Ex Parte Atala et al

Patent Trial and Appeal Board

Mar 21, 2013

11048097 (P.T.A.B. Mar. 21, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
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
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
11/048,097 02/01/2005 INV001Anthony Atala 105447-0003 2206
21269 7590 03/22/2013
PEPPER HAMILTON LLP
ONE MELLON CENTER, 50TH FLOOR
500 GRANT STREET
PITTSBURGH, PA 15219
EXAMINER
GOUGH, TIFFANY MAUREEN
ART UNIT PAPER NUMBER
1651
MAIL DATE DELIVERY MODE
03/22/2013 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte ANTHONY ATALA, AKIRA JORAKU,
CHRISTOPHER A. SULLIVAN and JAMES YOO
____________

Appeal 2011-001084
Application 11/048,097
Technology Center 1600
____________

Before DONALD E. ADAMS, STEPHEN WALSH, and
ULRIKE W. JENKS, Administrative Patent Judges.

JENKS, Administrative Patent Judge

DECISION ON REQUEST FOR REHEARING
Appellants request rehearing of the Decision on Appeal entered
December 21, 2012, which affirmed obviousness rejections of claims 15-28
and 36-41, directed to an artificial glandular oral tissue construct and an
artificial salivary gland construct. (Req. Reh‟g at 1.) “Appellants seek
reconsideration of claims 36-41.” (Id.) The request for rehearing is granted.
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GROUNDS PRESENTED
Appellants request rehearing on the grounds that the Board
overlooked “the fact that claims 36-41 were argued separately in the Appeal
Brief (and at oral argument).” (Req. Reh‟g at 1.) Appellants contend that:
I. “Claims 36-41 are discussed in passing in the Board's
affirmation of the obviousness rejection based on the combination of
Grikscheit and Baum” (Req. Reh‟g at 1); and
II. “[c]laim[s] 36-41 were not discussed at all in the Board's
affirmation of the second ground for rejection (Mooney in view of Baum)”
(Req. Reh‟g at 2).

DISCUSSION
Appellants assert that the Baum does not disclose gels, specifically
collagen, as a support but rather discloses gels as a coating on a support
(Req. Reh‟g 2, 3; App. Br. 10, 14). We begin by construing the claims.
Claims 36-41 are dependent on independent claim 15 or on independent
claim 23. Independent claims 15 and 23 do not specifically recite a support,
but require, in pertinent part, “a substrate.” The Specification defines
substrates (Spec. 14-17), and states that substrates provide mechanical and
biochemical support for cells to attach and grow (Spec. 5, 15).
The substrate is preferably a biocompatible substrate.
Biocompatible refers to materials that do not have toxic or
injurious effects on biological functions. Biodegradable refers
to material that can be absorbed or degraded in a patient's body.
Representative materials for forming the biodegradable material
include natural or synthetic polymers, such as, collagen,
poly(alpha esters) such as poly(lactate acid), poly(glycolic acid)
[PGA], polyorthoesters and polyanhydrides and their
copolymers, which degraded by hydrolysis at a controlled rate
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and are reabsorbed.
(Spec. 14.) The Specification further provides that “attachment of the cells
to the substrate is enhanced by coating the substrate with compounds such as
basement membrane components, agar, agarose, gelatin, gum arabic,
collagens, fibronectin, laminin, glycosaminoglycans, mixtures thereof.” (Id.
at 15.) Additionally, the Specification provides that:
Substrates can be treated with additives or drugs prior to
implantation (before or after the polymeric substrate is seeded
with cells), e.g., to promote the formation of new tissue after
implantation. . . . Growth factors and other additives (e.g.,
epidermal growth factor (EGF), heparin-binding epidermal-like
growth factor (HBGF), fibroblast growth factor (FGF),
cytokines, genes, proteins, and the like) can be added in
amounts in excess of any amount of such growth factors (if
any) which may be produced by the cells seeded on the
substrate.
(Id. at 16.)
Based on the Specification, a substrate encompasses either:
(a) polymer, for example PGA or collagen; (b) a polymer and a coating,
where the coating can be for example collagen; (c) a polymer, a coating, and
an additive or drug; or (d) a polymer and an additive or drug. “During
examination, „claims … are to be given their broadest reasonable
interpretation consistent with the specification, and … claim language
should be read in light of the specification as it would be interpreted by one
of ordinary skill in the art.”‟ In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d
1359, 1364 (Fed. Cir. 2004) (quoting In re Bond, 910 F. 2d. 931, 833 (Fed.
Cir. 1990)) Thus, based on the description provided in the Specification, the
biodegradable polymer PGA meets the claimed substrate limitation of
independent claims 15 and 23.
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Claims 36-41 require that the substrate further comprise “a collagen
based amorphous gel,” “matrigel,” or “growth factor reduced matrigel.”
Thus, based on the definition in the Specification, the substrate limitation of
claims 36 and 39 for example, reads on a PGA substrate coated with a
collagen based amorphous gel.

I.
Appellants contend that “the Board misapprehended Baum‟s
teachings as to extracellular matrix proteins and mischaracterized such
coatings as supports or substrates.” (Req. Reh‟g at 2.) (Emphasis omitted.)
“Appellants respectfully assert that Baum disclosed the list of extracellular
matrix proteins only as coatings to the support, not as the support itself”
(id.); and “there is no mention whatsoever of collagen gels as supports in
Baum” (id. at 3).
We do not agree with Appellants‟ position that the claims require
collagen gels as a support. (Req. Reh‟g at 2, 3.) We give claims their
broadest reasonable interpretation consistent with the specification. In re
Morris, 127 F.3d 1048, 1054 (Fed. Cir. 1997). As discussed above, the
Specification does not limit the term “substrate” to collagens or extracellular
matrix proteins. According to the Specification, synthetic polymers such as
PGA are encompassed by the definition of a substrate (Spec. 14). Claims
36-41 each require a substrate, such as PGA, further comprising a collagen
based amorphous gel, which includes Matrigel. Matrigel, as conceded by
Appellants, is an example of a collagen based amorphous gel (Req.
Reh‟g. 3).
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We agree with the Examiner‟s finding that “both Grikscheit and Baum
disclose[d] using collagens and matrigels either on or mixed with the
substrates to enhance cell attachment (Grikscheit 0098, Baum 0030)” (Ans.
17). Grikscheit disclosed using PGA as a polymer scaffold for the organoid
units (Dec. 4-5; FFs 1-2), in addition Grikscheit also disclosed adding a
collagen coating to the PGA substrate (Ans. 17; see also Grikscheit ¶ 0098).
Baum disclosed the use of a PGA support that is coated with an extracellular
matrix protein (Dec. 5-6; FF 5). Baum specifically recites Matrigel in a
short list of extracellular matrix protein coatings (Dec. 10). Grikscheit
disclosed seeding cells on a PGA support coated with collagen, and Baum
disclosed seeding cells on a PGA support coated with an extracellular matrix
protein, such as Matrigel. We agree with the Examiner‟s conclusion that “it
would be obvious to one of ordinary skill in the art to use the salivary cells
of Baum as well as disclosed extracellular matrix proteins in the construct of
Grikscheit.” (Ans. 17.) “The combination of familiar elements according to
known methods is likely to be obvious when it does no more than yield
predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416
(2007).
Appellants‟ arguments do not persuade us that our original Decision
erred. Appellants‟ position, essentially, is that Baum uses the collagen as a
coating for the support. However, as discussed above the present claims do
not exclude non-collagen based supports, such as PGA, that is coated with
collagen. We deny Appellants‟ request for relief as it relates to the rejection
under 35 U.S.C. § 103(a) over the combination of Grikscheit and Baum.
Arguments not made are waived. See 37 C.F.R. § 41.37(c)(1)(vii) (“Any
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arguments or authorities not included in the brief or a reply brief ... will be
refused consideration by the Board, unless good cause is shown.”).
II.
Appellants contend that “the skilled artisan would not utilize an
extracellular matrix protein coating as a support or gel substrate as recited in
Appellants' pending claims” (Req. Reh‟g at 4); and that “Mooney concluded
that the manner in which collagen is presented is critical explicitly stating:
„[i]n the form of a gel, collagen does not provide enough mechanical
stability for the tissue to develop‟” (id. at 5).
It is the Examiner‟s position that:
[B]oth Mooney and Baum disclose using collagens and
matrigels either on or mixed with the substrates to enhance cell
attachment (Mooney col. 11, lines 59-col. 12, lines 1-37, Baum
0030). The use of collagens and matrigels are very well known
in the art to be used as substrates for cell culture.
(Ans. 20.) Mooney specifically disclosed that “the matrix is a synthetic fiber
matrix, the individual fiber components of which matrix are coated with a
collagen coating agent, a polylysine coating agent or an FBS coating agent.”
(Mooney, col. 11, ll. 62-65; Ans. 20.) Matrix material contemplated by
Mooney includes PGA (Mooney, col. 11, l. 55; Ans. 20). We agree with the
Examiner‟s conclusion that it would have been “obvious to one of ordinary
skill in the art to substitute the isolated salivary epithelial cells of Baum in
an artificial tissue construct such as that produced by Mooney.” (Ans. 10-
11.) “The combination of familiar elements according to known methods is
likely to be obvious when it does no more than yield predictable results.”
KSR, 550 U.S. at 416.
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Appellants‟ argument that the combination of Mooney and Baum fail
to render obvious the use of collagen gels and/or Matrigel as supports (Req.
Reh‟g at 5) is not persuasive because the claims are not limited to these
substrates as supports. Nevertheless, we grant Appellants‟ Request for
Rehearing because we did not separately address the subject matter of claims
36-41 with respect to the combination of Mooney and Baum in the Decision.
We have reconsidered the arguments made in the Request for Rehearing as
well as those presented in the Appeal Brief and Reply Brief. However, we
find that the Examiner has the better position (see Ans. 8-12 and 16-20). We
affirm the rejections made by the Examiner because, as discussed above, the
presently pending claims do not limit the substrate support to collagen.

SUMMARY
We have reconsidered the evidence and arguments with respect to the
rejection of claims 36-41 under 35 U.S.C. § 103(a) over Grikscheit and
Baum but deny the requested relief.
We grant the Request for Rehearing of claims 36-41 under 35 U.S.C.
§ 103(a) over Mooney and Baum. We affirm the Examiner‟s rejection of
claims 36-41 under 35 U.S.C. § 103(a) over Mooney and Baum.

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

GRANTED

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