Ex Parte Sun et al

Patent Trial and Appeal Board

Dec 14, 2016

13177720 (P.T.A.B. Dec. 14, 2016)

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.
13/177,720 07/07/2011 Wendell Sun STR.0322US 7038
84398 7590
McCarter & English / KCI
265 Franklin St.
Boston, MA 02110
12/16/2016 EXAMINER
REYNOLDS, FRED H
ART UNIT PAPER NUMBER
1675
NOTIFICATION DATE DELIVERY MODE
12/16/2016 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):
docket @ mccarter.com
mvaneman @ McCarter, com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte WENDELL SUN and GARY MONTEIRO1
Appeal 2016-002935
Application 13/177,720
Technology Center 1600
Before JEFFREY N. FREDMAN, ROBERT A. POLLOCK, and
RYAN H. FLAX, Administrative Patent Judges.
POLLOCK, Administrative Patent Judge.
DECISION ON APPEAL
Appellants appeal under 35 U.S.C. § 134(a) from the final rejection of
claims 1—11, 13, and 44. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
STATEMENT OF THE CASE
The Specification discloses a method for shaping a tissue matrix
comprising “selecting a collagen-containing tissue matrix; partially
dehydrating the tissue matrix; applying mechanical forces to the tissue
matrix to change the orientation of collagen fibers within the tissue matrix;
and exposing the tissue matrix to radiation.” Spec. 15,31.
1 Appellants identify the real party-in-interest as LifeCell Corporation. App.
Br. 2.
Appeal 2016-002935
Application 13/177,720
According to the inventors, “the process of shaping tissue products
includes partially dehydrating tissues. It has been discovered that partial
dehydration of tissues causes the extracellular matrix of collagenous
materials to become more pliable, thereby allowing collagen fibers to be
reoriented.” Id36. Accordingly, “[a]fter partial dehydration, mechanical
forces are applied to tissues or acellular tissue matrices to reorient collagen
fibers within the extracellular matrix of the tissues. This can be done in a
variety of ways, as long as forces are directed in such a way to produce a
final desired shape.” Id. 139. “After collagen fibers are reoriented, tissue
products are treated to stabilize the three-dimensional structures of the
extracellular matrix.” Id. 142.
Further, “although cross-linking may assist in maintaining a three
dimensional shape, excessive crosslinking can alter the biological properties
of tissue products. Therefore, in some embodiments, the tissue product will
maintain a three-dimensional structure without excessive crosslinking.” Id.
at 44. “[S]ince chemical crosslinking agents can cause non-uniform and
excessive crosslinking and/or may be harmful, the method of the present
disclosure allows formation of a matrix that has a stable three-dimensional
shape without using chemical cross-linking agents.” Id. at 45. “In some
embodiments, the structure is stabilized by exposing the tissue product to
radiation. Radiation may cause a small degree of tissue cross-linking
sufficient to produce a stable three-dimensional structure.” Id. 142.
“[S]ince radiation is used to stabilize the three-dimensional shape, the
irradiation step may be performed as part of a terminal sterilization step to
both stabilize the tissue product shape and destroy pathogens.” Id. 146.
2
Appeal 2016-002935
Application 13/177,720
Claim 1, the sole independent claim before us, recites:
1. A method for shaping a tissue matrix, comprising:
selecting a collagen-containing tissue matrix;
partially dehydrating the tissue matrix;
applying mechanical forces to the tissue matrix to change
the orientation of collagen fibers within the tissue
matrix; and
exposing the tissue matrix while partially dehydrated to
ionizing radiation to cross-link at least a portion of the
tissue matrix.
Claims 1—11, 13, and 44 stand rejected under 35 U.S.C. § 103(a) as
obvious over the combination of Oliver,2 Ogle,3 Bayon,4 and Smestad.5
ANALYSIS
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. A proper rejection under 35 U.S.C. § 103
requires the Examiner to show that each and every limitation of the claim is
described or suggested by the combination of prior art references or would
have been obvious based on the knowledge of those of ordinary skill in the
art. In re Fine, 837 F.2d 1071, 1074 (Fed. Cir. 1988). Further, “rejections
2 Oliver et al., US 5,397,353, issued March 14, 1995.
3 Ogle et al., US 2003/0229394 Al, published Dec. 11, 2003.
4 Bayon et al., US 6,706,684 Bl, issued March 16, 2004.
5 Smestad et al., US 4,865,602, issued Sept. 12, 1989.
3
Appeal 2016-002935
Application 13/177,720
on obviousness grounds cannot be sustained by mere conclusory statements;
instead, there must be some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness.” In re Kahn,
441 F.3d 977, 988 (Fed. Cir. 2006).
The Examiner discusses the scope and content of the cited references
on pages 3 and 4 of the Answer. In setting forth the rejection, the Examiner
finds that Oliver differs from the instant claims in failing to “describe
applying mechanical forces to the partially dehydrated tissue matrix to
change the orientation of the collagen fibers,” and relies on Ogle for
disclosing “applying mechanical forces to a collagen matrix.” Ans. 4.
Accordingly, the Examiner finds that it would have been “obvious to take
the tissue matrices of Oliver et al, and add a step of placing a load on them
as described by Ogle et al to make the material more appropriate for certain
uses. As Ogle et al discusses a general procedure to modify the properties of
collagen containing products, an artisan in this field would attempt this
modification of the method of Oliver et al with a reasonable expectation of
success.” Id.
In further explaining the basis for the rejection, the Examiner states
that
there is no claim limitation requiring that the mechanical
forces are applied to a dehydrated material, that Oliver et al
and Smestad et al both either have a drying step or require a
partially dried material, and that common sense teaches that
it’s possible to remove a process step by maintaining the
material of Oliver et al in a partially dehydrated state for the
next few process steps.
Ans. 7; see also, Ans. 6 (“There is no claim limitation that the collagen
matrix be dehydrated while mechanical forces are applied.).
4
Appeal 2016-002935
Application 13/177,720
Appellants contend, inter alia, that the claimed process “relies on the
discovery that when tissue matrices are partially dehydrated, the materials
can be deformed to alter the collagen fiber orientation. Then, while still
partially dehydrated, the material can be subjected to a low-dose radiation to
effectively lock-in the new fiber orientation without causing unacceptable
damage to the material.” App. Br. 20. Appellants contend that the rejection
is in error because the partially dehydrated state in Oliver is only achieved
during an intermediate phase of a complex process and the Examiner “fails
to provide any rationale to both apply mechanical forces and irradiate the
material while the material is in a partially dehydrated state (as specified in
the claims.)” Id. at 19; see id. at 10-14, 19-20; see also Reply 7—10
(arguing that the claims require an ordered series of steps in which the tissue
matrix is partially dehydrated when mechanical forces are applied).
We first address whether independent claim 1 recites an ordered series
of steps in which mechanical forces are applied to a partially dehydrated
tissue matrix, which is then exposed to ionizing radiation while partially
dehydrated, as Appellants contend.
The Board must determine the scope of the claims by giving them
their broadest reasonable construction in light of the specification as they
would be interpreted by one of ordinary skill in the art. See 37 C.F.R.
§ 42.100(b); Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131, 2144-45
(2016) (upholding the use of the broadest reasonable interpretation
standard). “While the broadest reasonable interpretation standard is broad, it
does not give the Board an unfettered license to interpret the words in a
claim without regard for the full claim language and the written description.”
5
Appeal 2016-002935
Application 13/177,720
Trivascular, Inc. v. Samuels, No. 2015-1631, 2016 WL 463539, at *3 (Fed.
Cir. Feb. 5,2016).
In the claims before us, the steps of selecting a collagen-containing
tissue matrix,” “partially dehydrating the tissue matrix,” “applying
mechanical forces to the tissue matrix,” and “exposing the tissue matrix
while partially dehydrated to ionizing radiation” are presented one after
another—which is indicative of an ordered arrangement of tissue processing
steps in which a tissue matrix is first partially dehydrated, then subject to
mechanical forces to change the orientation of collagen fibers within the
tissue matrix and, finally, while still partially dehydrated, exposed to
ionizing radiation cross-link at least a portion of the tissue matrix.
The “partially dehydrating” step must occur prior to the step of
“exposing the tissue matrix while partially dehydrated” based solely on the
claim language. Our reading of the Specification as a whole makes clear
that the ordered arrangement also requiring the “applying mechanical
forces” step that occurs between the “partially dehydrating” and “exposing
the tissue matrix while partially dehydrated” steps to act on partially
dehydrated tissue matrix is the correct reading of claim 1. As noted above,
the Specification relies on the discovery that “partial dehydration of tissues
causes the extracellular matrix of collagenous materials to become more
pliable, thereby allowing collagen fibers to be reoriented.” Spec. 136.
“After partial dehydration, mechanical forces are applied to tissues or
acellular tissue matrices to reorient collagen fibers within the extracellular
matrix of the tissues. This can be done in a variety of ways, as long as
forces are directed in such a way to produce a final desired shape.” Id. 139.
“After collagen fibers are reoriented, tissue products are treated to stabilize
6
Appeal 2016-002935
Application 13/177,720
the three-dimensional structures of the extracellular matrix.” Id. 142.
“[Sjince chemical crosslinking agents can cause non-uniform and excessive
crosslinking and/or may be harmful, the method of the present disclosure
allows formation of a matrix that has a stable three-dimensional shape
without using chemical cross-linking agents.” Id. at 45. “In some
embodiments, the structure is stabilized by exposing the tissue product to
radiation. Radiation may cause a small degree of tissue cross-linking
sufficient to produce a stable three-dimensional structure.” Id. 142.
Thus, contrary to the Examiner’s construction, we view the instant
claims as an ordered series of steps requiring the application of mechanical
forces to a partially dehydrated tissue matrix. In view of this construction,
we agree with Appellants that the Examiner has not articulated a reason why
one of ordinary skill in the art would have been motivated to apply
mechanical forces to a partially dehydrated tissue matrix, which is
subsequently exposed to ionizing radiation while still in the dehydrated state,
as required by the claims.
For the above reasons, we do not sustain the rejection.
SUMMARY
We reverse the rejection of claims 1—11, 13, and 44 under
§ 35 U.S.C. 103(a) as obvious over the combination of Oliver, Ogle, Bayon,
and Smestad.
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).
REVERSED
7