Ex Parte Simard

Patent Trial and Appeal Board

Jul 25, 2016

13437159 (P.T.A.B. Jul. 25, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/437, 159 04/02/2012
88684 7590 07/27/2016
XBiotech, Inc,
5425 Park Central Court
Suite 111
Naples, FL 34109
FIRST NAMED INVENTOR
John Simard
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
5407-0115 7932
EXAMINER
ALLEN, MARIANNE P
ART UNIT PAPER NUMBER
1647
NOTIFICATION DATE DELIVERY MODE
07/27/2016 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):
sakptomail@iplawpro.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOHN SIMARD
Appeal2014-005641
Application 13/437,159
Technology Center 1600
Before DONALD E. ADAMS, JOHN G. NEW, and RICHARD J. SMITH,
Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL 1
This appeal2 under 35 U.S.C. § 134(a) involves claims 1-8 (Ans. 3;
see Br. 5). Examiner entered rejections under 35 U.S.C. § 102(b), 35 U.S.C.
§ 103(a), and obviousness-type double patenting. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellant identifies the Real Party in Interest as "XBiotech, Inc." (Br. 3.)
2 This Appeal is related to Appeal 2014-000775 (Application 13/162,705),
Opinion affirming the rejections of record entered June 16, 2016 (see Ans.
3) and Appeal 2015-000554 (Application 13/644,976).
Appeal2014-005641
Application 13/437,159
STATEMENT OF THE CASE
Appellant's "invention relates to the use of antibodies (Abs) [that]
specifically bind interleukin- I a (IL-1 a) to reduce skin inflammation and to
treat inflammatory skin diseases including psoriasis vulgaris and acne
vulgaris" (Spec. ,-i 3). Claim 1 is representative and reproduced in the
Claims Appendix of Appellant's Brief.
Claims 1--4 and 8 stand rejected under 35 U.S.C. § 102(b) as
anticipated by Witte. 3
Claims 1-8 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Witte, Simard, 4 Mizutani, 5 and Skurkovich. 6
Claims 1-7 stand rejected under the judicially created doctrine of
obviousness-type double patenting as being unpatentable over claims 1-6 of
copending Application 13/644,976.
Claim Interpretation:
The method of Appellant's claim 1 comprises administering, to a
subject, a composition comprising: (1) a pharmaceutically acceptable carrier
and (2) an amount of an agent (e.g., an anti-IL-la antibody) that selectively
binds IL-1 a and is effective to reduce skin inflammation in the subject (see
Appellant's claim 1). Claims 2-8 depend directly or indirectly from claim 1.
3 Witte et al., US 2003/0026806 Al, published Feb. 6, 2003.
4 Simard, US 2009/0298096 Al, published Dec. 3, 2009.
5 Hitoshi Mizutani et al., Endogenous neutralizing anti-IL-la autoantibodies
in inflammatory skin diseases: possible natural inhibitor for over expressed
epidermal IL-1, 20 Journal of Dermatological Science 63-71 (1999).
6 Skurkovich et al., US 2005/0276807 Al, published Dec. 15, 2005.
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Appeal2014-005641
Application 13/437,159
Obviousness-type Double Patenting:
Appellant does not contest the provisional obviousness-type double
patenting rejection. (See Ans. 8.) We therefore summarily affirm this
rejection. See MANUAL OF PATENT EXAMINING PROCEDURE§ 1205.02 ("If a
ground of rejection stated by the examiner is not addressed in the appellant's
brief, that ground of rejection will be summarily sustained by the Board.").
Anticipation:
ISSUE
Does the preponderance of evidence on this record support
Examiner's finding that Witte teaches Appellant's claimed invention?
FACTUAL FINDINGS (FF)
FF 1. Witte "relates to antibodies ... , compositions, uses and methods for
treating ... IL-1 mediated disorders" (Witte ,-i 2; see Ans. 6).
FF 2. Witte defines a "selective binding agent" as preferably "an antibody,
such as ... monoclonal antibodies (mAbs )," "such as [an] IgG l" mAb, that
binds "IL-la or IL-lW' or both of IL-la and IL-lB (Witte ,-i,-i 38, 40, and 90;
see Ans. 6-7).
FF 3. Witte teaches that "IL-1 mediated diseases includes ... psoriasis"
(Witte ,-i,-i 178 and 212; see id. ,-i 2; Ans. 6-7).
FF 4. Witte's "compositions are suitable for injection or infusion into an
animal by any route available to the skilled worker, such as subcutaneous,
intravenous, intramuscular, intraperitoneal, intracerebral (intraparenchymal),
intracerebroventricular, intramuscular, intraocular, intraarterial, or
intralesional routes" (Witte ,-i 225; Ans. 6-7).
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Appeal2014-005641
Application 13/437,159
FF 5. Witte teaches compositions comprising a pharmaceutically
acceptable carrier (Witte ,-i 225; see id. ,-i,-i 220-241; Ans. 6-7).
FF 6. Appellant discloses that "[p ]referred doses range from about 0.1 to 5
... mg/kg body weight" (Spec. ,-i 31; see generally Ans. 7).
FF 7. Witte teaches that
it may be necessary for the caretaker to titer the dosage and
modify the route of administration as required to obtain the
optimal therapeutic effect. A typical dosage may range from
about 0.1 µg/kg to up to about 100 mg/kg or more, depending
on the factors mentioned above. In other embodiments, the
dosage may range from 1 µg/kg up to about 100 mg/kg; or 5
µg/kg up to about 100 mg/kg; or 0.1 µg/kg up to about 100
mg/kg; or 1 µg/kg up to about 100 mg/kg[.] Typically, a
clinician will administer the composition until a dosage is
reached that achieves the desired effect.
(Witte ,-i 241; see Ans. 6-7.)
ANALYSIS
Examiner finds that Witte anticipates Appellant's claimed invention
(Ans. 6-7; see FF 1-7). Claim 1 is representative. Appellant, however,
contends that Witte fails to provide an enabling disclosure of Appellant's
claimed invention (Br. 7-12). We are not persuaded for the reasons
provided by Examiner (Ans. 8-12; see FF 1-7).
CONCLUSION OF LAW
The preponderance of evidence on this record supports Examiner's
finding that Witte teaches Appellant's claimed invention. The rejection of
claim 1under35 U.S.C. § 102(b) as being anticipated by Witte is affirmed.
Claims 2--4 and 8 are not separately argued and fall with claim 1.
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Appeal2014-005641
Application 13/437,159
Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 8. Examiner finds that Witte "does not teach the MABpl monoclonal
antibody recited in instant claims 5-6 or specifically treating acne as recited
in instant claim 7" and relies on Simard, Mizutani, and Skurkovich to make
up for the foregoing deficiencies in Witte (Ans. 7).
ANALYSIS
The combination of Witte, Simard, Mizutani, and Skurkovich:
Based on the combination of Witte, Simard, Mizutani, and
Skurkovich, Examiner concludes that, at the time Appellant's invention was
made, it would have been prima facie obvious "to administer an anti-IL-1 a
antibody such as MABp 1 to treat an inflammatory skin condition such as
psoriasis or acne" (see Ans. 7-8). Claim 1 is representative.
Appellant contends, inter alia, that "[ n ]one of the[] four references describes
any actual experiments using an IL-1 alpha-binding agent to reduce skin
inflammation in a human subject evidencing that what effect such an agent
would have on such disorders was entirely unpredictable" (Br. 14). We are
not persuaded for the foregoing reasons. Further, having found Appellant's
claim 1 anticipated by Witte, we find that claim 1 is also obvious in view of
Witte. Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir.
1983) ("anticipation is the epitome of obviousness.").
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Appeal2014-005641
Application 13/437,159
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
The rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Witte, Simard, Mizutani, and Skurkovich is
affirmed. Claims 2-8 are not separately argued and fall with claim 1.
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. § l.136(a).
AFFIRMED
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