Ex Parte Wang et al

Patent Trial and Appeal Board

May 3, 2018

13344343 (P.T.A.B. May. 3, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/344,343 01/05/2012 Jenn-Hann Larry Wang
12813 7590 05/03/2018
Gates & Cooper LLP - Minimed
6701 Center Drive West
Suite 1050
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.
P003 7008. USU 1 7256
EXAMINER
JANG, CHRISTIAN YONGKYUN
ART UNIT PAPER NUMBER
3735
MAILDATE DELIVERY MODE
05/03/2018 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 JENN-HANN LARRY WANG, BROOKS B. COCHRAN,
TRI T. DANG, and RAJIV SHAH
Appeal2017-005254
Application 13/344,343
Technology Center 3700
Before DONALD E. ADAMS, RICHARD M. LEBOVITZ, and
JEFFREY N. FREDMAN, Administrative Patent Judges.
FREDMAN, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal 1 under 35 U.S.C. § 134 involving claims to an
analyte sensor system. The Examiner rejected the claims as obvious. We
have jurisdiction under 35 U.S.C. § 6(b). We affirm.
Statement of the Case
Background
"[B]iosensors include devices that use biological elements to convert
a chemical analyte in a matrix into a detectable signal. . . . Perhaps the most
studied type of biosensor is the amperometric glucose sensor, an apparatus
commonly used to monitor glucose levels in individuals with diabetes"
1 Appellants identify the Real Party in Interest as Medtronic MiniMed, Inc.
(see App. Br. 2).
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Application 13/344,343
(Spec. 1:9-12). "A typical glucose sensor" relies on chemical reactions such
as where "glucose oxidase is used to catalyze the reaction between glucose
and oxygen to yield gluconic acid and hydrogen peroxide" (id. at 1:13-16).
"[F]or optimal sensor performance, sensor signal output should be
determined only by the analyte of interest (glucose), and not by any co-
substrates (02) or kinetically controlled parameters such as diffusion" (id. at
1: 18-20). "If, however, there is insufficient oxygen for all of the glucose to
react with the enzyme, then the current will be proportional to the oxygen
concentration, not the glucose concentration" (id. at 1 :23-25).
According to the Specification, "the stabilized polymeric
compositions disclosed herein maintain an ability to address the oxygen
deficit problem observed in glucose sensors while simultaneously providing
such sensors with further advantageous properties including an extended
shelf life as well as an enhanced performance profile" (Spec. 10:23-26).
The Claims
Claims 10-20 are on appeal. Independent claim 10 is representative
and reads as follows:
10. An analyte sensor system comprising:
a probe adapted to be inserted in vivo, wherein the probe
includes a first electrode array comprising:
a working electrode, a counter electrode, and a reference
electrode;
an analyte sensing layer disposed on the working
electrode;
an analyte modulating layer disposed on the analyte
sensing layer, wherein the analyte modulating layer comprises a
polyurethane and/ or polyurea polymer formed from a mixture
compnsmg:
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(a) a diisocyanate;
(b) a hydrophilic polymer comprising a hydrophilic diol
or hydrophilic diamine;
( c) a siloxane having an amino, hydroxyl or carboxylic
acid functional group at a terminus; and
( d) a polyurethane and/ or polyurea polymer stabilizing
compound selected for its ability to inhibit thermal and
oxidative degradation of polyurethane and/ or polyurea
polymers formed from the mixture, wherein the polyurethane
and/ or polyurea polymer stabilizing compound:
has a molecular weight of less than 1000 g/mol;
comprises a benzyl ring having at least one hydroxyl
moiety (ArOH).
The Issues
A. The Examiner rejected claims 10, 11, 13, 14, and 16-19 under 35
U.S.C. § 103(a) as obvious over Simpson2 and Narang3 (Final Act. 2--4).
B. The Examiner rejected claim 12 under 35 U.S.C. § 103(a) as obvious
over Simpson, Narang, and Bowers4 (Final Act. 4).
C. The Examiner rejected claim 15 under 35 U.S.C. § 103(a) as obvious
over Simpson, Narang, and Robin5 (Final Act. 4--5).
D. The Examiner rejected claim 20 under 35 U.S.C. § 103(a) as obvious
over Simpson, Narang, and Brister6 (Final Act. 5).
2 Simpson et al., US 2011/0077490 Al, published Mar. 31, 2011.
3 Narang et al., US 2005/0196431 Al, published Sept. 8, 2005.
4 Bowers et al., US 2002/0035220 Al, published Mar. 21, 2002.
5 Robin et al., US 3,812,220, issued May 21, 1974.
6 Brister et al., US 2007/0027385 Al, published Feb. 1, 2007.
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A. 35 U.S.C. § 103(a) over Simpson and Narang
The Examiner finds Simpson teaches a glucose sensor using working,
counter, and reference electrodes with a polyurethane coating layer but the
Examiner acknowledges "Simpson fails to teach the use of a polymer
stabilizing compound with a molecular weight of less than 1000 g/mol and
comprising a benzyl ring having at least one hydroxyl moiety" (Final Act. 2)
as recited in step (d) of claim 10. The Examiner finds Narang teaches "a
monomer stabilizing chemical such as catechol or pyrogallol" (Final Act. 2-
3), corresponding to the "stabilizing compound" recited in claim 10. The
Examiner finds it obvious that "the device taught by Simpson could utilize a
stabilizing entity as taught by Narang to prevent degradation of the device
when used in vivo, so as to allow for prolonged use of the device" (Final
Act. 3).
Appellants contend Narang "does not teach or suggest that
compounds such as catechol or pyrogallol can be used to inhibit thermal and
oxidative degradation of polymers. Instead, Narang only teaches that such
compounds can be used to inhibit polymerization" (App. Br. 4). Appellants
contend, therefore, "the Examiner's rationale that one of ordinary skill in the
art would believe that the device taught by Simpson could utilize a rate of
polymerization modulating agent as taught by Narang fails to provide the
rational underpinning required to support the legal conclusion of
obviousness" (id.). Appellants further contend "there is no reasonable
expectation of success that the compounds disclosed in Narang would
effectively inhibit the thermal and oxidative degradation of formed polymers
in the analyte sensor system of Simpson" (App. Br. 6).
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The Examiner responds "[i]t is well known in the art that antioxidants
are used to prevent both thermal and oxidative degradation" (Ans. 3), and
cites "Antioxidants", Urata, Sunkara, Nakajima, and Blacklock to
demonstrate that the catechol and pyrogallol antioxidants were known
stabilizers (see Ans. 3--4).
Appellants reply 7 that
even if the Examiner were correct in the belief that radical
stabilizing agents are inherently anti-oxidants (which is not
true), the mere observation that a compound can inhibits the
Narang polymerization reaction does not in fact mean that that
[sic] the compound inherently has anti-oxidizing activity in
every other environment with every expectation of success.
(Reply Br. 4). Appellants cite Lemanska, which they state "confirm[s] that
there are significant environmental (in this case pH) influences on the
antioxidant action of antioxidants, factors which make the activity of such
agents in new environments unpredictable" (Reply Br. 4).
The issue with respect to obviousness is: Does a preponderance of the
evidence of record support the Examiner's conclusion that inclusion of
Narang's catechol or pyrogallol stabilizing agents in the polyurethane layer
of Simpson's glucose sensor would have been expected to "inhibit thermal
and oxidative degradation of polyurethane and/or polyurea polymers formed
from the mixture," as required by claim 1 O?
7 We note that Appellants did not file a petition to the Technology Center
Director regarding an asserted new ground(s) of rejection based on the
Examiner's citation of evidentiary art in the Answer. Consequently,
Appellants have waived this contention. 37 C.F.R. § 41.37(c)(l)(iv). We
will, however, consider Appellants' newly cited Lemanska evidentiary
reference in rebuttal to the Examiner's evidence (see Reply Br. 4).
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Findings of Fact
1. Simpson teaches "a sensor device is provided for measuring an
analyte concentration, the sensor device comprising: a sensor unit
comprising a tissue piercing element and a sensor body, the sensor body
comprising at least one electrode and a membrane covering at least a portion
of the at least one electrode" (Simpson i-f 5).
2. Simpson teaches "the at least one electrode comprises a
working electrode and a reference electrode" (Simpson i-f 15) and also
teaches a counter electrode (Simpson i-f 146).
3. Simpson teaches
the diffusion resistance layer [of the sensor device] is formed of
a base polymer synthesized to include a polyurethane
membrane with both hydrophilic and hydrophobic regions to
control the diffusion of glucose and oxygen to an analyte
sensor. A suitable hydrophobic polymer component can be a
polyurethane or polyether urethane urea. Polyurethane is a
polymer produced by the condensation reaction of a
diisocyanate and a difunctional hydroxyl-containing material.
(Simpson i-f 201 ).
4. Narang teaches:
To control the rate at which the adhesives polymerize (and to
improve the shelf life), additives have been included in the
monomer adhesive compositions. For example, cyanoacrylate
polymerization inhibitors or stabilizers including ... catechol ..
. have been used. . . . The addition of these inhibitors and
stabilizers inhibits premature polymerization of the monomer
and slows down the rate of polymerization once the
composition is in contact with the tissue to be treated.
(Narang i-f 11 ).
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5. Narang teaches: "Examples of suitable radical stabilizing agents
include ... catechol, pyrogallol" (Narang i-f 139).
6. Antioxidants8 teaches
ANTIOXIDANTS ... used to prevent thermal degradation ...
inhibit 'oxidation' (i.e. degradation) ...
Antioxidants are generally divided into primary and secondary
categories. Each category has a specific function in polymer
stabilization.
Primary- used to protect the finished product. This type of
stabilization ensures performance over the life of the finished
good.
Secondary - used as a process stabilizer. Effective way to
protect the polymer during processing, especially when the
polymer undergoes multiple heat histories. Typical chemistries
employed include phosphites or thioesters.
Primary/Secondary Combination - Both primary and
secondary antioxidants are often used in a combination. In this
way, the polymer is protected both during the processing step
and throughout its service life.
(Antioxidants 1 ).
7. Urata9 teaches the "antioxidant includes hydroxyphenyl
compounds such as ... catechol ... and pyrogallol" (Urata i-f 61 ).
8. Sunkara 10 teaches: "Stabilizers suitable for reducing the rate of
thermal and oxidative degradation of the fluids of the invention include ...
pyrocatechol" (Sunkara i-f 39).
8 "Antioxidants," Ampacet Technical Service Report (2002) (We
number the pages sequentially starting with the first page).
9 Urata et al., US 2005/0166790 Al, published Aug. 4, 2005.
10 Sunkara et al., US 2006/0192172 Al, published Aug. 31, 2006.
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9. Nakajima 11 teaches: "As polymerization inhibitors used are
phenolic antioxidants ... t-butyl catechol, pyrogallol" (Nakajima i-f 104).
10. Blacklock 12 teaches: "The cyanoacrylate composition ...
wherein the free radical inhibitor/antioxidant stabilizer is selected from the
group consisting of ... catechol, pyrogallol" (Blacklock 4, claim 4).
11. Lemanska13 teaches "the pH-dependent TEAC values for
mono-, di-, and polyhydroxyflavones, respectively. The antioxidant action
of Trolox was previously shown to be unaffected over the whole pH range
tested" (Lemanska 872, col. 1 ).
12. Lemanska teaches "these literature data and additional
considerations support that the pH-dependent effect on hydroxyflavone
antioxidant activity is not assay dependent and mainly due to an increased
radical scavenging ability of the flavonoids upon their deprotonation"
(Lemanska 879, col. 2).
Principles of Law
"Obviousness does not require absolute predictability of success ...
all that is required is a reasonable expectation of success." In re Kubin, 561
F.3d 1351, 1360 (Fed. Cir. 2009).
Analysis
We adopt the Examiner's findings of fact and reasoning regarding the
scope and content of the prior art (Final Act. 2--4; FF 1-12) and agree that a
11 Nakajima, US 2006/0028497 Al, published Feb. 9, 2006.
12 Blacklock et al., US 2008/0021139 Al, published Jan. 24, 2008.
13 Lemanska et al., The Influence Of pH On Antioxidant Properties And The
Mechanism Of Antioxidant Action Of Hydroxyflavones, 31 Free Radical
Biology & Medicine 869-81 (2001).
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preponderance of the evidence supports the determination that the claims are
obvious over the cited prior art. We address Appellants' arguments below.
Appellants contend Narang "does not teach or suggest that
compounds such as catechol or pyrogallol can be used to inhibit thermal and
oxidative degradation of polymers. Instead, Narang only teaches that such
compounds can be used to inhibit polymerization" (App. Br. 4). Appellants
further contend "there is no reasonable expectation of success that the
compounds disclosed in Narang would effectively inhibit the thermal and
oxidative degradation of formed polymers in the analyte sensor system of
Simpson" (App. Br. 6).
We find this argument unpersuasive for two reasons. First, Narang
specifically teaches that stabilizers, such as catechol, may be used "to
improve the shelf life" of polymers (FF 4), suggesting that antioxidant
stabilizers such as catechol and pyrogallol will inhibit degradation of
polymers and providing a reason to include them in the composition.
Second, the Examiner has provided evidence that antioxidants
"prevent thermal degradation" and "inhibit 'oxidation"' in "polymer
stabilization" that lasts "throughout [the polymer's] service life" (FF 6).
This is an express teaching that antioxidants inhibit thermal and oxidative
degradation of polymers. The Examiner further evidences that catechol and
pyrogallol were known antioxidants (FF 7, 9-10) that are "suitable for
reducing the rate of thermal and oxidative degradation" (FF 8).
Therefore, a preponderance of the evidence of record supports the
Examiner's position that inclusion of antioxidants into polymers would have
been expected to improve the shelf life as taught by N arang by reducing
thermal degradation and inhibiting oxidation, providing a specific reason to
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incorporate these antioxidants into the polyurethane polymer of Simpson in
order to improve shelf life of Simpson's glucose sensor and reduce thermal
and oxidative degradation (FF 1-10).
Appellants next contend that
even if the Examiner were correct in the belief that radical
stabilizing agents are inherently anti-oxidants (which is not
true), the mere observation that a compound can inhibits the
Narang polymerization reaction does not in fact mean that that
[sic] the compound inherently has anti-oxidizing activity in
every other environment with every expectation of success.
(Reply Br. 4). Appellants cite Lemanska, which they state "confirm[s] that
there are significant environmental (in this case pH) influences on the
antioxidant action of antioxidants, factors which make the activity of such
agents in new environments unpredictable" (Reply Br. 4).
We find this argument unpersuasive because the prior art provides
reasons to expect that antioxidants will successfully inhibit thermal and
oxidative degradation of polymers. In addition to Narang's teaching that
these compounds will stabilize the polymers (FF 6-7), the additional
evidentiary art supports the Examiner's position that these specific
antioxidants, catechol and pyrogallol, were known antioxidants (FF 7, 9-10)
that were "suitable for reducing the rate of thermal and oxidative
degradation" (FF 8).
We are not persuaded by Appellants' citation of Lemanska, because
Lemanska does not address the specific antioxidants recited in the claim or
discussed by the cited evidentiary prior art and Lemanska is not drawn to the
effect of antioxidants on polymers. Moreover, Lemanska does not provide
persuasive evidence that pH changes in antioxidants would eliminate the
ability of the antioxidants "to improve the shelf life" (FF 4); "to prevent
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thermal degradation ... inhibit 'oxidation'" (FF 6); or to "reduc[e] the rate
of thermal and oxidative degradation" (FF 8) as suggested by the Examiner's
cited references. Finally, even if they did, in view of the teachings in the
prior art about the benefit of the claimed anti-oxidants, it would have been
routine to determine amounts and pH to achieve the desired effect.
We therefore disagree with Appellants' conclusion that "artisans in
this technology would not have been rationally motivated to combine
Narang with Simpson in a manner that generates the claimed invention"
(Reply Br. 5) and instead agree with the Examiner that "it would have been
obvious to one of ordinary skill in the art to utilize catechol and pyrogallol,
as taught by Narang, as a stabilizing compounds that is able to inhibit
thermal and oxidative degradation of polyurethane and/or polyurea
polymers" such as those of Simpson (Ans. 4).
Conclusion of Law
The evidence of record supports the Examiner's conclusion that
inclusion ofNarang's catechol or pyrogallol stabilizing agents in the
polyurethane layer of Simpson's glucose sensor would have been expected
to "inhibit thermal and oxidative degradation of polyurethane and/or
polyurea polymers formed from the mixture," as required by claim 10.
B.-D. 35 U.S.C. § 103(a)
Appellants do not separately argue these obviousness rejections,
instead relying upon their arguments to overcome the combination of
Simpson and Narang. The Examiner provides sound fact-based reasoning
for combining each of Bowers, Robin, and Brister with Simpson and Narang
(see Final Act. 4--5). Having affirmed the obviousness rejection of claim 10
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over Simpson and Narang for the reasons given above, we also find that the
further combinations render the rejected claims obvious for the reasons
given by the Examiner.
SUMMARY
In summary, we affirm the rejection of claim 10 under 35 U.S.C.
§ 103(a) as obvious over Simpson and Narang. Claims 11, 13, 14, and 16-
19 fall with claim 10. 37 C.F.R. § 41.37(c)(l)(iv) ("[T]he failure of
appellant to separately argue claims which appellant has grouped together
shall constitute a waiver of any argument that the Board must consider the
patentability of any grouped claim separately.")
We affirm the rejection of claim 12 under 35 U.S.C. § 103(a) as
obvious over Simpson, Narang, and Bowers.
We affirm the rejection of claim 15 under 35 U.S.C. § 103(a) as
obvious over Simpson, Narang, and Robin.
We affirm the rejection of claim 20 under 35 U.S.C. § 103(a) as
obvious over Simpson, Narang, and Brister.
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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