Ex Parte Mihara et alDownload PDFPatent Trial and Appeal BoardNov 27, 201712232341 (P.T.A.B. Nov. 27, 2017) Copy Citation 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. 12/232,341 09/16/2008 Masahiko Mihara 053466-0467 8331 22428 7590 11/29/2017 Foley & Lardner LLP 3000 K STREET N.W. SUITE 600 WASHINGTON, DC 20007-5109 EXAMINER BELYAVSKYI, MICHAIL A ART UNIT PAPER NUMBER 1644 NOTIFICATION DATE DELIVERY MODE 11/29/2017 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): ipdocketing @ foley. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte MASAHIKO MIHARA and YOSHIYUKI OHSUGI Appeal 2016-007858 Application 12/232,3411 Technology Center 1600 Before JEFFREY N. FREDMAN, ROBERT A. POLLOCK, and TIMOTHY G. MAJORS, Administrative Patent Judges. MAJORS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a method for reducing the excretion of urinary protein in lupus nephritis, which have been rejected as anticipated and obvious. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 Appellants identify the Real Party in Interest as CHUGAI SEIYAKU KABUSKIKI KAISHA. (Br. 2.) Appeal 2016-00007858 Application 12/232,341 STATEMENT OF THE CASE Appellants’ “invention relates to a preventative and/or therapeutic agent for systemic lupus erythematosus comprising an anti-interleukin-6 receptor antibody as an active ingredient.” (Spec. 1:7—10.) Claims 13—18 are on appeal. Claim 13 is illustrative: 13. A method for reducing the excretion of urinary protein in lupus nephritis comprising administering an anti-interleukin-6 (IL-6) receptor antibody as a single active ingredient to a patient suffering from lupus nephritis. (Br. 10 (Claims App.).) The claims stand rejected as follows: I. Claims 13—16 under 35 U.S.C. § 102(b) as anticipated by FR ’7672 or DE ’706,3 as evidenced by Medical Dictionary.4 II. Claims 13—16 under 35 U.S.C. § 102(b) as anticipated by Kiberd.5 III. Claims 13, 17, and 18 under 35 U.S.C. § 103(a) over FR ’767, DE ’706, or Kiberd in view of Tsuchiya.6 2 French Patent Application No. 2694767, published Feb. 18, 1994 (translation of record). 3 German Patent Application No. DE 3939706C1, published Mar. 21, 1991 (translation of record). 4 MedicalDictionaryweb.com 2012 (definition of “Lupus Nephritis”) available at http://www.medicaldictionaryweb.com/Lupus+Nephritis- defmition/ (last visited Feb. 16, 2017). 5 Kiberd, Interleukin-6 Receptor Blockage Ameliorates Murine Lupus Nephritis, 4:1 J. Am. Soc. Nephrol. 58-61 (1993). 6 Tsuchiya et al., US 5,795,965, issued Aug. 18, 1998. 2 Appeal 2016-00007858 Application 12/232,341 I The Examiner rejected claims 13—16 as anticipated by FR ’767 or DE ’706, as evidenced by Medical Dictionary. (Final Act. 2—5.) According to the Examiner, FR ’767 “teaches a method of treating diseases in which IL-6 is involved, including systemic lupus erythematosus comprising administering a therapeutically effective amount of anti-IL-6 receptor monoclonal antibody.” {Id. at 4.) Similarly, the Examiner finds, DE ’706 “teaches a method of treating diseases in which IL-6 is involved, comprising administering a therapeutically effective amount of anti-IL-6 receptor monoclonal antibody,” and “teaches examples of diseases treatable by the antibodies including systemic lupus erythematosus.” {Id.) Medical Dictionary, which the Examiner cites in support, defines “Lupus Nephritis” as “Glomerulonephritis associated with systemic lupus erythematosus.” (Medical Dictionary.) Appellants argue, inter alia, the Examiner’s rejection does not address the claimed invention. (Br. 6.) More specifically, Appellants contend, the Examiner relies on “an association between lupus nephritis and systemic lupus erythematosus (SLE)” and “an allegation is made that the prior art teaches treatment of a disease generally, without addressing the claimed invention, or showing that such treatment will reduce ‘the excretion of urinary protein’ in a subject with ‘lupus nephritis.’” {Id.)1 1 Appellants further argue that FR ’767 and DE ’706 are not enabled, and that the Office improperly picks and chooses elements from the generic disclosures of these references. (Br. 8.) 3 Appeal 2016-00007858 Application 12/232,341 Appellants’ argument is persuasive insofar as neither FR ’767 nor DE ’706 explicitly disclose administering an anti-IL-6 antibody to a patient suffering from lupus nephritis. FR ’767 and DE ’706 teach treatment of SLE. (FR ’767 4; DE ’706 8.) And the record suggests an “association” between SLE and lupus nephritis. (See, e.g., Medical Dictionary.) We are unpersuaded, however, that all SLE patients necessarily have lupus nephritis. Accordingly, the rejection of claims 13—16 as anticipated by FR ’767 or DE ’706 is reversed. II The Examiner rejected claims 13—16 as anticipated by Kiberd. (Final Act. 5—6.) The claims were not argued separately, and we choose claim 13 as representative. 37 C.F.R. § 41.37(c)(l)(iv). The Examiner finds that Kiberd “teach[es] a method for treating lupus nephritis comprising administering of [sic] IL-6 receptor antibody,” that “said antibody is a monoclonal” and “that administering neutralizing mAh to IL-6R proved to be effective therapeutically, as demonstrated by preserved glomerular function and structure.” (Id. at 5.) According to the Examiner, “although the reference is silent about reducing the excretion of urinary protein in lupus nephritis[,] it does not appear that the claim language or limitations result in a manipulative difference in the method steps when compared to the prior art disclosure.” (Id. at 5—6.) On this record, we agree with the Examiner’s finding that Kiberd anticipates claim 13. Kiberd discloses administration of a neutralizing monoclonal antibody to IL-6R — “an anti-interleukin-6 (IL-6) receptor antibody” as recited in claim 13. (Kiberd 58; see also id., passim.) Kiberd 4 Appeal 2016-00007858 Application 12/232,341 also discloses administration of the antibody to the same patient population as in claim 13 —patients suffering from lupus nephritis. (Id. at 58, 61.)8 The Examiner, in citing this substantial identity between the claims and the prior art, provides a reasoned basis for the determination that Kiberd’s antibodies would inherently reduce excretion of urinary protein in subjects with lupus nephritis. And Appellants have not provided sufficient persuasive evidence to the contrary: Where ... the claimed and prior art products are identical or substantially identical ... the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on “inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products. In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (citations and footnote omitted)). Kiberd will inherently obtain the same result as that required by claim 13 because “efficacy is inherent in carrying out the claim steps.” In re Montgomery, 677 F.3d 1375, 1381 (Fed. Cir. 2012). Here, the only claim step is administering the anti-IF6R antibody, and Kiberd performs this step (Kiberd 58). Appellants argue the rejection does not address the invention claimed and that the Office has not met its burden of demonstrating inherency. (Br. 8 The Specification discloses a range of effective doses (“0.01 mg to 100 mg per kg of body weight per administration”). (Spec. 27:30-37; compare with Kiberd’s 40-45 pg administration to mice on days 0, 1,2, 3, etc.) (Kiberd 58 (right col. (“Methods”).) 5 Appeal 2016-00007858 Application 12/232,341 5—6.) According to the Appellants, “[gjeneral statements of clinical efficacy, and effectiveness on other aspects of the disease, do not go to show that there exists nexus required for inherency.” {Id. at 7.) Also, Appellants argue Gaubitz9 and Kiberd rebut any assumption of inherency. (Id.) Appellants contend “Kiberd demonstrated that administration of a monoclonal antibody against IL-6R could be effective to treat aspects of the disease without being effective for treating proteinuria” and “evidence that treatment with IL-6R antibody did not decrease proteinuria in certain situations is very much relevant because it destroys the nexus required for inherency.” (Id.) Finally, Appellants argue, the art was unpredictable concerning a link between IL-6 and lupus as shown by Peterson10 and Ryffel.* 11 {Id. at 8.) Appellants’ arguments are unpersuasive. “In some cases,” as here, “the inherent property corresponds to a claimed new benefit or characteristic of an invention otherwise in the prior art.” Perricone v. Medicis Pharma Corp., 432 F.3d 1368, 1377 (Fed. Cir. 2005). As explained above, Kiberd teaches administering a monoclonal antibody to IL-6R to patients with lupus nephritis, and so claim 13 reads on Kiberd’s method. Even assuming Appellants were the first to appreciate an inherent reduction of urinary protein in these patients, a “new realization alone does not render the old 9 Gaubitz et al., Mycophenolate mofetil for the treatment of systemic lupus erythematosus: an open pilot trial, 8 Lupus 731—36 (1999). 10 Peterson et al., Serum and urinary interleukin-6 in systemic lupus erythematosus, 5 Lupus 571—75 (1996.) 11 Ryffel et al., Interleukin-6 Exacerbates Glomerulonephritis in (NZBxNZW)F! Mice, 144:5 Am. J. of Pathology 927-37 (1994). 6 Appeal 2016-00007858 Application 12/232,341 invention patentable.” Id.; see also In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990) (“It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.”). We turn to Appellants’ contentions about Gaubitz and Kiberd. Gaubitz treated SLE with a compound called mycophenolate mofetil — an ester derived from mycophenolic acid — and is not persuasive in showing what effects occur in patients receiving a neutralizing mAh to IL-6R as described in Kiberd. (Gaubitz 731.) Appellants contend Kiberd treated aspects of lupus nephritis “without being effective for treating proteinuria.” (Br. 7.) But, as the Examiner finds, Kiberd is silent about the effect on proteinuria. (Final Act. 5). Kiberd does not disclose that the neutralizing mAb to IL-6R was ineffective as Appellants’ argument suggests. Indeed, as Appellants’ Specification states, “[i]n the experiment by Kiberd ... no investigations were made on the timing of appearance of urinary protein.” (Spec. 2:24—26 (emphasis added).) Consequently, Appellants’ argument is unpersuasive in rebutting the Examiner’s determination that reduction in urinary protein is an inherent byproduct of Kiberd’s method. The alleged unpredictability in the art also unpersuasive in rebutting the rejection for anticipation. Again, Kiberd teaches administering the same agent (an anti-IL-6 receptor antibody) to the same patient population (those with lupus nephritis) as claimed. The evolving understanding of a link (or lack thereof) between IL-6 and lupus in the mid-1990s, as shown by Peterson and Ryffel, does not evidence that urinary protein was not reduced in Kiberd’s subjects. Moreover, rather than rebut the Examiner’s determination of inherency, Ryffel (cited by Appellants) supports the Examiner. Although Ryffel teaches that IL-6 antibody treatment did not 7 Appeal 2016-00007858 Application 12/232,341 inhibit glomerulonephritis, Ryffel discloses lower proteinuria in the treated mice compared to control (4.5 versus 4.9 g/1, respectively). (Ryffel 932.)12 Claim 13 requires “reducing the excretion of urinary protein” and therefore encompasses any reduction in protein levels. For the reasons above, the preponderance of the evidence on this record supports the Examiner’s rejection of claim 13 as anticipated by Kiberd. Claims 14—16 fall with claim 13. Ill The Examiner rejected claims 13, 17, and 18 as obvious over FR ’767, DE ’706, or Kiberd, in view of Tsuchiya. (Final Act. 7—8.) The Examiner relies on the disclosures of FR ’767, DE ’706, and Kiberd discussed above, and relies on Tsuchiya only for its teaching of a humanized PM-1 antibody (as recited in claim 17) and intravenous administration (as recited in claim 18.) {Id. at 7.) We reverse the rejection to the extent it is based on FR ’767 and DE ’706, which are deficient as explained above. As for the combination of Kiberd and Tsuchiya, Appellants do not provide separate argument regarding claims 17 or 18, or the obviousness rejection generally. To the extent Appellants contend the art is unpredictable, that contention was addressed above (II). Absent evidence to the contrary, we are persuaded that reducing the excretion of urinary protein would be inherent in administering an anti-IL-6 receptor antibody to subjects with lupus nephritis, which would further be the natural result of 12 This difference may not be large, but the claims do not specify any particular numerical reduction that is required. 8 Appeal 2016-00007858 Application 12/232,341 administering in the form or route specified in dependent claims 17 and 18 respectively. For these reasons, the preponderance of the evidence supports the Examiner’s conclusion that claims 13, 17, and 18 would have been obvious over Kiberd and Tsuchiya. SUMMARY The rejections for anticipation and obviousness based on FR ’767 or DE ’706 are reversed. The rejection of claims 13—16 as anticipated by Kiberd, and the rejection of claims 13, 17, and 18 as obvious over Kiberd and Tsuchiya are affirmed. 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 9 Copy with citationCopy as parenthetical citation