Ex Parte Shafer

Board of Patent Appeals and Interferences

Jun 30, 2010

11152944 (B.P.A.I. Jun. 30, 2010)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte LISA L. SHAFER
__________

Appeal 2009-015315
Application 11/152,944
Technology Center 1600
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Decided: July 1, 2010
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Before ERIC GRIMES, DEMETRA J. MILLS, and MELANIE L.
McCOLLUM, Administrative Patent Judges.

GRIMES, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134 involving claims to a method
of treating a central nervous system disorder. The Examiner has rejected the
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.
STATEMENT OF THE CASE
The Specification discloses a “system for delivering a therapeutic
composition comprising an anti-inflammatory enhancing agent to a CNS
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[central nervous system] of a subject.… The system comprises a therapy
delivery device and a catheter operably coupled to the therapy delivery
device” (Spec. 10, ¶ 35). The Specification also discloses that an “‘anti-
inflammatory enhancing agent’ means an agent that is capable of enhancing
the effects of IL-10, IL-4 or other endogenous anti-inflammatory molecules”
(id. at 10, ¶ 30), and includes recombinant IL-10 (id. at 10, ¶ 31).
Claims 15-25 and 27 are on appeal. Claim 15 is representative and
reads as follows:
15. A method for treating a CNS disorder associated with an
inflammation or an inflammatory agent in a subject in need thereof, the
method comprising:
implanting a distal portion of a catheter in a patient within the
patient’s central nervous system (CNS); and
delivering an anti-inflammatory enhancing agent through the catheter
to the subject’s CNS in an amount effective to treat the CNS disorder.

Issue
The Examiner has rejected claims 15-23, 25 and 27 under 35 U.S.C.
§ 103(a) as being obvious in view of Szczepanik1 and Kay 2 (Answer 4), and
has rejected claim 24 as being obvious in view of Szczepanik, Kay and
Johnson3 (Answer 5). Since the same issue is dispositive with respect to
both rejections, we will consider them together. Claims 16-23, 25, and 27

1 Szczepanik et al., IL-10 and glucocorticoids inhibit Aβ (1-42)- and
lipopolysaccharide-induced pro-inflammatory cytokine and chemokine
induction in the central nervous system, 5 JOURNAL OF ALZHEIMER’S
DISEASE 105-117 (2003)
2 Kay et al., Patent Application Publication US 2002/0077294 A1, published
June 20, 2002
3 Johnson et al., US 6,083,919, issued July 4, 2000
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have not been argued separately and therefore stand or fall with claim 15. 4
37 C.F.R. § 41.37(c)(1)(vii).
The Examiner finds that Szczepanik discloses that the “intravenous
administration of IL-10 generally inhibited Aβ-induced cytokine production
in the mouse hippocampus and cortex …, demonstrating that anti-
inflammatory cytokines may be effective at modulating the inflammatory
response to amyloid peptides in Alzheimer’s disease” (Ans. 4). The
Examiner finds that Kay discloses that drugs, including IL-10, “can be
administered … via continuous infusion with an implantation device or
catheter … including intracerebroventricularly or intraparenchymally” (id. at
5). The Examiner concludes that “it would have been obvious to the person
of ordinary skill in the art … to improve Szczepanik et al.’s method of
administering IL-10 to treat Alzheimer’s disease by applying the
implantation device or catheter as disclosed by [Kay] … because the artisan
has good reason to pursue the known options within his or her technical
grasp to obtain predictable results” (id.).
Appellant contends that it would not have been obvious to modify
Szczepanik’s method of treating Alzheimer’s disease by administering IL-10
using Kay’s intracerebroventricular or intraparenchymal administration
because “Szczepanik does not suggest that improved IL-10 administration
methods are needed” (Appeal Br. 14), because Szczepanik and Kay are

4 Although claims 16-23, 25, and 27 are listed separately in the Appeal Brief
(pages 22-28), the arguments presented are the same as those for claim 15.
Appellant therefore has not presented any substantive arguments for claims
16-23, 25, and 27 that are separate from those for claim 15.
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nonanalogous art (id. at 16), and because Kay discloses a “laundry list” of
administration methods (id. at 18).
The issue presented is: Does the evidence of record support the
Examiner’s conclusion that one of skill in the art would have been
considered it obvious to modify Szczepanik’s method of treating
Alzheimer’s disease by administering IL-10 using Kay’s intracerebro-
ventricular or intraparenchymal administration?
Findings of Fact
1. Szczepanik discloses that “Alzheimer’s disease (AD) is
characterized by … extracellular deposits of amyloid-β (Aβ) peptide”
(Szczepanik, abstract).
2. Szczepanik discloses that “an acute intracerebroventricular (icv)
injection of Aβ … in the mouse induces a time- and dose-dependent
production of IL-1α, IL-1β, IL-6 and MCP-1 in the hippocampus and
cortex” (id.).
3. Szczepanik discloses that “[t]reatment with anti-inflammatory
agents such as prednisolone, dexamethasone, or IL-10 inhibited … Aβ- …
induced cytokine and chemokine production in the brain” (id.).
4. Szczepanik discloses that “IL-10 … was administered intravenous
(i.v.) through the tail vein” of the mice (id. at 106).
5. Szczepanik discloses that the “effectiveness of IL-10 to inhibit Aβ-
induced cytokine production suggests that the up-regulation of endogenous
interleukins or the exogenous application of these agents may have
therapeutic utility in AD” (id. at 115).
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6. Kay discloses “methods of raising hematocrit in a mammal
comprising administering a therapeutically effective amount of an IL-1
inhibitor” (Kay 1, ¶ 0007).
7. Kay discloses that “IL-1 inhibitors and/or TNF inhibitors can be
used alone or with one or more additional hematopoietic factors or other
therapeutic molecules, such as … IL-10 … in the treatment of hematopoietic
disorders” (id. at 13, ¶ 0183).
8. Kay discloses that the composition “may be administered as a
continuous infusion via implantation device or catheter” (id. at 12, ¶ 0173).
9. Kay discloses that the
route of administration of the compositions are in accord with
known methods including, but not limited to, oral, nasal,
pulmonary, rectal administration or injection or infusion by
subcutaneous, intravenous, intraperitoneal, intracerebral
(intraparenchymal), intracerebroventricular, intramuscular,
intraocular, intraarterial, or intralesional routes, or by sustained
release systems or implantation device which may optionally
involve the use of a catheter.
(Id. at 12, ¶ 0177.)
Analysis
Claim 15 is directed to a method for treating a central nervous system
(CNS) disorder associated with an inflammation comprising implanting a
catheter within a patient’s CNS and delivering an anti-inflammatory
enhancing agent (e.g., IL-10) through the catheter.
Szczepanik discloses that the Aβ peptide that forms brain deposits in
Alzheimer’s disease patients induces cytokine production in the brains of
mice. Szczepanik also discloses that intravenous IL-10 inhibits the cytokine
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production, and suggests that administering IL-10 may be useful in treating
Alzheimer’s disease. Kay discloses that intraparenchymal and
intracerebroventricular methods of administering therapeutic agents,
including compositions containing IL-10, are well known in the art. In view
of these disclosures, it would have been obvious to one of ordinary skill in
the art to administer IL-10 to an Alzheimer’s disease patient, as suggested by
Szczepanik, using a catheter to deliver the IL-10 to the patient’s brain, as
taught by Kay. A skilled worker would recognize from Szczepanik that the
therapeutic effect of IL-10 takes place in the patient’s brain, since that is
where the Aβ peptide induces cytokine production, and Kay shows that
delivering IL-10 directly to the brain was a known alternative to
Szczepanik’s intravenous delivery. The combination only requires
combining a known drug with a known method of administering that drug.
Appellant contends that one of skill in the art would not have been
motivated to administer Szczepanik’s IL-10 via Kay’s intracerebro-
ventricular or intraparenchymal methods because “Szczepanik does not
suggest that improved IL-10 administration methods are needed” (Appeal
Br. 14).
This argument is not persuasive. Although there must be a reason to
combine prior art elements in order to make the combination obvious under
§ 103, the reason does not have to be expressly articulated in the prior art.
See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007) (“[T]he analysis
need not seek out precise teachings directed to the specific subject matter of
the challenged claim, for a court can take account of the inferences and
creative steps that a person of ordinary skill in the art would employ.”).
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Here, a person of ordinary skill in the art would have recognized that
Szczepanik used tail vein injection of IL-10 when evaluating a mouse model
for Alzheimer’s disease, not in describing an actual treatment for
Alzheimer’s patients. As discussed above, Kay’s disclosure of different art-
known methods of administering drugs would have suggested administering
Szczepanik’s IL-10 directly to the brain because that is its site of action.
Appellant also contends that one of skill in the art would not have
been motivated to combine the cited references because Szczepanik and Kay
are nonanalogous art (Appeal Br. 16).
This argument is also unpersuasive. Kay and Szczepanik both relate
to method for the administration of a therapeutic agent, e.g., IL-10. Thus,
both references relate to the same field of endeavor, even if they were
administering their therapeutic agents for different purposes. The references
are not non-analogous art.
Finally, Appellant contends that one of skill in the art would not have
been motivated to combine the cited references because Kay merely includes
intracerebroventricular or intraparenchymal administration methods in a
“laundry list” of such methods (Appeal Br. 18).
This argument is not persuasive. The Examiner cites Kay to show
that intracerebroventricular and intraparenchymal administration methods
were art-recognized methods for administering therapeutic agents. Based on
Kay, a skilled worker would recognize that a therapeutic agent could be
administered via any appropriate method known in the art. Intracerebro-
ventricular or intraparenchymal administration would have been obvious
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choices in view of Szczepanik’s disclosure that the brain is the target site for
IL-10.
Conclusion of Law
The evidence or record supports the Examiner’s conclusion that one
of skill in the art would have been considered it obvious to modify
Szczepanik’s method of treating Alzheimer’s disease by administering IL-10
using Kay’s intracerebroventricular or intraparenchymal administration.
SUMMARY
We affirm the rejection of claim 15-23, 25, and 27 under 35 U.S.C.
§ 103(a) based on Szczepanik and Kay and the rejection of claim 24 in view
of Szczepanik, Kay, and Johnson.
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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