Ex Parte Smith et al

Patent Trial and Appeal BoardNov 23, 2015

12415585 (P.T.A.B. Nov. 23, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE 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 APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 12/415,585 03/31/2009 Henry J. Smith JSMIT-006C 2944 7663 7590 11/24/2015 STETINA BRUNDA GARRED & BRUCKER 75 ENTERPRISE, SUITE 250 ALISO VIEJO, CA 92656 EXAMINER SZPERKA, MICHAEL EDWARD ART UNIT PAPER NUMBER 1644 MAIL DATE DELIVERY MODE 11/24/2015 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte HENRY J. SMITH and JAMES R. SMITH1 ____________ Appeal 2013-005745 Application 12/415,585 Technology Center 1600 ____________ Before ULRIKE W. JENKS, JACQUELINE T. HARLOW, and RICHARD J. SMITH, Administrative Patent Judges. SMITH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C § 134 involving claims to a method of treating pre-eclampsia in a pregnant woman. (Appeal Br. 15.) We have jurisdiction under 35 U.S.C § 6(b). We affirm. 1 According to Appellants, the real parties in interest are Henry J. Smith and James R. Smith. (Appeal Br. 3.) Appeal 2013-005745 Application 12/415,585 2 STATEMENT OF THE CASE The Specification states that “[p]re-eclampsia or toxemia during pregnancy is one of the leading causes of maternal and infant mortality.” (Spec. ¶ 3.) Furthermore, “[i]t was postulated that women who produced large amounts of [circulating] sFlt-12 early in their pregnancy were prone to develop pre-eclampsia.” (Spec. ¶ 6.) Claims on Appeal Claims 1 and 3–8 are on appeal.3 Claim 1 is illustrative and reads as follows: 1. A method of treating pre-eclampsia in a pregnant woman, the method comprising using targeted apheresis with a device containing immobilized anti-Flt-1 antibody to remove sFlt-1 from the circulation of the pregnant woman. Examiner’s Rejection Claims 1 and 3–8 stand rejected under 35 U.S.C. § 103(a) as being unpatentable over Karumanchi4 in view of Zuccato5 and/or Bӧhm.6 (Final Act. 3).7 2 The Specification indicates that sFlt-1 refers to the soluble form of the fms- like tyrosine kinase receptor. (Spec. ¶¶ 5–6.) 3 Claim 2 was cancelled and claims 9–14 have been withdrawn. 4 U.S. Patent Publication No. US 2004/0126828 A1, published July 1, 2004 (hereinafter “Karumanchi”). 5 PCT Application WO 96/16666, published June 6, 1996 (hereinafter “Zuccato”). 6 U.S. Patent No. 5,817,528, issued Oct. 6, 1998 (hereinafter “Bӧhm”). 7 Office Action Summary dated Feb. 15, 2012. Appeal 2013-005745 Application 12/415,585 3 Appellants have presented arguments for the patentability of claims 1 and 3–8 as a group, and have indicated that claims 3–8 stand or fall with claim 1. (Appeal Br. 5.) ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? FINDINGS OF FACT (FF) FF 1. Karumanchi teaches “administering a purified sFlt-1 antibody or antigen-binding fragment thereof” to a subject to treat pre-eclampsia. (Karumanchi, ¶ 11.) FF 2. Karumanchi teaches that “RNA interference and antisense nucleobase oligomers are also used to decrease the levels of sFlt-1.” (Karumanchi, ¶ 8.) FF 3. The Examiner finds that Karumanchi discloses that “high levels of sFlt-1 are undesirable and that any means for reducing the biological activity of sFlt-1 in women suffering from pre-eclampsia is therapeutically desirable.” (Final Act. 5.) FF 4. Zuccato teaches a method for immunoadsorption of pathogenic factors, including removing pathogenic factors from the blood using antibodies bound to solid support material. (Zuccato, Abstract; Figures 3 and 4; p. 8, ll. 11–22; p. 9, l. 33–p.10, l. 27.) Appeal 2013-005745 Application 12/415,585 4 FF 5. Zuccato teaches that “[i]mmunoadsorption or immunopheresis technique is a specific application of affinity chromatography which is used [for removing] from plasma and/or blood some specific substances which are directly or indirectly responsible [for] a given disease.” (Zuccato, p. 8, ll. 18–22.) FF 6. The Examiner finds that “an immune complex is formed when an antibody binds to the antigen for which said antibody is specific,” and that Zuccato teaches that immune complexes may have unwanted biological properties or activities. (Final Act. 4; Ans. 2–3; Zuccato, pp. 4–9 (see, e.g., p. 4, ll. 14–16).) FF 7. Bӧhm discloses a method to produce columns coupled to specific proteins (e.g., antibodies) for the removal of predetermined substances from the blood of patients suffering from various conditions. (Bӧhm, col. 3, ll. 58–63; Examples 5–7.) FF 8. The Examiner finds that the teachings of Bӧhm are generic and speak to the diversity of applications for which apheresis can be used. (Ans. 6.) ANALYSIS The Examiner’s position is that claim 1 would have been obvious given the multiple ways disclosed by Karumanchi to reduce sFlt-1 in the blood to treat pre-eclampsia, and the wide adaptability of apheresis to remove a vast array of antigens in numerous disease settings, as disclosed by Zuccato and Bӧhm. (Final Act. 4; Ans. 8.) The Examiner also notes that there is no persuasive evidence to support secondary considerations. (Ans. 4.) Appeal 2013-005745 Application 12/415,585 5 Appellants argue against any motivation to combine Karumanchi with Zuccato and/or Bӧhm. (Appeal Br. 5–10; Reply Br. 5–7.) In particular, Appellants argue that Karumanchi involves administering a pharmaceutical and “never mentions…the use of a device of any kind.” (Appeal Br. 9.) Furthermore, according to Appellants, Zuccato is not understood “to teach or suggest that immunocomplexes in general should be removed.” (Id. at 10.) Appellants also contend that the Examiner has improperly applied hindsight in combining the references, and that pharmacology and apheresis are nonanalogous arts. (Id. at 11–13.) We are not persuaded by Appellants’ arguments. We view the use of targeted apheresis to remove an undesirable substance (sFlt-1) from the blood, using immobilized antibodies to the substance, to be the mere combination of familiar elements according to known methods, yielding predictable results. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416–17 (2007). Accordingly, we find that the Examiner has established a prima facie case of obviousness and that Appellants have not overcome that prima facie case. Motivation to Combine References Appellants take particular issue with the Examiner’s finding that a skilled artisan would be motivated to perform apheresis rather than administering neutralizing antibodies—a finding based on Zuccato’s teaching that at least some immunocomplexes may result in unwanted biological activities (FF 6), and that the use of apheresis rather than administration of antibodies precludes the formation of such immunocomplexes. (Final Act. 4; Appeal Br. 10; Reply Br. 5–7.) In Appeal 2013-005745 Application 12/415,585 6 particular, Appellants argue that “the amount of immune complexes formed when anti-sFlt-1 antibody is administered is negligible,” that there is no “immune complex problem that needs to be addressed,” and that the Examiner’s argument that the motivation to look to apheresis “to avoid immune complex formation is invalid.” (Reply Br. 6–7.) We find this argument unpersuasive. It is well settled that “[i]n considering motivation in the obviousness analysis, the problem examined is not the specific problem solved by the invention but the general problem that confronted the inventor before the invention was made.” In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) (citing cases). Moreover, “the law does not require that the references be combined for the reasons contemplated by the inventor.” In re Beattie, 974 F.2d 1309, 1312 (Fed. Cir. 1992) (citing cases). Accordingly, that Appellants may not have been motivated to remove sFlt-1 with apheresis because it formed an immune complex in the blood does not rebut the Examiner’s finding regarding a motivation to combine Karumanchi and Zuccato based on immunocomplex formation. Moreover, we agree with the Examiner’s finding that motivation “comes from the fact that it was well known in the art that undesirable substances in blood can be removed by passing blood or plasma through a device comprising antibodies that specifically bind the undesirable substance.” (Final Act. 4.) Hindsight We find Appellants’ argument that the Examiner engaged in hindsight to be unpersuasive. Rather than using hindsight, the Examiner points to specific disclosures in the prior art that describe the limitations of Appellants’ claimed method. (Final Act. 4.) We therefore find that the Appeal 2013-005745 Application 12/415,585 7 Examiner’s obviousness conclusion is based on sufficiently articulated reasoning that overcomes any concerns about hindsight bias. See KSR, 550 U.S. at 418. Analogous Art We understand Appellants to argue that the Examiner’s prima facie case of obviousness must fail because the asserted art is not analogous to each other or to the claimed invention. That is, according to Appellants, pharmacology (administration of pharmaceuticals) is nonanalogous to the use of a medical device. (Appeal Br. 12–13.) It is well settled that “[t]wo separate tests define the scope of analogous prior art: (1) whether the art is from the same field of endeavor, regardless of the problem addressed and, (2) if the reference is not within the field of the inventor’s endeavor, whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” In re Klein, 647 F.3d. 1343, 1348 (Fed. Cir. 2011)(citing In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). We find Appellants’ argument unpersuasive because, even though only one test need be satisfied, the applicability of the prior art to claim 1 satisfies both Bigio tests. The prior art and claim 1 are all in the same field of endeavor, i.e., health care, and specifically in the field of treating undesirable substances in the blood. Furthermore, as noted by the Examiner, the methods of Karumanchi and apheresis techniques both use antibodies in the treatment of patients. (Ans. 9.) Finally, even if one were to contend that the prior art references are not within the field of Appellants’ endeavor, we Appeal 2013-005745 Application 12/415,585 8 find that such references are still reasonably pertinent to the particular problem with which Appellants are involved. CONCLUSION OF LAW A preponderance of evidence of record supports the Examiner’s conclusion that claim 1 is obvious under 35 U.S.C. § 103(a). Claims 3–8 fall with claim 1. 37 C.F.R. § 41.37(c)(1)(iv). SUMMARY We affirm the rejection of claims 1 and 3–8 under 35 U.S.C. § 103(a). 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 tc