Xencor, Inc.

Patent Trials and Appeals Board

Apr 1, 2020

14200652 - (D) (P.T.A.B. Apr. 1, 2020)

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.
14/200,652 03/07/2014 Gregory Moore 067461-5165-US 7883
67374 7590 04/01/2020
MORGAN, LEWIS & BOCKIUS LLP (SP)
ONE MARKET, SPEAR STREET TOWER, SUITE 2800
SAN FRANCISCO, CA 94105
EXAMINER
WU, JULIE ZHEN QIN
ART UNIT PAPER NUMBER
1642
NOTIFICATION DATE DELIVERY MODE
04/01/2020 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):
DONALD.MIXON@MORGANLEWIS.COM
SFIPDOCKETING@MORGANLEWIS.COM
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte GREGORY MOORE, MATTHEW BERNETT,
RUMANA RASHID, and JOHN DESJARLAIS

Appeal 2019-004191
Application 14/200,652
Technology Center 1600
Before FRANCISCO C. PRATS, TAWEN CHANG, and DAVID COTTA,
Administrative Patent Judges.
CHANG, Administrative Patent Judge.
DECISION ON APPEAL
Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 48–65. We have jurisdiction under
35 U.S.C. § 6(b).
We REVERSE.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the real party in interest as Xencor,
Incorporated. Appeal Br. 4.
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Application 14/200,652

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BACKGROUND
The Specification states that “[o]ne avenue being explored [to
improve antibody-based therapeutics] is the engineering of additional and
novel antigen binding sites into antibody-based drugs such that a single
immunoglobulin molecule co-engages two different antigens.” Spec. ¶ 2.
The Specification states that such molecules are often referred to as
bispecifics. Id.
According to the Specification, CD3, which activates T cells, is an
“antigen[] that [is] attractive as [a] co-target[] in a therapeutic bispecific
format.” Spec. ¶ 5. Further according to the Specification, “[t]here are a
number of multispecific antibody or antibody-fragment formats that are in
development, relying on one binding site binding to CD3,” and “[t]he
present invention provides a number of optimized anti-CD3 variable
sequences that can be used in bispecific formats.” Id. ¶ 6.
CLAIMED SUBJECT MATTER
The claims are directed to a composition comprising an anti-CD3
binding domain. Claim 48 is illustrative:
48. A composition comprising an anti-CD3 binding domain,
said anti-CD3 binding domain comprising:
a) a variable heavy chain comprising a vhCDR1 having
the amino acid sequence of SEQ ID NO:[]411; a vhCDR2
having the amino acid sequence of SEQ ID NO: 413; and a
vhCDR3 having the amino acid sequence of SEQ ID NO: 417;
and
b) a variable light chain comprising a vlCDR1 having the
amino acid sequence of SEQ ID NO: 420; a vlCDR2 having the
amino acid sequence of SEQ ID NO: 425; and a[]vlCDR3
having the amino acid sequence of SEQ ID NO: 433.
Appeal Br. 38 (Claims App. A).

Appeal 2019-004191
Application 14/200,652

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REJECTION(S)
A. Claims 48–65 are provisionally rejected on the ground of
obviousness-type nonstatutory double patenting as being unpatentable
over claims 58, 76–79, and 81–86 of copending Application No.
14/216,705. Ans. 3.
B. Claims 48–65 are rejected on the ground of obviousness-type
nonstatutory double patenting as being unpatentable over claims 1–16
of U.S. Patent No. 9822186B2. Ans. 7.

OPINION
A. Issue
The Examiner has provisionally rejected the claims on appeal on the
ground of obviousness-type nonstatutory double patenting over claims 58,
76–79, and 81–86 of the ’705 Application, and also rejected these claims on
the ground of obviousness-type nonstatutory double patenting over claims
1–16 of the ’186 patent. The same issues are dispositive to both rejections;
we therefore discuss them together.
1. Basis for the rejections
The Examiner finds that the claims on appeal are directed to a
composition comprising an anti-CD3 binding domain comprising a variable
heavy chain and a variable light chain, each comprising particular specified
amino acid sequences (SEQ ID Nos: 411, 413, 417 and SEQ ID Nos.: 420,
425, and 433, respectively). Ans. 3–4.
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Application 14/200,652

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a) The ’705 application
The Examiner finds that the claims of the ’705 application are
directed to a composition comprising a heterodimeric Fc domain,2 a
heterodimeric protein, or a “triple F”3 format heterodimeric antibody, each
of which comprises a first and second variant Fc domain comprising certain
amino acid substitutions (S364K/E357Q and L368D/K370S, respectively).
Ans. 4.
The Examiner finds that the Specification and figures of the ’705
application teach that the heterodimeric Fc domain, protein, and antibody of
the application comprise an anti-CD3 scFv, and further discloses numerous
anti-CD3 scFv, including those comprising the amino acid sequences recited
in the claims on appeal. Ans. 5–6. Accordingly, the Examiner concludes
that “the claimed compositions . . . of the copending [’705] application
include . . . heterodimeric antibody comprising a CD3-binding scFv
comprising CDR sequences that are identical to the anti-CD3 binding

2 We understand Fc to refer to the “fragment crystallizable” region of an
antibody.
3 Figure 1B of the ’705 application is reproduced below:

Figure 1B depicts an antibody having the “triple F” (scFv-Fab-Fc), or the
“bottle-opener,” configuration. ’705 application ¶ 21. We understand scFv
and Fab to refer to, respectively, “single chain Fv region” and “antigen
binding fragment,” where Fv further refers to the antibody variable region.

Appeal 2019-004191
Application 14/200,652

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domain CDR sequences that are recited by the instant claims.”4 Id. The
Examiner further concludes that “the claims at issue . . . are not patentably
distinct from each other because claims . . . of the copending Application
No. 14/216,705 . . . are directed to species of the instant claims: the
copending application discloses [that] the copending claims include products
comprising the scFv construct recited by the instant claims.” Id. at 6.
b) The ’186 patent
The Examiner finds that the claims of the ’186 patent are directed to
“heterodimeric antibodies comprising a scFv region that binds to CD3.”
Ans. 7. The Examiner finds that, “[a]lthough the claims of the ’186 [patent]
did not explicitly recite specific anti-CD3 scFv binding domain sequences
for the patented heterodimeric antibody, the issued patent disclosed
numerous anti-CD3 scFv binding domains” comprising the CDR sequences
recited in the claims on appeal. Id. at 8. Accordingly, the Examiner
concludes that, “even though the instant claims recite specificities not
explicitly recited by the claims of the ’186 patent, species of the instant
claims encompassed by the claims of the reference application are disclosed
in the specification of the ’186 patent, and thus the instant claims are not
patently distinct from the claims of the reference application.” Id. at 9.
2. Appellant’s contentions
Appellant contends that “whether the alleged claims of a reference
patent ‘encompass’ the present claims is not the standard for determining
obviousness-type double patenting” and that the Examiner impermissibly

4 We understand “CDR” to refer to “complentarity-determining region.”
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Application 14/200,652

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relied on the disclosures of the ’705 application and the ’186 patent as prior
art. Appeal Br. 26–28, 33–34.
The issue with respect to these rejections is whether the Examiner’s
reliance on the disclosures of the ’705 application and/or the ’186 patent in
making the rejections is a permissible use of the disclosures to learn the
meaning of terms and interpret the coverage of the reference claims or an
impermissible use of the disclosures as prior art.
B. Analysis
The predecessor of our reviewing court has explained that, in
considering whether a claim in an application is unpatentable on the basis of
obviousness-type double patenting, “the [reference] patent disclosure may
not be used as prior art.” In re Vogel, 422 F.2d 438, 441 (CCPA 1970). The
Court further explained that
[t]his does not mean that the disclosure may not be used at all.
. . . [I]n certain instances it may be used as a dictionary to learn
the meaning of terms in a claim. It may also be used as
required to answer the . . . question [of whether any claim in the
application defines merely an obvious variation of the invention
disclosed and claimed in the patent.] The disclosure . . . sets
forth at least one tangible embodiment within the claim, and it
is less difficult and more meaningful to judge whether that
thing has been modified in an obvious manner. It must be
noted that this use of the disclosure is not in contravention of
the cases forbidding its use as prior art, nor is it applying the
patent as a reference under 35 U.S.C. § 103, since only the
disclosure of the invention claimed in the patent may be
examined.
Id. at 441–442.
In this case, the claims on appeal all require an anti-CD3 binding
domain comprising a variable heavy chain and a variable light chain, each
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Application 14/200,652

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comprising certain recited amino acid sequence(s). Appeal Br. 38 (Claims
App. A.)
The Examiner has not pointed to any claim of the ’705 application or
the ’186 patent that comprises the recited amino acid sequence(s), but relies
instead on the specifications of the reference application or patent to suggest
these missing elements. As discussed in greater detail below in the context
of each cited reference application and patent, we find that each of the
rejections improperly relies on the specification of the reference patent or
application as prior art in concluding that the claims on appeal are an
obvious variant of the reference claims,5 rather than merely using the
reference specifications to construe the reference claims and determine their
coverage. Accordingly, we agree with Appellant that the Examiner has not
adequately explained how the claims on appeal define an obvious variant of
the cited claims of the’705 application and the ’186 patent.
1. The ’705 Application
The reference claims of the ’705 Application are directed to
heterodimeric Fc domain, protein, antibody, and/or compositions comprising
them, wherein the Fc domain comprises certain amino acid substitutions.
Appeal Br. 41–43 (Claims App. B).
The Examiner does not explain, except by relying on the ’705
application’s specification, why an anti-CD3 binding domain comprising a
variable heavy chain and a variable light chain, each comprising certain
recited amino acid sequence(s), is not patentably distinct from a

5 The Examiner has not suggested that the cited reference applications and
patents otherwise qualify as prior art.
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heterodimeric Fc domain, protein, or antibody having certain amino acid
substitutions in the Fc domain. In particular, the Examiner asserts that
Figures 36 and 37 of the ’705 application illustrate that the heterodimeric Fc
domain, protein, and “triple F” antibody of the ’705 application “comprise
an anti-CD3 scFv” and that the specification of the ’705 application
discloses “numerous anti-CD3 scFv,” including those comprising amino acid
sequences recited in the claims on appeal. Ans. 5.
The Examiner asserts, therefore, that “the claimed composition . . . of
the copending application include those heterodimeric antibody comprising
a CD3-binding scFv comprising CDR sequences that are identical to the
anti-CD3 binding domain CDR sequences that are recited by the instant
claims.” Ans. 5–6. Citing In re Basell Poliolefine Italia S.P.A., 547 F.3d
1371 (Fed. Cir. 2008), the Examiner asserts that the rejection’s reliance on
the specification of the ’705 application is proper because the specification
“may be used to learn the meaning of terms and interpreting the coverage of
a claim.” Id. at 8 (internal quotation marks omitted).
We are not persuaded. Although claim 81 and the dependent claims
of the ’705 application recite an scFv comprising a variable heavy chain, a
variable light chain, and a scFv linker covalently attaching the two,6 similar
to, e.g., instant claim 51, none of the reference claims recite an anti-CD3
binding domain, much less one comprising specific amino acid sequences.

6 The other claims of the ’705 application recite a heterodimeric protein Fc
domain or a heterodimeric protein, Appeal Br. 41–43 (Claims App. B),
which would appear to be less similar to the anti-CD binding domains
recited in the instant claims.
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We do not read Basell Poliolefine as suggesting that a claim to a
species (e.g., anti-CD3 binding domain comprising specific amino acid
sequences) is not patentably distinct from a reference claim to a genus (e.g.,
a generic scFv) simply because the reference specification discloses the
species. Rather, the Basell Poliolefine court found that the claims on appeal
and reference claims all, in essence, “consist of various permutations of
polymerization of olefins with various numbers of carbon atoms using
catalysts of titanium halides and aluminum alkyls,” even if “some
expressions are generic to others.” Basell Poliofine, 547 F.3d at 1378.
Indeed, the court acknowledged that “a generic expression does not
render obvious all of the species that it encompasses,” but emphasized that
the claims at issue in Basell Poliofine “are both generic and specific to each
other in interchangeable ways, involving the same groups of species.” Id.
In contrast, the claims on appeal here recite at most a species (an antibody
comprising an anti-CD3 binding domain comprising specific amino acid
sequences) within the broad genus recited in the reference claims (an
antibody comprising an scFv).
Finally, we acknowledge that the Basell Poliofine court cites to the
fact that the reference patent specification refers to specific olefins, as an
indication that “those olefins were intended to fall within the meaning of the
[reference] claims” and as support for the conclusion that the claims on
appeal are invalid for obviousness-type double patenting. Basell Poliofine,
547 F.3d at 1378. We note, however, that ethylene, propylene, butane, etc.
were known in the art, whereas in this case the Examiner has provided no
evidence that a skilled artisan would have had knowledge of the sequences
recited in the claims on appeal, absent the disclosure in the reference
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Application 14/200,652

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specification. On the record before us, therefore, the Examiner’s reliance on
the disclosure in the reference specification to render the claims on appeal
obvious is an impermissible use of the reference specification as prior art,
rather than a permissible use of the specification as an aid to interpret the
coverage of the reference claim.
2. The ’186 Patent
Claim 1 of the ’186 patent, the only independent claim of the patent,
recites a heterodimeric antibody comprising, among other things, a first
heavy chain comprising an scFv that binds CD3. Appeal Br. 45 (Claims
App. C). However, the claims of the ’186 patent do not appear to require the
particular sequences recited in the claims on appeal.7
The Examiner does not explain, except by relying on the ’186 patent
specification, why an antibody comprising an anti-CD3 binding domain that
comprises a variable heavy chain and a variable light chain comprising
particular recited sequences is not patentably distinct from an antibody
comprising a generic CD3-binding scFv. In particular, the Examiner asserts
that, “[a]lthough the claims of ’186 did not explicit recite specific anti-CD3
scFv binding domain sequences for the patented heterodimeric antibody,”
the patent specification discloses numerous anti-CD3 scFv binding domains,
including domains that comprise the amino acid sequences recited in the
instant claims. Ans. 8. The Examiner asserts, therefore, that “the patented

7 We note that dependent claims 7–16 of the ’186 patent also further recite a
first heavy chain comprising either the Fc domain of SEQ ID NO:520 or
amino acids 255–485 of SEQ ID NO:520. While SEQ ID NO: 520
comprises amino acid sequences identical to those recited in the claims on
appeal, the claimed amino acid sequences do not fall within the Fc domain
or amino acids 255–485 of SEQ ID No:520.
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heterodimeric antibodies of [the ’186 patent] include the heterodimeric
antibody comprising a CD3-binding scFv comprising the CDR sequences
that are identical to the anti-CD3 binding domain CDR sequences as recited
by the instant claims.” Id. Citing Basell Poliolefine, the Examiner asserts
that the rejection’s reliance on the specification of the ’705 application is
proper because the specification “may be used to learn the meaning of terms
and interpreting the coverage of a claim.” Id. (internal quotation marks
omitted).
For the same reasons discussed above with respect to the double
patenting rejection over claims of the ’705 application, we find the
Examiner’s reliance on the disclosures in the ’186 patent to be an
impermissible use of the reference disclosures as prior art, rather than a
permissible use of the disclosures as an aid to interpret the coverage of the
reference claim.

CONCLUSION
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
48–65 Obviousness-type
Double Patenting:
’705 application
48–65
48–65 Obviousness-type
Double Patenting:
’186 patent
48–65
Overall
Outcome
48–65

REVERSED