Ex Parte Davis

Patent Trial and Appeal Board

Dec 12, 2018

13506798 (P.T.A.B. Dec. 12, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/506,798 05/17/2012
114215 7590
Scarinci Hollenbeck, LLC
3 Park Avenue, 15th Floor
New York, NY 10016
12/12/2018
FIRST NAMED INVENTOR
David C. Davis
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.
PAT-01998-521 6316
EXAMINER
MARCSISIN, ELLEN JEAN
ART UNIT PAPER NUMBER
1641
MAIL DATE DELIVERY MODE
12/12/2018 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 DAVID C. DA VIS
Appeal2017-010222 1
Application 13/506,798
Technology Center 1600
Before RICHARD M. LEBOVITZ, JEFFREY N. FRED MAN, and
DAVID COTTA, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims directed to an in-the-field lateral flow
immunoassay (LFIA) apparatus for detection of the concentration of a virus-
directed antibody directed against a canine parvovirus (CPV) in dog saliva.
The Examiner rejected the claims under 35 U.S.C. § 103 as obvious.
Appellants appeal the Examiner's determination under 35 U.S.C. § 134 that
the claims are unpatentable. We have jurisdiction under 35 U.S.C. § 6(b ).
The Examiner's decision is AFFIRMED.
1 The Appeal Brief ("Appeal Br.") identified David C. Davis as the real-
party-in-interest.
Appeal2017-010222
Application 13/506,798
STATEMENT OF THE CASE
Claims 1 and 2, the only pending claims in this appeal, stand finally
rejected under pre-AIA 35 U.S.C. § I03(a) as obvious over Boehringer et al.,
US 2008/0138842 Al (published June 12, 2008) ("Boehringer") in view of
Chandler, US 6,146,589 (issued Nov. 14, 2000) ("Chandler (2000)"),
Calenoff, US 5,567,594 (issued Oct. 22, 1996) ("Calenoff (1996)"),
Rimmelzwaan et al., (Evaluation of enzyme-linked immunosorbent assays
based on monoclonal antibodies for the serology and antigen detection in
canine parvovirus infections, Veterinary Quarterly, Vol. 12, No. 1, 14--20
(1990)) ("Rimmelzwaan"), Valdes et al., US 5,882,652 (issued Mar. 16,
1999) ("Valdes"), and Chandler et al., US 5,877,028 (issued Mar. 2, 1999)
("Chandler (1999)"). Ans. 2-3.
Claims 1 and 2 are independent claims. The main dispute in this
appeal involves step c) of claims 1 and 2 in which a polyclonal antibody is
present in the sample pad of the claimed device. In claim 1, the polyclonal
antibody is selected from anti-IgG and anti-IgA; in claim 2, the polyclonal
antibody is anti-IgA. Otherwise, the limitations in both claims are
substantially the same.
Claim 1 is illustrative of the claimed subject matter and reproduced
below:
1. An in-the-field lateral flow immunoassay (LFIA)
apparatus for detection of the concentration of a virus-
directed antibody directed against a canine parvovirus
(CPV) in dog saliva to determine whether or not the dog
will catch CPV disease when exposed, utilizing a test
cassette, comprised of:
a) a test cassette housing utilized in the detection of the
virus-directed antibody directed against CPV in the saliva
of a dog;
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Appeal2017-010222
Application 13/506,798
b) a sample port formed in said test cassette housing
for accessing a sample pad;
c) said sample pad, wherein said sample pad is
accessed via said sample port formed in said cassette
housing for receiving the saliva sample, wherein said
sample pad includes a filtering component that filters out
test-interfering glycoproteins and interfering antibodies
and wherein said sample pad contains a polyclonal
antibody (Pab) selected from the group consisting of Pab
anti-IgG and Pab anti-IgA;
d) a strip of material that allows lateral flow of liquid
and is fitted within said cassette housing, wherein said
strip of material is in contact with said sample pad,
wherein said strip has an upstream proximal and a
downstream distal end;
e) a first permeable conjugate pad in contact with said
strip and downstream from both said sample pad and said
filtering component;
f) a first conjugate of unfixed canine parvovirus/VP2
antigen (CPV/VP2) coupled to biotin to which the virus-
directed antibody directed against CPV binds, wherein
said first conjugate of unfixed canine parvovirus/VP2
antigen (CPV/VP2) coupled to biotin is contained within
said first permeable conjugate pad;
g) a second permeable conjugate pad in contact with
said lateral flow strip and downstream from said first
permeable conjugate pad;
h) an unfixed-to-strip ligand that does not bind to the
CPV virus-directed antibody and is avidin bound to a
detectable label species thereby forming a second
conjugate,
wherein said unfixed-to-strip ligand is contained
within said second permeable conjugate pad and wherein
said first conjugate encounters and binds to said second
conjugate to form a third conjugate;
i) a plurality of tracers in an array of concentrations
affixed to said strip in a plurality of virus-directed
antibody detection zones that permit a direct visual
titering out the quantity of virus-directed antibody in the
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Appeal2017-010222
Application 13/506,798
dog saliva sample, wherein said plurality of detection
zones are downstream from said second permeable
conjugate pad, wherein said plurality of tracers in said
array of concentrations form detectable complexes
producing directly visible marks upon encountering said
third conjugate in said plurality of detection zones that
are visual indicators of the quantity of virus-directed
antibody in the dog saliva sample;
j) a control zone downstream of said detection zone,
wherein said control zone comprises a bound second
control tracer directed toward said second permeable
conjugate pad unfixed-to-strip ligand and forms a visible
complex upon binding; and
k) an absorbent pad that is in contact with the distal
end of said strip for absorbing liquid from said strip.
OBVIOUSNESS REJECTION
Claim 1 is directed to an in-the-field lateral flow immunoassay
("LFIA") apparatus. The LFIA apparatus is for detection of the
concentration of a virus-directed antibody directed against a canine
parvovirus (CPV) in dog saliva.
For illustrative purposes, a preferred embodiment of the LFIA
apparatus is reproduced below to show a configuration of an apparatus in
accordance with the claim. The apparatus has been labeled with the various
features of claim 1.
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Appeal2017-010222
Application 13/506,798
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