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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)

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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 describesInterleukin (“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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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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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