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 .
Status of Claims
Claims 1-6, 10, 14, 20, 23-26, 41, 52, 59-61, 66-67, and 69-70 are pending.
Priority
Instant application 18/547,893, filed 08/25/2023 claims priority as follows:
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Information Disclosure Statement
All references from IDS(s) received 02/22/2024, 10/09/2025, and 12/17/2025 have been considered unless marked with a strikethrough.
Election/Restrictions
Applicant’s election of Group I, claims 1-6, 10, 14, 20, 23-26, 41, 52, 59-61, 66, and 70 in the reply filed on 1/14/2026 is acknowledged. Additionally, applicant’s election of the species compound Example 181 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)).
The elected species reads on claims 1-6, 14, 23-26, 41, 59-61, 66, and 70.
Examination will begin with the elected species. In accordance with MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species was searched and applicable art was not identified. Therefore, the search was extended to the compounds recited in claim 70 and applicable prior art was not identified. Therefore, the search was extended again to a limited number of species which anticipate the claims. Therefore, the entire scope of the claims has not yet been examined in accordance with Markush search practice. See MPEP 803.02.
Claims 10, 52, 67, and 69 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/14/2026.
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 1-6, 14, 20, 23-26, 41, and 66 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed. The courts have stated that, “To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.” Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) (“[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed.”). Thus, an applicant complies with the written description requirement “by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention.” Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966.” Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated that, “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) (“In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus …”) Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the application. These include level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed genus is sufficient. See MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
Claim 1 is drawn to compounds of formula I, which are defined as being substituted with at least one “E” moiety. The “E” moiety is defined in the claim as “an electrophilic moiety that is capable of reacting with a nucleophile so as to form a covalent bond between an atom of the nucleophile and an atom of the electrophilic moiety”.
The other elements of Formula (I) in claim 1 (e.g., R1, R2, Ar, etc.) are structurally defined. However, the “E” moiety is only functionally defined, and encompasses a broad range of possible substituents. Moreover, a known correlation between the whole structure of the genus in claim 1 and the function recited for the “E” moiety has not been sufficiently established or disclosed.
The skilled artisan must rely upon the applicant’s disclosure in order to predict which of the myriad compounds embraced by formula (I) have the function of an FGFR inhibitor. The definition of the “E” moiety recited in claim 1 appears to extend to a large variety of different types of electrophiles beyond those contemplated in the specification such as, for example, Lewis acids, acid halides, polarizable neural molecules, carbenes, radicals, etc. See, for example, the various types of electrophilic moieties disclosed in Effenberger (Angewandte Chemie International Edition in English, vol. 19, no. 3, Mar. 1980, pp. 151–71), which includes halogen electrophiles, oxygen electrophiles, sulfur electrophiles, nitrogen electrophiles, alkylating agents, acylating agents, formylating agents, and carbamylating agents. See also Electrophile - Wikipedia. 9 Nov. 2020, https://web.archive.org/web/20201109215348/https://en.wikipedia.org/wiki/Electrophile.
However, Applicant has not explored and disclosed a representative number of species to adequately support the breadth of the entire genus. Instead, only a subset of the genus is supported by the claims and/or specification, specifically a small selection from the “E” moieties recited in claims 59-61.
Methods of synthesizing compounds are, in general, known to the person of ordinary skill, however methods of making the myriads of compounds embraced by the instant claims is beyond the skill of the artisan, particularly when certain elements are merely described partially. As such, the instant specification and instant claims do not provide sufficient description such that one could anticipate what elements must be present to achieve the recited functions.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the entire scope of the claimed invention.
Claim Rejections - 35 USC § 102
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.
Claims 1-4, 14, 23-26, 59, and 66 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xing et al. (US 20240174648 A1; corresponds to CN 110627775 A, published 2019; cited in IDS).
Xing discloses tyrosine kinase inhibitors having the general formula (title, abstract, para. [0006]):
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In particular, Xing discloses compounds wherein ring G is
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(para. [0030]). For example, Xing disclose the specific compounds:
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(page 67, TDM-180881) and
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(page 67, TDM-180882).
The above compounds anticipate instant claims 1-4, 14, 23-26, 59.
Regarding claim 66, Xing discloses dissolving the above compounds in DMSO (para. [0459]). Therefore, Xing discloses a pharmaceutical composition comprising a compound of claim 1 and a pharmaceutically acceptable excipient.
Therefore, claims 1-4, 14, 23-26, 59, and 66 are anticipated by Xing.
Claims 1-2, 14, 20, 59-61, and 66 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gray et al. (US 20120094999 A1).
Gray is drawn to EGFR inhibitors and methods of treating disorders (title, abstract). In particular, Gray discloses the compound 2-30 (page 33, Table 2):
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The above compound anticipates claims 1-2, 14, 20, 59, and 60-61.
With respect to claim 66, Gray discloses a pharmaceutical composition comprising the above compound and a pharmaceutically acceptable carrier (e.g., para. [0328]).
Therefore, claims 1-2, 14, 59-61, and 66 are anticipated by Gray.
Claims 1-6, 14, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wei et al. (US 20170313714 A1).
Wei is drawn to EGFR inhibitors and methods of treating disorders (title, abstract). In
particular, Wei discloses the compound (page 78, para. [0467]):
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The nitrile group (-CN) is being interpreted as an “E” moiety. Therefore, the above compound anticipates claims 1-6, 14, and 20.
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.
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.
Claims 5-6 and 41 are rejected under 35 U.S.C. 103 as being unpatentable over Xing et al. (US 20240174648 A1; corresponds to CN 110627775 A, published 2019; cited in IDS) applied to claims 1-4, 14, 23-26, 59, and 66 above.
Xing discloses tyrosine kinase inhibitors having the general formula (title, abstract, para. [0006]):
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In particular, Xing discloses compounds wherein ring G is
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(para. [0030]). For example, Xing disclose the specific compounds:
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(page 67, TDM-180881) and
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(page 67, TDM-180882).
The only difference between Xing’s compounds and compounds recited in claims 5, 6, and 41 is the position of the “E” moiety. In Xing’s example compounds the “E” moiety is at the 4-position of the indolyl ring; whereas claims 5, 6, and 41 require substitution at the 5-position of the indolyl ring. However, please note that Xing generally teaches that the “E” substituent (“R1” in Xing) on the indolyl moiety may be at other positions (see, e.g., para. [0030]):
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MPEP 2144.09, second paragraph, states, “Compounds which are position isomers or 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). The homolog is expected to be preparable by the same method and to have generally the same properties. This expectation is then deemed the motivation for preparing the homolog. This circumstance has arisen many times. See In re Schechter and LaForge, 98 USPQ 144, 150, which states “a novel useful chemical compound which is homologous or isomeric with compounds of the prior art is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compounds.” See In re Wilder, 166 USPQ 545, 548. Note also In re Deuel 34 USPQ2d 1210, 1214 which states, “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds … a known compound may suggest its analogs or isomers, either geometric isomers (cis v. trans) or position isomers (e.g., ortho v. para).”
Therefore, position isomers of Xing’s compounds (being substituted at the 5-position rather than the 4-position) and their utility as tyrosine kinase inhibitors would have been prima facie obvious before the effective filing date of the instant application. A skilled artisan would have been motivated to prepare a position isomer of the compounds in Xing with a reasonable expectation of success in obtaining a compound with utility as a tyrosine kinase inhibitor.
Therefore, claims 5-6 and 41 are rejected.
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 1-6, 14, 20, 23-26, 59-61, and 66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 43-65 of copending Application No. 17/788,334 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application are drawn to compounds having the formula:
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Support for the compounds claimed in the reference application include, for example:
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. The claims are therefore directed to overlapping subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claim 70 is 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.
Conclusion
Claims 1-6, 14, 20, 23-26, 41, 59-61, and 66 are rejected. Claim 70 is objected to. Claims 10, 52, 67, and 69 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kyle Nottingham whose telephone number is (571)270-0640. The examiner can normally be reached M-F from 10:00 am - 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton 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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/K.N./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621