Ex Parte Raboisson et al

Patent Trial and Appeal Board

Jan 11, 2017

12443190 (P.T.A.B. Jan. 11, 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.
12/443,190 03/27/2009 Pierre Jean-Marie Bernard Raboisson TIB0-0068 /
TIP0091USPCT
7052
45511 7590 01/13/2017
Raker & Hostetler T T P
EXAMINER
CIRA CENTRE, 12TH FLOOR
2929 ARCH STREET
WANG, SHENGJUN
PHILADELPHIA, PA 19104-2891 ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
01/13/2017 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 PIERRE JEAN-MARIE BERNARD RABOISSON,
OLIVER LENZ, TSE-I LIN, and KENNETH SIMMEN1
Appeal 2015-000428
Application 12/443,190
Technology Center 1600
Before ERIC B. GRIMES, KIMBERLY McGRAW, and RYAN H. FLAX,
Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a method of treating hepatitis C virus infection. Claims
1—23 are on appeal as rejected under 35 U.S.C. § 103(a). We have
jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
The Specification indicates “the compounds of the present invention
inhibit HCV [Hepatitis C virus] replication. ... In the present invention
1 Appellants identify the Real Party in Interest to be Janssen R&D Ireland.
App. Br. 1.
Appeal 2015-000428
Application 12/443,190
HCV replication both refers to the replication of the HCV virus as a whole
or the replication of the HCV RNA genome.” Spec. 3:35—38. Further,
“[t]he compounds of the invention herein are derivatives of pyrimidine[,] . . .
[which are] compounds that are inhibitors of kinase activities associated
with . . . the treatment of fibroproliferative disorders.” Id. at 4:11—14.
The appealed claims can be found in the Claims Appendix of the
Appeal Brief. Claim 1 is the sole independent claim, is representative, and
is reproduced below:
1. A method for treating hepatitis C virus infection
comprising identifying a warm-blooded animal infected with
hepatitis C virus;
administering to the warm-blooded animal an amount of a
compound of formula (I) effective to treat the hepatitis C virus
infection:
wherein Ar is an optionally substituted phenyl ring;
Y is H, halo, NO2, or an optionally substituted member selected
from the group consisting of alkyl, cycloalkyl, alkenyl, alkynyl,
heteroalkyl, heteroalkenyl, heteroalkynyl, aryl, heteroaryl,
arylalkyl, heteroarylalkyl, acyl, and heteroacyl,
or Y can be NR2, wherein each R is independently H or an
optionally substituted alkyl, cycloalkyl, alkenyl, alkynyl,
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Application 12/443,190
acyl, aryl, or arylalkyl group or a heteroform of any of
these groups, and wherein two R groups can cyclize to
form an optionally substituted 3-8 membered heterocyclic
ring;
R1 represents an optionally substituted group that is alkyl,
cycloalkyl, heteroalkyl, acyl, alkoxy, alkylamino, heteroacyl,
aryl, heteroaryl, arylalkyl, or heteroarylalkyl, wherein each
heteroalkyl, heteroacyl, heteroaryl, and heteroarylalkyl includes
one or more heteroatoms that is O, N, S, or P,
provided that R1 is not a group of the formula -CH2-
CH(OH)-R4, wherein R4 is H or an optionally substituted
hydrocarbyl group that does not comprise an amine;
R2 is H, or R2 is CH2 and R1 and R2 cyclize to form an optionally
substituted piperidinyl, morpholinyl, or piperazinyl ring, or a
pyrrolidinyl ring substituted with at least one amino or halo
substituent;
Z is H, halo, N02, or an optionally substituted member that is
alkyl, cycloalkyl, alkenyl, alkynyl, heteroalkyl, heteroalkenyl,
heteroalkynyl, aryl, heteroaryl, arylalkyl, heteroarylalkyl, acyl,
or heteroacyl, or Z is NR2,
wherein each R is independently H or an optionally
substituted alkyl, cycloalkyl, alkenyl, alkynyl, acyl,
heteroacyl, aryl or arylalkyl group or a heteroform of any
of these groups;
each W is independently halo, NR2, N02, CN, CF3, or an
optionally substituted member that is alkyl, cycloalkyl,
alkenyl, alkynyl, heteroalkyl, heteroalkenyl,
heteroalkynyl, aryl, heteroaryl, acyl, heteroacyl, arylalkyl,
or heteroarylalkyl,
wherein each R is independently H or an optionally
substituted alkyl, cycloalkyl, alkenyl, alkynyl, acyl, aryl,
heteroalkyl or heteroaryl group;
m is 0 or 1;
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Appeal 2015-000428
Application 12/443,190
n is 0-3;
and
(a) Y is a 5-6 membered cyclic amine, OH, F, Cl,
Br, or I; or
(b) m is 1; or
(c) R1 is OH or an optionally substituted alkoxy r an
optionally substituted alkylamine, or
(d) R2 is CH2 and R'and R2 cyclize to form an
optionally substituted piperidine, morpholine, or
piperazine ring, or a pyrrolidine ring substituted
with at least one amino or halo substituent;
(e) R1 is C-NH2, a nitrile, a lactam or a lactone ring,
or a ketone, or an optionally substituted 4-5
membered cyclic amine; or
(f) R1 is comprises at least two substructures
independently selected from the group consisting
of:
(1) C-NH-C,
(2) C-OH,
(3) C=0,
(4) P=0,
(5) S=0,
(6) C=N,
(7) a non-cyclic ether oxygen,
(8) a tertiary non-acylated amine;
(9) a 5-6 membered aromatic or
heteroaromatic ring,
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Application 12/443,190
(10) C-X where X is OH, Cl, or F,
(11) Ct-O-R4, wherein CT is a carbon bonded
to three other carbon atoms, and R4 is H or an
optionally substituted hydrocarbyl group, and
(12) an optionally substituted 3 to 8
membered carbocyclic ring; or
(g) R1 is -(CH2)3-OR4 or -(CH2)2-N(R4)2, wherein
each R4 is independently H or an optionally
substituted hydrocarbyl group;
or a pharmaceutically acceptable salt thereof.
App. Br. 8—10 (Claims App’x).
The following rejections are on appeal:
Claims 1—6, 9, 12, 13, 21, and 23 stand rejected under 35 U.S.C.
§ 103(a) over Axon 7632 and Sarbah.3 4Final Action 5.
Claims 1—23 stand rejected under 35 U.S.C. § 103(a) over Axon 1594
and Sarbah. Final Action 6.
Oral argument by Appellants’ counsel was heard on January 5, 2017.
We adopt the Examiner’s findings of fact, reasoning on scope and
content of the prior art, and conclusions set out in the Final Action and
Answer. The findings of fact set forth below are provided only to highlight
certain evidence of record.
2 U.S. Patent Application Pub. No. US 2006/0281763 A1 (published Dec.
14, 2006) (hereinafter “Axon 763”).
3 Steedman A. Sarbah, MD, et al., Risk Factors for Hepatocellular
Carcinoma in Patients with Cirrhosis, 49 Digestive Diseases and Sci.
850-53 (2004) (hereinafter “Sarbah”).
4 International Patent Application Pub. No. WO 2004/024159 Al (published
Mar. 25, 2004) (hereinafter “Axon 159”).
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Application 12/443,190
FINDINGS OF FACT
FF1. Axon 763 discloses and claims the same compound recited
by appealed claim 1. Axon 763, claim 1; see also Final Action 5
(discussing Axon 763).
FF2. Axon 763 discloses:
The compounds of the invention are useful in treating conditions
associated with fibroproliferation. Thus, the compounds of
formula (I) or their pharmaceutically acceptable salts or prodrug
forms are used in the manufacture of a medicament for
prophylactic or therapeutic treatment of mammals, including
humans, in respect of conditions characterized by excessive
activity of TGFp. . . .
Other conditions that are potential clinical targets for TGFp
inhibitors include myelofibrosis, tissue thickening resulting from
radiation treatment, nasal polyposis, polyp surgery, liver
cirrhosis, and osteoporosis.
Diseases benefited by TGFp inhibition include . . . hepatic
diseases associated with excessive scarring and progressive
sclerosis, including cirrhosis due to all etiologies, disorders of
the biliary tree, and hepatic dysfunction attributable to infections
such as hepatitis virus ....
Axon 763 Tflf 113—118; see also Final Action 5 (discussing Axon 763).
FF3. The Specification, in the background section, indicates
“[hjepatitis C virus is the leading cause of chronic liver disease
worldwide and has become a focus of considerable medical research,”
“[a]n estimated 170 million persons worldwide are infected with
hepatitis C virus (HCV),” and “[cjhronic hepatitis C infection leads to
cirrhosis in at least 20 percent of patients within 2 decades of the
onset of infection.” Spec. 1—3.
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FF4. The Specification states:
Said pharmaceutical composition is useful in the treatment of an
infection with hepatitis C virus, and is also useful for inhibiting
HCV replication!/] The term “therapeutically effective amount”
as used herein means that amount of active compound or
component or pharmaceutical agent that elicits the biological or
medicinal response in a tissue, system, animal or human that is
being sought, in the light of the present invention, by a
researcher, veterinarian, medical doctor or other clinician, which
includes alleviation of the symptoms, prophylactic activity,
stabilization and/or reduction of the disease being treated.
Spec. 30:18-31:8.
FF5. Sarbah confirms that it was known that hepatitis C virus
is/was a known cause of chronic liver disease. Sarbah 850 (abstract);
see also Final Action 5 (discussing Sarbah).
DISCUSSION
The Examiner has established a prima facie case that claim 1 would
have been obvious over the cited combination of prior art and Appellants
have not presented persuasive evidence or argument that the Examiner is
incorrect. Appellants address the obviousness rejections together,
identifying the disclosures of Axon 763 and Axon 159 as similar; therefore,
we address Appellants’ arguments together below.
Axon 763 discloses and defines as its own invention, at its own claim
1, the very compound of appealed claim 1. FF1. Axon 763 also discloses
that this compound is useful in treating cirrhosis caused by hepatitis virus
infection. FF2. The appealed application’s Specification’s background
acknowledges hepatitis C virus infection is not uncommon, was well
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Application 12/443,190
studied, and that it was a known and significant cause of cirrhosis of the
liver. FF3. This is supported by the disclosure of Sarbah. FF5.
Appellants argue that the Axon 763 reference does not disclose the
anti-viral activity of the claimed compound. App. Br. 5. Therefore,
Appellants’ case for non-obviousness presents the question whether the
claims are limited to the recited compound treating hepatitis C virus
infection by affecting (e.g., reducing) the hepatitis C virus itself, e.g.,
antiviral activity, as opposed to affecting the symptoms of the hepatitis C
virus infection.
The USPTO, for more than 100 years, has applied the broadest
reasonable construction standard in proceedings. Cuozzo Speed Tech., LLC
v. Lee, 136 S. Ct. 2131, 2145 (2016); see also In re Hyatt, 211 F.3d 1367,
1372 (Fed. Cir. 2000). “[A] claim must be read in view of the specification
of which it is a part.” Renishawpic v. Marposs Societa per Azioni, 158 F.3d
1243, 1248 (Fed. Cir. 1998). “When the specification explains and defines a
term used in the claims, without ambiguity or incompleteness, there is no
need to search further for the meaning of the term.” Multiform Dessicants
Inc. v. Medzam Ltd., 133 F.3d 1473, 1478 (Fed Cir. 1998).
The language of claim 1 relating to treating (or effective to treat) the
hepatitis C virus infection cannot be interpreted so narrowly so as to exclude
“alleviation of the symptoms, prophylactic activity, stabilization and/or
reduction of the disease being treated,” which is how the Specification
describes treatment of an infection with the hepatitis C virus and an
associated therapeutically effective amount of the treating composition.
FF4. This interpretation includes reduction of the disease, e.g., by anti-viral
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Application 12/443,190
action, but also includes alleviating the symptoms of the disease, e.g.,
cirrhosis of the liver. Because Axon 763 expressly discloses treating
cirrhosis and hepatic dysfunction resulting from hepatitis virus infection in
this way, and where hepatitis C virus was a well-known cause of the disease
(FF3), Appellants’ non-obviousness argument is not persuasive.
For the reasons above, we affirm the obviousness rejections.
SUMMARY
The rejection of claims 1—6, 9, 12, 13, 21, and 23 under 35 U.S.C.
§ 103(a) over Axon 763 and Sarbah is affirmed.
The rejection of claims 1—23 under 35 U.S.C. § 103(a) over Axon 159
and Sarbah 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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