Ex Parte Murase et al

Patent Trial and Appeal Board

Oct 19, 2016

11910382 (P.T.A.B. Oct. 19, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111910,382 10/01/2007
24267 7590 10/21/2016
CESARI AND MCKENNA, LLP
88 BLACK FALCON AVENUE
BOSTON, MA 02210
FIRST NAMED INVENTOR
Hironobu Murase
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.
218113-0002 5286
EXAMINER
LEONG, SUSAN DANG
ART UNIT PAPER NUMBER
1756
NOTIFICATION DATE DELIVERY MODE
10/21/2016 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@c-m.com
USPTOMail@c-m.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HIRONOBU MURASE, MOTOAKI KUWAHARA and
MASA YUKI YAMADA
Appeal2015-004364
Application 11/910,3 82
Technology Center 1700
Before LINDA M. GAUDETTE, A VEL YN M. ROSS, and BRIAND. RANGE,
Administrative Patent Judges.
GAUDETTE, Administrative Patent Judge.
DECISION ON APPEAL
Appeal2015-004364
Application 11/910,3 82
Appellants1 appeal under 35 U.S.C. § 134(a) from the Examiner's decision2
finally rejecting claims 1, 2, 5-17, 19, and 23. We have jurisdiction under 35
U.S.C. § 6(b).
We AFFIRM.
The "invention relates to a biosensor, which is capable of determining,
quickly and in high accuracy, quantity of neutral fat contained in a biological
sample or the like." Specification filed October 1, 2007 ("Spec."), 1:6-8. The
biosensor includes a reaction layer comprising a lipoprotein lipase, a glycerol
dehydrogenase, and an electron mediator. Id. at 13:2--4. In use, the addition of a
sample containing lipoprotein to the biosensor liberates glycerol and fatty acid, via
decomposition of neutral fat in the lipoprotein by the lipoprotein lipase contained
in the reaction layer. Id. at 13:19-22. The glycerol dehydrogenase in the reaction
layer oxidizes the glycerol and at the same time reduces the electron mediator. Id.
at 13:22-25. Concentration of a substrate can be accurately determined by
oxidation current value of the resultant electron mediator. Id. at 13:26-27.
According to the Specification, the glycerol dehydrogenase is preferably a
coenzyme dependent type. Id. at 15: 16-17. The coenzyme may be "a quinone
coenzyme such as pyrrolo-quinoline quinone (PQQ), CoQ or the like; a vitamin
coenzyme such as flavin adenine dinucleotide (FAD), FMN, NAD, NADP, biotin
or the like." Id. at 15:19-22.
The Examiner maintains the following grounds of rejection under pre-AIA
35 U.S.C. § 103(a) (see Examiner's Answer mailed December 29, 2014 ("Ans."),
2-14):
1 Appellants identify the real party in interest as CCI Corporation and Ultizyme
International Ltd. Appeal Brief filed August 11, 2014 ("Br."), 2.
2 Final Office Action mailed November 6, 2013 ("Final Act.").
2
Appeal2015-004364
Application 11/910,3 82
1. Claims 1, 2, 6, and 7 are rejected as unpatentable over Bhullar et al.
(US 2002/0100684 Al, pub. Aug. 1, 2002 ("Bhullar")) in view ofNakako et al. (JP
62177443, pub. Aug. 4, 1987, English Abstract ("Nakako")) and Wong et al. (US
2005/0067303 Al, pub. Mar. 31, 2005 ("Wong")).
2. Claims 1, 2, 6, 7, and 23 are rejected as unpatentable over Bhullar in
view ofNakako and Laurinavicius et al. (Bioelectrochemical application of some
PQQ-dependent enzymes, 55 Bioelectrochemistry 29-32 (2002)
("Laurinavicius")).
3. Claims 5, 8-17, and 19 are rejected over Bhullar, Nakako, and Wong
as applied to claim 1, further in view of various secondary references (see Ans. 4--
12).
Appellants' arguments in support of patentability as to all appealed claims
are based on limitations found in claim 1, the sole independent claim on appeal.
See Br. 5-7 (stating that the dependent claims are patentable for the same reasons
argued in connection with claim 1 ). For reference, claim 1 is reproduced below:
1. A biosensor for measuring concentration of neutral fat,
based on value of current flowing in an electrode system, comprising:
an insulating substrate;
an electrode system having a working electrode and a counter
electrode, formed onto said insulating substrate; and
a reaction layer having a lipoprotein lipase, a glycerol
dehydrogenase, a surfactant, and an electron mediator, formed at the
upper part or the vicinity of said electrode system, wherein the
glycerol dehydrogenase is a coenzyme dependent type and the
coenzyme is pyrrolo-quinoline quinone or flavin adenine dinucleotide.
3
Appeal2015-004364
Application 11/910,3 82
The Examiner finds Bhullar discloses a biosensor 10 for measuring the
concentration of triglycerides (neutral fat) comprising an insulating substrate 14
and an electrode system 50 as recited in claim 1. Ans. 2. The Examiner finds
Bhullar discloses a reaction layer 80 comprising a lipoprotein lipase, an electron
mediator, and a triglyceride enzyme. Id. at 2-3. The Examiner finds one of
ordinary skill in the art at the time of the invention would have been motivated to
replace Bhullar's triglyceride enzyme with a glycerol dehydrogenase coenzyme
dependent type based on Nakako's teaching that using a combination of lipase and
glycerol dehydrogenase in a reaction film of a lipid sensor increases the quantity of
hydrogen ion and provides high sensitivity. Id. at 3.
Claim 1 recites: "the coenzyme is pyrrolo-quinoline quinone or flavin
adenine dinucleotide" (emphasis added). Dependent claim 23 specifies that the
coenzyme is PQQ.
With respect to the coenzyme FAD, the Examiner finds Wong discloses a
biosensor to detect and/or quantify triglycerides that utilizes a glycerol
dehydrogenase coupled to a reductase, wherein a preferred reductase is FAD. Ans.
4 (citing Wong i-fi-145, 63). The Examiner finds one of ordinary skill in the art
would have been motivated to replace the glycerol dehydrogenase of Bhullar' s
biosensor, as modified by Nakako, with FAD dependent glycerol dehydrogenase
based on Wong's teaching that the latter provides a rapid sensor. Id. (citing Wong
i163).
With respect to the coenzyme PQQ, the Examiner finds "Laurinavicius
discloses a biosensor where PQQ dependent glycerol dehydrogenase ... is used as
the enzyme for the quantitative determination of an analyte in a biosensor." Id. at
14. The Examiner determines
4
Appeal2015-004364
Application 11/910,3 82
Id.
[i]t would have been obvious to one having ordinary skill in the art at
the time of the invention to replace the glycerol dehydrogenase of
modified Bhullar with the PQQ dependent glycerol dehydrogenase as
taught by Laurinavicius because utilizing one known type of glycerol
dehydrogenase in place of another known type of glycerol
dehydrogenase that is also as an enzyme to detect an analyte in a
biosensor is well within the ambit of one of ordinary skill in the art.
Rejection of claim 1 over Bhullar, Nakako, and Wong
Appellants agree that Wong discloses the use of a redox enzyme comprising
glycerol dehydrogenase that can be NAD-dependent. Br. 4--5. Appellants also
acknowledge Wong discloses a reductase that can have an F AD/FMN co-factor.
Id. at 4. Appellants argue, however, that the redox enzyme is different and
separate from the reductase. Appellants thus contend the Examiner erred in
finding Wong discloses or suggests that the redox enzyme, glycerol hydrogenase,
can be FAD-dependent.
The Examiner, in response, asserts that the argued claim limitation reads on
Wong's disclosure of using a glycerol dehydrogenase coupled to a reductase/redox
agent, wherein preferred reductases include FAD. Ans. 16 ("Thus, [Wong's]
glycerol dehydrogenase is FAD dependent.").
Appellants have not explained persuasively why the Examiner's finding that
"the glycerol dehydrogenase of Wong is FAD dependent because it is coupled to
the FAD" (id. at 17-18) is erroneous or unreasonable. Accordingly, we are not
convinced of error in the Examiner's rejections of claims 1, 2, 5-17, 19 over
Bhullar, Nakako, and Wong.
Rejection of claim 1 over Bhullar, Nakako, and Laurinavicius
Appellants note that claim 1 requires the presence of a surfactant in the
reaction layer. Br. 5. Appellants cite Adachi et al. (US 5 ,346,819, iss. Sept. 13,
5
Appeal2015-004364
Application 11/910,3 82
1994 ("Adachi"))3 as evidence that one of ordinary skill in the art would have
understood that a surfactant should not be used when measuring the concentration
of glycerol using a PQQ-dependent glycerol dehydrogenase. Id. at 6. Appellants
also rely on Specification Examples 2-1 and 2-2 as evidence that a biosensor
comprising a reaction layer containing both a surfactant and a PQQ-dependent
glycerol dehydrogenase was unexpectedly superior to a similar sensor that did not
include a surfactant. See id. at 5---6; Ex. D, Amendment filed May 22, 2013, 7-8.
We have considered Appellants' arguments but do not find them persuasive
for the reasons explained by the Examiner in the Response to Argument section of
the Answer. See Ans. 18-21. In particular, we find the evidence supports the
Examiner's findings that "the use of PQQ glycerol dehydrogenase in a biosensor is
well known in the art" (Final Act. 14) and that one of ordinary skill in the art
would not have been dissuaded from using PQQ glycerol dehydrogenase in the
Bhullar/Nakako sensor despite the presence of a surfactant in the reaction layer
(see Ans. 20-21 (explaining that Adachi teaches only that the use of a certain,
unspecified surfactant may cause errors)).
In our view, the Examiner's strong prima facie showing of obviousness is
not overcome by Appellants' arguments and evidence of unexpected results in the
Specification (see Br., Ex. D) and previously submitted declaration discussed by
the Examiner in the Answer (see Ans. 18-19). See Sud-Chemie, Inc. v. Multisorb
Techs., Inc., 554 F.3d 1001, 1009 (Fed. Cir. 2009) ("[E]vidence of unexpected
results and other secondary considerations will not necessarily overcome a strong
prima facie showing of obviousness."). We note the evidence in the Specification
relied on by Appellants provides a comparison of two reaction layer compositions,
3 The Examiner relies on Adachi in rejecting dependent claim 17. See Final Act.
10-11.
6
Appeal2015-004364
Application 11/910,3 82
differing only in that one includes Triton X-100 as a surfactant. See Spec. 32:30-
35:7. Appellants have not explained clearly how, based on this single comparison,
a conclusion reasonably may be drawn that an unexpectedly superior biosensor
would be achieved when using other surfactants and/or reaction layer compositions
within the scope of the claims (see Br. 5---6; Ex. D, 7-8). See In re Klosak, 455
F.2d 1077, 1080 (CCPA 1972) (noting that the burden of analyzing and explaining
data to support nonobviousness rests with the Appellant).
Accordingly, we are not convinced of error in the Examiner's rejections of
claims 1, 2, 6, 7, and 23 over Bhullar, Nakako, and Laurinavicius.
In sum, for the reasons stated in the Examiner's Answer and above, the
Examiner's decision to reject claims 1, 2, 5-17, 19, and 23 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
7