Ex Parte Merchant

Patent Trial and Appeal Board

Mar 23, 2017

13497083 (P.T.A.B. Mar. 23, 2017)

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.
3192-011-01 4656
EXAMINER
KESSEL, MARIS R
ART UNIT PAPER NUMBER
1759
MAIL DATE DELIVERY MODE
13/497,083 03/20/2012
86723 7590
Kilyk & Bowersox, P.L.L.C.
400 holiday Court, Suite 102
Warrenton, VA 20186
Stephen A. Merchant
03/23/2017 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 STEPHEN A. MERCHANT
Appeal 2016-002755
Application 13/497,0831
Technology Center 1700
Before TERRY J. OWENS, CHRISTOPHER C. KENNEDY, and
BRIAN D. RANGE, Administrative Patent Judges.
RANGE, Administrative Patent Judge.
DECISION ON APPEAL
SUMMARY
Appellant appeals under 35 U.S.C. § 134(a) from the Examiner’s
decision rejecting claims 1—11, 25, 27, and 28. We have jurisdiction. 35
U.S.C. § 6(b).
We AFFIRM.
1 According to the Appellant, the real party in interest is Fresenius Medical
Care Holdings, Inc. Appeal Br. 3.
Appeal 2016-002755
Application 13/497,083
STATEMENT OF THE CASE2
Appellant describe the invention as relating to a biosensor for
determining concentration of creatinine or other analytes in a sample fluid.
Spec. 12. Claim 1, reproduced below with spacing added for readability, is
the only independent claim on appeal and is illustrative of the claimed
subject matter:
1. An amperometric biosensor for determination of creatinine in
a sample fluid comprising
an enzyme-redox polymer coated-electrode which
comprises
an enzyme-polymer composition and
an electrode having an electrode surface comprising
conductive electrode material,
wherein the enzyme-polymer composition
comprises at least one redox polymer and
a plurality of enzymes immobilized on the
electrode surface
wherein a coating of the enzyme-polymer
composition comprises crosslinked redox-
polymer that is attached to the electrode
surface of the conductive electrode material,
wherein the enzymes comprise at least one redox enzyme
and at least one enzyme catalyzing hydrolysis of creatinine
or a hydrolyzed derivative thereof,
wherein the redox polymer is attached to the enzymes and
the electrode surface, and
wherein the redox polymer provides direct electrical
communication between the at least one redox enzyme and
the electrode surface.
2 In this decision, we refer to the Final Office Action mailed January 26,
2015 (“Final Act.”), the Appeal Brief filed June 22, 2015 (“Appeal Br.”), the
Examiner’s Answer mailed November 20, 2015 (“Ans.”), and the Reply
Brief filed December 31, 2015 (“Reply Br.”).
2
Appeal 2016-002755
Application 13/497,083
Appeal Br. 32 (Claims App’x).
REFERENCES
The Examiner relies upon the prior art below in rejecting the claims
on appeal:
Pamidi et al. US 2004/0211666 A1 Oct. 28, 2004
(hereinafter “Pamidi”)
Simpson et al. US 2008/0197024 Al Aug. 21,2008
(hereinafter “Simpson”)
Liu et al. US 2009/0099434 Al Apr. 16, 2009
(hereinafter “Liu”)
REJECTIONS
The Examiner maintains the following rejections on appeal:
Rejection 1. Claims 1—10, 25, 27, and 28 under 35 U.S.C. § 103 as
unpatentable over Liu in view of Pamidi. Ans. 2.
Rejection 2. Claim 11 under 35 U.S.C. § 103 as unpatentable over
Liu in view of Pamidi in further view of Simpson. Id. at 8.
ANALYSIS
We review the appealed rejections for error based upon the issues
identified by the Appellant and in light of the arguments and evidence
produced thereon. Cf. Ex parte Frye, 94 USPQ2d 1072, 1075 (BPAI 2010)
(precedential) (cited with approval in In re Jung, 637 F.3d 1356, 1365 (Fed.
Cir. 2011) (“it has long been the Board’s practice to require an applicant to
identify the alleged error in the examiner’s rejections”)). After considering
the evidence presented in this Appeal and each of Appellant’s contentions,
we are not persuaded that Appellant identifies reversible error. Thus, we
affirm the Examiner’s rejections for the reasons expressed in the Final Office
3
Appeal 2016-002755
Application 13/497,083
Action and the Answer except as otherwise noted below. We add the
following primarily for emphasis.
Rejection 1, claims 1—6, 9, and 10. The Examiner rejects claims 1—
10, 25, 27, and 28 as obvious over Liu in view of Pamidi. Ans. 2. Appellant
does not separately argue claims 2—6, 9, or 10. We therefore focus on claim
1, and claims 2—6, 9, and 10 stand or fall with that claim. 37 C.F.R.
§ 41.37(c)(l)(iv) (2013). We separately address other claims further below.
The Examiner finds that Liu teaches an amperometric biosensor for
determination of creatinine in a sample fluid that meets the recitations of
claim 1 except that “Liu fails to explicitly teach a plurality of enzymes, and
wherein the enzymes comprise at least one redox enzyme and at least one
enzyme catalyzing hydrolysis of creatinine or a hydrolyzed derivative
thereof.” Ans. 2—3 (providing citations to Liu). The Examiner finds that
Pamidi teaches a biosensor for determination of creatinine in a sample fluid
and teaches the recited enzymes. Id. at 3 (providing citations to Pamidi).
The Examiner concludes that it would have been obvious to one of ordinary
skill in the art to substitute Liu’s catalysts with the enzyme system taught by
Pamidi to provide for the detection of creatinine. Id. A preponderance of
the evidence supports the Examiner’s findings and conclusion.
Appellant argues that Liu teaches two embodiments and that Liu’s
first embodiment relates to detecting glucose oxidase, lactate oxidase, or
laccase. Appeal Br. 13. Appellant further argues that Liu’s second
embodiment, which Appellant argues contains pertains to creatinine,
requires separation of the sensing layer and working electrode unlike the
recitations of claim l. Id. A preponderance of the evidence, however,
supports that Liu teaches that its analyte monitoring “embodiments” (Liu |
105) may monitor creatinine (id. at 1108). One of those “embodiments” is
4
Appeal 2016-002755
Application 13/497,083
the first embodiment described at paragraph 135 of Liu, and Appellant does
not dispute that this particular embodiment teaches “[a] sensing layer that is
in direct contact with the working electrode . . .
Regarding this first embodiment, Liu states, “for example, a glucose,
lactate, or oxygen electrode may be formed having a sensing layer which
contains a catalyst, such as glucose oxidase, lactate oxidase, or laccase,
respectively . . . Id. at 1135. The language “for example,” indicates that
the embodiment is appropriate for detecting other analytes as well, and a
person of skill in the art would reference other portions of Liu (e.g., id. at |
108) to determine that Liu may also be used to detect creatinine. Ans. 11.
Appellant further argues that Pamidi requires separation of the sensing
layer and working electrode and that Padimi thus teaches away from
attempting to detect creatinine without such separation. Appeal Br. 14.
Padimi, however, merely teaches that an embodiment of its invention has a
separation layer. Padimi 1139. Padimi does not disparage or discourage
detection of creatinine in the apparatus described by Liu’s paragraph 135.
See In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994) (“A reference maybe
said to teach away when a person of ordinary skill, upon reading the
reference, would be discouraged from following the path set out in the
reference, or would be led in a direction divergent from the path that was
taken by the applicant.”). Padimi also does not indicate that the enzyme
system of Liu could not be exchanged with a predictable result. Ans. 12.
Appellant also argues that the enzyme mixture of Padimi does not
include a redox polymer and that the references do not teach that the
enzymes of Padimi would be compatible with the redox polymers of Liu.
Appeal Br. 17—18. Liu, however, teaches that its system can be used to
detect creatinine. Liu ]f 105. Moreover, the preponderance of the evidence
5
Appeal 2016-002755
Application 13/497,083
supports the Examiner’s finding that Liu, just like Pamidi, teaches various
enzyme systems “such as glucose oxidase for detecting glucose, lactate
oxidase for detecting lactase, etc.” Ans. 13 (providing citations to Liu and
Pamidi). Thus, a preponderance of evidence supports the Examiner’s
finding that a person of skill would also expect Pamidi’s teachings regarding
the creatinine enzyme system to be compatible with Liu. See, e.g., Ans. 13
(“Enzyme system[s] can be exchanged depending on the analyte with a
predictable result.”). Appellant cites no persuasive evidence to the contrary.
We thus sustain the Examiner’s rejection of claims 1—6, 9, and 10, and
27 because Appellant has not identified reversible error.
Rejection 1, claims 7—8, 25, and 27. Appellant’s argument with
respect to these claims is substantially the same as Appellant’s arguments
raised with respect to claim 1. Appeal Br. 20-23. Accordingly, we sustain
the Examiner’s rejection of these claims for the reasons explained above.
Rejection 1, claim 28. Claim 28 recites, with emphasis added, “the
biosensor of claim 1, wherein said plurality of immobilized enzymes
comprise creatinine amidohydrolase, creatinine amidinohydrolase, and
sarcosine oxidase, wherein sarcosine oxidase is regeneratable on the
electrode surface after reduction to SOx(FADH2) by interaction with
the redox polymer in the enzyme-polymer composition.”
Appellant argues that claim 28’s recitation is what “permits the direct
measurement of the current generated by the enzymatic reaction . . . .”
Appeal Br. 27. Appellant argues that the references do not teach or suggest
that the recited reaction pathways will necessarily result. Id. at 24—29; see
also Reply Br. 6—8.
The Examiner, however, correctly concludes that claim 28 is directed
to an apparatus. Ans. 17. Claim 28’s recitation emphasized above recites a
6
Appeal 2016-002755
Application 13/497,083
characteristic of the apparatus. “Where, as here, the claimed and prior art
products are identical or substantially identical, or are produced by identical
or substantially identical processes, the PTO can require an applicant to
prove that the prior art products do not necessarily or inherently possess the
characteristics of his claimed product.” In re Best, 562 F.2d 1252, 1256
(CCPA 1977). As explained above, the Examiner has established that the
proposed combination of Liu and Pamidi meets the elements of claim 1, and
Appellant does not persuasively dispute that the combination also meets the
“wherein said plurality of immobilized enzymes comprise creatinine
amidohydrolase, creatinine amidinohydrolase, and sarcosine oxidase”
recitation of claim 28. Appeal Br. 24—29; see also Ans. 7—8; Pamidi 196.
The Examiner has thus established that the claimed and prior art products
are identical or substantially identical, and Appellant, meanwhile, has not
met the burden of establishing that the Examiner’s proposed combination of
Liu and Pamidi would not have the recited “wherein sarcosine oxidase is
regeneratable . . .” characteristic. Appellant’s argument therefore does not
establish reversible error.
Rejection 2, claim 11. The Examiner rejects claim 11 as obvious
over Liu in view of Pamidi in further view of Simpson. Ans. at 8. Claim 11
recites, “A dialysis system comprising a dialyzer, and the amperometric
biosensor of claim 1.” Appeal Br. 34 (Claims App’x). In addition to
findings concerning Liu and Pamidi similar to those discussed above, the
Examiner finds that Simpson teaches an intravenous analyze sensor like Liu
wherein the sensor system may include a dialysis machine. Ans. 10. The
Examiner concludes that “it would have been obvious to one of ordinary
skill in the art at the time the invention was made to modify the senor system
of Liu to include a dialysis machine as taught by Simpson because the
7
Appeal 2016-002755
Application 13/497,083
monitoring of creatinine is generally used to assess the effectiveness of
dialysis.” Id.
Appellant persuasively argues that the recitations of claim 11
structurally limit the scope of the claim because the claimed system must
comprise a dialyzer. Appeal Br. 30. Appellant, however, does not
persuasively dispute the Examiner’s findings regarding Simpson and does
not dispute the Examiner’s rationale for combining Simpson with Liu and
Pamidi. Ans. 10. We thus sustain the Examiner’s rejection based on the
combination of these three references.
DECISION
For the above reasons, we affirm the Examiner’s rejection of claims
1-11,25,27, and 28.
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
8