Ex Parte Look et alDownload PDFPatent Trial and Appeal BoardDec 22, 201612668174 (P.T.A.B. Dec. 22, 2016) 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. 12/668,174 11/22/2010 Gary Charles Look 089265-1001 4068 38706 7590 12/27/2016 FOT FY Rr T ARDNFR T T P EXAMINER 3000 K STREET N.W. JAVANMARD, SAHAR SUITE 600 WASHINGTON, DC 20007-5109 ART UNIT PAPER NUMBER 1627 NOTIFICATION DATE DELIVERY MODE 12/27/2016 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): ipdocketing @ foley. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte GARY CHARLES LOOK, LAURI SCHULTZ, ALEXANDRE MIKHAYLOVICH POLOZOV, NIKHIL BHAGAT, JIAN WANG, DAVID E. ZEMBOWER, WILLIAM F. GOURE, TODD PRAY, and GRANT A. KRAFFT1 Appeal 2015-001185 Application 12/668,174 Technology Center 1600 Before ULRIKE W. JENKS, RICHARD J. SMITH, and JOHN E. SCHNEIDER, Administrative Patent Judges. JENKS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims directed to a method of inhibiting neurotoxic amyloid [3-derived diffusible ligands (ADDLs). The Examiner rejects the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. 1 According to Appellants, the real party in interest is Acumen Pharmaceuticals, Inc. (Br. 2.) Appeal 2015-001185 Application 12/668,174 STATEMENT OF THE CASE Claims 4, 14, 15, 17—32, 34, and 35 are on appeal, and can be found in the Claims Appendix of the Appeal Brief. Claim 4 is representative of the claims on appeal, and reads in pertinent part as follows: 4. A method for inhibiting neurotoxic ADDL formation in a patient suffering from mild cognitive impairment wherein the method comprises inhibiting neurotoxic ADDL formation by administering to said patient a therapeutically effective amount of a compound of the formula: or a pharmaceutically acceptable salt, stereoisomer, tautomer, or prodrug thereof; with the proviso that the compound exhibits an IC50 of about 50 pM or less in the FRET assay; and wherein the compound of formula I inhibits neurotoxic ADDL formation so as to treat the patient. (Br. 15—16, Claims Appendix). The claims stand rejected as follows: Claims 4, 14, 15, 17—32, 34, and 35 under 35 U.S.C. § 103(a) as unpatentable over Ansorge2 as evidenced by Klein3 (Ans. 4—7). 2 Ansorge et al., WO 2005/037257 A2, published Apr. 28, 2005 (“Ansorge”). In the Answer and Final Office Action the Examiner relies on the English language equivalent US 2007/0037752 Al, published Feb. 15, 2007, when referencing Ansorge, and we will do the same in this opinion. 3 Klein et al., WO 2004/031400, published Apr. 15, 2004 (“Klein”). 2 Appeal 2015-001185 Application 12/668,174 Claims 4, 14, 15, 17—32, 34, and 35 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 29 and 30 of copending U.S. Application No. 11/777,2644 (Final Act. 2-3). Claims 4, 14, 15, 17—32, 34, and 35 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claim 23 of copending U.S. Application No. 11/777,2665 (Final Act. 3). Obviousness-type Double Patenting'. Appellants do not mention the pending nonstatutory obviousness type patenting rejections in their Brief. Appellants previously “requested] that th[ese] obviousness-type double patenting rejection[s] be held in abeyance and will address the rejection[s] when the claims of one of these applications are found to be otherwise allowable and Applicants can then evaluate whether the then allowed claims still entail consideration of an obviousness- type double patenting rejection” (see Response 19—20, filed June 4, 2013). We interpret Appellants’ request as a waiver of the appeal of the obviousness-type double patenting rejections. Therefore, we summarily affirm, and will not further discuss, the obviousness-type double patenting rejections of record (see Ans. 7). 4 Issued on Apr. 14, 2015, as US 9,006,283. 5 Issued Feb. 24, 2015, as US 8,962,677. 3 Appeal 2015-001185 Application 12/668,174 Obviousness over Ansorge as evidenced by Klein The issue is: Does the preponderance of evidence relied upon by the Examiner support a conclusion of obviousness? Findings of Fact We adopt the Examiner’s findings of fact and reasoning regarding the scope and content of the prior art as set out in the Answer and Final Office Action mailed Sept. 25, 2013. For emphasis only, we highlight the following: FF1. Ansorge teaches “substances specifically inhibiting peptidases cleaving Ala-p-nitroanilide” for use in medicine (Ansorge 110, see Abstract). FF2. Ansorge teaches compounds the “are used for a prophylaxis and a therapy of diseases” such as “chronic neuronal diseases, for example Marbus Alzheimer, Pick’s disease, of the progressive supranuclear palsy, of a corticobasal degeneration, of a frontotemporal dementia” among others (Ansorge 1 55). FF3. Ansorge teaches compound A11.005 reproduced below: The chemical structure of compound A11.005 is shown above (Ansorge 176, Table 1). 4 Appeal 2015-001185 Application 12/668,174 FF4. The Examiner finds that compound A11.005 is structurally similar to the elected species, compound 2 (see Ans. 6). Compound 2 of the Specification is reproduced below: (Spec. 28, Table 1 A). The Examiner finds that Ansorge’s compound A11.005 “which most closely resembles the elected specie (compound 2, page 28), with the exception of nitro versus hydroxyl substituted phenyl” (Ans.6). FF5. Example 2 of Ansorge teaches the administration of alanyl aminopeptidases and dipeptidyl peptidase IV into autoimmune encephalomyelitis (EAE) induced mice. Specifically, “[a]ctinonine was used as the alanyl aminopeptidase inhibitor, Lys[Z(N02)] pyrrolidide was used as the dipeptidyl peptidase IV inhibitor” and observing the mice, the results “demonstrate unequivocally a most strong and long-lasting [vD2] therapeutic effect after a combined inhibition of both peptidases” (Ansorge 178). Principle of Law The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention. Ex parte Obiaya, 227 USPQ 58, 60 (BPAI 1985). ft is sufficient that the reference “suggests doing what appellants have done.” In reKronig, 539 F.2d 1300, 1304 (CCPA 1976). 5 Appeal 2015-001185 Application 12/668,174 Analysis Appellants contend that “Ansorge does not teach or suggest that the compounds recited therein treat mild cognitive impairment in a patient” (Br. 9, see also 10 (“Nowhere does Ansorge teach inhibiting neurotoxic ADDL formation in a patient suffering from mild cognitive impairment”)). We are not persuaded by Appellants’ contention that Ansorge does not teach a patient population with mild cognitive impairment (Br. 9). We begin with claim construction of the phrase “mild cognitive impairment,” giving the claims “their broadest reasonable interpretation consistent with the specification.” In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000). The Specification describes that the administration of the compound reduces or eliminates mild cognitive impairment in patients that have not yet developed characteristic Alzheimer’s pathology. In particular embodiments, a therapeutically effective amount intends to indicate the amount of one or more compounds described herein administered or delivered to the patient which is most likely to result in the desired response to treatment (Spec. 20, see also 17 (“Patients amenable to treatment include individuals at risk of disease but not exhibiting symptoms, as well as patients presently exhibiting symptoms”), see Ans. 8—9.) We agree with the Examiner that the Specification does not specifically define “mild cognitive impairment,” however, based on the disclosure in the Specification, “mild cognitive impairment should be understood as to encompass a symptom of Alzheimer disease” (Ans. 9). In other words, mild cognitive impairment can include patients that are symptomatic as well as patients that are not symptomatic. Specifically, the Specification further suggests that “the compounds described herein can be administered prophylactically to the general 6 Appeal 2015-001185 Application 12/668,174 population without the need for any assessment of the risk of the patient” (Spec. 17). Here, the Specification describes prophylactically treating a genus of patients that includes patients that are not yet symptomatic as well as patients that will never develop disease. Thus, the broadest reasonable interpretation of “mild cognitive impairment” includes symptomatic as well as non-symptomatic general patient populations. We are not persuaded by Appellants’ contention that Ansorge does not teach a patient population with mild cognitive impairment as encompassed by the Specification (Br. 9). Ansorge teaches that the compounds can be administered prophylactically to patients, which is understood by the ordinary artisan to encompass patients that do not yet exhibit disease (FF2). The Examiner interprets that the only positively recited method step in the claim is the step of administering the compound of formula I to a patient population. It is respectfully noted that Examiner is still of the opinion that if the same compounds are employed to treat the same diseases, then one of ordinary skill in the art can assume, with a reasonable degree of success, that the same mechanism of action is being engaged. Furthermore, Ansorge teaches diseases including of chronic neuronal diseases, for example Marbus Alzheimer, Pick's disease, of the progressive supranuclear palsy, of a corticobasal degeneration, of a frontotemporal dementia (see claim 83). (Ans. 8.) The Examiner identifies that Ansorge teaches the administration of compounds to patients with Alzheimer symptoms or prophylactically to patients that do not yet have symptoms of disease (Ans. 6 (“the claimed compounds taught in Ansorge to treat the same diseases will ultimately undergo the same cascade of events, even though said art is silent on the 7 Appeal 2015-001185 Application 12/668,174 matter”)). The Examiner reasonably finds that Ansorge teaches the administration of compounds of formula I to the same patient population. We agree with the Examiner’s conclusion that the result of administering the same compound to the same patient population results in the same action (see Ans. 6). The Examiner acknowledges that “Ansorge does not teach that diseases such as Alzheimer’s and others as recited in claim 4 that lead to cognitive impairment are mediated by ADDL” (Ans. 6), however, this would flow naturally form the administration of the compound to the same patient population, in this case Alzheimer’s patients or prophylactically to a general patient population (FF2). “[I]t is not required . . . that the prior art disclose or suggest the properties newly-discovered by an applicant in order for there to be a prima facie case of obviousness.” In re Dillon, 919 F.2d 688, 697 (Fed. Cir. 1990). See also Atlas Powder Co. v. Ireco, Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999) (“[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.”). Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Prindle, 297 F.2d 251, 254 (CCPA 1962). We agree with the Examiner’s position that administering the compounds, the only active step required by the claim, to the same patient population will provide the same result, that is inhibiting the neurotoxic effect of the accumulation of ADDF (Ans. 6 (“the claimed compounds taught in Ansorge to treat the same diseases will ultimately undergo the same cascade of events, even though said art is silent on the matter”)). 8 Appeal 2015-001185 Application 12/668,174 Appellants contend that “[t]he Examiner’s assertion that the compounds of Ansorge inherently possess the indicated FRET activity is erroneous” (Br. 12). We are not persuaded by Appellants’ contention. The Examiner explains that the limitation “with the proviso that the compound exhibits an IC50 of about 50 gM or less in the FRET assay; and wherein the compound of formula I inhibits neurotoxic ADDL formation so as to treat the patient” are features that are associated with the compound.6 We find no error with the Examiner’s position that a compound and its properties are not separable. The Examiner has provided sufficient evidence that Ansorge compound meets the structural limitations of formula I shifting the burden to Appellants to show that they do not meet this limitation. “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. . . . [The] fairness [of the burden-shifting] 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). Here, the compound identified by the Examiner is the same as the claimed compound, and when administered to either symptomatic patients or prophylactically to a general patient population that does not display symptoms, the mechanism of action between the compound and ADDL is same. 6 We note that compound 26 of the Specification (see Spec. 32) is positional homolog to the compound identified by the Examiner in Ansorge (FF3), compound 26 was shown to have an IC50 of 16.5. 9 Appeal 2015-001185 Application 12/668,174 We conclude that the preponderance of the evidence of record supports the Examiner’s conclusion that Ansorge as evidenced by Klein renders obvious the treatment method of claim 4. We thus affirm the rejection of claim 4 under 35 U.S.C. § 103(a) as being obvious, and because claims 14, 15, 17—32, 34, and 35 were not separately argued, they fall with claim 4. 37 C.F.R. § 41.37(c)(l)(iv). SUMMARY We affirm the rejection of claims 4, 14, 15, 17—32, 34, and 35 under 35 U.S.C. § 103(a) as unpatentable over Ansorge as evidenced by Klein. We summarily affirm the rejection claims 4, 14, 15, 17—32, 34, and 35 on the ground of nonstatutory obviousness-type double patenting over claims 29 and 30 of copending U.S. Application No. 11/777,264 (now US 9,006,283). We summarily affirm the rejection claims 4, 14, 15, 17—32, 34, and 35 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 21 and 21 of copending U.S. Application No. 11/777,266 (now US 8,962,677). 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 10 Copy with citationCopy as parenthetical citation