Ex Parte Geistlich et al

Board of Patent Appeals and Interferences

May 21, 2012

10299008 (B.P.A.I. May. 21, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte PETER GEISTLICH and LOTHAR SCHLOESSER
__________

Appeal 2010-011988
Application 10/299,008
Technology Center 1600
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Before DEMETRA J. MILLS, LORA M. GREEN, and STEPHEN WALSH,
Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b).
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STATEMENT OF CASE
21. A resorbable extracellular matrix for reconstruction
of cartilage tissue, said matrix comprising collagen material comprising a
mixture of collagen I and collagen II in a respective ratio of about 1:19 to
about 25:75, wherein said matrix is prepared by mixing a slurry of collagen
I and a slurry of collagen II to form a mixed slurry of collagen I and
collagen II in said respective ratio, and drying said mixture, wherein said
mixture is partially cross-linked by UV irradiation, or said mixture is
partially cross-linked by heating said mixture to a temperature of at least
about 100°C and up to about 140°C, wherein said mixture is partially
cross-linked over a time period of from about 30 minutes up to about 8
hours.

48. The implant of claim 46 wherein said matrix is a carrier of a
material selected from mesenchymal stem cells and a cartilage cell growth-
promoting nucleic acid sequence.

Cited References

Stone et al. US 5,624,463 Apr. 29, 1997
Li et al. US 6,042,610 Mar. 28, 2000
Geistlich et al. US 6,752,834 B2 Jun. 22, 2004

Rudert et al., Synthesis of articular cartilage-like tissue in vitro, 117 ARCH
ORTHOP TRAUMA SURG 141-146 (1998).

Evans et al., Using Gene Therapy to Protect and Restore Cartilage, 379S
CLIN ORTHOP RELAT RES S214-S219 (2000).

Grounds of Rejection
Claims 21, 25-29, 31-34, 36, and 40-47 are rejected under 35 U.S.C. §
103(a) over Geistlich in view of Stone, Li and Rudert.
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Claim 48 is rejected under 35 U.S.C. § 103(a) over Geistlich in view
of Stone, Li, Rudert, and Evans.

FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages 3-
10.

Discussion
ISSUE
The Examiner concludes Geistlich and Stone teach a composition of
collagen types I and II. (Ans. 3-4.) Stone teaches a bioresorbable collagen
device of this substance. (Id. at 4.) However, neither Geistlich nor Stone
teach a composition having the claimed collagen ratio. Li is relied on by the
Examiner for the disclosure of a device comprising collagen types I and II in
a ratio of 1:1. (Id. at 5.) Rudert is relied on for the disclosure of the use of a
polymer fleece in growing chondrocyte culturing in three dimensional
artificial cartilage constructs for cartilage repair. (Id.)
The Examiner concludes that
it would have been obvious for one of ordinary skill in the art to
incorporate into Gestlichs [sic] bioresorbable collagen matrix a
sufficient amount of purified Type I and Type II collagens
suspensions as taught by Stone and Li and prepare a resorbable
matrix with fleece for reconstruction of cartilage. One of
ordinary skill in the art would have been motivated to use a
matrix comprising Type I and Type II collagen as it is
beneficial in repairing the cartilage in animal and human
subjects as it is biocompatible, bioresorbable and allows the
growth and differentiation of chondrocytes required for a
healthy cartilage.

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(Ans. 5-6.)

Appellants argue that Geistlich teaches a multilayer membrane with a
matrix layer of collagen II, which includes at least one barrier layer of
collagen I and III, having a close, relatively impermeable texture, and that
deleting the barrier layer would render Geistlich’s membrane unsatisfactory
for its intended purpose. (App. Br. 7.) Appellants argue that one skilled in
the art would not combine Stone or Li with Geistlich, (id. at 9), or Rudert
with Stone and Li (id. at 10.) In particular, Appellants argue that both Stone
and Li subject the collagen material to harsh chemical or dehydrochemical
cross-linking by heat to produce a stiff, mechanically solid, durable implant
device. (Id.)
The issue is: Has the Examiner provided evidence to support the
conclusion that the claimed subject matter is obvious?

PRINCIPLES OF LAW
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
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Moreover, “obviousness requires a suggestion of all limitations in a
claim.” CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333, 1342 (Fed.
Cir. 2003) (citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).
Under § 103, “there must be some articulated reasoning with some
rational underpinning to support the legal conclusion of obviousness.” KSR
Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 418 (2007).

ANALYSIS
Among other things, Appellants argue that Li and Stone do not
disclose a resorbable extracellular matrix for reconstruction of cartilage
tissue wherein said mixture is partially cross-linked over a time period of
from about 30 minutes up to about 8 hours. (App. Br. 9-10.) Thus, Li and
Stone do not make up for the deficiencies of Geistlich. We are persuaded by
Appellants’ argument.
The Examiner proposes incorporating into Geistlich’s bioresorbable
collagen matrix with a barrier layer, a sufficient amount of purified Type I
and Type II collagen suspensions as taught by Stone and Li and prepare a
resorbable matrix for reconstruction of cartilage. We do not find that the
Examiner has set forth a prima facie case of obviousness.
In particular, Example 7 of Stone describes cross-linking type I and
type II collagen by heating for 26 hours (Example 7) or by chemical cross-
linking (Examples 9 and 10). (Id. at 9.) In addition, Li discloses producing
a stiff, mechanically solid, durable implant device (Li, col. 5, ll. 3-36; id. at
10). Li discloses describes cross-linking type I and type II collagen by
chemical cross-linking. (Col. 12, ll. 1-5.) Appellants, thus argue, that the
collagen type I and II materials of Stone and Li have been cross-linked under
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harsh crosslinking conditions to produce stiff solid materials. We do not
find the Examiner has explained why one of ordinary skill in the art would
substitute the solid, crosslinked materials produced by chemical or long
period crosslinking of Stone and Li, for the multilayer collagen II membrane
of Geistlich produced by UV radiation for about 8 hours.
Thus, we do not find that the Examiner has provided evidence in the
prior art of a resorbable extracellular matrix for reconstruction of cartilage
tissue wherein said mixture is partially cross-linked by UV irradiation, or
said mixture is partially cross-linked by heating said mixture to a
temperature of at least about 100°C and up to about 140°C, wherein said
mixture is partially cross-linked over a time period of from about 30 minutes
up to about 8 hours, as claimed.

CONCLUSION OF LAW
The cited references do not support the Examiner’s obviousness
rejections. The rejections are reversed.

REVERSED

cdc