Ex Parte Schwartz et al

Patent Trial and Appeal Board

Jun 3, 2016

12309430 (P.T.A.B. Jun. 3, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
12/309,430 0910412009
20350 7590 06/07/2016
KILPATRICK TOWNSEND & STOCKTON LLP
Mailstop: IP Docketing - 22
1100 Peachtree Street
Suite 2800
Atlanta, GA 30309
C. Eric Schwartz
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
072244-1203 7150
EXAMINER
SPRINGER, STEPHANIE K
ART UNIT PAPER NUMBER
1629
NOTIFICATION DATE DELIVERY MODE
06/07/2016 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):
ipefiling@kilpatricktownsend.com
j lhice@kilpatrick.foundationip.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte C. ERIC SCHWARTZ and PER GJORSTRUP 1
Appeal2014-005544
Application 12/309,430
Technology Center 1600
Before JEFFREY N. FREDMAN, JOHN G. NEW, and
RICHARD J. SMITH, Administrative Patent Judges.
NEW, Administrative Patent Judge.
DECISION ON APPEAL
1 Appellants state the real party-in-interest is Resolvyx Pharmaceuticals,
Inc. App. Br. 3.
Appeal2014-005544
Application 12/309,430
SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner's Final Rejection of claims 15 and 16 as unpatentable under 35
U.S.C. § 102 and claim 16 under 35 U.S.C. § 112, first paragraph, as lacking
adequate written description support. 2,3 The Examiner has withdrawn the
§ 102 rejection and filed a New Ground of Rejection on appeal pursuant to
37 C.F.R. 41.39(a)(2). The Examiner newly rejects claims 15 and 16 as
unpatentable under 35 U.S.C. § 112, first paragraph, as lacking written
description support.
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
NATURE OF THE CLAIMED INVENTION
Appellants' invention is directed to methods of treating mucositis
comprising administering a compound of formula A, a compound of any one
of formulae 1 to 46, a lipoxin compound, or an oxylipin compound.
Abstract
2 Claims 1-14 are canceled. App. Br. 14.
3 The Examiner had previously rejected as unpatentable claims 15 and 16
under 35 U.S.C. § 102(e) or§ 102(a) as being anticipated by Petasis (US
2005/0228047, October 13, 2005) ("Petasis"). Final Act. 4. On appeal, the
Examiner has withdrawn this rejection and entered the New Ground of
Rejection cited supra. Ans. 5, 2. The Final Rejection of claim 16 under
35 U.S.C. § 112, first paragraph, for lack of written description support is
included with the New Grounds of Rejection, to which claim 15 is added.
Id. Appellants have replied to the New Ground of Rejection in their Reply
Brief under 37 C.F.R. § 41.39(b)(2).
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Appeal2014-005544
Application 12/309,430
CLAIMS ON APPEAL
Claim 15 recites:
15. An ophthalmic formulation comprising a compound of
formula 45, or a pharmaceutically acceptable salt thereof,
wherein said compound of formula 45 has the structure:
App. Br. 14. Claim 16 recites:
Id.
16. A method of treating an ophthalmic disease or condition
in a patient in need thereof, said method comprising
administering to said patient an ophthalmic formulation
comprising a compound of formula 45, or a pharmaceutically
acceptable salt thereof, wherein said compound of formula 45
has the structure:
ISSUES AND ANALYSES
We agree with, and adopt, the Examiner's findings and conclusion
that claims 15 and 16 lack adequate written description support. We address
the arguments raised by Appellants on appeal below.
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Appeal2014-005544
Application 12/309,430
Issue
Appellants argue the Examiner erred in finding Appellants'
Specification fails to provide adequate written description support for claims
15 and 16. Reply Br. 8.
Analysis
The Examiner finds that, although Appellants' Specification generally
discloses that the claimed composition may be composed as ophthalmic
formulations, a person of ordinary skill in the art would not recognize that
the ophthalmic formulation of claim 15 was in Appellants' possession at the
time of invention. Ans. 3. The Examiner also finds a person of ordinary
skill would similarly not recognize that the method of claim 16 was in
Appellants' possession at the time of the invention, because there is no
disclosure of the treatment of ophthalmic disease or condition in Appellants'
Specification. Id.
Specifically, the Examiner finds Appellants' Specification is explicitly
drawn to the treatments of mucositis and, particularly, oral mucositis. Ans.
3. The Examiner finds the Specification recites a number of formulations
suitable for a variety of routes of administration, including orally,
sublingually, rectally, nasally, intraperitoneally, and subcutaneously. Id.
(citing Spec. 63---68).
However, with respect to the claimed limitation of an ophthalmic
formulation, the Examiner finds Appellants' Specification recites only:
"[ o ]phthalmic formulations, eye ointments, powders, solutions and the like,
are also contemplated as being within the scope of this invention." Id.
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Appeal2014-005544
Application 12/309,430
(quoting Spec. 67). The Examiner finds the Specification makes no further
disclosure regarding ophthalmic formulations or other formulations suitable
for administration to the eye, nor does it disclose that the compositions are
effective for the treatment of any ophthalmic diseases or conditions. Id.
Rather, the Examiner finds, the only disease or disorder recited in the
Specification is mucositis, particularly oral mucositis, which, the Examiner
finds, does not involve tissues of the eye. Id. at 3--4 (citing Spec. Title,
Abstr., Summary of the Invention, etc.). The Examiner concludes that,
although the Specification states that the disclosed compounds may be
formulated for ophthalmic administration, a person of ordinary skill in the
art would not recognize that the Applicants were in possession of the
instantly claimed ophthalmic formulations. Id. at 4.
Appellants respond that the Examiner's conclusion that the claims
"contain subject matter which was not described in the specification in such
a way as to reasonably convey to one skilled in the relevant art that the
inventor [ ... ], at the time the application was filed, had possession of the
claimed invention" is directly contradicted by the Specification's disclosure
that: "' [ o ]phthalmic formulations, eye ointments, powders, solutions and the
like, are also contemplated as being within the scope of this invention."'
Reply Br. 5 (quoting Ans. 2-3, 3 (quoting Spec. 67)). Appellants contend a
person of ordinary skill in the art would recognize that an ophthalmic
formulation would be composed only if the practitioner contemplated
ophthalmic delivery of an active ingredient, as Appellants argue is expressly
contemplated by Appellants' Specification. Id. at 6 (citing Spec. 67).
Therefore, Appellants contend, the use of the disclosed formulation for
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Appeal2014-005544
Application 12/309,430
treatment of an ophthalmic disease or condition in a patient is also
contemplated by Appellants' Specification. Id.
Appellants argue further that the term "mucositis" is well-understood
in the art to embrace a number of indications related to the painful
inflammation and ulceration of mucous membranes. Reply Br. 6.
Therefore, argue Appellants, demonstration of the utility of the disclosed
compounds for the treatment of mucositis, taken with the clear
contemplation of employing invention compounds in the preparation of
ophthalmic formulations, is supportive of the conclusion that Appellants
were in possession of the claimed invention at the time the present
application was filed. Id.
We are not persuaded by Appellants' arguments. With respect to
claim 15, the first paragraph of Section 112 recites, inter alia, "[t ]he
specification shall contain a written description ... of the manner and process
of making and using it, in such full, clear, concise, and exact terms as to
enable any person skilled in the art to which it pertains, or with which it is
most nearly connected, to make and use the same." 35 U.S.C. § 112.
Moreover, an adequate written description of a claimed genus requires more
than simply a generic statement of an invention's boundaries. Ariad
Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1349 (Fed. Cir.
2010). In this instance, we agree with the Examiner that the single sentence
of the Specification disclosing "[ o ]phthalmic formulations, eye ointments,
powders, solutions and the like, are also contemplated as being within the
scope of this invention" does not provide more than a generic statement of
the boundaries of Appellants' invention and, as such, is insufficient to
provide written descriptive support of the invention. At best, the
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Appeal2014-005544
Application 12/309,430
Specification renders the claims obvious but "a description that merely
renders the invention obvious does not satisfy the requirement" Ariad, 598
F.3d at 1352. We consequently affirm the Examiner's rejection of claim 15.
With respect to claim 16, we are similarly not persuaded by
Appellants' arguments. Appellants' Specification is directed to "methods of
treating mucositis." See Spec. Abstr. Appellants attempt to persuade us that
the term "mucositis" can apply to inflammation and ulceration of all mucous
membranes, including those of the eye. See Reply Br. 6. However, such a
definition is not supported by Appellants' Specification, which defines
"mucositis" thus:
Mucositis, for the purposes of this application, refers to mucosal
injury induced or associated with the administration of radiation
or drugs (chemotherapy) for the treatment of cancer and related
diseases. Mucositis typically manifests itself as ulcerations,
tissue necrosis, and atrophy of the mucous membranes anywhere
along the digestive tract, from the mouth to the anus. For
example, the present methods may be used to treat ulcerations
and tissue necrosis associated with radiation therapy and/ or
chemotherapy.
Spec. 3 (emphasis added). Appellants' Specification thus defines mucositis
as occurring along the length of the alimentary tract, which does not include
the mucous membranes of the eye. Moreover, Appellants' definition is
consistent with definitions of "mucositis" generally employed in the art.
See, e.g., D.E. Peterson et al., Management of Oral and Gastrointestinal
Mucositis: ESMO Clinical Practice Guidelines, 22 (Suppl. 6) ANNALS OF
ONCOLOGY, vi78-vi84 (2011) ("Mucositis is defined as inflammatory and/or
ulcerative lesions of the oral and/or gastrointestinal tract. Infectious
disease, immune deficiency and medications can be causative") (emphasis
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Application 12/309,430
added). Appellants adduce no evidence in support of their assertion that the
term "mucositis" can also be applied to inflammation or ulceration of the
tissues of the eye. As such, Appellants' assertion is unsupported attorney
argument and we accord it little probative value. In re Geisler, 116 F.3d
1465, 1470 (Fed. Cir. 1997). Consequently, we find "mucositis," as defined
by Appellants' Specification and as understood generally in the art, is not
understood to apply to inflammation and/or ulceration of the mucous
membranes of the eye, but rather to those of the digestive tract.
The passage of the Specification on page 67, quoted above,
generically discloses ophthalmic formulations, but fails to disclose any
method of using the formulation in a disease or any other condition of the
eye. Appellants argue that, because the Specification discloses the
ophthalmic formulations, eye ointments, etc., it must also disclose a method
of using those formulations in a treatment, otherwise: "[ w ]hy else would one
bother to prepare an ophthalmic formulation?" Reply Br. 6. Why else
indeed? The Specification is entirely silent as to how, why, when, or under
what conditions such ophthalmic formulations might be used. We therefore
agree with the Examiner's conclusion that a person of ordinary skill would
not recognize that Appellants were in possession of the claimed method at
the time of invention.
Consequently we agree with the Examiner's conclusion that claims 15
and 16 lack the written description support required by the first paragraph of
Section 112, and we affirm the rejection.
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Application 12/309,430
DECISION
The Examiner's rejection of claim 15 and 16 as unpatentable under
35 U.S.C. § 112, first paragraph, is affirmed.
No time period for taking any subsequent action in connection with
this appeal maybe extended under 37 C.F.R. § 1.136(a)(l). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED
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