DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/24/2026 has been entered.
Status of Application
The response filed 08/24/2026 has been received, entered and carefully considered. The response affects the instant application accordingly:
Claim 1 have been amended.
A clean copy substitute specification is submitted.
Due to restriction, claims 9-10 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 1, 8-10 are pending.
Claims 1 and 8 are present for examination at this time.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
All grounds not addressed in the action are withdrawn or moot as a result of amendment or patenting of copending application.
New grounds of rejection are set forth in the current office action as a result of amendment or patenting of copending application.
Priority
Receipt of the English translation with affidavit of translation of the certified copies of papers required by 37 CFR 1.55 was submitted on 03/27/2026 wherein the effective filing date is certified foreign priority document of 08/09/2019 as it is perfected with an English translation.
Current Grounds of Rejection and Objection
Specification
The substitute specification filed 07/17/2026 has not been entered because it does not conform to 37 CFR 1.125(b) and (c) because:
the substitute specification does not contain a marked copy showing all the changes relative to the specification of record with the text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived.
Only an clean version (without markings) was supplied which should have been accompanied with a marked version, and the clean version is also incorrect as it does not appear to contain the same subject matter as originally filed. For example the compounds of I-2 and I-3 are missing the configuration indicators or (R); wherein the substitute specification is not compliant and not representative of the original specification and not entered.
Additionally the substitute specification filed 03/27/2026 is not entered as it does not conform to 37 CFR 1.125(b) and (c) because: the substitute specification does not contain a marked copy showing all the changes relative to the specification of record with the text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. Only a clean version (without markings) was supplied which should have been accompanied with a marked version, and was incorrect as it does not clearly depict the chemical structures where it remains unclear and not readable.
The specification of record of the original disclosure of 02/03/2022 remains objected to because of the following issues: all the chemical structures in the specification are not clear and not readable. The chemical structures are fuzzy and do not clearly depict the structures (i.e.
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, the a and b configuration indicators, and substituents are unclear, H’ s look like A’s in several structures like
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have substituents overlap and looks like a ring).
Appropriate correction is required.
Response to Arguments:
Applicant's states that the specification has been amended taking the issues into account and withdrawal of the objection is requested. This is fully considered but not persuasive as addressed above, the substitute specification is not compliant as it does not have a marked up copy with the clean copy and some of the chemical structures in the clean copy are not reflective of the original content of the original specification filed wherein it is not compliant and not entered.
Accordingly, the rejection stands.
Status of Claims with Regards to Prior Art
The compounds of claims 1 and recited for claim 8 appear to be free of the prior art but subject to the double patenting rejection below.
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 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 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Pat. 12735448 (previously presented copending Application No. 18276321).
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are directed to the crystalline forms of the instant compound which are species of the instant claimed compound and fall within the breath instantly claimed. Patented claim 8 is to a pharmaceutical composition with the crystalline for of the compound falling within the breath instantly claimed.
Response to Arguments:
Applicant's arguments are centered on the assertion that the present application has an earlier filing date than the copending application. This is fully considered but not persuasive as the copending application is now patented wherein the double patenting rejection is no longer provisional.
Accordingly, the rejection stands.
Conclusion
Claims 1 and 8 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GIGI GEORGIANA HUANG whose telephone number is (571)272-9073. The examiner can normally be reached Monday-Thursday 9:00-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GIGI G HUANG/Primary Examiner, Art Unit 1613
