DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-5 and 9-13 are pending. Claims 6-8 and 14 are canceled. Claims 1-5 and 9-13 are amended.
Claims 1-5 and 9-13, previously examined as to the elected species of presbyopia, are herein examined on their merits in light of all species.
Information Disclosure Statement
The IDS filed 11/4/2025 has been reviewed.
Previous Rejections
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn. The following rejections and/or objections are either reiterated or newly
applied. They constitute the complete set presently being applied to the instant application.
Rejections Withdrawn
Claim Rejections - 35 USC § 103
In light of the amendments to the claims the rejection of claims 1-6 and 8-13 under 35 U.S.C. 103 as being unpatentable over Prospectus/Technical Sheet for Glaucostat Josefa Valcarecel GLAUCOSTAT® 2% colirio as evidenced by US 4,906,467 in view of Romano. Brit. Jr. Ophthal. (1970) 54, 510 Double Blind cross-over comparison of aceclidine and pilocarpine in open-angle glaucoma and Kaufman PL, Lutjen Drecoll E, Croft MA. Presbyopia and glaucoma: two diseases, one pathophysiology? The 2017 Friedenwald Lecture. Invest Ophthalmol Vis Sci. 2019;60:1801–1812. https://doi.org/10.1167/iovs.19-26899 and Yu et al US 2005/0196370 (9/8/2005) as evidenced by the specification is withdrawn.
In light of the amendments to the claims the rejection of claim 7 under 35 U.S.C. 103 as being unpatentable over Prospectus/Technical Sheet for Glaucostat Josefa Valcarecel GLAUCOSTAT® 2% colirio as evidenced by US 4,906,467 in view of Romano. Brit. Jr. Ophthal. (1970) 54, 510 Double Blind cross-over comparison of aceclidine and pilocarpine in open-angle glaucoma and Kaufman PL, Lutjen Drecoll E, Croft MA. Presbyopia and glaucoma: two diseases, one pathophysiology? The 2017 Friedenwald Lecture. Invest Ophthalmol Vis Sci. 2019;60:1801–1812. https://doi.org/10.1167/iovs.19-26899 and Yu et al US 2005/0196370 (9/8/2005) as evidenced by the specification as applied to claims 1-6 and 8-13 and further in view of Malakhov et al. WO 2009015286 (1/29/2009) is withdrawn.
Double Patenting
In light of the abandonment of the application the provisional rejection of claims 1-13 on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claims 4-9 and 11-13 of U.S. Patent Appn. No. 17/502066 in view of Yu et al US 2005/0196370 (9/8/2005) is withdrawn as moot.
Rejections Maintained
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The rejection of claims 1-5 and 9-13 on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-13 and 15-18 of U.S. Patent No. 9844537 is maintained.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims are directed to a method of inhibiting or reducing ciliary spasm or pain in a subject comprising administering a polyol combination with aceclidine and a nonionic surfactant and a viscosity enhancer.
The claims of U.S. Patent No. 9844537 are directed to a method of treating presbyopia comprising administering to a subject in need thereof an ophthalmological composition comprising aceclidine, a viscosity enhancer and a nonionic surfactant and about 2.0% to about 3.0% w/v mannitol. The claims of U.S. Patent No. 9844537 do not expressly recite administering less than 0.2% tropicamide..
It would be prima facie obvious for a skilled artisan following the method of the claims of U.S. Patent No. 9844537 to administer less than about 0.02% tropicamide because no tropicamide is recited in the claims and no tropicamide or 0% tropicamide overlaps with less than 0.02%.
The rejection of claims 1, 4 and 9-13 on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-11 and 13-15 of U.S. Patent No. 10052313 is maintained.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims are directed to a method of inhibiting or reducing ciliary spasm or pain in a subject comprising administering a polyolol combination with aceclidine and a nonionic surfactant and a viscosity enhancer.
The claims of U.S. Patent No. 10052313 are directed to a method of treating presbyopia comprising administering to a subject in need thereof an ophthalmological composition comprising aceclidine, a viscosity enhancer and a nonionic surfactant and mannitol. The claims of U.S. Patent No. 10052313 do not expressly recite administering less than 2% aceclidine.
It would be prima facie obvious for a skilled artisan following the method of the claims of U.S. Patent No. 10052313 to administer less than about 2% aceclidine because the claims of U.S. Patent No. 10052313 recite about 1.75% aceclidine and this overlaps with less than about 2% aceclidine.
The rejection of claims 1-5 and 9-13 on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10,617,763 in view of Yu et al US 2005/0196370 (9/8/2005) is maintained.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims are directed to a method of treating presbyopia comprising administering to a subject in need thereof an ophthalmological composition comprising aceclidine as the only active agent and a nonionic surfactant and a viscosity agent.
The claims of U.S. Patent No. 10617763 are directed to a method of treating presbyopia comprising administering to a subject in need thereof an ophthalmological composition comprising aceclidine and a cryoprotectant. The claims of U.S. Patent No. 10617763 differ from those of the instant application in that they do not expressly recite a polyol, a viscosity agent or a nonionic surfactant. These deficiencies are made up for with the teachings of Yu et al.
Yu et al. (Yu) discloses an ophthalmic solution that comprises aceclidine, mannitol, hydroxypropylmethyl cellulose and a nonionic surfactant. (See Yu [0040], [0090],[0114], [0084], claim 4 and [0026]). Yu teaches that hydroxypropylmethyl cellulose is a viscosity agent. (See [0064]). Mannitol is a polyol. Yu teaches that its compositions are stable, can treat dry eye and have sufficient anti-microbial activity that they can also be used as contact lens disinfecting solutions. (See Abstract).
It would be prima facie obvious for a skilled artisan following the method of the claims of U.S. Patent No. 10617763 to add mannitol, viscosity agents and nonionic surfactant in order to have a stable composition that can treat dry eye and have sufficient anti-microbial activity that they can also be used as contact lens disinfecting solutions as taught by Yu.
The rejection of claims 1, 3-5 and 9-13 on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claim 5 of U.S. Patent No. 11648247 in view of Yu et al US 2005/0196370 (9/8/2005) is maintained.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims are directed to a method of inhibiting or reducing ciliary spasm or pain in a subject comprising administering a polyol combination with aceclidine and a nonionic surfactant and a viscosity enhancer.
Claim 5 of U.S. Patent No. 11648247 is directed to a method of treating presbyopia comprising administering to a subject in need thereof an ophthalmological composition comprising about 1.75% aceclidine, a viscosity enhancer and a nonionic surfactant and mannitol. Claim 5 of U.S. Patent No. 11648247 does not expressly recite administering less than 2% aceclidine.
It would be prima facie obvious for a skilled artisan following the method of the claims of U.S. Patent No. 11648247 to administer less than about 2% aceclidine because claim 5 of U.S. Patent No. 11648247 recites about 1.75% aceclidine and this overlaps with less than about 2% aceclidine.
The provisional rejection of claims 1-5 and 9-13 on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claims 11-23 of U.S. Patent Appn. No. 18/239045 in view of Yu et al US 2005/0196370 (9/8/2005) is maintained.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims are directed to a method of treating presbyopia comprising administering to a subject in need thereof an ophthalmological composition comprising aceclidine, a polyol and a nonionic surfactant and a viscosity agent.
The claims of U.S. Patent Appn. No. 18/239045 are directed to a method of treating presbyopia comprising administering to a subject in need thereof an ophthalmological composition comprising aceclidine as the only active agent, hydroxypropylmethylcellulose and a nonionic surfactant. The claims of U.S. Patent Appn. No. 18/239045 differ from those of the instant application in that they do not expressly recite a polyol or an amount of a polyol. This deficiency is made up for with the teachings of Yu et al.
Yu et al. (Yu) discloses an ophthalmic solution that comprises aceclidine, mannitol, hydroxypropylmethyl cellulose and a nonionic surfactant. (See Yu [0040], [0090],[0114], [0084], claim 4 and [0026]). Mannitol is a polyol. Yu teaches that mannitol can be used to adjust the osmolality of the composition to its desired use. Yu teaches that its composition are stable, can treat dry eye and have sufficient anti-microbial activity that they can also be used as contact lens disinfecting solutions. (See Abstract).
It would be prima facie obvious for a skilled artisan making the composition of the claims of U.S. Patent Appn. No. 18/239045 to add the desired amount of mannitol in order to have a stable composition that can treat dry eye and have sufficient anti-microbial activity that they can also be used as contact lens disinfecting solutions as taught by Yu.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The rejection of claims 1-5 and 9-13 on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,179,328 in view of Yu et al US 2005/0196370 (9/8/2005) is maintained.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims are directed to a method of treating presbyopia comprising administering to a subject in need thereof an ophthalmological composition comprising aceclidine, a polyol and a nonionic surfactant and a viscosity agent.
The claims of U.S. Patent No. 11,179,328 are directed to a method of treating presbyopia comprising administering to a subject in need thereof an ophthalmological composition comprising aceclidine as the only active agent, hydroxypropylmethylcellulose, and a nonionic surfactant. The claims of U.S. Patent No. 11,179,328 differ from those of the instant application in that they do not expressly recite a polyol or an amount of a polyol. This deficiency is made up for with the teachings of Yu et al.
Yu et al. (Yu) discloses an ophthalmic solution that comprises aceclidine, mannitol, hydroxypropylmethyl cellulose and a nonionic surfactant. (See Yu [0040], [0090],[0114], [0084], claim 4 and [0026]). Mannitol is a polyol. Yu teaches that mannitol can be used to adjust the osmolality of the composition to its desired use. Yu teaches that its composition are stable, can treat dry eye and have sufficient anti-microbial activity that they can also be used as contact lens disinfecting solutions. (See Abstract).
It would be prima facie obvious for a skilled artisan making the composition of the claims of U.S. Patent No. 11,179,328 to add the desired amount of mannitol in order to have a stable composition that can treat dry eye and have sufficient anti-microbial activity that they can also be used as contact lens disinfecting solutions as taught by Yu.
Response to Arguments
The comments filed November 4, 2025 have been considered and are found to be mostly persuasive.
Applicants note the amendments to the claims and note the cancelation of claims 6-8, thereby rendering the rejections of claims 6-8 moot. The rejections of claims 6-8 have been withdrawn above.
Applicants argue that Romano teaches away from inhibiting or reducing ciliary spasm or pain due to its teachings that browache or headache was more frequent with aceclidine. Based on Romano, one of ordinary skill in the art would not have sought to use aceclidine in patients with presbyopia, wherein headaches and eyestrain are common symptoms. Moreover, one of ordinary skill in the art would not have expected a drug that causes brow ache to inhibit or reduce ciliary spans or pain in a subject with presbyopia.
Applicants argue that Yu does not teach aceclidine as a sole active agent but only teaches aceclidine with at least one other active agent.
With respect to the double patenting rejection Applicants request that the double patenting rejections be held in abeyance until the claims of the current case are deemed allowable.
Applicants’ arguments have been reviewed and are found to be sufficiently persuasive. The obviousness rejections have been withdrawn above.
Applicants request to hold the double patenting rejection in abeyance until there is an indication of allowability of claims is noted. Applicant is reminded that a request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see MPEP 37 CFR 1.111(b) and 714.02).
Thus, the double patenting rejections are maintained (with the exception of one that is rendered moot due to the abandonment of U.S. Patent Application No. 17/502066) as no action regarding this rejection has been taken by applicants at this time.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 SARAH CHICKOS whose telephone number is (571)270-3884. The examiner can normally be reached on M-F 9-6.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SARAH CHICKOS
Examiner
Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619