Ex Parte Simard

Patent Trial and Appeal Board

Mar 22, 2018

13928020 (P.T.A.B. Mar. 22, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/928,020 06/26/2013
88684 7590 03/26/2018
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.
5407-0159 1031
EXAMINER
ALLEN, MARIANNE P
ART UNIT PAPER NUMBER
1647
NOTIFICATION DATE DELIVERY MODE
03/26/2018 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
(APPLICANT: XBiotech, Inc.)
Appeal2017-003194
Application 13/928,020 1
Technology Center 1600
Before DONALD E. ADAMS, JOHN G. NEW, and RICHARD J. SMITH,
Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL
This Appeal2 under 35 U.S.C. § 134(a) involves claims 7, 9--12, and
14--16 (Final Act. 3 1 ). Examiner entered rejections under the written
description and enablement provisions 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.
1 Appellant identifies the real party in interest as "XBiotech, Inc." (Br. 3).
2 This Appeal is related to Appeal 2014-005641, Application 13/437,159,
abandoned Jan. 12, 2017 and 2015-000554, Application 13/644,976, now
Simard, US 9,724,409 B2, issued Aug. 8, 2017 (Simard '409) (see Br. 4).
3 Office Action mailed September 14, 2015.
Appeal2017-003194
Application 13/928,020
STATEMENT OF THE CASE
Appellant's disclosure "relates to the use of antibodies (Abs) which
specifically bind interleukin-la (IL-la) to treat inflammatory skin diseases
was well as psychiatric conditions" (Spec. i-f 3). Appellant's independent
claims 7 and 16 are representative and reproduced below:
7. A method of reducing anxiety in a human subject having
anxiety and acne, the method comprising the step of
administering to the subject a pharmaceutical composition
comprising a pharmaceutically acceptable carrier and an
amount of an anti-IL-la antibody effective to reduce anxiety in
the subject, wherein anxiety in the subject is reduced after the
step of administering the pharmaceutical composition.
16. A method of reducing anxiety in a human subject having
anxiety and acne, the method comprising the step of
administering to the subject a pharmaceutical composition
consisting essentially of a pharmaceutically acceptable carrier
and an amount of an anti-IL- I a antibody effective to reduce
anxiety in the subject, wherein both acne and anxiety in the
subject is reduced after the step of administering the
pharmaceutical composition.
(Br. 11-12.)
The claims stand rejected as follows: 4
Claims 15 and 16 stand rejected under the written description
provision of 35 U.S.C. § 112, first paragraph.
Claims 7, 9-12, and 14--16 stand rejected under the enablement
provision of 35 U.S.C. § 112, first paragraph.
4 Office records indicate that Application 13/437,159 was abandoned Jan.
12, 2017. Therefore, the provisional rejection involving the claims of
Application 13/437,159 is moot and will not be discussed further (cf Ans.
2-3).
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Application 13/928,020
Claims 7, 9--12, and 14--16 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Kurokawa, 5 Grahame, 6 Skurkovich, 7
Simard '096, 8 and Witte. 9
Claims 7, 9--12, and 14--16 stand rejected under the judicially created
doctrine of obviousness-type double patenting as being unpatentable over
the claims of Simard '409 in view of Grahame. 10
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 1. Appellant's Specification provides a section entitled "Pharmaceutical
Compositions and Methods" (see Spec. 8). In this section of Appellant's
Specification, Appellant discloses that "[ t ]he anti-IL- I a Ab compositions
(and other agents that specifically target IL-1 a) may be administered to
5 Ichiro Kurokawa et al., New developments in our understanding of acne
pathogenesis and treatment, 18 Experimental Dermatology 821-32 (2009).
6 V. Grahame et al., The Psychological Correlates of Treatment Efficacy in
Acne, 3 Dermatol Psychosom 119--25 (2002).
7 Skurkovich et al., US 2005/0276807 Al, published Dec. 15, 2005.
8 Simard, US 2009/0298096 Al, published Dec. 3, 2009.
9 Witte et al., US 2003/0026806 Al, published Feb. 6, 2003.
10 Because Simard '409 is now an issued U.S. Patent, this rejection is no
longer provisional (cf Ans. 2).
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Application 13/928,020
animals or humans in pharmaceutically acceptable carriers (e.g., sterile
saline)" (Spec. i-f 28).
FF 2. Appellant exemplifies "Xilonixâ„¢," which "is a sterile injectable
liquid formulation of 15 mg/mL MABp 1 in a stabilizing isotonic buffer (pH
6.4)" (Spec. i-f 33).
FF 3. Appellant's Table listing the ingredients of the Xilonixâ„¢ drug
product is reproduced below:
MABpl Ab GMP XBioted1 ! 15 rnglmL
---~~;, USP i qs.
Appellant's Table listing the ingredients of the T2-18C3 drug product,
provides "[t]he exact composition of the Drug Product" (Spec. i-f 40).
FF 6. Appellant discloses that "[a]ny suitable type of Ab that specifically
binds IL-1 a and reduces a characteristic of a psychiatric condition, skin
inflammation and/or an inflammatory skin disease such as acne vulgaris or
psoriasis vulgaris in a subject might be used in [Appellant's] invention"
(Spec. ,-r 19).
FF 7. Appellant discloses that "[a Jn effective amount of anti-IL- I a Ab
compositions is an amount which shows clinical efficacy in patients as
measured by the improvement in one or more symptoms of skin
inflammation" (Spec. i-f 31 ).
FF 8. Appellant discloses "Interim Results of A Phase II Open Label Study
of the Safety, Pharmacokinetics, and Efficacy of a True Human TM Anti-
Inflammatory Therapeutic Antibody (RA-18C3[llJ) in Subjects with
Moderate to Severe Acne Vulgaris" (Spec. i-f 46; see also id. i-fi-147--49).
FF 9. Appellant discloses that "[i]t has been hypothesized that a causal
relationship exists between underlying inflammatory processes present in
11 "RA-18C3 is a sterile injectable liquid formulation of MABp 1 in a
stabilizing isotonic buffer" (Spec. i-f 47).
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Application 13/928,020
skin diseases and psychiatric medical conditions. To further explore this
possibility, the Hospital Anxiety and Depression Scale (RADS) was used to
assess the depression and anxiety profiles of the trial population," wherein
Appellant discloses that treatment of patients exhibiting "moderate to severe
acne vulgaris" with an effective amount of RA- l 8C3 resulted in an
"improvement in anxiety score [together with] a substantial ... reduction in
'facial inflammatory lesion[, i.e. acne,] count"' (Spec. i-fi-1 48--49).
ANALYSIS
A pharmaceutical composition consisting essentially of a pharmaceutically
acceptable carrier and an amount of an anti-IL- I a antibody:
Appellant's claims 7 and 16 are reproduced above. Appellant's claim
15 depends from and further limits Appellant's claim 7 to require that "the
pharmaceutical composition consists essentially of the pharmaceutically
acceptable carrier and the anti-IL-la antibody" (Br. 11 (emphasis added)).
Examiner finds that Appellant's Specification fails to provide written
descriptive support for a pharmaceutical composition that consists
essentially of a pharmaceutically acceptable carrier and an amount of an
anti-IL-la antibody (Ans. 5). In this regard, Examiner finds that Appellant's
"[S]pecification does not disclose the transitional phrase 'consisting
essentially of' or the basic and novel characteristics of the claimed invention
that must not be materially affected" (Ans. 3). To the contrary, Examiner
finds that Appellant's Specification "specifically discloses that other
substances may be added to the compositions, including other agents that
specifically target IL-1 a and substances that stabilize/preserve the
composition" (Ans. 10 (citing Spec. i128) (emphasis added); FF 1 ).
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Application 13/928,020
Appellant, however, contends that the Specification exemplifies two
pharmaceutical compositions that consist essentially of a pharmaceutically
acceptable carrier and an anti-IL-la antibody and, thus, pharmaceutical
compositions within the scope of Appellant's claim 15 "are clearly described
in [Appellant's] [S]pecification" (see Br. 6; see FF 2-3). We agree.
We recognize that Appellant's claims 15 and 16 encompass a
pharmaceutical composition that consists essentially of, inter alia, any anti-
IL-1 a antibody, whereas the exemplified embodiments in Appellant's
disclosure describe pharmaceutical compositions that consist essentially of,
inter alia, specific anti-IL-I a antibodies (see Br. 11; cf FF 2-3). Examiner,
however, failed to establish that the pharmaceutical compositions
exemplified in Appellant's Specification are not representative of a
pharmaceutical composition that consists essentially of a pharmaceutically
acceptable carrier and an anti-IL-la antibody, as recited in Appellant's
claims 15 and 16. Therefore, we are not persuaded by Examiner's assertion
that Appellant's "claims are not limited to the particular compositions"
exemplified in Appellant's Specification (Ans. 10).
Both acne and anxiety in the subject is reduced after the step of
administering the pharmaceutical composition:
Appellant's claim 16 is reproduced above. The method of Appellant's
claim 16 requires, inter alia, that both anxiety and acne are reduced in a
subject after the step of administering the pharmaceutical composition.
Examiner finds that Appellant's Specification fails to provide written
descriptive support for an amount of an anti-IL- I a antibody that is effective
to reduce both acne and anxiety (Ans. 4). More specifically, Examiner finds
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Application I3/928,020
that Appellant's Specification provides "no disclosure that amounts effective
to reduce anxiety are sufficient to reduce acne (or vice versa)" (id.). In this
regard, Examiner finds that Appellant's claim I6 "does not require [a] causal
link between the acne and the anxiety" or "that the acne and anxiety are in
any way associated (i.e. the acne causes anxiety or the anxiety causes acne)"
(id.).
Stated differently, Appellant's claim I6 does not require that the
treated subject's anxiety, i.e. psychiatric condition, is caused by acne (cf Br.
I I (Appellant's claim I4 depends from and further limits Appellant's claim
7 to require that the subject's "anxiety is caused by the acne")). To the
contrary, Appellant's claim I6 requires "administering to [a] subject a
pharmaceutical composition consisting essentially of a pharmaceutically
acceptable carrier and an amount of an anti-IL- I a antibody effective to
reduce anxiety[, i.e. a psychiatric condition,] in the subject" and, in addition,
to reduce acne in the subject (Br. I2). Thus, we interpret the method of
Appellant's claim I 6 to require that the administration of a pharmaceutical
composition consisting essentially of an anti-IL- I a antibody and a carrier to
a subject results in a reduction in anxiety, attributed to any cause, and,
separately, a reduction in acne. In this regard, we note that Appellant
discloses that "[a ]ny suitable type of Ab that specifically binds IL- I a and
reduces a characteristic of a psychiatric condition[] ... and/or an
inflammatory skin disease such as acne vulgaris ... in a subject might be
used in [Appellant's] invention" (FF 6).
As Examiner explains, Appellant's Specification fails to disclose an
anti-IL- I a antibody that reduces a characteristic of a psychiatric condition,
i.e., anxiety, which is not caused by acne (see generally Ans. 4). To the
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contrary, Appellant discloses that "[a Jn effective amount of anti-IL- I a Ab
compositions is an amount which shows clinical efficacy in patients as
measured by the improvement in one or more symptoms of skin
inflammation," i.e., acne (FF 7).
We recognize that Appellant's disclosure exemplifies a method of
treating patients exhibiting "moderate to severe acne vulgaris" with an anti-
IL-1 a antibody that results in a "reduction in facial inflammatory lesion[, i.e.
acne,] count" and a corresponding "improvement in [the] anxiety score" of
these patients whose anxiety is caused by acne (FF 8-9). Appellant,
however, fails to direct our attention to a disclosure, in Appellant's
Specification, of an anti-IL- I a antibody that reduces anxiety, which is not
caused by acne, in a subject, as is broadly encompassed in Appellant's claim
16 (cf Br. 6-7). Therefore, we are not persuaded by Appellant's contention
to the contrary (id.).
CONCLUSION
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, as it relates to a
pharmaceutical composition consisting essentially of a pharmaceutically
acceptable carrier and an amount of an anti-IL- I a antibody. The rejection of
claims 15 and 16 under the written description provision of 35 U.S.C. § 112,
first paragraph, for failing to provide written descriptive support for the
claimed invention, as it relates to a pharmaceutical composition consisting
essentially of a pharmaceutically acceptable carrier and an amount of an
anti-IL-la antibody is reversed.
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The preponderance of evidence on this record supports Examiner's
finding that Appellant's Specification fails to provide written descriptive
support for the claimed invention, as it relates to a method that results in a
reduction of both acne and anxiety in the subject after the step of
administering the pharmaceutical composition. The rejection of claim 16
under the written description provision of 35 U.S.C. § 112, first paragraph,
for failing to provide written descriptive support for the claimed invention,
as it relates to a method that results in a reduction of both acne and anxiety
in the subject after the step of administering the pharmaceutical composition
is affirmed.
Enablement:
ISSUE
Does the evidence of record support Examiner's conclusion that
undue experimentation would be required to practice Appellant's claimed
invention?
ANALYSIS
Examiner finds that Appellant's Specification "does not provide
sufficient information to enable any method within the [scope of
Appellant's] claims (Ans. 11-12; see also id. at 12 (Appellant's
"[S]pecification does not disclose reducing anxiety due to any cause in
patients who also happen to have acne")). Specifically, Examiner finds that
Appellant's:
[C]laims are directed to a method of reducing anxiety in a
human subject having anxiety and acne. Claim 14 requires that
the subject's anxiety is caused by the acne. Claims 7 and 16 do
not require that the acne and anxiety are in any way associated
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Application 13/928,020
(i.e. the acne causes anxiety or the anxiety causes acne).
Claims 7, 9-12, and 15 embrace reducing anxiety due to any
cause. Claims 14 and 16 embrace administration of any anti-
IL- Ia antibody in any manner. None of the claims requires that
the acne condition improves or improves to any particular
degree and that this improvement results in the reduced anxiety.
(Ans. 4.) In this regard, Examiner finds that Appellant's Specification
provides "no disclosure or evidence that administration of ... [an] anti-IL-
1 a antibody could be used to reduce anxiety due to causes" unrelated to acne
(id. at 5). Stated differently, Examiner finds that Appellant's "claims fairly
embrace treating anxiety due to [non-acne related] causes in patients who
happen to also have acne" and Appellant's disclosure provides "no evidence
that administering anti-IL-1 a antibodies to these patients would reduce
anxiety due to these causes" (id. at 6). We agree.
We are not persuaded by Appellant's contention that Example 6 of
Appellant's Specification provides an enabling disclosure of Appellant's
claimed invention (see Br. 7; cf FF 6-9). Notwithstanding Appellant's
contention to the contrary, Example 6 of Appellant's Specification relates to
a method of treating acne, which results in an improvement in anxiety
caused by acne (see FF 6-9). Appellant fails to identify an enabling
disclosure in Appellant's Specification of a method of reducing anxiety, not
caused by acne, in a subject by administering to the subject a pharmaceutical
composition comprising, or consisting essentially of, a pharmaceutically
acceptable carrier and an amount of an anti-IL- I a antibody effective to
reduce anxiety in the subject (see Br. 11-12). In this regard, Appellant
discloses that "[a ]ny suitable type of Ab that specifically binds IL-1 a and
reduces a characteristic of a psychiatric condition[, i.e. anxiety,] ... in a
subject might be used in [Appellant's] invention" (FF 6). Appellant has not,
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however, provided an enabling disclosure of a method of administering a
pharmaceutical composition comprising, or consisting essentially of, a
pharmaceutically acceptable carrier and an amount of an anti-IL- I a antibody
effective to reduce anxiety not caused by acne.
CONCLUSION
The evidence of record supports Examiner's conclusion that undue
experimentation would be required to practice Appellant's claimed
invention. The rejection of claims 7, 9, 11, 12, and 14--16 under the
enablement provision of 35 U.S.C. § 112, first paragraph, is affirmed. Claim
10 is not separately argued and falls with claim 7.
Obviousness:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 10. Kurokawa discloses that "[a]cne is a chronic obstructive and
inflammatory disorder affecting the pilosebaceous follicles mainly in
adolescents" (Kurokawa 830; Ans. 6; see generally Kurokawa 824--825 and
826-827).
FF 11. 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
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Application 13/928,020
induce scar formation" (Kurokawa 830; Ans. 6; see generally Kurokawa
824--825 and 826-827).
FF 12. Kurokawa discloses that "new acne treatments may ... inhibit[] ...
IL-la" (Kurokawa 830; Ans. 6; see generally Kurokawa 824--825 and 826-
827).
FF 13. Skurkovich discloses that "[a Jene, specifically acne vulgaris is a skin
disease that is estimated to affect 85-100% of the population at one time in
their life" (Skurkovich i-f 6; Ans. 7; see generally Skurkovich i-f 5).
FF 14. 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 i-f 7; Ans. 7.)
FF 15. 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 i-f 143; see also id. i-f 152; id. i-f 162 (Skurkovich discloses that
"[t]he term 'interleukin-I' ... refers to both interleukin-I-alpha (IL-la) and
interleukin- I -beta (IL-1 B), unless specified otherwise"); Ans. 7).
FF 16. Skurkovich discloses a "method of treating acne in a patient, the
method comprising administering to the patient an effective amount of an
antibody to interleukin-I" (Skurkovich 15: col. 2, 11. 3-5; see Ans. 7).
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FF 1 7. Skurkovich discloses that "acne can lead to embarrassment and
psychosocial suffering in afflicted individuals, especially in susceptible
adolescents, even if acne is mild" (Skurkovich i-f 12; Ans. 7).
FF 18. Simard '096 "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 '096 i-fi-13 and 36; Ans. 7).
FF 19. Witte "relates to antibodies ... , compositions, uses and methods for
treating ... IL-1 mediated disorders" (Witte i-f 2; see Ans. 7).
FF 20. Witte defines a "selective binding agent" as preferably "an antibody,
such as ... monoclonal antibodies (mAbs)," "such as [an] IgGl" mAb, that
binds "IL-la or IL-IW' or both of IL-la and IL-IB (Witte i-fi-138, 40, and 90;
see Ans. 7).
FF 21. 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-f 225; Ans. 7).
FF 22. Witte teaches compositions comprising a pharmaceutically
acceptable carrier (Witte i-f 225; see id. i-fi-1 220-241; Ans. 7).
FF 23. Examiner finds that Appellant discloses "that an appropriate dosage
of antibodies would include 0.1 to 5mg/kg body weight" (Ans. 7; see Spec.
,-r 31 ).
FF 24. 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
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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-f 241; see Ans. 7.)
FF 25. Grahame discloses that "acne is a distressing and debilitating skin
disorder that can cause sufferers psychological and emotional distress,"
wherein "[t]he psychological impact has been shown to be largely reversed
following effective treatment, and this improvement in psychological well-
being is still present at follow-up assessment" (Grahame 124: second
column, last paragraph; id. at 119: first column ("Treatment outcome results
obtained from acne patients showed that there was a significant ... decrease
on how patients self-rated[, inter alia,] their anxiety"); see Ans. 6-7 (citing
Grahame 119, 123, 124, and Tables 3--4)).
ANALYSIS
Based on the combination of Kurokawa, Grahame, Skurkovich,
Simard '096, 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 MABpl to treat acne with an expectation that
the number of acne lesions would be reduced. This successful treatment
would result in decreased anxiety in acne patients as taught by Grahame"
(Ans. 8).
Appellant contends that the prior art relied upon by Examiner "fail to
provide the skilled artisan sufficient evidence to arrive at the conclusion that
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the administration of an anti-IL- I a antibody would reasonably be expected
to improve acne in a subject" (Br. 8). We are not persuaded. When
Kurokawa, Skurkovich, Simard '096, 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 I 0-24; see Ans.
6-9). In addition, Skurkovich and Grahame both disclose that acne can
cause emotional distress, i.e. anxiety, and that acne treatment reduced patient
anxiety (FF I 7 and 25). Thus, notwithstanding Appellant's contention to the
contrary, the combination of Kurokawa, Skurkovich, Simard '096, Witte,
and Grahame makes obvious the subject matter of Appellant's claim
invention (see Br. 9 ("the relied upon references do not reasonably suggest
that the successful treatment of acne in a human subject would result in
decreased anxiety in such subject"); see also id. at 9--IO).
Skurkovich discloses a "method of treating acne in a patient, the
method comprising administering to the patient an effective amount of an
antibody to interleukin- I," wherein "[ t ]he term 'interleukin- I' ... refers to
both interleukin-I-alpha (IL-I a) and interleukin-I-beta (IL-I B), unless
specified otherwise" (FF I5-I6). Therefore, we are not persuaded by
Appellant's contention that the combination of Kurokawa, Grahame,
Skurkovich, Simard '096, and Witte fails to
describe[] any experiments showing [the treatment of acne] ...
and none [of these references] connect IL- I a to acne with
enough evidence that would lead one of skill in the art to
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believe that there was [a] reasonable expectation of success that
an anti-IL-la antibody would improve acne in a subject.
(Br. 8; see also id. at 8-9.) In this regard, we note that a reference is not
limited to its exemplified, or preferred, embodiments, but is instead available
for all that it discloses and suggests to one of ordinary skill in the art. In re
Lamberti, 545 F.2d 747, 750(CCPA1976).
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness. The rejection of claim 7 under 35 U.S.C.
§ 103(a) as unpatentable over the combination of Kurokawa, Grahame,
Skurkovich, Simard '096, and Witte is affirmed. Claims 9-12 and 14--16 are
not separately argued and fall with claim 7.
Obviousness-type Double Patenting:
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness-type double patenting?
FACTUAL FINDINGS (FF)
FF 26. Simard '409 claims:
A method of reducing the number of acne lesions in a human
subject with acne, the method comprising the step of
administering to the subject a pharmaceutical composition
comprising a pharmaceutically acceptable carrier and an
amount of an anti-IL-1 a antibody effective to reduce the
number of acne lesions in the subject, wherein the number of
acne lesions in the subject is reduced after the step of
administering the pharmaceutical composition and at least some
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of the lesions are resolved within 72 hours after the step of
administering the pharmaceutical composition.
(Simard '409 10-11.)
ANALYSIS
Examiner finds that the claims of Simard '409, in view of Grahame,
are not patentably distinct from Appellant's claimed invention (Ans. 2).
Appellant contends that this rejection is "in error for [its] reliance on
Grahame ... for the reasons provided in [A]ppellant's argument regarding
Grahame presented [in response to the obviousness rejection] above" (Br.
10). We are not persuaded.
As discussed above, Grahame both disclose that acne can cause
emotional distress, i.e., anxiety, and that acne treatment reduced patient
anxiety (FF 25). Thus, Grahame provides a person of ordinary skill in this
art with a reasonable expectation of successfully treating anxiety associated
with acne by treating the acne. "Obviousness does not require absolute
predictability of success ... all that is required is a reasonable expectation of
success." In re O'Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988). Therefore,
we are not persuaded by Appellant's contention that "Grahame ... admits
that the generalizability of any conclusion stated therein is limited by the
small sample size, and that the lack of an age and sex matched control group
may have impacted the interpretation of the obtained data," which fails to
overcome the reasonable expectation of success on this record (Br. 9).
Further, because Simard '409 suggests the treatment of acne with a
composition comprising pharmaceutically acceptable carrier and an anti-IL-
1 a antibody, Simard '409 provides a reasonable expectation of successfully
treating acne, which according to Grahame will result in a reduction in
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anxiety associated with acne (FF 25-26). Thus, Appellant's contention that
"the relied upon references do not reasonably suggest that the successful
treatment of acne in a human subject would result in decreased anxiety in
such subject" is not persuasive (see Br. 9; see also id. at 9-10).
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness-type double patenting. The rejection of claim 7
under the judicially created doctrine of obviousness-type double patenting as
being unpatentable over the claims of Simard '409 in view of Grahame is
affirmed. Claims 9-12 and 14--16 are not separately argued and fall with
claim 7.
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).
AFFIRMED
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