DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 20-28 are pending. Claims 22-28 are objected to. Claims 20 and 21 are rejected.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/09/2026 has been entered.
Response to Amendment/Arguments
Applicant’s amendments have overcome the previously presented rejections.
Election/Restrictions
Applicant’s elected species was previously found allowable. As per MPEP 803.02: should the elected species be found allowable, the examination of the Markus-type claim will be extended. If the examination is extended and a non-elected species found not allowable, the Markush-type claim shall be rejected and claims to the non-elected invention held withdrawn from further consideration. In view of Applicant’s amendments, the examination of the Markush-type claims has been extended to include the scope of claims 20 and 21 where the compound is the following:
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This species is not allowable under 35 USC § 103 and has been rejected for nonstatutory double patenting.
Claims 22-28 remain withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 20 and 21 are rejected under 35 U.S.C. 103 as being obvious over WO 2020131807 A1 by Brodney et al. which claims priority to U.S. Provisional 62/780,667 filed December 17th, 2018.
The applied reference has a common joint inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior art teaches (title) “[i]nhibitors of APOL1 and methods of using same”. Brodney et al. disclose compound 16 which is analogous to instant compound 242 of claim 20 (page 36; page 180 of ‘667):
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Brodney et al. also disclose pharmaceutical compositions comprising the prior art compounds and a pharmaceutically acceptable carrier (paragraph [0007]; paragraph [0005] of ‘667).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art compound is analogous to instant compound 242 but differs by the absence of a CH2 linker.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Brodney et al. disclose the following genus where linker Y may be divalent linear or branched C1-C8 alkyl (paragraph [0004]; paragraph [0003] of ‘667):
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Regarding the modification required to produce the instant compound, this genus embraces variations of compound 16 where Y is C3 linear alkyl as in the compound below:
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“Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.” In re Deuel 34 USPQ2d 1210 at 1214. Furthermore MPEP 2144.09 (II) states: “Compounds which are […] homologs (…) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).”
In the interest of generating additional compounds that have the same utility as the compounds taught by the prior art, a person having ordinary skill in the art would seek to make additional compounds that are most closely related to compounds specifically taught by the prior art that have the desired utility. Accordingly, a person of ordinary skill would have been motivated to generate permutations of compound 16 where Y is C3 alkyl as in instant compound 242 of claim 20. MPEP 2144.09 (VIII) states, “[a] prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963).”
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 20 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11618746 in view of WO 2020131807 A1 by Brodney et al.
The patent discloses compound 16 which is analogous to compound 242 of instant claim 20 (Col. 351):
Compound 16
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The prior art compound differs from the instant compound by having an ethyl linker where the instant compound contains propyl:
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Brodney et al. disclose the following genus which embraces both the instant compound and compound 16 of the patent (paragraph [0004]; paragraph [0003] of ‘667):
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Compound 16 is embraced by prior art formula (I) where R1 is halogen, m is 2, R2 is halogen, n is 1, Y is C2 linear alkyl, R3 an R4 together with the carbon to which they attached form a carbonyl, R5-R8 are each hydrogen.
Instant compound 242 is embraced by prior art formula (I) where R1 is halogen, m is 2, R2 is halogen, n is 1, Y is C3 linear alkyl, R3 an R4 together with the carbon to which they attached form a carbonyl, R5-R8 are each hydrogen.
The prior art discloses the genus of formula (I) above where linker Y may be divalent linear or branched C1-C8 alkyl. “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.” In re Deuel 34 USPQ2d 1210 at 1214. Furthermore MPEP 2144.09 (II) states: “Compounds which are […] homologs (…) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).”
In the interest of generating additional compounds that have the same utility as the compounds taught by the prior art such as those which overlap with the instant claims and patent, a person having ordinary skill in the art would seek to make additional compounds that are most closely related to compounds specifically taught by the patent that have the desired utility. Accordingly, a person of ordinary skill would have been motivated to generate permutations of compound 16 where Y is C3 alkyl as in instant compound 242 of claim 20. MPEP 2144.09 (VIII) states, “[a] prima facie case of obviousness based on structural similarity is rebuttable by proof that the claimed compounds possess unexpectedly advantageous or superior properties. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963).”
Regarding claim 21, claim 18 of the patent discloses a pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier (Col. 381).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLI A CHICKS whose telephone number is (571)270-0582. The examiner can normally be reached M-Th 7 a.m.- 5 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James H Alstrum-Acevedo can be reached at (571)272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A.C./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626