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 and Response to Amendments
The amendments filed July 11, 2025 have been entered. Claims 20, 45-47, 51, 56, 71-72, 80, 255, 257, 291, 302 and new claims 311-315 are pending
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 62/693,768 and 62/861,825, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Provisos, excluded compounds and new compounds (183-337) do not find support in the prior-filed applications. The effective filing date of this application is July 2, 2019.
Withdrawn Rejections
Rejections and objections not reiterated herein have been withdrawn or rendered moot in view of applicant’s amendments and/or remarks.
Response to Election/Restriction
The application was examined based on Applicant’s election of Group II, claims 257, 291 and 302 and their dependent claims drawn to: A method of inhibiting STING activity and a method of treating an associated disease or a disease in which increased STING signaling contributes ,comprising administering a compound of formula (I)
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wherein Z is CR1, Y1 and Y2 are each CR1, Y3 is N, Y4 is C, X1 is NR2, X2 is CH, the rings containing variables Z, Y1, Y2, Y3, Y4, X1 and X2 are aromatic (fully unsaturated), W is C(=O), C(=S), C(=NRd) or C(=NH), Q-A is as claimed and n is 0; which included the elected species compound 282
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(of claim 255) and the elected disease Amyotrophic lateral sclerosis (ALS)”.
Applicant’s amendment has overcome the prior art rejection of the previous Office action. Claims 20, 45-47, 51, 56, 71-72, 80, 257, 291, 302 and 311-315 have been fully searched and examined. Claim 255 has not been fully searched.
The need to limit examination is warranted based on the extensive permutations permitted on the core of the compounds and all the available variables, which require separate electronic searches and which structures are classified in different classes. Subject matter outside of the searched/examined scope in claim 255 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions there being no allowable generic or linking claim.
Applicant’s argument regarding the 112(a) Lack of enablement rejection.
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In response, at the Biological Assays, the present disclosure stated:
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In addition, inhibitory concentrations (ICs) were not tested, as is commonly done for inhibitors. Instead EC50 values were measured. There is a part of the specification that indicates that the compounds are antagonists of STING, and therefore, the examiner is considering that the statement at the Biological Assays section is a mis-statement. The examiner has withdrawn the 112(a) lack of enablement rejection. Applicant is required to correct the incorrect statement in the specification.
Claim Objections
Claim 255 is objected to for failing to comply with rule 1.141(a) (pasted below for convenience). Claim 255 has approximately 288 species. This number of compounds cannot be considered a reasonable number according to rule 1.141(a). In re Fressola, 22 USPQ 2nd 1828, indicates that the Examiner may reject for Applicants’ failure to follow a Rule.
§ 1.141 Different inventions in one national application.
(a) Two or more independent and distinct inventions may not be claimed in one national application, ex-cept that more than one species of an invention, not to exceed a reasonable number, may be specifically claimed in different claims in one national application, provided the application also includes an allowable claim gen-eric to all the claimed species and all the claims to species in excess of one are written in dependent form (§ 1.75) or otherwise include all the limitations of the generic claim.
In the instant case, claim 255 contains 288 compound species, many of which are not encompassed by the scope of generic Formula (I)
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. Claim 255, for instance, is drawn to compound
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however, in Formula I of claims 257, 291 and 302, the ring containing Z, Y1, Y2 and Y3 a cannot be a thiazolyl ring. In addition, in Formula (I) Z cannot have a substituent.
Claim 255 should be amended to either include all the limitations of Formula (I) or depend from a generic claim to all the claimed species. Failure to amend the claims consistent with the rules may result in a restriction requirement.
Specification Objections
The disclosure is objected to because of the following informalities: There is a non-existing compound represented in the specification. See page 96 with compound 124. Applicant’s arguments regarding this objection are addressed below.
The specification is also objected to because of the incorrect statement about the compounds activity as follows:
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Correction is required.
Improper Markush Grouping Rejection
Claim 255 is rejected on the basis that it contains an improper Markush group 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 the rejected claim is improper because the alternatives defined by the Markush grouping do not share both a substantial structural feature and a common use. There are marked structural differences in the bicyclic ring of the compounds, such as that they encompass distinct classes of ring structures and lack a common core. See at least compounds 100-109 and 180. A common use would not be expected from the structurally dissimilar compounds.
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.
Claim 255 is 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.
Claim 255 discloses compound 124. Compound 124 can’t exist because N can’t make 5 bonds.
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Applicant’s arguments have been considered but were found unpersuasive.
Applicant submits that one of skill in the art would readily recognize one of the resonance structures of an N-oxide.
In response, the structure in compound 124 is not a resonance structure of an N-oxide. One of ordinary skill in the art would know that a resonance structure must be a bona fide Lewis structure. The structure of 124 is not possible because it violates the octet rule. Nitrogen is a first-row atom, which can only have a maximum of eight valence electrons.
Conclusion
Claims 20, 45-47, 51, 56, 71-72, 80, 257, 291, 302 and 311-315 are allowable. Claim 255 is rejected.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE RODRIGUEZ-GARCIA whose telephone number is (571)270-5865. The examiner can normally be reached Monday-Friday 9:30am-4:30pm.
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/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1759