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 .1
Status of Claims
Claims 1-33 are pending.
Election/Restrictions
Applicant's election with traverse of Group I and the species identified by Applicant’s attorney as Example 405, in the reply filed on May 14, 2026 and subsequent phone Interview of July 12, 2026 is acknowledged.
Applicant elected species Example 405, (4-(((2S,6S)-6-(methoxymethyl)-6-methyl-1,4-dioxan-2-yl)methoxy)phenyl)-2-oxo-6-(trifluoromethyl)-1,2-dihydropyridine-3-carboxamide
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The traversal is on the ground(s) that Groups I and II are unified by special technical features that define a contribution over the art of record (37 CFR 14.75(a) and PCT Rule 13.2, i.e. narrowing amendments, i.e. a substituted phenyl. This is not found persuasive because the election of species has further included Example 58, which as detailed below, has been made obvious by WO 2021/003295.
Example 58 is the sixth compound of claim 27, page 17 of 46 from the May 14, 2026 version of the claims and found on page 98 of the specification, bottom of the page.
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Non-elected Group II claims 29-30 and 33 are withdrawn.
Non-species claims 2, 14-15, 18, 23, 29-30 are withdrawn.
Claims 1, 3-13, 16, 17, 19-22, 24-28, 31 and 32 are under examination.
The requirement is still deemed proper and is therefore made FINAL.
Claims 2, 14-15, 18, 23, 29-30 and 33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species and Group II, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on May 14, 2026.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on June 13 2024 and May 7 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claims 16 and 19 are objected to because of the following informalities:
For R12 of claims 16 and 19, “CN” recited twice; see line 1 of the definition of R12 and see line 3 of the definition of R12. Appropriate correction is required.
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, 3-13, 16, 17, 19-22, 24-26, 28, 31 and 32 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 Claimed Invention
The claimed invention (claim 1) is directed to a compound of formula I, where R1, R2, R3, R4, n and p are broadly claimed as recited therein.
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.
Certain narrower embodiments of the claimed invention are presented in dependent claims 3-13, 16, 17, 19-22, 24-26, 28, 31 and 32. Some of these claims further limit the claimed groups and substituents as detailed therein. Claim 27 recites the claimed and elected species and other individual species. Claim 27 is NOT rejected for written description, but not the art rejection as detailed below.
The Supporting Disclosure
Applicants’ supporting disclosure contains certain descriptions and embodiments of the claimed invention.
In the present case, the important factors leading to a conclusion of inadequate written description is the absence of sufficient working examples of the invention as claimed, and the lack of predictability in the art.
In the present case there is no disclosure of compounds having the broad and full scope definitions of the groups and substituents of claim 1. In fact, the scope of compounds that provide adequate written description are the about 440 compounds of claim 27, detailed by Examples 1-440 (starting at page 69) and supported by the anti-viral (influenza) activity data of Table 1, starting at page 346.
In contrast to the broad claimed scope of claim 1 and rejected dependent claims, Example compounds 1-440 are limited to the scope as detailed below, where such compounds have anti-viral (anti-influenza) activity as detailed at Table 1.
In claim 1, R1 is broadly claimed as halogen and hydrogen. In contrast, the 440 compounds exemplified by the specification with Table 1’s antiviral activity are where R1 is limited to hydrogen.
In claim 1, R2 is broadly claimed any C1-C8haloalkyl. In contrast, the 440 compounds exemplified by the specification with Table 1’s antiviral activity are where R2 is limited to CF3.
In claim 1, (R4)n is broadly claimed as halo, CN, C1-C5alkyl, C1-C5alkoxy, or C3-C5cycloalkyl; where n is broadly claimed as 0, 1, 2, 3, 4. In contrast, the 440 compounds exemplified by the specification with Table 1’s antiviral activity are where the compounds are limited to where R4 is a halogen (fluoro, chloro), CN, alkoxy (methoxy), alkyl (methyl), cycloalkyl (cyclopropyl) and n is 1. Note that at most 3 compounds are given as examples where R4 is halogen as fluoro and chloro, and at most 1-2 examples are provided where R4 is CN, methoxy, methyl and cyclopropyl.
In claim 1, (R3)p is broadly claimed as
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where p is broadly claimed as 1, 2, 3.
In contrast, the 440 compounds exemplified by the specification with Table 1’s antiviral activity are limited to where R3 is hydrogen, NH2, OH, CN, NHS(O)2-CH3, OCF2H, methoxy, alkyl (unsubstituted or substituted), alkyl, O-alkyl, O-cycloalkyl, NH-alkyl, O-alkyl-N(CH3)2, C(O)-NH2, N-alkyl2, Aryl-alkyl-O-, heterocyclically-alkyl-O, cycloalkyl-alkyl-O, heteroaryl-alkyl-O, heteroaryl, alkyl-O-aryl, alkyl-O-heteroaryl, methylenyl-hydroxyl, heterocycloalkyl (substituted or unsubstituted) and p is limited exclusively to 1. Note with the groups of R3, the various aryl, heteroaryl, cycloalkyl, heterocycloalkyl ring systems can form fused ring systems, or spiro ring systems. Also note for R3, the alkyl chains are both branched and unbranched, and the aryl, heteroaryl, cycloalkyl, heterocycloalkyl ring systems, are all optionally substituted with the groups of claim 1 and detailed in Example compounds 1-440.
Applicant’s disclosure of the 440 compounds of claim 27 and Table 1 data, is not a sufficient representation of all the claimed compounds of claim 1 and rejected dependent claims as presently pending.
Other than the working examples of the specification (440 compounds), Applicant has not reasonably described a scientific or “systematic” approach to synthesize the full scope of claim 1 and claims dependent. See MPEP 2163.02, the standard for determining compliance with the written description.2
Although Applicant has written description support for the 440 compounds of claim 27 in view of the antiviral data of Table 1, Applicant has not provided reasonably provided a description the support the broader scope of the claimed compounds of formula I.
Accordingly, Applicants have not adequately described the invention for the breadth that is claimed. It thus appears that Applicants were not in possession of the claimed invention at the time the application was filed, the full scope of compounds of formula I, and that Applicants’ species do not support the claimed genus.
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.
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.
Claims 1, 3-6, 27, 28, 31, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2021/003295 (WO 295). WO 295 is cited as Foreign Patent Document No. 2 on the IDS dated June 13, 2024.
Regarding claims 1 and 3, and the claimed species Example 58 found in claim 27, WO 295 discloses compound 239-73, 2-oxo-5-phenyl-6-(trifluoromethyl)-1,2-dihydropyridine-3-carboxamide. See page 338, paragraph 411.
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It is pointed out that all 440 compounds of claim 27 AND described by the specification of Examples 1-440, including Example 58, contain the pharmacophore base of compound 239-7 taught by WO 295.
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Compound 239-7 Example 584
Example 58 is found in claim 27, sixth compound down on page 17 of 46 from the May 14, 2026 version of the claims.
While WO 295 teaches compound 239-7, this compound differs from claimed species Example 58 by not teaching a substituted phenyl, substituted with a cycloalkyl-alkoxy, such as cyclohexyl methoxy.
To address this, WO 295 teaches a compound of formula I’, where at a position equivalent to the substituted phenyl of Example and the unsubstituted phenyl of Compound 239-7, Compound I’ teaches Y is CR2, where R2 is an C1-4 alkoxy (such as methoxy). See Claim 1.
Note that the alkyl portion of the R2 alkyl can be a cycloalkyl-alkyl, such as cyclohexyl-methyl as required by Example 58. See paragraph 85 of WO 295 specification defining alkyl so as to include saturated aliphatic groups including cycloalkyl substituted alkyl groups.
Prior to the filing of the instant application a person having ordinary skill in the art (PHOSITA) following the teachings of WO 295 would have found it prima facie obvious to substitute a cyclohexyl methoxy group upon Compound 239-7. MPEP 2143(b) simple substitution) of one known element for another (unsubstituted phenyl for substituted phenyl to obtain predictable results.
A PHOSITA would have a reasonable expectation of success as WO 295 teaches Compound 239-7 that differs from claimed compound Example 58 but for the presence of a cyclohexyl methoxy substituted phenyl, where claim 1 of WO 295 teaches such a cyclohexyl methoxy substituted phenyl (and paragraph 85 of WO 295) as detailed above.
Note regarding claims 3-6 and 27, WO 295 teaches Compound 239-7, while differing from claimed compound Example 58 (listed in claim 27, 6th compound on page 17 of 46) but for the presence of a cyclohexyl methoxy substituted phenyl, where claim 1 of WO 295 teaches such a cyclohexyl methoxy substituted phenyl (and paragraph 85 of WO 295) as detailed above.
Regarding claims 28 and 31, WO 295 teaches pharmaceutical compositions and dosage forms thereof of its compounds. See claims 46-47.
Regarding claim 32, WO 295 teaches combinations thereof, where it notes combinations of active ingredients in reference to the definition of effective amounts of compound or pharmaceutical composition administered. See paragraph 78.
Conclusion and Correspondence
In summary no claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM Y LEE/Examiner, Art Unit 1623
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
1 CONTINUING DATA
This application is a 371 of PCT/IB2022/056778 07/22/2022
PCT/IB2022/056778 has PRO 63/224,691 07/22/2021
2 Whenever the issue arises, the fundamental factual inquiry is whether the specification conveys with reasonable clarity to those skilled in the art that, as of the filing date sought, inventor was in possession of the invention as now claimed. See, e.g., Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991). An applicant shows that the inventor was in possession of the claimed invention 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 v. Am. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the inventor was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68,119 S.Ct. 304,312, 48 USPQ2d 1641, 1647 (1998); Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997); Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"
3 CAS Registry Number: 2576697-52-2
4 (5-(4-(cyclohexylmethoxy)phenyl)-2-oxo-6-(trifluoromethyl)-1,2-dihydropyridine-3-carboxamide)
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