Ex Parte Rosenquist et al

Patent Trial and Appeal Board

Jan 25, 2017

12642984 (P.T.A.B. Jan. 25, 2017)

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.
12/642,984 12/21/2009 Asa Rosenquist TIBO-0059(TIP 137
US/PCT)
3634
45511 7590 01/27/2017
Raker & Hostetler T T P
EXAMINER
CIRA CENTRE, 12TH FLOOR
2929 ARCH STREET
HA, JULIE
PHILADELPHIA, PA 19104-2891 ART UNIT PAPER NUMBER
1675
NOTIFICATION DATE DELIVERY MODE
01/27/2017 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):
eofficemonitor@bakerlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ASA ROSENQUIST,
FREDRIK THORSTENSSON, PER-OLA JOHANSSON,
INGEMAR KVARNSTROM, BERTIL SAMUELSSON, and
HANS WALLBERG1
Appeal 2014-001110
Application 12/642,984
Technology Center 1600
Before DEMETRA J. MILLS, JOHN G. NEW, and RYAN H. FLAX,
Administrative Patent Judges.
NEW, Administrative Patent Judge.
1 Appellants state the real parties-in-interest are Medivir AB, Sweden and
Janssen R&D Ireland. App. Br. 1.
Appeal 2014-001110
Application 12/642,984
DECISION ON APPEAL
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 58—83, 85—87, 110, and 113—117,
which stand rejected as unpatentable under the judicially-created doctrine of
obviousness type double patenting. Specifically, the claims stand rejected as
being not patentably distinct from claim 27 of Simmen et al. (US 7,659,245
B2, Feb. 9, 2010) (the “’245 patent”) or claims 11—13 of Simmen et al. (US
8,148,399 B2, April 3, 2012) (the “’399 patent”).
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellants’ invention is directed to compounds that inhibit the NS3
protease of flavivirus such as hepatitis C virus (“HGV”). The compounds
comprise a novel linkage between a heterocyclic P2 unit and those portions
of the inhibitor more distal to the nominal cleavage site of the native
substrate, which linkage reverses the orientation of peptidic bonds on the
distal side relative to those proximal to the cleavage site. Abstract.
REPRESENTATIVE CLAIM
Claim 58 is representative of the claims on appeal and recites:
58. A method for treatment of hepatitis C virus (HCV)
infection comprising administering to an individual afflicted
with or at risk of HCV infection an effective amount of a
compound of formula VI:
2
Appeal 2014-001110
Application 12/642,984
m
815
.✓<2 V
#<46 rif n —r—
VI
wherein
A is C(=0)0R1 or C(=0)NHS02R2, wherein;
R1 is hydrogen or C1-C6 alkyl; and
R2 is Ci-C6 alkyl, Co-C6 alkylcarbocyclyl, or
C0-C3 alkylheterocyclyl, each of which is optionally
substituted with 1 to 3 substituents which are each
independently halo, oxo, nitrile, azido, nitro, C1-C6
alkyl, C0-C3 alkylcarbocyclyl, C0-C3
alkylheterocyclyl, NH2C(=0)-, Y -NRaRb, Y-O-
Rb, YC(=0)Rb, Y-(C=0)NRaRb, Y-
NRaC(=0)Rb, Y-NHSOpRb, Y-S(=0)pRb,
Y S (=0)pNRaRb, Y-C(=0)0rb, or Y-
NRaC(=0)0Rb;
Y is independently a bond or C1-C3 alkylene;
Ra is independently H or C1-C3 alkyl;
Rb is independently H, C1-C6 alkyl, C0-C3 alkylcarbocyclyl, or
C0-C3 alkylheterocyclyl;
p is independently 1 or 2;
M is CR7R7;
3
Appeal 2014-001110
Application 12/642,984
R7 taken together with R7 forms a C3-C6 cycloalkyl ring
substituted with J;
q' is 0 and k is 1;
Rz is H, or together with the asterisked carbon forms an olefmic
bond;
Rq is H or C1-C6 alkyl;
W is -O- or-S-;
Rg is a ring system containing 1 or 2 saturated, partially saturated
or unsaturated rings, each of which has 4-7 ring atoms and
each of which has 0 to 4 hetero atoms selected from S, O,
and N, the ring system being optionally spaced from W by
a C1-C3 alkyl group; any of which R8 groups can be
optionally mono, di, or tri substituted with R9, wherein
R9 is independently halo, oxo, nitrile, azido, nitro, C1-C6 alkyl,
C0-C3 alkylcarbocyclyl, C0-C3 alkylheterocyclyl,
NH2C(=0)-, YNRaRb, Y-O-Rb, Y-C(=0)Rb, Y-
(C=0)NRaRb, Y-NRaC(=0)Rb, Y-NHSOpRb,
YS(=0)pRb, Y-S(=0)pNRaRb, Y-C(=0)0Rb, or Y-
NRaC(=0)0Rb; wherein said carbocyclyl or heterocyclyl
moiety is optionally substituted with R10; wherein
R10 is C1-C6 alkyl, C3-C7 cycloalkyl, C1-C6 alkoxy, amino,
sulfonyl, (C1-C3 alkyl)sulfonyl, N02, OH, SH, halo,
haloalkyl, carboxyl, or amido;
J is a single 3 to 10-membered saturated or partially unsaturated
alkylene chain that extends from the R7/R7 cycloalkyl and
forms a macrocycle, which chain is optionally interrupted
by one to three heteroatoms that are each independently -
0-, -S-, or—NR12-, and wherein 0 to 3 carbon atoms in the
chain are optionally substituted with R14;
wherein;
4
Appeal 2014-001110
Application 12/642,984
R12 is H, Ci-C6 alkyl, C3-C6 cycloalkyl, or COR13;
R13 is C1-C6 alkyl, C0-C3 alkylcarbocyclyl, or C0-C3
alkylheterocyclyl;
R14 is independently H, C1-C6 alkyl, C1-C6 haloalkyl, C1-C6
alkoxy, hydroxyl, halo, amino, oxo, thio, or C1-C6
thioalkyl;
m is 0; n is 0;
G is -NRy- or -NRjNRj-;
Ry is J;
one Rj is H and the other Rj is J;
R16 is H; or R16 is C1-C6 alkyl, C0-C3 alkylcarbocyclyl, or C0-C3
alkylheterocyclyl, any of which can be substituted with
halo, oxo, nitrile, azido, nitro, C1-C6 alkyl, C0-C3
alkylcarbocyclyl, C0-C3 alkylheterocyclyl, NH2CO-, Y-
NRaRb, Y-O-Rb, YC(=0)Rb, Y-(C=0)NRaRb, Y-
NRaC(=0)Rb, Y-NHSOpRb, Y-S(=0)pRb,
YS(=0)pNRaRb, Y-C(=0)ORb, or Y-NRaC(=0)ORb;
or a pharmaceutically acceptable salt thereof.
App. Br. 5-7.
ISSUES AND ANALYSES
We agree with, and adopt, the Examiner’s findings and conclusion
that the appealed claims are not prima facie patentably distinct over the
patents cited by the Examiner. We address the arguments raised by
Appellants below.
5
Appeal 2014-001110
Application 12/642,984
Issue
Appellants argue the Examiner erred because the nonstatutory
doctrine of obviousness-type double patenting does not permit comparison
of the instant claims with the claims of the patents cited by the Examiner.
App. Br. 2-3.
Analysis
Appellants contend that a patent issuing from the present application,
would not be a “later patent” with respect to either U.S. 7,659,245 (the “’245
patent”) or U.S. 8,148,399 (the “’399 patent”). App. Br. 2—3. Appellants
argue that their application on appeal (the “’984 application”) is a division of
a parent application that was filed prior to the applications that matured,
respectively, into the ’245 patent and the ’399 patent.2 Id. Furthermore,
Appellants assert their application was necessitated by a restriction
requirement that the Office made in that parent application. Id. Appellants
therefore argue, pursuant to 35 U.S.C. § 121, that the ’984 application is
“entitled to the benefit of the filing date of the [parent] application,” such
that it cannot be characterized as a “later patent” to which the ’245 patent or
the ’399 patent may be compared as prior art in assessing nonstatutory
obviousness-type double patenting. Id. at 3^4.
2 The ’984 application on appeal is a division of Appl. Ser. No. 10/572,349,
now US 7,671,032, which was filed on January 22, 2007, as the National
Stage entry of an International patent application that was filed on January
28, 2005. The ’245 patent issued from a patent application that was filed on
January 16, 2008, as the National Stage entry of an International patent
application that was filed on July 28, 2006. The ’399 patent issued from a
patent application that was filed on January 10, 2007, as the National Stage
entry of an International patent application that was filed on July 28, 2006.
6
Appeal 2014-001110
Application 12/642,984
Appellants point to the holding of the Federal Circuit that, “when the
existence of multiple patents is due to the administrative requirements
imposed by the Patent and Trademark Office, 35 U.S.C. § 121 provides that
the inventor shall not be prejudiced by having complied with those
requirements.” App. Br. 4 (quoting Applied Materials, Inc. v. Advanced
Semiconductor Materials Am., Inc., 98 F.3d 1563, 1568 (Fed. Cir. 1996)).
We are not persuaded. As an initial matter, Appellants reliance upon
35 U.S.C. § 121 is misplaced. Section 121 recites, in relevant part:
A patent issuing on an application with respect to which a
requirement for restriction under this section has been made, or
on an application filed as a result of such a requirement, shall not
be used as a reference either in the Patent and Trademark Office
or in the courts against a divisional application or against the
original application or any patent issued on either of them, if the
divisional application is filed before the issuance of the patent on
the other application. The validity of a patent shall not be
questioned for failure of the Director to require the application to
be restricted to one invention.
In other words, § 121 prevents patents arising from a parent application and
patents arising from one or more divisional applications resulting from
restrictions entered by the Office upon the parent application from being
used as references against each other. Specifically, as the Federal Circuit
held in Applied Materials, “[W]hen two or more patents result from a PTO
restriction requirement, whereby aspects of the original application must be
divided into separate applications, § 121 insulates the ensuing patents from
the charge of double patenting.” Applied Materials, 98 F.3d at 1568.
Such is not the case in the appeal before us. The Examiner finds, and
Appellants do not dispute, that the ’984 application ((present application)
and its parent application No. 10/572,349) are, in the context of their
7
Appeal 2014-001110
Application 12/642,984
respective prosecution histories, entirely unrelated to the ’245 and ’399
patents. See Ans. 7. Consequently, the bars imposed by Section 121 are not
at issue in this appeal.3 In other words, the ’245 and ’399 patents have no
indicated application continuity with parent application No. 10/572,349, or
the restriction requirement made therein, as required by 35 U.S.C. § 121.
Furthermore, we are not persuaded by Appellants’ argument that,
because the ’638 application on appeal can claim the benefit of the parent
application it is not a “later patent” with respect to the ’245 and ’399 patents.
We understand the plain meaning of the term to mean a patent which issues
subsequent to another patent, even if it can claim the priority benefit of a
previous application. See, e.g., Sun Pharmaceutical Industries, Ltd. v. Eli
Lilly and Co., 611 F.3d 1381, 1385 (Fed. Cir. 2010). In this context, we
disagree with Appellants that the application on appeal, if issued, would not
constitute a “later patent” than the ’245 and ’399 patents.
We agree with Appellants that one purpose of the nonstatutory
doctrine of obviousness-type double patenting is to “prevent unjustified
timewise extension of the right to exclude.” Takeda Pharma. Co., v.
Doll, 561 F. 3d 1372, 1375 (Fed. Cir. 2009) (internal citation omitted). It is
Appellants’ contention that, because the ’984 application claims the benefit
3 The restriction requirement in Application No. 10/572,399, restricted the
application, as follows:
Group 1, claim(s) 1-54, drawn to a compound of formula VI and a
pharmaceutical composition comprising a pharmaceutically acceptable
carrier.
Group 2, claim(s) 55 and 57, drawn to a method of using the
compound of formula VI in therapy, treatment or prophylaxis.
Group 3, claim(s) 56, drawn to a method of manufacture of a
medicament.
8
Appeal 2014-001110
Application 12/642,984
of the filing date of its parent application, which precedes the filing dates of
the ’245 and ’399 patents, Appellants will not have an unjustified extension
of the right to exclude because the right to exclude will expire for the ’984
application prior to those of the ’245 and ’399 patents. This reasoning is
correct insofar as it goes.
However, the Federal Circuit has articulated another purpose of the
doctrine of nonstatutory obviousness-type double patenting to which we
must also pay heed. According to the Federal Circuit:
The second rationale is to prevent multiple infringement suits by
different assignees asserting essentially the same patented
invention [citing In re Fallaux, 564 F.3d 1313, 1319 (Fed. Cir.
2009)] (recognizing that “harassment by multiple assignees”
provides “a second justification for obviousness-type double
patenting”); see also Chisum on Patents § 9.04[2][b][ii] (“The
possibility of multiple suits against an infringer by assignees of
related patents has long been recognized as one of the concerns
behind the doctrine of double patenting.”).
In re Hubbell, 709 F.3d 1140, 1145 (Fed. Cir. 2013). This purpose is not
addressed by Appellants. Whereas it is true that the current assignees of the
instant application and the ’245 and ’399 patents substantially overlap4,
there is nothing to prevent future licensing of the patents/application to
additional parties, thus posing the issue of multiple infringement actions. It
is this rationale that also requires our affirmation of the Examiner’s
rejection.
4 The ’245 patent is assigned to Tibotec Pharmaceuticals Ltd. (Ireland) (now
Janssen R&D Ireland). The ’399 patent is assigned to Tibotec
Pharmaceuticals Ltd. and Medivir AB (Sweden). The assignees of the ’638
application are Medivir AB and Janssen R&D Ireland.
9
Appeal 2014-001110
Application 12/642,984
Appellants make no substantive argument that the invention claimed
in the ’984 application is patentably distinct from the inventions disclosed in
the ’245 and ’399 patents. Rather, Appellants incompletely argue the policy
underlying the law of double patenting rather than the law itself, which
prevents a later patent from claiming an obvious variant of a previously
issued patent. See Applied Materials, 98 F.3d at 1568. For these reasons we
do not find Appellants’ arguments persuasive, and we affirm the Examiner’s
rejection.
DECISION
The Examiner’s rejection of claims 58—83, 85—87, 110, and 113—117
as unpatentable under the nonstatutory doctrine of obviousness type double
patenting is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1). See 37 C.F.R.
§ 1.136(a)(l)(iv).
AFFIRMED
10