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 .
Status of Claims
Claims 1-20 are pending.
Claims 13-16 and 18-20 are withdrawn (see restriction/election below).
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C.
120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to
Application Serial No. PCT/US2021/014982, filed 01/26/2021. The application also claims priority to
PRO application number 62966119, filed on 01/27/2020.
Information Disclosure Statement
All references from IDS(s) received 04/05/2024 have been considered unless marked with a strikethrough.
Election/Restrictions
Applicant’s election of Group I in the reply filed on 7/10/2025 is acknowledged. Because
applicant did not distinctly and specifically point out the reasons for traverse, the election/restriction requirement is deemed proper and final.
Claims 13-16 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method of use, there being no allowable generic or linking claim.
Applicant’s election of species of the Compound 139 elected in the reply filed on 7/10/2025 is acknowledged.
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Claims 1-12 and 17 will be examined on their merits.
No anticipatory art was found of the elected species, so the Examiner expanded the species pursuant to MPEP 803.02. The expanded specie reads on claims 1-12 and 17, see double patenting rejection below.
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 1-12 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. US11554120B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘120 patent recite an overlapping genus structure used as TLR7 agonists.
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(Formula I, Claim 1, ‘120 patent)
Specifically, the claims of the ‘120 patent recite where R3 can be a NH(C4-C8 bicycloalkyl) as required by the limitations of the instant claims. The ‘120 patent fails to explicitly teach structural examples with a homolog or isomer of those included in the proviso of the instant claims, however it would be obvious to a person skilled in the art at the time that obvious variants of the compounds in the proviso would have similar properties since they are structurally similar. See MPEP 2144.09(I) and (III).
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. “An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.” In rePayne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In rePapesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In reDillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) (discussed below and in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds.
Prior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In rePayne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979)
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385,
1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are
consistent with the proper "functional approach" to the determination of obviousness as laid down in
Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement
to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a
reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same
field or a different one based on design incentives or other market forces if the variations are
predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of
ordinary skill to modify the prior art reference or to combine prior art reference teachings to
arrive at the claimed invention.
Applying KSR example rationale (E), it would have been prima facie obvious to extract the genus structure of the ‘120 patent and try different variations from the structures of the compounds included in the proviso of the instant application. A skilled artisan would have been motivated to do so because structurally similar compounds are known to have similar properties and would have had a reasonable expectation of success. Therefore, claims 1-12 and 17 would have been obvious to a person skilled in the art at the time.
Art Made of Record but Not Included
A 102/103 rejection was considered over US11554120B2 (filed 7/31/2019) because the ‘120 patent teaches an overlapping genus where R3 can be a NH(C4-C8 bicycloalkyl) as required by the limitations of the instant claims. The ‘120 patent fails to explicitly teach structural examples with a homolog or isomer of those included in the proviso of the instant claims, however it would be obvious to a person skilled in the art at the time that obvious variants of the compounds in the proviso would have similar properties since they are structurally similar. This rejection was not made because the patent would be considered an exception under 102(b)(2)(c) as both the ‘120 patent and the instant application are owned by Bristol-Myers Squibb.
A 103 rejection was considered over US20070142449A1 because the ‘449 application teaches an overlapping genus structure (Claim 1). However, it fails to teach key embodiments of the genus structure including where the Ar1 ring would be substituted with an NH2 as well as fails to teach an embodiment with a bicyclic ring where instant R3 requires. The compounds of the ‘449 application are also angiogenesis inhibitors not TLR7 agonists. Therefore for all reasons combined, a 103 rejection was not made.
A 103 rejection was considered over EP1689751B1 because the ‘751 patent teaches an overlapping genus (Claim 1). However, it fails to teach key embodiments of the genus structure including where the Ar1 ring would be substituted with an NH2 as well as fails to teach an embodiment with a bicyclic ring where instant R3 requires. The ‘751 patent does mention the possibility of a polycyclic or bicyclic embodiment but only conjugated to the R1-4 groups, not the R6 groups where it would need to be to anticipate the structure of the instant claims. The compounds of the ‘751 patent are also PDE-5 inhibitors not TLR7 agonists. Therefore for all reasons combined, a 103 rejection was not made.
A 103 rejection was considered over Zhang, G. et al. (EP3546457A1; published 10/02/2019; cited in IDS filed 04/05/2024;“Zhang”) because Zhang teaches a similar genus structure (see below).
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(Zhang, Claim 1)
However, Zhang fails to teach the same substitution pattern of the pyrimidine on the pyrazolopyrimidine derivatives. Because one would have to adjust the position of the free amino, both nitrogens in the ring, and L1, as well as Zhang fails to teach a bicyclic ring as required by instant R3, a 103 rejection was not made.
Conclusion
Claims 1-12 and 17 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clint Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621