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 .
DETAILED ACTION
Claims 1-22 are pending in the application. Claims 1, 2, 5-11, 14, 16 and 18 are rejected. Claims 3, 4, 12, 13, 15, 17 and 19-22 are withdrawn.
Restriction/Election of Species
In view of Applicant’s amendment, filed on July 9, 2026, to the claims, the Examiner expanded the prior art search to include the entire scope of claim 1 which appears to be patentable and free of the prior art.
Information Disclosure Statement
The Information Disclosure Statement(s) (IDS) filed on July 9, 2026 is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the Examiner has considered the IDS documents and signed copies of the 1449 forms are attached.
Response to Amendments
Objections and rejections made in the Office Action mailed February 9, 2026 that do not appear below have been overcome by Applicant’s amendments to the claims and have been withdrawn.
Response to Arguments - 35 USC § 112(b)
In reply, Applicant traverses the 35 U.S.C. § 112(b) rejection of claim 16 as presented in the Nonfinal Rejection mailed February 9, 2026. The arguments regarding claim 16 have been fully and carefully considered, but are not persuasive as indicated below.
Applicant argues that “[t]erms such as ‘first eluting isomer’ or ‘second eluting isomer’ are well-recognized terminology in the field of medicinal chemistry and a person skilled in the art would readily understand that such terms refer to distinct stereoisomers separated by chromatographic methods as described in the specification (Examples 101 and 102 and Examples 165 and 166).” See page 38 of Applicant’s Remarks dated July 9, 2026. However, considering that the order and manner in which chemical isomers separate and emerge from a chromatographic column depend on various factors (e.g., column type, solvent(s), temperature, pH, etc.) involved in column chromatography that have not been recited in the claim, it is still unclear how the scope of the claim is being limited by the expressions “first eluting isomer” and “second eluting isomer.” Applicant argues that “[a]lthough the specific stereochemistry of the final compounds obtained was not assigned, the specification teaches one of skill in the art how to obtain the compound made and tested.” See pages 38 and 39 of Applicant’s Remarks dated July 9, 2026. However, although claims are interpreted in light of the specification, limitations from the specification are not read in to the claims. “Though understanding the claim language may be aided by explanations contained in the written description, it is important not to import into a claim limitations that are not part of the claim. For example, a particular embodiment appearing in the written description may not be read into a claim when the claim language is broader than the embodiment.” Superguide Corp. v. DirecTV Enterprises, Inc., 358 F.3d 870, 875, 69 USPQ2d 1865, 1868 (Fed. Cir. 2004). See MPEP § 2111.01 (II). For these reasons, the 35 U.S.C. § 112(b) rejection of claim 16 is proper. In addition to the suggestions described below, Applicant may also cancel the aforementioned expressions and their associated structures and, instead, provide structures representing the “two possible stereoisomers” (see page 39 of Applicant’s Remarks dated July 9, 2026) to overcome the issue of indefiniteness.
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.
Claim 16 remains 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 16 remains 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 16 recites the expressions “first eluting isomer” and “second eluting isomer” on page 16 and is rejected as indefinite. Both expressions are in reference to the following chemical structure:
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It is unclear how the scope of the claim is being limited by the expressions “first eluting isomer” and “second eluting isomer.” It is suggested that Applicant cancel these expressions and also delete one instance of the above chemical structure in the claim to overcome this issue of indefiniteness.
Claim 16 recites the expressions “First eluting isomer” and “Second eluting isomer” on page 21 and remains further rejected as indefinite. Both expressions are in reference to the following chemical structure:
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It is unclear how the scope of the claim is being limited by the expressions “First eluting isomer” and “Second eluting isomer.” It is suggested that Applicant cancel these expressions and also delete one instance of the above chemical structure in the claim to overcome this issue of indefiniteness.
Response to Arguments - 35 USC § 102
The claims rejections under 35 U.S.C. § 102(a)(2) as presented in the Nonfinal Rejection mailed February 9, 2026 is rendered moot by Applicant’s amendment, filed on July 9, 2026, and the rejection is hereby withdrawn.
Response to Arguments - 35 USC § 103
The claims rejections under 35 U.S.C. § 103 as presented in the Nonfinal Rejection mailed February 9, 2026 is rendered moot by Applicant’s amendment, filed on July 9, 2026, and the rejection is hereby withdrawn.
Response to Arguments – Double Patenting
In reply, Applicant traverses the Double Patenting rejection of claims 1, 2, 5-11, 14, 16 and 18 as presented in the Nonfinal Rejection mailed February 9, 2026. Applicant’s arguments are rendered moot in view of the outstanding rejection of claim 16 under 35 U.S.C. § 112(b).
Double Patenting
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
The analysis employed for an obviousness-type double patenting rejection parallels the analysis for a determination of obviousness under 35 U.S.C. § 103. 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.
Claims 1, 2, 5-11, 14, 16 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 10-12 of copending U.S. Application No. 18/837,817 (‘817). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-3 and 10-12 of ‘817 are drawn towards compounds encompassed by variable definitions of the instantly claimed compound of Formula I.
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For instance, Compound No. 2 (structure reproduced above) as recited in claim 1 of ‘817 is encompassed by variable definitions of the instantly claimed compound of Formula I, wherein A1, A3 and A4 are each independently CH; A2 is CR1, further wherein R1 is halo; R2 is OR11, further wherein R11 is C3 cycloalkyl substituted with C1 alkyl; Y is O; R6 is hydrogen; R7 is hydrogen; X is O; R4 is hydrogen; and R5 is heteroaryl substituted with halo.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 extension fee 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 DAVID SHIM whose telephone number is (571)270-1205. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RENEE CLAYTOR can be reached at (571)272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.M.S./Examiner, Art Unit 1626
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626
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