Ex Parte ShaferDownload PDFBoard of Patent Appeals and InterferencesJun 30, 201011152944 (B.P.A.I. Jun. 30, 2010) Copy Citation 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 __________ Decided: July 1, 2010 __________ 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 Appeal 2009-015315 Application 11/152,944 2 [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 Appeal 2009-015315 Application 11/152,944 3 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. Appeal 2009-015315 Application 11/152,944 4 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). Appeal 2009-015315 Application 11/152,944 5 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 Appeal 2009-015315 Application 11/152,944 6 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.”). Appeal 2009-015315 Application 11/152,944 7 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 Appeal 2009-015315 Application 11/152,944 8 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 lp MEDTRONIC, INC. 710 MEDTRONIC PARKWAY NE MINNEAPOLIS MN 55432-9924 Copy with citationCopy as parenthetical citation