DETAILED ACTION
The amendment submitted on May 20, 2026 has been entered. Claims 1-4, 8-11, and 14-20 are pending in the application and are rejected for the reasons set forth below. No claim is allowed, although the application would be allowable if a terminal disclaimer were to be submitted.
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 Leahy-Smith America Invents Act (AIA ), Public Law 112-29, 125 Stat. 284.
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 possi-ble 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 provi-sions 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 accompa-nied 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 that 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 1-4, 8-11, and 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,029,729 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. Claim 1 of the ‘729 Patent, of which the present application is a continuation, is directed to a non-lyophilized phar-maceutically acceptable and ophthalmologically suitable liquid composition for use in treating ophthalmic conditions, diseases, or for use in related procedures, comprising ketorolac, phenylephrine, a chelating agent, and a carrier, wherein the composition lacks a buffer and retains at least about 97% of the ketorolac and phenylephrine when for a storage period of at least about three months. Dependent claims 2-20 of the Patent are drawn to substantially the same subject matter of instant claims 2-4, 8-11, and 14-16 of the instant application. Claim 21 of the Patent is drawn to a “method of modulating one or more conditions of an eye,” which is described in the Patent (see, e.g., col. 91, ll. 1-10) as having the same utility of instant claims 17-20. One would therefore have viewed the subject matter of instant claims 17-20 as being prima facie obvious over the claims of the ‘729 Patent.
Claims 1-4, 8-11, and 14-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19/684,558 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. Note that the ‘558 Application is a continuation of the instant application. This is a provisional non-statutory double patenting rejection because the patentably indistinct claims have not, in fact, been patented.
Background Prior Art
The prior art made of record (see attached form PTO-892) and not relied upon is consid-ered pertinent to applicant’s disclosure. Kaur et al. and Reddy et al. disclose that phenylephrine and ketorolac were known in the prior art to be useful in the treatment and prevention of eye pain, inflammation, and miosis during ophthalmic surgery. These references are therefore relevant background information relating to the subject matter of claims 17-20.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Theodore R. Howell whose telephone number is (571)270-5993. The exam-iner can normally be reached Monday - Thursday, 8:00 am - 7:00 pm (Eastern Time). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (571)272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https:// patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
THEODORE R. HOWELL
Primary Examiner
Art Unit 1628
/THEODORE R. HOWELL/Primary Examiner, Art Unit 1628
June 3, 2026
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