Ex Parte Gupta et al

Patent Trials and Appeals Board

Jan 30, 2019

14311069 - (D) (P.T.A.B. Jan. 30, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/311,069 06/20/2014
20350 7590 02/01/2019
KILPATRICK TOWNSEND & STOCKTONLLP
Mailstop: IP Docketing - 22
1100 Peachtree Street
Suite 2800
Atlanta, GA 30309
Vineet Gupta
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.
096392-000212US-0911751 8901
EXAMINER
GEMBEH, SHIRLEY V
ART UNIT PAPER NUMBER
1615
NOTIFICATION DATE DELIVERY MODE
02/01/2019 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):
ipefiling@kilpatricktownsend.com
KTSDocketing2@kilpatrick.foundationip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte VINEET GUPTA and M. AMIN ARNAO UT 1
Appeal2017-010886
Application 14/311,069
Technology Center 1600
Before ULRIKE W. JENKS, JOHN E. SCHNEIDER, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
SCHNEIDER, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal2 under 35 U.S.C. § 134 from the Examiner's
rejection of claims to a cell based assay which have been rejected as
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
1 Appellants identify the Real Party in Interest as The General Hospital
Corporation. Br. 3.
2 We have considered and herein refer to the Specification of June 20, 2014
("Spec."); Final Office Action of Apr. 25, 2016 ("Final Act."); Appeal Brief
of Mar. 23, 2017 ("Br."); and Examiner's Answer of May 24, 2017 ("Ans.").
Appeal2017-010886
Application 14/311,069
STATEMENT OF THE CASE
"Integrins are non-covalently linked a/B heterodimeric receptors that
mediate cell adhesion, migration and signaling. Together with their ligands,
integrins play central roles in many processes including development,
hemostasis, inflammation and immunity, and in pathologic conditions such
as cancer invasion and cardiovascular disease." Spec. ,r 2. "The B2
integrins, which have a common B-subunit (B2, CD 18) but distinct a-
subunits (CDl la, CDl lb, CDl lc and CDl ld), are critical leukocyte
receptors that are important not only for the function of leukocytes but also
the development of the inflammatory response in vivo." Id.
Current assays for the identification of regulators of
CD 11 b/CD 18 rely on purified proteins adsorbed to microtiter
plates. Even though these assays are compatible with high-
throughput screening (HTS), purification of the requisite
amount of CD 11 b/CD 18 from mammalian cells for a HTS
campaign can be exceedingly difficult and the natural
conformation of integrin may not be retained upon adsorption
to the plastic surfaces.
Id. ,r 4. The Specification describes an assay for the rapid identification of
small molecule modulators of integrin CD1 lb/CD18. Id. ,r 13.
Claims 1-5, 7-9, 11, and 13-18 are on appeal. Claim 1 is
representative reads as follows:
1. A no-wash, cell-based assay for the identification
of small molecule modulators of integrin CD 11 b/CD 18, the
assay consisting of:
contacting cells with a solution comprising a test
compound on a substrate treated with a compound that affects
cell adhesion;
inverting the substrate such that non-adherent cells move
away from the substrate by the action of gravity;
2
Appeal2017-010886
Application 14/311,069
removing the solution from the substrate after inverting
the substrate without contacting the substrate with an additional
liquid to wash or rinse the substrate; and
detecting adherent cells on the substrate.
Claims 1-5, 7-9, 11, and 13-18 have been rejected under 35 U.S.C.
§ I03(a) as unpatentable over Xiong3 in view of Amaout4 and in further
view of Gallatin, 5 Ason, 6 and Young. 7
DISCUSSION
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner's conclusion that the subject matter of
the claims would have been obvious over Xiong combined with Amaout,
Gallatin, Ason, and Young.
The Examiner finds that Xiong teaches an assay for identification of
CD 11 b/CD 18 modulation where the adhesion to a substrate is performed in
the presence of calcium and magnesium ions. Final Act. 4. The Examiner
finds that Amaout teaches contacting cells with a solution comprising a test
3 Xiong et al., Modulation of CDI lb/CD18 Adhesive Activity by Its
Extracellular, Membrane-Proximal Regions, 171 J. Immunol. 1042 (2003)
("Xiong").
4 Amaout, US 2005/0227296 Al, published Oct. 13, 2005 ("Amaout").
5 Gallatin et al., US 6,251,395 Bl, issued June 26, 2001 ("Gallatin").
6 Ason and Reznikoff, A high-throughput assay for Tn5Tnp-induced DNA
cleavage, 32 Nucleic Acids Res. E83 (2004) ("Ason"). Citations are to the
pages numbers in the reprint.
7 Young et al., High-Throughput with HyperCyt® Flow Cytometry to Detect
Small Molecule Formylpeptide Receptor Ligands, IO J. Biomolecular
Screening 374 (2005) ("Young").
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Appeal2017-010886
Application 14/311,069
compound on a substrate and physically repositioning the substrate such that
non-adherent cells move away from the substrate. Final Act. 4. The
Examiner finds that Amaout teaches methods for identifying compounds
capable of binding to selected integrins and selecting the compound that
affects cell adhesion from the group comprising ICAM-1, icb3, fibrinogen,
and NIP. Id. The Examiner goes on to find that Gallatin teaches assays
which involve dislodging non-adherent cells from an inverted plate. Id. The
Examiner finds that Ason teaches a no-wash step in a high throughput assay
and that Young teaches a no-wash cell adhesion assay. Id.
Id.
The Examiner concludes:
It would have been obvious to one of ordinary skill in the
art to have been motivated to expand the teachings of Xiong to
include small molecules as taught by Amaout, modify the
teaching of Xiong to include Ason' s high throughput assay and
substituting the minimal wash taught by Ason with a no-wash
cell based assay of Young with a reasonable expectation of
success because Ason teaches that the no wash steps are
advantageous since it identifies effectors that are specific.
Appellants contend that the Examiner has failed to provide a reason
why one skilled in the art would modify the teachings of Xiong, Amaout or
Gallatin to eliminate the steps of washing away the non-adherent cells or
removing them by centrifugation. Br. 7-8. Appellants also contend that one
skilled in the art would not be lead to combine the teachings of Young and
Ason with the other references as Young and Ason relate to different types
of assays. Br. 8. Finally, Appellants contend that there is evidence of
unexpected results to overcome a prima facie case of obviousness. Br. 9-10.
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Appeal2017-010886
Application 14/311,069
Principles of Law
[T]he examiner bears the initial burden, on review of the prior
art or on any other ground, of presenting a prima facie case of
unpatentability. If that burden is met, the burden of coming
forward with evidence or argument shifts to the applicant.
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992).
"[R]ejections on obviousness grounds cannot be sustained by mere
conclusory statements; instead, there must be some articulated reasoning
with some rational underpinning to support the legal conclusion of
obviousness." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,418 (2007)
(quoting In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006)).
"Obviousness requires more than a mere showing that the prior art
includes separate references covering each separate limitation in a claim
under examination." Unigene Labs., Inc. v. Apotex, Inc., 655 F.3d 1352,
1360 (Fed. Cir. 2011). "Rather, obviousness requires the additional showing
that a person of ordinary skill at the time of the invention would have
selected and combined those prior art elements in the normal course of
research and development to yield the claimed invention." Id.
Analysis
We have considered the arguments advanced by the Examiner and
Appellants and find that Appellants have the better position. While Gallatin
teaches inverting a plate containing adherent and non-adherent cells, it also
teaches that the non-adherent cells are dislodged from the inverted plate
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Appeal2017-010886
Application 14/311,069
using centrifugation, not gravity as recited in the claims. Gallatin col. 101,
11. 16-19. The Examiner has not adequately explained why one skilled in
the art would eliminate the centrifugation step Gallatin and use gravity for
separating the non-adherent cells from the adherent cells.
The Examiner's only response to Appellants' argument relative to
Gallatin is that Gallatin teaches dislodging the non-adherent cells from an
inverted plate. Ans. 8. The Examiner does not address the issue of why one
skilled in the art would use gravity to dislodge the cells as called for in the
claims rather than using centrifugation as taught by Gallatin. See id.
Appellants argued that there is evidence in the record demonstrating
unexpected results. Br. 9-10. In support of this contention, Appellants cite
to the declaration8 of one of the inventors, Dr. Gupta. While we do not rule
on the sufficiency of Appellants' argument, we note that the Examiner failed
to fully address this argument and the declaration in the Answer. See Ans. 9.
8 Declaration Under 37 C.F.R. § 1.132, filed March 7, 2016 ("Deel.").
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Application 14/311,069
Conclusion of Law
We conclude that a preponderance of the evidence does not support
the Examiner's conclusion that the subject matter of the claims would have
been obvious over Xiong combined with Amaout, Gallatin, Ason, and
Young.
SUMMARY
We reverse the rejection under 35 U.S.C. § 103(a).
REVERSED
7