AMGEN K-A, INC

Patent Trials and Appeals Board

Dec 21, 2020

2020002264 (P.T.A.B. Dec. 21, 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.
15/129,811 09/27/2016 Ajay Nirula MEDIM-36256.254 9378
72960 7590 12/21/2020
Casimir Jones, S.C.
2275 Deming Way Ste 310
Middleton, WI 53562
EXAMINER
LI, RUIXIANG
ART UNIT PAPER NUMBER
1646
NOTIFICATION DATE DELIVERY MODE
12/21/2020 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 AJAY NIRULA, HIDEMI NAKAGAWA, KENJI OHTAKI,
HIROKI MATSUDO, PAUL KLEKOTKA, and GREGORY KRICORIAN
Appeal 2020-002264
Application 15/129,811
Technology Center 1600
Before JEFFREY N. FREDMAN, ULRIKE W. JENKS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
Appellant’s1 appeal under 35 U.S.C. § 134(a) involves claims to a
method of treating nail or scalp psoriasis, which have been rejected as
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We affirm.

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 Amgen K-A,
Inc. (Appeal Br. 1.)
Appeal 2020-002264
Application 15/129,811
2

STATEMENT OF THE CASE
Appellant’s Specification states: “Psoriasis is a chronic and
debilitating immune-related inflammatory disease that can involve the scalp
and nail beds.” (Spec. ¶ 3.) Additionally, Appellant’s Specification states:
“In some cases, nail or scalp psoriasis may be the only affected area and
these patients are unlikely to meet the requirements for systemic or biologic
therapies.” (Id.) Moreover, “[t]he systemic therapies may cause further hair
loss, and thereby exacerbate the hair loss associated with scalp psoriasis
itself,” and for nail psoriasis, “have undesirable systemic effects.” (Id. ¶¶ 4–
5.)
Furthermore, the topical treatments for “scalp psoriasis are difficult
and unpleasant to apply and as a result patient compliance and adherence to
treatment regimens is often reduced,” and for nail psoriasis “[d]ue to the
anatomical structure of the nail unit, it is generally difficult to achieve
sufficient concentrations of adsorptive treatment agents in the involved nail,
nail bed or matrix by topical administration.” (Id.)
Appellant’s invention provides a method of treating nail or scalp
psoriasis. (Id. ¶ 9.)
Claims 1, 5–6, 8–21, 26–30, and 62 are on appeal. Claim 1,
reproduced below, is representative of the claimed subject matter:
1. A method for treating nail or scalp psoriasis, comprising
administering to a patient in need thereof a composition
comprising an antibody or an antigen-binding fragment thereof
and a pharmaceutically acceptable carrier, wherein the antibody
or antigen-binding fragment thereof (i) specifically binds to IL-
17 Receptor A (IL-l 7RA) and inhibits binding of IL-17 A to IL-
l 7RA and (ii) comprises a light chain variable domain
Appeal 2020-002264
Application 15/129,811
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comprising the amino acid sequence of SEQ ID NO:7 and a
heavy chain variable domain comprising the amino acid
sequence of SEQ ID NO: 8; and wherein the patient has a Nail
Psoriasis Severity Index (NAPSI) score of at least 6 on one or
more nails and/or a Psoriasis Scalp Severity Index (PSSI) score
of at least 15.
REFERENCES
The prior art relied upon by the Examiner is:
Name Reference Date
Liu et al. WO 2011/088120 A1 July 21, 2011
K. Papp et al., Brodalumab, an Anti-Interleukin-17-Receptor Antibody for
Psoriasis, 366 (13) NEJM 1181–19, 2012

REJECTION
The following ground of rejection by the Examiner is before us on
review:
Claims 1, 5, 6, 8–21, 26–30, and 62 under 35 U.S.C. § 103(a) as
unpatentable over either Liu or Papp. (Non-Final Act. 3).

DISCUSSION
There is no dispute by Appellant that both Liu and Papp teach a
method of treating plaque psoriasis using an antibody that has the same CDR
amino acid sequences recited in the claims on appeal. (See Appeal Br. 3.)
That antibody, identified as AM-14, AMG 827, and brodalumab, specifically
binds to human IL-17RA (a human interleukin-17 receptor, that is a
common receptor subunit for IL-17A, IL-17F, and 17A/F heterodimer) and
inhibits the activation of IL-17RA through antagonizing the IL-17 pathway.
(See, e.g., Liu 4 (“AM-14 specifically binds to human IL-17RA and inhibits
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Application 15/129,811
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the biological activity of IL-17A . . . and/or the activation of IL-17RA”),
Papp 1182 (“Brodalumab (AMG 827) . . . antagonizes the interleukin-17
pathway . . . bind[ing] with high affinity to interleukin-17RA and block[ing]
the biological activity of interleukins 17A, 17F, 17A/F herterodimer.”).)
Papp explains that levels of interleukin-17 are elevated in the lesional
skin of patients with psoriasis, and correlate with disease severity. (Papp
1182.)
The Examiner explains that Liu teaches subcutaneous administration
in concentrations of 70, 140, 210, or 280 mg, and shows the effectiveness of
the antibody in treating plaque psoriasis in Examples 1–4. (Non-Final
Action 3; See Liu 206–207, 214–218.) The Examiner explains that Papp
describes the results of a phase II study using the antibody for treating
patients with moderate to severe plaques psoriasis, where the administration
of the antibody is subcutaneously of 70, 140, or 210 mg over several weeks
or at 280 mg monthly. (Id. at 4; See Papp 1182.) The Examiner recognizes
that neither Liu nor Papp explicitly teach treatment of nail or scalp psoriasis,
but concludes that such would have been obvious to do with a reasonable
expectation of success given that plaque psoriasis, which is taught to be
treated in Liu and Papp, “may appear in different parts of the skin” and
“scalp and nail psoriasis share the characteristic histopathological features of
plaque psoriasis.” (Ans. 6; see also Non-Final Action 4 (noting that Liu and
Papp “teach treatment of several types of psoriasis, plaque psoriasis, pustular
psoriasis and psoriatic erythroderma, which may appear in parts of the skin,
such as on the scalp and nail”).)
Appellant argues, however, that one of ordinary skill in the art would
not have expected the antibody taught in Liu and Papp “could be used
successfully to treat nail or scalp psoriasis based on [its] efficacy against
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Application 15/129,811
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psoriasis in general.” (Appeal Br. 4.) In particular, Appellant states that
“Papp clearly did not expect that [the antibody studied] alone would be able
to treat scalp psoriasis and continued to treat scalp psoriasis with a topical
therapy during the disclosed trial.” (Id.) Appellant also asserts that “[n]ail
and scalp psoriasis were known at the time the subject application was filed
to be distinctive subsets of psoriatic disease that historically have been
difficult to treat.” (Id.) Appellant also argues that “there was also
uncertainty in the art in 2016 as to whether antagonizing IL-17 signaling
could be used as a treatment for nail or scalp psoriasis.” (Id.)
We do not find Appellant’s arguments persuasive. “Obviousness does
not require absolute predictability of success. . . . For obviousness under
§ 103, all that is required is a reasonable expectation of success.” In re
O’Farrell, 853 F.2d 894, 903–04 (Fed. Cir. 1988).
The prior art Appellant points to regarding the difficulty of treating
scalp psoriasis, and even Appellant’s Specification, indicate that the
difficulty in treating scalp psoriasis relates to the “thick scale on the scalp,
which prevents deep penetration of topical medications into the dermis.”
(Armstrong2 S15.) We note however, that systemic treatments with biologic
agents have fared much better. (Id.) Appellant’s Specification notes that
often patients with scalp psoriasis “do not qualify for treatment with
biological agents [administered systemically]” because “the scalp qualifies
as a small percentage of body surface area.” (Spec. ¶ 4.) That, however,
does not establish that treatments other than topical administration would not
be expected to be able to treat nail and scalp psoriasis when such non-topical

2 A. Armstrong et al., Secukinumab in the Treatment of Palmoplantar, Nail,
Scalp, and Pustular Posriasis, 9:6 J. Clin. & Aesthetic Derm., Supp. 1, S12–
S16 (2016).
Appeal 2020-002264
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treatment has been shown to treat moderate to severe plaque psoriasis. In
short, the prior art does not provide any reason to doubt that the Papp and
Liu antibody, which is administered subcutaneously, not topically, would
not achieve a benefit in the treatment of nail and scalp psoriasis.
Appellant contends that Armstrong “questions whether secukinumab
would be effective in treating nail and scalp psoriasis” and thus supports
uncertainty “as to whether antagonizing IL-17 signaling could be used as a
treatment for nail or scalp psoriasis.” (Appeal Br. 4.) Like the Examiner
(Ans. 8–9), we disagree with Appellant’s interpretation. Armstrong teaches
that secukinumab, an antibody that blocks the IL-17A ligand, a “key
molecule in the T helper (Th) 17 pathway” not only was able to treat
moderate to severe psoriasis, but was likewise efficacious in the treatment of
palmoplantar (a phenotype that had “pose[d] a treatment challenge”), nail,
and pustular psoriasis, (S12, S14–15, S16–17). The results for the scalp
studies had not yet been reported. Nevertheless, Armstrong demonstrates
that antagonizing IL-17 signaling is a way to treat nail psoriasis and other
psoriasis that previously posed a treatment challenge, just as it could be used
in treating moderate to severe psoriasis.
As noted above, the antibody, identified as AM-14, AMG 827, and
brodalumab, specifically binds to human IL-17RA (a human interleukin-17
receptor) and inhibits the activation of IL-17RA through antagonizing the
IL-17 pathway and was effective to treat plaque psoriasis upon subcutaneous
injection. We find that Armstrong’s teaching of positive treatment in both
moderate to severe plaque psoriasis and in nail, palmoplantar, and pustular
psoriasis by antagonizing the IL-17 pathway supports a reasonable
expectation of success of using IL-17 pathway antagonist antibody of Papp
and Liu that successfully improved moderate to severe plaque psoriasis.
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Appellant also cites to Gudjonsson3, as evidence that “[n]ail and scalp
psoriasis were known at the time the subject application was filed to be
distinctive subsets of psoriatic disease that historically have been difficult to
treat.” (Id. at 4.) Although we agree with Appellant that nail and scalp
psoriasis are recognized as subsets of psoriatic disease, Gudjonsson does not
teach that nail and scalp psoriasis have a different disease mechanism than
plaque psoriasis. Nor does it address difficulty of treatment of these subsets
of psoriasis. Rather, Gudjonsson simply notes distinctions in the amount of
plaques on scalp and nail in psoriatic patients that are HLA-Cw6 positive or
HLA-Cw6 negative. (See, e.g., Gudjonsson Figs. 1–3.)
In short, neither Armstrong nor Gudjonsson provide any reason to
doubt that the antibody given subcutaneously that was established to work
well for moderate to severe psoriasis in Papp (and Liu) would not also
provide improvement in scalp psoriasis or nail psoriasis. Furthermore, that
Papp permitted use of topical treatments while also administering the
antibody subcutaneously does not provide any evidence supporting non-
obviousness of the claimed invention which simply requires that the
treatment method “compris[e]” administration of brodalumab. “The
transition ‘comprising’ in a method claim indicates that the claim is open-
ended and allows for additional steps.” Invitrogen Corp. v. Biocrest Mfg.,
L.P., 327 F.3d 1364, 1368 (Fed. Cir. 2003). Thus, Appellant’s claim does
not exclude additional concurrent or subsequent treatment, such as was done
in Papp. Indeed, dependent claims 19–21 include additional treatments as
part of the method, such as topical treatments. Moreover, Papp specifically

3 J. Gudjonsson et al., HLA-Cw6-Positive and HLA-Cw6-Negative Patients
with Psoriasis Vulgaris have Distinct Clinical Features, 118 J. Invest.
Derm., 362–365, 2002.
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attributes the benefit of the administered antibody as being the “block[ing
of] signaling of interleukins 17A, 17F, and the interleukin-17A/F
heterodimer, all of which play a role in the inflammation of psoriasis.”
(Papp 1187.) Appellant does not provide any persuasive evidence
establishing that those same interleukins are not also involved in nail and
scalp psoriasis. Consequently, one would have reasonably expected some
benefit to patients with scalp or nail psoriasis with the non-topical
administration of brodalumab.
We turn now to Appellant’s assertion of unexpected results. (Appeal
Br. 5–6.) According to Appellant, Examples 1–4 provided in the
Specification demonstrate impressive reductions and the dramatic
improvements were “unexpectedly reported for patients that were treated
with the antibody.” (Id.) This argument is unavailing. First, unexpected
results must be established by factual evidence. In re De Blauwe, 736 F.2d
699, 705 (Fed. Cir. 1984). Attorney argument unsupported by objective
evidence is not sufficient. In re Wood, 582 F.2d 638, 642 (CCPA 1978).
Appellant’s Specification does not report the results as being unexpected,
much less when compared to the evidence that the antibody was known to
treat moderate to severe plaque psoriasis. Rather, Appellant’s Specification
simply notes that the scores were greatly reduced in subjects compared to
the placebo group (see Spec. ¶¶ 158, 159), or the degree of severity was
“greatly improved.” “To be particularly probative, evidence of unexpected
results must establish that there is a difference between the results obtained
and those of the closest prior art, and that the difference would not have been
expected by one of ordinary skill in the art at the time of the invention.”
Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d 967, 977
Appeal 2020-002264
Application 15/129,811
9
(Fed. Cir. 2014). Appellant’s argument that the reported results were
unexpected is not supported with factual evidence.
For the foregoing reasons, we affirm the Examiner’s rejection of
claims 5–6, 8–21, 26–30, and 62 as being obvious over Liu or Papp.
DECISION SUMMARY
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1, 5, 6, 8–
21, 26–30,
62
103(a) Liu, Papp 1, 5, 6, 8–
21, 26–30,
62

TIME PERIOD FOR 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