Ex Parte Wasielewski

Board of Patent Appeals and Interferences

Apr 21, 2010

10612784 (B.P.A.I. Apr. 21, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte RAY C. WASIELEWSKI
____________________

Appeal 2009-007472
Application 10/612,784
Technology Center 3700
____________________

Decided: April 21, 2010
____________________

Before: LINDA E. HORNER, WILLIAM F. PATE III, and STEVEN D.A.
MCCARTHY, Administrative Patent Judges.

PATE III, Administrative Patent Judge.

DECISION ON APPEAL
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Application 10/612,784

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STATEMENT OF CASE
Appellant appeals under 35 U.S.C. § 134 (2002) from a rejection of
claims 1, 2, 4-6, 14, 15, 27-32 and 37. App. Br. 3. We have jurisdiction
under 35 U.S.C. § 6(b) (2008).
The claims are directed to the use of snap-on semiannular augments to
inhibit multi-directional instability after total hip arthroplasty. Claim 1,
reproduced below, is illustrative of the claimed subject matter:
1. A prosthetic device for use with a hip replacement
prosthesis that includes an acetabular cup assembly to be
fastened to a patient’s pelvis and a femoral stem to be fastened
to the patient’s femur, where the femoral stem includes a ball
component at its proximal end received within the acetabular
cup assembly to form a ball joint type coupling, the prosthetic
device comprising:
an acetabular liner for releasably engaging an acetabular
cup permanently mounted to the patient’s pelvis; and
a semiannular augment to be mounted to a rim of an
acetabular liner of a hip replacement prosthesis, wherein the
semiannular augment assists in improving stability of a ball
joint type coupling by increasing the height of a portion of the
rim of the acetabular liner, at least temporarily, between the
acetabular liner and a femoral stem of the hip replacement
prosthesis while allowing rotational and angular movement
between the acetabular cup assembly and the femoral stem;
the semiannular augment being formed from an augment
material comprising at least one of a biologic material, a
biologically absorbable material, and a combination of biologic
and biologically absorbable materials; and
wherein the augment material is supplemented with at
least one of an agent to promote the formation of scar tissue, a
clotting agent, and an antibacterial agent; and
wherein the augment material is formulated not to
transform into scar tissue.

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REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Mikhail
Klüber
5,549,701
DE 197 16 051 A1
Aug. 27, 1996
Nov. 13, 1997

REJECTIONS
Claims 1, 2, 4-6, 14, 15, 27-32, and 37 stand rejected under 35 U.S.C.
§ 112, first paragraph, as failing to comply with the written description
requirement. Ans. 3. Claims 109 and 110 have been cancelled. App. Br. 3;
Ans. 2.
Claims 1, 2, 4-6, 14, 15, 27-32, and 37 stand rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Klüber or, in the alternative, under 35
U.S.C. § 103(a) as being unpatentable over Klüber and Mikhail. Ans. 4-5.
The Examiner withdrew the rejection of claims 1, 2, 4-6, 14, 15, 27-
32, and 37 under 35 U.S.C. § 112, second paragraph and 35 U.S.C. § 102(b).
Ans. 6, 7; Reply Br. 7.

ISSUES
The first issue raised by Appellant is whether the Examiner erred by
finding that the claim phrase “wherein the augment is formulated not to
transform into scar tissue” lacks descriptive support in the original
disclosure. App. Br. 11-15; Reply Br. 2-5.
For the grounds of rejection under § 103, claims 1, 2, 4-6, 14 and 15
are argued as a group. App. Br. 20-22. Claims 27-32 and 37 are also argued
as a group. App. Br. 23-24. In both groups Appellant contends that the
Examiner erred by finding Klüber discloses an augment material that “is
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formulated not to transform into scar tissue.” Thus, the first issue related to
the obviousness rejection for our consideration is whether the Examiner
erred by finding Klüber discloses an augment material that “is formulated
not to transform into scar tissue.” In the second group of claims Appellant
contends at least three limitations are not disclosed by Klüber. However,
Appellant argues only two limitations, App. Br. 23-24, one of which is the
augment material “formulated not to transform into scar tissue” allegedly
missing from the first group of claims. Appellant additionally contends that
Klüber fails to disclose “at least one integrated fastener” because Klüber’s
screw, read by the Examiner as the claimed “fastener,” is not “integrated.”
App. Br. 23; Ans. 67, 10. It is noted that this limitation also appears in
claim 14, although claim 14, along with dependent claim 15, are included in
the first claim grouping. Thus, the next issue for our consideration is
whether the Examiner erred by interpreting Klüber’s screw as “at least one
integrated fastener.” Appellant does not contest the Examiner’s conclusion
that it would have been obvious to modify Klüber to account for the
perceived differences between the prior art and the claimed subject matter.
Ans. 5. Appellant also does not contest any of the Examiner’s findings or
conclusions pertaining to Mikhail. Ans. 5-6.

FINDINGS OF FACT
1. The Specification provides:
[0040] In the exemplary embodiment utilizing the biologically
reabsorbable snap-on augments 26, such augments 26 could be
formulated to [be] absorbed over a relatively short period (i.e.,
several weeks or months) and could also be formulated so as to
be replaced by tissue (such as scar-tissue) that would provide
for long-term hip stability and, hopefully, normal motion. Such
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formulations of biologic materials are well known by those of
ordinary skill in the art.

[0041] As will be apparent to those of ordinary skill in the art
there are many other biologic and/or biologically reabsorbable
materials that can be used for the snap-on augments 26 or snap
clips 28, and there are also new biologic materials being
developed on a consistent basis, all of which fall within the
scope of the invention.
2. The Specification provides that an example of a biologically reabsorbable
material that can be used for the augments 26 is poly-L-lactic acid
(PLLA). P. 11, para. [0041]; p. 12, para. [0043].
3. As discussed in detail below, the Specification lacks descriptive support
for an “augment material [] formulated not to transform into scar tissue.”
4. Klüber, as translated from the original German, discloses a resorbable
luxation securing ring (A), made of PLLA that prevents dislocation
during the healing phase and “is transformed into yielding connective
tissue.” P. 1, para. 1; p. 2, paras. 3 and 6.
5. Klüber discloses that screws C are received in holes G to secure the
retaining ring A to the socket component B. P. 2, para. 5.

PRINCIPLES OF LAW
The Written Description Requirement of 35 U.S.C. § 112, first paragraph
New or amended claims which introduce elements or limitations
which are not supported by the as-filed disclosure violate the written
description requirement. See, e.g., In re Lukach, 442 F.2d 967 (CCPA
1971). The purpose of the written description requirement is to prevent an
applicant from later asserting that he invented that which he did not; the
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applicant for a patent is therefore required “to recount his invention in such
detail that his future claims can be determined to be encompassed within his
original creation.” Amgen Inc. v. Hoechst Marion Roussel Inc., 314 F.3d
1313, 1330 (Fed. Cir. 2003) (citing Vas-Cath Inc. v. Mahurkar, 935 F.2d
1555, 1561 (Fed. Cir. 1991)). While there is no in haec verba requirement,
newly added claim limitations must be supported in the specification
through express, implicit, or inherent disclosure. The fundamental factual
inquiry is whether the specification conveys with reasonable clarity to those
skilled in the art that, as of the filing date sought, applicant was in
possession of the invention as now claimed. See, e.g., Vas-Cath, Inc., 935
F.2d at 1563-64. When an explicit limitation in a claim is not present in the
written description it must be shown that a person of ordinary skill would
have understood that the description requires that limitation. Hyatt v. Boone,
146 F.3d 1348, 1353 (Fed. Cir. 1998). If the originally filed disclosure does
not provide support for each claim limitation, a new or amended claim must
be rejected under 35 U.S.C. § 112, first paragraph as lacking adequate
written description. Whether a specification complies with the written
description requirement of 35 U.S.C. § 112, first paragraph, is a question of
fact. Regents of Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559, 1566 (Fed.
Cir. 1997) (citing Vas-Cath, Inc., 935 F. 2d at 1563). The Examiner has the
initial burden of presenting evidence or reasoning to explain why persons
skilled in the art would not recognize in the original disclosure a description
of the invention defined by the claims. In re Wertheim, 541 F.2d 257, 263
(CCPA 1976). Claim construction is an essential element in determining
adequacy of the written description. (See e.g., MPEP § 2163).

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35 U.S.C. § 103(a)
The Supreme Court in KSR reaffirmed the framework for determining
obviousness as set forth in Graham v. John Deere Co., 383 U.S. 1 (1966).
The factual inquiries set forth in Graham that are to be applied to establish a
background for determining obviousness under 35 U.S.C. § 103(a) are
summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at
issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating
obviousness or nonobviousness.
Graham, 383 U.S. at 17-18.
Claim construction is the first step in an obviousness analysis. Key
Pharms. v. Hercon Labs. Corp., 161 F.3d 709, 714 (Fed. Cir. 1998)
(citations omitted). A patent applicant is free to recite features of an
apparatus either structurally or functionally. See In re Swinehart, 439 F.2d
210, 212 (CCPA 1971). “Yet, choosing to define an element functionally,
i.e., by what it does, carries with it a risk.” In re Schreiber, 128 F.3d 1473,
1478 (Fed. Cir. 1997). As stated in Swinehart:
where the Patent Office has reason to believe that a functional
limitation asserted to be critical for establishing novelty in the
claimed subject matter may, in fact, be an inherent
characteristic of the prior art, it possesses the authority to
require the applicant to prove that the subject matter shown to
be in the prior art does not possess the characteristic relied on.
439 F.2d at 213.
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While features of an apparatus may be recited either structurally or
functionally, claims directed to an apparatus must be distinguished from the
prior art in terms of structure rather than function. See e.g., In re Schreiber,
128 F.3d at 1477-78.

ANALYSIS
The rejection of claim 1, 2, 4-6, 14, 15, 27-32, and 37 under 35 U.S.C.
§ 112, first paragraph as failing to comply with the written description
requirement is affirmed.
The Examiner correctly concluded that the phrases “formulated to be
replaced by” and “transformed into” differ in scope. Ans. 7. No express
definitions are provided in the Specification for these terms. They are given
their ordinary and customary meaning. To “replace” a material means to
remove the original material and substitute new material in its place. THE
AMERICAN HERITAGE® DICTIONARY OF THE ENGLISH LANGUAGE (2000). To
“transform” a material means to change the original material into a new
material. Id. At best, Appellant’s premise, that the term “could” in
paragraph [0040] (see Fact 1) inherently implies “could or could not,” might
support a claim directed to augments that are “not formulated to be replaced
by scar tissue.” If Appellant wished to cover the same scope as the
Specification, the same language could have been employed. While there is
no in haec verba requirement regarding descriptive support in the
Specification, taking into consideration the differing scope of the phrases
“replaced by” and “transformed into,” the newly added limitation
encompasses subject matter outside the scope of the Specification as
originally filed.
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Appellant’s argument that the newly added limitation only literally
recites inherent properties of materials described in the Specification, such
as PLLA, is not supported by the facts of record. App. Br. 14; Reply Br. 4;
Fact 2. Firstly, the Matsusue article, submitted for the first time with the
Reply Brief is not timely. 37 C.F.R. § 41.33(d). Secondly, the mere
disclosure of PLLA alone is not sufficient to provide descriptive support for
a material that is formulated “not to transform into scar tissue.” Appellant
himself contends the exact opposite in arguing the prior art rejections,
asserting that the mere fact that Klüber discloses a single ingredient, PLLA,
in the augments is irrelevant to whether Klüber discloses augment material
that is formulated not to transform into scar tissue. App. Br. 21. The fact
that one of ordinary skill in the art would know how to employ PLLA to
formulate an augment material that does not transform into scar tissue is
relevant to the enablement requirement but not to the separate written
description requirement. See Ariad Pharms., Inc. v. Eli Lilly and Co., ___
F.3d ___, 2010 WL 1007369, at *6 (Fed. Cir. Mar. 22, 2010). A
description that merely renders the invention obvious does not satisfy the
written description requirement. See id. at *14 (citing Lockwood v. Am.
Airlines, 107 F.3d 1565, 1571-72 (Fed. Cir. 1997)). Appellant is improperly
attempting to claim a particular result without describing the structure that
accomplishes it. See id. (citing Univ. of Rochester v. G.D. Searle & Co., 358
F.3d 916, 927-28 (Fed. Cir. 2004)).
For these reasons we adopt the Examiner’s finding that the
Specification lacks descriptive support for an “augment material []
formulated not to transform into scar tissue.” Fact 3. The Examiner has
explained that the claimed embodiment lies outside the scope of the
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Specification and has reasoned that mere disclosure of PLLA does not
suffice to support this limitation. Thus, the Examiner has established a
prima facie case.

The rejection of claims 1, 2, 4-6, 14, 15, 27-32, and 37 under 35 U.S.C.
§ 103(a) as being unpatentable over Klüber or, in the alternative, under 35
U.S.C. § 103(a) as being unpatentable over Klüber and Mikhail is affirmed.
Klüber discloses an augment material that “is formulated not to
transform into scar tissue.” Firstly, even if Klüber does describe a
transformation of the PLLA, there is no indication that the transformation is
into “scar tissue.” Klüber discloses the material is transformed into
“yielding connective tissue.” Fact 4. There is no evidence of record
establishing that the “yielding connective tissue” described by Klüber is
“scar tissue.”
Secondly, the Examiner reasonably concluded that since Klüber’s
retaining ring is structurally indistinguishable from Appellant’s claimed
augment, Klüber’s retaining ring would act in the same manner as
Appellant’s augment when placed in the body and “not [be] transformed into
scar tissue.” Ans. 5. The fact that the translator chose the term “transform”
to describe the process undergone by Klüber’s material is not dispositive.
The same word may have different meanings in different contexts and the
prior art must be considered as a whole. Klüber provides no additional
details of what exactly is meant by “transform.” Unlike Appellant, Klüber
does not also employ the term “replace” which would tend to indicate
recognition of distinct meanings. Since the Examiner has a reasonable basis
to believe that the limitation asserted by Appellant to be critical for
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establishing novelty in the claimed subject matter is, in fact, an inherent
characteristic of Klüber, the burden shifts to Appellant to establish that this
belief is erroneous. Swinehart, 439 F.2d at 213. Appellant has not provided
sufficient evidence to do so.
Regarding the term “integrated,” a predecessor to our reviewing court
on several prior occasions interpreted the term “integral” to cover more than
a unitary construction. See, e.g., In re Kohno, 391 F.2d 959, 960 n.4 (CCPA
1968); In re Dike, 394 F.2d 584, 590 (CCPA 1968); In re Larson, 340 F.2d
965, 967-68 (CCPA 1965); In re Clark, 214 F.2d 148, 150 (CCPA 1954).
The Federal Circuit has also endorsed this interpretation. See, e.g.,
Advanced Cardiovascular Sys., Inc. v. Scimed Life Sys., Inc., 887 F.2d 1070,
1074 (Fed. Cir. 1989) (nothing of record limited “integral” to mean “of one-
piece” construction). Appellant has not pointed to any definition in the
Specification or elsewhere which would mandate that the term “integrated
fastener” be afforded such a narrow construction so as to exclude Klüber’s
screws contained within the holes bored in the retaining ring. See Fact 5.
Appellant’s own fasteners 28 are not described as being of unitary
construction with the augment, and the Specification describes that “[s]crew
mechanisms” may be used. Spec., para. [0032]. Thus, Appellant’s argument
that Klüber fails to disclose “at least one integrated fastener” is not
persuasive.
Appellant’s “teaching away” argument is noted (App. Br. 24), but
lacking from this argument is any reasoning to show that Klüber criticizes,
discredits, or otherwise discourages the solution claimed—fundamental to
establish that a reference “teaches away.” See, e.g., In re Fulton, 391 F.3d
1195, 1201 (Fed. Cir. 2004).
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DECISION
The rejection of claim 1, 2, 4-6, 14, 15, 27-32, and 37 under 35 U.S.C.
§ 103(a) as being unpatentable over Klüber or, in the alternative, under 35
U.S.C. § 103(a) as being unpatentable over Klüber and Mikhail is affirmed.
The rejection of claim 1, 2, 4-6, 14, 15, 27-32, and 37 under 35 U.S.C.
§ 112, first paragraph as failing to comply with the written description
requirement is affirmed.

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv) (2009).

AFFIRMED

nhl

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