Ex Parte Labgold et al

Patent Trial and Appeal Board

Jul 10, 2014

12212007 (P.T.A.B. Jul. 10, 2014)

UNITED STATES PATENT AND TRADEMARKOFFICE
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.
12/212,007 09/17/2008 Marc Robert Labgold SIOM-0002-UT1 9536
80308 7590 07/10/2014
Steven B. Kelber
Alchemy-Partners, PC
5885 Trinity Parkway
Suite 370
Centreville, VA 20120
EXAMINER
KESSEL, MARIS R
ART UNIT PAPER NUMBER
1759
MAIL DATE DELIVERY MODE
07/10/2014 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 MARC ROBERT LABGOLD and GEORGE G. JOKHADZE
____________

Appeal 2013-002227
Application 12/212,007
Technology Center 1700
____________

Before CHUNG K. PAK, TERRY J. OWENS , and PETER F. KRATZ,
Administrative Patent Judges.

PAK, Administrative Patent Judge.

DECISION ON APPEAL

This is a decision on appeal1under 35 U.S.C. § 134(a) from the Examiner’s
final rejection of claims 1, 3 through 7, 9 through 11, and 13 through 21. Claims 2,
8, and 12, and 22 through 27, the other claims pending in the above-identified
application, stand withdrawn from consideration by the Examiner. A hearing was
held on June 19, 2014. We have jurisdiction pursuant to 35 U.S.C. § 6.
We AFFIRM-IN-PART.
STATEMENT OF THE CASE
The subject matter on appeal is directed to assay systems and methods for
“the detection of target substances in a larger volume.” (Spec. 2, ¶ 5.) Details of

1 Appeal Brief filed July 30, 2012 (“App. Br.”) at 1 and 4.
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Application 12/212,007

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the appealed subject matter are recited in representative claims 1, 5, 11, and 21
reproduced below from the Claims Appendix of the Appeal Brief:
1. An assay system for the detection of a target in a liquid
sample, wherein
said assay system consists essentially of:
a first capture moiety which binds to any target present in said
sample, said first capture moiety complexed with an enzymatic redox
reaction component which enzyme is a an oxidase or dehydrogenase
of a substrate;
a second capture moiety which bind to any said target present in
said sample in a way not to interfere with binding of said first capture
moiety to said target, said second capture moiety being bound to a an
element that facilitates separation of target bound thereby from the
remainder of said sample;
a substrate recognized by said enzyme, which substrate, when
acted upon by said enzyme, releases electrons; and
a circuit which detects the presence of electric potential,
electric current, or both, developed by the release of electrons from
said substrate when digested by said enzyme.
5. An assay system for the detection of a target in a sample,
wherein said assay system consists essentially of:
a first capture moiety which binds to any target present in said
sample, said first capture moiety complexed with an enzymatic redox
reaction component which enzyme is a an oxidase or dehydrogenase
of a substrate;
a substrate recognized by said enzyme, which substrate, when
acted upon by said enzyme, releases electrons; and
a circuit which detects the presence of electric potential,
electric current, or both, developed by the release of electrons from
said substrate when acted upon by said enzyme.
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11. An assay method for detecting the presence of a target in a
sample, said method comprising using the assay system of Claim 1
wherein said first capture moiety and said second capture moiety are
combined with said sample under conditions which permit binding of
said first and second capture moiety to any said target in said sample,
any said target in said sample bound by said first and second capture
moieties is retained by retaining said collection moiety, thereafter said
substrate is added to said bound target, wherein any potential or
current generated by reaction between said oxidase or dehydrogenase
and said substrate is detected as a signal reflecting the presence of said
target in said sample.
21. An assay method for detecting the presence of a target in a
sample, said method comprising using the assay system of Claim 5,
wherein said first capture moiety complexed with an oxidase or
dehydrogenase of a substrate is combined with said sample under
conditions which permit binding of said first capture moiety to and
said target in said sample and thereafter said substrate is added to said
sample, wherein any electric potential or current generated by the
action of said enzyme upon said substrate is detected as indicating the
presence of said target in said sample.
(Emphasis added.)
The Examiner maintains the following grounds of rejection in the
Examiner’s Answer mailed October 2, 2012 (“Ans.”):
1. Claims 1, 4 through 7, 9, 11, 13, 15 through 17, and 21 stand
provisionally rejected on the ground of non-statutory obviousness-type double
patenting over claims 1, 2, 4, 7 through 14, 16, 18 through 22 and 24 of U.S. Patent
Application 12/211,992 filed September 17, 2008;
2. Claims 1, 3 through 7, 9 through 11, 13, 14, 16, and 19 through 21
stand rejected under 35 U.S.C. § 103(a) as unpatentable over Robinson;2

2 G.A. Robinson et al., Bioelectrochemical Enzyme Immunoassay of Human
Choriogonadotropin with Magnetic Electrodes, 31 CLINICAL CHEMISTRY 1449
(1985) (“Robinson”).
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Application 12/212,007

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3. Claim 15 stands rejected under 35 U.S.C. § 103(a) as unpatentable
over Robinson in view of Yamauchi;3 and
4. Claims 17 and 18 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Robinson in view of Boitieux.4
DISCUSSION
I. OBVIOUSNESS-TYPE DOUBLE PATENTING
Appellants do not question the propriety of the Examiner’s obviousness-type
double patenting rejection of claims 1, 4 through 7, 9, 11, 13, 15 through 17and 21
as unpatentable over the claims of U.S. Patent Application 12/211,992 set forth in
the Answer. (App. Br. 18.) Thus, we summarily affirm this rejection.

II. 35 U.S.C. § 103
Upon consideration of the evidence on this record, we concur with
Appellants that the Examiner has not demonstrated that one of ordinary skill in the
art, armed with the knowledge reflected in the applied prior art, would have been
led to the subject matter recited in claims 1, 3 through 7, 9 through 11, and 13
through 21 within the meaning of 35 U.S.C. § 103(a). In particular, the Examiner
has not carried the burden of demonstrating that Robinson’s circuit for
amperometric measurement of glucose oxidase reaction5 or for detection of an

3 U.S. Patent 5,516,644 issued to Yamauchi et al. on May 14, 1996 (“Yamauchi”).
4 Jean-Louis Boitieux et al, Oxygen Electrode-Based Enzyme Immunoassay for the
Amperometric Determination of Hepatitis B Surface Antigen, 163 ANALYTICA
CHIMICA ACTA 309 (1984) (“Boitieux”).
5 Moreover, the Examiner has not shown that the amperometric measurement of
glucose oxidase reaction taught by Robinson involves the measurement of “electric
potential, electric current, or both, developed by the release of electrons from [a]
substrate” when digested or acted upon by an enzyme. The Examiner has not
contradicted or explained relevance of Appellants’ literature evidence, e.g.,
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applied current required to reoxidize a ferrocene derivative is capable of detecting
the presence of electric potential and/or electric current developed by the release of
electrons from a substrate when it is digested or acted upon by an enzyme as
explained by Appellants at pages 18 through 22 of the Appeal Brief and pages 2
through 7 of the Reply Brief. On the present record, the Examiner has not
proffered any evidence to show that the claimed functionally defined circuit
designs are identical or substantially identical to the circuit design taught by
Robinson. Cf. In re Best, 562 F.2d 1252, 1255 (CCPA 1977). Nor has the
Examiner proffered any evidence to show that any known circuit design, inclusive
of Robinson’s circuit design, is capable of detecting the presence of electric
potential and/or electric current developed by the release of electrons from a
substrate digested by or acted upon by an enzyme as asserted by the Examiner.
(Ans. 4-23.) In other words, the Examiner has not demonstrated that the circuit
design taught by Robinson inherently or necessarily has the function recited in the
claims on appeal. As stated by the predecessor to our reviewing court in In re
Oelrich, 666 F.2d 578, 581 (CCPA 1981), “[i]nherency . . . may not be established
by probabilities or possibilities. The mere fact that a certain thing may result from
a given set of circumstances is not sufficient.”
The Examiner has also relied upon the disclosure of Yamauchi or Boitieux to
show the features recited in dependent claims 15, 17, and/or 18. However, neither

Boitieux relied upon by the Examiner, which is said to show that amperometric
detection or measurement involves the measurement of oxygen consumption.
(Compare App. Br. 22 with Ans. 4-23.) The Examiner has not shown that the
circuit used for oxygen consumption measurement taught by Robinson, as
explained by Boitieux, is capable of detecting the presence of electric potential
and/or electric current developed by the release of electrons from a substrate
digested by or acted upon by an enzyme as required by the claims on appeal. (Ans.
4-23.)
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Yamauchi nor Boitieux is relied upon to provide a disclosure that would remedy
the above discussed deficiency in Robinson.
Accordingly, we are constrained to reverse the Examiner’s § 103(a) rejections
for the reasons set forth by Appellants in the Appeal Brief.

ORDER
Upon consideration of the record, and for the reasons given above, it is
ORDERED that the decision of the Examiner to provisionally reject claims
1, 4 through 7, 9, 11, 13, 15 through 17 and 21 on the ground of non-statutory
obviousness-type double patenting over the claims of U.S. Patent Application
12/211,992 filed September 17, 2008 is AFFIRMED;
FURTHER ORDERED that the decision of the Examiner to reject claims 1,
3 through 7, 9 through 11, and 13 through 21 under 35 U.S.C. § 103(a) is
REVERSED; and
FURTHER ORDERED that no time period for taking any subsequent action
in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1).

AFFIRMED-IN-PART
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