Ex Parte O et al

Patent Trial and Appeal Board

Sep 29, 2016

11286593 (P.T.A.B. Sep. 29, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111286,593 11123/2005
26710 7590 10/03/2016
QUARLES & BRADYLLP
Attn: IP Docket
411 E. WISCONSIN A VENUE
SUITE 2350
MILWAUKEE, WI 53202-4426
FIRST NAMED INVENTOR
Shawn W. O'Driscoll
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www .uspto.gov
ATTORNEY DOCKET NO. CONFIRMATION NO.
630666.00051 2342
EXAMINER
SHARMA, YASHITA
ART UNIT PAPER NUMBER
3774
NOTIFICATION DATE DELIVERY MODE
10/03/2016 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address( es):
pat-dept@quarles.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SHAWN W. O'DRISCOLL, DAVID G. LEWALLEN, and
RODRIGO MARDONES
Appeal2013-003404
Application 11/286,593
Technology Center 3700
Before JOHN C. KERINS, BRANDON J. WARNER, and
RICHARD H. MARSCHALL, Administrative Patent Judges.
WARNER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Shawn W. O'Driscoll et al. ("Appellants") 1 appeal under 35 U.S.C.
§ 134(a) from the Examiner's decision rejecting claims 1-3, 7, 10, and 11.
Appeal Br. 3. Claims 4---6, 8, 9, 12, and 13 have been canceled, and claims
14--30 have been withdrawn. Id. We have jurisdiction over the appeal under
35 U.S.C. § 6(b).
We REVERSE.
According to Appellants, the real party in interest is Mayo Foundation
for Medical Education and Research. Appeal Br. 2.
Appeal2013-003404
Application 11/286,593
CLAIMED SUBJECT MATTER
Appellants' disclosed invention "relates to an improved method and
new devices for the treatment of osteochondral defects," specifically, "a
biosynthetic composite for osteochondral defect repair." Spec. i-f 3. Claim 1,
reproduced below with emphasis added, is the sole independent claim and is
representative of the subject matter on appeal.
1. A composite for the repair of osteochondral defects, the
composite comprising:
a biocompatible porous scaffold; and
a cartilage-generating graft secured to a surface of the
scaffold, wherein the cartilage[ -]generating graft is harvested
periosteum,
wherein the periosteum does not undergo an in vitro cell
culture expansion step.
EVIDENCE
The Examiner relied on the follo\~1ing evidence in rejecting the claims
on appeal:
Kaplan
Levine
Masuda
us 5,282,861
US 2003/0220696 Al
US 2003/0229400 Al
REJECTIONS
The following rejections are before us for review:
Feb. 1, 1994
Nov. 27, 2003
Dec. 11, 2003
I. Claims 1, 7, 10, and 11 stand rejected under 35 U.S.C. § 102(a)
as anticipated by Masuda.
II. Claim 2 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Masuda and Levine.
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Appeal2013-003404
Application 11/286,593
III. Claim 3 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Masuda, Levine, and Kaplan.
ANALYSIS
All the claims on appeal recite a composite for the repair of
osteochondral defects, where the composite includes "a biocompatible
porous scaffold" and "a cartilage-generating graft secured to a surface of the
scaffold," wherein "the cartilage[-]generating graft is harvested periosteum,"
and wherein "the periosteum does not undergo an in vitro cell culture
expansion step." See Appeal Br., Claims App. (emphasis added).
In rejecting the independent claim, the Examiner relies on Masuda for
disclosing the recited composite, including the disputed limitation italicized
above regarding the cartilage-generating graft being harvested periosteum
that does not undergo in vitro cell culture expansion. Final Act. 3--4 (citing
Masuda, claim 1, i-fi-15, 39). In particular, the Examiner correctly identifies
the disputed limitation as a "product-by-process" limitation-where a
product is limited by and defined by the recited process, but the patentability
of which is based on the structure of the product itself rather than its method
of production-but takes the position that Masuda's final composite,
including a tissue graft that does undergo in vitro cell culture expansion, 2
would nevertheless be the same product. Id. at 4.
2 The disclosure of Masuda's claim 1, as relied on by the Examiner,
describes an osteochondral implant that includes "engineered cartilage tissue
attached to a biocompatible support scaffold," and expressly states that "the
cartilage tissue is derived from chondrogenic cells [which the Examiner
considers to encompass periosteum per paragraph 39 of Masuda] cultured in
vitro. Masuda, claim 1 (emphasis added); see also id. i-fi-139, 42, 55.
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Appeal2013-003404
Application 11/286,593
But Appellants persuasively assert, and provide evidence on the
record to support, that there is a structural distinction between graft tissue
that does not undergo an in vitro cell culture expansion step (as in the
claimed composite) versus graft tissue that does undergo an in vitro cell
culture expansion step (as in Masuda). See Appeal Br. 5-9 (citing evidence
of record in Exhibits A and B). Specifically, Appellants explain that
evidence demonstrates that undergoing an in vitro cell culture expansion
step results in Masuda's graft tissue having a physical characteristic that is
distinct from the graft tissue as claimed-namely, a higher ratio of
PG/collagen. Id. at 5-7; Exhibit A. Further, Appellants explain that
evidence demonstrates that collagen provides tensile strength to cartilage,
such that harvested periosteum that does not undergo an in vitro cell culture
expansion step, as claimed, results in graft tissue that has a higher tensile
strength than that of Masuda (due to higher collagen levels). Id. at 7-8;
Exhibit B. In other words, although the products may be similar-they are
both graft tissues-they are not the same.
In response to these arguments, the Examiner does not dispute that the
evidence demonstrates there to be a structural distinction between the graft
tissue in the claimed composite (which does not undergo an in vitro cell
culture expansion step) and the graft tissue in Masuda's composite (which
expressly does undergo an in vitro cell culture expansion step). See
Ans. 7-8. Instead, the Examiner takes the position that Masuda's graft
tissue "prior to this step" would be structurally the same as the graft tissue as
claimed, such that "an intermediate composite product," where this "prior"
graft tissue is secured to a scaffold, "anticipates the required structure of
claim 1." Id. at 8. However, Appellants correctly note that the Examiner
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Appeal2013-003404
Application 11/286,593
"does not point out" any disclosure in Masuda of such "prior" graft tissue
actually being "secured to a surface of a scaffold" to form a composite
product. Reply Br. 4--5. Like Appellants, we find no disclosure in Masuda
of any such "intermediate" product, as this reference describes only a
composite product formed with graft tissue that has undergone an in vitro
cell culture expansion step. See id. (citing Masuda i-f 57); see also Masuda
,-r,-r 7, 11, 23.
Accordingly, based on the record before us-because an anticipation
rejection requires a finding in a single reference of each and every limitation
as set forth in the claims-we cannot sustain Rejection I. As to Rejections II
and III, we note that these rejections are premised on the same purported
disclosure from Masuda, and that Levine and Kaplan are relied on for
teaching additional features, but not to cure the deficiency of Masuda
identified above. See Final Act. 5---6. Thus, we also cannot sustain
Rejections II or III.
DECISION
We REVERSE the Examiner's decision rejecting claims 1-3, 7, 10,
and 11.
REVERSED
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