Ex parte Lazzara

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Board of Patent Appeals
and Interferences

Informative

Opinion

UNITED STATES PATENT AND TRADEMARK OFFICE

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES

Ex parte RICHARD J. LAZZARA, THOMAS S. HEYLMUN, and
KEITH D. BEATY

Appeal 2007-0192
Application 09/237,605
Technology Center 3700

Decided: November 13, 2007

Before MURRIEL E. CRAWFORD, JENNIFER D. BAHR, and
LINDA E. HORNER, Administrative Patent Judges.

HORNER, Administrative Patent Judge.

DECISION ON REQUEST FOR REHEARING

STATEMENT OF THE CASE
Richard J. Lazzara et al. (“Appellants”) have filed a request for rehearing
under 37 C.F.R. § 41.52 seeking reconsideration of our decision of May 30, 2007
(“Decision”), wherein we reversed the rejection of claims 51 and 60-75 under

35 U.S.C. § 103(a) and entered a new ground of rejection of claims 51 and 60-75

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Application 091237,605
under 35 U.S.C. 5 112, second paragraph. The Appellants argue that the Board
misapprehended or overlooked that "the claim language in question -
'substantially uniform array of irregularities' - is acceptable according to [the]
Federal Circuit" (Request for Rehearing 2). As such, the Appellants request the
Board to reconsider its decision to enter a new ground of rejection under 35 U.S.C.
5 112, second paragraph, and request the Board to review the rejection of the
pending claims under 3 5 U.S.C. 5 103.
ANALYSIS
In our Decision of May 30, 1997, we found that the claimed "substantially
uniform array of irregularities" was ambiguous and that neither the remainder of
the claim language, nor the Specification, nor the Declarations submitted in the
Evidence Appendix attached to Appellants' Brief, provided any description of a
standard for measuring the degree of uniformity such that one of ordinary skill in
the art would understand what is meant by "a substantially uniform array of
irregularities" as claimed (Decision 12-13).
The Appellants request that we reconsider our decision in light of Federal
Circuit cases which found, within the context of claim interpretation post-grant in
an infringement dispute, that the term "substantially" and the phrase "substantially
uniform" are amenable to interpretation using their ordinary and customary
meanings (Request for Rehearing 2-4). The Appellants appear to be arguing that
the cited Federal Circuit case law stands for a p e r se rule that if the term
"substantially" is used in a claim, and if the Specification fails to provide a

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definition of the term with numerical specificity, then the term must be interpreted
broadly in accordance with its customary meaning. We do not read the Federal
Circuit cases to stand for such a per se rule.
Rather, the case law requires some sort of standard by which one of ordinary
skill in the art can measure a term of degree such as "substantially" so as to
understand what is claimed. While the standard for measuring a term of degree
need not be defined with numerical specificity, the standard must be able to be
derived from information in the patent regarding the purpose of the invention - or
of the specific aspect of the invention to which the term of degree applies - as well
as from experimentation. See Seattle Box Co. v. Indust. Crating & Packing, Inc.,
73 1 F.2d 8 18, 820-21, 826 (Fed. Cir. 1984).
The Appellants rely, in particular, on the cases of Cordis Corp. v. Medtronic
AVE, Inc., 339 F.3d 1352 (Fed. Cir. 2003) and Ecolab, Inc. v. Envirochem, Inc.,
264 F.3d 1358 (Fed. Cir. 2001), in which the court interpreted claim elements
including the phrase "substantially uniform" (Id.). In Cordis, the court interpreted
the meaning of a claimed stent composed of a tubular member having a "wall
surface having a substantially uniform thickness." The court in Cordis noted that
"[tlhe patents [at issue] do not set out any numerical standard by which to
determine whether the thickness of the wall surface is 'substantially uniform. "' Id.
at 1360. The court found that "[tlhe term 'substantially,' as used in this context,
denotes approximation." Id. (citation omitted). As such, the court held that "the
walls must be of largely or approximately uniform thickness." Id. The
Specification likewise did not provide any further definition of the variation for

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Application 091237,605
which the thickness of the wall surface would be "substantially uniform." 	Id. 	The
court held that because there was no clear and unmistakable surrender of claim
scope during the prosecution history of the patent, the broad definition of
"substantially uniform thickness," i.e., that "the walls must be of largely or
approximately uniform thickness," was the proper definition. Id. at 1362.
In Ecolab, the court stated that "nonnumerically limited descriptive claim
terms are construed using the same rules of construction as any other claim term."
264 F.3d at 1366. The court in Ecolab thus construed the claim element
"substantially uniform alkaline detergent" by reviewing the intrinsic evidence,
which consists of the claim language, the written description, and the prosecution
history. Id. (citation omitted). The court explained,
This intrinsic evidence is consulted to determine if the
patentee has chosen to be his or her own lexicographer,
or when the language itself lacks sufficient clarity such
that there is no means by which the scope of the claim
may be ascertained from the claim language itselJ:
(internal citations omitted). When the foregoing
circumstances are not present, we presume that the terms
in the claim mean what they say. In other words, we
follow the general rule that terms in the claim are to be
given their ordinary and accustomed meaning.
Id. (citations omitted) (emphasis added). The court provided the ordinary and
customary meanings of the terms "substantially" and "uniform,"l found that the
The court looked to the dictionary definitions of "substantially," meaning
"considerable in extent" or "largely but not wholly that which is specified" and
"uniform," meaning "always the same in degree; unvarying." 	Ecolab, 264 F.3d at
1367 (citing, respectively, THEAMERICAN	HERITAGE	COLLECTION	DICTIONARY	1475 (3d
ed. 1997), AMERICAN	HERITAGE	DICTIONARY	SECOND	COLLEGE	ED. 1213 (2d ed. 1982),

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written description did not reveal any special definition for the terms, and further
found that "the use of the term 'substantially' to modify the term 'uniform' does
not render this phrase so unclear such that there is no means by which to ascertain
the claim scope." Id. at 1367. The court also found that the term "substantially"
"is a descriptive term commonly used in patent claims to 'avoid a strict numerical
boundary to the specified parameter."' 	Id. (quoting Pall Corp. v. Micron Seps., 66
F.3d 1211, 1217 (Fed. Cir. 1995) (additional citations omitted)).
In light of these decisions, the Appellants submit that the proper definition
of "substantially uniform array of irregularities," based on the ordinary and
customary meanings of the terms, is that "the irregularities described [in claims 5 1,
63, and 681 have largely, but not wholly, the same form, manner, or degree"
(Request for Rehearing 4). The Appellants contend that this definition is
consistent with the Specification, which describes the surface of Example 3 as
having "a high level of etch uniformity over the surface," meaning that "the
irregularities on the roughened surface were not absolutely or perfectly uniform"
(Request for Rehearing 4-5). As such, the Appellants argue that "the claims are as
precise as the subject matter permits" (Request for Rehearing 5).
In a more recent Federal Circuit decision, however, the court in Medrad,
Inc. v. MRI Devices Corp., 401 F.3d 1313 (Fed. Cir. 2005), declined to adopt the
definition of "substantially uniform" from Ecolab, explaining:
A particular term used in one patent need not have the
same meaning when used in an entirely separate patent,
and WEBSTER'S	NINTH	NEWCOLLEGIATE	DICTIONARY	1176 (9th ed. 1983)).

Appeal 2007-0192
Application 09/237,605

particularly one involving different technology. In fact,
there are many situations in which the interpretations will
necessarily diverge. A patentee may define a particular
term in a particular way, and in that event the term will
be defined in that fashion for purposes of that particular
patent, no matter what its meaning in other contexts. See
Hormone Research Found., Inc. v. Genentech, Inc., 904
F.2d 1558, 1563 (Fed. Cir. 1990). Moreover, claim terms
are typically given their ordinary and accustomed
meaning as understood by one of ordinary skill in the
pertinent art, and the generally understood meaning of
particular terms may vary from art to art. Interactive Gift
Express, Inc. v. Compuserve Inc., 256 F.3d 1323, 1332
(Fed.Cir.2001); Dow Chem. Co. v. Sumitomo Chem. Co.,
257 F.3d 1364, 1372 (Fed.Cir.2001). Even absent an
express definition of a term in the specification or
prosecution history, or a clearly established
understanding of the meaning of the term in the art, the
manner in which the term is used in the patent may
dictate a definition that differs from the definition that
would be given to the same term in a different patent
with a different specification or prosecution history. See
Young Dental Mfg. Co. v. Q3 Special Prods., Inc., 112
F.3d 1137, 1143 (Fed.Cir.1997) (“The specification that
is relevant to claim construction is the specification of the
patent in which the claims reside.”).

Id. at 1318-19 (finding that “[t]he use of a term in a patent on a detergent [as in
Ecolab] is of little pertinence to the use of a similar term in a patent on MRI RF
coils. Rather, absent some particular reason to do otherwise, the claim terms must
be interpreted as would one of ordinary skill in the art of MRI technology and in
light of the particular patent in suit.”’).

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Application 091237,605
The court in Medrad first looked to the words of the claim itself in an
attempt to define the metes and bounds of the "substantially uniform" recitation
and found that "[tlhe term 'substantially uniform first magnetic field' is ambiguous
in that it fails to suggest how much a magnetic field may deviate from absolute
uniformity before it is no longer uniform." Id. at 1319. The Court found guidance
for the definition of "substantially uniform" in the preamble, which claimed an
"imaging system for forming images of a region of interest." Id. at 1320. The
court held that "[tlhe problem of image distortion puts an upper bound on the
degree of nonuniformity allowable in the magnetic field, which is part of an
'imaging system for forming images of a region of interest."' 	Id. 	The Court
found that the interpretation was further supported by the Specification, which
stated as an object of the invention to provide greater image uniformity than
provided in the prior art, and found that the interpretation aligns with the
conventional understanding of the term in the MRI industry, based on expert
testimony of the meaning of "a substantially uniform magnetic field" in the art. Id.
As in Medrad, we find that the phrase "substantially uniform array of
irregularities" used in the claims is ambiguous in that it fails to suggest how much
the irregularities may deviate from absolute uniformity before they are no longer
uniform. See Medrad, 40 1 F.3d at 1319. However, unlike in Medrad, we find no
guidance in the remainder of the claims that would lead to an understanding of this
claim limitation. While the claims require a roughened region (claim 5 1) or an
acid-etched surface (claims 63 and 68) "for facilitating osseointegration with said
bone," there is no evidence in the record that the stated purpose of facilitating

Appeal 2007-0 192
Application 091237,605
osseointegration places an upper bound on the degree of nonuniformity allowable
in the roughened region or acid-etched surface of the claims. On the contrary, the
Specification indicates that it is the fact that the surface is roughened, and not
necessarily the degree of uniformity of the irregularities, that promotes
osseointegration with the bone (Specification 1: 13-14 and 17-18).
The claims also recite the steps of the acid-etching process, which include
removing a native oxide layer and then uniformly acid etching with a second acid
solution. This general description of the treatment method is insufficient to define
what is meant by "substantially uniform array of irregularities" because, if it was,
then Haruyuki would inherently contain such an array as it follows the same two-
step treatment process. The Appellants have chosen to make "substantially
uniform array of irregularities" the critical and defining limitation of the claim. As
such, it must be clear as to what falls within its scope.
The parent application (now U.S. Patent No. 5,876,453), which is
incorporated by reference in the present application (see Specification 3:23-25),
describes the roughening or acid-etching process and further describes that it is a
primary object to "produce an implant surface having a roughness that is
substantially uniform over the area of the implant that is intended to bond to the
bone in which the implant is placed" and a further object to "provide an improved
surgically implantable device having on its surface a substantially uniform
micromorphology ('453 patent, col. 2,ll. 58-64). The parent application further
describes that it is a more specific object of the invention to "provide an improved
etch-solution process that will result in a substantially uniform surface topography

Appeal 2007-0 192
Application 091237,605
on surgically implantable devices" ('453 patent, col. 3,ll. 4-7). The parent
application teaches that the fine roughness of the treated surface, in combination
with the high degree of uniformity of that roughness over the treated surface,
renders a surface topography that is "well suited for osseointegration with adjacent
bone" ('453 patent, col. 6,ll. 27-3 1). While the uniformity of the array of
irregularities is "well suited" for osseointegration, it is not clear from the
Specification that a surface having arrays of irregularities that are not substantially
uniform does not also facilitate osseointegration with the bone due to the
roughness of the surface. As such, we fail to see how one having ordinary skill in
the art would be able to decipher from the stated purpose of the invention what
variation in uniformity is permitted in order to achieve the purpose of
osseointegration.
The Appellants contend that "[aln array of irregularities having a portion
with irregularities having peak-to-valley heights of 1 to 3 microns and another
portion with irregularities having peak-to-valley heights of 0.01 microns would not
fall within the scope of the claims" because the "very purpose of including the
term 'substantially uniform' is to exclude surfaces in which the irregularities
have 'widely varying heights"' (Request for Rehearing 6) (emphasis in original).
We understand this argument to say that a variation in height of 0.99 microns
between one portion of the array (having a height of 1 micron) and another portion
of the array (having a height of 0.01 microns) would be considered not
substantially uniform. We fail to see how this is the case in view of the
Appellants' own Specification, which describes that its second etching process

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results in a final etched surface consisting of a substantially uniform array of
irregularities where "[s]ubstantial numbers of the irregularities . . . hav[e] base-to-
peak heights in the range from about 0.3 microns to about 1.5 microns" ('453
patent, col. 6,ll. 3 1-36). As such, the Appellants' own working examples result in
a variance of 1.2 microns between peaks. See also '453 patent, col. 8, 1. 19
(Example No. 3 having arrays of cones ranging in height from about 0.3 microns to
2.0 microns for a variance of 1.7 microns).
Further, unlike in Medrad, we find no guidance in the declaration submitted
by Dr. Gubbi on June 30, 2003 ("the Gubbi Declaration"), that would inform us as
to how one of ordinary skill in the art of dental implants would understand the
claimed "substantially uniform array of irregularities" and the degree of
nonuniformity allowable within the scope of the claims. As noted by Appellants,
the Gubbi Declaration was not submitted to prove definiteness (Request for
Rehearing 5, n. 1). Rather, the Appellants provided the Gubbi Declaration to
compare "a titanium dental implant [that] was given a treatment according to the
method described in this patent application to produce an Osseotite' 	surface" with
"titanium implants [that] were exposed to the two-step procedure described in . . .
Haruyuki." (Gubbi Decl., ID). Dr. Gubbi concluded, "the treatments of
[Haruyuki] produced surfaces that do not resemble the surface achieved by the
methodology of the subject patent application, as shown in Exhibit A" (Gubbi
Decl. I H). As such, the Gubbi Declaration provides the declarant's observations
as to the visual appearance of the prior art surface as compared to the Osseotite'
surface, but it is of no assistance in further defining the claim language so as to

Appeal 2007-0 192
Application 091237,605
distinguish the claimed surface from the prior art surface. In particular, the
declaration fails to reach a conclusion that the prior art sample surfaces do not
contain "substantially uniform arrays of irregularities." Rather, Dr. Gubbi merely
concludes that the prior art surfaces "do not resemble" the Osseotitemsurface
(Gubbi Decl., YH). Thus, the Appellants do not provide any expert testimony as to
what one having ordinary skill in the art would understand a "substantially uniform
array of irregularities" to mean in the dental implant art.
In Seattle Box, the Federal Circuit confronted an indefiniteness challenge to
a patent claim that used the phrase "substantially equal to," and noted that words of
degree can be indefinite if the patent's specification fails to provide a standard for
measuring the degree claimed:
Definiteness problems often arise when words of degree
are used in a claim. That some claim language may not
be precise, however, does not automatically render a
claim invalid. When a word of degree is used the
[factfinder] must determine whether the patent's
specification provides some standard for measuring that
degree. The [factfinder] must decide, that is, whether one
of ordinary skill in the art would understand what is
claimed when the claim is read in light of the
specification.
73 1 F.2d at 826 (affirming the trial court's determination that an expert would
know the limitations of the claims because the specification clearly sets forth a
standard for measuring the degree used in the claim language). The patent
concerned an invention for packaging oil pipe of various diameters and weights for
transport and claimed, specifically, a "spacer block" "of a height substantially

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Application 091237,605
equal to or greater than the thickness of the tier of pipe length." Id. at 820-2 1. The
alleged infringer challenged the patent as indefinite on the theory that a person of
ordinary skill in the art could not determine "just how equal 'substantially equal to'
is." Id. at 826. The court rejected this challenge, concluding that an expert would
have known the claim's limitations because "[tlhe specification clearly sets forth,
for example, that the divider blocks are intended to absorb the weight of overhead
loads." Id. In addition, "even if [the alleged infringer] needed to experiment so as
to determine the limits of the . . . claims, the claims would not be invalid under
section 112." Id. Thus, the information provided in the patent regarding the
purpose of the invention, along with additional information that could be obtained
through experimentation, was sufficient to provide a "standard" for determining
the scope of "substantially equal to," a term of degree. See id. Although Seattle
Box demonstrates that a standard for measuring a term of degree need not be
defined with numerical specificity, it stands for the proposition that some standard
must exist even if the "standard" may be derived from information in the patent
regarding the purpose of the invention - or of the specific aspect of the invention to
which the term of degree applies - as well as from experimentation. See Seattle
Box, 73 1 F.2d at 820-2 1, 826.
In this case, however, consideration of the purpose of the invention does not
yield the same type of assistance in understanding the standard by which the term
of degree at issue, "substantially uniform," is to be measured. As we explained
above in our discussion of Medrad, the purpose of the present invention, as
explained by the claims and Specification, is to facilitate osseointegration with the

Appeal 2007-0 192
Application 091237,605
bone. This information does not provide a standard for measuring the degree of
substantially uniformity of the irregularities because a roughened surface with
widely varying degrees of irregularities might also facilitate osseointegration. Nor
would experimentation help in determining the degree of uniformity of an array of
irregularities for facilitating osseointegration, because the Specification does not
even provide a measure of the enhancement of integration of the implant to the
bone as compared to prior art implants.
Appellants correctly point out that there is no doctrinal rule that requires an
applicant to define "substantially" with mathematical precision. See Modine Mfg.
Co. v. United States Int'l. Trade Comm'n., 75 F.3d 1545, 1557 (Fed. Cir. 1996),
abrogated on other grounds, Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki
Co., Ltd., 234 F.3d 558 (Fed. Cir. 2000) (en banc). We further understand that the
Patent Office is to give claims "their broadest reasonable interpretation consistent
with the specification" and "in light of the specification as it would be interpreted
by one of ordinary skill in the art." In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d
1359, 1364 (Fed. Cir. 2004). However, in this case, we have no evidence in the
record as to how the claims would be interpreted by one of ordinary skill in the art.
We further note that during prosecution, it is the appellants' burden to precisely
define the invention, not the PTO's. 	In re Morris, 127 F.3d 1048, 1056 (Fed. Cir.
1997). Appellants always have the opportunity to amend the claims during
prosecution. In contrast, during an infringement litigation, such as in those cases
relied upon in Appellants' Request for Rehearing, the claim is construed post-
issuance and the patent has a presumption of validity. In such cases, it is the

Appeal 2007-0 192
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challenger's burden to overcome the presumption of validity with evidence clearly
showing the claims are indefinite.
In this case, the Specification fails to provide a standard against which one
could interpret the claimed degree of uniformity, nor do we see how one would be
able to determine the claim scope by experimentation. Further, the Appellants
have provided no evidence as to how the claimed "substantially uniform array of
irregularities" would be understood by one having ordinary skill in the dental
implant art. Therefore, one of ordinary skill would not know what degree of
roughness would fall within the claim scope and what would not.
DECISION
Accordingly, while we have granted Appellants' request for rehearing to the
extent that we have reconsidered our decision, the request is denied with respect to
making any changes in the decision. No time period for taking any subsequent
action in connection with this appeal may be extended under 37 C.F.R. 5 1.136(a).
See 37 C.F.R. 5 1.136(a)(l)(iv) (2006).
DENIED
vsh

Appeal 2007-0192
Application 09/237,605

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