Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Detailed Action
Claims 1-16 are currently pending.
Claim Objections
Claim 2 is objected to because “and” is recited twice between the definitions of R4 and R5, and R5 and R6. Only the latter is necessary.
Claim 16 is objected to because the preamble should read “for the prophylaxis” to accord with similarly worded Claims 11-15, especially Claim 13.
Appropriate correction is required.
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 1-6 and 9-16 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 regards as the invention.
Claim 1 defines X1, X2, and X3 as potentially being C. However, it is unclear how the carbon is meant to be substituted, if at all, in the case where C is does not form four bonds with adjacent ring atoms and R1 or R2. For example, X3 in an embodiment where C forms only one or no double bond at all with adjacent atoms does not satisfy the tendency of tetravalent carbon to form four bonds. Claim 7 is clear in that it specifically permits X3 to be at least CH:
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. It is unclear if such additional hydrogen substitution is permissible for the X ring members of Formula I. Therefore, the metes and bounds of independent Claim 1 are not established and Claim 1 is rendered indefinite. For the purpose of compact prosecution, X ring members that are “C” are interpreted to encompassed hydrogen substitution to satisfy valency requirements of carbon. Claims 2-6 and 10-16 are rejected by virtue of dependency.
Claim 9 recites several structures denoted by ambiguous enantiomer or diastereomer designations. Regarding for example enantiomer pairs 1 and 2, “Absolute stereochemistry (R or S) of the chiral center in each of isomer “1” and/or isomer “2” in the Examples was not determined” (Specification: Para 62). It is unclear what isomers are being claimed by each enantiomer label. Further, diastereomers describing up to 4 distinct structures also lack clearly defined structural specificity. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). See MPEP 2173.05 (s). Explicit (R) or (S) designations are required to clearly establish the metes and bounds of the specific enantiomers and diastereomer structures claimed. It is noted that the metes and bounds of a racemate structure is clear.
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.
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.
Claims 1, 6, 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over Szymaniak (WO2022182861, 12/16/2024 IDS).
Szymaniak teaches HRSV and HMPV inhibitors (Abstract) as follow:
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(Page 153)
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(Page 156)
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(Page 160)
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(Page 160) and
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(Page 160),
in which the following definitions of examined Formula I apply: either X1 is C and X3 is S or X1 is N and X3 is CH; X2 is C; R2 is H or C1alkyl; R3 is CF3; R4 is p-fluorophenyl; and R5 is C3alkyl (isopropyl), substituted with (C=O)NH2, and R6 which is O, wherein both R5 and R6 together with their intervening atoms form a cycle. R1 in each case is H or methyl which are unacceptable substituents according to examined Formula I. However, Szymaniak Formula (I) broadly describes the 5-membered ring of the claimed core (ring A) as “optionally substituted” with little restriction (Page 4, Lines 1-10). Of the acceptable substituents of the limited embodiments of ring A of Pages 8 and 9, methoxy or OC1alkyl, appears throughout. One of skill in the art seeking to form inhibitors for the same use would therefore find it obvious to use the acceptable alternative embodiments to the R1 position taught by Szymaniak to form compounds for the same purpose. The resultant modified compounds wherein the instant R1 positions are methoxy instead of H or methyl would be expected to yield inhibitors for the same use because Szymaniak broadly teaches the ring may be “optionally substituted” without limitation to form inhibitors. Further, the third ring of Page 8 differs from that of Compound 431 specifically in that an intervening O atom is present:
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, more strongly motivating one of skill in the art to make the described modification and reasonably expect success in doing so with the explicit alternative group before the effective filing date of the instant claims.
The inhibitors are formulated in compositions with carriers (Page 43). “[M]ethods of treating an HRSV or HMPV [both human viruses] infection in a subject by administering a pharmaceutical composition comprising the compounds of the present invention” are taught (Abstract). Prevention, or prophylaxis, of both viruses is taught (Page 4, Lines 4-5). Treating includes “causing regression of the disease state or condition…[or] causing regression of an existing disease state or condition”, necessarily stopping replication of said viruses (Page 56, Lines 7-11). Antiviral assays are also conducted to assess “viral inhibition” (Page 304, Lines 15+). See ASSAYS section along with RSV and MPV antiviral data and tables beginning on Page 289. Therefore, one of skill in the art, having modified the compounds as described above for the same use would then find it obvious to deploy said compounds in the same methods of use and for the formulation of compositions for administration as claimed before the effective filing date of the instant claims.
Claims 1, 6, 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over McGrath (WO2021066922, 12/16/2024 IDS).
McGrath teaches HRSV and HMPV inhibitors (Abstract) including the following:
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(Page 229), in which the following definitions of examined Formula I apply: X1 is C; X2 is C; X3 is S; R2 is H; R3 is CF3; R4 is p-fluorophenyl; and R5 is C3alkyl (isopropyl), substituted with (C=O)NH2, and R6 which is O, wherein both R5 and R6 together with their intervening atoms form a cycle. R1 is CF3, which is unacceptable according to examined Formula I. However, McGrath Formula (I) broadly describes the 5-membered ring of the claimed core (ring A) as “optionally substituted” with little restriction (Page 4, Lines 1-5). Of the acceptable substituents of the limited embodiments of Pages 8 and 9, methoxy or OC1alkyl, appears throughout. One of skill in the art seeking to form inhibitors for the same use would therefore find it obvious to use the acceptable alternative embodiments to the R1 position taught by McGrath to form compounds for the same purpose. The resultant modified compound wherein the instant R1 position is methoxy instead of CF3 would be expected to yield inhibitors for the same use because McGrath broadly teaches the ring may be “optionally substituted” without limitation to form inhibitors. Additionally, the third ring of Page 8 differs from that of Compound 608 in the exact way that modification is suggested above, wherein CF3 is OMe:
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, more strongly motivating one of skill in the art to make the described modification and reasonably expect success in doing so with the explicit alternative group before the effective filing date of the instant claims.
The inhibitors are formulated in compositions with carriers (Pages 32 and 46). “[M]ethods of treating an HRSV or HMPV [both human viruses] infection in a subject by administering a pharmaceutical composition comprising the compounds of the present invention” are taught (Abstract). Prevention, or prophylaxis, of both viruses is taught (Page 3, Lines 28-30). Treating includes “causing regression of the disease state or condition…[or] causing regression of an existing disease state or condition”, necessarily stopping replication of said viruses (Page 44). Antiviral assays are also conducted to assess “viral inhibition” (Page 250, Lines 17+). See ASSAYS section along with RSV and MPV antiviral data and tables beginning on Page 242. Therefore, one of skill in the art, having modified the compounds as described above for the same use would then find it obvious to deploy said compounds in the same methods of use and for the formulation of compositions for administration as claimed before the effective filing date of the instant claims.
Conclusion
Claims 1-6 and 9-16 are rejected. Claims 2 and 16 are objected to.
Claims 7-8 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.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 8:30am - 4:30pm EST.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
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