AMGEN K-A, INC

Patent Trials and Appeals Board

Dec 17, 2020

2020002001 (P.T.A.B. Dec. 17, 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.
15/513,132 03/21/2017 Hidemi NAKAGAWA MEDIM-36323.251 4706
72960 7590 12/17/2020
Casimir Jones, S.C.
2275 Deming Way Ste 310
Middleton, WI 53562
EXAMINER
LI, RUIXIANG
ART UNIT PAPER NUMBER
1646
NOTIFICATION DATE DELIVERY MODE
12/17/2020 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):
docketing@casimirjones.com
pto.correspondence@casimirjones.com
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte HIDEMI NAKAGAWA and HIROKI MATSUDO
____________

Appeal 2020-002001
Application 15/513,132
Technology Center 1600
____________

Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW,
Administrative Patent Judges.

KATZ, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 seeks our review,2 under 35 U.S.C. § 134(a), of the
Examiner’s decision to reject claims 15, 16, and 18–23 (Appeal Br. 1–2.)
We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM.

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 Amgen K-A,
Inc. (See Appeal Br. 1.)
2 We consider the Specification dated March 21, 2017 (“Spec.”), Final
Office Action issued February 25, 2019 (“Final Act.”), the Appeal Brief
filed October 14, 2019 (“Appeal Br.”), and the Examiner’s Answer issued
November 8, 2019 (“Ans.”).
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INTRODUCTION
Appellant’s Specification describes Interleukin (“IL”)-17RA as a type
I transmembrane receptor that binds with proinflammatory cytokines,
including IL-17A, IL-17F, and IL-17A/F. (Spec. ¶¶ 3, 5.) The Specification
explains that blocking Interleukin-17RA “represents a novel mechanism to
inhibit the inflammation and clinical symptoms associated with autoimmune
and inflammatory diseases including” psoriasis. (Id. ¶ 5.) The Specification
describes AM-14 as a specific monoclonal antibody that binds to human IL-
17RA and blocks the biological activities of IL-17A, IL17F, and IL17A/F
heterodimer. (Id. ¶ 6.)
The Specification further describes treating psoriasis patients who
have been previously treated or cannot be treated with anti-tumor necrosis
factor-alpha (“TNF-alpha”) antibodies. (Id. ¶ 31.) For example, the
Specification describes psoriasis patients who cannot be treated with an anti-
TNF-alpha antibody as patients who exhibit primary or secondary failure to
anti-TNF-alpha antibody treatment. (Id. ¶ 41.)
Appellant’s claim 15 recites:
A method for the treatment of pustular psoriasis or
psoriatic erythroderma, comprising
administering an anti-IL-17RA monoclonal antibody to a
psoriasis patient who has failed treatment with an anti-TNF-
alpha antibody,
wherein each of the CDR1, CDR2, and CDR3 of the
heavy chain variable region (VH) of the anti-IL-17RA
monoclonal antibody comprises the amino acid sequence of
SEQ ID NOs: 1, 2, and 3, respectively, and
each of the CDR1, CDR2, and CDR3 of the light chain
variable region (VL) of the anti-IL-17RA monoclonal antibody
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Application 15/513,132

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comprises the amino acid sequence of SEQ ID NOs: 4, 5, and 6,
respectively.
(Appeal Br. 9.)
ANALYSIS
The Examiner rejects claims 15, 16, and 18–233 under 35 U.S.C.
§ 103 as unpatentable over Guettner4 and Martin.5 (See Final Act. 3–5.)
Appellant does not argue for the separate patentability of any of the rejected
claims in the Appeal Brief. Accordingly, we focus on claim 15 in our
review. See 37 C.F.R. § 41.37(c)(1)(iv).
The Examiner finds Guettner teaches a method of treating a patient
with pustular psoriasis or psoriatic erythroderma by administering an IL-17
receptor antibody. (Final Act. 3, citing Guettner abstract, 3–4, 12, 14, 15.)
Guettner teaches that the patient “may be an anti-TNF alpha psoriasis
treatment non-responder, partial responder, . . . relapser or rebounder.”
(Guettner 60; see Final Act. 3.) The Examiner finds that Guettner does not
teach the specific anti-IL-17RA monoclonal antibody recited by claim 15,
comprising amino acid sequences of SEQ ID Nos: 1–6. (See Final Act. 3–
4.)
The Examiner finds that Martin teaches the monoclonal anti-IL-17RA
antibody of claim 15, comprising amino acid sequences of SEQ ID Nos: 1–
6. (See Final Act. 4, citing sequence alignment in Office Action issued
November 2, 2018.) The Examiner finds that Martin teaches administering

3 Claims 1–14 are withdrawn. Claims 17 and 24–34 are cancelled.
4 Guettner et al., WO 2012/045848 A1, published April 12, 2012 (referred to
as the ’848 PCT by Appellant).
5 Martin et al., WO 2011/046958 A1, published April 21, 2011 (referred to
as the ’958 PCT by Appellant).
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Application 15/513,132

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anti-IL-17RA antibodies to treat various diseases including pustular
psoriasis and erythrodermic psoriasis. (See Final Act. 4, citing Martin 99.)
The Examiner finds that it would have been obvious to administer Martin’s
anti-IL-17RA antibody to treat pustular psoriasis or psoriatic erythroderma
because Guettner teaches administering anti-IL-17 receptor antibodies to
treat the conditions in patient who have failed anti-TNF-alpha antibody
treatment. (See Final Act. 4.)
Appellant argues Guettner teaches treating psoriasis using anti-IL-17
monoclonal antibodies, e.g., secukinumab, rather than an anti-IL-17 receptor
antibody. (Appeal Br. 3.) Appellant argues that treating psoriasis with an
IL-17 binding antibody does not automatically suggest treating psoriasis
with an IL-17 receptor binding antibody. (Id.)
We are not persuaded by Appellant’s argument because Guettner
teaches administering an anti-IL-17 receptor antibody. For example,
Guettner teaches treating psoriasis by administering an IL-17 antagonist.
(Guettner 3:25–4:2.) Guettner teaches “examples of IL-17 antagonists
include IL-17 binding molecules and IL-17 receptor binding molecules.”
(Id. at 12:13–18.) Guettner teaches IL-17 receptor binding molecules
include “antibodies to the IL-17 receptor.” (Id. at 13:3–13.) Finally,
Guettner teaches administering a therapeutically effective amount of an IL-
17 antagonist, “e.g., an IL-17 receptor antibody.” (Id. at 20:3–6.) Although
Guettner teaches working examples of administering secukinumab to treat
psoriasis (see Examples 2 and 3), all disclosures of the prior art including the
unpreferred embodiments must be considered. See Merck & Co. v. Biocraft
Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989).
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Appellant further argues that the Examiner has not provided a reason
to combine and modify the prior art teachings to arrive at the claimed
invention. (Appeal Br. 4.) Appellant argues that the rejection takes the
position that “one of ordinary skill in the art could have carried out the
claimed method,” not that a person of ordinary skill in the art would have
had a reason to do so. (Id.)
We are not persuaded by Appellant’s argument because the Examiner
provides articulated reasoning with some rational underpinning to support
the legal conclusion of obviousness. (See Final Act. 4.) The Examiner finds
that a person of ordinary skill in the art would have been motivated to
administer Martin’s anti-IL-17RA monoclonal antibody, which is useful for
treating psoriasis, in Guettner’s method for treating psoriasis in patients who
have failed anti-TNF-alpha antibody treatment with an anti-IL-17 receptor
monoclonal antibody. (See id.) Combining Guettner’s treatment method
with Martin’s specific antibody is no more than the combination of familiar
elements according to known methods yielding predictable results. See KSR
Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007).
Finally, Appellant argues that the Examiner impermissibly engaged in
hindsight reconstruction of the claimed invention using Appellant’s
invention as a roadmap. (Appeal Br. 5.)
We are not persuaded by Appellant’s argument as the Examiner has
shown that the prior art: (1) teaches the claimed elements and limitations
and (2) provides a reason to combine the references with a reasonable
expectation of success in the combination. Accordingly, the Examiner’s
rejection properly takes into account only knowledge that was within the
level of ordinary skill at the time the claimed invention was made and does
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not include knowledge gleaned only from applicant’s disclosure. See In re
McLaughlin, 443 F.2d 1392, 1395 (CCPA 1971).
Appellant fails to present any argument persuading us that the
Examiner erred.
CONCLUSION
Upon consideration of the record and for the reasons given, we affirm
the Examiner’s rejection.
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
15, 16, 18–23 103 Guettner, Martin 15, 16, 18–23

No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136.

AFFIRMED