Ex Parte Bartlett et al

Patent Trial and Appeal Board

Sep 25, 2013

11514447 (P.T.A.B. Sep. 25, 2013)

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.
11/514,447 08/31/2006 Justin B. Bartlett 9516-415-999 (JD
501872-9
4905
20583 7590 09/26/2013
JONES DAY
222 EAST 41ST ST
NEW YORK, NY 10017
EXAMINER
WEBB, WALTER E
ART UNIT PAPER NUMBER
1612
MAIL DATE DELIVERY MODE
09/26/2013 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 JUSTIN B. BARTLETT, GEORGE W. MULLER,
PETER H. SCHAFER, CHRISTINE GALUSTIAN,
ANGUS G. DALGLEISH and BRENDAN MEYER
__________

Appeal 2012-002485
Application 11/514,447
Technology Center 1600
__________

Before JEFFREY N. FREDMAN, ERICA A. FRANKLIN, and
ANNETTE R. REIMERS, Administrative Patent Judges.

FRANKLIN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1 under 35 U.S.C. § 134(a) involving claims to a
method of eliciting an enhanced immune response from an immunogen in a
subject. The Patent Examiner rejected the claims as obvious. We have
jurisdiction under 35 U.S.C. § 6(b). We reverse.

1 Appellants identify Celgene Corporation as the real party in interest (App.
Br. 3).
Appeal 2012-002485
Application 11/514,447

2
STATEMENT OF THE CASE
Claims 52, 71-80 and 82-85 are on appeal. Claims 52, 82 and 84 are
representative and read as follows:
52. A method of eliciting an enhanced immune response from an
immunogen in a subject comprising administering to the subject an
immunomodulatory compound prior to initial introduction of the
immunogen as a vaccine to the subject, wherein the immunomodulatory
compound is a compound of formula I, or a pharmaceutically acceptable salt
or stereoisomer thereof:

wherein:
one of X and Y is C=O, the other of X and Y is C=O or CH2;
R2 is hydrogen or lower alkyl.

82. The method of claim 52, wherein the immunomodulatory
compound is 4-(amino)-2-(2,6-dioxo(3-piperidyl))-isoindoline-l,3-dione.

84. The method of claim 52, wherein the immunomodulatory compound
is 3-(4-amino-l-oxo-l,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione.

The Examiner rejected the claims as follows:
• claims 52 and 71-80 under 35 U.S.C. § 103(a) as unpatentable over
Robarge;2 and
• claims 82-85 under 35 U.S.C. § 103(a) as unpatentable over
Robarge and Muller.3

2 Patent Application Publication No. US 2003/0096841 A1 by Michael J.
Robarge et al., published May 22, 2003.
3 Patent No. US 6,281,230 B1 issued to George W. Muller et al., Aug. 28,
2001.
Appeal 2012-002485
Application 11/514,447

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OBVIOUSNESS
I. Claims 52 and 71-80
The Examiner found Robarge taught immunomodulator compounds
encompassed by Formula I:

Which inhibit the production of TNF-α and may be used in
combination with anti-cancer vaccines. (Ans. 5.) The Examiner found that
Robarge disclosed the following embodiment I-2:

(Id.) According to the Examiner, embodiment I-2 reads on the formula of
claim 52. (Id. at 5 and 9.) Additionally, the Examiner found that Robarge
taught that the compounds of the invention may be administered prior to or
subsequent to administration of another therapeutic agent, such as the anti-
cancer vaccine. (Id. at 5.) The Examiner found that Robarge taught that the
combination therapy provides an increased or synergistic benefit. (Id.)
Appellants contend, among other things, that the Examiner’s finding
that Robarge disclosed the compound of independent claim 52 is not
supported by the evidence. (Reply Br. 5.) In particular, Appellants assert
that the compound of formula I set forth in claim 52 “does not contain a
Appeal 2012-002485
Application 11/514,447

4
methylene group between the amino group and isoindoline ring, among
others.” (Id.) We agree with Appellants. Accordingly, we reverse the
Examiner’s obviousness rejection over Robarge.
II. Claims 82-85
The Examiner applied Robarge to claims 82-85 as applied to the
rejection of claims 52 and 71-80. (Ans. 6.) However, the Examiner found
that Robarge includes a proviso that when n is 0, the R1 is not H, which
removes the compounds of claims 82 and 84. (Id.) To cure this deficiency,
the Examiner found that Muller taught the specific compounds of claims 82
and 84. (Id. at 7)(citing Muller Examples 14 and 16.) The Examiner found
that Muller taught that these compounds are also useful in reducing the
levels of TNF-α and treating inflammation and oncogenic or cancerous
conditions in mammals. (Id.) According to the Examiner, it would have
been obvious to a person of ordinary skill in the art at the time the invention
was made to have used the compounds in Muller, having “‘very close’”
structural similarity and utilities as the compounds in Robarge, in the
method of Robarge. (Id.)
Appellants contend, among other things, that any presumption of
prima facie case of obviousness for claims 82-85 is rebutted in view of
unexpected results. (See App. Br. 20-21 and 14.) Specifically, Appellants
submit the declaration of Dr. J. Blake Bartlett4 as “attest[ing] to the
unexpected and surprising results obtained from administering the currently
recited immunomodulatory compounds prior to the administration of an
immunogen.” (Id. at 14.) Appellants assert that Dr. Bartlett refers to the

4 Declaration of Dr. J. Blake Bartlett, submitted Feb. 23, 2009.
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Application 11/514,447

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experimental results summarized in Figure 2 of the Specification, wherein it
was demonstrated that the compounds of claims 82 and 84, but not
thalidomide, inhibited the effects of Treg cells on T cell proliferation upon
pretreatment of Treg cells. (Id. at 14 and 21.) Appellants assert that these
results were surprising and unexpected because, while thalidomide is
structurally similar to the claimed compounds tested, thalidomide showed no
effect in inhibiting Treg cells after pre-incubation with Treg cells. (Id. at 15.)
After considering the evidence and arguments, we agree with
Appellants that even presuming that the record supports prima facie
obviousness, this conclusion is overcome when considered with the evidence
of unexpected results. Appellants have provided in their Specification and
through the declaration of Dr. Bartlett evidence showing unexpected results
commensurate in scope with the breadth of claims 82-85. See In re
Grasselli, 713 F.2d 731, 743 (Fed. Cir. 1983). Specifically, we find that Dr.
Bartlett has expertise in the field of immunology and oncology (see Decl. of
Dr. J. Blake Bartlett, ¶¶ 1-2) and provided a sound opinion, supported by the
experimental results described in the Specification, that “the difference
between thalidomide and the tested immunomodulatory compounds, i.e.,
3-(4-amino-1-oxo-l,3-dihydro -isoindol-2-yl)-piperidine-2,6-dione and 4-
amino-2-(2,6-dioxo-3-(piperidyl))-isoindoline-l,3-dione, in the effects on
Treg cells (in particular, accompanied by the absence of any effect by
thalidomide up to 200μM) was unexpected and surprising” (see id. at ¶ 18).
Accordingly, we reverse obviousness rejection over Robarge and
Muller.

Appeal 2012-002485
Application 11/514,447

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SUMMARY
We reverse each of the obviousness rejections.

REVERSED

cdc