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 .
Request for Continued Examination
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 28th 2026 has been entered.
DETAILED ACTION
Status of the Claims
Claims 1 and 4-32 are pending. Claims 18-32 have been withdrawn as being directed towards nonelected groups. Claims 7-15 have been withdrawn as being directed towards nonelected species until a generic claim has been found allowable. Claims 1, 4-6, and 16-17 are examined on their merits.
35 U.S.C. § 103 Rejections Overcome by Amendment and Argument
Applicant’s amendments and arguments in the response filed on April 28th 2026 are acknowledged. Applicant has amended the claims to be directed only to a method of treating or preventing an adenovirus infection in the eye of a mammal via topical administration of filociclovir. Applicant’s amendments are sufficient to overcome the 103 rejections over claims 1 and 16-17, as the combination of Kern and Sanjay does not address adenoviral infection, the 103 rejections over claims 1 and 16-17 are withdrawn.
Applicant further argues that Hartline’s cell plate experiments do not suggest direct treatment for any viral infection, but only serve as a demonstration for a novel assay method, and that Hartline teaches away from antiviral treatment by directly stating that more direct measurements of antiviral activity would be required to fully describe the antiviral activity of any of the described compounds. Applicant’s argument is found persuasive, and the 103 rejections over claims 4-6 are withdrawn.
Nonstatutory Double Patenting Rejections Maintained
The nonstatutory double patenting rejections of claims 1, 4-6, and 16-17 are maintained.
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, 4-6 and 16-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-10, and 31 of copending Application No. 17/437,236 (‘236 Application) in view of Sanjay (Sanjay et al, Herpes Zoster Ophthalmicus. Curr Treat Options Neurol 13, 79–91 (2011)), Maudgal, (Maudgal et al., Topical Treatment of Experimental Herpes Simplex Keratouveitis With 2′-O-glycylacyclovir: A Water-Soluble Ester of Acyclovir. Arch Ophthalmol. 1984;102(1):140–142), and Colin (Colin J. Ganciclovir ophthalmic gel, 0.15%: a valuable tool for treating ocular herpes. Clin Ophthalmol. 2007 Dec;1(4):441-53).
Applicant claims:
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144
549
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The ‘236 Application claims:
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85
604
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The instant claims differ from those of the ‘236 Application in that they are a subspecies of the ‘236 application, with the additional requirement of topical ophthalmic administration of the filociclovir.
One of ordinary skill in the art would have a reasonable expectation of success in administering filociclovir topically to the eye, because drugs of the same class (nucleoside analogue antivirals) are commonly administered topically to the eye for ocular infections.
See Sanjay, who teaches administration of acyclovir topically to the cornea for the treatment of ophthalmic infection by herpes zoster (Sanjay, pg. 79).
See Maudgal, who teaches administration via topical eyedrop of 2‘-O-glycylacyclovir for the treatment of herpes simplex keratitis (Maudgal, Abstract).
See Colin, who treats ocular herpes simplex with a topical ganciclovir gel (Colin, Abstract).
Regarding applicant’s argument that Sanjay only suggests combination treatments, applicant is reminded that the claims as currently written encompass combination treatments.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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