Ex Parte Yoo et al

Patent Trial and Appeal Board

Jul 21, 2015

11279671 (P.T.A.B. Jul. 21, 2015)

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.
11/279,671 04/13/2006 James Yoo 9865-51 8536
20792 7590 07/21/2015
MYERS BIGEL SIBLEY & SAJOVEC
PO BOX 37428
RALEIGH, NC 27627
EXAMINER
PARAS JR, PETER
ART UNIT PAPER NUMBER
1632
MAIL DATE DELIVERY MODE
07/21/2015 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)

1
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JAMES YOO, JOEL STITZEL, ANTHONY ATALA, and
GEORGE CHRIST
__________

Appeal 2012-010516
Application 11/279,6711
Technology Center 1600
__________

Before DEMETRA J. MILLS, CHRISTOPHER G. PAULRAJ, and
ROBERT A. POLLOCK, 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).
We affirm.

STATEMENT OF CASE
According to the Specification, the present invention concerns
methods and apparatus for the growth of skeletal muscle in vitro. Spec. 1 ll.
13–14.

1 According to Appellants, the real party in interest is Wake Forest
University Health Sciences. App. Br. 3.
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Application 11/279,671

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The following claim is representative.
1. A method of producing organized skeletal muscle
tissue from precursor muscle cells, comprising:
(a) providing precursor muscle cells on a decellularized
tissue support in a tissue media; then
(b) cyclically stretching and relaxing said support at least
twice along a first axis during a first time period; and then
(c) maintaining said support in a substantially static
position during a second time period; and then
(d) repeating steps (b) and (c) for a number of times
sufficient to enhance the functionality of the muscle tissue or
produce organized skeletal muscle tissue on said solid support
from said precursor muscle cells;
wherein said first time period is from 2 to 30 minutes in
duration and said second time period is from 10 to 100 minutes
in duration, said precursor muscle cells are mammalian
precursor muscle cells; said organized skeletal muscle tissue is
characterized by a contractile response to KCl-induced
depolarization in vitro; and said support comprises a collagen
support.

Cited References
Vandenburgh US 4,940,853 July 10, 1990
(hereinafter “Vandenburgh”)
Lee et al. US 6,057,150 May 2, 2000
(hereinafter “Lee”)
McQuillan et al. US 2005/0028228 A1 Feb. 3, 2005
(hereinafter “McQuillan”)

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Mark S. Clarke & Daniel L. Feeback, Mechanical Load Induces
Sarcoplasmic Wounding and FGF Release in Differentiated
Human Skeletal Muscle Cultures, 10 FASEB J. 502 (1996)
(hereinafter “Clarke”).

R. Tatsumi et al. Mechanical Stretch Induces Activation of
Skeletal Muscle Satellite Cells in Vitro, 267 Experimental Cell
Research 107 (2001) (hereinafter “Tatsumi”).

Herman Vandenburgh & Seymour Kaufman, In vitro Model for
Stretch-Induced Hypertrophy of Skeletal Muscle, 203 Sci. 265
(1979) (hereinafter “Vandenburgh et al.”).2

Grounds of Rejection
Claims 1–5, 8, 12–16, 19, 35, 36, 39, 40, 43, and 44 are rejected under
35 U.S.C. § 103(a) as being unpatentable over McQuillan, Vandenburgh,
Vandenburgh et al., Lee, Tatsumi, and Clarke.

FINDINGS OF FACT
We adopt the the Examiner’s findings of fact as set forth in the
Answer. Ans. 4–22.

ISSUE
The issue is: Does the cited prior art support the Examiner’s finding
that the claimed subject matter is obvious?

2 The Examiner cites this reference as Vandenburgh et al. For consistency,
we do the same.
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PRINCIPLES OF LAW
In making our determination, we apply the preponderance of the
evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427
(Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings
before the Office). The Board “determines the scope of claims in patent
applications not solely on the basis of the claim language, but upon giving
claims their broadest reasonable construction ‘in light of the specification as
it would be interpreted by one of ordinary skill in the art.’” Phillips v. AWH
Corp., 415 F.3d 1303, 1316 (Fed. Cir. 2005) (quoting In re Am. Acad. of Sci.
Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004).
“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.
“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).

ANALYSIS
Appellants provide separate arguments for claims 1, 5, 12, 16, 43 and
44 in the Brief. We agree with the Examiner’s fact findings, statement of
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the rejection, and responses to Appellants’ arguments as set forth in the
Answer. We determine that the Examiner has provided sufficient evidence
and an articulated rationale to support a prima facie case of obviousness.
We provide the following additional comment to argument set forth in the
Answer.
With respect to claim 1, Appellants argue that, “that none of the six
cited references teach or suggest that their respective constructs are
characterized by a contractile response to KCl-induced depolarization in
vitro.” App. Br. 8. (emphasis omitted). Appellants further argue that
the claimed contractile response is not an inherent feature,
Appellant notes that as described in the specification at page 9,
lines 7-8, the control scaffolds “failed to show any detectable
contractile response.” Accordingly, while the control scaffolds
and cyclically stimulated scaffolds were subjected to identical
incubation conditions, the control scaffolds, which were
maintained under static culture conditions, did not have the
ability to contract in response to KCI-induced depolarization in
vitro. In contrast, scaffolds that were cyclically stimulated did
exhibit a contractile response to KCI-induced depolarization in
vitro. Moreover, as described in the application as filed, in
order for the organized skeletal muscle tissue of the claimed
method to be characterized by a contractile response, it can
require the appropriate level of cellular organization and
functionality to be achieved. For example, in the scaffolds
subjected to cyclic stimulation, unidirectional orientation was
achieved within five days, and further conditioning resulted in
an engineered tissue structurally and histologically similar to
skeletal muscle that at three weeks was capable of generating a
contractile response to KCl-induced depolarization in vitro.
See, Specification, page 7, lines 4-11.

App. Br. 8–9.
In response, the Examiner concluded that
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Artisans such as Vandenburgh, Tatusmi [sic] et al., and Clarke
et al. were arriving at muscle tissue following cycles of
stretching and relaxing muscle progenitor cells and the amount
of stretching/relaxing and cycles of stretching/relaxing are a
matter of design choice as Vandenburgh, Tatusmi [sic] et al.,
and Clarke et al. teach that a variety of stretch/relax cycles can
be used to arrive at muscle tissue. Given that the art teaches
how to make muscle tissue from muscle progenitor cells and
given that the methods of the prior art are the same as those
described in the specification, the muscle tissue made by the
combination of references would have been the same as that
described in the specification and would have thus exhibited a
contractile response to KCI-induced depolarization.

Ans. 11. We find that the Examiner has the better argument. The Examiner
has established that the cited prior art teaches how to make muscle tissue
from muscle progenitor cells, and that those prior art methods are the same
or similar to those described in the Specification. Accordingly, muscle
tissue made by the combination of references would have been the same as
that described in the Specification and would have thus exhibited a
contractile response to KCI-induced depolarization. Appellants have not
presented evidence that one of ordinary skill in the art following the
stretching protocols of the cited prior art would not have resulted in an
organized skeletal muscle tissue characterized by a contractile response to
KCl-induced depolarization in vitro, as claimed.
Where . . . the claimed and prior art products are
identical or substantially identical, or are produced by identical
or substantially identical processes, the PTO can require an
applicant to prove that the prior art products do not necessarily
or inherently possess the characteristics of his claimed
product. . . . Whether the rejection is based on “inherency”
under 35 U.S.C. § 102, on “prima facie obviousness” under 35
U.S.C. § 103, jointly or alternatively, the burden of proof is the
same, and its fairness is evidenced by the PTO’s inability to
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manufacture products or to obtain and compare prior art
products.

In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (emphasis added, footnote
omitted.)
Appellants also argue, among other things, that
Vandenburgh does not teach or suggest the claimed step
of maintaining a substantially static position. This is because
even during the alleged “rest” period of Vandenburgh,
continuous stretch activity is still being applied (“resting the
tissue specimens by discontinuing only the repetitive
activity…” Vandenburgh, col. 10, lines 8-10 (emphasis added)
and “the tissue specimens were allowed to rest for a 30-minute
period during which only continuous stretch activity was
applied” Vandenburgh, col. 10, lines 12-14 (emphasis added)).

App. Br. 13. We are not persuaded. We agree with the Examiner that while
Appellants argue that the term “static,” as claimed, suggests that no stretch is
being applied (App. Br. 13.), the Specification indicates that the “static
position” may be an intermediate position between the stretch and relaxed
position (Specification, page 6, lines 19–20). (Ans. 14.) The Specification
further discloses that, “[t]he length of stretching of the solid support may be
to a dimension at least 5% greater in length than the static position.” (Spec.
6.)
In addition, the Examiner finds that,
Pulse stretching [in Vandenburgh] at 1 mm and then relaxing at
0.005mm/hr would meet the instant specification’s definition of
“static position” wherein the “static position” is intermediate
between the stretch and relaxed position. In addition to this, it
is noted that artisans such as Clarke et al. taught that rest
periods can also be periods with no stretch (Clarke et al., Figure
1B).

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(Ans. 15.) Appellants have not established that the level of continuous
stretch of Vandenburgh is not an intermediate stretch between the stretch
and relaxed position, consistent with Appellants’ definition of “static” in the
Specification.
With respect to Appellants’ additional arguments, including the
argument that the Examiner fails to establish motivation to combine the cited
prior art, we agree with the Examiner’s responses set forth in the Response
to Arguments section of the Answer and adopt them as our own. We note,
in particular, that the Examiner specifically addresses arguments raised with
respect to claim 5 (Ans. 19); claim 12 (Ans. 20); claim 16 (Ans. 21); and
claims 43 and 44 (Ans. 12), which we agree with and adopt as our own.
The obviousness rejection is affirmed.

CONCLUSION OF LAW
The cited references support the Examiner’s obviousness rejection,
which is affirmed with respect to all rejected claims for the reasons of
record.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED
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