consider (for example) a hypothetical licensee to the
'922 patent. Such a licensee might legitimately believe that it has the full
permission of the patent owner to practice the technology disclosed and
claimed in the '922 patent, but if the '529 Application should issue as a
patent, such licensee will need to obtain a new license from the patent owner

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of the '922 patent as that owner would also own the results of the
'529 Application. Worse still, if the current owner of the '922 patent should
sell the rights to the pending '529 Application, licensees of the '922 patent
would have to negotiate with an entirely different entity.

We conclude that the Board erred in dismissing the anti-harassment
rationale as inadequate to support the Examiner's OTDP rejections. The
Federal Circuit has repeatedly recognized the anti-harassment rationale as a
policy justification underpinning the OTDP doctrine and, applying that law
here, we are compelled to reverse the Board and sustain the rejections for
OTDP on appeal.

The Federal Circuit has invoked the anti-harassment rationale and
endorsed the Office's rules designed to address it, even where there was no
evident term extension concern. In Fallaux, for example, after remarking
that "[i]t is true that the unjustified patent term extension justification for
obviousness-type double patenting has limited force in this case," the court
turned to "a second justification for obviousness-type double patenting-
harassment by multiple assignees." Fallaux, 564 F.3d at 1318-19 (affirming
the Board and OTDP rejections on appeal). Indeed, the court explained, the
"harassment justification . . . is particularly pertinent here because the
Fallaux application and the [reference] patents are not commonly owned,"
noting "this defect was of the applicant's creation" due to assignments that
split ownership between different entities. Id. at 1319. The appealed claims
in Fallaux had an earlier patent term filing date and earlier expiration date
compared to the reference patent's respective patent term filing and
expiration dates-much like the claims of the '529 Application and the

'922 patent at issue before us. Id. at 1315. Thus, as in this case, improper
timewise extension of patent term was absent in Fallaux.

Four years later, the court revisited and "reaffirmed" the anti-
harassment rationale as underpinning the OTDP doctrine. Hubbell, 709 F.3d
at 1147 (explaining "in Fallaux, this court reaffirmed the multiple assignee
harassment rationale and applied it to a situation where, as here, the patents
were related to the application only by way of a common inventor").

Although the main dispute in Hubbell was whether OTDP rejections could
be sustained where the application and reference patent were not commonly
owned and shared only partial overlap in named inventors, the court
repeatedly invoked the anti-harassment rationale in affirming the Board. Id.
at 1147-48 (finding "if Hubbell's rejected application claims were to issue,
the potential for harassment by multiple assignees would exist" because an
in fringer of the reference claims would also in fringe the pending claims and,
thus, "the multiple assignee harassment justification adopted in Van Ornum
and reaffirmed in Fallaux applies here"). And, like Fallaux, improper term
extension was not an identified concern given the respective patent term
filing dates and apparent expiration dates for the appealed and reference
claims. See id. at 1142-43 n.1-2.

More recently, in Cellect, the court identified the risk of separate
ownership as a reason to uphold the Office's OTDP rejections. Indeed, the
court seemingly accepted the Office's argument that a terminal disclaimer
ensuring continued common ownership would have been required to
overcome OTDP rejections "even if the patents had the same expiration
date." Cellect, 81 F.4th at 1229. Although term extension issues were
manifest in Cellect as the relevant patents did not share expiration dates, the

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court "also agree[d] with the USPTO that the Board did not err in
determining that a risk of separate ownership existed and, even in the
absence of separate ownership, that a terminal disclaimer would have been
required to ensure common ownership." Id. at 1230 (agreeing the risk of
divided ownership and separate lawsuits existed despite patentee's argument
that it had not and would not split ownership of the patents, explaining
"[p]romises do not substitute for sound applications of rules of law"). Here
again, the court recognized the anti-harassment rationale behind the OTDP
doctrine. Id.

Given the foregoing precedents, we disagree with the Board's
characterization of the anti-harassment rationale as "immaterial" and its
attempt to brush aside decisions applying that rationale as mere "dicta." See
Appeal Dec. 10 n.6; Reh'g Dec. 16-23. As explained above, in at least
Fallaux and Hubbell, there was no apparent term extension concern and no
asserted rationale based on it-the OTDP rejections were premised on later-
filed and later-expiring reference patents.7 Yet the Federal Circuit, citing

7 The Board suggests improper term extension was at issue in Hubbell, but
that is incorrect. Reh'g Dec. 17. According to the Board, "[i]n Hubbell,
there was no dispute that the reference patent [with species claims], which
was filed post-URAA, was filed prior to the application at issue [with genus
claims]." Id. Thus, the Board concluded "there can be no dispute that the
issuance of genus claim of the application would extend the term of the
reference patent species claim." Id. The Board is mistaken. The flaw in the
Board's reasoning is its reliance on and comparison of actual filing dates,
not patentterm filing dates for determining the terms. Comparing patent
term filing dates, the term of the rejected genus claim (with an earlier patent
term filing date) would end before the term of the reference species claim
(with a later patent term filing date) and, therefore, the species claim's term
was not extended. Hubbell, 709 F.3d at 1142-43 n.1, n.2.

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the anti-harassment rationale, affirmed the Office's OTDP rejections all the
same. Although we note the Board's (and Appellant's) attempts to dismiss
Fallaux and Hubbell, the notion that the court's discussion of the anti-
harassment rationale in those cases is dicta would mean that the rejections
were affirmed for no underlying OTDP rationale at all. See ARP Br. 9-10;
see Brief for Prof. Mark A. Lemley and Prof. Lisa Larrimore Ouellette as
Amici Curiae in Support of Examiner, p. 5, Appeal 2024-002920 (PTAB
Nov. 8, 2024).

If, contrary to our conclusion here, the Federal Circuit's precedents
should not be read as permitting OTDP rejections based on the anti-
harassment rationale where no term-extension concern is apparent, the
Office would welcome that clarification from the court. Indeed, the issue is
now before the court in In re: Ablynx N.V., Appeal No. 26-1333 (sub nom
Ex parte Baumeister). See Ex parte Baumeister, 2025 WL 3515282 at *10
(PTAB Nov. 20, 2025) (determining that Van Ornum, Fallaux, and related
progeny supported the examiner's OTDP rejection, and rejecting appellant's
argument that those precedents were "wrongly decided" because the "Board
is not the proper venue to address this argument"); see also id. at *5
(determining that "Fallaux remains good law" and rejecting appellant's
argument "that the reference patents do not qualify as [OTDP] references
because they each have a later patent term filing date compared to the instant
application and expires later than any patent issuing from the instant
application").

#### C. A Future Framework for OTDP at the USPTO

We reverse the Board's determination and sustain the Examiner's
rejections for OTDP for the reasons discussed above, applying existing

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precedents as we understand them. Nonetheless, the ARP also takes this
opportunity to provide our thoughts about the continued significance of
examining for OTDP at the Office, and to propose a possible framework for
an approach to OTDP that is reasonably administrable by examiners and
more predictable to our stakeholders, should the Federal Circuit clarify that
OTDP rejections cannot be based solely on the anti-harassment rationale.
The proposed framework acknowledges the precedents and the policy
justifications behind the OTDP doctrine while endeavoring to apply the
doctrine in a way that avoids harm to existing and future innovation
identified by amici.

##### 1. Whether Examination for OTDP Remains Necessary

If the primary policy justification for the OTDP doctrine is the
improper timewise extension of a first patent's term of exclusivity arising
from a later-filed second patent covering obvious variants of the subject
matter claimed in the first patent, it must be acknowledged that this policy
justification plays a diminished role following the passage of the URAA.
That law, effective June 8, 1995, changed patent term from seventeen years
from a patent's issuance to a twenty-year patent term that begins to run from
the patent's earliest claimed priority date. See 35 U.S.C. § 154(a). By tying
the putative expiration date of related patents to a single common filing date,
that change in the law curbed abuses in continuation practices where,
previously, related applications claiming essentially the same subject matter
might be filed seriatim with each newly-issued patent getting a new 17-year
term-effectively extending the patent monopoly well beyond the original
life of the first-issued patent. Boehringer Ingelheim Int'l GmbH v. Barr
Labs., Inc., 592 F.3d 1340, 1346 (Fed. Cir. 2010) ("The doctrine of

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obviousness-type double patenting is an important check on improper
extension of patent rights through the use of divisional and continuation
applications, at least for patents issued from applications filed prior to the
amendment of 35 U.S.C. § 154 to create twenty-year terms running from the
date of the earliest related application.").

The Federal Circuit has acknowledged that the URAA mitigated
concerns about improper term extension as forming a basis for the rejection
or in validation of claims for OTDP. In Fallaux, for example, the court noted
the "limited force" the patent term extension justification holds for post-
URAA patents, explaining "this is surely true of many double patenting
rejections today, in no small part because of the change in the Patent Act
from a patent term of seventeen years from issuance to a term of twenty
years from filing." Fallaux, 564 F.3d at 1318. So too in Allergan, where the
court noted that "[i]n many cases . . . post-URAA, there is little risk of an
unjustified extension of term subject to [OTDP] because all patents to an
invention that share a priority date are expected to expire on the same day."
Allergan, 111 F.4th at 1367.

At the same time, the court has also recognized that the OTDP
doctrine is still important, even for post-URAA patents. Abbvie, 764 F.3d at
1373 ("Although this court has recognized that the doctrine of [OTDP] is
less significant in post-URAA patent disputes, we have also recognized its
continued importance."). OTDP "continues to apply where two patents that
claim the same invention have different expiration dates." Id. at 1374. This
may happen when the challenged claims and the reference claims are filed as
part of different patent families with different patent term filing dates, such
as in Gilead. See Gilead, 753 F.3d at 1210. There, the court held that an

earlier-filed and "earlier-expiring patent can qualify as an [OTDP] reference
for a later-expiring patent" regardless of the patents' respective issue dates.
Id. at 1214-1217 ("Looking instead to the earliest expiration date of all the
patents an inventor has on his invention and its obvious variants best fits and
serves the purpose of the doctrine of double patenting.").

The court has also held that the OTDP doctrine may apply where a
grant of PTA under 35 U.S.C. § 154(b) causes related patents to have
different expiration dates. Indeed, the court has affirmed rejections for
OTDP when, for instance, two related patents share the same patent term
filing date but a later-issued patent claiming obvious subject matter has, by
reason of awarded PTA, a longer term than an earlier-issued patent with less
or no PTA. See Cellect, 81 F.4th at 1219-21 (comparing, e.g., the '742
patent's claims with claims of the '369 reference patent), 1226 (holding a
"crucial purpose of [OTDP] is to prevent an inventor from securing a
second, later-expiring patent for non-distinct claims," which "purpose
applies equally to situations in which the later patents have received grants
of PTA resulting from examination delays at the USPTO").8 There are
exceptions, however, as seen in Allergan where a first-filed, first-issued
parent patent that received PTA was not invalidated for OTDP by its later
filed and issued progeny patents that received no PTA. Allergan, 111 F.4th
at 1363-64 (depicting filing, issue, and expiration timeline of related
patents), 1369 ("We therefore hold that a first-filed, first-issued, later-

8 Although OTDP may apply based on different expirations resulting from
the grant of PTA, it cannot be based on different expiration dates arising
from PTE under § 156. Novartis, 909 F.3d at 1372 (holding the "judge-
made doctrine" of OTDP should not be used to "cut off a statutorily
authorized time extension" for otherwise validly obtained PTE).

expiring claim cannot be invalidated by a later-filed, later-issued, earlier-
expiring reference claim having a common priority date.").

Although improper term extension concerns are less prevalent post-
URAA, we heed the Federal Circuit's instruction that the OTDP doctrine is
still needed. Accordingly, under the proposed framework, the Office would
continue to review patent applications for potential OTDP. For reasons we
discuss below, however, the ARP is of the view that the Office's review for
OTDP should be more streamlined, predictable, and, to the extent possible,
aimed at mitigating the term extension issues the court has flagged for post-
URAA patents. Further, and to those ends, the Office's review should be
based on facts of record known during examination-not speculation about
matters unknown to the Office at that time.

##### 2. Potential Harassment as a Freestanding Rationale for OTDP Rejections During Examination

Were the Office not bound by the Federal Circuit's precedents
applying the OTDP anti-harassment rationale, this ARP would clarify that
the risk of separate ownership and hypothetical harassment generally should
not form a standalone basis for OTDP rejections during examination. This is
so because, absent evidence that an applicant/patentee has engaged in
splitting ownership to patents covering obvious variants of the same
invention and that the public has been subject to separate lawsuits on such
patent, the Office is just speculating. And such speculation encumbers
patents with terminal disclaimers including an anti-alienation and anti-
enforcement provision that is premised on contingencies that may never
come to be. As Judge Rich presciently observed nearly sixty-years ago, the
anti-harassment rationale is more theory than real. In re Jentoft, 392 F.2d

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633, 641 (CCPA 1968) (remarking “we do not see the courts bogged down
with harassment suits").

Further, the Office's grant of a patent without an OTDP rejection or
terminal disclaimer to overcome the rejection would not immunize that
patent from all future challenges. If, in fact, a patentee does split ownership
of multiple patents and facilitate harassment lawsuits, the courts are
empowered to adjudicate validity under the judge-made OTDP doctrine or to
penalize the offending behavior as appropriate. Jentoft, 392 F.2d at 641 ("In
those rare instances where there is a situation which a court can be
persuaded amounts to harassment, it has means for dealing with it by
inflicting the plaintiff with attorney's fees.").

There are also policy downsides to sustaining OTDP rejections based
on a freestanding anti-harassment rationale. As many of the amici point out,
allowing later-filed, later-expiring patents to in validate earlier-filed, earlier-
expiring patents based merely on the possibility of split ownership and
separate infringement lawsuits, discourages follow-on and inter-company
collaborative research and may ultimately harm future innovation. See, e.g.,
Brief for Canon Inc. et al., as Amici Curiae in Support of Appellant, p. 6-10,
Appeal 2024-002920 (PTAB Nov. 8, 2024) ("Canon Br."); Brief for
Regeneron Pharma., Inc. et al. as Amici Curiae, in Support of Appellant, p.
8-10, Appeal 2024-002920 (PTAB Nov. 8, 2024). Once the OTDP doctrine
is untethered from the term-extension rationale, patents covering
improvements, even if filed years after a foundational patent or application,
might be used to invalidate or reject those foundational innovations-
disincentivizing the discovery and patenting of such improvements. See
Canon Br. at 7 ("This creates a backwards-looking OTDP problem that is

Appeal 2024-002920
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entirely unprecedented" where "the mere act of continuing to innovate by
filing new patent applications that stand on their own could retroactively
threaten the validity of a company's existing patents."). If the rule is that
possible harassment is a sufficient rationale on its own, there are few
limiting principles to this OTDP regime. Indeed, where a broad seminal
patent claim is obvious over a "reference" patent claiming an improvement
on that technology (regardless of respective filing or expiration dates), and if
the patents are commonly owned or share even one inventor in common, that
could be enough to reject or invalidate the seminal claim for OTDP.

An example may help illustrate a problem with applying the OTDP
doctrine in this way. Imagine a scenario where inventors Smith, Rogers, and
Jones file a patent application claiming a foundational genus or platform
technology (e.g., nucleic-acid vaccines), which application is assigned to
their employer Acme Corp. Jones then leaves Acme, starts his own
company (Beta Corp.), and two years later with the help of inventor Davis,
develops a method of treating pancreatic cancer with an mRNA vaccine for
which they file a patent application that is assigned to Beta. Assume, for
purposes of this example, that the Acme application is still pending at the
time the Beta application issues as a patent. And further assume the Acme
application claims are obvious over the Beta patent claims, but the Beta
claims are a true improvement and nonobvious over the Acme claims.

Under this example scenario, there is no apparent term-extension
concern if Acme's patent were to issue-it has an earlier patent term filing
date than Beta's patent. But, applying the anti-harassment rationale alone,
the Office could properly reject the Acme claims for OTDP. While Acme
may be able to overcome the OTDP rejection by filing a terminal disclaimer,

the common ownership language in the terminal disclaimer would preclude
Acme from enforcing the patent unless Acme also acquired ownership of the
Beta patent. One might alternatively suggest that Acme could amend its
claims-a paradoxical (if not unfair) position that asks Acme to amend its
foundational discovery to try to avoid a follow-on innovation and, therein, to
give up broader claim scope that it might have otherwise been entitled to had
Beta never filed a patent application on its later-developed technology. In
short, the standalone anti-harassment rationale potentially sets a "trap" with
no viable escape for at least some applicants. See Canon Br. at 8 (explaining
"a later-expiring patent by a co-inventor at a different company could
potentially invalidate an earlier patent, and the earlier patent holder would
have no mechanism to cure the defect").9

### 3. Rubric for Examination of OTDP at the Office

Under the proposed framework, the Office would continue to examine
for OTDP with an emphasis on the doctrine's fundamental purpose-
"prevent[ing] an unjustified timewise extension of patent exclusivity beyond
the life of a patent." Allergan, 111 F.4th at 1367 (describing the avoidance
of improper term extension as the "doctrine's primary goal"). As discussed

9 This hypothetical scenario is not far removed from the facts of Hubbell,
where four inventors at CalTech filed an application claiming a genus of
proteins with certain domains and two of the inventors subsequently left to
join the faculty at the University of Zurich, where they developed follow-on
technology and filed an application claiming species of the aforementioned
proteins. See Hubbell, 709 F.3d at 1140, 1142-44. The ARP submits that
the dissent in Hubbell seized on something important in recognizing, under
facts such as these, that "[t ]his court need not create a new protocol wherein
the contributions of distinct entities and separate ownership are rejected for
'double patenting' instead of examined under the established rules."
Hubbell, 709 F.3d at 1151 (Newman, J., dissenting).

Appeal 2024-002920
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above, the Federal Circuit has made clear that OTDP can still apply to post-
URAA patents where two patents that claim obvious variants of the same
invention have different expiration dates. See, e.g., Abbvie, 764 F.3d at
1374.

Although examiners generally are not instructed to make predictions
about the expiration dates for patents that may issue on the applications they
are reviewing, they need not do so to examine for OTDP consistent with the
doctrine's primary purpose. See Reh'g Req. 6-8 (arguing that predicting
expiration dates involves speculation and is inconsistent with MPEP § 804).
Rather, looking to patent term filing dates, which start the statutory clock on
a patent's ordinary twenty-year term, can serve as a surrogate for expiration
dates. And examiners already regularly consider and compare patent term
filing dates as part of their review for possible anticipation or obviousness.
The OTDP analysis would thus ask a simple question: Does a putative
OTDP reference have a later patent term filing date than the patent term
filing date of the application under examination? Ifthe answer is "yes," the
Office's OTDP analysis under a term-extension rationale for that alleged
reference ends.1º If, alternatively, the reference has an earlier patent term
filing date, the analysis may proceed to a comparison of the claims and, as
appropriate, a rejection for OTDP may be made.

10 In limited instances, such as when the reference's term is shortened due to
a known terminal disclaimer where the natural twenty-year term of the
claims under examination would extend beyond the reference's term, the
OTDP inquiry may proceed. When a patent has been granted PTA, thus
extending its known expiration, that may also factor into the analysis. The
focus, however, should be on using known facts of record, not speculation on
unknown matters such as hypothetical future grants of PTA, possible
withdrawal of terminal disclaimers, or potential priority benefit changes.

Appeal 2024-002920
Application 17/135,529

The analysis above would be appropriate for applications and/or
patents from different patent families, but does not address what the Office
should do to mitigate term-extension concerns and potential OTDP within a
single family. See generally Cellect, 81 F.4th 1216 (affirming OTDP
rejections between members of related family patents). Related patents and
applications that share the same patent term filing date ordinarily should
expire at the same time. However, as cases like Cellect and Allergan make
clear, that is not always true. Applications and patents within the family that
have later actual filing dates can be awarded PTA that extends their term
beyond the term of earlier-filed patents or applications in the family. To the
extent such later-filed applications or patents claim obvious variants of
subject matter claimed in the earlier-filed ancestral applications or patents,
the OTDP policy against improper timewise extension would be implicated.

On the otherhand, first- or earlier-filed and issued patents within a
family would not be subject to invalidation or rejection for OTDP by the
later-filed progeny of those patents on the basis of improper term extension.
As the Federal Circuit held in Allergan, "the first-filed, first-issued patent in
its family .. . is the patent that sets the maximum period of exclusivity for
the claimed subject matter and any patentably indistinct variants." Allergan,
111 F.4th at 1369-70 (citing Novartis, 909 F.3d at 1374 (noting that "the
traditional concern with obviousness-type double patenting" is not raised
where "it is the earlier-filed, earlier issued . . . patent, not the later-filed,
later-issued ... patent, that has the later expiration date")). Thus, in keeping
with the Federal Circuit's reasoning, when examining for OTDP within the
same patent family, the Office would focus on actual filing dates (and issue
dates, ifknown, as applicable). Applications with later actual filing dates

Appeal 2024-002920
Application 17/135,529

can be rejected for OTDP over their earlier-filed parent applications or
patents within the family, but such rejections would not work in reverse.
This approach would better ensure that later-filed patents will not have a
term that extends longer than their parent patents claiming substantially the
same innovation. 11

Finally, we suggest that the standalone anti-harassment rationale
should be, if not abandoned as part of examination at the Office as detailed
above, at least circumscribed in some ways to mitigate unfairness to
applicants and downstream harms to innovation. One option would be to
require actual evidence of previous ownership splitting and harassment
resulting from the conduct of a particular applicant before the anti-
harassment rationale could be wielded on its own against that applicant as a
basis for OTDP rejections. That an applicant might get caught facilitating
such conduct and thereby suffer the consequences in future dealings with the
Office would, we expect, act as a deterrent. Another option is requiring the
examiner to establish the obviousness of the challenged claims and reference
claims over each other-essentially a two-way test-before a standalone
anti-harassment rationale could form the basis for OTDP at the Office.
Historically, that test has been reserved for rare circumstances, especially
aimed at pre-URAA patents, where the Office was solely responsible for
delays that caused an applicant's follow-on patent to be issued before an
earlier-filed application. See In re Berg, 140 F.3d 1428, 1437 (Fed. Cir.

11 Absent a change or clarification in the law by the Federal Circuit, if the
anti-harassment rationale is sufficient on its own, the Office will continue to
examine for OTDP across or within families of patents regardless of the
respective actual or patent term filing dates.

Appeal 2024-002920
Application 17/135,529

1998). But it could be appropriate to address the departed inventor "trap"
scenario discussed above and circumstances in which the reference claims
and the challenged claims do not stem from common ownership or a
complete overlap in inventors, giving applicants a fairer and more realistic
means of overcoming the rejection. See Hubbell, 709 F.3d at 1152
(Newman, J., dissenting) (explaining that although OTDP has evolved, it has
"never departed from the requirement of either common inventorship or
common ownership, and never departed from the available remedy of
terminal disclaimer"). In other words, the Office would ask whether a third-
party application would issue as a patent under the same circumstances and,
if so, would not reject the claims for OTDP. Whether the Office might
pursue such options, however, is contingent on further guidance from the
Federal Circuit about the reach of the anti-harassment rationale.

## IV. CONCLUSION

For reasons discussed above, we reverse the Board's Appeal Decision
and Rehearing Decision. The Examiner's rejections of record for
obviousness-type double patenting, therefore, are affirmed.

## V. GUIDANCE TO USPTO PERSONNEL ON APPLYING ALLERGAN

Finally, we take this opportunity to provide guidance to USPTO
personnel on how the Office will apply Allergan at this time. USPTO
personnel should continue to follow existing pre-Allergan OTDP practice
discussed in MPEP § 804 unless a determination is made that the holding of
Allergan applies because (1) the application (or patent under reexamination)
and the OTDP reference are in the same family and have the same patent
term filing date, and (2) the claims under examination are first-filed, first-

Appeal 2024-002920
Application 17/135,529

issued, and later-expiring. In this context, consistent with Allergan, a first-
filed, first-issued claim is a claim present in a patent that has the first actual
filing date and the first issue date of all the patents in that family. This can
arise in reexamination of a patent or in an application for reissue. It will
rarely, if ever, arise in original examination because a patent examiner will
rarely, if ever, be in a position to determine that the claims under
examination will be first-filed, first-issued, and later-expiring claims.

## DECISION SUMMARY

### Outcome of Decision on Rehearing:

Claim(s) Rejected

35 U.S.C. §

Reference(s)/ Basis

Denied

Granted

1-18

Nonstatutory Double Patenting: US Patent 10,882,922, Klein

1-18

1-4, 6-18

Nonstatutory Double Patenting: US Patent 11,186,649, Klein

1-4, 6- 18

1-4, 6-18

Nonstatutory Double Patenting: US Patent 11,530,268, Klein

1-4, 6- 18

1-4, 6-18

Nonstatutory Double Patenting: US Patent 11,613,576, Klein

1-4, 6- 18

1-18

Nonstatutory Double Patenting: US Patent 11,192,960, Klein

1-18

Provisional Nonstatutory Double Patenting: US Patent Application 18/183,107, Klein

1-18

Overall Outcome

1-18

Final Outcome of Appeal after Rehearing:

Claim(s) Rejected

35 U.S.C. $

Reference(s)/ Basis

AffirmedReversed

1-18

Nonstatutory Double Patenting: Patent 10,882,922, Klein

US1-18

1-4, 6-18

Nonstatutory Double Patenting: Patent 11,186,649, Klein

US1-4, 6- 18

1-4, 6-18

Nonstatutory Double Patenting: Patent 11,530,268, Klein

US1-4, 6- 18

1-4, 6-18

Nonstatutory Double Patenting: Patent 11,613,576, Klein

US1-4, 6- 18

1-18

Nonstatutory Double Patenting: Patent 11,192,960, Klein

US1-18

1-18

Provisional Nonstatutory Double Patenting: US Patent Application 18/183,107, Klein

1 1-18

Overall Outcome

1-18

## TIME PERIOD FOR RESPONSE

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § l.136(a)(l)(iv).

Ex parte Baurin

Texto completo

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