DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group II in the reply filed on 10/14/2025 is acknowledged. Applicant also elected the active to be mycophenolic acid.
Status of Application
Applicant has elected Group II in response to restriction requirement and elected the species mycophenolic acid as the active for the examination.
Due to restriction, based on election of Group II and the active to be mycophenolic acid (nonelected species are betamethasone, and the combination of betamethasone with mycophenolic acid), claims 13-25, 27-28 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 10-29 are pending.
Claims 10-12, 26, 29 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 .
Priority
This application is a continuation-in-part of the prior application 17/582627 and a continuation-in-part of 17/418813, and adds disclosure not presented in the prior application. The instant claims 11-12 are directed to the claimed method which is administered for up to 4 weeks (claim 11) and up to 2 weeks (claim 12) which is supported by the instant disclosure but not supported in the disclosure of the prior application wherein the instant claims are given the priority date of 01/23/2023 which is the filing date of the instant application.
Information Disclosure Statement
The information disclosure statement filed 10/01/2023 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 10-12, 26, 29 are rejected under 35 U.S.C. 103 as being unpatentable over Donnenfeld (Focus on Complications and Complexity: Dry Eye After LASIK) in view of Chong et al. (WO 2010/004435).
Rejection:
Donnenfeld teaches that essentially all patients have dry eye at least transiently after LASIK, and that dry eye is the most common complication of LASIK surgery and ophthalmologist should take steps to minimize dry eye and employ postoperative therapeutic interventions (postoperative treatments from eye surgery, First paragraph and Conclusion).
Donnenfeld does not expressly teach the topical administration of a composition containing 0.01% to 0.05% w/w betamethasone sodium phosphate, 0.05% to 0.50% w/w mycophenolic acid, and a pharmaceutically acceptable carrier; but does establish that dry eye is the most common complication of LASIK surgery and ophthalmologists should take steps to minimize dry eye and employ postoperative treatments.
Chong et al. teaches treating dry eye (keratoconjunctivitis sicca) with topical administration of an ophthalmic solution containing sodium mycophenolic acid (claim 1, 20-22, 27, [49]). The sodium mycophenolic acid is from about 0.1-about 4%w/v including about 0.05-about3%w/v (claim 3-4). The solutio is applied at doses sufficient to provide a therapeutic benefit including 1-8 times/day, or applied every two day, once every four days, or once a week as needed to treat the ocular disorder [9, 56]. Chong et al. also demonstrates administering the composition for 14 days ([105-107], see full document specifically areas cited).
Wherein it would be it would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to treat the dry eye from LASIK with a dry eye formulation with betamethasone like betamethasone sodium phosphate as suggested by Chong et al. and produce the claimed invention; as it is it prima facie obvious to treat the dry eye from LASIK with a known formulation with an immunosuppressant like mycophenolic acid as presented with Chong et al. with a reasonable expectation of success. While Chong et al. does not teach the exact claimed values for the mycophenolic acid, it is embraced by the taught range wherein it is prima facie obvious to optimize within the taught range and arrive at the claimed values as a means of attaining the desired therapeutic profile with a reasonable expectation of success absent evidence of criticality for the claimed range.
Claims 10-12, 26, 29 are rejected under 35 U.S.C. 103 as being unpatentable over Peyman (U.S. Pat. Pub. 2005/0063997).
Rejection:
Peyman teaches treating a patient following cataract surgery to aid in post-surgical recovery and prevent capsular opacification with an ocular composition containing mycophenolic acid and/or macrolide antibiotic (abstract, [14, 38]). The amount of mycophenolic acid is about 0.5-about 10%, can be applied one to several time per day ([23], see full document specifically areas cited).
While Peyman does not teach the exact claimed values, they do overlap (a (i.e. about 0.5 embraces values like 0.3%) wherein even a slight overlap in ranges establishes a prima facie case of obviousness. Additionally a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close as the proportions are so close that prima facie one skilled in the art would have expected them to have the same properties MPEP 2144.05 (I). It is also prima facie obvious to treat the eye post-surgery for as long as needed to attain the desired therapeutic profile (i.e. prevent capsular opacification post-surgery) with a reasonable expectation of success absent evidence of criticality for the claimed time period.
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 10-12, 26, 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 9-14, 26-28 of copending Application No. 17582627 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the method of the copending claims fall within the breath of the instant claims as written; and it would be prima facie obvious to administer the composition until the condition is resolved absent evidence of criticality for the claimed time period.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 10-12, 26, 29 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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/GIGI G HUANG/Primary Examiner, Art Unit 1613