Detailed Action
The present office action is in response to the reply filed on 23 Feb 2026.
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
Claims 143-156 of the pending application have been examined on the merits. Acknowledgement is made of the amendments filed 01 Feb 2024. Acknowledgement is made of the cancellation of claims 1-142.
Priority
Applicants identify the instant application, Serial #: 18/478,109, filed 29 Sep 2023, as a Continuation of U.S. Patent Application #: 18/164,326, filed 03 Feb 2023, which claims priority from U.S. Provisional Application #: 63/306,195, filed 03 Feb 2022.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 29 Dec 2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Applicant Election
Applicant’s election of example 304 (below) in the reply filed on 21 Apr 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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A search for the elected compound did not return prior art. Examiner expanded the Markush search to the full scope of the instant claims and returned prior art.
Claim Objections
Claims 146, 148, 152, and 154 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 U.S.C. § 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 143 and 149 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2014/151616 (provided in IDS 12/29/23), hereinafter ‘616, further in view of Patani et al. (Chem Rev, 1996, 96:3147-3176), hereinafter Patani.
The instant claims are directed to a number of chemical compounds with similar core structures that are indicated as RAF kinase inhibitors including the following compound (claim 143):
N-(2-Fluoro-4-methyl-5-(8-morpholinoimidazo[ 1 ,2-a ]pyridin-6-yl )phenyl )-2-( trifluoromethyl )isonicotinamide
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207
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The claims further claim a pharmaceutical composition of the compounds of claim 143 (claims 149).
‘616 teaches the following compound:
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‘616 further teaches that Example 849 inhibits b-RAF with an IC50 of 3.8 nM and c-RAF FL with an IC50 of 0.9 nM. However, Example 849 differs from the instant compound by teaching a hydrogen in place of the fluorine of the core phenyl moiety.
Patani teaches that bioisosterism represents one approach used by the medicinal chemist for the rational modification of lead compounds into safe and more clinically effective agents and the concept of bioisosterism is often considered to be qualitative and intuitive (pg. 3147, columns 1-2). One such bioisostere is the substitution of hydrogen by fluorine which is one of the more commonly employed monovalent isosteric replacements (pg. 3149, column 1). Patani teaches that the ability of fluorine to replace hydrogen is an effective method of exploring the affinity of an agent to the target site by virtue of its greater electronegativity while other parameters such as steric size and lipophilicity are maintained (pg. 3150, column 1).
Based on the teachings of ‘616 and Patani, the person of ordinary skill in the art would modify Example 849, taught by ‘616, and replace the hydrogen of the phenyl moiety with a fluorine, as taught by Patani, to create a safe and clinically effective agent for the inhibition of b-RAF and c-RAF FL. The artisan would be motivated to change hydrogen to fluorine to explore the affinity of the to the target site by varying electronegativity of the substituent, as taught by Patani.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 143-145, 147, 149-151, 153, and 155-156 are rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1, 7-8, 10, 17, 19, 21, 28, and 30 of U.S. Patent No. 11,814,384, hereinafter ‘384. Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims are drawn to the following compounds:
Name
Structure
Claims
1-Tert-butyl-N-{ 2-fluoro-4-methyl-5-[8-(morpholin-4-yl )imidazo[ 1,2- a]pyridin-6-yl ]phenyl }imidazole-4-carboxamide
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143-145 and 149-151
1-(Tert-butyl )-5-fluoro-N-(2-fluoro-4-methyl-5-(2-methyl-8-morpholino-[ 1,2, 4 ]triazolo[ 1, 5-a ]pyridin-6-yl )phenyl)- 1H-pyrazole-4-carboxamide
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143-144, 147, 149-150, and 153
1-Tert-butyl-5-fluoro-N-{2-fluoro-4-methyl-5-[8-(morpholin-4-yl)imidazo[ 1 ,2-a ]pyridin-6-yl]phenyl} pyrazole-4-carboxamide
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143-144, 149-150, 155-156
The instant claims further claim a composition of the above compounds (claims 149-151, 153, and 156).
‘384 does not claim any specific compounds. However, based on the limitations of the reference claims, the artisan would be able to envision the compounds of the instant claims. Reference claim 1 is drawn to compounds of Formula (Ia):
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Where X is N or C-R1; Y is N or C-R2; Z is N or C-R3; W is an optionally substituted cyclic or heterocyclic moiety; and R1-3 are each selected from H, -CN, halogen, optionally substituted alkyl, optionally substituted cycloalkyl, or optionally substituted cycloalkylalkyl. The reference further limits W to being selected from
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(claim 28) showing the artisan that W can align with the instant claims. Reference claim 7 limits Y to C-R2, and further claims limit R2 to H (claim 17) or optionally substituted alkyl (claim 19). Further reference claims depending from claim 7 limit X and Z to N (claim 8) and X to N and Z to C-R3 (claim 10). The reference specification, shedding light on the claims, defines alkyl as a straight or branched hydrocarbon chain radical consisting solely of carbon and hydrogen atoms, containing no unsaturation, having from one to fifteen carbon atoms (column 6, lines 10-13). Based on these limitations, the artisan would be able to envision the instant compounds from the reference claims and so the claims are rejected.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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/J.D.M./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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