Ex Parte Lee et al

Patent Trial and Appeal Board

Feb 18, 2016

12865434 (P.T.A.B. Feb. 18, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/865,434 08/11/2010 Sang Jin Lee
20792 7590 02/18/2016
MYERS BIGEL & SIBLEY, P.A.
PO BOX 37428
RALEIGH, NC 27627
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.
9865-103 2980
EXAMINER
GHERE!, SUZETTE JAIME J
ART UNIT PAPER NUMBER
3738
MAIL DATE DELIVERY MODE
02/18/2016 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 SANG JIN LEE, JAMES J. YOO, and
ANTHONY ATALA
Appeal2014-000821
Application 12/865,434
Technology Center 3700
Before LYNNE H. BROWNE, ANNETTE R. REIMERS, and
LISA M. GUIJT, Administrative Patent Judges.
BROWNE, Administrative Patent Judge.
STATEMENT OF THE CASE
Sang Jin Lee et al. (Appellants) appeal under 35 U.S.C. § 134 from
the Examiner's decision rejecting claims 1-5, 7-12, 14--18, 20-25, and 27-
32. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
CLAIMED SUBJECT MATTER
Claim 1, reproduced below, is illustrative of the claimed subject
matter:
Appeal2014-000821
Application 12/865,434
1. An anisotropic muscle implant comprising:
(a) a biodegradable scaffold comprising a plurality of fibers
oriented along a longitudinal axis, wherein said fibers comprise:
(i) a natural polymer; and
(ii) a synthetic polymer,
wherein said natural polymer and said synthetic polymer
are in a ratio of between 2: 1 and 1 :2 by weight; and
(b) mammalian myotubes in said scaffold and oriented along
said longitudinal axis of said fibers.
REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Simpson
Atala
Li
US 2004/0037813 Al Feb. 26, 2004
US 2006/0257377 Al Nov. 16, 2006
US 2007/0269481 Al Nov. 22, 2007
REJECTIONS
I. Claims 1-5, 7, 9-12, 14--18, 20-25, and 27-32 stand rejected under
35 U.S.C. § 103(a) as being unpatentable over Li and Atala.
II. Claim 8 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Li and Simpson.
DISCUSSION
Rejection I
Claims 1-5, 7, 9-12, 14--18, 20-25, 27, 29, and 31
Appellants argue claims 1-5, 7, 9-12, 14--18, 20-25, 27, 29, and 31
together. Br. 9. We select independent claim 1 as the illustrative claim, and
claims 2-5, 7, 9-12, 14--18, 20-25, 27, 29, and 31 stand or fall with claim 1.
The Examiner finds that Li discloses all of the limitations of claim 1
except for "the natural polymer and the synthetic polymer are in a ratio of
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Application 12/865,434
between 1: 1 weight or 2: 1 and 1 :2 by weight." Final Act. 4. The Examiner
further finds that Atala teaches "tailor[ing] the ratios for a custom fit of the
application for example as taught normal levels of collagen and elastin vary
in different parts of the anatomy e.g. heart muscle or a blood vessel." Id.
Based on these findings, the Examiner determined that it would have been
obvious "to modify the invention of Li et al and provide the claimed ratio of
the natural and synthetic fibers." Id.
Appellants argue that "no motivation to so tailor a combination of
natural and synthetic polymers to create the composite scaffold as disclosed
and claimed is provided by the examiner." Br. 7. However, the Examiner
reasons that it would have been obvious to one of ordinary skill in the art at
the time of invention to adapt the ratio of natural polymer to synthetic
polymer in order to fit "different parts of the anatomy," as discussed supra.
Final Act. 4. Thus, the Examiner articulates a reason for the proposed
combination. Appellants do not explain why the Examiner's reasoning is
flawed. Accordingly, Appellants do not apprise us of error.
Appellants further argue that the Examiner has not "established the
claimed ratio of natural and synthetic polymers as a results-effective
variable, a required condition precedent with respect to the obviousness of
discovering optimum or workable ranges." Br. 7. This is not responsive to
the Examiner's rejection of the claims, as the Examiner did not assert that
discovering the optimum range of the ratio is routine experimentation. See
Final Act. 4. Thus, Appellants do not apprise us of error.
Appellants further argue that "[ c ]ollagen and elastin are each natural
polymers, and varying their ratio with respect to each other would clearly
not vary the ratio between natural and synthetic polymers as claimed." Br. 7
(emphasis in original). This argument appears to misconstrue the rejection.
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Application 12/865,434
The paragraph of Atala cited by the Examiner (Final Act. 4) states that
"[r]atios of collagen, elastin and PLGA may be tailored to fit the application:
for instance[], normal levels of collagen and elastin vary from the more
elastic vessels closer to the heart to less compliant vessels further from the
heart." Atala if 85 (emphasis added). Atala discloses that PLGA
(poly(lactide-co-glycolides )) is a synthetic material. Atala iii! 81, 82.
Because Atala does teach varying the ratio of the natural polymers collagen
and elastin, with the synthetic polymer PLGA, Appellants' argument is
unconvincing. 1
Appellants attempt to rebut the Examiner's prima facie case of
obviousness by showing criticality of the claimed ratio. Br. 8. Appellants
support their argument of criticality by citing to their specification, which
states that "the composition of the nanofibers is important." Id. The
Examiner finds that "no criticality has been disclosed by applicant's
disclosure." Ans. 7.
Appellants can rebut a prima facie case of obviousness by showing
the criticality of the range.
The law is replete with cases in which the difference between the
claimed invention and the prior art is some range or other
variable within the claims .... [I]n such a situation, the applicant
must show that the particular range is critical, generally by
showing that the claimed range achieves unexpected results
relative to the prior art range.
In re Woodruff, 919 F.2d 1575, 1578; 16 USPQ2d 1934 (Fed. Cir. 1990).
See also In re Scher!, 156 F.2d 72, 74--75 (CCPA 1946) ("Where the issue of
1 We note that Atala further discloses, as Example 1, a scaffold made of 60%
natural and 40% synthetic polymers. See Atala if 166.
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Application 12/865,434
criticality is involved, the applicant has the burden of establishing his
position by a proper showing of the facts upon which he relies.").
A mere assertion that "the composition of the nanofibers is
important," is insufficient to establish criticality in this case. Appellants fail
to show that the claimed range achieves unexpected results or a noticeable
difference in the qualities of the nanofibers as compared with the prior art
nanofibers. As Appellants fail to show that the claimed range is critical, the
prima facie case is not rebutted.
For these reasons, we sustain the Examiner's decision rejecting claim
1, and claims 2-5, 7, 9-12, 14--18, 20-25, 27, 29, and 31, which fall
therewith.
Claims 28, 30, and 32
Appellants argue that "the more narrowly-defined ratio of 1: 1" recited
in claims 28, 30, and 32 is not taught by the prior art. Br. 10. However, the
ratio disclosed by Atala overlaps the claimed ratio of 1: 1. Appellants have
not established criticality for this ratio either. Thus, for the reasons
discussed supra with respect to the rejection of claim 1, Appellants do not
rebut the prima facie case.
We sustain the Examiner's decision rejecting claims 28, 30, and 32.
Rejection II
The Examiner fails to explain the relevance of Simpson and does not
refer to any part of Simpson in making the Examiner's rejection. Final Act.
5. Accordingly, the Examiner has failed to set forth a prima facie case of
obviousness.
We do not sustain the Examiner's decision rejecting dependent claim
8 as unpatentable over Li and Simpson.
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Appeal2014-000821
Application 12/865,434
DECISION
The Examiner's rejection of claims 1-5, 7, 9-12, 14--18, 20-25, and
27-32 is AFFIRMED.
The Examiner's rejection of claim 8 as unpatentable over Li and
Simpson is REVERSED.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED-IN-PART
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