Ex parte Batteux

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Board of Patent Appeals
and Interferences

# Informative

Nie erat Opinion

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE BOARD OF PATENT APPEALS

AND INTERFERENCES
Ex parte FREDERIC BATTEUX,
and BERNARD WEILL :
MAILED
Appeal 2007-0622 MAR 2 7 2007
Application 10/475,555 AT. & TM. OFFICE
Technology Center 1600 BOARD OF PATENT APPEALS
AND INTERFERENCES

HEARD: March 8, 2007

Before SCHEINER, GRIMES, and LINCK, Administrative Patent Judges.
LINCK, Administrative Patent Judge.

DECISION ON APPEAL
Appellants appeal the Examiner’s §§ 102(b) and 103(a) rejections of
claims 1-5 and 8-18, all pending claims in the above-identified application,
filed October 22, 2003.' We have jurisdiction to decide this appeal under
35 U.S.C. § 6(b).
We affirm.

' The assignee is Universite Rene Descartes (Paris V).

The opinion in support of the decision being entered today was not written
for publication and is not binding precedent of the Board.
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
Ex parte FREDERIC BATTEUX,
and BERNARD WEILL
Appeal 2007-0622
Application 101475,555
Technology Center 1600
HEARD: March 8,2007
Before SCHEINER, GRIMES, and LINCK, Administrative Patent Judges.
LINCK, Adm inistrative Patent Judge.
DECISION ON APPEAL
Appellants appeal the Examiner's $8 102(b) and 103(a) rejections of
claims 1-5 and 8-18, all pending claims in the above-identified application,
filed October 22,2003.' 	We have jurisdiction to decide this appeal under
35 U.S.C. 8 6(b).
We affirm.
' The assignee is Universite Rene Descartes (Paris V).

Appeal 2007-0622
Application 101475,5 55
STATEMENT OF THE CASE
The claimed invention is "[a] method for treating hepatocellular
deficiency, comprising administering mangafodipir to a patient in need
thereof." Claim 1. 	Some of the dependent claims limit the hepatocellular
deficiency to one "of toxic origin" (claim 2), or induced by acetaminophen
(claim 3) or alcohol (claim 4); or to a deficiency that "manifests itself in the
form of fulminant hepatitis" (claim 5). Others specify dosage ranges (claims
8 and 9), or the method of administration (claims 10-14), or both dosage
range and method of administration (claims 15-18).
There are three grounds of rejection in this case. The first to be
reviewed on appeal is of claims 1,2,9, 11, 14, and 18 under 35 U.S.C.
§ 102 (b) based on Yicheng et al., "Experimental Liver Cancers: Mn-DPDP-
enhanced Rims in MR-Microangiographic-Histologic Correlation Study,"
Radiology 1993; 188: 45-51 ("Yicheng"). 	The second ground to be
reviewed is of claims 1 and 8-18 under § 102(b) based on Karlsson et al.
WO 97149409, published December 3 1, 1997. The last ground to be
reviewed is of claims 2-5 under 35 U.S.C. 8 103(a) based on Karlsson and
Cecil, Textbook of Medicine, vol. 1, 8 15 & 8 17 (2 1" ed. 2000) (W.B.
Saunders Co., editor) ("Cecil").
The Examiner also relies on portions of "Drugs of the Future" (1997)
and Stedman's Medical Dictionary ( 2 7 ~	ed. (on-line) ("Stedman's")) 	to
establish the molecular weight of mangafodipir ("MnDPDP") 	and the
meaning of certain terms, respectively. Appellants do not challenge the
Examiner's use of these references.

Appeal 2007-0622
Application 101475,555
ISSUES ON APPEAL
Claim I
The Examiner contends that Yicheng's administration of MnDPDP to
mice and rabbits suffering from hepatocellular carcinoma ("HCC"), 	induced
with a chemical carcinogen, anticipates claim 1. Answer 5-6, 11-17. The
Examiner further contends that Karlsson's treatment of a patient with
MnDPDP either prior to, during or subsequent to a liver transplant
anticipates claim 1. Answer 6-8, 17-2 1. 	To support his position and
respond to Appellants' arguments, the Examiner relies on, inter alia,
MEHL/Biophile Int'l Corp. v. Milgraum, 192 F.3d 1362, 1365, 52 USPQ2d
1303, 1305-06 (Fed. Cir. 1999). Answer 4 ("it-is not required that those of
ordinary skill in the art recognize the inherent characteristics or the function
of the prior art").
Appellants contend they have discovered a new use for an old
compound and thus are entitled to a patent (Br. 4), given that neither
reference administered MnDPDP "with the specific intent" to treat
hepatocellular deficiency (Br. 7, 14). Appellants further contend the
Examiner has not established that "the prior art regimen would necessarily
result . . . in practicing the claimed methods" (Br. 8 (discussing Yicheng)).
See also Br. 14 (making the same argument with respect to Karlsson). To
support their contentions, Appellants rely heavily on Jansen v. Rexall
Sundown Inc., 342 F.3d 1329,68 USPQ2d 1154 (Fed. Cir. 2003) and
Rapoport v. Dement, 254 F.3d 1053,59 USPQ2d 1215 (Fed. Cir. 2001).

Appeal 2007-0622
Application 101475,555
We frame the issues to be decided as follows:
Do Yicheng andlor Karlsson inherently anticipate claim 1, even
though neither reference discloses any intent to treat patients for
hepatocellular deficiency? Would the disclosed prior art methods
necessarily result in "treating hepatocellular deficiency"?
FINDINGS OF FACT
Interpretation of Claim 1
Claim 1 does not specify a dosage or any treatment regimen, or
require that "an effective amount" of MnDPDP be administered to a patient.
Thus, claim 1 does not require "treating" to be effective against
hepatocellular deficiency.
The term "hepatocellular deficiency" is interpreted broadly in view of
the definition in the specification and includes hepatocellular carcinoma, or
HCC, and the total absence of the liver. See Spec. at 3 ("A set of
pathological manifestations resulting from the destruction of hepatocytes are
included under the term 'hepatocellular deficiency"' (quoted by the
Examiner (Answer 15))). See also Answer 5-6.
The term "patient in need thereof' includes animals such as mice and
rabbits. See Answer 6.
Claim 1 does not require administration of MnDPDP for any
particular length of time or any number of treatments.
The Prior Art Teachings
Yicheng discloses "both animal and clinical studies" with MnDPDP, a
contrasting agent "designed to be taken up by hepatocytes." 	Yicheng at 1.

Appeal 2007-0622
Application 101475,555
Yicheng describes administering MnDPDP to mice and rabbits to image
liver tumors, induced with chemical carcinogens. Id.
The term "toxin" includes chemical carcinogens. See Answer 5.
Yicheng uses a dosage calculated to be within that disclosed by
Appellants (19 mg/kg). See Answer 6 (citing Yicheng at 46, col. 1, middle
of 2ndfull paragraph).
Karlsson discloses treating patients with MnDPDP to prevent or treat
ischemia-related diseases and discloses using it to treat a patient in
connection with a liver transplant: "A further use of the compounds . . . is in
relation to organ transplantation, e.g. with . . . liver . . . transplants. In this
regard, the compounds may be administered to the organ donor or recipient
either prior to, during or subsequent to transplant surgery." Karlsson at 7.
Karlsson teaches a dosage range calculated to overlap with that
disclosed by Appellants (0.007-76 mg/kg). See Answer 7-8 (citing Karlsson
at 14, 2ndfull paragraph).
Other Findings
Substantially all liver transplants are due, at least in part, to
"hepatocellular deficiency," as broadly defined. See Cecil at 8 17, Table
155-1 (identifying the "10 most common indications for liver
transplantation"). The "Surgeon General Reports," submitted by Appellants,
also supports this finding. Br. 13 (reference "describes that liver
transplantation is a therapy for a variety of indications causing damage to
the liver") (emphasis added).

Appeal 2007-0622
Application 101475,555
A patient suffering from "hepatocellular deficiency" would
necessarily be treated for that deficiency if administered MnDPDP, as
required by claim 1 and as taught by Yicheng or Karlsson.
PRINCIPLES OF LAW
Regarding claim interpretation during patent prosecution,
the Board is required to use a different standard for
construing claims than that used by district courts. . . . [I]t is
error for the Board to "appl[y] the mode of claim
interpretation that is used by courts in litigation, when
interpreting the claims of issued patents in connection with
determinations of infringement and validity." In re Zletz, 893
F.2d 319, 321 (Fed.Cir.1989); accord In re Morris, 127 F.3d
1048, 1054 (Fed.Cir. 1997) ("It would be inconsistent with
the role assigned to the PTO in issuing a patent to require it
to interpret claims in the same manner as judges who, post-
issuance, operate under the assumption the patent is valid.").
Instead . . . ,the PTO is obligated to give claims their
broadest reasonable interpretation during examination.
In re American Academy of Science Tech Center, 367 F.3d 1359, 1369,
70 USPQ2d 1827, 1834 (Fed. Cir. 2004).
Following a long line of cases, the Federal Circuit clarified the law on
inherency, i.e., whether those skilled in the art must be aware of
the inherent characteristic, particularly with respect to method claims:
A single prior art reference that discloses, either
expressly or inherently, each limitation of a claim invalidates
that claim by anticipation. Minn. Mining & Mfg. Co. v.
Johnson & Johnson Orthopaedics, Inc., 976 F.2d 1559, 1565
[24 USPQ2d 13211 (Fed. Cir. 1992). Thus, a prior art
reference without express reference to a claim limitation may
nonetheless anticipate by inherency. See In re Crucferous

Appeal 2007-0622
Application 101475,555
Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir. 2002). "Under
the principles of inherency, if the prior art necessarily
functions in accordance with, or includes, the claim's
limitations, it anticipates." Id. (quoting MEHL/Biophile Int'l
Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999).
Moreover, "[Ilnherency is not necessarily coterminous with
knowledge of those of ordinary skill in the art.Artisans of
ordinary skill may not recognize the inherent characteristics
or functioning of the prior art." Id.;see also Schering Corp.
v. Geneva Pharms., 339 F.3d 1373, 1377 (Fed. Cir. 2003)
(rejecting the contention that inherent anticipation requires
recognition in the prior art) (citing In re Crucferous Sprout
Litig., 301 F.3d at 135 1; MEHL/Biophile, 192 F.3d at 1366).
Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1375-76, 77 USPQ2d
1321, 1325-26 (Fed. Cir. 2005).~"Thus, when considering a prior art
method, the anticipation doctrine examines the natural and inherent results in
that method without regard to the full recognition of those benefits or
characteristics within the art field at the time of the prior art disclosure." Id
Inherency, however, may not be established by probabilities
or possibilities. 	The mere fact that a certain thing may result
from a given set of circumstances is not sufficient. [Citations
omitted.] If, however, the disclosure is sufficient to show
that the natural result flowing from the operation as taught
would result in the performance of the questioned function, it
seems to be well settled that the disclosure should be
regarded as sufficient.
Hansgirg v. Kemmer, 102 F.2d 212,214,40 USPQ 665,667 (CCPA 1939),
quoted in Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1269,
2 We note this case was decided only a few days before Appellants' Appeal
Brief was filed.

Appeal 2007-0622
Application 10/475,555
20 USPQ2d 1746, 1749 (Fed. Cir. 1991). 	In other words, "a limitation or
the entire invention is inherent and in the public domain if it is the 'natural
result flowing from' the explicit disclosure of the prior art." Schering Corp.
v. Geneva Pharms., 339 F.3d 1373,1379,67 USPQ2d 1664,1669 (Fed. Cir
2003), quoted in Perricone, 432 F.3d at 1377,77 USPQ2d at 1327.
With respect to a number of the dependent claims, the "existence of
overlapping or encompassing ranges shifts the burden to the applicant to
show that his invention would not have been obvious." In re Peterson, 3 15
F.3d 1325, 1330,65 USPQ2d 1379, 1383 (Fed. Cir. 2003). See also In re
Woodruff, 919 F.2d 1575,1578, 16 USPQ2d 1934,1936 (Fed. Cir. 1990).
DISCUSSION
This case turns on two questions: (1) Do Yicheng and/or Karlsson
inherently anticipate claim 1, even though neither reference discloses any
intent to treat patients for hepatocellular deficiency? (2) Would the
disclosed prior art methods necessarily result in "treating hepatocellular
deficiency"? Based on the record before us and our above findings, we
conclude the answer to both these questions is yes.
Appellants argue Jansen and Rapoport require a different result. See
Br. passim. The Examiner distinguishes these cases. Answer passim. We
agree with the Examiner that these cases can be distinguished, both on their
facts and on their procedural postures.
Jansen was an infringement case, requiring the court to construe the
subject claim "so as to sustain [its] validity, if possible." 	Whittaker Corp. v.
UNR Indus., 91 1 F.2d 709,712, 15 USPQ2d 1742, 1743 (Fed. Cir. 1990)

Appeal 2007-0622
Application 10/475,55 5
(citing ACS Hosp. Sys., Inc. v. Montejore Hosp., 732 F.2d 1572, 1577,221
USPQ 929, 932 (Fed.Cir. 1984). In contrast, during prosecution, a claim
must be given its broadest reasonable interpretation. Unlike the case here, in
Jansen, the patentee was arguing a broad construction to establish
infringement. 342 F.3d at 1331,68 USPQ2d at 1156. However, the court
"strictly construed" the claim against the inventor, in view of statements
made during prosecution. Id. at 1334,68 USPQ2d at 1158.
In Rapoport (an interference proceeding), the Board found no inherent
anticipation. In affirming the Board, the Federal Circuit stated: "Most
importantly . . . ,the issue of anticipation-whether 	by inherency or
otherwise-is 	a question of fact, and we uphold decisions of the Board on
factual matters if there is substantial evidence in the record to support the
Board's findings." 	254 F.3dat 1063, 59USPQ2d at 1222.
Further, at least two panels of the Board have previously distinguished
Jansen and/or Rapoport in similar circumstances. See Ex parte Hempstead,
App. No. 2006-061 1 (decided April 5,2006). See also Ex Parte Renshaw,
App. NO. 2006-1066 (2006 WL 2558174).
In any case, to the extent they cannot be distinguished, we believe the
better line of cases is that culminating in Perricone. Unless the claim
language distinguishes the claimed method, the subject matter cannot be
patented, as it is already in the public domain.
In spite of lack of intent to treat hepatocellular deficiency, we find
both Yicheng and Karlsson anticipate claim 1, either expressly or under the
doctrine of inherency. Yicheng administers MnDPDP to mice and rabbits
("patients") in which HCC (a cchepatocelluardeficiency") has been induced.

Appeal 2007-0622
Application 101475,5 55
Given the broad language of claim 1, "treating hepatocellular deficiency,
comprising administering mangafodipir to a patient in need thereof' is the
"natural result flowing fiom" Yicheng7sdisclosure. Yicheng's lack of intent
to treat hepatocellular deficiency does not impact our analysis. See, e.g.,
Perricone, 432 F.3d at 1378,77 USPQ2d at 1327 (quoted above).
Likewise, Karlsson expressly teaches administering MnDPDP to a
patient undergoing a liver transplant, either before or during surgery. During
those time periods, such a patient would be suffering from a hepatocellular
deficiency, regardless of the underlying cause. Thus, administration of
MnDPDP during those time periods, "treating hepatocellular deficiency,
comprising administering mangafodipir to a patient in need thereof' would
be the "natural result flowing from" such administration. Again, Karlsson's
lack of intent to treat hepatocellular deficiency does not influence our
analysis.
Turning to the second question, Appellants argue that application of
Karlsson "would not necessarily result in practicing the claimed methods."
Br. 14. This argument appears to be based on the fact that Karlsson "doesn't
care which organ is to be transplanted" and "does not identify a patient to
whom the compound is to be administered, the time [ofl administration,
whether it be the donor, the recipient, or both." 	Id. We disagree with
Appellants' position. We acknowledge Karlsson describes treating patients
in circumstances not involving a liver transplant and administering the drug
at times other than before or during such a transplant. However, inclusion of
situations not involving treating hepatocellular deficiency does not negate
Karlsson's other, more relevant, teachings. When administered to a patient

Appeal 2007-0622
Application 101475,555
before or during a liver transplant, Karlsson's treatment would "necessarily
result" in practicing the method of claim 1. 	.
Appellants further argue: "While the patient population to be treated
in Karlsson may overlap those with hepatocellular deficiency, there are
other patients that perhaps wouldn't need a liver transplant but would still
benefit significantly from the treatment described and claimed by the
Applicants." Br. 15 (emphasis Appellants'). 	While this may be true,
Appellants must claim their invention such that the claim does not overlap
the prior art. They have failed to do so here.
Thus, we find both Yicheng and Karlsson anticipate claim 1.
Rejection of Dependent Claims 2, 9, 11, 14, and 18 in view of Yicheng
In addition to claim 1, the Examiner rejected claims 2, 9, 11'14, and
18 under 8 102(b) based on Yicheng.
Claim 2 further limits claim 1 by requiring the hepatocellular
deficiency be "of toxic origin." Yicheng induces HCC with a chemical
carcinogen and thus satisfies this additional limitation.
Claim 9 further limits claim 1 by including a dosage range for the
mangafodipir, "between 5 and 50 mgkglday." 	Yicheng teaches using 25
pmolkg (Yicheng 46, col. l), calculated to be 19mgkg. Answer 6. Since
this dose was "administered during the day" of Yicheng's experiment, it
"represents 19mgkglday which is encompassed by . . . a dosage [range] of
between 5 and 50 mgkglday." Answer 6.3
Appellants do not dispute either of the Examiner's calculations.
11

Appeal 2007-0622
Application 101475,555
Claim 11 further limits claim 1 by requiring administration "via
injection." Karlsson discloses such administration. Karlsson, at 12.
Claim 14 further requires the mangafodipir be administered by
"intravenous injection." 	Yicheng injects mangfodipir into "the ear vein of
the rabbit or the tail vein of the rat." 	Yicheng at 45, col. 3. See also
Answer 5 .
Claim 18 depends upon claim 9, limiting the dosage to between 5 and
50 mgkglday and requiring administration "via injection." These additional
limitations are disclosed in Yicheng. See the discussion above with respect
to claims 9 and 14.
Thus, we agree with the Examiner that claims 2, 9, 11, 14, and 18 are
anticipated by Yicheng.
Rejection of Dependent Claims 8-18 in view of Karlsson
In addition to claim 1, the Examiner has rejected claims 8-18 under
102(b) as anticipated by Karlsson.
Claims 8 and 9 require mangafodipir to be administered in ranges
comprising "between 0.1 and 10 mgkg/daymand "between 5 and 50
mgkglday," respectively. Karlsson discloses a dosage range between
and 100 pmollkg of body weight." Karlsson at 14. The Examiner has
calculated this range to be 0.007 to 76 mgkg. Answer 8. According to the
Examiner, a "per day" rate would be immediately envisaged by one of
ordinary skill in the art. Id. 	We agree with the Examiner's finding.
Claims 10-14 each recite a mode of administration, i.e., "orally"
(claim lo), or "via injection" (claim 11) (which is further limited to

Appeal 2007-0622
Application 101475,555
"subcutaneous" (claim 12), "intramuscular" (claim 13), or "intravenous"
(claim 14)). Karlsson expressly discloses administering MnDPDP orally,
and via injection, intravenous injection, and parenteral injection (defined by
Stedman's to be "intravenous, subcutaneous, intramuscular, or
intramedullary injection"). 	Karlsson at 12-13. See also Answer 7-8.
Claims 15-18 further require that mangafodipir be administered orally
or via injection in the dosage ranges of claims 8 and 9. Karlsson discloses
these additional limitations, as explained above.
Thus, we find claims 8-18 are anticipated by Karlsson.
Rejection of Claims 2-5 Under 35 U.S.C. $103(a)
The Examiner rejected claims 2-5 over Karlsson and Cecil, as
Karlsson does not expressly disclose the specific causes of hepatocellular
deficiency requiring a liver transplant. Claims 2-5 are limited to
hepatocellular deficiency "of toxic origin" (claim 2), "induced by
acetaminophen" (claim 3), "induced by alcohol" (claim 4) or "manifests
itself in the form of fulminant hepatitis" (claim 5).
Cecil identifies each of these causes of liver failure. Answer 9 (citing
Cecil at 8 15, col. 2; 817, col. 2; and Table 155-1). Based on Cecil's
teachings, the Examiner concludes "because the liver transplant recipient of
Karlsson et al. could have been reasonably expected to be as such because of
liver damage caused by alcohol, acetaminophen or liver failure, the claimed
subject matter would have been obvious to one of ordinary skill in the art."
Id. 	We agree with the Examiner that the subject matter of claims 2-5 would
have been obvious in view of the teachings of Karlsson and Cecil.

Appeal 2007-0622
Application 101475,555
CONCLUSIONS
We affirm the Examiner's rejection of claims 1, 2, 9, 11, 14, and 18
under 8 102(b) based on Yicheng and that of claims 1 and 8-18 under §
102(b) based on Karlsson. These references anticipate the subject matter of
the rejected claims, either expressly or inherently. We also affirm the
Examiner's § 103(a) rejection of claims 2-5 based on Karlsson and Cecil.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C..F.R. 8 1.136(a)(l)(iv) (2006).
AFFIRMED
Toni R. Scheiner 	1
Administrative Patent Judge 	)
1
1
) BOARD OF PATENT
Eric 	es 	1
Administrative Patent Judge 	) 	APPEALS AND
d	9	/	&	&	;1INTERFERENCES
Nancy J. Linck 	1
Administrative Patent Judge 	)

Appeal 2007-0622
Application 10/475,555

OBLON, SPIVAK, MCCLELLAND, MAIER & NEUSTADT, P.C.
1940 DUKE STREET
ALEXANDRIA VA 22314

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