Ex Parte Shah et al

Patent Trial and Appeal Board

Sep 24, 2018

14532364 (P.T.A.B. Sep. 24, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/532,364 11/04/2014 Rajiv Shah
12813 7590 09/26/2018
Gates & Cooper LLP - Minimed
6060 Center Drive
Suite 830
Los Angeles, CA 90045
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.
G&C 130.130-US-Il 9971
EXAMINER
KAUR,GURPREET
ART UNIT PAPER NUMBER
1795
NOTIFICATION DATE DELIVERY MODE
09/26/2018 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):
docketing-us@gates-cooper.com
gates-cooper@blackhillsip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte RAJIV SHAH, QINGLING YANG,
ROBERT C. MUCIC, and JENN-HANN LARRY WANG
Appeal2017-010931
Application 14/532,364
Technology Center 1700
Before JEFFREY B. ROBERTSON, A VEL YN M. ROSS, and
BRIAND. RANGE, Administrative Patent Judges.
ROSS, Administrative Patent Judge.
DECISION ON APPEAL 1
Appellant2 appeals under 35 U.S.C. § 134(a) from a final rejection of
claims 6-9 and 21-25. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
1 In our Decision we refer to the Specification filed November 4, 2014
("Spec."), the Final Office Action appealed from dated September 1, 2016
("Final Act."), the Appeal Brief filed January 31, 2017 ("Appeal Br."), and
the Examiner's Answer dated June 12, 2017 ("Ans.").
2 Appellant is Applicant, Medtronic MiniMed, Inc., which according to the
Appeal Brief, is also the real party in interest. Appeal Br. 2.
Appeal2017-010931
Application 14/532,364
STATEMENT OF THE CASE
The subject matter on appeal relates to enzyme matrices for use in
ethylene oxide sterilization of analyte sensor systems, such as glucose
sensors. Spec 1. Claim 6, reproduced below, is illustrative of the claimed
subject matter:
6. A method of inhibiting damage to glucose oxidase caused
by ethylene oxide vapor during a sterilization process, the
method comprising disposing the glucose oxidase within a
matrix comprising a polyvinyl alcohol polymer comprising N-
methyl-4( 4' -formylstyryl)pyridinium (PV A-SbQ), so that
damage to glucose oxidase is inhibited.
Appeal Br. 8 (Claims App'x).
REJECTI0NS 3
The Examiner maintains the rejection of claims 6-9, 21-23, and 25
stands rejected under 35 U.S.C. § I03(a) as unpatentable over Yang4 in view
of Thomas 5 and as evidenced by Sorensen. 6 Final Act. 3-5; Ans. 3.
Appellant argues all claims together as a group and does not present
argument for any individual claim separate from those advanced for all
claims. See generally Appeal Br. Therefore, consistent with the provisions
3 Appellant cancelled claim 24 (Appeal Br. 2), rendering moot the
Examiner's rejections of claim 24 as indefinite and as obvious.
4 Yang et al., US 2012/0190950 Al, published July 26, 2012 ("Yang.")
5 Thomas et al., US 2009/0257911 Al, published October 15, 2009
("Thomas").
6 Sorensen et al., US 2009/0274577 Al, published November 5, 2009
("Sorensen").
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Application 14/532,364
of 37 C.F.R. § 4I.37(c)(l)(iv) (2013), we limit our discussion to independent
claim 6, and all other claims stand or fall together with that claim.
OPINION
The Examiner rejects claim 6 as unpatentable over the combination of
Yang in view of Thomas, and as evidenced by Sorensen. Final Act. 3. The
Examiner finds that Yang describes a "method of inhibiting damage to
glucose oxidase from hydrogen peroxide [0085] by disposing the glucose
oxidase within poly(vinyl alcohol)-styrylpyridinium (PVA-SbQ) polymer
matrix [0090]." Id. The Examiner acknowledges that Yang does not
describe inhibiting damage to the glucose oxidase from the effects of
ethylene oxide, but finds that Thomas "teach[ es an] ethylene oxide based
sterilization process of [an] analyte sensor could potentially damage
enzymes [0129] such as glucose oxidase [0068]." Id. at 4. Relying on
Sorensen, the Examiner determines that both hydrogen peroxide and
ethylene oxide were known oxidizing agents for use in sterilization. Id. The
Examiner reasons that one skilled in the art would have found it obvious to
use a poly(vinyl alcohol)-styrylpyridinium ("PVA-SbQ") polymer matrix
known to inhibit damage to glucose oxidase upon exposure to hydrogen
peroxide (Yang) in a sterilization method that uses ethylene oxide (Thomas).
Id.
Appellant argues that the Examiner's rejection is based on an
incorrect understanding of Yang and therefore, the prima facie case for
obviousness must fail. Appeal Br. 3. In particular, Appellant contends that
Yang describes multiple layers of glucose oxidase at different concentrations
as responsible for preventing damage to the glucose oxidase from hydrogen
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Application 14/532,364
peroxide, and not poly(vinyl alcohol)-styrylpyridinium as the Examiner
contends. Id. Appellant stresses that Yang describes poly(vinyl alcohol)-
styrylpyridinium as optional, and thus, not required to prevent damage. Id.
at 4.
Appellant's argument is not persuasive of reversible error. As the
Examiner explains, Yang teaches using poly(vinyl alcohol)-styrylpyridinium
to "entrap" the glucose oxidase. Ans. 5. In particular, Yang states:
In certain embodiments of the invention, the electrolyte retaining
layer comprises a polypeptide (e.g.[,] glucose oxidase)
entrapped within a crosslinked poly(vinyl alcohol)-
styrylpyridinium matrix which further functions as an analyte
sensing layer. [Yang ,r 10 ( emphasis added)].
In some embodiments of the invention, the analyte sensing layer
comprises glucose oxidase entrapped within a UV crosslinked
poly(vinyl alcohol)-styrylpyridinium (PVA-SbQ) polymer
matrix. [Id. ,r 14 (emphasis added)].
Another composition useful in an electrolyte retaining layer
comprises a poly(vinyl alcohol)-styrylpyridinium compound
(PV A-SbQ), a water soluble photosensitive polymer useful to
entrap and/or encapsulate polymers and enzymes such as
glucose oxidase. [Id. ,r 49 (emphasis added)].
In certain embodiments of the invention, water soluble
photosensitive poly(vinyl alcohol)-styrylpyridinium (PVA-SbQ)
polymers are used to entrap or encapsulate polypeptides (e.g.l]
glucose oxidase and/or human and/or bovine serum albumin)
within a matrix that comprises one or more of the layers within a
layered sensor architecture (e.g.[,] a protein layer, an electrolyte
retaining layer, an analyte sensing layer etc.). [Id. ,r 50 (emphasis
added)].
As the Examiner finds (Ans. 5), the composition taught in Yang, i.e.,
glucose oxidase disposed within a matrix of poly( vinyl alcohol)-
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Application 14/532,364
styrylpyridinium (PV A-SbQ), is the same as claimed. Therefore, it would
be expected that the property of inhibiting damage to the glucose oxidase-
caused through use of an oxidizing agent during sterilization-would also be
achieved by Yang's composition. Id.
Appellant additionally argues that "Yang teaches artisans that multiple
layers of glucose oxidase at different concentrations can prevent damage to
glucose oxidase from hydrogen peroxide," thus, Yang would lead one
skilled in the art toward using multiple layers of glucose oxidase not
poly(vinyl alcohol)-styrylpyridinium to inhibit damage to glucose oxidase.
Appeal Br. 6. Therefore, Appellant reasons that Yang teaches away because
multiple layers of glucose oxidase is in "a direction divergent from the path
that was taken by the Appellant." Id.
This argument is not persuasive, however, because "[a] reference does
not teach away ... if it merely expresses a general preference for an
alternative invention but does not 'criticize, discredit, or otherwise
discourage' investigation into the invention claimed." DePuy Spine, Inc. v.
Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed. Cir. 2009)
(quoting In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004)). Appellant has
not identified any passage in Yang that actually criticizes, discredits, or
discourages use of poly(vinyl alcohol)-styrylpyridinium. Indeed, far from
discouraging the skilled artisan from disposing glucose oxidase within a
matrix comprising a PV A-SbQ, Yang identifies numerous embodiments
where glucose oxidase is entrapped in PVA-SbQ (see supra, 4), which is not
a teaching away.
Therefore, on this record, we sustain the Examiner's rejection of
claims 6-9, 21-23, and 25.
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Application 14/532,364
CONCLUSION
Appellant failed to identify a reversible error in the Examiner's
rejection of claims 6-9, 21-23, and 25 as unpatentable over Yang in view of
Thomas and as evidenced by Sorensen.
DECISION
For the above reasons, the Examiner's rejection of claims 6-9, 21-23,
and 25 is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l).
AFFIRMED
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