Ex Parte Butler

Board of Patent Appeals and Interferences

Sep 24, 2010

10406153 (B.P.A.I. Sep. 24, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte CHARLES E. BUTLER
__________

Appeal 2010-007000
Application 10/406,153
Technology Center 1600
__________

Before TONI R. SCHEINER, FRANCISCO C. PRATS, and
STEPHEN WALSH, Administrative Patent Judges.

WALSH, Administrative Patent Judge.

DECISION ON APPEAL1
This is an appeal under 35 U.S.C. § 134(a) involving claims to wound
repair compositions and methods for their use. The Patent Examiner
rejected the claims as indefinite and as obvious. We have jurisdiction under
35 U.S.C. § 6(b). We affirm.

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.

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STATEMENT OF THE CASE
Claims 1, 2, 4-6, 8 and 11-41 are on appeal. Claims 1, 8 and 25 are
representative and read as follows:
1. A composition for wound repair comprising a biodegradable barrier
material integrated with a support material, wherein the barrier material is
decellularized tissue.

8. The composition of claim 1, wherein the decellularized tissue is
selected from the group consisting of extracellular matrix, ground substance,
basement membrane, decellularized tissue including basement membrane,
decellularized tissue excluding basement membrane, and particulate
decellularized tissue.

25. A composition for wound repair comprising support material disposed
between two or more layers of barrier material, wherein the barrier material
is decellularized dermal tissue.

The Examiner rejected the claims as follows:
• claim 8 under 35 U.S.C. § 112, second paragraph, as being
indefinite for failing to particularly point out and distinctly claim the subject
matter regarded as the invention;
• claims 1, 2, 4-6, 8, 11, 14-18, 21-25, 29-33, and 36-41 under
35 U.S.C. §103(a) over Liu,2 Spievack,3 Orgill I,4 and if necessary further in
view of Brendel5 or Goldstein;6

2 US Patent No. 5,578,046 issued to Cheng-Kung Liu et al., Nov. 26, 1996.
3 US Patent No. 6,893,666 B2 issued to Alan R. Spievack, May 17, 2005.
4 US Patent No. 5,716,411 issued to Dennis P. Orgill et al., Feb. 10, 1998.
5 US Patent No. 4,801,299 issued to Klaus Brendel et al., Jan. 31, 1989.
6 US Patent No. 5,613,982 issued to Steven Goldstein, Mar. 25, 1997.
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• claims 12, 13, 27 and 28 under 35 U.S.C. §103(a) over Liu,
Spievack, Orgill I, Bolea,7 and if necessary further in view of Brendel or
Goldstein;
• claims 19, 20, 34 and 35 under 35 U.S.C. §103(a) over Liu,
Spievack, Orgill I, Boyce,8 and if necessary further in view of Brendel or
Goldstein;
• claim 26 under 35 U.S.C. §103(a) over Liu, Spievack, Orgill I,
Campos,9 and if necessary further in view of Brendel or Goldstein;
• claims 1, 2, 4-6, 8, 11, 21-26, and 36-41 under 35 U.S.C. §103(a)
over Orgill II,10 Spievack, Orgill I, and if necessary further in view of
Brendel or Goldstein;
• claims 14-18 and 29-33 under 35 U.S.C. §103(a) over Orgill II,
Spievack, Orgill I, Liu, and if necessary further in view of Brendel or
Goldstein;
• claims 12, 13, 27 and 28 under 35 U.S.C. §103(a) over Orgill II,
Spievack, Orgill I, Bolea, and if necessary further in view of Brendel or
Goldstein; and
• claims 19, 20, 34, and 35 under 35 U.S.C. §103(a) over Orgill II,
Spievack, Orgill I, Boyce, and if necessary further in view of Brendel or
Goldstein.

7 US Patent No. 6,821,291 B2 issued to Stephen L. Bolea et al., Nov. 23,
2004.
8 US Patent No. 5,899,939 issued to Todd M. Boyce et al., May 4, 1999.
9 US Patent No. 5,290,217 issued to Luis I. Campos, Mar. 1, 1994.
10 Patent Application Publication No. WO 00/16822 by Dennis P. Orgill et
al., published Mar. 30, 2000.
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INDEFINITENESS
The Issue
Claim 8 defines a composition wherein decellularized tissue is
selected from a group including extracellular matrix, ground substance and
others. The Examiner’s position is that the Specification failed to describe a
difference between “ground substance” and decellularized tissue, as well as
the difference between “extracellular matrix” and decellularized tissue.
(Ans. 4). According to the Examiner these differences are uncertain. (Id.).
Appellant contends that that the terms “ground substance” and
“extracellular matrix” are not indefinite as they are “well known terms of
anatomy and would be understood by one of skill in the art.” (App. Br. 6).
In support, Appellant refers to Stedman’s Medical Dictionary for the
definition of “ground substance.” (Id.). Further, Appellant asserts that the
term “extracellular matrix” is listed in claim 8 as “a species of the more
generic term, decellularized tissue.” (Id.).
The issue with respect to this rejection is whether a person skilled in
the art would have understood claim 8.
Findings of Fact
1. Stedman’s Medical Dictionary defines “ground substance” as “the
amorphous material in which structural elements occur; in connective tissue,
it is composed of proteoglycans, plasma constituents, metabolites, water, and
ions present between cells and fibers.” (See App. Br., Ex. 1).
Principles of Law
The test for definiteness under 35 U.S.C. § 112, second paragraph, is
whether “those skilled in the art would understand what is claimed when the
claim is read in light of the specification.” Orthokinetics, Inc. v. Safety
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Travel Chairs, Inc., 806 F.2d 1565, 1576 (Fed. Cir. 1986) (citations
omitted).
Analysis
Appellant established that “ground substance” and “extracellular
matrix” were well known terms in the art that would have been understood
by one of ordinary skill in the art. (See, e.g., FF-1). The rejection did not
establish that a person of ordinary skill in the art would have needed more
refined definitions to understand the claim, and therefore did not state a
prima facie case of indefiniteness. See Orthokinetics, Inc., 806 F.2d at 1576.
We reverse.
OBVIOUSNESS
The Issue
The Examiner’s position is that Liu disclosed a composite sheet useful
in hernia repair, as a surgical mesh, and as a wound dressing. (Ans. 5). The
Examiner found that Liu disclosed that its composite comprised a core layer
surrounded by a shell layer, both of which may be formed of bioabsorbable
material, including collagen. (Id.).
The Examiner found that Spievack disclosed devitalized (acellular)
tissue compositions for tissue repair or regeneration. (Id. at 6). The
Examiner found that Spievack disclosed that its devitalized tissue comprised
a devitalized extracellular matrix including an epithelial basement
membrane essentially free of cells. (Id.). The Examiner also found that
Spievack disclosed that its composition may be in the form of a sheet and
used as a scaffold for dermal or epidermal repair. (Id.). Additionally, the
Examiner found that Spievack taught that its compositions may contain
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collagen and glycosaminoglycans and can be cross-linked to control the rate
at which it is resorbed. (Id.).
The Examiner found that Orgill I disclosed skin regeneration for burns
and wounds by applying a bi-layer containing a collagen-
glycosaminoglycan (CG) matrix having an outer silicone layer that functions
as a moisture barrier. (Id.). The Examiner found that Orgill I disclosed that
its matrix is cross-linked and biodegradable. (Id.). Additionally, the
Examiner found that Orgill I disclosed placing the CG matrix in contact with
the skin, while the silicone side is away from the wound. (Id.). Also, the
Examiner found that Orgill I taught that its CG matrix can be seeded with
cells to hasten the formation of new skin. (Id.).
The Examiner found that Brendel and Goldstein disclosed producing
decellularized extracellular matrices for implanting in the body to stimulate
tissue regeneration. (Id.). According to the Examiner, if needed, these
references provide an additional suggestion to use devitalized tissue as the
shell layer of Liu. (Id. at 8).
According to the Examiner, it would have been obvious to modify
Liu’s composite by using Spievack’s devitalized tissue as the shell layer.
(Id. at 7). The Examiner reasoned that Spievack’s devitalized tissue would:
(a) improve in vivo endogenous cell propagation and tissue restoration, as
taught by Spievack; and (b) provide a matrix into which cells can migrate
from surrounding tissue and which matrix can be seeded with cells to hasten
tissue formation, as suggested by Orgill I. (Id.). The Examiner also
reasoned that the devitalized tissue of Spievack, which is decellularized
tissue, would inherently be a barrier layer when forming the shell layer of
Liu. (Id.). According to the Examiner, it would be expected that Spievack’s
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devitalized tissue would function similarly to Orgill I’s cross-linked CG
shell matrix because both matrices contain CG and can be cross-linked.
(Id.). Further, the Examiner explained that Liu disclosed that its shell could
be formed of collagen, which also comprises the matrices of both Spievack
and Orgill I. (Id.).
Regarding the rejections over combinations including Orgill II, the
Examiner found that Orgill II disclosed tissue repair using a composition
comprising a structural biomaterial such as polypropylene mesh integrated
with at least one biodegradable matrix, such as a CG matrix. (Id. at 10).
According to the Examiner, it would have been obvious to a skilled artisan
at the time of the invention to substitute the Orgill II CG matrix with
Spievack’s devitalized tissue for the same reasons discussed regarding the
combination of Liu and Spievack, supra.
Appellant contends that there is “no suggestion in the cited art of the
use of a decellularized tissue in a composite with a mesh that is suitable for
hernia repair.” (App. Br. 7). Appellant asserts that “[n]either the material or
Spievack nor Orgill [I] could be used to provide the structural strength
necessary for hernia repair.” (Id.). Additionally, Appellant asserts that “Liu
offers no suggestion that the polymer outer shell would overcome the
problems of maximizing cellular infiltration or neovascularization while
providing a barrier against visceral adhesion, and while also promoting
incorporation of mesh into the abdominal wall….” (Id.).
Also according to Appellant, Liu “teaches away from a composite of a
biodegradable barrier material of decellularized tissue integrated with a
support material” because Liu disclosed “only composites in which the core
and shell are both bioabsorbable or both non-absorbable” rather than
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“integrating a nondegradable structural support material with biodegradable
barrier materials.” (Id. at 7-8). Appellant also asserts Liu teaches away
from the claimed compositions “in which the inner layer provides structural
strength while the outer layer provides a matrix for tissue ingrowth with a
reduce incidence of adhesions” by teaching that both or all layers must be
bonded into a single structural unit. (Id. at 8-9).
Appellant contends that Liu’s materials are processed differently than
the claimed compositions because Liu disclosed that its materials are
“extruded polymers or polymers melted and formed into a unified structural
entity.” (Id. at 9-10). According to Appellant, such materials “cannot
include or suggest a decellularized tissue that functions as described in the
present specification and examples,” i.e., materials that “would allow for the
formation of highly porous, fibrous matrix that would permit new tissue
ingrowth prior to matrix degradation.” (Id. at 11).
Appellant further contends that it is not clear that Spievack’s
devitalized tissue would functionally combine with Liu’s composite to
provide a “unified solid structural composition as required by Liu,” or that
the combination “would result in greater reductions in adhesion surface area,
adhesion grade and bowel involvement than other known matrix materials
when used for abdominal wound repair.” (Id. at 11).
Additionally, Appellant asserts that Orgill I described “only materials
for use on the skin surface for repair of skin wounds” which would not be
suitable for use in hernia repair “because they would be expected to adhere
to the viscera.” (Id. at 11-12). Appellant also asserts that Orgill I differs
from the “claimed materials” because Orgill I’s materials are “completely
bioabsorbed and no structural mesh is left in the skin.” (Id. at 12). Further,
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Appellant asserts that “neither Spievack nor Orgill I” described using “their
respective materials as coatings on surgical mesh for use next to a visceral
surface.” (Id.). According to Appellant, it was a “surprising discovery that
the claimed matrix material adheres to the musculofascial tissue, but exhibit
very low adherence to visceral organs” so as to be useful in a hernia repair
composite. (Id.).
Regarding the rejections over combinations including Orgill II, and
claim 25 in particular, Appellant asserts the claimed invention is patentable
“because the use of decellularized tissue with a support material is
significantly and unexpectedly better at reducing adhesion than the use of
the previously disclosed matrix materials with a support material.” (Id. at
13-14). According to Appellant, the Declaration of Dr. Robert Allen Smith
provides evidence of these asserted surprising results. (Id. at 14).
Additionally, Appellant asserts that the Specification examples and research
published after the present application was filed “illustrate the improved
performance of construct that used decellularized tissue over [the prior art]
that used collagen-glycosaminoglycan matrix,” i.e., reduced adhesion
strength and adhesion grade. (Id.).
The issues with respect to these rejections are: whether the record
supports the Examiner’s conclusion that the cited references would have
made the claimed compositions and methods prima facie obvious, and if so,
whether Appellant has provided evidence of unexpected results such that the
totality of evidence weighs in favor of nonobviousness.
Findings of Fact
2. We agree with the Examiner’s findings concerning the explicit
teachings of each of the prior art references. (See Ans. 4-13).
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3. Orgill II stated “[i]n a particular embodiment, the tissue repair is a
hernia repair….” (Orgill II p. 5, ll. 14-15).
Principles of Law
The question of obviousness is resolved on the basis of underlying
factual determinations including (1) the scope and content of the prior art,
(2) any differences between the claimed subject matter and the prior art, (3)
the level of skill in the art, and (4) where in evidence, so-called secondary
considerations. Graham v. John Deere Co., 383 U.S. 1, 17-18 (1966).
“[W]hile it is true that claims are to be interpreted in light of the
specification . . . , it does not follow that limitations from the specification
may be read into the claims. . . . It is the claims that measure the invention.”
Sjolund v. Musland, 847 F.2d 1573, 1581-82 (Fed. Cir. 1988) (emphasis in
original, citation omitted).
A prior art reference is said to teach away from an Applicant’s
invention “when a person of ordinary skill, upon reading the reference,
would be discouraged from following the path set out in the reference, or
would be led in a direction divergent from the path that was taken by the
applicant.” In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994).
A showing of unexpected results must be commensurate in scope with
the breadth of the claims. In re Grasselli, 713 F.2d 731, 743 (Fed. Cir.
1983); see also In re Greenfield, 571 F.2d 1185, 1189 (CCPA 1978)
(“[O]bjective evidence of non-obviousness must be commensurate in scope
with the claims.”).

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Analysis
We are not persuaded of nonobviousness by Appellant’s arguments
asserting that the prior art either does not teach or suggest, or teaches away
from, compositions and/or methods having features not required by the
claims. The features not found in actual claim limitations are: (a) that are
suitable use in hernia repair; (b) that “maximize[e] cellular infiltration or
neovascularization while providing a barrier against visceral adhesion, and
while also promoting incorporation of mesh into the abdominal wall;” (c) “in
which the inner layer provides structural strength while the outer layer
provides a matrix for tissue ingrowth with a reduce incidence of adhesions;”
(d) that “would allow for the formation of highly porous, fibrous matrix that
would permit new tissue ingrowth prior to matrix degradation;” (e) that
“would result in greater reductions in adhesion surface area, adhesion grade
and bowel involvement than other known matrix materials when used for
abdominal wound repair;” and (f) using “their respective materials as
coatings on surgical mesh for use next to a visceral surface.” (See App. Br.
7-15). We do not read these features into the claims. Sjolund, 847 F.2d at
1581-82. Accordingly, these features are not differences between the
claimed subject matter and the prior art with respect to an obviousness
analysis. See Graham, 383 U.S. at 17-18.
To the extent that claim 24 recites hernias among the list of possible
wounds for repair, both Liu and Orgill II expressly disclosed that their
compositions were useful in “hernia repair.” (See Ans. 5 and FF-3).
Nor are we persuaded by Appellant’s assertion that Liu taught away
from “a composite of a biodegradable barrier material of decellularized
tissue integrated with a support material” by disclosing composites in which
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the core and shell are both bioabsorbable, as Appellant asserts. (See App.
Br. 7-8). As the Examiner explained, only claim 26 requires the support
material to be made of a material that is non-absorbable, e.g., polypropylene.
(See Ans. 14). In rejecting claim 26 over combinations including Liu, the
Examiner found that Campos disclosed using polypropylene mesh for hernia
repair (Ans. 10), a finding unchallenged by Appellant. Liu did not address
combining polypropylene, or any other non-absorbable support material with
a biodegradable barrier material. Consequently, Liu cannot be said to have
discouraged such combination, see Gurley, 27 F.3d at 553, or criticized or
discredited such an alternative.
Appellant argues that unexpected or surprising results have been
shown. In particular, Appellant contends that it was a “surprising discovery
that the claimed matrix material adheres to the musculofascial tissue, but
exhibits very low adherence to visceral organs” so as to be useful in a hernia
repair composite. (App. Br. 12). According to Appellant “the use of
decellularized tissue with a support material is significantly and
unexpectedly better at reducing adhesion than the use of the previously
disclosed matrix materials with a support material.” (Id. at 13). Appellant
relies upon the Declaration of Dr. Smith as evidence, with particular
relevance to claim 25. (Id. at 14).
However, the claims do not require the instant compositions or
methods to reduce adhesion strength and/or adhesion grade. Moreover, as
the Examiner explained (Ans. 17) the Declaration of Dr. Smith and the
Specification examples specifically refer to the use of an
AlloDerm/propylene mesh, which the claims also do not require. (Compare
Smith Dec. ¶¶ 5-8 with Claims App’x). Therefore, we do not find that
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Appellant has provided evidence of unexpected and surprising results that
are commensurate in scope with the breadth of the claims. See Grasselli,
713 F.2d at 743; see also Greenfield, 571 F.2d at1189. Consequently, we
conclude that the totality of evidence, including Appellant’s evidence of
unexpected results, weighs in favor of obviousness.
Appellant also contends that “new claims 42-53 have been added to
overcome [the obviousness] rejection” and are allowable over the cited art.
(App. Br. 15). However, these claims were in an amendment after final
rejection which was not entered. (Ans. 17). These claims are not pending
and therefore not on appeal.
Claims 2, 4-6, and 11-24, and 26-41 have not been argued separately
and therefore stand or fall with claim 1. 37 C.F.R. § 41.37(c)(1)(vii).
Accordingly, we affirm the Examiner’s obviousness rejections of claims 1,
2, 4-6, 8 and 11-41.
CONCLUSIONS OF LAW
The rejection did not establish a prima facie case of indefiniteness for
claim 8.
Appellant has not demonstrated unexpected results commensurate in
scope with the claimed subject matter.
The evidence supports the Examiner’s determination that claims 1, 2,
4-6, 8 and 11-41 would have been obvious over the combined prior art to a
person of ordinary skill in the art at the time of the invention.
SUMMARY
We reverse the rejection of claim 8 under 35 U.S.C. § 112, second
paragraph, as being indefinite;
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we affirm the rejection of claims 1, 2, 4-6, 8, 11, 14-18, 21-25, 29-33,
and 36-41 under 35 U.S.C. §103(a) over Liu, Spievack, Orgill I, and if
necessary further in view of Brendel or Goldstein;
we affirm the rejection of claims 12, 13, 27 and 28 under 35 U.S.C.
§103(a) over Liu, Spievack, Orgill I, Bolea, and if necessary further in view
of Brendel or Goldstein;
we affirm the rejection of claims 19, 20, 34 and 35 under 35 U.S.C.
§103(a) over Liu, Spievack, Orgill I, Boyce, and if necessary further in view
of Brendel or Goldstein;
we affirm the rejection of claim 26 under 35 U.S.C. §103(a) over Liu,
Spievack, Orgill I, Campos, and if necessary further in view of Brendel or
Goldstein;
we affirm the rejection of claims 1, 2, 4-6, 8, 11, 21-26, and 36-41
under 35 U.S.C. §103(a) over Orgill II, Spievack, Orgill I, and if necessary
further in view of Brendel or Goldstein;
we affirm the rejection of claims 14-18 and 29-33 under 35 U.S.C.
§103(a) over Orgill II, Spievack, Orgill I, Liu, and if necessary further in
view of Brendel or Goldstein;
we affirm the rejection of claims 12, 13, 27 and 28 under 35 U.S.C.
§103(a) over Orgill II, Spievack, Orgill I, Bolea, and if necessary further in
view of Brendel or Goldstein; and
we affirm the rejection of claims 19, 20, 34, and 35 under 35 U.S.C.
§103(a) over Orgill II, Spievack, Orgill I, Boyce, and if necessary further in
view of Brendel or Goldstein.

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

AFFIRMED

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