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 .
Priority
This application was filed 06/15/2023 and is a CON of 17/972399 (10/4/2022, US Pat 11773061) which is a CON of PCT/US2022/076415 (09/14/2022) which has a PRO of 63/336008 (0/28/2022) and PRO 63/93286 (12/23/2021) and PRO 63/244146 (09/14/2021). Claims 1-84 have been canceled. Claims 85-104 are before the Examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 85, 89-96 and 99-104 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the NX ring to be 5 or 6 membered, does not reasonably provide enablement for the NX ring to be 2-4 membered or 7-10 membered The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope wit these claims. There are many examples of the instant NX ring being five or six membered. However, there are no examples of the instant NX ring being 2- or 7-10 membered. It would require undue experimentation for the ordinary artisan to make and/or use the instantly claimed compounds (or LNP) when the NX ring is 2- or 7-0 membered when the only examples made and used are 5 or 6 membered rings. The specification lacks guidance for the ordinary artisan t make and/or use these compounds (or LNPs_ when the NX ring is very small or very large. Guidance is lacking. Examples are lacking. Without this, it is not seen where the instant specification is enabling for compounds and LNPs when the NX ring is 2-4 or 7-10 membered.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 85-97 and 99-104 are rejected under 35 U.S.C. 103 as being unpatentable over Kuboyama (USPGPub 20140045913 & US Pat 9408914). Kuboyama teaches a Markush similar to the instantly claimed Markush where the center ring (equivalent to the instant NX ring) is 5-membered and the equivalent ((CH2)a and (CH2)b) to the instant X and X5 moieties are alkylene of 0-3 caron members long. The instant claims must have X4 and X5 to be 2-14 members long. Examples of such (where a and b are 0 and 1) are in US Pat 9408914 C27 #24 and #25; C33 compounds #56; and C51 #126. It would have been obvious to one of ordinary skill in the art at the time of the invention to make the compounds taught by Kuboyama with the equivalent to the instant X4 and X5 being 2 or 3 instead of the shown 0 or 1 of the examples with the reasonable expectation of getting compounds having the same or similar properties. Kuboyama teaches that the moiety can be 0-3 members. Kuboyama has examples of the moiety being 0 and 1. The instant claims have the same moiety being 2 or more. The overlap is 2 or for the Kuboyama moiety. It would have been reasonable to expect the teachings of Kuboyama with the moiety of X4 and X5 to work for the reasons taught by Kuboyama.
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 85-102 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11773061. Although the claims at issue are not identical, they are not patentably distinct from each other because generically claims 85-95 and 98-102 as well as specifically claims 96-98 overlap with the patented claims. The instant claim 85 is a larger Markush than the patented claims but the specific smaller Markus of the instant claim 96 is almost same as the Markush of patented claim 1. The compounds CY63-CY71 are the same compounds in the instant claims as in the patented claims.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D MARGARET M SEAMAN whose telephone number is (571)272-0694. The examiner can normally be reached M-F 8am-4pm Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D MARGARET M SEAMAN/Primary Examiner, Art Unit 1625
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