Ex Parte Albani

Patent Trial and Appeal Board

Jun 9, 2016

12302685 (P.T.A.B. Jun. 9, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/302,685 08/19/2009 Salvatore Albani
28213 7590 06/13/2016
DLA PIPER LLP (US)
4365 EXECUTIVE DRIVE
SUITE 1100
SAN DIEGO, CA 92121-2133
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.
UCSD1940-l 9260
EXAMINER
EWOLDT, GERALD R
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
06/13/2016 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):
gtdocket@dlapiper.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte SALVATORE ALBANI
Appeal2014-000739
Application 12/302,685
Technology Center 1600
Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
RICHARD J. SMITH, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL 1
This appeal under 35 U.S.C. § 134(a) involves claims 1, 2, 4, 27, and
28 (App. Br. 3). 2 Examiner entered a rejection under 35 U.S.C. § 103(a).
We have jurisdiction under 35 U.S.C. § 6(b ).
We REVERSE.
1 Appellant identifies the Real Party in Interest as "The Regents of the
University of California" (App. Br. 3).
2 "Claims 5, 8-10, 13-15, and 17-25 [stand] withdrawn" from consideration
(App. Br. 3).
Appeal2014-000739
Application 12/302,685
STATEMENT OF THE CASE
Claim 1 is representative and reproduced below:
1. A composition comprising a peptide selected from the group
consisting of SEQ ID NO: 1 to SEQ ID NO: 56 and SEQ ID NO:
57 and a chloroquine molecule.
App. Br. 21 (Claims Appendix).
Examiner finds, and Appellant does not dispute, that Appellant's
"[ c ]laim 1 ... encompass[ es] a composition comprising a peptide of any of
SEQ ID NOs: 1-57 and a chloroquine molecule." (Ans. 3).
Claims 1, 2, 4, 27, and 28 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of 0 'Dell, 3 Weinblatt, 4 Hsiao, 5 Albani, 6
and Koffeman. 7
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
3 O'Dell et al., Treatment of Rheumatoid Arthritis With Methotrexate and
Hydroxychloroquine, Methotrexate and Sulfasalazine, or a Combination of
the Three Medications, 46(5) AM. COLL. RHEUM. 1164--1170 (2002).
4 M. E. Weinblatt, METHOTREXATE IN RHEUMATOID ARTHRITIS:
TOXICITY ISSUES, 35(5) BRIT. J. RHEUM. 403--406 (1996).
5 Hsiao et al., Evaluation for synergistic suppression of T cell responses to
minor histocompatibility antigens by chloroquine in combination with
tacrolimus and a rapamycin derivative, SDZ-RAD, 30 BONE MARROW
TRANSPLANTATION 905-913 (2002).
6 Albani, WO 03/026579 A2, published April 3, 2003.
7 Koffeman et al., Epitope-Specific Immunotherapy of Rheumatoid Arthritis
60(11) AM. COLL. RHEUM. 3207-16 (2009).
2
Appeal2014-000739
Application 12/302,685
FACTUAL FINDINGS (FF)
FF 1. Examiner finds that O'Dell discloses an "immunosuppressive
combination composition of methotrexate (MTX) and hydroxychloroquine
(HCQ) for the treatment of rheumatoid arthritis (RA)" (Ans. 3).
FF 2. Examiner finds that O'Dell fails to disclose a composition
comprising a peptide having any of SEQ ID NOs: 1-57 (id.).
FF 3. W einblatt discloses that MTX "is hepatotoxic" (Weinblatt 403; Ans.
4).
FF 4. Hsiao discloses that "hydroxychloroquine[ is a] lysosomotrophic
amine[ s] that inhibit[ s] processing and presentation of MHC class II antigens
to CD4+ T cells in vitro ... and unlike most current immunosuppressive
agents, hydroxychloroquine has little renal or hepatic toxicity" (Hsiao 905-
906; see generally Ans. 4 ).
FF 5. Albani discloses a method "for the combination of epitope-specific
and cytokine/anticytokine therapy to achieve effective control of immune
mediated disease processes," which "include, but are not limited to,
rheumatoid arthritis" (Albani i-f 11 ).
FF 6. Examiner finds that Albani discloses antigen-specific epitopes that
include "the peptides of SEQ ID Nos:l-57'' (Ans. 4; see e.g., Appellant's
SEQ ID Nos: 1-3; cf Albani 9: Table 1, SEQ ID Nos: 21-23)
FF 7. Albani defines the term cytokine as encompassing "chemokines,
interleukins, lymphokines, monokines, colony stimulating factors, and
receptor associated proteins, and functional fragments thereof. As used
herein, the term "functional fragment" refers to a polypeptide which
possesses biological function or activity that is identified through a defined
functional assay" (Albani i-f 36).
3
Appeal2014-000739
Application 12/302,685
ANALYSIS
Based on the combination of O'Dell, Weinblatt, Hsiao, Albani, and
Koffeman, Examiner concludes that, at the time Appellant's invention was
made, it would have been prima facie obvious to combine "HCQ and the
epitope-specific peptides of [Albani] for the treatment of RA" (Ans. 4). In
this regard, Examiner asserts that Albani suggests "replac[ing] MTX with
the epitope-specific peptides of [Albani] to both reduce toxicity and create a
more specific composition for the treatment of RA with reduced side
effects" (id.). We are not persuaded.
As Appellant explains, "Albani describes methods for generally
treating immune mediated diseases with combinations of antigen-specific
epitopes and cytokines or agents that affect cytokine activity or expression"
(App. Br. 11; FF 5-7). Albani does not "describe or suggest combinations
of chloroquine molecules, [as suggested by 0 'Dell, Weinblatt, and Hsiao],
much less [the combination of chloroquine molecules] with an immune
tolerance agent (e.g., a peptide selected from the group consisting of SEQ ID
NO: 1 to SEQ ID NO: 56 and SEQ ID NO: 57)" (App. Br. 12; see FF 1--4;
cf FF 5 and 7).
On this record, Examiner failed to establish an evidentiary basis to
support a conclusion that MTX and/or HCQ are functionally equivalent to
Albani' s cytokines or agents that affect cytokine activity or expression (see
FF 5-7; cf FF 1--4).
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner fails to
support a conclusion of obviousness. The rejection of claims 1, 2, 4, 27, and
4
Appeal2014-000739
Application 12/302,685
28 under 35 U.S.C. § 103(a) as unpatentable over the combination of
O'Dell, Weinblatt, Hsiao, Albani, and Koffeman is reversed.
REVERSED
5