Ex Parte KatzDownload PDFPatent Trial and Appeal BoardJul 28, 201612306552 (P.T.A.B. Jul. 28, 2016) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 12/306,552 10/16/2009 David M. Katz 68705 7590 08/01/2016 TAROLLI, SUNDHEIM, COVELL & TUMMINO, LLP 1300 EAST NINTH STREET SUITE 1700 CLEVELAND, OH 44114 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. CWR-8170US PCT 4810 EXAMINER KIM, JENNIFER M ART UNIT PAPER NUMBER 1628 NOTIFICATION DATE DELIVERY MODE 08/01/2016 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): rkline@tarolli.com docketing@tarolli.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte DAVID M. KA TZ 1 Appeal2014-005663 Application 12/306,552 Technology Center 1600 Before DEMETRA J. MILLS, FRANCISCO C. PRATS, 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 a claims to a method of treating non-neurodegenerative pathologies or respiratory disorders. We have jurisdiction under 35 U.S.C. § 6(b ). We affirm. 1 According to Appellant, the real party in interest is Case W estem Reserve University. (Br. 2.) Appeal2014-005663 Application 12/306,552 STATEMENT OF THE CASE Claims on Appeal Claims 1 and 3-19 are on appeal.2 (Claims Appendix, Br. 29-39.) Claims 1 and 8 are illustrative and read as follows: 1. A method of treating non-neurodegenerative pathologies associated with derangement in brain-derived neurotrophic factor signaling in the brain stem of a subject comprising: administering to the subject an amount of at least one ampakine effective to increase brain-derived neurotrophic factor expression in at least one of brain stem neurons and nodose sensory neurons of the subject. (Id. at 29.) 8. A method of treating respiratory disorders in a subject caused by loss- of-function mutations of the gene encoding methyl-CpG binding protein 2 (MeCP2), comprising: administering to the subject an amount of at least one ampakine effective to increase brain-derived neurotrophic factor expression in brain stem neurons and nodose sensory neurons and improve respiratory function of the subject. (Id. at 32-33.) Examiner's Rejections 1. Claims 1and3-7 stand rejected under 35 U.S.C. § 102(b) as anticipated by Gall, 3 as evidenced by Zoghbi. 4 (Final Act. 2.)5 2 Appellant elected the ampakine species 1-(1,4-benzodioxan-6- ylcarbonyl)piperidine, also known as GR87. (Response to Election Requirement dated Mar. 30, 2012. See also Final Act. 2.) 3 Gall et al., US 6,030,968, issued Feb. 29, 2000 ("Gall"). 4 Zoghbi et al., US 6, 7 09 ,817 B 1, issued Mar. 23, 2004 ("Zoghbi"). 5 Office Action dated Mar. 13, 2013. 2 Appeal2014-005663 Application 12/306,552 2. Claims 8-19 stand rejected under 35 U.S.C. § 103(a) as unpatentable over Zoghbi and Gall. (Id. at 5.) FINDINGS OF FACT We adopt as our own the Examiner's findings and analysis concerning the scope and content of the prior art. The following findings are included for emphasis and reference convenience. FF 1. The Specification states that "[b ]y non-neurodegenerative pathology, it is means [sic] diseases and disorders that are not associated with neuronal injury or neuronal death .... These non-neurodegenerative pathologies can include pervasive development disorders, such as Rett Syndrome and autism." (Spec. i-f 44.) FF 2. Gall teaches "[m]ethods for increasing the level of neurotrophic factors and neurotrophic factor receptors in the brain of a mammal ... comprising administering to a mammal an effective amount of an allosteric upmodulator of ... (AMPA) receptors" (e.g., an ampakine). (Gall Abstract.) FF 3. Gall teaches that pathologies that would benefit from its invention (administration of ampakines) include Rett syndrome. (Gall col. 6, 11. 21-23 and 37.) FF 4. Gall teaches brain derived neurotrophic factor (BDNF) mRNA levels were significantly increased by treatment with ampakine GR87. (Gall col. 14, 11. 6-45.) FF 5. Gall teaches that "[t]ypical dosages for systemic administration range from 0.1 to 50 milligrams per kg weight of subject per administration." (Gall col. 10, 11. 38--40.) 3 Appeal2014-005663 Application 12/306,552 FF 6. Zoghbi teaches that Rett syndrome (RTT) patients exhibited a "positive correlation ... between truncating mutations and ... breathing abnormalities." (Zoghbi col. 11, 11. 60-66.) FF 7. The Examiner finds that Gall teaches the treatment of Rett syndrome (R TT) by administration of GR87 with the same therapeutic amounts as claimed by Appellant, and that treatment of "non- neurodegenerative pathologies" (including associated respiratory abnormalities) is inherent upon treatment of the same disorder (R TT) by administration of the same active agent (GR87) to RTT patients. (Final Act. 3.) FF 8. Zoghbi teaches that "defects in MECP2 are related to Rett syndrome" and that "MECP2 is clearly involved in Rett syndrome and its related features."6 (Zoghbi col. 13, 1. 15-20.) ISSUES Whether a preponderance of evidence of record supports the Examiner's (1) finding of anticipation under 35 U.S.C. § 102(b), and (2) conclusion of obviousness under 35 U.S.C. § 103(a). DISCUSSION Principles of Law Claims under examination are given their broadest reasonable interpretation consistent with the specification, as interpreted by one of ordinary skill in the art. In re Am. Academy of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). 6 MECP2 refers to methyl-CpG-binding protein 2. (Zoghbi col. 8, 11. 52- 53.) 4 Appeal2014-005663 Application 12/306,552 A claim is anticipated if a prior art reference discloses every limitation of the claimed invention, either explicitly or inherently. In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). In considering the disclosure ofa reference for anticipation, it is proper to take into account not only specific teachings of the reference but also the inferences that one skilled in the art would reasonably be expected to draw therefrom. In re Preda, 401 F .2d 825, 826 (CCP A 1968). "It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable." In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990) (citing cases). When the examiner has required the applicant to elect single chemical species for examination, the issue on appeal is the patentability of the single elected species. It is appropriate to limit discussion to that single issue and take no position respecting the patentability of the broader generic claims, including the remaining, non-elected species. See Ex parte Ohsaka, 2 USPQ2d 1461 (Bd. Pat. App. Int. 1987). We limit discussion and consideration to the elected species, and take no position respecting the patentability of the broader generic claims, including the remaining, non- elected species. Rejection No. I-Anticipation Claim 1 Analysis We agree with the Examiner's finding that claim 1 is anticipated by Gall, as evidenced by Zoghbi. (FF 1-7.) Appellant challenges that finding with several arguments. 5 Appeal2014-005663 Application 12/306,552 Appellant asserts that Gall does not "disclose treating non- neurodegenerative pathologies with ampakine in any amount. (Br. 7.) We are not persuaded. Non-neurodegenerative pathologies, as recited in claim 1, includes Rett syndrome. (FF 1.) Moreover, Gall discloses treatment of that pathology (RTT) with a specified amount of ampakine (GR87). (FF 3- 5.) Appellant argues that Gall does not specifically disclose or inherently teach the limitations of claim 1. (Br. 7-8.) We understand this argument to refer to the recited increase in BDNF expression in brain stem neurons or nodose sensory neurons, and that "the outcome of the step" taught by Gall "provides a result that was not prior known, and thus not inherently anticipated." (Id. at 8-9.) We are not persuaded. Gall discloses a method of increasing BDNF expression in the brain by administration of an ampakine (FF 2--4), and the mere discovery or claiming of a new benefit or outcome (treating non-neurodegenerative pathologies) of that method does not render Appellant's process patentable. See Woodruff, 919 F.2d at 1578. Moreover, inherent anticipation may correspond to a claimed new benefit, or a scientific explanation for the prior art's function, but the new realization alone does not render the old invention patentable. Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377-78 (Fed. Cir. 2005) (citing cases). Accordingly, we find no error in the Examiner's finding of and reliance on inherent anticipation. 7 7 Appellant's reference to "improper hindsight" (Br. 9) is inapt since that concept applies, if at all, in the context of obviousness, not anticipation. 6 Appeal2014-005663 Application 12/306,552 Appellant argues that Gall, as evidenced by Zoghbi, "do not enable a person skilled in the art to practice the claimed method." (Br. 10.) In support of that argument, Appellant focuses on alleged deficiencies in Gall. (Id.) Because Gall is presumptively enabled, and teaches the claimed method of increasing BDNF, the burden shifts to Appellant to rebut that presumption. See In re Antor Media Corp., 689 F.3d 1282, 1287-88 (Fed. Cir. 2012) (citing cases). We find that Appellant has not persuasively rebutted the presumption of enablement that applies to Gall. Gall need only enable the portions of its disclosure alleged to anticipate. Id. at 1290. Moreover, proof of efficacy is not required for Gall to be enabling for purposes of anticipation; rather, the proper issue is whether Gall "describes the claimed invention sufficiently to enable a person of ordinary skill in the art to carry out the invention." See Impax Labs., Inc. v. Aventis Pharms. Inc., 468 F.3d 1366, 1383 (Fed. Cir. 2006). Here, Gall describes experiments wherein BDNF was increased by administration of the elected ampakine (GR87), and expressly states that Rett syndrome is a pathology (a non-neurodegenerative pathology according to Appellant) that would benefit from administration (in a dosage range) of the invention. (FF 2-5.) Accordingly, we conclude that Gall is enabled because it sufficiently describes the claimed invention to enable a person of ordinary skill in the art to carry it out. Claims 3-6 Appellant states that claims 3---6 depend directly or indirectly from claim 1 and are allowable because of the "deficiencies in the rejection with respect to claim 1 and the specific limitations recited in claims 3-6." (Br. 16.) Claims 3-6 are thus anticipated for the reasons set forth above, and for 7 Appeal2014-005663 Application 12/306,552 failing to assert any additional arguments beyond those presented in response to the rejection of claim 1. See 37 C.F.R. § 41.37(c)(l)(iv); Hyatt v. Dudas, 551F.3d1307, 1314 (Fed. Cir. 2008). Claim 7 Appellant argues that "the range of ampakine administered to the subject in Gall [] is not described with sufficient specificity to be anticipatory of the range recited in claim 7." (Br. 17.) We are not persuaded. Claim 7 recites a range of "about 10 mg/kg per day to about 50 mg/kg per day." (Br. 32.) The term "about" in defining the claimed range is one of degree, and is given its broadest reasonable interpretation consistent with the specification, as interpreted by one of ordinary skill in the art. See Am. Academy of Sci. Tech Ctr., 367 F.3d at 1364. The Specification states that "[t]he quantity of active component in a unit dose preparation may be varied or adjusted from 0.1 mg/kg per day to about 100 mg/kg per day, for example, ranging from 10 mg/kg per day to about 50 mg/kg per day according to the particular application and the potency of the active component." (Spec. i-f 84.) Accordingly, for purposes of our analysis herein, we conclude that a person of ordinary skill in the art would interpret "about 50 mg/kg per day" in claim 7 as including (at least) "49.9 mg/kg per day." Based on the foregoing construction, Gall's teaching of0.1to50 milligrams per kg (FF 5) discloses a range that overlaps and is broader than the claimed range. Moreover, because Appellant does not establish the criticality of its claimed range, Gall anticipates claim 7. See Ineos USA LLC v. Berry Plastics Corp., 783 F.3d 865, 869-70 (Fed. Cir. 2015). 8 Appeal2014-005663 Application 12/306,552 Rejection No. 2--0bviousness The Examiner concluded that it would have been obvious to a person of ordinary skill in the art, based on the teachings of Zoghbi and Gall, to use ampakines (including GR87) for the treatment of R TT patients (e.g., with breathing abnormalities per Zoghbi) because Gall teaches that GR87 is useful for treatment of RTT. (Final Act. 6.) Furthermore, one of skill in the art would have been motivated to do so in order to achieve an expected benefit of ampakines (GR87) in the treatment of RTT as taught by Gall. (Id.) In addition, the Examiner found a reasonable expectation of success in the treatment of R TT with GR87 because Gall teaches that GR87 has therapeutic benefit in the treatment of RTT. (Id.) The Examiner also found that improving breathing problems in patients suffering from R TT is an obvious result upon the treatment of R TT which causes the symptoms of breathing difficulties. (Id.) We find that the Examiner has satisfied the burden of showing "some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). Moreover, the Examiner has established a prima facie case of obviousness and, as discussed below, Appellant has not overcome that prima facie case. We note at the outset that the test for obviousness is what the combined teachings of Zoghbi and Gall would have suggested to one of ordinary skill in the art. See In re Keller, 642 F.2d 413, 425 (CCPA 1981) (citing cases). Furthermore, "'a reference must be considered not only for what it expressly teaches, but also for what it fairly suggests.'" In re Baird, 9 Appeal2014-005663 Application 12/306,552 16 F.3d 380, 383 (Fed. Cir. 1994) (quoting Jn re Burckel, 592 F.2d 1175, 1179 (CCPA 1979)). Claim 8 Appellant repeats many of the arguments set forth above in connection with claim 1, and they are unpersuasive for the reasons set forth above. Appellant also argues that Zoghbi teaches that "only some of the features of Rett syndrome may be accounted for by the loss of MeCP2 function." (Br. 20.) However, given that Zoghbi specifically correlates RTT with breathing abnormalities (FF 6) and with loss of MeCP2 function (FF 8), we find that Zoghbi "fairly suggests" a correlation between breathing abnormalities and loss of MeCP2 function. See Baird, 16 F.3d at 383. Appellant also argues that there was "uncertainty in the art regarding the effects of MeCP2 on BDNF expression" and that "the outcome of a method of Gall ... would not be inherent." (Br. 21-23.) We understand this argument to essentially be that the mechanism of action of MeCP2 and BDNF expression, particularly as it relates to respiratory disorders, was unclear or unknown prior to the present invention. But even if that were so, because Gall discloses the same administration step as recited in claim 8, the particular benefits (e.g., improved respiratory function) "must naturally flow" from that method even if not recognized at the time of Gall's disclosure. See Perricone, 432 F.3d at 1378. While Perricone involved anticipation based on inherency, 8 the Examiner's obviousness conclusion is 8 .... 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 ... In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (emphasis added.) 10 Appeal2014-005663 Application 12/306,552 based on an actual recognition in the art; namely, Zoghbi's teaching and suggestion of the benefit (improved respiratory function) that Appellant asserts is new. (FF 6, 8.) Appellant also argues that one skilled in the art would not have had a reasonable expectation of success. (Br. 23-24.) A reasonable expectation of success "refers to the likelihood of success in combining references to meet the limitations of the claimed invention." Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821F.3d1359, 1367 (Fed. Cir. 2016). Here, given the teachings of Gall and Zoghbi (FF 2-8), we agree with the Examiner's finding that a person of ordinary skill in the art would have had a reasonable expectation of success in combining the references to meet the limitations of claim 8. (Final Act. 6.) See also KSR, 550 U.S. at 421 ("A person of ordinary skill is also a person of ordinary creativity, not an automaton."); In re Sovish, 769 F.2d 738, 743 (Fed. Cir. 1985) (skill is presumed on the part of one of ordinary skill in the art). Appellant provides no rebuttal evidence to support a finding of a lack of a reasonable expectation of success on the part of one of ordinary skill in the art familiar with the disclosures of Gall and Zoghbi. Appellant bears burden of providing factual evidence of nonobviousness to rebut prima facie case. Ex parte Phillips, 28 USPQ2d 1302 (Bd. Pat. App. Int. 1993). Claims 9-13 Appellant states that claims 9-12 depend directly or indirectly from claim 8 and are allowable because of the "deficiencies in the rejection with respect to claim 1 [sic, 8] and the specific limitations recited in claims 9- 12." (Br. 24.) Appellant also states that "[c]laim 13 recites similar limitations as claims 7 and 8 and is therefore allowable because of the 11 Appeal2014-005663 Application 12/306,552 aforementioned deficiencies in the rejection with respect to claims 7 and 8." (Id.) Claims 9-13 are thus obvious for the reasons set forth above, and for failing to assert any additional arguments beyond those previously presented. See 37 C.F.R. § 41.37(c)(l)(iv). Claim 14 Appellant asserts essentially the same arguments set forth above in connection with claims 1 and 8, and they are unpersuasive for the reasons set forth above. In addition, Appellant argues that the Examiner has engaged "improper hindsight" in the rejection of claim 14 based on the combination of Zoghbi and Gall. (Br. 25-26.) However, rather than using hindsight, the Examiner points to specific disclosures in the prior art that describe the limitations of Appellant's claimed method. (Final Act 5----6.) \Ne therefore find that the Examiner's obviousness conclusion is based on sufficiently articulated reasoning that overcomes any co11cen1s about hindsight bias. See KSR, 550 U.S. at 418. Claims 15-19 Appellant states that claims 15-18 depend directly or indirectly from claim 14 and are allowable because of the "deficiencies in the rejection with respect to claim 1 [sic, 14] and the specific limitations recited in claims 15- 18." (Br. 27.) Appellant also states that "[c]laim 19 recites similar limitations as claims 7 and 14 and is therefore allowable because of the aforementioned deficiencies in the rejection with respect to claims 7 and 14." (Id.) Claims 15-19 are thus obvious for the reasons set forth above, and for failing to assert any additional arguments beyond those previously presented. See 37 C.F.R. § 41.37(c)(l)(iv). 12 Appeal2014-005663 Application 12/306,552 Conclusion A preponderance of evidence of record supports the Examiner's finding that claims 1 and 7 are anticipated under 35 U.S.C. § 102(b). Claims 3---6 were not argued separately and fall with claim 1. A preponderance of evidence of record supports the Examiner's conclusion that claims 8 and 14 are obvious under 35 U.S.C. § 103(a). Claims 9-13 were not argued separately and fall with claim 8 and claims 15-19 were not argued separately and fall with claim 14. We limit this decision to the elected species, and take no position respecting the patentability of the broader generic claims, including the remaining, non-elected species. SUMMARY We affirm the rejections of all claims on appeal. 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 13 Copy with citationCopy as parenthetical citation