Ex Parte Ambati

Patent Trial and Appeal Board

Jan 25, 2019

11357288 (P.T.A.B. Jan. 25, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/357,288 02/16/2006
23911 7590 01/29/2019
CROWELL & MORING LLP
INTELLECTUAL PROPERTY GROUP
P.O. BOX 14300
WASHINGTON, DC 20044-4300
FIRST NAMED INVENTOR
Jayakrishna Ambati
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.
104072.B870257 3987
EXAMINER
WEN, SHARON X
ART UNIT PAPER NUMBER
1644
NOTIFICATION DATE DELIVERY MODE
01/29/2019 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):
edocket@crowell.com
tche@crowell.com
apomeroy@crowell.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JAY AKRISHNA AMBATI 1
Appeal 2017-011580
Application 11/357 ,288
Technology Center 1600
Before TONI R. SCHEINER, RICHARD M. LEBOVITZ, and
FRANCISCO C. PRATS, Administrative Patent Judges.
LEBOVITZ, Administrative Patent Judge.
DECISION ON APPEAL
This appeal involves claims to a method of inhibiting ocular
angiogenesis. The Examiner rejected the claims as lacking a written
description under 35 U.S.C § 112, first paragraph. Pursuant to 35 U.S.C.
§ 134(a), Appellants appeal the Examiner's determination that the claims are
unpatentable. We have jurisdiction under 35 U.S.C. § 6(b ). The rejection is
reversed.
STATEMENT OF THE CASE
Claims 1-6, 9, 10, and 22 are the subject of this appeal. These claims
were previously before the Patent Trial and Appeal Board in Appeal 2012-
1 The Appeal Brief ("Br.") lists University of Kentucky Research
Foundation as the real-party-in-interest.
Appeal 2017-011580
Application 11/357,288
001918, in which the sole rejection under 35 U.S.C. § 103 was reversed.
Decision on Appeal (entered Oct. 2, 2015).
Claims 1-6, 9, 10, and 22 stand rejected by the Examiner under pre-
AIA 35 U.S.C. § 112, first paragraph as failing to comply with the written
description requirement. Ans. 2. Claim 1, the only independent claim on
appeal, is reproduced below:
1. A method of inhibiting ocular angiogenesis comprising
exposing a choroidal cell to a CCR3-inhibitory effective
amount of an antibody which inhibits the activity of CCR3.
WRITTEN DESCRIPTION
35 U.S.C. § 112 requires a written description of the claimed
invention that allows a person of skill in the art to recognize that the inventor
invented what is claimed. Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d
1336, 1351 (Fed. Cir. 2010) (en bane). To that end, to satisfy the written
description requirement, the inventor "must ... convey with reasonable
clarity to those skilled in the art that, as of the filing date sought, he or she
was in possession of the invention." Vas-Cath Inc. v. Mahurkar, 935 F.2d
1555, 1563-64 (Fed. Cir. 1991). "One shows that one is 'in possession' of
the invention by describing the invention, with all its claimed limitations."
Lockwood v. Am. Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997)
(internal citation omitted).
Claim 1 is directed to a method of inhibiting ocular angiogenesis
comprising a step of administering "a CCR3-inhibitory effective amount of
an antibody which inhibits the activity of CCR3." CCR3 is a chemokine
receptor that is predominantly expressed by eosinophils, but also is found on
other leukocytes and some endothelial and epithelial cells. Spec. 2: 24--25.
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Application 11/357,288
The Examiner determined that the claims are directed to a genus of
antibodies which inhibit the activity of the CCR3 receptor. Ans. 3. The
Examiner rejected the claims as failing to comply with the written
description requirement of 35 U.S.C. § 112, first paragraph, because the
Examiner found that the Specification does not describe the genus of
inhibitory antibodies in sufficient detail to establish that the inventors had
possession of it. Id. In support of the rejection, the Examiner cited Ari ad
Pharms., University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568
(Fed. Cir. 1997), and Centocor Ortho Biotech Inc. v. Abbott Labs., 636 F.3d
1341 (Fed. Cir. 2011).
In Lilly, the court held that, when a genus of peptides is claimed, the
written description must sufficiently define the genus to allow one skilled in
the art to "visualize or recognize the identity of the members of the genus,"
for example, by describing a representative number of species or a
description of "structural features commonly possessed by members of the
genus that distinguish them from others." Lilly, 119 F.3d at 1568.
Centocor involved claims directed to a recombinant anti-TNF-a
antibody, comprising a human constant region and a human variable region,
which inhibits binding of the A2 antibody to human TNF-a and which binds
to a neutralizing epitope of human TNF-a. Centecor, 636 F.3d at 1346. The
court in Centecor found that the claimed genus lacked an adequate written
description because the specification did not disclose a single antibody that
disclosed the claimed limitations, particularly an antibody with the claimed
binding properties and which comprised a human variable region. Centecor,
636 F.3d at 1350-1351. In reaching this decision, the court rejected the
position that the disclosure alone of the antigen to which the antibody binds
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Application 11/357,288
provides an adequate written description of the antibody. Centecor, 636
F.3d at 1351. Amgen Inc. v. Sanofi, 872 F.3d 1367, 1378 (2017), also
involving antibody claims, more fully articulated this principle,
emphasizing:
An adequate written description must contain enough
information about the actual makeup of the claimed products-
"a precise definition, such as by structure, formula, chemical
name, physical properties, or other properties, of species falling
within the genus sufficient to distinguish the genus from other
materials," which may be present in "functional" terminology
"when the art has established a correlation between structure and
function." Ariad, 598 F.3d at 1350.
The claims at issue in this appeal are not directed to antibodies, per se,
as they were in Centecor and Amgen. Rather, the rejected claims are
directed to a method of using known antibodies to inhibit ocular
angiogenesis. The inventors do not assert that the antibodies, themselves,
are novel as they were asserted to be so in Centecor and Amgen. The
Specification discloses that the antibodies to be used in the claimed method
were known prior to the filing date of the application:
Additional compounds for inhibiting the CCR3 receptor include
antibodies which specifically bind the CCR3 receptor, eotaxin,
eotaxin-2 or eotaxin-3. Exemplary antibodies which specifically
bind and inhibit the CCR3 receptor are described in U.S. Patent
Nos. 6,806,061 and 6,207,155, and in U.S. published
applications 20050191702, 20050069955, and 20020147312.
Exemplary antibodies which specifically bind and inhibit eotaxin
and eotaxin-2 are described in U.S. Patent Nos. 6,946,546 and
6,635,251, and in U.S. published applications 20040191255 and
20040014132.
Spec. 5:16-22.
It was not established by the Examiner that the Specification lacks a
disclosure of a representative number of the claimed inhibitory antibodies in
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Application 11/357,288
fulfillment of the written description requirement. As indicated in the
passage reproduced above, the inventors cited four U.S. patents and five
published U.S. patent applications as disclosing antibodies within the scope
of the claim. Spec. 5: 16-22. The Examiner stated that "these antibodies do
not share any structural features common to the members of the genus of the
antibody recited that has the required function of inhibiting CCR3." Ans. 7.
However, the Examiner did not address what is disclosed in these nine
patent disclosures, and determine based on this evidence that a genus is not
described.
The Examiner further stated that the application disclosure is deficient
because it "lacks any teaching regarding the amino acid residues that are
critical for the function." Ans. 3.
The Examiner did not establish that one of ordinary skill in the art
would have considered identification of the specific amino acid residues
responsible for binding to an epitope necessary to establish possession of a
genus directed to antibodies, particularly antibodies that were already known
in the prior art.
"The 'written description' requirement implements the principle that a
patent must describe the technology that is sought to be patented; the
requirement serves both to satisfy the inventor's obligation to disclose the
technologic knowledge upon which the patent is based, and to demonstrate
that the patentee was in possession of the invention that is claimed." Capon
v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005).
The descriptive text needed to meet these requirements varies
with the nature and scope of the invention at issue, and with the
scientific and technologic knowledge already in existence. The
law must be applied to each invention that enters the patent
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Application 11/357,288
process, for each patented advance is novel in relation to the state
of the science. Since the law is applied to each invention in view
of the state of relevant knowledge, its application will vary with
differences in the state of knowledge in the field and differences
in the predictability of the science.
Capon, 418 F.3d at 1357.
Furthermore:
Precedent illustrates that the determination of what is needed to
support generic claims to biological subject matter depends on a
variety of factors, such as the existing knowledge in the
particular field, the extent and content of the prior art, the
maturity of the science or technology, the predictability of the
aspect at issue, and other considerations appropriate to the
subject matter.
Capon, 418 F.3d at 1359.
The claims in this case are not directed to novel antibodies. The
disclosure necessary to fulfil the written description requirement must be
considered in this context, namely that the specification relied upon the
existing scientific and technical knowledge of CCR3 inhibitory antibodies.
The inventors are not claiming the antibodies, but a new use of them. The
Examiner did not provide sufficient evidence that the disclosure of such
known antibodies and the discovery that they are useful to treat ocular
angiogenesis is inadequate to demonstrate the inventors had possession of
the claimed invention, including all of its limitations. Lockwood, 107 F.3d
at 1572; Capon, 418 F.3d at 1357.
The Examiner has the initial burden of presenting evidence or reasons
why a person skilled in the art would not recognize that the written
description of the invention provides support for the claims. Hyatt v.
Dudas, 492 F.3d 1365, 1371 (Fed. Cir. 2007). The burden was not met here
because the Examiner did not establish that disclosure of nine patent
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Application 11/357,288
publications describing antibodies within the scope of the claim were
insufficient to establish possession of the claimed method of treating ocular
angiogenesis with inhibitory CCR3 antibodies. Accordingly, we reverse the
rejection of independent claim 1, and dependent claims 2---6, 9, 10, and 22.
REVERSED
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