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 .
DETAILED ACTION
Claims 1-19 are pending in the instant application.
Claims 1-3, 6, and 19 are amended.
Claims 1-19 are examined herein.
Priority
The instant application is a CIP of U.S. Patent Application No. 17715369, filed on 07 April 2022, and claims benefit of priority to the following
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The claims to the benefit of priority are acknowledged. However, there is no support in any of the priority documents for the new limitation “wherein administration occurs 2 or more times within 24 hours of initial administration” found in independent claim 1, or the new limitation “wherein from about 0.0875 milligrams to about 0.35 milligrams of aceclidine are administered to the subject in need thereof within 8 hours,” recited in independent claim 19. As such, the effective filing date of the claims is 17 April 2023, the filing date of the instant application.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 09 November 2023, 24 April 2024, 14 August 2024, 17 September 2025, and 08 July 2026 are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Arguments
The amendment filed on 08 July 2026 has been entered.
In view of applicant amendments and arguments the 103 rejections of record over the Glaucostat® technical sheet, Romano, Kauffman, Abdelkader, and Yu are withdrawn. The prior art fails to render the method of using the instant composition for the treatment of presbyopia obvious. The Glaucostat® technical sheet and Romano guide the skilled artisan to the use of aceclidine for glaucoma, not presbyopia. Kauffman fails to overcome this deficiency. While Kauffman teaches patients with glaucoma are often also suffering from presbyopia, there is nothing in Kauffman that suggests aceclidine can be used to treat presbyopia. So, while there would be an overlap of glaucoma patients treated in Romano that were also suffering from presbyopia, there is nothing showing that the presbyopia symptoms were also being treated with the prescribed glaucoma treatment. The work of Abdelkader, Abdelkader teaches the administration of carbachol, a muscarinic agonist, and brimonidine for the treatment of presbyopia, fails to overcome the deficiencies of the technical sheet, Romano, and Kaufman. The work of Yu, which teaches the mixture of antiglaucoma drugs for the treatment of eye conditions also fails to overcome the deficiencies of the technical sheet, Romano, and Kaufman, Therefore the skilled artisan would not find the method of treating presbyopia with aceclidine and brimonidine obvious over the prior art.
In view of applicant amendment to claim 1, the 103 rejection of record over Horn in view of the Glaucostat® technical sheet is withdrawn. The administration of a second drop of the composition within 30 minutes of the initial drop results in an unexpected improvement in maintaining an ideal pupil size for correcting presbyopia for a longer period of time (paragraph [0530]). This result could not have been anticipated by the prior art as the Glaucostat® technical sheet only recites applying 1 drop three times daily, which implies 8 hours between each application.
Regarding the double patenting rejection, Applicant requests the rejection be held in abeyance until patentable subject matter is found. Therefore, the rejection is maintained.
All rejections and objections not found below have been withdrawn.
MAINTAINED REJECTIONS
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, 6, and 10-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8 and 9 of U.S. Patent No. 9089562B2 in view of the Glaucostat® technical sheet (cited by Applicant on 1449 IDS). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, the Patent discloses the method of treating presbyopia comprising administering a composition comprising aceclidine at a concentration of 0.25% to 2.0% w/v (claim 8).
The patent does not disclose multiple doses within 30 minutes.
The Glaucostat® technical sheet teaches a 2% w/v ophthalmic composition comprising aceclidine administered 3 times daily.
It would be prima facie obvious to one of ordinary skill in the art to administer the composition taught in the patent twice or more daily as aceclidine is known in the art to be administered multiple times a day.
Regarding claims 6 and 10-13, the patent discloses the composition further comprises the excipients hydroxypropylmethyl cellulose (a nonionic surfactant and/or viscosity agent), sodium chloride (a viscosity agent), glycerin also known as glycerol (a polyol), and citrate (claim 9).
Claims 1 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14, and 17 of U.S. Patent No. 9320709 in view of the Glaucostat® technical sheet (cited by Applicant on 1449 IDS). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, the patent discloses a method of treating a refractive error of the eye comprising administering a composition comprising 0.25 % to 2.0 % aceclidine (claims 14 and 1).
The patent does not disclose multiple doses within 30 minutes of the initial dose.
The Glaucostat® technical sheet teaches a 2% w/v ophthalmic composition comprising aceclidine administered 3 times daily.
It would be prima facie obvious to one of ordinary skill in the art to administer the composition taught in the patent twice or more daily as aceclidine is known in the art to be administered multiple times a day.
Regarding claim 18, the patent discloses the method wherein the pupil is reduced to 1.7 to 2.0 mm (claim 17).
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6, 9, and 11-12 of U.S. Patent No. 9833441 in view of the Glaucostat® technical sheet (cited by Applicant on 1449 IDS). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, the patent discloses a method of treating presbyopia (claim 11) and irregular astigmatism (claim 12) comprising administering a composition comprising 0.25 % to 2.0 % (claim 9) aceclidine (claim 6).
The patent does not disclose multiple doses within 30 minutes of the initial dose.
The Glaucostat® technical sheet teaches a 2% w/v ophthalmic composition comprising aceclidine administered 3 times daily.
It would be prima facie obvious to one of ordinary skill in the art to administer the composition taught in the patent twice or more daily as aceclidine is known in the art to be administered multiple times a day.
Claims 1 and 6-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 4, 5, 7, 8, 17, and 19 of U.S. Patent No. 9844537 in view of the Glaucostat® technical sheet (cited by Applicant on 1449 IDS). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, the patent discloses a method of treating presbyopia (claim 17) and irregular astigmatism (claim 19) comprising administering a composition comprising 0.25 % to 2.0 % aceclidine and a polyol (claim 1).
The patent does not disclose multiple doses within 30 minutes of the initial dose.
The Glaucostat® technical sheet teaches a 2% w/v ophthalmic composition comprising aceclidine and glycerin administered 3 times daily.
It would be prima facie obvious to one of ordinary skill in the art to administer the composition taught in the patent twice or more daily as aceclidine is known in the art to be administered multiple times a day.
Regarding claim 6, the patent discloses additional excipients including a nonionic surfactant (claim 3 and a viscosity enhancer (claim 7).
Regarding claims 7 and 8, the patent discloses the non-ionic surfactants are selected from the group consisting of a polysorbate, a polyoxyl castor oil, a polyoxyl stearate, a poloxamer, a polyethylene glycol, a polyoxyethylene glycol alkyl ether, tyloxapol and 2-[[10,13-dimethyl-17-(6-methylheptan-2-yl)-2,3,4,7,8,9,11,12,14,15,16,17-dodecahydro-1H-cyclopenta[a]phenanthren-3-yl]oxy]ethanol (claim 4).
Regarding claim 9, the patent discloses the non-ionic surfactant is polysorbate 80 (claim 5).
Regarding claim 10 and 11, the patent discloses the viscosity enhancer is selected from a cellulose derivative, hyaluronate, a carbomer and a gum (claim 8).
Regarding claim 12, the patent discloses a cellulose derivative (claim 8).
The patent does not specifically recite hydroxypropylmethyl cellulose.
The Glaucostat® technical sheet teaches hydroxypropylmethyl cellulose.
Under the guidance of the technical sheet it would be be prima facie obvious for the skilled artisan to choose hydroxypropylmethyl cellulose as the cellulose derivative recited in the patent.
Regarding claims 13 and 14, the patent recites the polyol to be mannitol (claim 2).
Claims 1 and 6-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 and 14 of U.S. Patent No. 10052313 in view of the Glaucostat® technical sheet (cited by Applicant on 1449 IDS). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1 and 6-14, the patent discloses a method of treating presbyopia (claim 14) comprising administering a composition comprising 1.75% aceclidine, 2.5% mannitol, 4.0% polysorbate 80, and 1.25% hydroxypropylmethyl cellulose (claim 13).
The patent does not disclose multiple doses within 30 minutes of the initial dose.
The Glaucostat® technical sheet teaches a 2% w/v ophthalmic composition comprising aceclidine administered 3 times daily.
It would be prima facie obvious to one of ordinary skill in the art to administer the composition taught in the patent twice or more daily as aceclidine is known in the art to be administered multiple times a day.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, and 5 of U.S. Patent No. 10617763 in view of the Glaucostat® technical sheet (cited by Applicant on 1449 IDS). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claim 1, the patent discloses a method of treating presbyopia (claim 4) and irregular astigmatism (claim 5) comprising administering a composition comprising 0.25 % to 2.5 % aceclidine (claim 2).
The patent does not disclose multiple doses within 30 minutes of the initial dose.
The Glaucostat® technical sheet teaches a 2% w/v ophthalmic composition comprising aceclidine and glycerin administered 3 times daily.
It would be prima facie obvious to one of ordinary skill in the art to administer the composition taught in the patent twice or more daily as aceclidine is known in the art to be administered multiple times a day.
Claims 1, 6-12, and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 14, 16, and 18 of copending Application No. 18239045 (reference application) in view of the Glaucostat® technical sheet (cited by Applicant on 1449 IDS). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 1, the reference application recites a method of treating presbyopia comprising administering 1.25 to 2.5% of aceclidine (claim 1).
The patent does not disclose multiple doses within 30 minutes of the initial dose.
The Glaucostat® technical sheet teaches a 2% w/v ophthalmic composition comprising aceclidine and glycerin administered 3 times daily.
It would be prima facie obvious to one of ordinary skill in the art to administer the composition taught in the patent twice or more daily as aceclidine is known in the art to be administered multiple times a day.
Regarding claim 6-12, the reference application recites the composition further comprising a nonionic surfactant (claim 18), and a viscosity enhancer (claim 16).
Regarding claim 18, the reference application recites the reduction of pupil size to 1.5 to 2.5 mm (claim 14).
Claims 1, 6-14, and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, and 9 of copending Application No. 18241733 (reference application) in view of the Glaucostat® technical sheet (cited by Applicant on 1449 IDS). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 1, the reference application recites a method of inhibiting or reducing ciliary spasm or pain in a subject with presbyopia comprising administering 2% aceclidine and a polyol (claim 1).
The patent does not disclose multiple doses within 30 minutes of the initial dose.
The Glaucostat® technical sheet teaches a 2% w/v ophthalmic composition comprising aceclidine and glycerin administered 3 times daily.
It would be prima facie obvious to one of ordinary skill in the art to administer the composition taught in the patent twice or more daily as aceclidine is known in the art to be administered multiple times a day.
Regarding claims 6-14, the reference application recites the composition comprising a polyol (claim 1), a non-ionic surfactant (claim 4), and a viscosity agent (claim 5).
Regarding claim 16, the reference application recites the improvement of vision acuity (claim 9).
Claims 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-20 of copending Application No. 19387928 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding claim 1, the reference application recites the method of treating presbyopia comprising administering a composition comprising 1-2% w/v aceclidine salt, a sub-genus of the aceclidine genus recited in the instant claims, wherein the administration occurs 2 or more times within 24 hours of initial administration (claim 17).
Regarding claim 2, the reference application recites the method wherein the administration occurs 2 or more times within 1 hour of initial administration (claim 18).
Regarding claim 3, the reference application recites the method wherein administration occurs 2 or more times within 5 minutes of initial administration (claim 19).
Regarding claims 4 and 5, the reference application recites the method where the composition includes 0.007-0.08& w/v brimonidine (claim 17).
Regarding claims 6-14, the reference application recites the method wherein the composition further comprises one or more excipients selected from nonionic surfactants, viscosity agents and a polyol (claim 20).
Claim Objections
Claims 15, 17, and 19 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Claims 1-14, 16 and 18 are rejected.
Claims 15, 17, and 19 are objected to.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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