Ex Parte Malaviya et al

Board of Patent Appeals and Interferences

Dec 30, 2010

10483930 (B.P.A.I. Dec. 30, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
_________________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________________

Ex parte PRASANNA MALAVIYA, HERBERT EUGENE SCHWARTZ,
PAMELA LYNN PLOUHAR, and MARK JOSEPH PELO,
Appellants1
____________________

Appeal 2010-002089
Application 10/483,930
Technology Center 1600
____________________

Before CHUNG K. PAK, CAROL A. SPIEGEL, and JEFFREY T. SMITH,
Administrative Patent Judges.

SPIEGEL, Administrative Patent Judge.

DECISION ON APPEAL2

1 The real party in interest is DePuy Products, Inc., a Johnson & Johnson
Company (Amended Appeal Brief filed 15 April 2009 ("App. Br.") at 2).
This decision also cites to the Examiner's Answer mailed 23 July 2009
("Ans."), to the Reply Brief filed 10 September 2009, and to the
Specification ("Spec.) of Application 10/483,930 ("the 930 Application").
2 The two-month period for filing an appeal or commencing a civil action, as
in 37 C.F.R. § 1.304, or for filing a request for rehearing, as recited in 37
C.F.R. § 541.52, 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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2
Appellants appeal under 35 U.S.C. § 134(a) from an Examiner's final
rejection of all pending claims, claims 65, 67, 68, 71, 72, 78, and 79 (App.
Br. 2; Ans. 2; Reply Br. 1). We have jurisdiction under 35 U.S.C. § 134.
We AFFIRM.
I. Statement of the Case
The subject matter on appeal is directed to an implantable porous
scaffold made from a naturally occurring extracellular matrix ("ECM")
material such as small intestine submucosa ("SIS"), which scaffold is useful
for repairing or regenerating damaged or diseased tissue (Spec. 7:2-7).
Claim 65 is the only independent claim on appeal and reads (App. Br.
Claims App'x, emphasis added):
65. A method of making an implantable scaffold for repairing
or regenerating body tissue, the method comprising the steps
of:
providing an extracellular matrix material selected from
the group consisting of: small intestine submucosa, stomach
submucosa, bladder submucosa, respiratory submucosa,
alimentary submucosa, genital submucosa, and liver basement
membrane;
physically comminuting the extracellular matrix in the
presence of a liquid to form a slurry comprising intertwined
strips of extracellular matrix suspended in a liquid; and
lyophilizing the intertwined strips of extracellular matrix
to form an open cell foam of extracellular matrix.

Claim 71 recites "A product made by the process of claim 65" (id.). Claim
78 recites "A product made according to the method of claim 65" (id.; Ans.
4).
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The Examiner (1) rejected claims 65, 67, 68, 71, 72, 78, and 79 under
35 U.S.C. § 103(a) over the combined teachings of Bell,3 Badylak,4 and
Gayer;5 (2) provisionally rejected claim 65 under 35 U.S.C. § 101 as
claiming the same invention as that of claim 80 of copending Application
10/195,354; (3) rejected claims 65, 71, 72, 78, and 79 on the ground of
nonstatutory obviousness-type double patenting over claims 1, 5, and 15 of
U.S. Patent 7,201,917; and, (4) provisionally rejected claims 65, 71, 72, 78,
and 79 on the ground of nonstatutory obviousness-type double patenting
over claims 1 and 6 of copending Application 10/195,354 (Ans. 4-7).
Appellants have not appealed rejections (2) through (4) (App. Br. 3;
Ans. 3-4). Therefore, we summarily sustain rejections (2) through (4). As
to rejection (1), Appellants argue the claims as a single group (App. Br. 4).
Therefore, we decide the appeal of rejection (1) on the basis of claim 65. 37
C.F.R. § 41.37(c)(1)(vii).
II. Rejection of Claims 65, 67, 68, 71, 72, 78, and 79
The Examiner rejected claims 65, 67, 68, 71, 72, 78, and 79 under 35
U.S.C. § 103(a) over the combined teachings of Bell, Badylak, and Gayer.
As to claims 65 and 71, the Examiner found that Bell teaches a method and a
construct for producing graft tissue from a naturally occurring ECM, "which
includes the form of collagen foam," wherein the ECM material is processed

3 US Patent 5,800,537, Method and Construct for Producing Graft Tissue
from an Extracellular Matrix, issued 1 September 1998 to Eugene Bell
("Bell").
4 US Patent 5,275,826, Fluidized Intestinal Submucosa and Its Use as an
Injectable Tissue Graft, issued 4 January 1994 to Badylak et al. ("Badylak").
5 US Patent 6,214,049 B1, Method and Apparatus for Augmenting
Osteointegration of Prosthetic Implant Devices, issued 10 April 2001 to
Gayer et al. ("Gayer").
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in the form of sheets or strips and then freeze-drying the pieces of ECM to
produce a foam (Ans. 5). The Examiner also found that Bell failed to teach
"providing the ECM from small intestine submucosa (SIS) … or
comminuting in the presence of a liquid" (id. at 6). However, the Examiner
found that Badylak teaches not only an injectable tissue graft composition
preferably made from a comminuted SIS starting material, but also that SIS
can be fluidized by comminuting without loss of its apparent biotropic
properties (id.). The Examiner concluded that it would have been obvious to
use SIS as the source of the ECM in the method of Bell in view of Badylak's
teaching that SIS can be comminuted in a liquid without loss of its apparent
biotropic properties (id. at 6-7) with a reasonable expectation of success
given that Bell, Badylak, and Gayer all teach methods of making scaffolds
for repair of damaged tissues (id. at 7). Furthermore, according to the
Examiner, "The limitation wherein the ribbon-like, cohesive pieces of
extracellular matrix are intertwined is deemed to be an inherent effect of the
physical step of comminuting the extracellular matrix into ribbon-like pieces
in the presence of a liquid as there is no separate physical step required for
twisting or intertwining the strips of matrix disclosed by Applicant" (id.).
Appellants essentially argue that
while the combination of Bell, Badylak, and Gayer discloses
forming powders, particulates, sheets, and strips of
extracellular matrix …, none of the references alone or in
combination discuss taking the steps recited in the claimed
method of "comminuting the extracellular matrix in the
presence of a liquid to form a slurry comprising strips of
extracellular matrix suspended in a liquid," and subsequently
"lyophilizing the intertwined strips of extracellular matrix to
form an open cell foam of extracellular matrix" (Reply Br. 4,
original emphasis).
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Appellants emphasize that while Bell teaches (1) collagen foam may be
seeded with ECM particulates and (2) ECM strips or sheets may be formed
into tissue grafts or model systems, none of Bell, Badylak or Gayer teach
intertwining ECM strips to form an open cell foam therefrom (Reply
Br. 6-7). Appellants further argue that the Examiner has failed to articulate
the reasoning necessary for combining or modifying the methods of Bell and
Badylak to reach the claimed invention (App. Br. 9), i.e., the "good results"
disclosed in Badylak refer to hydrated SIS powder, not SIS strips or sheets
(id. at 10).
At issue is whether a preponderance of the evidence of record
supports a conclusion of obviousness.
II. Findings of Fact
The following findings of fact ("FF") are supported by a
preponderance of the evidence of record.
A. Bell
[1] Bell discloses processing a tissue source having an ECM to remove
cells, but not cellular growth factors, therefrom and fragmenting the
processed ECM to form ECM particulates (Bell col. 1, ll. 59-67).
[2] The ECM particulates may be applied to a collagen scaffold in the
form of a foam, thread, fabric or film, which can be seeded with living
cells or the ECM particulates alone may provide a scaffold which can
be seeded with living cells (id. at abstract; col. 1, l. 52-col. 2, l. 1; col.
2, ll. 53-56).
[3] For example, collagen foam is formed by freeze-drying a collagen
solution, the foam is cross-linked, the cross-linked foam is filled with
a collagen solution containing ECM particulates and freeze-dried
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again but not cross-linked to produce a foam having surfaces coated
with ECM particulates (id. at col. 9, ll. 39-47).
[4] In another embodiment, a tissue source is processed in the form of
sheets or strips which can be freeze-dried and, optionally, further
shaped or molded, to form useful graft tissue which provides a site for
host cells to populate (id. at col. 4, l. 63-col. 5, l. 13).
C. Badylak
[5] Badylak discloses that SIS can be fluidized by comminuting without
loss of its apparent biotropic properties for administration to host
tissues in need of repair (Badylak col. 1, ll. 34-39).
[6] Specifically, SIS is physically comminuted, e.g., by grinding in a
frozen state, and drying to form a powder (id. at col. 2, ll. 46-60).
[7] Thereafter, it may be hydrated to form a fluid tissue graft composition
at a desired viscosity (id. at col. 2, ll. 60-64).
D. Gayer
[8] Gayer discloses that methods for purifying, isolating, and
reconstituting collagen are well known in the art (Gayer col. 10, ll. 36-
50).
III. Analysis
A. Legal principles
In determining whether obviousness is established by combining the
teachings of the prior art, "the test is what the combined teachings of the
references would have suggested to those of ordinary skill in the art." In re
Keller, 642 F.2d 413, 425 (CCPA 1981). Furthermore, a reference must be
considered in its entirety, and it is well-established that the disclosure of a
reference is not limited to preferred embodiments or specific working
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examples contained therein. In re Fracalossi, 681 F.2d 792, 794 n.1 (CCPA
1982). In KSR, the Court emphasized that "the [obviousness] analysis need
not seek out precise teachings directed to the specific subject matter of the
challenged claim, for a court can take account of the inferences and creative
steps that a person of ordinary skill in the art would employ." KSR Int'l Co.
v. Teleflex, Inc., 550 U.S. 398, 418 (2007). As stated in KSR,

When there is a design need or market pressure to solve a problem
and there are a finite number of identified, predictable solutions, a
person of ordinary skill has good reason to pursue the known options
within his or her technical grasp. If this leads to the anticipated
success, it is likely the product not of innovation but of ordinary skill
and common sense. In that instance the fact that a combination was
obvious to try might show that is was obvious under § 103.

Id. at 421. Furthermore, "[o]bviousness does not require absolute
predictability of success. … [A]ll that is required is a reasonable expectation
of success." In re O'Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988).
B. Analysis
The claimed method comprises (a) providing a tissue source having an
ECM, e.g., SIS, (b) physically comminuting the SIS in the presence of a
liquid to form a slurry comprising intertwined strips of ECM, and (c) freeze-
drying, i.e., lyophilizing, the intertwined strips of ECM to form an open cell
foam of ECM. Appellants' Specification does not specifically define "an
open cell foam of ECM." Therefore, we interpret an open foam cell of ECM
to be a porous ECM matrix. It is well settled that during examination, the
PTO must interpret terms in a claim using "the broadest reasonable meaning
of the words in their ordinary usage as they would be understood by one of
ordinary skill in the art, taking into account whatever enlightenment by way
of definitions or otherwise that may be afforded by the written description
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contained in the applicant’s specification." In re Morris, 127 F.3d 1048,
1054 (Fed. Cir. 1997).
Bell discloses processing tissue sources to obtain a cellular growth
factor-containing ECM material which can be comminuted into particulates
or strips and used in scaffolds for tissue grafts (FF 1-4). Bell teaches that
scaffolds can be made in the form of foams, threads, fabrics or films coated
with ECM particulates or ECM particulates per se (FF 2). Badylak teaches
that SIS can be fluidized by comminuting and freeze-dried without losing its
apparent biotropic properties (FF 5-6). Thus, we agree with the Examiner
that it would have been obvious to comminute SIS in the presence of a
liquid (i.e., fluidized comminuting) into forms, such as particulates or strips,
in order to obtain a cellular growth factor-containing ECM material usable
as a scaffold for tissue grafts as suggested by at least the combined teachings
of Bell and Badylak with a reasonable expectation of maintaining the
apparent biotropic properties of SIS after freeze-drying based on the
teachings of at least Badylak. We agree with the Examiner that the applied
prior art fairly teaches or suggests that foams, strips, and particulates are
functionally equivalent tissue graft construct materials (see e.g., Ans. 9).
We also agree with the Examiner that Bell must be considered in its entirety
and that such consideration is not limited to preferred embodiments or
specific working examples therein. Fracalossi, 681 F.2d at 794 n.1.
Similarly, considering Badylak in its entirety, we agree with the Examiner
that one of ordinary skill in the art would have reasonably expected "strips"
of fluidized comminuted SIS to provide "good results" based on the "good
results" obtained with fluidized comminuted SIS particulates. Appellants'
unsupported arguments do not convince us otherwise.
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Finally, the test in an obviousness analysis is what the combined
teachings of the applied prior art would have suggested to those of ordinary
skill in the art. Keller, 642 F.2d at 425. Here, Bell suggests that use of
either strips and particulates is acceptable in forming tissue graft scaffolds,
while Badylak teaches that SIS may be comminuted in the presence of liquid
without losing its apparent biotropic (cell growth) properties. An artisan of
ordinary skill in the art has good reason to pursue known options within
his/her technical grasp where, as here, there are a finite number of identified,
predictable solutions to forming a cellular growth factor ECM material
scaffold for use in tissue grafting.
We note that Appellants have not provided any evidence of secondary
considerations, e.g., unexpected results.
C. Conclusion
Therefore, based on the foregoing, we sustain the rejection of claims
65, 67, 68, 71, 72, 78, and 79 under § 103(a) over the combined teachings of
Bell, Badylak, and Gayer since a preponderance of the evidence of record
supports a conclusion of obviousness.
IV. Order
Upon consideration of the record, and for the reasons given, it is
ORDERED that the decision of the Examiner to reject claims 65, 67,
68, 71, 72, 78, and 79 under 35 U.S.C. § 103(a) over the combined teachings
of Bell, Badylak, and Gayer is AFFIRMED;
FURTHER ORDERED that the decision of the Examiner to
provisionally reject claim 65 under 35 U.S.C. § 101 as claiming the same
invention as that of claim 80 of copending Application 10/195,354 is
AFFIRMED;
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FURTHER ORDERED that the decision of the Examiner to reject
claims 65, 71, 72, 78, and 79 on the ground of nonstatutory obviousness-
type double patenting over claims 1, 5, and 15 of U.S. Patent 7,201,917 is
AFFIRMED;
FURTHER ORDERED that the decision of the Examiner to
provisionally reject claims 65, 71, 72, 78, and 79 on the ground of
nonstatutory obviousness-type double patenting over claims 1 and 6 of
copending Application 10/195,354 is AFFIRMED; and,
FURTHER ORDERED that 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)(vi).
AFFIRMED

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