ANJI PHARMACEUTICALS INC.

Patent Trials and Appeals Board

Feb 15, 2022

2021002815 (P.T.A.B. Feb. 15, 2022)

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. 14/399,157 11/05/2014 Keith R. Walley AJH-00301 5102 25181 7590 02/15/2022 FOLEY HOAG, LLP (General) PATENT GROUP, SEAPORT WEST 155 SEAPORT BLVD BOSTON, MA 02210-2600 EXAMINER WEN, SHARON X ART UNIT PAPER NUMBER 1644 NOTIFICATION DATE DELIVERY MODE 02/15/2022 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): Patent@foleyhoag.com pair_foleyhoag@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte KEITH R. WALLEY, JOHN H. BOYD, and JAMES A. RUSSELL Appeal 2021-002815 Application 14/399,157 Technology Center 1600 Before JEFFREY N. FREDMAN, JOHN E. SCHNEIDER, and RACHEL H. TOWNSEND, Administrative Patent Judges. SCHNEIDER, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims 1, 11, 13, 14, and 67−73.2 We have jurisdiction under 35 U.S.C. § 6(b). We affirm in part and enter a new ground of rejection. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appellant identifies the real party in interest as Anji Pharmaceuticals Inc. Appeal Br. 2. 2 Claims 4, 44, and 48 are pending in the application but have been withdrawn from consideration. Final Act. 1. Appeal 2021-002815 Application 14/399,157 2 CLAIMED SUBJECT MATTER The claims are directed to proprotein convertase subtilisin kexin 9 (PCSK9) inhibitors and their use in the amelioration or treatment of an inflammatory response to infection and to treat complications associated therewith. Spec. 1. Claim 1, reproduced below, is illustrative of the claimed subject matter: 1. A method of treating sepsis or septic shock in a subject who has sepsis or septic shock, the method comprising: administering an effective amount of a proprotein convertase subtilisin kexin 9 (PCSK9) inhibitor to the subject, wherein the PCSK9 inhibitor is selected from AMG145, 1D05- IgG2, SAR236553/REGN727 (Alirocumab), RN-316, and RG7652. REFERENCES The prior art relied upon by the Examiner is: Name Reference Date Bylock US 2013/0195879 A1 Aug. 1, 2013 Thain, et al., A Low Density Lipoprotein (ldl) Receptor Modulator, Pcsk- 9, Is Associated With Increased Mortality in Septic Shock, 85 Am. J. Respiratory and Critical Care Medicine A5999 (2012) REJECTIONS Claims 1, 11, 13, 14, and 67−71 have been rejected under 35 U.S.C. §102 as anticipated by Bylock. Claims 72 and 73 have be rejected under 35 U.S.C. § 103 as unpatentable over Bylock in view of Thain. Appeal 2021-002815 Application 14/399,157 3 OPINION Claims 1, 11, 13, 14, and 67−71 Issue The issue with respect to this rejection is whether a preponderance of the evidence supports the Examiner’s conclusion that claims 1, 11, 13, 14, and 67−71 are anticipated by Bylock. The Examiner finds Bylock discloses method of treating sepsis comprising administering alirocumab. Final Act. 4. The Examiner finds Bylock discloses a method for treating various cardiovascular diseases including sepsis. Id. The Examiner finds that the diseases listed in Bylock also read on septic shock. Id. Appellant contends Bylock does not disclose the use of PCSK9 inhibitors to treat sepsis. Appeal Br. 5−6. Appellant contends while Bylock discloses “(1) ‘sepsis’; (2) ‘alirocumab’ (a PCSK9 inhibitor); and (3) treating a cardiovascular disease with a compound and an additional agent; . . . these separate recitations cannot properly be pieced together to establish that the claimed method was disclosed in Bylock.” Id. at 6. Appellant goes on to contend “What is missing from Bylock is any disclosure that would connect use of a PCSK9 inhibitor specifically to treating sepsis or septic shock.” Id. Appellant argues: Indeed, Bylock proposes no specific uses or functions for PCSK9 inhibitors, leaving one of skill in the art to rely solely on background knowledge to determine situations appropriate for the use of PCSK9 inhibitors as a secondary agent. Despite this clear deficiency, the Examiner has cited no prior art teaching or any other motivation for one skilled in the art to use PCSK9 inhibitors to treat sepsis, whether alone or in combination with another agent. Appeal 2021-002815 Application 14/399,157 4 Id. at 6-7. Appellant goes on to contend that Bylock fails to enable the use of PCSK9 inhibitors to treat sepsis. Id. at 7. Appellant contends the parts of Bylock that mention PCSK9 inhibitors merely recite them for their known functions that might be relevant to cardiovascular conditions as a genus, and not for their newly discovered effects disclosed in the instant application. Id. Principles of Law “[U]nless a prior art reference discloses within the four corners of the document not only all of the limitations claimed but also all of the limitations arranged or combined in the same way as recited in the claim, it cannot be said to prove prior invention of the thing claimed and, thus, cannot anticipate under 35 U.S.C. § 102.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). Analysis We have considered the arguments presented by the Examiner and Appellant as well as the evidence of record and find Appellant has the better argument. While Bylock discloses treating sepsis and the use of alirocumab, we discern nothing in Bylock that connects the two disclosures together such that one skilled in the art would use alirocumab to treat sepsis. As Appellant points out, Bylock focuses on the use of inhibitors of 5-lipoxygenase activating protein (FLAP) to treat cardiovascular disease including sepsis. Appeal Br. 5. Bylock teaches adding a PCSK9 inhibitor such as alirocumab as part of a combination therapy but Bylock does not tie the use of the additional agent to treatment of sepsis. See Bylock ¶¶ 627-636. Instead, as Appellant points out, the additional agents are used because of their general Appeal 2021-002815 Application 14/399,157 5 use in treating cardiovascular conditions and are identified as being used for specific purposes other than treating sepsis. Appeal Br. 6. While we reverse the rejection of claims 1, 11, 13,14, and 67-71 based on anticipation, we find the claims to be unpatentable under 35 U.S.C. § 103 over Bylock combined with Thain. Bylock teaches alirocumab acts as a PCSK9 inhibitor and teaches its administration to a patient who has cardiovascular diseases in general but does not teach or suggest that it can be used to treat sepsis specifically. Bylock ¶¶ 627 & 632. As seen above, claim 1 uses the transitional phrase “comprising” which permits the presence of active agents other that the PCSK9 inhibitor. Bylock teaches the combination of a FLAP inhibitor and an additional active agent such as a PCSK9 inhibitor. See Bylock ¶¶ 627-636 Thain teaches PCSK9 is associated with increased mortality from septic shock. Thain A 5999. We find Thain’s association of PCSK9 with septic shock and Bylock’s teaching that alirocumab is a PCSK9 inhibitor and its administration to patients, would have led one skilled in the art to use alirocumab to treat septic shock with a reasonable expectation of success. This is a new ground of rejection under 37 C.F.R. § § 41.50(b). Claims 72 and 72 Claims 72 and 73 depend from claim 1 and add the limitation that the patient treated has one or more GOF PCSK9 alleles or a rs644000 A allele (GOF). The issue before us in whether a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 72 and 73 would have been obvious to one of ordinary skill in the art at the time the invention was made over Bylock combined with Thain. Appeal 2021-002815 Application 14/399,157 6 The Examiner reiterates the findings with respect to Bylock recited above. Final Act. 6. The Examiner finds: it would have been obvious to one of ordinary skill in the art to treat sepsis or septic shock in patients with SNP rs644000 in PCSK9 gene because PCSK9 rs644000 polymorphism was well known to be associated with increased mortality in patients with septic shock as taught by Thain (see entire document). Therefore, one of ordinary skill in the art would have been motivated to use the method taught by Bylock in patients with GOF PCSK9 rs644000 polymorphism as they have high risk of mortality. Id. Appellant contends “the Examiner has erred by (1) improperly relying on Bylock as establishing that the claimed method existed in Bylock; and (2) failing to apply the enablement requirement correctly in the context of anticipation to the claimed method as a whole.” Appeal Br. 9. We have considered the arguments presented by the Examiner and Appellant and find the Examiner has the better position. As discussed above, Thain teaches the correlation between septic shock and PCSK 9 as well as the alleles associated with increased risk of septic shock. Thain A5999. Bylock teaches the administration of alirocumab as a PCSK9 inhibitor. Bylock ¶¶ 236. The combined teachings of Bylock and Thain would have motivated one skilled in the art to use alirocumab to treat a patient with septic shock who has the recited alleles. With respect to enablement, Appellant contends the “mere mention in Bylock of alirocumab is insufficient to put one skilled in the art in possession of the claimed methods of treating sepsis using alirocumab.” Appeal Br. 9. We are not persuaded by this argument. While Bylock does not appear to provide any guidance as to the use of alirocumab to treat sepsis to septic shock, as discussed above, that teaching Appeal 2021-002815 Application 14/399,157 7 is provided by Thain. In addition, Bylock teaches administration of alirocumab to patients and provides the same amount of guidance provided by the instant Specification. Compare Bylock ¶¶ 627-635 with Spec. 16-30. Based on the foregoing we conclude that a preponderance of the evidence supports the Examiner’s conclusion that the subject matter of claims 72 and 73 would have been obvious to one of ordinary skill in the art at the time the invention was made over Bylock combined with Thain. CONCLUSION The Examiner’s affirmed in part and a new ground of rejection is entered. More specifically, The rejection of claims 1, 11, 13, 14, and 67−71 under 35 U.S.C. § 102 as anticipated by Bylock is reversed. The rejection of claims 72 and 73 under 35 U.S.C. § 103 as unpatentable over Bylock in view of Thain is affirmed. A new ground of rejection is entered. Claims 1, 11, 13, 14, and 67−71 are rejected under 35 U.S.C. § 103 as unpatentable over Bylock in view of Thain. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed New Ground 1, 11, 13, 14, 67−71 102 Bylock 1, 11, 13, 14, 67−71 72, 73 103 Bylock, Thain 72, 73 1, 11, 13, 14, 67−71 103 Bylock, Thain 1, 11, 13, 14, 67−71 Appeal 2021-002815 Application 14/399,157 8 Overall Outcome 72, 73 1, 11, 13, 14, 67−71 TIME PERIOD FOR RESPONSE This Decision contains a new ground of rejection pursuant to 37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b) provides that “[a] new ground of rejection . . . shall not be considered final for judicial review.” 37 C.F.R. § 41.50(b) also provides that the Appellant, WITHIN TWO MONTHS FROM THE DATE OF THE DECISION, must exercise one of the following two options with respect to the new ground of rejection to avoid termination of the appeal as to the rejected claims: (1) Reopen prosecution. Submit an appropriate amendment of the claims so rejected or new evidence relating to the claims so rejected, or both, and have the matter reconsidered by the examiner, in which event the proceeding will be remanded to the examiner.… (2) Request rehearing. Request that the proceeding be reheard under § 41.52 by the Board upon the same record…. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED IN PART; § 41.50(B)