Ex Parte Barber

Patent Trial and Appeal Board

Dec 14, 2016

13057662 (P.T.A.B. Dec. 14, 2016)

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.
13/057,662 06/14/2011 Glen N. Barber 7051-0002 4301
86056 7590 12/16/2016
Cuenot, Forsythe & Kim, LLC
5425 Park Central Court
Suite 111
Naples, EL 34109
EXAMINER
KIM, YUNSOO
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
12/16/2016 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):
sakptomail@iplawpro.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GLEN N. BARBER1
Appeal 2015-005032
Application 13/057,662
Technology Center 1600
Before JEFFREY N. FREDMAN, TIMOTHY G. MAJORS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a method
of modulating interferon type I production, which have been rejected as
failing to comply with the written description requirement and as
anticipated. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.
STATEMENT OF THE CASE
Stimulator of Interferon Genes (STING) molecules modulate the
innate, or primary, immune system. (Spec. | 5.) “It is thought that the
innate immune system initially keeps the infection under control, allowing
time for the adaptive immune system to develop an appropriate response.”
1 Appellant identifies the Real Party in Interest as Glen N. Barber. (Br. 3.)
Appeal 2015-005032
Application 13/057,662
(Spec. 1116.) “The various components of the innate immune system
trigger and augment the components of the adaptive immune system,
including antigen-specific B and T lymphocytes.” (Id.) Included in “[t]he
main protective mechanisms of primary immunity” are “antimicrobial
substances such as interferon (IFN) (inhibits viral replication).” (Id.)
Claims 52—64 are on appeal. Claim 52 is representative and reads as
follows:
52. A method of modulating interferon type I production in a
subject having a disease that can be ameliorated by modulating
a Stimulator of Interferon Genes (STING) protein by
introducing into an intracellular compartment of a cell in or
from the subject an agent which alters the function or
expression of the STING protein in the cell, wherein the STING
protein has the amino acid sequence of SEQ ID. NO: 1.
(Br. 10.)
The following grounds of rejection by the Examiner are before us on
review:
1. Claims 52—64 under 35 U.S.C. § 112, first paragraph, as failing
to comply with the written description requirement.
2. Claims 52—64 under 35 U.S.C. § 102 as anticipated by
Matsudo.2
DISCUSSION
Written Description
The Examiner’s findings with respect to lack of written description
are set forth in the Answer at 2—5. Upon consideration of the evidence on
2 Matsudo et al., WO 03/048202 A2 published June 12, 2003.
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Application 13/057,662
this record and each of Appellant’s contentions, we agree with the
Examiner’s finding that the genus of claimed “agent which alters the
function or expression of the STING protein in the cell” is extensive, the
structures embodied by that genus that “give rise to such agents are so
different,” and that the Specification fails to provide sufficient correlation
between a structure responsible for the claimed function of “an agent which
alters the function or expression of the STING protein in the cell,” nor does
it disclose a representative number of species within the genus of agents
performing that function. Thus, we conclude that the preponderance of
evidence on this record supports the Examiner’s finding that claim 52
contains 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 as required to comply with the written description requirement of
35 U.S.C. § 112, first paragraph.
For emphasis only, we provide the following:
A “sufficient description of a genus . . . requires the disclosure of
either a representative number of species falling within the scope of the
genus or structural features common to the members of the genus so that one
of skill in the art can ‘visualize or recognize’ the members of the
genus.” AriadPharmaceuticals, Inc. v. EliLilly & Co., 598 F.3d 1336
1350 (Fed. Cir. 2010) (citing Regents of the University of California v. Eli
Lilly & Co., 119 F.3d 1559, 1568-69 (Fed. Cir. 1997)).
Not only does Lilly support the Examiner’s conclusion regarding the
lack of written description support for claim 52, so does the more recent
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Application 13/057,662
Ariad decision. In that case, Ariad claimed methods comprising the single
step of reducing NF-kB activity and the patent specification at issue
there hypothesized three classes of molecules potentially capable of such
activity: specific inhibitors, dominantly interfering molecules, and decoy
molecules. Ariad, 598 F.3d at 1354. The Court held that to describe the
method, the patent specification must provide an adequate description of the
molecules admittedly necessary to perform the methods. As to the first class
of molecules, the Court noted that the “vague functional description” of one
compound in that class and “an invitation for further research” was
insufficient. Id. at 1356. As to the second class of molecules, the Court
found that neither the specification, nor the prior art taught the structure to
which a molecule would have to bind to effect interference, and, thus, the
description was lacking as representing “a wish, or arguably a plan” for
future research. Id. at 1356—57. As to the third class of molecules, the Court
found that, while the specification provided specific example sequences of
decoy molecules, that fact did not answer the question of whether the
specification adequately described using the molecules for the function
claimed. Id. at 1357. On that latter point, the Court held that the disclosure
was lacking because the only disclosure was that if the NF-kB bound the
decoy “‘negative regulation can be effected,’” which was determined to be
“a mere mention of a desired outcome.” Id.
The Examiner noted, and Appellant does not dispute, that Appellant
has claimed a method of modulating an immune response by administering
“any STING altering agent,” which broad genus “encompass[es] STING
itself, as well as antibodies, nucleic acids, other physiological protein ligands
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Application 13/057,662
of STING and peptidomimetics of all of the above.” (Ans. 3—4.) The
Examiner also noted, and Appellant does not dispute, that the claimed genus
“affects STING by various means” but that the Specification has only
disclosed the structure of “the full length STING as set forth in the SEQ ID
Nos: 1—2” and does not disclose a requisite domain or sequence giving rise to
the function claimed, i.e., “altering] the function or expression of the
STING protein in the cell.” (Id.) Moreover, the Examiner explained, and
Appellant does not dispute, that while the Specification discloses various
methods of modulations of immune response by “STING,” it “do[es] not
disclose methods of immune modulations by ‘any agent[,’ such as
antibodies, nucleic acids, small organic molecules, other physiological
protein ligands of STING and peptidomimetics,] that alters the function or
expression of the STING.” (Ans. 5.) The disclosure with respect to the
broadly claimed “agents” that includes numerous classes of molecules, while
mentioning a desired outcome, represents “a wish, or arguably a plan” for
future research for agents that are other than STING protein or nucleic acid
(RNAi).
Appellant contends that claims 53, 54, and 61 are adequately
described because of their narrower scope. However, as the Examiner
noted, and Appellant does not dispute, the Specification does not disclose a
requisite domain or sequence giving rise to the function claimed. Thus,
claim 53 ’s recitation that the “agent is a nucleic acid molecule that is
specifically hybridizable to a polynucleotide encoding the STING protein,”
claim 54’s inclusion of “functional fragments]” of a “nucleic acid molecule
that encodes the STING protein” as the agent and claim 61 ’s inclusion of
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“functional fragment” of STING as the agent, are also 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.
Claims 55—60, 63, and 64 have not been argued separately and
therefore fall with claim 52. 37 C.F.R. § 41.37(c)(l)(iv).
Anticipation
The Examiner’s findings with respect to anticipation are set forth in
the Answer at 5—10. Upon consideration of the evidence on this record and
each of Appellant’s contentions, we conclude that the preponderance of
evidence on this record supports the Examiner’s finding that Matsudo
anticipates claim 52, as well as claim 64.
Claims 53—63 have not been argued separately and therefore fall with
claim 52. 37 C.F.R. § 41.37(c)(l)(iv).
SUMMARY
We affirm the rejection of claims 52—64 under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description requirement.
We affirm the rejection of claims 52—64 under 35 U.S.C. § 102 as
anticipated over Matsudo.
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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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