MEDIMMUNE, LLC

Patent Trials and Appeals Board

Sep 20, 2021

2020006272 (P.T.A.B. Sep. 20, 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.
15/023,858 03/22/2016 Partha S. Chowdhury 12638-079-999 7008
20583 7590 09/20/2021
Jones Day
250 Vesey Street
New York, NY 10281-1047
EXAMINER
ALLEN, MICHAEL D
ART UNIT PAPER NUMBER
1642
NOTIFICATION DATE DELIVERY MODE
09/20/2021 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):
japarker@jonesday.com
ncgeorge@jonesday.com
wtokmakidis@jonesday.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte PARTHA S. CHOWDHURY, DAVID TICE,
ZHAN XIAO, PHILIPP STEINER, KRISTA KINNEER,
MARLON REBELATTO, and ANDREW PIERCE

Appeal 2020-006272
Application 15/023,8581
Technology Center 1600
____________

Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS, and
TAWEN CHANG, Administrative Patent Judges.

LEBOVITZ, Administrative Patent Judge.

DECISION ON APPEAL
The Examiner rejected the claims under 35 U.S.C. § 112(a) for lack of
enablement, under 35 U.S.C. § 102(a)(1) as anticipated, under 35 U.S.C.
§ 103 as obvious, as containing an improper Markush grouping, and under
nonstatutory obviousness-type double-patenting. Pursuant to 35 U.S.C.
§ 134(a), Appellant2 appeals from the Examiner’s decision to reject the
claims. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 “The ’858 application.”
2 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 MedImmune
LLC. Appeal Br. 3.
Appeal 2020-006272
Application 15/023,858

2
STATEMENT OF THE CASE
The Examiner rejected claims 1, 13, 14, 59, 61, 90–92, 94–96, 99,
102, and 103 in the Final Office Action (“Final Act.”) as follows:
1. Claims 1, 13, 14, 59, 61, 102, and 103 under 35 U.S.C. § 112(a) for
lack of enablement. Final Act. 4.
2. Claims 1, 13, 14, 102, and 103 under 35 U.S.C. § 102(a)(1) as
anticipated by Chowdhury (WO 2013/078191 A1, published May 30, 2013)
(“Chowdhury”). Final Act. 19.
3. Claims 1, 13, 14, 59, 61, 102, and 103 under 35 U.S.C. § 103 as
obvious in view of Garcia et al. (WO 2012/125864 A2, published Sept. 20,
2012 having priority to Mar. 15, 2011) (“Garcia”) and Chowdhury ’191.
Final Act. 20.
4. Claims 1, 13, 14, 59, 61, 102, and 103 under “the judicially-created
basis that they contain an improper Markush grouping of alternatives.” Final
Act. 21.
5. Claims 1, 13, 14, 59, 61, 90–92, 94–96, 99, 102, and 103 on the
ground of nonstatutory obvious-type double patenting over claims 1–39 of
U.S. Patent No. 9,220,775 B2 (issued Dec. 29, 2015) (“the ’775 patent”) in
view of Garcia and Chowdhury ’191. Final Act. 24.
6. Claims 1, 13, 14, 59, 61, 90–92, 94–96, 99, 102, and 103 on the
ground of nonstatutory obvious-type double patenting over claims 1–56 of
U.S. Patent No. 10,040,857 B2 (issued Aug. 7, 2018) (“the ’857 patent”) in
view of Garcia and Chowdhury ’191. Final Act. 24–25.
Appeal 2020-006272
Application 15/023,858

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Claim 1, the only independent claim on appeal, is reproduced below:

1. A method of resensitizing a HER3-expressing tumor
characterized by unregulated cell growth or HER3-expressing
tumor cell characterized by unregulated cell growth in a subject
to a HER targeted therapy, comprising a) administering to the
subject a therapeutically effective amount of an antibody or
antigen binding fragment thereof which specifically binds to an
epitope within the extracellular domain of HER3, wherein the
tumor or tumor cell had previously acquired resistance to the
HER targeted therapy following treatment with the HER
targeted therapy, wherein the HER targeted therapy is an EGFR
targeted therapy, and wherein the antibody or antigen binding
fragment thereof is a monoclonal antibody or antigen binding
fragment thereof that comprises

(A) an antibody VL, wherein the VL comprises the amino acid
sequence:
[FW1] X1GSX2SNIGLNYVS (SEQ ID NO:49) [FW2]
RNNQRPS(SEQ ID NO: 50) [FW3]
AAWDDX3X4X5GEX6 (SEQ ID NO: 51) [FW4]
wherein [FW1], [FW2], [FW3] and [FW4] represent VL
framework regions, and wherein
(a) X1 represents amino acid residues Arginine (R) or
Serine (S),
(b) X2 represents amino acid residues Serine (S) or
Leucine (L),
(c) X3 represents amino acid residues Serine (S) or
Glycine (G),
(d) X4 represents amino acid residues Leucine (L) or
Praline (P),
(e) X5 represents amino acid residues Arginine (R),
Isoleucine (I), Praline (P) or
Serine (S), and
(f) X6 represents amino acid residues Valine (V) or
Alanine (A), and

(B) an antibody VH, wherein the VH comprises the amino acid
sequence:
Appeal 2020-006272
Application 15/023,858

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[FW5] YYYMQ (SEQ ID NO: 52) [FW6]
X7IGSSGGVTNYADSVKG (SEQ ID NO: 53) [FW7]
VGLGDAFDI (SEQ ID NO: 54) [FW8] wherein [FW5], [FW6],
[FW7] and [FW8] represent VH framework regions, and
wherein X7 represents amino acid residues
Tyrosine (Y), Isoleucine (I) or Valine (V); and

b) simultaneously administering to the subject a therapeutically
effective amount of the HER targeted therapy.

CLAIM 1
Claim 1 is directed to a method of “resensitizing a HER3-expressing
tumor characterized by unregulated cell growth or HER3-expressing tumor
cell characterized by unregulated cell growth.” HER3 is the human
epidermal growth factor (“EGFR”) 3, which is a receptor protein tyrosine
kinase (“RTK”) and among a group of “well-established oncogenic RTKs
driving the tumorigenesis of multiple types of solid tumors, including major
categories such as breast, colorectal, and lung cancers.” Spec. ¶ 4. The claim
requires that the tumor expresses HER3. The method also requires that the
HER3-expressing tumor “had previously acquired resistance to the HER
targeted therapy” which is recited in the claim to be EGFR targeted therapy.
In step a) of the claim, “a therapeutically effective amount of an
antibody or antigen binding fragment thereof which specifically binds to an
epitope within the extracellular domain of HER3” is administered to a
subject. The antibody or antigen binding fragment of the antibody is a
monoclonal antibody or antigen binding fragment of the monoclonal
antibody. It comprises (A) an antibody variable light chain (“VL”) and (B)
an antibody variable heavy chain (“VH”), each with a specific sequence.
The variable light and heavy chains pair and dimerize to form the
antigen binding site of the antibody. Each of the VL and HL are recited in
Appeal 2020-006272
Application 15/023,858

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the claim to have four framework regions (“FW”) (numbered 1–4 for VL
and 5–8 for VH) and three complementarity determining regions (“CDRs”)
(SEQ ID NOS 49–51 for VL and SEQ ID NOS 52–54 for VH).
In step b) of the claim, a therapeutically effective amount of the HER
targeted therapy is simultaneously administered to the subject.
In sum, a monoclonal antibody, or fragment of it, comprising VL and
VH chains (each chain comprising 3 CDRs of a specific sequence for the
complete set of 6 CDRs, and each chain comprising 4 framework regions),
is administered to a subject having a HER3-expressing tumor, who is
simultaneously being administered EGFR/HER targeted therapy. The
purpose of administering both therapies is to resensitize the subject’s HER3-
expressing tumor to the EGFR/HER targeted therapy.

ENABLEMENT REJECTION
The Examiner rejected the claims under § 112(a) for lack of
enablement. The Examiner explained the basis for the rejection:
because the specification, while being enabling for methods of
resensitizing a Her3+ tumor characterized by uncontrolled cell
growth, wherein the tumor has previously acquired resistance to
a Her targeted therapy, via administration of said Her targeted
therapy simultaneously with an anti-Her3 antibody that
comprises a complete set of parental CDRs, does not
reasonably provide enablement for similar methods targeting
cancers that do not express Her3, treating patients with anti-
Her3 antibodies and other Her targeted therapy at intervals such
that the two agents are not simultaneously present, or methods
using any antibody with fewer than all parental CDRs or with
any mutated CDRs, wherein the mutant antibody has not been
tested to bind antigen.
Ans. 3; see also Final Act. 4–5.
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Application 15/023,858

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The Examiner also referred to the lack of enablement for claim “1iii”
of a “polyclonal antibody defined by two antibodies.” Ans. 9.
As indicated above, the Examiner found the claims to not be enabled
for: 1) tumors that do not express HER3; 2) antibodies lacking a complete
set of parental CDRs; 3) the circumstance where the anti-HER3 antibody
and HER target therapy are not administered simultaneously; and 4) a
polyclonal antibody defined by two antibodies. However, independent
claim 1, as explained above, requires: 1) the tumor to express HER3, 2) the
antibody to comprise the complete set of 6 CDRs, 3) simultaneous
administration of the anti-HER3 antibody and the EGFR/HER therapy, and
4) the antibody to be a monoclonal antibody or fragment of it.
The Examiner’s rejection appears to be based on the version of claim
1 pending on December 8, 2017, which had parts i), ii), and iii). The
Examiner made an enablement rejection of that claim on January 24, 2018,
which appears to be substantially the same rejection repeated in the Final
Action of October 9, 2019 and in the Answer. But that claim was amended
on April 23, 2018 and January 15, 2019. The Examiner apparently has not
updated the rejection to reflect the subject matter claimed in the amended
claims. Indeed, the Examiner states in the most recent Final Action and
Answer that the claims are enabled “for methods of resensitizing a Her3+
tumor characterized by uncontrolled cell growth, wherein the tumor has
previously acquired resistance to a Her targeted therapy, via administration
of said Her targeted therapy simultaneously with an anti-Her3 antibody that
comprises a complete set of parental CDRs,” which is the same scope of the
amended claim 1 now on appeal. See Ans. 3; Final Act. 4–5.
Appeal 2020-006272
Application 15/023,858

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The enablement rejection, as it now stands, does not address the
current scope of the claims. Instead, it is based on a claim pending on
December 8, 2017 which was subsequently amended by Appellant. For this
reason, we are compelled to reverse the enablement rejection under
35 U.S.C. § 112(a).

ANTICIPATION AND OBVIOUSNESS REJECTIONS
The anticipation and obviousness rejections both cite Chowdhury
’191, an international application published May 30, 2013. Chowdhury ’191
was published less than one year before the filing dates of the priority
provisional applications, 61/887,181 and 61/881,805, on which the ’858
application involved in this appeal is based, namely, October 4, 2013 and
September 24, 2013, respectively. Final Act. 19–20.
The inventors of Chowdhury ’191 are 1) Partha S. Chowdhury, 2)
David Tice, 3) Zhan Xiao, 4) Philipp Steiner, 5) Krista Kinneer, and 6)
Marlon Rebelatto.
The listed inventors of Provisional Application 61/887,181, filed
October 4, 2013, Provisional Application 61/881,805, filed September 24,
2013, and the instant application claiming benefit of the two provisional
applications, are each the same six inventors of Chowdhury ’191 plus
Andrew Pierce. Under 35 U.S.C. § 102(b)(1)(A):
A disclosure made 1 year or less before the effective filing date
of a claimed invention shall not be prior art to the claimed
invention under subsection (a)(1) if —
(A) the disclosure was made by the inventor or joint
inventor . . . .
In this case, the inventors of Chowdhury ’191 are the same as those
listed for the ’858 application. The one additional inventor of the ’858
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Application 15/023,858

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application does not change the fact that the disclosure in Chowdhury ’191
“was made by the inventor or joint inventor” of the ’858 application because
all the inventors of Chowdhury ’191 are the inventors of the ’858
application. Thus, under 35 U.S.C. § 102(b)(1)(A), Chowdhury ’191 is not
prior art to the ’858 application and the rejections under §§ 102(a)(1) and
103 are improper.
The Examiner did not dispute that the inventors are the same, but
maintained the rejections because “priority is not awarded to the claims
above due to lack of enablement.” Final Act. 20. However, as explained
above the enablement rejection is reversed. In addition, the Examiner erred
in making the priority determination because the Examiner did not consider
the scope of the amended claim on appeal, but instead based the
determination on claim 1 pending on December 8, 2017 which had parts i),
ii), and iii). Final Act. 2–4.
For the aforementioned reasons, the rejections under 35 U.S.C.
§§ 102(a)(1) and 103 are reversed.

MARKUSH GROUPING
The Examiner rejected the claims on “the judicially-created basis that
they contain an improper Markush grouping of alternatives.” Final Act. 21;
Ans. 17. The Examiner states that the improper Markush grouping “includes
species of the claimed invention that do not share both a substantial
structural feature and a common use that flows from the substantial
structural feature.” Ans. 17. The Examiner further explained:
In the instant case, the antibodies of claim 1 i-iii, on
which many other claims above depend, are recited in the
alternative, 2C2 or CL16 or via formula (encompassing 384
variants). However, as discussed above in the scope of
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Application 15/023,858

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enablement rejection, the structural feature of antibodies that
provides their function is their full set of CDRs. Not all of
CL16, 2C2, or the antibodies of the formula of claim 1iii
contain the same set of six CDRs. Therefore, they do not all
share a structural feature that provides their function/use. Thus,
claims that recite any of said antibodies in the alternative
contain an improper Markush group and are rejected here.
Ans. 18.
Claim 1, as listed in the Claim Appendix, does not have parts i, ii, and
iii. Claim 1 also recites the full set of CDRs. The Examiner is not addressing
the currently pending claim as it had been amended during prosecution. For
this reason, we are compelled to reverse the rejection based on improper
Markush grouping.

OBVIOUSNESS-TYPE DOUBLE-PATENTING REJECTIONS
Appellant did not provide any arguments with respect to the
obviousness-type double-patenting rejections, but instead stated: “Without
acquiescing to the propriety of the rejections, Appellant requests that the
double patenting rejections be held in abeyance during this appeal.” Appeal
Br. 19. Because no substantive arguments are provided, we summarily
affirm the obviousness-type double-patenting rejections for the reasons set
forth by the Examiner. Final Act. 23–25; Ans. 19–21.

Appeal 2020-006272
Application 15/023,858

10

CONCLUSION
In summary:
Claim(s)
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 13, 14,
59, 61, 102,
103
112 Enablement 1, 13, 14,
59, 61, 102,
103
1, 13, 14,
102, 103
102(a)(1) Chowdhury ’191 1, 13, 14,
102, 103
1, 13, 14,
59, 61, 102,
103
103 Chowdhury ’191,
Garcia
1, 13, 14,
59, 61, 102,
103
1, 13, 14,
59, 61, 102,
103
Improper Markush
Group
1, 13, 14,
59, 61, 102,
103
1, 13, 14,
59, 61, 90–
92, 94–96,
99, 102, 103
Nonstatutory
Double Patenting
US 9,220,775 B2,
Chowdhury ’191,
Garcia
1, 13, 14,
59, 61, 90–
92, 94–96,
99, 102, 103

1, 13, 14,
59, 61, 90–
92, 94–96,
99, 102, 103
Nonstatutory
Double Patenting
US 10,040,857 B2,
Chowdhury ’191,
Garcia
1, 13, 14,
59, 61, 90–
92, 94–96,
99, 102, 103

Overall
Outcome
1, 13, 14,
59, 61, 90–
92, 94–96,
99, 102, 103

TIME PERIOD
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED