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 .
Application Staus
The amendment filed on 7/02/2026 in response to the Non-Final office action of 1/02/2026 is acknowledged and has been entered.
Claims 1-5, 7 and 9-25 are currently under consideration.
Applicant’s elected, without traverse, the species of compound Vb
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as set forth in Claim 9 in the reply filed on 11/25/2025. The Examiner has searched the elected species and has deemed the elected species with the para substitution of R1 to be free of the prior art. The examiner has moved on to the next species wherein R1 is the meta position as set forth below in the 102 rejection as well as the compound of claim 24 wherein G is CH. While searching the next species wherein R1 is in the meta position, the prior revealed another species encompassed by the generic formula (Ib) in claim 1 as set forth below.
Accordingly, claims 1-3, 9-17, 19-22 and 24-25 which read on the elected species and the next species, are under consideration.
Claims 4-5, 18 and 23 are withdrawn from consideration as being drawn to a non-elected species.
Rejections Withdrawn:
The rejection Claims 1-5, 7 and 9-23 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of Applicants amendments.
The rejection of Claim(s) 1-3, 15-17, 19-22 and 24-25 under 35 U.S.C. 102(a)(1) as being anticipated by Langlet et al. (Cell 2017; 171:824-835, IDS) are withdrawn in view of Applicants arguments.
The rejection of Claim(s) 1-3, 15-17 and 19-22 under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry Number 2423080-92-4 (Entered 2020-06-11) is withdrawn in view of Applicants arguments.
The rejection of Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Langlet et al. (Cell 2017; 171:824-835, IDS), as applied above to claims 1-3, 15-17, 19-22 and 24-25 is withdrawn in view of Applicants amendments.
Th provisional rejection of Claims 1-3 on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 17/598,695 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the compound of formula I of the copending Application overlap in scope with the compound of formula (Ib) claimed in the instant application is withdrawn upon reconsideration.
Rejections Maintained, but modified upon reconsideration:
Improper Markush
Claims 1-5, 7 and 15-22 remain rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claim 1 which has the generic formula (Ib)
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is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: While genus set forth in formula (Ib) appears to contain a similar backbone of a 5 membered ring bonded to a fused bicyclic ring composed of a 5 membered nitrogen containing ring and a 6 membered ring
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, the claims encompass an enormous number of compounds considering that each
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is independently a single or double bond, Y1 is C, N or O, Y2 is C or N, each Y3, Y4, Y5 and Y6 is independently CR2, N, NR2 or O or S, Z1 is C, N or O, Z2 is C, N or O and Z3 is C, N or O. As such, the genus as claimed does not share a single structural similarity.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
In response to this rejection, Applicants contend that , within claim 1, the Markush group for each position provides a group of similar structures which all behave the same in the context of the invention. For example, Applicants assert that the first grouping provides an aryl or heteroaryl group as pictured. Applicants further contend that the second grouping provides for a single or double bond and that the remaining groups can be analyzed in a similar manner and are similar to each other.
These arguments have been carefully considered, but are not found persuasive.
In the instant case, the Examiner recognizes that Applicants appear to be walking through each of the variables as being Markush groups which is understandable. However, the Examiner is not questioning each of the variables individually, per se. In contrast, the Examiner is questioning the roll up of each of the variables individually in the creation of a core structure. For example, consider a portion of the claimed compound having the structure:
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, wherein Y1 is C, N or O, Y2 is C or N and each of Y3, Y4, Y5 and Y6 is independently CR2, N, NR2, O or S. As such, one example could be
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. However, there are hundreds of alternative structures that could be made, in view of the alternatives claimed, including the double bonds being single bonds. The MPEP states that Members of a Markush group share a "single structural similarity" when they belong to the same recognized physical or chemical class or to the same art-recognized class. A recognized physical class, a recognized chemical class, or an art-recognized class is a class wherein there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved. In the instant case, the specification does not specifically teach that the resultant chemical compounds are an art-recognized class or chemical class, nor does the prior art (see MPEP 2117). The specification has only provided structures comprising the following core:
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. Accordingly, it is unclear what is the substantial structural feature that is essential to their use and how far you can deviate and still function.
New Rejections upon further consideration:
Claim Rejections - 35 USC § 112
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 24 and 25 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.
Regarding claim 24, claim 24 recites the structure
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wherein Q is either N or C. However, if Q is N it cannot be substituted with two variables (e.g. R20a and R20b) because of its valency. This becomes more unclear when defining R20a and R20b as a hydrogen, wherein at least one R20a or R20b is not hydrogen. Since the valency is exceeded if Q is N, it is unclear if either R20a or R20b can be a hydrogen. For prior art purposes, the examiner has interpreted N to only be bonded to one (1) and can include a hydrogen.
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) 1-3, 15-17 and 19-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Varnes et al. (J. Bioorg. Med. Chem. Lett. 2016; 26: 197-202, cited in the previous office action as pertinent prior art).
Varnes et al. teach biaryl pyrazoles and analogs thereof having the structures:
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which read on the instant claims wherein A is a benzene ring, wherein R1 is -S(O)2CH3 or alternatively, A is a heteroaryl, wherein either X7 or X8 is either a N or O (page 200, Table 1).
Claim(s) 24-25 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Univ. Columbia (US) et al. (WO2020/198351A1, 2020-10-01, IDS).
The applied reference has a common inventor/assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Univ. Columbia et al. teach compounds having the following structures which read on the instant invention,
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and
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which reads on the compound of claim 24, wherein G is CH, Q is N, R2a, R2b, R2c, R2d, R3, R4 and R6 are hydrogen, c is 1, d is 1, R20a or R20b is a hydrogen or -C(O)R19a, R19a is a C1 alkyl (Page 54, cmpd 35 and 36).
Conclusion
Therefore, claims 1-3, 15-17, 19-22 and 24-25 are rejected.
Claims 9-14 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
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