Ex Parte Diamond et al

Board of Patent Appeals and Interferences

Dec 1, 2009

10447454 (B.P.A.I. Dec. 1, 2009)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
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Ex parte MICHAEL P. DIAMOND and GHASSAN M. SAED
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Appeal 2009-006914
Application 10/447,454
Technology Center 1600
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Decided: December 2, 2009
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Before TONI R. SCHEINER, DEMETRA J. MILLS, and
MELANIE L. McCOLLUM, Administrative Patent Judges.

SCHEINER, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 from the final rejection of
claims 1 and 4-11,1 directed to a biological model for the development of
adhesions. The claims have been rejected on the grounds of anticipation and
obviousness. We have jurisdiction under 35 U.S.C. § 6(b).

1 Pending claims 12-19 have been withdrawn from consideration, while
claims 2 and 3 have been canceled (App. Br. 2).
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STATEMENT OF THE CASE
“Adhesions are scar tissue that connects other tissue in anatomically
abnormal locations.” (Spec. 1). “The development of adhesions is . . . an
abnormal manifestation of the healing process.” (Id.).
Claim 1 is representative of the subject matter on appeal:
1. A biological model for adhesion development comprising a pair of
opposed, viable explants of mammalian peritoneum tissue obtained from
mammalian peritoneum, the opposed surfaces of said tissue explants being
about 1 mm to about 20 mm apart, and said explants being maintained in a
culture media containing exogenous pro fibrotic agents under conditions
sufficient to permit the formation of adhesions in vitro on one or both of the
explant surfaces.

The Examiner relies on the following evidence:

Hiroto Toh et al., In Vitro Analysis of Peritoneal Adhesions in Peritonitis, 61
JOURNAL OF SURGICAL RESEARCH 250-255 (1996).

Ghassan M. Saed et al., Alteration of Type I and III Collagen Expression in
Human Peritoneal Mesothelial Cells in Response to Hypoxia and
Transforming Growth Factor-β1, 7 WOUND REPAIR AND REGENERATION
504-510 (1999).

Andrew E. Jahoda et al., Fibrin Sealant Inhibits Connective Tissue
Deposition in a Murine Model of Peritoneal Adhesion Formation, 125
SURGERY 53-59 (1999).

The Examiner rejected the claims as follows:
• Claims 1, 4-6, 8 and 11 under 35 U.S.C. § 102(b) as anticipated by
Toh.

• Claims 1 and 4-11 under 35 U.S.C. § 103(a) as unpatentable over Toh,
Saed, and Jahoda.

We reverse.
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ANTICIPATION
Issue
The Examiner finds that Toh discloses a model for development of
peritoneal adhesion comprising “opposed monolayers of mesothelial cells
obtained from human peritoneum” (Ans. 4).
Appellants contend that the claimed model requires a pair of tissue
explants, and Toh’s monolayers of mesothelial cells are not tissue explants
(App. Br. 4, 6).
In view of these conflicting positions, the issue raised by this rejection
is as follows: Has the Examiner established that Toh describes an adhesion
model comprising a pair of tissue explants?
Findings of Fact (“FF”)
FF1 Claim 1 is directed to “[a] biological model for adhesion
development comprising a pair of opposed, viable explants of mammalian
peritoneum tissue . . . maintained in a culture media containing exogenous
pro fibrotic agents under conditions sufficient to permit the formation of
adhesions in vitro on one or both of the explant surfaces.”
FF2 According to the Specification, “[t]he peritoneum . . . [is]
composed of mesothelial cells and sub-mesothelial tissue that contain
fibroblasts, macrophages and blood vessels.” (Spec. 6: 9-11.) “The
biological processes that result in . . . the development of adhesions include
migration, proliferation, and/or differentiation of several cell types,
including inflammatory and immune cells, mesothelial cells, and fibroblasts”
and “[s]ubstances produced locally by these cells . . . are central to the
development of adhesions” (id. at 6: 13-18).
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FF3 Example 1 of the Specification describes the preparation of
“viable explants of parietal peritoneum tissue [that] can be maintained in
vitro long enough to support the development of adhesions” as follows:
Segments of the parietal peritoneum are excised to create
tissue explants 1 cm in length by 1 cm in height by
approximately 2-3 mm in width. Harvested explants are then
immediately rinsed in standard media . . . to remove blood, and
then transferred to 1 ml of the same medium in a sterile culture
dish. Cultures are maintained . . . for a total of 5 days . . . [to]
demonstrate the ability to maintain viable tissue explants
throughout the five day period proposed for the in vitro model
of adhesion development.

(Spec. 11: 5-19.)
FF4 The ordinary meaning of “explant” is “[l]iving tissue excised
from the body and maintained in culture medium.”2
FF5 Toh describes “an in vitro model of peritoneal adhesion using
peritoneal mesothelial cell culture” (Toh, Abstract).
FF6 Toh’s model comprises opposing monolayers of mesothelial
cells (i.e., mesothelial cell-coated microcarriers placed in the wells of a
microtiter plate also coated with mesothelial cells), cultured in the presence
of an exogenous pro fibrotic agent (e.g., TNF-α). (Toh 250, col. 2.)
FF7 Toh’s monolayers of mesothelial cells were obtained by
digesting resected human omentum3 with trypsin, discarding the omentum
sheets and centrifuging the supernatant to collect disaggregated mesothelial

2 http://www.nature.com/nrd/journal/v1/n12/glossary/nrd959_glossary.html
(accessed November 18, 2009).
3 The omentum is a fold of peritoneum supporting the viscera. See
http://wordnetweb.princeton.edu/perl/webwn?s=omentum (accessed
11/18/09).
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cells, suspending the cells in culture medium in a culture flask, allowing the
cells to attach and proliferate to form a monolayer on the flask, trypsinizing
the monolayer to resuspend the cells, seeding the resuspended cells into
microplates and microcarriers, and allowing the cells to proliferate to form
confluent monolayers. (Toh 250, col. 2.)
Principles of Law
“A claim is anticipated only if each and every element as set forth in
the claim is found, either expressly or inherently described, in a single prior
art reference.” Verdegaal Bros., Inc. v. Union Oil Co. of California, 814
F.2d 628, 631 (Fed. Cir. 1987).
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 contained in the applicant’s
specification.” In re Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997).
Analysis
Claim 1, which represents the claimed adhesion model in its broadest
aspect, requires “opposed, viable explants of mammalian peritoneum tissue.”
The Specification explains that the processes that lead to the development of
adhesions involve several different types of cells and the substances that
they produce (FF2), and all of the adhesion models in the Specification’s
examples use blocks of excised tissue (FF3), not monolayers of a single cell
type. Moreover, the Specification’s use of intact tissue is consistent with the
ordinary meaning of “explant” (i.e., living tissue excised from the body and
maintained in culture) (FF4). Against this background, it is unreasonable to
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equate Toh’s monolayers, derived from individual cells isolated from
disaggregated tissue (FF6, FF7), with the tissue explants required by the
claims.
Conclusions of Law
The Examiner has not established that Toh describes an adhesion
model comprising a pair of tissue explants.
The rejection of claims 1, 4-6, 8, and 11 as anticipated by Toh is
reversed.
OBVIOUSNESS
Issue
The Examiner rejected claims 1 and 4-11 as unpatentable over Toh,
Saed, and Jahoda (Ans. 5-7).
The issue raised by this rejection is as follows: Has the Examiner
established that an adhesion model comprising a pair of tissue explants
would have been obvious given the disclosures of Toh, Saed, and Jahoda?
Analysis
The Examiner cites Saed and Jahoda for “the use and/or effects of
blood clot, TGF beta-1 or talc in the peritoneal model” to meet the
limitations of several of the dependent claims (Ans. 6). However, as
discussed above, Toh does not describe an adhesion model comprising a pair
of tissue explants, as required by all the claims on appeal. The Examiner’s
rejection does not address this underlying deficiency in the reference.
Conclusions of Law
The Examiner has not established that an adhesion model comprising
a pair of tissue explants would have been obvious given the disclosures of
Toh, Saed, and Jahoda.
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SUMMARY
• The rejection of claims 1, 4-6, 8, and 11 under 35 U.S.C. § 102(b) as
anticipated by Toh is reversed.

• The rejection of claims 1 and 4-11 under 35 U.S.C. § 103(a) as
unpatentable over Toh, Saed, and Jahoda is reversed.

REVERSED

alw

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