Ex Parte Rosenquist et al

Patent Trial and Appeal Board

Jan 31, 2017

12557638 (P.T.A.B. Jan. 31, 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.
12/557,638 09/11/2009 Asa Rosenquist 140309-04D1 4817
45511 7590
Baker & Hostetler LLP
CIRA CENTRE, 12TH FLOOR
2929 ARCH STREET
PHILADELPHIA, PA 19104-2891
EXAMINER
HA, JULIE
ART UNIT PAPER NUMBER
1675
NOTIFICATION DATE DELIVERY MODE
02/02/2017 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, SUSANA AYESA,
BJORN CLASSON, LASZLO RAKOS, and
BERTIL SAMUELS SON1
Appeal 2014-003103
Application 12/557,638
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 2014-003103
Application 12/557,638
DECISION ON APPEAL
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 57—92, 94—96, 101, and 111—114,
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”). Abstract.
REPRESENTATIVE CLAIM
Claim 57 is representative of the claims on appeal and recites:
57. A method for treatment of hepatitis C virus (HCV)
infection comprising administering to an individual afflicted
with or at risk of the infection, an effective amount of a
compound of formula I':
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Appeal 2014-003103
Application 12/557,638
Rs
W
R ;..
Rie'
fCHgfca 'fCNjiik
■ \1" /
v, 8. ,A.X-i—E "y
6 Rsj ' n i jin o
wherein
A is C(=0)0R1 or C(=0)NHS02R2;, wherein;
R1 is hydrogen, Ci-Cealkyl, Co-C3alkylcarbocyclyl, or Co-
C^alkylheterocyclyl;
R2 is Ci-Cealkyl, Co-C^alkylcarbocyclyl, or Co-
C^alkylheterocyclyl;
wherein
R2 is optionally substituted with 1 to 3 substituents
independently selected from the group consisting of halo,
oxo, nitrile, azido, nitro, Ci-Cealkyl, Co-
C^alkylcarbocyclyl, Co-C3alkylheterocyclyl, NH2CO-, Y-
NRaRb, Y-O-Rb, Y-C(=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 YNRaC( =0)0Rb;
each Y is independently a bond or C1-C3 alkyl;
each Ra is independently H or C1-C3 alkyl;
each Rb is independently H, C1-C6 alkyl, C0-C3
alkylcarbocyclyl or C0-C3 alkylheterocyclyl;
each p is independently 1 or 2;
M is CR7R7;
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Appeal 2014-003103
Application 12/557,638
R7 taken together with R7 forms a C3-C6 cycloalkyl ring
substituted with J;
q is 1 and k is 1;
W is -CH2-, -0-, -0C(=0)NH, -0C(=0), -S- ,-NH-, -NRa,
-NHSO2-, -NHC(=0)NH-, -NHC(=0)-, -NHC(=S)NH-,
or a bond;
R8 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 hereto atoms that are
each independently S, O and N, the ring system being
optionally spaced from W by a C1-C3 alkylene group, any
of which R8 groups can be optionally mono-, di-, or
trisubstituted with R9, wherein
each R9 is independently halo, oxo, nitrile, azido, nitro,
Ci-Cealkyl, Co-C3alkylcarbocyclyl, Co-
C3alkylheterocyclyl, 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 is optionally substituted with
R10; wherein
R10 is C1-C6 alkyl, C3-C7 cycloalkyl, Ci-Cealkoxy, amino,
amido, sulfonyl, (C1-C3 alkyl)sulfonyl, N02, OH, SH,
halo, haloalkyl, or carboxyl;
E is -C(=0)-, -C(=S)-, -S(=0)2-, -S(=0)-, or -C(=N-Rf)-;
Rf is H, -CN, -C(=0)NRaRb; or -C(=0)Ci-C3alkyl;
J is a single 3 to 10-membered saturated or partially
unsaturated alkylene chain that extends from the R7/R7
cycloalkyl- to G and forms a macrocycle, which chain is
optionally interrupted by one to three heteroatoms that are
independently -0-, -S- or-NR12-, and wherein 0 to 3
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Appeal 2014-003103
Application 12/557,638
carbon atoms in the chain are optionally substituted with
R14 wherein-
R12 is H, Ci-C6 alkyl, C3-C6 cycloalkyl, or C(=0)R13;
R13 is C1-C6 alkyl, C0-C3 alkylcarbocyclyl, or C0-C3
alkylheterocyclyl;
each R14 is independently H, C1-C6 alkyl, Ci-Cr, haloalkyl,
C1-C6 alkoxy, hydroxyl, halo, amino, oxo, thio or C1-C6
thioalkyl;
m is O; n is O;
G is —NRy-;
Ry is J;
R16 is H, C1-C6 alkyl, C0-C3 alkylcarbocyclyl, C0-C3
alkylheterocyclyl, any of which is optionally substituted
with halo, oxo, nitrile, azido, nitro, C1-C6 alkyl, C0-C3
alkylcarbocyclyl, C0-C3 alkylheterocyclyl, NH2CO-, Y-
NRaRb, Y-O-Rb, Y-C(=0)Rb, Y-(C=0)NRaRb, Y-
NRaC(=0)Rb, Y-NHSOpRb, Y-S(=0)pRb, Y-
S(=0)pNRaRb, YC(=0)0Rb, or Y-NRac(=0)0Rb;
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.
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Appeal 2014-003103
Application 12/557,638
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. 3. Appellants
argue that their application on appeal (the “’638 application”) is a division of
a parent patent application that had been filed prior to the applications that
matured, respectively, into the ’245 patent and the ’399 patent.2 Id.
Furthermore, assert Appellants, 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 ’638
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 ’638 application on appeal is a division of Appl. Ser. No. 10/572,418,
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.
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Application 12/557,638
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 ’638 application ((present application)
and its parent application No. 10/572,418) are, in the context of their
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Application 12/557,638
respective prosecution histories, entirely unrelated to the ’245 and ’399
patents. See Ans. 7. Consequently, the bars imposed by Section 121 against
potential prejudice to an applicant 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. 10/572,418, 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
3 The restriction requirement in Application No. 10/572,418, restricted the
application, as follows:
Group 1, claim(s) 1-53, drawn to a compound of formula I and
pharmaceutical composition and a pharmaceutically acceptable carrier.
Group 2, claim(s) 54 and 56, drawn to a method of using the
compound for therapy or treatment of prophylaxis of flavivirus infection
such as HGV.
Group 3, claim(s) 55, drawn to a method of manufacture of a
medicament.
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Application 12/557,638
Appellants’ contention that, because the ’638 application claims the benefit
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 ’638
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 ’638 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.
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Appeal 2014-003103
Application 12/557,638
Appellants make no substantive argument that the invention claimed
in the instant ’638 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 57—92, 94—96, 101, and 111—114
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
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