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, 4, 8, 10, 14-15, 20, 23, 30-31, 37, 47, 64-66, 68, and 71-74 are pending.
Election/Restrictions
Applicant’s election without traverse of Group I, corresponding to claims 1, 4, 8, 10, 14-15, 20, 23, 30-31, 37, 47, 64-66, as well as the compound species (below)
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in the reply filed on 5/4/2026 is acknowledged.
The elected species reads upon claims 1, 4, 8, 10, 20, 23, 30, 37, 47, and 64-65.
Claims 14-15, 31, and 66 are drawn to the elected group I but not to the elected species.
Expansion of Election of Species Requirement
As indicated above, the elected species reads upon claims 1, 4, 8, 10, 20, 23, 30, 37, 47, and 64-65. The elected species has been searched and is deemed to be free of the prior art and non-obvious. Accordingly, the search has been expanded as called for under current Office Markush practice (M.P.E.P. § 803.02).
The examiner has searched the following species:
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262
492
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Wherein in Formula (I), R1 is CN, X is a direct bond to R2 which is methyl, ring A is
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90
98
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, Y is a direct bond, ring B is
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111
82
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, and R5 is hydrogen
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290
499
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Wherein in Formula (I), R1 is CN, X is -CHCH3-, R2 is
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48
40
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, ring A is
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, Y is a direct bond, ring B is
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, and R5 is hydrogen.
Claims 14-15, 31, 66, 68, and 71-74 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/4/2026.
Claims 14-15, 31, 66, 68, and 71-74 remain withdrawn as they do not require the particulars of the expanded species examination.
Claims 1, 4, 8, 10, 20, 23, 30, 37, 47, and 64-65 are examined using the above species.
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, 4, 8, 10, 20, 23, 30, 37, 47, and 64 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. In claim 1, “a compound having the following structure of Formula (I)” is not defined in the specification with reasonable clarity as to what entities the applicant is intending to reference.
Vas-Cath Inc. V. Mahurka, 19 USPQ2d 1111, states that applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention, for purposes of the “written description” inquiry, is “whatever is now claimed” (See page 1117).
A review of the language of the claim indicates that these claims are drawn to “a compound having the following structure of Formula (I)”. A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B (1), the court states “An adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention”. Hence, an adequate written description of the ingredients requires more than a mere statement that it is a compound having the following structure of Formula (I).
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). Accordingly, reciting “a compound having the following structure of Formula (I)”, in the absence of knowledge as to what constitutes a compound having the following structure of Formula (I), is not a description. In the instant case, on pages 1-2, Brief Summary, Applicant discloses “a compound having the following structure of Formula (I)”. However, other than the mere mention on pages 1-2, Brief Summary, wherein Applicant simply states “a compound having the following structure of Formula (I)”, Applicant does not provide representative examples of a compound having the following structure of Formula (I).
There are select species of the claimed genus disclosed that is within the scope of the claimed genus, i.e., compounds 1-680 on pages 45-177.
The disclosure of select species may provide an adequate written description of a genus when the species disclosed is representative of the genus. However, the present claim encompasses numerous species that are not further described.
There is substantial potential for variability among the species.
One of skill in the art would not recognize from the disclosure that the applicant was in possession of the genus of what constitutes “a compound having the following structure of Formula (I)”. The specification does not clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed (see Vas-Cath at page 1116).
Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. 112 is severable from its enablement provision (see page 1115).
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, 4, 8, 10, 20, 23, 30, 37, 47, and 64 are rejected under 35 U.S.C. 103 as being unpatentable over Abraham, A.D., (WIPO Publication No. WO 2022/187443 A1; Published 9/9/2022), in view of Kozlova, A. (“Investigation of chalcogen bioisosteric replacement in a series of heterocyclic inhibitors of tryptophan 2,3-dioxygenase”, European Journal of Medicinal Chemistry, Vol. 227, Published 10/7/2021, Pp. 1-12.)
Applicant discloses the following formula (I)
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Abraham teaches the following compound 860 (See page 297).
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Abraham teaches the Applicant’s compound, wherein R1 is CN, X is a direct bond to R2 which is methyl, ring A is
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98
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, Y is a direct bond, ring B is
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111
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, and R5 is hydrogen (See page 297) (reading on claims 1, 4, 8, 10, 20, 23, 30, 47, and 64).
Abraham teaches the following compound 862 (See page 297).
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Abraham teaches the Applicant’s compound, wherein R1 is CN, X is -CHCH3-, R2 is
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, ring A is
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, Y is a direct bond, ring B is
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, and R5 is hydrogen (See page 297) (reading on claims 1, 4, 10, 20, 37, 47, and 64).
Abraham also teaches that these compounds act as FGFR inhibitors (See page 1; Background). Abraham teaches an oxygen at the Applicant’s sulfur position, but does not teach a sulfur atom.
Kozlova teaches that oxygen and sulfur can be substituted for one another (See Page 1; Introduction).
In the instant case, Abraham and Kozlova provide a teaching, suggestion, or motivation, to one having ordinary skill in the art, before the Applicant’s effective filing date, to replace the oxygen taught by Abraham, with a sulfur taught by Kozlova to be an effective replacement, to arrive at the Applicant’s instant compound.
Abraham teaches most of the limitations of the Applicant’s formula (I) except for an oxygen instead of sulfur, and that the compound taught by Abraham retains activity as an FGFR inhibitor, while Kozlova teaches that oxygen and sulfur are part of a group of atoms that share similar characteristics, and that the two have been known in the art to be replacements for one another in drug development.
This provides one having ordinary skill in the art, with a list of finite and predictable options to choose from, and a reasonable expectation of success in replacing the oxygen atom from the compound taught by Abraham, to arrive at a similar compound with a sulfur at the corresponding position, while retaining the same activity as a FGFR inhibitor.
Therefore, it would have been obvious to one having ordinary skill in the art, before the Applicant’s effective filing date, to combine the teachings of both references, to arrive at the Applicant’s instant formula (I).
Double Patenting
The non-statutory 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 non-statutory 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 non-statutory 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 non-statutory 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.
(Of Note: The following double patenting rejections are NON-PROVISIONAL)
Claims 1, 4, 8, 10, 20, 23, 30, 37, 47, and 64 are rejected on the ground of non-statutory double patenting as being unpatentable over the following claims of U.S. Patent No. US12351581B2: 1-30 (for present claims 1, 4, 8, 10, 20, 23, 30, 37, 47, and 64), in view of Abraham, A.D., (WIPO Publication No. WO 2022/187443 A1, Published 9/9/2022), in view of Kozlova, A. (“Investigation of chalcogen bioisosteric replacement in a series of heterocyclic inhibitors of tryptophan 2,3-dioxygenase”, European Journal of Medicinal Chemistry, Vol. 227, Published 10/7/2021, Pp. 1-12.)
Although the claims are not identical, they are not patentably distinct from one another because the claims of US12351581B2 are also drawn to the same compound of the instant application. The US12351581B2 claims 1-30 are all drawn to the same compound of formula (I) as taught in Applicant’s claims 1, 4, 8, 10, 20, 23, 30, 37, 47, and 64 . A notable limitation in the formula of the Applicant that is not in that of US12351581B2 is the use of sulfur, rather than oxygen as taught by US12351581B2. However, this variation between the formulas is not patentably distinct, as explained further below.
Applicant discloses the following formula (I)
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Abraham teaches the following compound 860 (See page 297).
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Abraham teaches the Applicant’s compound, wherein R1 is CN, X is a direct bond to R2 which is methyl, ring A is
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90
98
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, Y is a direct bond, ring B is
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111
82
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, and R5 is hydrogen (See page 297) (reading on claims 1, 4, 8, 10, 20, 23, 30, 47, and 64).
Abraham teaches the following compound 862 (See page 297).
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Abraham teaches the Applicant’s compound, wherein R1 is CN, X is -CHCH3-, R2 is
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40
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, ring A is
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98
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, Y is a direct bond, ring B is
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, and R5 is hydrogen (See page 297) (reading on claims 1, 4, 10, 20, 37, 47, and 64).
Abraham also teaches that these compounds act as FGFR inhibitors (See page 1; Background). Abraham teaches an oxygen at the Applicant’s sulfur position, but does not teach a sulfur atom.
Kozlova teaches that oxygen and sulfur can be substituted for one another (See Page 1; Introduction).
In the instant case, Abraham and Kozlova provide a teaching, suggestion, or motivation, to one having ordinary skill in the art, before the Applicant’s effective filing date, to replace the oxygen taught by Abraham, with a sulfur taught by Kozlova to be an effective replacement, to arrive at the Applicant’s instant compound.
Abraham teaches most of the limitations of the Applicant’s formula (I) except for an oxygen instead of sulfur, and that the compound taught by Abraham retains activity as an FGFR inhibitor, while Kozlova teaches that oxygen and sulfur are part of a group of atoms that share similar characteristics, and that the two have been known in the art to be replacements for one another in drug development.
This provides one having ordinary skill in the art, with a list of finite and predictable options to choose from, and a reasonable expectation of success in replacing the oxygen atom from the compound taught by Abraham, to arrive at a similar compound with a sulfur at the corresponding position, while retaining the same activity as a FGFR inhibitor.
Therefore, it would have been obvious to one having ordinary skill in the art, before the Applicant’s effective filing date, to combine the teachings of both references, to arrive at the Applicant’s instant formula (I).
It would have been prima facie obvious to one skilled in the art to arrive at the Applicant’s instant claims, in view of the claims of US12351581B2, and Abraham and Kozlova.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OROD MOTEVALLI whose telephone number is (571)272-6026. The examiner can normally be reached Monday - Friday 10:00AM - 6:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OROD MOTEVALLI/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
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