Ex Parte Simard

Patent Trial and Appeal Board

Jul 20, 2016

13644976 (P.T.A.B. Jul. 20, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/644,976 10/04/2012
88684 7590 07/22/2016
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.
5407-0128 1043
EXAMINER
ALLEN, MARIANNE P
ART UNIT PAPER NUMBER
1647
NOTIFICATION DATE DELIVERY MODE
07/22/2016 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
Appeal2015-000554
Application 13/644,976
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, 3-6, and 14-
16 (Ans. 3; see Br. 5). Examiner entered rejections under 35 U.S.C. § 112,
second paragraph, the written description provision of 35 U.S.C. § 112, first
paragraph, 35 U.S.C. § 103(a), and obviousness-type double patenting. We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM-IN-PART.
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. In
addition, Appellant identifies Appeal 2014-005641 (Application 13/437,159)
as related to this Appeal (see Br. 4).
Appeal2015-000554
Application 13/644,976
STATEMENT OF THE CASE
Appellant's "invention relates to the use of antibodies (Abs) [that]
specifically bind interleukin- I a (IL-1 a) to treat inflammatory skin diseases"
(Spec. ,-i 3). Claim 1 is representative and reproduced in the Claims
Appendix of Appellant's Brief.
Claim 15 stands rejected under 35 U.S.C. § 112, second paragraph, as
indefinite in the recitation of the phrase "at least some of the lesions are
resolved."
Claims 15 and 16 stand rejected under the written description
provision of 35 U.S.C. § 112, first paragraph.
Claims 1, 3-6, and 14 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination ofKurokawa, 3 Skurkovich,4 Simard,5 and
Witte. 6
Claims 1 and 3-6 stand rejected under the judicially created doctrine
of obviousness-type double patenting as being unpatentable over claims 1-7
of copending Application 13/437, 159.
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 the number of acne lesions in the
3 Ichiro Kurokawa et al., New developments in our understanding of acne
pathogenesis and treatment, 18 Experimental Dermatology 821-832 (2009).
4 Skurkovich et al., US 2005/0276807 Al, published Dec. 15, 2005.
5 Simard, US 2009/0298096 Al, published Dec. 3, 2009.
6 Witte et al., US 2003/0026806 Al, published Feb. 6, 2003.
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Application 13/644,976
subject (see Appellant's claim 1 ). Claims 3-6 and 14-16 depend directly or
indirectly from claim 1.
Obviousness-type Double Patenting:
Appellant does not contest the provisional obviousness-type double
patenting rejection. (See Ans. 7.) 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.").
Definiteness:
ISSUE
Does the preponderance of evidence support Examiner's conclusion
that claim 15 is indefinite?
FACTUAL FINDINGS (FF)
FF 1. Examiner finds claim 15 indefinite in the recitation of the phrase "at
least some of the lesions are resolved" (Ans. 4; cf Appellant's Claim 15).
FF 2. Example 2 of Appellant's Specification discloses the treatment of a
subject with a "single 3 ml subcutaneous injection of ... [anti-ILl-a
antibody] MABpl ... representing a dose of0.6 mg/kg," wherein "[a]fter
24-hours the patient was re-evaluated" and the following observations were
made: "Large lesions on the shoulder and back had dramatically reduced in
size. Reduced inflammatory infiltration of facial lesions was evidenced by
less redness of the lesions and reduced lesion sizes compared to pre-dose.
The lesions appears to be drying" (Spec. ,-i,-i 35-37).
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Application 13/644,976
FF 3. Appellant's Specification discloses that the subject identified in FF 2
above, was re-evaluated 72-hours post treatment with anti-ILl-a antibody
MABpl representing a dose of 0.6 mg/kg, wherein the following
observations were made: "Most lesions showed dramatically less
inflammation or many were altogether non-apparent. Lesions on the
shoulder and back that had remarkable induration were resolved, only
slightly discolored and soft to the touch. The patient's face looked
essentially [normal]" (Spec. ,-i 38).
ANALYSIS
Examiner finds that Appellant's Specification "does not provide the
metes and bounds of what is required to meet th[ e] limi ta ti on [in Appellant's
claim 15, which requires at least some of the lesion are resolved]. For
example, it is not known what level of inflammation, induration, and/or
discoloration is encompassed by the recitation of 'resolved"' (Ans. 4; see
also id. at 9 ("It is not known from [Appellant's Specification] what level of
discoloration is embraced by 'slightly discolored' and what level of firmness
is embraced by 'soft to the touch"'); see FF 1).
Appellant contends, however, that Appellant's Specification makes
clear that the phrase "at least some of the lesions are resolved," as it is
recited in Appellant's claim 15, "makes clear that resolution involves the
transformation of acne lesions from being indurated and inflamed to no
longer being indurated and inflamed (only slightly discolored and soft to the
touch" (Br. 8; see FF 2-3). We find that Appellant has the better position on
this issue and the rejection is reversed.
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Application 13/644,976
CONCLUSION OF LAW
The preponderance of evidence fails to support Examiner's conclusion
that claim 15 is indefinite. The rejection of claim 15 under 35 U.S.C. § 112,
second paragraph, as indefinite is reversed.
Written Description:
ISSUE
Does the preponderance of evidence on this record support
Examiner's finding that Appellant's Specification fails to provide written
descriptive support for the claimed invention?
FACTUAL FINDINGS (FF)
FF 4. Examiner finds that Appellant's Specification fails to provide written
descriptive support for "all methods of administration and pharmaceutically
acceptable carriers embraced by" Appellant's claim 15, or otherwise
"disclos[ e] or contemplat[ e] [] the generic claim in [Appellant's] example
[2]" (Ans. 3; cf FF 2-3).
FF 5. Example 6 of Appellant's Specification exemplifies a clinical study
of the treatment of individuals "with [ m ]oderate to [ s ]evere [a Jene
[ v ]ulgaris" with "a sterile injectable liquid formulation of MABp 1 in a
stabilizing isotonic buffer" otherwise known as "RA-l 8C3" (Spec. ,-i,-i 46-
47).
FF 6. Appellant's Specification discloses that "[t]he total facial
inflammatory lesion count" of individuals treated with the RA-l 8C3
formulation resulted in "an average improvement of 35±8% (median 34% [])
on day 42" (Spec. ,-i 47).
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FF 7. Examiner finds that Appellant's Specification fails to provide written
descriptive support for "all methods of administration and pharmaceutically
acceptable carriers embraced by the claims," "how the RA-l 8C3
[formulation] was administered, in what amounts, [or] how frequently"
(Ans. 4).
ANALYSIS
In sum, Examiner finds that Appellant's Specification fails to provide
written descriptive support for Appellant's claims 15 and 16 that requires the
administration to a subject, a composition comprising: (1) a
pharmaceutically acceptable carrier and (2) an amount of an agent (e.g., an
anti-IL-1 a antibody) that selectively binds IL-1 a and is effective to reduce
the number of acne lesions in the subject (see Appellant's claim 1 ), wherein:
(a) at least some of the lesions are resolved within 72 hours after the step of
administering the pharmaceutical composition (see Appellant's claim 15; FF
2-3; cf FF 4) or (b) wherein the number of acne lesions in the subject is
reduced by at least 35% by the forty-second day after the step of
administering the pharmaceutical composition (see Appellant's claim 16; FF
5-6; cf FF 7). We are not persuaded (see Br. 6-8; FF 2-3 and 5-6). We
find Appellants' Specification provides at least two specific examples of
treatment of patients with acne vulgaris, following the method recited in
Appellants' claim with such sufficient detail that we conclude that a person
of ordinary skill in the art would realize that Appellants were in possession
of the claimed invention at the time of filing. See Spec. ,-i,-i 32-43; see also
Ariad Pharmaceuticals, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1351 (Fed.
Cir. March 2010).
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Application 13/644,976
CONCLUSION OF LAW
The preponderance of evidence on this record fails to support
Examiner's finding that Appellant's Specification fails to provide written
descriptive support for the claimed invention. The rejection of claims 15
and 16 under the written description provision of 35 U.S.C. § 112, first
paragraph is reversed.
Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 8. Kurokawa discloses that "[a]cne is a chronic obstructive and
inflammatory disorder affecting the pilosebaceous follicles mainly in
adolescents" (Kurokawa 830; Ans. 5; see generally Kurokawa 824-825 and
826-827).
FF 9. Kurokawa discloses that "[ e ]ctopeptidases and P. acnes proliferation
and the resulting increase in bacterial TLR2 ligands in the follicular canal
may increase IL-1 a production ... resulting in inflammation and rupture of
follicular walls and the induction of tissue matrix metalloproteinases that
induce scar formation" (Kurokawa 830; Ans. 5; see generally Kurokawa
824-825 and 826-827).
FF 10. Kurokawa discloses that "new acne treatments may ... inhibit[] []
IL-la" (Kurokawa 830; Ans. 5; see generally Kurokawa 824-825 and 826-
827).
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FF 11. Skurkovich discloses that " [a] cne, specifically acne vulgaris is a skin
disease that is estimated to affect 85-100% of the population at one time in
their life" (Skurkovich iJ 6; Ans. 5; see generally Skurkovich iJ 5).
FF 12. Skurkovich discloses that
At least four factors are important in the development of acne
lesions; follicular epidermal hyperproliferation and
hyperkeratinization, excess sebum, Propionibacterium acnes,
and inflammation. Follicular epidermal hyperproliferation and
hyperkeratinization may be stimulated by increased levels of
androgens and the alteration in the sebum and lipid levels in
acne lesions. In addition, the presence of interleukin- I -alpha
(IL-la) may lead to hyperkeratinization and hyperproliferation
of the infu[ n ]dibulum.
(Skurkovich iJ 7; Ans. 5.)
FF 13. Skurkovich discloses that "an antibody to IL-1 [] alone ... can be
administered using direct injections to the skin area afflicted by an
inflammatory ... skin disease such as acne vulgaris," wherein "[ s ]uch
injections can include cutaneous or subcutaneous injections using a syringe"
(Skurkovich iJ 143; see also id. iJ 152; Ans. 5).
FF 14. Simard "relates to antibodies (Abs)[, e.g., MABpl,] which
specifically bind interleukin- I a(IL-1 a) and methods of using such Abs to
treat, prevent, or detect a pathology associated with aberrant IL-1 a
expression" (Simard iii! 3 and 36; Ans. 5).
FF 15. Witte "relates to antibodies ... , compositions, uses and methods for
treating ... IL-1 mediated disorders" (Witte iJ 2; see Ans. 6).
FF 16. 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 iii! 38, 40, and 90;
see Ans. 5)
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FF 17. 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. 5).
FF 18. Witte teaches compositions comprising a pharmaceutically
acceptable carrier (Witte ,-i 225; see id. ,-i,-i 220-241; Ans. 5).
FF 19. Appellant discloses that " [ i ]t is expected that an appropriate dosage
of Abs would be in the range of about 0.2 to 20 ... mg/kg body weight for
subcutaneous administration" (Spec. ,-i 31; see Ans. 5).
FF 20. 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. 5.)
ANALYSIS
Based on the combination of Kurokawa, Skurkovich, Simard, and
Witte, Examiner concludes that, at the time Appellant's invention was made,
it would have been prima facie obvious "to administer an anti-IL-la
antibody such as MABp 1 to treat acne with an expectation that the number
of acne lesions would be reduced" (Ans. 6). Claim 1 is representative.
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Appellant contends, inter alia, that although Kurokawa "suggests pursuing a
large number of different targets [including the inhibition of IL-1 a] for
possible new acne treatments, [Kurokawa] does not provide any evidence
supporting that IL-1 a inhibition would have a reasonable likelihood of being
able to reduce acne lesions" (Br. 10; FF 10). We are not persuaded. When
Kurokawa, Skurkovich, Simard, and Witte are considered in combination, a
person of ordinary skill in this art would have recognized that the number of
acne lesions in a human subject may be reduced by administering an
effective amount of a composition comprising an anti-IL-I a antibody and a
pharmaceutically acceptable carrier (FF 8-20; see Ans. 9-13).
For the foregoing reasons, we are not persuaded by Appellant's
contention that Skurkovich, Simard, and Witte "when combined with
Kurokawa still do not provide any evidence that IL-1 a inhibition would have
a reasonable likelihood of being able to reduce acne lesions" (Br. 10). We
are not persuaded (see FF 8-20; Ans. 9-13). In this regard, notwithstanding
Appellant's contention to the contrary, Skurkovich expressly discloses that
"an antibody to IL-1 [] alone ... can be administered using direct injections
to the skin area afflicted by an inflammatory ... skin disease such as acne
vulgaris," which, as Skurkovich discloses, may result in acne lesions caused
by hyperproliferation and hyperkeratinization due to the presence of IL-1 a
(FF 12-13; see also FF 10 and 14).
Taken as a whole, we are not persuaded by Appellant's contention
that the combination of Kurokawa, Skurkovich, Simard, and Witte fails to
suggest, and/or provide a reasonable expectation of success, for a method of
reducing the number of acne lesions in a human subject with acne by
administering an effective amount of a composition comprising an anti-IL-
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1 a antibody and a pharmaceutically acceptable carrier (Br. 11; see generally
id. at 8-11; cf FF 8-20; Ans. 5-6 and 9-13).
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 Kurokawa, Skurkovich, Simard, and Witte is
affirmed. Claims 3-6 and 14 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-IN-PART
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