TORAY INDUSTRIES, INC.

Patent Trials and Appeals Board

Apr 26, 2021

2020006221 (P.T.A.B. Apr. 26, 2021)

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.
15/567,496 10/18/2017 Akira KURIHARA 1254-0599PUS1 6315
2292 7590 04/26/2021
BIRCH STEWART KOLASCH & BIRCH, LLP
8110 Gatehouse Road
Suite 100 East
Falls Church, VA 22042-1248
EXAMINER
AEDER, SEAN E
ART UNIT PAPER NUMBER
1642
NOTIFICATION DATE DELIVERY MODE
04/26/2021 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):
mailroom@bskb.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte AKIRA KURIHARA, HYONGI CHON, TAKAYUKI FUJITA,
and FUMIYOSHI OKANO
Appeal 2020-006221
Application 15/567,496
Technology Center 1600
Before RICHARD M. LEBOVITZ, JOHN G. NEW, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims directed to a method for treating cancer
that is not a brain cancer as being obvious and for lack of written
description. Oral argument was heard April 8, 2021. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM IN PART.

1 We use the term “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as TORAY
INDUSTRIES, INC. (Appeal Br. 3.)
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Application 15/567,496

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STATEMENT OF THE CASE
According to Appellant’s Specification “various types of antibody
medicines for treating cancer, targeting a specific antigen protein on cancer
cells have been known in the world.” (Spec. ¶ 4.) “Most of the target
antigen proteins provide certain levels of medicinal effects as a cancer-
specific therapeutic agent and attract attention; however they express also on
a plurality of normal cells.” (Id.) Thus, treatments with antibodies targeting
such antigens are of concern because normal cells as well as cancer cells
“are damaged as a result of administration of [such] antibodies.” (Id.)
Appellant’s invention is directed to targeting a cancer antigen that is a
transmembrane protein having a portion thereof expressed on the surface of
cancer cells with an antibody against an extracellular region of that antigen.
(Id. ¶¶ 8–9.)
Claim 7, reproduced below, is illustrative of the claimed subject
matter:
7. A method for treating cancer, said method comprising:
administering to a subject a therapeutically effective
amount of an antibody capable of binding to the extracellular
region of CSPG5 protein expressed on the surface of cancer cells
to treat the cancer,
wherein the CSPG5 protein comprises the amino acid
sequence of SEQ ID NO: 8, 4, 6, 10, or 12,
wherein the antibody has a cytotoxic effect, wherein the
cytotoxic effect comprises antibody-dependent cell-mediated
cytotoxicity (ADCC) and/or complement-dependent cytotoxicity
(CDC), with the proviso that the cancer is not a brain tumor.
(Appeal Br. 30.)
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REFERENCE
The prior art relied upon by the Examiner is:
Name Reference Date
Cairns US 2008/0124331 A1 May 29, 2008

REJECTIONS
The following grounds of rejection by the Examiner are before us on
review:
Claims 7, 10, 11, and 14–30 are rejected under 35 U.S.C. § 112(a) or
35 U.S.C. § 112 (pre-AIA), first paragraph, as failing to comply with the
written description requirement.
Claims 7, 10, 11 and 14–30 are rejected under 35 U.S.C. § 103(a) as
being unpatentable over Cairns.

DISCUSSION
I. Written Description
The Examiner finds that “[t]he specification does not disclose, and the
art does not teach, the genus of antibodies as broadly encompassed in the
claims.” (Final Action 3.) The Examiner explains that “[t]he claimed
method requires use of a product defined by functions (an antibody that both
binds to a recited polypeptide and has a cytotoxic effect of ADCC and/or
CDC).” (Id. at 5.) Moreover, the Examiner finds that “[t]he claims lack a
correlation between the structure of an antibody that both binds to a recited
polypeptide and has a cytotoxic effect of ADCC and/or CDC.” (Id.) And,
the Examiner finds that “[w]ithout a correlation between structure and
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function, the claims define the antibody to be used in the claimed invention
by function.” (Id.)
The Examiner acknowledges that the Specification discloses 18
monoclonal antibodies that bind the CSPG5 extracellular domain (“ECD”)
and that there are several polyclonal antibodies and a single monoclonal
antibody known in the art that bind to the CSPG5 ECD but that “the
specification only mentions one CSPG5-binding antibody that has a
cytotoxic effect (‘monoclonal antibody #1’).” (Final Action 3.) The
Examiner notes, with respect to “monoclonal antibody #1,” that the
Specification does not indicate that it has been deposited and it does not
identify the polypeptide sequence of it. (Id.) Thus, according to the
Examiner, the Specification
fails to describe common attributes or characteristics that
adequately identify members of the genus, and because the
genus is highly variant, the disclosure is insufficient to describe
the genus. Thus, one of skill in the art would reasonably
conclude that the disclosure fails to provide a representative
number of species to describe the genus as broadly claimed.
(Id. at 6.)
We disagree with the Examiner that the claimed method is not
adequately described. Although Appellant’s claim is not to an antibody or
genus of antibodies itself (Appeal Br. 10), we agree with the Examiner that
to comply with the written description requirement of 35 U.S.C. § 112, an
adequate description of the method of using the claimed genus of antibodies
to treat cancer requires an adequate written description of the genus of
antibodies. “Regardless whether a compound is claimed per se or a method
is claimed that entails the use of the compound, the inventor cannot lay
claim to that subject matter unless he can provide a description of the
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compound sufficient to distinguish infringing compounds from non-
infringing compounds, or infringing methods from non-infringing methods.”
Univ. of Rochester v. GD Searle & Co., 358 F.3d 916, 926 (Fed. Cir. 2004).
Furthermore, we note that for claims that include a genus of
antibodies that may be used in a method of treatment, when the genus is
claimed using functional language to define a desired result, “the
specification must demonstrate that the applicant has made a generic
invention that achieves the claimed result and do so by showing that the
applicant has invented species sufficient to support a claim to the
functionally-defined genus.’” Ariad Pharm., Inc. v. Eli Lilly & Co., 598
F.3d 1336, 1349 (Fed. Cir. 2010) (en banc). A number of factors must be
considered “for evaluating the adequacy of the disclosure [of generic
claims], including ‘the existing knowledge in the particular field, the extent
and content of the prior art, the maturity of the science or technology, [and]
the predictability of the aspect at issue.’” Id. at 1351 (quoting Capon v.
Eshhar, 418 F.3d 1349, 1359 (Fed. Cir. 2005).)
Appellant’s Specification teaches that CSPG5 protein molecules that
include SEQ ID Nos: 8, 4, 6, 10, or 12 are expressed on the surface of a
variety of cancer cells and that an antibody that binds to the ECD of such
protein molecules damages the cancer cell expressing the protein. (Spec.
¶¶ 9, 17.) The Specification demonstrates that a polyclonal antibody as well
as a monoclonal antibody to the ECD region of the foregoing protein shows
cytotoxic activity. (Id. ¶ 13 (referring to Figure 4, Figure 5), ¶¶ 113–114
(Example 4), ¶¶ 121–122 (Example 7).)
Additionally, Mr. Okano, one of the inventors of the claimed
invention, attested in a declaration that the biological activity of the claimed
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invention is not predicated on binding at a specific location of the ECD of
CSPG5, but rather the subsequent cytotoxic activity is driven by the
antibody Fc domain once the antibody binds. (Okano I Declaration dated
May 22, 2019, 2.) Dr. Shahir Rizk agreed. (Declaration Under 37 C.F.R. §
1.132 of Dr. Shahir Rizk dated November 8, 2019 (“Rizk Declaration”)
¶ 23.) Dr. Rizk2 explains that, in his view, the antibodies that bind
specifically to the ECD region of the CSPG5 protein that includes SEQ ID
Nos: 8, 4, 6, 10, or 12 are not required to neutralize activity of that protein or
bind with a specific affinity or have specific functional behavior such as
blocking binding to achieve the claimed ADCC and/or CDC function. (Id.
¶¶ 7, 23–24, 27.)
As the Examiner noted, antibodies that bind the ECD of CSPG5 were
known in the field prior to the application filing date. Moreover, Appellant
described in its Specification 18 additional monoclonal antibodies that bind
the ECD of CSPG5 comprising at least one of the claimed SEQ ID NOs.
(See Okano I Declaration 2 (citing Spec. ¶ 118).)
Furthermore, Mr. Okano testified that the generation and isolation of
monoclonal antibodies through hybridoma technology was considered
routine in the art at the time the claimed invention was made. (Okano I
Declaration 2.) Dr. Rizk attested to the same. (Rizk Declaration ¶ 11.)
Given the foregoing facts, we find Appellant’s disclosure of numerous
antibodies that bind to the ECD of CSPG5 sufficient to show possession of

2 Dr. Rizk has a Ph.D. in Biochemistry from Duke University, holds faculty
appointments at the Indiana University School of Medicine as an Adjunct
Assistant Professor of Biochemistry and Molecular Biology, and Indiana
University South Bend as an Assistant Professor of Biochemistry and has
practical experience with antibodies. (Rizk Declaration ¶ 3.)
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the genus of antibodies embraced by the claim, i.e., that bind the ECD of the
CSPG5 protein which comprises the amino acid sequence of SEQ ID NO: 8,
4, 6, 10, or 12, and also has the claimed ADCC and/or CDC function.
Therefore, we do not affirm the Examiner’s rejection of claims 7, 10,
11, and 14–30 under 35 U.S.C. § 112, first paragraph for failing to comply
with the written description requirement.

II. Obviousness
The Examiner finds that Cairns teaches a surface-expressed tumor-
associated antigenic target polypeptide TAT165, that has SEQ ID NO: 126
which is nearly identical to SEQ ID NO: 4 of Appellant’s Specification.
(Final Action 11; Ans. 20.) The Examiner notes that Cairns teaches
“TAT165 is expressed in glioma and glioblastoma, which are tumors that
arise in both brain and spine.” (Ans. 20.) The Examiner further finds that
Cairns “claims antibodies that bind the extracellular domain of SEQ ID
NO:126, which preferably exhibit ‘effector functions’ such as those that
promote death of cancer cells (claims 2 and 24, [0712] and [0727]-[0728], in
particular).” (Final Action 11.) Moreover, the Examiner finds that “Cairns
teaches methods of preparing and obtaining TAT antibodies (Example 12, in
particular[.])” (Ans. 23.)
The Examiner also finds that Cairns teaches “modifying Fc regions of
said antibodies in order to generate antibodies that induce an ADCC or CDC
cytotoxic response ([0794] and [0932], in particular).” (Final Action 11.)
And, the Examiner finds that Cairns teaches “methods of assessing ADCC
activity of antibodies ([0728], in particular), [as well as] methods of
assessing CDC activity of antibodies ([0731], in particular).” (Ans. 23.)
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In addition, the Examiner finds Cairns teaches treating cancer such as
lymphoma, leukemia or breast cancer, by administering an antibody that
binds SEQ ID NO:126. (Final Action 11 (citing Cairns ¶¶ 38, 732, 1088,
and claim 25); Ans. 23.)
The Examiner, however, recognizes that Cairns “does not demonstrate
that an antibody that binds the extracellular domain of instant SEQ ID NO: 4
or SEQ ID NO: 8 and generates a cytotoxic response has actually been
administered to a subject with cancer.” (Final Action 12.) The Examiner
concludes that it would have been obvious to one of ordinary skill in the art
to carry out the method “envisioned by Cairns” with a reasonable
expectation of success. (Id.)
We agree with the Examiner’s findings and conclusion of
obviousness. There is no dispute that SEQ ID NO:126, which is a
polypeptide derived from SEQ ID NO:48, is 99.7% identical to Appellant’s
SEQ ID NO:4. Cairns teaches an isolated antibody that binds to an ECD of
any one of SEQ ID NOS: 79–154. (Cairns ¶¶ 102, 105 (claim 16).) In
addition, Cairns teaches methods of producing such antibodies. (See, e.g.,
id. ¶¶ 1130–1137.) And, Cairns claims an antibody that binds the ECD of
SEQ ID NO:126. (Id. at claim 2.)
Also, Cairns teaches that the anti-TAT antibodies can induce
cytotoxicity via ADCC or CDC. (Cairns ¶ 932.) And Cairns teaches how to
assay for such antibodies and to enhance such activity. (See, e.g., id. ¶¶ 728,
731, 794, 1143–1149.) Furthermore, Cairns teaches that TAT165 is
upregulated in glioma and glioblastoma as compared to normal brain tissue.
(Id. ¶¶ 1005, 1085.) And Cairns teaches treating cancer in mammals by
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administering antibodies to the disclosed TAT polypeptides. (Id. ¶¶ 38, 46,
217, 223, 236, 324, 325.)
According to Appellant, “Cairns does not determine the protein
topology or the cellular localization of any polypeptide translated from the
nucleic acid of SEQ ID NO:48,” and Cairns only mentions the possibility of
generating antibodies which are directed against numerous identified
sequences that might be useful for treatment of any number of diseases.
(Appeal Br. 22.) Consequently, Appellant argues Cairns’ disclosure is just
“a speculative invitation to research generally.” (Id.)
Furthermore, Appellant argues that Cairns only mentions that
TAT165 is expressed in glioma, glioblastoma, and brain tumor but “does not
disclose preparing an antibody therefor, let alone data that an antibody
against TAT165 is actually effective in treating cancer, let alone cancer that
is not a brain tumor.” (Appeal Br. 22.) Thus, Appellant concludes that
Cairns does not support a prima facie case of obviousness. (Id.)
We do not find Appellant’s arguments persuasive. Whether or not
Cairns determines the topology of the protein of SEQ ID NO:126, Cairns
does, as noted above, describe and claim an isolated antibody to the ECD of
that protein. Furthermore, because Cairns discloses that the TAT165 protein
is overexpressed in gliomas, glioblastomas, and brain tumors as compared to
normal cells, one of ordinary skill in the art would have been motivated to
raise antibodies to that protein. Furthermore, we agree with the Examiner
that “[o]ne of skill in the art would [have reasonably] predict[ed] that an
antibody with ADCC and/or CDC activity that targets just any cancer cells
expressing SEQ ID NO: 126 on the cancer cell surface would therapeutically
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treat the cancer because the cytotoxic activity of said antibodies would
therapeutically kill cancer cells targeted by the antibodies.” (Ans. 21.)
Cairns teaches that TAT165 is upregulated in glioma and
glioblastoma. It is well known that glioma is a cancer that starts in the glial
cells of the brain or spinal cord. There is no evidence of record that the glial
cells of the spinal cord are different than the glial cells of the brain, and they
are generally recognized as representing a continuum of central nervous
system tissue. See A.B. Butler et al., Comparative Vertebrate
Neuroanatomy:Evolution and adaptation, 40–41 (1996). Therefore, we
conclude that Cairns’ disclosure that SEQ ID NO: 126 of TAT165 is
upregulated in glioma would have provided one of ordinary skill in the art
with motivation to treat cancerous glial cells of the spinal cord by
administering an antibody to the ECD region of the protein containing SEQ
ID NO: 126 of TAT165.
Because a glial tumor of the spinal cord is not evidently different from
a glial tumor of the brain, we affirm the Examiner’s obviousness rejection of
claims 7, 10, 11, 14, 15, 20, and 27–29, which only require that the method
is applied to treat cancer that is not a brain tumor.
However, we reverse the Examiner’s obviousness rejection as to
claims 16–19, 21–26, and 30 because those claims are directed to certain
specific cancers as follows:
claims 16 and 18 recite “wherein the cancer is leukemia,”
claims 17 and 19 recite “wherein the cancer is malignant lymphoma,”
claims 21 and 30 recite “wherein the cancer is selected from the group
consisting of breast cancer, lung cancer, adenocarcinoma, mastocytoma,
squamous cell carcinoma, melanoma, and neuroblastoma,” claim 22
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depends from claim 21 and claims 23–26 depend from claim 22. The
Examiner has not provided sufficient evidence to establish a prima facie case
of obviousness for treating any of the specifically recited cancers of claims
16–19, 21, and 30. Also, for the reasons just discussed, we conclude that the
Examiner has not provided sufficient evidence to establish a prima facie case
of obviousness of claim 22, which depends from claim 21, or claims 23–26,
which depend from claim 22.
DECISION SUMMARY
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
7, 10, 11,
14–30
112, first
paragraph
Written
Description
7, 10, 11,
14–30
7, 10, 11,
14–30
103 Cairns 7, 10, 11,
14, 15, 20,
27–29
16–19, 21–
26, 30
Overall
Outcome
7, 10, 11,
14, 15, 20,
27–29
16–19, 21–
26, 30

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED IN PART