Ex Parte Simard

Patent Trial and Appeal Board

Jun 13, 2016

13162705 (P.T.A.B. Jun. 13, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
13/162,705 06/17/2011
88684 7590 06/15/2016
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.
5407-0089 8076
EXAMINER
ALLEN, MARIANNE P
ART UNIT PAPER NUMBER
1647
NOTIFICATION DATE DELIVERY MODE
06/15/2016 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
Appeal2014-000775
Application 13/162,705
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 appeal under 35 U.S.C. § 134(a) involves claims 1-8 and 11-22
(Ans. 3). 2 Examiner entered rejections under 35 U.S.C. § 102(b) and 35
U.S.C. § 103(a). 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2 "Claims 16-22 [stand] withdrawn [from consideration] as being directed to
a non-elected invention" (Ans. 3).
Appeal2014-000775
Application 13/162,705
STATEMENT OF THE CASE
Appellant's "invention relates to the use of antibodies (Abs) [that]
specifically bind interleukin-la (IL-la) to treat one or more symptoms of
arthritis" (Spec. i-f 3). Claim 1 is representative and reproduced in the
Claims Appendix of Appellant's Brief.
Claims 1, 2, 5-8, 11, 12, 14, and 15 stand rejected under 35 U.S.C.
§ 102(b) as anticipated by Witte. 3
Claims 1--4 stand rejected under 35 U.S.C. § 103(a) as unpatentable
over the combination of Witte and Aberg. 4
Claims 1, 5, 6, and 13 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Witte and Bumier. 5
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 anti-IL-1 a antibody that is effective to reduce at
least one symptom of the inflammatory pathology in the subject (see
Appellant's claim 1). The preamble of Appellant's claim 1 defines the
subject's inflammatory pathology as a pathology associated with arthritis in
a human subject (id.). Claims 2-8 and 11-22 depend directly or indirectly
from claim 1.
3 Witte et al., US 2003/0026806 Al, published Feb. 6, 2003.
4 Aberg, US 7,718,674 B2, issued May 18, 2010.
5 Bumier et al., US 2009/0258070 Al, published Oct. 15, 2009.
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Application 13/162,705
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 rheumatoid arthritis and other IL-1 mediated disorders" (Witte i-f 2;
see Ans. 5).
FF 2. Witte defines a "selective binding agent" as preferably "an antibody,
such as ... monoclonal antibodies (mAbs)," "such as [an] IgGl" mAb, that
binds "IL-1 a or IL-1 W' or both of IL-1 a and IL-1 B. (Witte i-fi-1 3 8, 40, and 90;
see Ans. 5 and 7-8).
FF 3. Witte teaches that "IL-1 mediated diseases include[] ...
inflammatory conditions of a joint, including osteoarthritis, psoriatic
arthritis[, ] rheumatoid arthritis[,] inflammatory eye disease [and] ...
uveitis" (Witte i-fi-1178, 198, 199, and 218; see id. i-f 2; Ans. 5).
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-f 225; Ans. 5).
FF 5. Witte teaches compositions comprising a pharmaceutically
acceptable carrier (Witte i-f 225; see id. i-fi-1220-241; Ans. 5 and 8).
FF 6. 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
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Application 13/162,705
subcutaneous administration and about 0.001 to 50 ... mg per eye for
topical administration to the eye" (Spec. i-f 35; see Ans. 5).
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 µ g/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
µ g/kg up to about 100 mg/kg; or 0 .1 µ g/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. 5.)
ANALYSIS
Examiner finds that Witte anticipates Appellant's claimed invention
(Ans. 4--5; see FF 1-7). Appellant, however, contends that Witte fails to
provide an enabling disclosure of Appellant's claimed invention (Br. 9-17).
We are not persuaded for the reasons provided by Examiner (Ans. 6-10; 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 1 under 35 U.S.C. § 102(b) as being anticipated by Witte is affirmed.
Claims 2, 5-8, 11, 12, 14, and 15 are not separately argued and fall with
claim 1.
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Application 13/162,705
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 specifically disclose wrist and
shoulder joint inflammation" and relies on Aberg to suggest "that wrist and
shoulder joints are involved in inflammatory conditions such as bursitis,
osteoarthritis, and rheumatoid arthritis (Ans. 5; see Aberg 22 ("Orthopedic
disorders affecting [the shoulder] include ... rheumatoid arthritis" and
"Bursitis usually occurs in the shoulder ... [and may be caused by ...
rheumatoid arthritis"); Aberg 24--25 ("Rheumatoid Arthritis can affect many
joints in the body, including the ... wrist")).
FF 9. Examiner finds that Witte "does not specifically disclose topical
administration to the eye to treat eye inflammation or uveitis" and relies on
Bumier' s disclosure of "topical administration of therapeutics to the eye ...
to treat eye inflammation and uveitis" (Ans. 6; see Bumier i-fi-1231 and 229
("for the treatment of eye disorders [that may be associated with rheumatoid
arthritis, such as inflammation of the eye and uveitis,] topical formulations
... may be applied directly to the eye"); Bumier i158 (Bumier's formulation
may comprise "an antibody")).
ANALYSIS
The combination of Witte and A berg:
Based on the combination of Witte and Aberg, Examiner concludes
that, at the time Appellant's invention was made, it would have been prima
facie obvious "to treat wrist and should joint inflammation[, which are
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Application 13/162,705
recognized to be associated with rheumatoid arthritis,] using the method of
Witte" for the treatment of IL-1 mediated disorders, such as rheumatoid
arthritis, using a composition comprising a carrier and an amount of an anti-
IL-1 a antibody effective to reduce at least one symptom of the inflammatory
pathology (Ans. 5; see FF 1-8).
For the foregoing reasons, we recognize, but are not persuaded by,
Appellant's contention that the combination of Witte and Aberg fails to
provide an enabling disclosure of Appellant's claimed invention (Br. 17).
The combination of Witte and Burnier:
Based on the combination of Witte and Bumier, Examiner concludes
that, at the time Appellant's invention was made, it would have been prima
facie obvious "to administer the antibodies of Witte topically to the eye to
treat uveitis as suggested by Bumier," wherein an antibody composition is
topically applied to the eye to treat rheumatoid arthritis associated eye
disorders such as inflammation of the eye and uveitis (Ans. 6; see FF 1-7
and 9).
For the foregoing reasons, we recognize, but are not persuaded by,
Appellant's contention that the combination of Witte and Bumier fails to
provide an enabling disclosure of Appellant's claimed invention (Br. 18).
We recognize, but are not persuaded by Appellant's contention that
Bumier' s disclosure is limited to "small molecules not large proteins such as
antibodies" and "does not ... suggest that administering antibodies to the
eye would be useful for treating ocular diseases such as uveitis" (Br. 18; cf
FF 9). Lastly, we recognize Appellant's contention that "[i]t is well known
that small molecules generally offer better tissue penetration than
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antibodies" (Br. 18). Appellant, however, fails to provide or identify an
evidentiary basis on this record to support this contention. In re Pearson,
494 F.2d 1399, 1405 (CCPA 1974) ("Attorney's argument in a brief cannot
take the place of evidence").
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 and Aberg is affirmed. Claims 2--4 are not
separately argued and fall with claim 1.
The rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Witte and Bumier is affirmed. Claims 5, 6, and 13
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. § 1.136(a).
AFFIRMED
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