Ex Parte Dzau et al

Board of Patent Appeals and Interferences

Jul 20, 2012

10850994 (B.P.A.I. Jul. 20, 2012)

MOD PTOL-90A (Rev.06/08)

APPLICATION NO./
CONTROL NO.
FILING DATE FIRST NAMED INVENTOR /
PATENT IN REEXAMINATION
ATTORNEY DOCKET NO.
10/850,994 05/20/2004 Dzau, Victor J.

EXAMINER
J. MICHAEL SCHIFF
4320 VON KARMAN AVENUE
NEWPORT BEACH, CA 92660
Marvich, Maria
ART UNIT PAPER NUMBER
1633
MAIL DATE DELIVERY MODE

07/23/2012 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.

UNITED STATES DEPARTMENT OF COMMERCE
U.S. Patent and Trademark Office
Address : COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
UNITED STATES PATENT AND TRADEMARK OFFICE
_____________________________________________________________________________________

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte VICTOR J. DZAU, GARY H. GIBBONS,
and RYUICHI MORISHITA
____________

Appeal 2011-005465
Application 10/850,994
Technology Center 1600
____________

Before DONALD E. ADAMS, DEMETRA J. MILLS, and ERIC GRIMES,
Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL

This appeal under 35 U.S.C. § 134 involves claims 13 and 14 (App.
Br. 2; Ans. 2). We have jurisdiction under 35 U.S.C. § 6(b).
Appeal 2011-005465
Application 10/850,994

2
STATEMENT OF THE CASE
1,2

The claims are directed to a method for treating dermatitis on a
mammal. Claim 13 is representative and is reproduced in the Claims
Appendix of Appellants‟ Brief.
Claims 13 and 14 stand rejected under the judicially created doctrine
of obviousness-type double patenting as being unpatentable over the claims
of Morishita I.
3

Claims 13 and 14 stand provisionally rejected under the judicially
created doctrine of obviousness-type double patenting as being unpatentable
over the claims of Morishita II.
4

We reverse the rejection over Morishita I and affirm the provisional
rejection over Morishita II.

The rejection over Morishita I:
ISSUE
Does the preponderance of evidence on this record support
Examiner‟s rejection under the judicially created doctrine of obviousness-
type double patenting?

1
The Final Rejection of claims 13 and 14 under 35 U.S.C. § 102(e) was not
presented in the Answer, nor did Examiner address Appellants‟ contentions
with regard to this ground of rejection (see Fin. Rej. 10; App. Br. 20-21).
Accordingly, we find that Examiner has withdrawn the rejection of claims
13 and 14 under 35 U.S.C. § 102(e).
2
Application No. 10/424,011 is now abandoned. Accordingly the
provisional obviousness-type double patenting rejection over claims 1, 2,
and 5-8 of Application No. 10/424,011 is moot.
3
Morishita et al., US 6,262,033 B1, issued July 17, 2001.
4
Morishita et al., US 2004/0162251 A1, published August 19, 2004.
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Application 10/850,994

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FACTUAL FINDINGS (FF)
FF 1. Claim 1 of Morishita I is drawn to:
A method for treatment of NF-κB-associated diseases which
comprises administering to an animal an effective amount of a
polynucleotide NF-κB chromosomal binding site decoy which
antagonizes NF-κB mediated transcription of a gene located
downstream of a NF-κB binding site wherein said
polynucleotide comprises the 8
th
through the 17
th
nucleotide of
SEQ ID NO:1.

(Morishita I, Claim 1.)
FF 2. Claim 2 of Morishita I is drawn to “[t]he method according to claim
1 wherein the NF-κB-associated disease is selected from the group
consisting of; an ischemic disease, an inflammatory disease, and an
autoimmune disease” (Morishita I, Claim 2).
FF 3. Examiner relies on Medford5 to suggest that “a connection between
dermatitis and NFKB regulation” was known at the time of Appellants‟
claimed invention (Ans. 13-14).
FF 4. Appellants‟ Application is a continuation of 09/875,305, now
abandoned, which is a continuation of U.S. Patent No. 6,774,118, which is a
continuation of 08/144,717, filed October 29, 1993, now abandoned.
ANALYSIS
Based on Morishita I, Examiner concludes that “[i]t would have been
obvious to one of ordinary skill at the time of the invention was made that
the decoy should treat dermatitis as recited in the instant claims as this is an
inflammatory disease as recited in claims 2 and 7 of” Morishita I (Ans. 6).
We are not persuaded. Notwithstanding Examiner‟s assertion to the

5
Medford et al., US 6,399,376 B1, issued June 4, 2002, effective filing date
November 5, 1993.
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Application 10/850,994

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contrary, Morishita I does not have a claim 7. Further, Examiner failed to
identify any suggestion in Morishita I that would lead a person of ordinary
skill in this art specifically to a method of treating dermatitis as is required
by Appellants‟ claimed invention.
We recognize, but are not persuaded by, Examiner‟s reliance on
Medford (FF 3). Not only did Examiner not rely on Medford in the
statement of the rejection, but Medford, filed on November 5, 1993, is not
prior art against Appellants‟ claimed invention, which has an effective filing
date of October 29, 1993 (FF 3-4). Therefore, notwithstanding Examiner‟s
assertion to the contrary, Examiner failed to establish that “a connection
between dermatitis and NFKB regulation” was known at the time of
Appellants‟ claimed invention (see FF 3).
CONCLUSION OF LAW
The preponderance of evidence on this record fails to support
Examiner‟s rejection under the judicially created doctrine of obviousness-
type double patenting. The rejection of claims 13 and 14 under the
judicially created doctrine of obviousness-type double patenting as being
unpatentable over the claims of Morishita I is reversed.

The provisional rejection over Morishita II:
ISSUE
Does the preponderance of evidence on this record support
Examiner‟s provisional rejection under the judicially created doctrine of
obviousness-type double patenting?
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Application 10/850,994

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FACTUAL FINDINGS (FF)
FF 5. Claim 1 of Morishita II is drawn to “[a] pharmaceutical composition
for performing treatment against a skin disease, the pharmaceutical
composition comprising at least one decoy and a pharmaceutically
acceptable carrier” (Morishita II, Claim 1).
FF 6. Claim 2 of Morishita II is drawn to “[a] composition according to
claim 1, wherein the at least one decoy is selected from the group consisting
of[, inter alia,] an NF-κB decoy” (Morishita II, Claim 2).
FF 7. Claim 4 of Morishita II is drawn to “[a] composition according to
claim 1, wherein the skin disease is[, inter alia,] atopic dermatitis . . . [or]
contact dermatitis” (Morishita II, Claim 4).
ANALYSIS
The claims of Morishita II are directed to a pharmaceutical
composition for treating, inter alia, dermatitis using a decoy such as an NF-
κB decoy. We agree with the Examiner that the claims on appeal are an
obvious variant of the claims of Morishita II.
Appellants contend that “[a]rguments 1, 2, 4, and 5 explained above
with respect to . . . [Morishita I] apply equally well to” Morishita II (App.
Br. 20). We take each argument in turn.

Argument 1:
Appellants contend that “[o]bviousness-type double patenting should
not be applied where two inventions originate from two different
organizations” (App. Br. 8 (emphasis removed)). In this regard, Appellants
contend that Morishita II forms the basis for rejection solely because one of
the named inventors appears on both applications and that “[d]eciding . . .
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the patentability of an invention based on who is named as an inventor is
arbitrary” (id.). We are not persuaded. A provisional obviousness-type
double patenting rejection is appropriate where, as here, the claimed subject
matter of two applications is not patentably distinct and the two applications
have at least one common inventor. See Manual of Patent Examining
Procedure § 804.

Argument 2:
Appellants contend that “[t]he Office should apply a two-way test
because of delays in prosecution beyond appellant‟s control” (App. Br. 9
(emphasis removed) and 20). We are not persuaded. A review of the
prosecution history of this Application reveals, inter alia, that Appellants
filed two prior Notices of Appeal: one December 15, 2005 and the other on
November 30, 2007. In both instances, Appellants elected to re-file the
Application rather than continuing to Appeal. Our review also reveals
Appellants‟ ongoing refinement of the claimed subject matter exemplified
by a number of claim amendments throughout the prosecution of this
Application. In sum, Appellants fail to demonstrate that prosecution was
delayed solely for reasons outside of Appellants‟ control. See Eli Lilly &
Co. v. Barr Labs., Inc., 251 F.3d 955, 969 n.7 (Fed. Cir. 2001) (“The two-
way test is only appropriate in the unusual circumstance where, inter alia,
the United States Patent and Trademark Office („PTO‟) is „solely responsible
for the delay in causing the second-filed application to issue prior to the
first.‟”) (quoting In re Berg, 140 F.3d 1428, 1437 (Fed. Cir. 1998), emphasis
added by the Eli Lilly court).

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Argument 4:
Appellants contend that “[o]bviousness-type double patenting should
not be applied when there would be no unjustified patent term extension”
(App. Br. 17 (emphasis removed)). We are not persuaded for the reasons set
forth above with regard to Argument 1.

Argument 5:
Appellants contend that “[t]he requirements for a Terminal Disclaimer
under 37 CFR 1.321(c) are not properly tailored to achieve the objectives of
the doctrine of obviousness-type double patenting” (App. Br. 19 (emphasis
removed)). We are not persuaded for the reasons set forth above with regard
to Argument 1.

Lastly, Appellants contend that Morishita II‟s “application is less
advanced in prosecution than the present application. A Request for
Continued Examination was filed on July 1, 2010. Should this appeal be
viewed favorably by the Board, the application under consideration here is
expected to issue first” (App. Br. 20). We are not persuaded by Appellants‟
contention which fails to establish the current status of the Morishita II
application. We are also not persuaded by Appellants‟ asserted
expectations. In sum, on this Appeal, Examiner presented a prima facie case
of obviousness-type double patenting, which Appellants have failed to rebut.
CONCLUSION OF LAW
The preponderance of evidence on this record fails to support
Examiner‟s provisional rejection under the judicially created doctrine of
obviousness-type double patenting. The provisional rejection of claims 13
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and 14 under the judicially created doctrine of obviousness-type double
patenting as being unpatentable over the claims of Morishita II is affirmed.

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).

AFFIRMED

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