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 .
Current Status
This action is responsive to the amended claims of 07/09/2026. Claims 1 and 318-342 are pending. Claim 342 is new. Claims 339-341 are withdrawn. Claims 1, 318-338, and 342 have been examined on the merits.
Election/Restrictions
The amendments to the claims of 07/09/2026 have overcome the prior art rejection of the action mailed 01/14/2026.
Thus, the Markush search has been extended. The full scope of Formula (I) defined by independent claim 1 has been searched – no prior art was retrieved (see SEARCH 6 of the attached search notes). Claims 336-337 recites species outside of the scope of amended claim 1 Formula (I) – not art was retrieved for these species (see SEARCH 6). Thus, the Markush search has been fully extended for the Formula (I). The election requirement is rendered moot.
The elected Group I claims 1, 318-338, and 342 are still subject to rejections, thus, the restriction requirement is still in place.
Claims 339-341 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/04/2025.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The effective filing date is 10/13/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/09/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Examiner acknowledges receipt of and has reviewed the amendments and remarks of 07/09/2026; no new matter is found.
The objections to claims 1, 318, 329, 331-332, and 338 are withdrawn (¶11-13 of previous action). Applicant has amended in line with Examiner’s suggestions.
The possible objections raised for previously withdrawn claims 327-328 (¶14 of previous action) have been sufficiently addressed by Applicant, in line with Examiner’s suggestion.
The possible objections raised for previously withdrawn claims 336-337 (¶14 of previous action) have not been sufficiently addressed. Due to the amendments and subsequent expansion of the search, these claims are now under examination, and the objection is made below.
The 112(b) rejections of claims 1, 318, 329, 331-332, and 338 are withdrawn due to amendments. For the rejections of ¶16-20 of the previous action, Applicant has amended in line with Examiner’s suggestions.
The 102 rejection of claims 1, 318, 329, 331-332, and 338 over CHEN (WO 2011/068821) is withdrawn. CHEN teaches a compound wherein A is phenyl and T2 is an unsubstituted alkyl. Claim 1 Formula (I) now requires A be chosen from one of two formulas defining saturated cycles not inclusive of phenyl and T2 be chosen from substituted alkyls.
The anticipatory non-statutory double patenting rejection of claims 1, 318, 329, 331-332, and 338 over co-pending application no. 18/856,543 is maintained and modified below to account for the amendments made to the claims and new claim 342.
Response to Amendment
Claim Objections – Necessitated by Amendment
Claims 336-337 are objected to because of the following informalities: Claims 336-337 recite structures of compounds of Formula (I); however, many of the structures contain overlapping atoms/bonds making the structures difficult to read; e.g., compound 104
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. Please provide new structures wherein the alignment of all elements is improved. Due to the quantity of disclosed compound structures, Applicant is asked to review all structures of claims 336-337. Appropriate correction is required.
Claim Rejections - 35 USC § 112 –
Necessitated by Amendments and New Claim
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 323-324, 336-337, and 342 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.
Claim 323 recites the limitation Ring A is "
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". There is insufficient antecedent basis for this limitation in the claim. Parent claim 1 recites wherein Ring A is chosen from
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; these two formulae for Ring A do not include a partially unsaturated 6-membered cycle as recited in claim 323. Thus, the Ring A of claim 323 lacks antecedent basis. The metes and bounds of claim 323 are undefined rendering the claim indefinite.
To overcome: Applicant could cancel claim 323.
Claim 324 recites the limitation Ring A is "
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". There is insufficient antecedent basis for this limitation in the claim. Parent claim 1 recites wherein Ring A is chosen from
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; these two formulae for Ring A do not include partially unsaturated 6-membered cycles as recited in claim 324. Thus, the Ring A of claim 324 lacks antecedent basis. The metes and bounds of claim 324 are undefined rendering the claim indefinite.
To overcome: Applicant could cancel claim 324.
Claims 336-337 recite species of compound outside of the scope of Formula (I) of claim 1. Claim 336 recites compounds 112-113, 135, 137, 241-242, 255-256, 287, 290, 293-300, 305-312, 317-324, 378, 380-384, 388-390, 413, and 416; Claim 337 recites the “a” counterpart of each of these species (e.g., 112a, 113a, etc.). There is insufficient antecedent basis for these limitations in the claim. Each of these species comprise a Ring A which is either
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or
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. Parent claim 1 recites wherein Ring A is chosen from
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; these two formulae for Ring A do not include a partially unsaturated 6-membered cycle as recited in the above species from claims 336 and 337. Thus, these species lack antecedent basis. The metes and bounds of claims 336-337 are undefined rendering the claims indefinite.
To overcome: Applicant could strike the recited species from the claims.
Claim 342 recites Ring A is selected from the group consisting of:
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. There is insufficient antecedent basis for these limitations in the claim. The third bullet point describing Ring A as chosen from partially unsaturated monocyclic carbo- and heterocycles is not encompassed by the Ring A as described in parent claim 1. Ring A can only be chosen from the first two bullet points, according to parent claim 1. Thus, the metes and bounds of the claim 342 are undefined rendering the claim indefinite.
To overcome: please strike the third bullet point and all following limitations from the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 323-324, 336-337, and 342 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Each of claims 323-324, 336-337, and 342 recite Ring A moieties or species of compound containing Ring A moieties which are outside of the scope of the parent claim 1 (see ¶20-23 for the Ring A moieties and species). Since these Ring A moieties and species are not within the scope of the parent claim 1, these claims do not properly further limit the parent claim 1.
Note, for claim 342, even if Applicant were to strike the offending Ring A moieties from the claim, the claim would not properly further limit the parent claim 1 since the Ring A would be chosen from the same two formulae as recited in claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting –
Necessitated by Amendments and New Claim
The nonstatutory 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 nonstatutory 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 nonstatutory 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 nonstatutory 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.
Claims 1, 318-332, 334-335, 338, and 342 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 18/856,543 (reference application – claims of 10-11-2024). Although the claims at issue are not identical, they are not patentably distinct from each other.
Reference claim 1 recites many compounds, all of which either fall under instant Formula (I) of instant claim 1 (and dependents) or fall under Formula (I) with the Ring A as described in instant claims 323-324 and 342. For example,
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wherein X1, X5, X7, X8 are CH; X6 is CRw wherein Rw is halogen (F); X3 is C; X2 and X4 are N wherein at least two and no more than four of the X1-X8 are N; T1 is T3 wherein T3 is C(=O)(OH); T2 is
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; L1 is C1 alkyl; L2 is a bond; ring A is
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wherein W1 is N and W2 is CRY2 wherein RY2 is H; L3 is a bond; ring B is formula (B-IV) or (B-V); B10-B12 and B9 are CR1 and C(Raa) respectively, wherein R1 is H and Raa is H; B7-B8 are O; L4 is a bond; ring C is phenyl; b is 2; and Rb is halogen (F & Cl). The other compounds of reference claim 1 map to instant Formula (I) if the moieties of the reference compounds are mapped to the instant formula in the following manner:
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. The reference claim 1 also recites compounds which fall under claims 323-324 and 342 wherein Ring A is a partially unsaturated cycle; e.g.,
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. Reference claim 2 is drawn to a pharmaceutical composition thereof comprising a pharmaceutically acceptable excipient. Reference claims 3-9 teach a method of use thereof. To practice the method the artisan would have to be in possession of the compound. Thus, since reference claim 1 is drawn to a series of compounds which are species of the instant claims, the reference claims anticipate the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 318-332, 334-338, and 342 are rejected.
Claim 333 is objected to for depending from a rejected claim.
The close art is ZHONG (WO 2020/103815; pub. 28 May 2020; provided IDS of 04/12/2023). ZHONG teaches compounds analogous to instant Formula (I) of independent claim 1 and the outliers of instant claims 323-324, 336-337, and 342, such as compound 111:
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(Pg. 143 Compound 111). The compounds of ZHONG differ at T1, the compounds require at least two structural changes to reach even the simplest of the instantly claimed T1 moieties (e.g., -CH3 to either -C(O)(OH) or -CH(X)(OH)). Further, for instant claim 1 Formula (I) Ring A is not chosen from partially unsaturated rings – only two defined formulae of fully saturated cycles. For claims 323-324, 336-337, and 342, which recite partially unsaturated Ring A forms, the prior art compounds do not approach the instantly claimed T1 and provide no teaching-suggestion-motivation to synthesize such compounds. Thus, ZHONG does not anticipate or make obvious the instant claims.
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 SARA ELIZABETH BELL whose telephone number is (703)756-5372. The examiner can normally be reached Monday-Friday 9:00-5:30.
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/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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