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 .
Election/Restrictions
Applicant’s election without traverse of the invention of Group I and a species that is compound 2-1 (as below) in the reply filed on 12/11/2025 is acknowledged.
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Examiner has searched the above compound and additionally expanded the search to a species wherein R2 is F instead of Cl.
Claims 1, 3, 7, 10-11, 19-21 are examined herein. Claims 2, 4-6, 8-9, 13, 15-18, and 22-51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/11/2025.
Priority
Examiner acknowledges that, according to the Filing receipt received 12/11/2023, that the instant application 18/262,821 filed 07/25/2023 is a 371 of PCT/CN2022/074328 filed 01/27/2022, which claims foreign priority of CN202110159956.6 filed 02/05/2021, CN202110533304.4 filed 05/17/2021, CN202110718245.8 filed 06/28/2021, CN202110936768.X filed 08/16/2021, and CN202111355330.9 filed 11/16/2021.
Information Disclosure Statement
The Information Disclosure Statements filed on 07/02/2024, 07/15/2024, 04/30/2025, 07/17/2025, 09/26/2025, and 12/22/2025 have been considered in full except CN 115990269 A, cited in the IDS filed 07/02/2024, for which no copy of the foreign reference was filed. A signed copy of list of references cited from the IDS is included with this Office Action.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 7, 10-11, 19-21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “nitrogen oxide…thereof”. However, nitrogen oxide is a gas. It is unclear how a “nitrogen oxide” of the claimed compounds could be formed. Clarification is required.
Claim 7 recites the following compounds.
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Compounds 4-14 and 4-15 are not within the scope of claim 1 because A is not
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. Compounds 5-13 through 5-18 are not within the scope of claim 1 because the carbocyclic ring formed by R3 and the carbon ortho to R1 cannot be further substituted by methyl. The scope of claim 7 is therefore unclear. Correction is required.
Claim 11 recites “comprising the same”. The limitation “the same” lacks antecedent basis and it is unclear to what “the same” refers.
Claim Rejections - 35 USC § 112(a)
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 1, 3, 7, 10-11, 19-21 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 a compound, pharmaceutically acceptable salt, or stereoisomer thereof, does not reasonably provide enablement for an ester, polymorph, solvate, nitrogen oxide, isotope-labeled product, metabolite, or prodrug thereof. 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 the invention commensurate in scope with these claims.
The claims are drawn to compounds of the generic formula as in claim 1 or an ester, polymorph, solvate, nitrogen oxide, isotope-labeled product, metabolite, or prodrug thereof. However, the numerous examples presented all failed to produce an ester, polymorph, solvate, nitrogen oxide, isotope-labeled product, metabolite, or prodrug. These cannot be simply willed into existence, nor are they considered predictable. Moreover, the terms “metabolite” and “prodrug” convey no particular structure recognized in the art, such that one of ordinary skill would not be able to predict the identities of these compounds, while esters and isotope-labeled products can result in substitutions at many locations that could reduce or eliminate the activity of the compound itself. As was stated in Morton International Inc. v. Cardinal Chemical Co., 28 USPQ2d 1190 “The specification purports to teach, with over fifty examples, the preparation of the claimed compounds with the required connectivity.” Hence, applicants must show that an ester, polymorph, solvate, nitrogen oxide, isotope-labeled product, metabolite, or prodrug of the claimed compounds can be made, or limit the claims accordingly.
Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 11 is directed toward a kit comprising the compound of claim 1, optionally wherein the kit comprises an additional therapeutic agent as a second therapeutic agent. The specification does not define or otherwise provide guidance regarding that which is intended in the use of a “second therapeutic agent”, nor are any exemplary compounds or medicaments considered by the instant disclosure. There are hundreds, if not thousands, of compounds that are therapeutic to some degree. It is unclear what therapeutic agents the inventors consider combinable with the instantly claimed compound.
The applicants may only claim whatever he or she regards as his or her invention, i.e., the applicant may not claim subject matter that he or she does not regard as his or her invention. The use of “second therapeutic agent” does not set forth that which the applicants regard as their invention. Patent Protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. Tossing out the mere germ of an idea does not constitute enabling disclosure. Genentech Inc. v. Novo Nordisk 42 USPQ2d 1001.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 10-11 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Masuda et al. (WO2014057687A1; 2014).
Masuda et al. discloses the following compound (Abstract).
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The compound is within the scope of claim 1 wherein R1 is methyl, R2 is fluoro (halogen), R3 forms a 6-membered carbocyclic ring with an ortho-carbon atom of R1, and R4- R6 are hydrogen. Claims 10 and 11 necessarily require the above compound and are also rejected.
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.
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) 1, 3, 7, 10-11, 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masuda et al. (WO2014057687A1; 2014) as applied to claims 1 and 10-11 above.
Masuda et al. discloses the compound as in the above rejection. Masuda et al. additionally discloses that the compound is an anti-tumor compound to be conjugated with an antibody and used as an anti-tumor agent (abstract).
Masuda et al. does not disclose a compound wherein R2 is Cl, as in the elected compound 2-1. This limitation is obvious over Masuda et al.
It has been previously established that halogens are equivalent substitutions for each other. Ex parte Wiseman, 98 USPQ 277 (1953). Moreover, the presence of a true homologous or isomeric relationship is not controlling when establishing prima facie obviousness (MPEP 2144.09). Absent surprising or unexpected results, it would have been prima facie obvious for one of ordinary skill in the art to substitute the fluoro group for a chloro group in the compound disclosed by Masuda et al., in order to arrive at instantly claimed compound 2-1.
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, 3, 7, 10-11, 19-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 10, and 20-21 of copending Application No. 19/279,242 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the '242 application are narrower than, and therefore anticipate, the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 7, and 10-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, and 17-18 of copending Application No. 19/279,201 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the '201 application are narrower than, and therefore anticipate, the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 7, 10-11, and 19-21 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 13-14 of copending Application No. 18/846,709 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the '709 application substantially overlap with the instant claims, such that it would be prima facie obvious for one of ordinary skill in the art to arrive at the instant invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADELINE E BRAUN whose telephone number is (703)756-4533. The examiner can normally be reached M-F 8:30am-5:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.E.B./Examiner, Art Unit 1624 01/12/2026
/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624