Ex Parte Li et al

Patent Trials and Appeals Board

May 8, 2019

13541262 - (D) (P.T.A.B. May. 8, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/541,262 07/03/2012 YiwenLi
12813 7590 05/10/2019
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.
130.110-US-Ol 4060
EXAMINER
AGAHI,PUYA
ART UNIT PAPER NUMBER
3791
NOTIFICATION DATE DELIVERY MODE
05/10/2019 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 YIWEN LI, JENN-HANN LARRY WANG, and RAJIV SHAH 1
Appeal2017-006978
Application 13/541,262
Technology Center 3700
Before FRANCISCO C. PRATS, RICHARD J. SMITH, and
RYAN H. FLAX, Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision under 35 U.S.C. § 134(a) involving claims directed
to an analyte sensor apparatus and method of sensing an analyte. Claims
10-21 are on appeal as rejected under 35 U.S.C. § 103. We have
jurisdiction under 35 U.S.C. § 6(b ).
We affirm.
1 Appellants identify the Real Party in Interest as "Medtronic MiniMed,
Inc." Br. 2.
Appeal2017-006978
Application 13/541,262
STATEMENT OF THE CASE
Independent claim 10 is representative and is reproduced below:
10. An analyte sensor apparatus comprising:
a base layer;
a conductive layer disposed over the base layer wherein
the conductive layer includes a working electrode;
an analyte sensing layer disposed over the conductive
layer, wherein the analyte sensing layer detectably alters the
electrical current at the working electrode in the conductive layer
in the presence of an analyte;
an adhesion promoting layer disposed over the analyte
sensing layer, wherein the adhesion promoting layer comprises
hexamethyldisiloxane; and
an analyte modulating layer disposed over the analyte
sensing layer, wherein the analyte modulating layer modulates
the diffusion of the analyte therethrough.
Br. 9 (Claims Appendix). Independent claim 21 is recites a method for
using a similarly defined sensor. Id. at 10.
The following rejections are appealed:
Claims 10 and 15-21 stand rejected under 35 U.S.C. § I03(a) over
Gottlieb2 and Muguruma. 3 Final Action 3.
Claims 11-14 stand rejected under 35 U.S.C. § I03(a) over Gottlieb,
Muguruma, and Li. 4 Id. at 6.
2 US 2010/0030045 Al (published Feb. 4, 2010) ("Gottlieb").
3 US 7,087,149 B 1 (issued Aug. 8, 2006) ("Muguruma").
4 US 2012/0186997 Al (published July 26, 2012) ("Li").
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DISCUSSION
"[T]he examiner bears the initial burden, on review of the prior art or
on any other ground, of presenting aprimafacie case ofunpatentability. If
that burden is met, the burden of coming forward with evidence or argument
shifts to the applicant." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
Arguments made by Appellants in the Appeal Brief have been considered in
this Decision (no Reply Brief was submitted); arguments not so-presented in
the Brief are waived. See 37 C.F.R. § 4I.37(c)(l)(iv) (2015); see also Ex
parte Borden, 93 USPQ2d 1473, 1474 (BPAI 2010) (informative) ("Any
bases for asserting error, whether factual or legal, that are not raised in the
principal brief are waived.").
As applicable to the rejections on appeal and Appellants' arguments
there-over, "[ t ]he combination of familiar elements according to known
methods is likely to be obvious when it does no more than yield predictable
results." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,416 (2007). Put
another way, "when a patent claims a structure [ or method] already known
in the prior art that is altered by the mere substitution [ or addition] of one
element for [ or to] another known in the field, the combination must do
more than yield a predictable result." Id. It is obvious to those skilled in the
art to substitute one known equivalent for another. See In re Omeprazole
Patent Litigation, 483 F.3d 1364, 1374 (Fed. Cir. 2007) ("[T]his court finds
no ... error in [the] conclusion that it would have been obvious to one
skilled in the art to substitute one ARC [ alkaline reactive compound] for
another.").
"In determining whether the subject matter of a patent claim is
obvious, neither the particular motivation nor the avowed purpose of the
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Application 13/541,262
patentee controls. What matters is the objective reach of the claim. If the
claim extends to what is obvious, it is invalid under§ 103." Id. at 419.
"[T]he question is whether there is something in the prior art as a whole to
suggest the desirability, and thus the obviousness, of making the
combination, not whether there is something in the prior art as a whole to
suggest that the combination is the most desirable combination available."
In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004) ( citation omitted).
The Examiner determined claims 10 and 15-21 would have been
obvious over the combination of Gottleib and Muguruma and that claims
11-14 would have been obvious over this same combination also adding Li.
Final Action 3-9; Answer 2---6. Specifically, the Examiner determined that
Gottleib taught almost every claim element, i.e., analyte sensor with the
claimed layers, but did not specify the claimed adhesion promoting layer's
hexamethyldisiloxane material. The Examiner found that Muguruma taught
or suggested that hexamethyldisiloxane was an adhesion promoting material
also used in an analyte sensor and was an equivalent alternative material to
the y-aminopropyltrimethoxysilane taught as a preferred adhesion promoting
material by Gottlieb and, so, was an obvious substitute for such material in
Gottlieb's sensor. Final Action 3---6; see also Gottlieb ,r,r 66, 84, 85;
Muguruma 6:46-58. Similarly, the Examiner noted that Gottlieb and
Muguruma did not disclose certain materials and dimensions required by
claims 11-14, but found them taught by Li and obvious to add to Gottlieb' s
disclosed sensor. Final Action 6-8. We discern no error in the Examiner's
determinations.
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Appellants argue there would have been no motivation to combine the
( above-discussed) teachings of Muguruma and Gottlieb because "there is no
way for an artisan to determine if the adhesion promoter disclosed in
Muguruma [i.e., hexamethyldisiloxane] would truly work 'better' in the
Gottlieb sensor that the adhesion promoter that Gottlieb teaches is to be used
in their sensors [i.e., y-aminopropyltrimethoxysilane ]." Br. 4. Appellants
also argue that, even if the teachings of Gottlieb and Muguruma were
combined, they would still fail to teach individual analyte sensor and
adhesion promoting layers, as claimed, because Muguruma discloses these
layers are combined as one layer. Br. 5---6. Finally, Appellants argue
Muguruma teaches away from its combination with Gottlieb because
"Muguruma focuses on simplifying the biosensor" and Gottlieb has more
layers. Br. 6-7. None of these arguments is persuasive.
Supreme Court precedent informs us that claiming the mere
substitution of one element for another known in the field is not patentably
distinguishable over a prior art combination that teaches or suggests the
claimed subject matter and the equivalence of the substituted elements.
KSR, 550 U.S. at 416. Likewise, our reviewing court has held that such a
substitution is obvious. Omeprazole, 483 F.3d at 1374. Thus, it would have
been obvious to substitute Muguruma's disclosed alternative to Gottlieb's
y-aminopropyltrimethoxysilane, i.e., hexamethyldisiloxane. Further, the
Examiner did not incorporate Muguruma's teachings into Gottlieb whole-
cloth, but merely combined the references to show that substituting
Muguruma' s disclosed hexamethyldisiloxane for Gottlieb' s
y-aminopropyltrimethoxysilane would have been obvious because they are
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taught or suggested to be known equivalent adhesive materials. Thus, there
would have been no reason to eliminate any of Gottlieb' s disclosed
structural features. Finally, for the same reason, Muguruma does not teach
away from its combination with Gottlieb; Gottlieb's structure would be
preserved in such a combination, but would use Muguruma' s material.
For the reasons above, we are not persuaded that the Examiner erred
in determining obvious and conclude a prima facie case therefor has been
made and not rebutted. Appellants make no separate argument over the
second obviousness rejection also incorporating Li in the prior art
combination; we affirm it for the reasons discussed above. Also, Appellants
present no substantive argument for the patentability of any dependent
claims. Thus, the rejections over the respective dependent claims are also
affirmed.
SUMMARY
The obviousness rejections under 35 U.S.C. § 103 are each affirmed.
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)(l )(iv).
AFFIRMED
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