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 1-19 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, and 17 September 2025, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Claim Interpretation
The relative term “about” is recited throughout the instant claims. The specification clearly defines this term in paragraph [056].
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 24 hours.
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 24 hours.
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 24 hours.
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 24 hours.
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 24 hours.
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 24 hours.
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 24 hours.
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 24 hours.
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 Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over the Glaucostat® technical sheet (cited by Applicant on 1449 IDS) in view of Romano et al. (Brit. Jr. ophthal.1970;54:510-529; cited by Applicant on 1449 IDS) and Kaufman et al. (IOVS.2019;60(5):1801-1812; cited by Applicant on 1449 IDS).
The Glaucostat® technical sheet teaches an ophthalmic solution for treating glaucoma comprising 2% aceclidine three times daily.
The technical sheet does not teach administering the composition.
Romano et al. teaches the ocular administration of Glaucostat to patients with glaucoma (page 512).
Romano does not explicitly teach if the glaucoma patients also had presbyopia.
Kauffman teaches presbyopia as the progressive loss of near focus as one ages caused by the loss of accommodative amplitude (page 1801). Accommodative amplitude is completely lost by the mid-40s age, with clinical symptoms of presbyopia beginning around age 40. At the same time the rise in primary open-angle glaucoma (POAG) begins (page 1802). Meaning patients with glaucoma are often also suffering from presbyopia. Therefore, some of the patients treated by Romano also had presbyopia.
It would have been prima facie obvious to one of ordinary skill in the art to administer Glaucostat, as taught by Romano, to a person with presbyopia, as Kaufmann demonstrates the overlap in conditions of glaucoma and presbyopia. The work of Romano would guide the skilled artisan to choosing aceclidine, over any other muscarinic agonist for glaucoma, as aceclidine has good patient tolerance (page 520). The Glaucostat® technical sheet teaches the administration of the solution three times a day.
Regarding claims 2 and 3, the Glaucostat® technical sheet teaches the usual does is 1 drop, three times daily. It does not explicitly teach multiple drops within an hour of administration or 5 minutes of initial administration. However, in the absence of criticality, this is routine optimization. See MPEP 2144.05.II.A.
Regarding claim 18, Romano teaches aceclidine produced significant miosis, with a mean pupil diameter of 1.71 mm (page 516).
Regarding claim 19, the combination of art does not explicitly teach the administration of 0.0875 to 0.35 mg of aceclidine administered within 8 hours. The Glaucostat® technical sheet and Romano teach a 2% solution, that is 20 mg for every 1 mL, or 1 mg for every eye drop using the standard eye drop volume of 50.0 µL. The taught solutions would need to be administered at a volume of 4.375 µL to 17.5 µL, in the absence of criticality, this is routine optimization. See MPEP 2144.05.II.A.
Claim(s) 1-5, 15-16, and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over the Glaucostat® technical sheet (cited above) in view of Romano et al. (cited above) and Kaufman et al. (cited above) in further view of Abdelkader et al. (Eye Vis (Lond). 2016;3(31):1-6).
The teachings of the Glaucostat® technical sheet, Romano, and Kaufman are disclosed above and incorporated by reference herein.
Regarding claims 4 and 5, the above combined teachings fail to teach the method of administering aceclidine in combination with brimonidine.
Abdelkader teaches the administration of carbachol, a muscarinic agonist, and brimonidine for the treatment of presbyopia.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious.
In this case at least prong B of KSR applies – substitution of one known element for another. The above combined teaches teach the administration of aceclidine for presbyopia. Abdelkader teaches the administration of carbachol and brimonidine. It would be prima facie obvious to one of ordinary skill in the art to substitute aceclidine for carbachol, as they are both muscarinic agonists and would be expected to exhibit similar pharmacological effects. This substitution would also be guided by the work of Romano as it is stated aceclidine has better penetration that carbachol (page 510).
Thus, all of the elements of claims were known to one of ordinary skill in the art at the time the invention was made and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of invention. Therefore, the claimed invention, as a whole, would have been obvious to one of ordinary skill in that art at the time the invention was made.
Abdelkader does not teach brimonidine at a concentration of 0.001 to 0.1%, but rather 0.2%. In the absence of criticality, this is routine optimization. See MPEP 2144.05.II.A.
Regarding claims 15 and 16, Abdelkader teaches the improvement of vision acuity and the maintenance of distance and night vision, as demonstrated by all patients reporting the ability to drive safely day or night with no distortions in perception or movement (page 3).
Claim(s) 1-3, 6-14 and 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over the Glaucostat® technical sheet (cited above) in view of Romano et al. (cited above) and Kaufman et al. (cited above) in further view of Yu et al. (US20050196370A1; cited by Applicant on 1449 IDS).
The teachings of the Glaucostat® technical sheet, Romano, and Kaufman are disclosed above and incorporated by reference herein.
Regarding claim 6, the above combined teachings fail to teach the method of administering an aceclidine composition comprising one or more excipients chosen from nonionic surfactants, viscosity agents and a polyol.
Yu teaches ophthalmic compositions for treating dry eye comprising oil-in-water emulsions containing a demulcent (paragraph [0028]), a surfactant (paragraph [0029]), and a viscosity modifying agent (paragraph [0142]). Yu teaches the utilization of these emulsions for the delivery of miotics and antiglaucoma drugs (paragraph [0090]). Aceclidine is recited in combination with timolol maleate (paragraph [0090]). Pilocarpine and carbachol, two other muscarinic agonists, are also recited (paragraph [0090]).
It would be prima facie obvious to one of ordinary skill in the art to formulate the aceclidine, as taught by the Glaucostat® technical sheet and Romano, to include additional excipients, as taught by Yu, to increase the stability of the composition. The Glaucostat® technical sheet teaches the solution has a validity period of 30 days (page 4). Yu teaches the ophthalmic compositions are stable and free of microbial growth for up to two years (paragraph [0029]), this would greatly increase shelf life and be preferable to one skilled in the art.
Regarding claims 7, 8, and 9, Yu teaches polysorbate-80 as a nonionic surfactant (paragraph [0064]).
Regarding claims 10, 11, and 12, Yu teaches hydroxypropylmethyl cellulose as a viscosity agent (paragraph [0142]).
Regarding claims 13 and 14, Yu teaches mannitol (paragraph [0084]).
Claims 1-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Horn et al. (9844537; cited by Applicant on 1449 IDS) in view of the Glaucostat® technical sheet (cited by Applicant on 1449 IDS).
Regarding claim 1, Horn discloses a method of treating presbyopia (claim 17), irregular astigmatism (claim 19), and refractive error (column 6, line 41) comprising administering a composition comprising 0.25 % to 2.0 % aceclidine (claim 1).
Horn does not disclose multiple doses within 24 hours.
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 by Horn twice or more daily as aceclidine is known in the art to be administered multiple times a day.
Regarding claims 2 and 3, the Glaucostat® technical sheet teaches the usual does is 1 drop, three times daily. It does not explicitly teach multiple drops within an hour of administration or 5 minutes of initial administration. However, in the absence of criticality, this is routine optimization. See MPEP 2144.05.II.A.
Regarding claims 4 and 5, Horn discloses the composition further comprising brimonidine at a concentration less than 0.065% (column 20, line 62).
Regarding claim 6, Horn discloses additional excipients including a nonionic surfactant (claim 3 and a viscosity enhancer (claim 7).
Regarding claims 7 and 8, Horn 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, Horn discloses the non-ionic surfactant is polysorbate 80 (claim 5).
Regarding claim 10 and 11, Horn discloses the viscosity enhancer is selected from a cellulose derivative, hyaluronate, a carbomer and a gum (claim 8).
Regarding claim 12, Horn discloses hydroxypropylmethyl cellulose as a viscosity agent (column 5, line 23).
Regarding claims 13 and 14, the patent recites the polyol to be mannitol (claim 2).
Regarding claims 15 and 16, Horn teaches the disclosed composition to maintain distance vision and result in reduced glare at night (column 9, line 28).
Regarding claim 18, Horn teaches pupil constriction to 1.8-2.0 mm (column 35, line 15).
Regarding claim 19, the above teaching of Horn and the Glaucostat® technical sheet teaches a method of treating presbyopia, irregular astigmatism, and refractive error comprising administering a composition comprising 0.25 % to 2.0 % aceclidine 3 times daily. The dosing amount can be formulated to where the recited 0.0875 to 0.35 mg of aceclidine are administered.
Conclusion
Claims 1-19 are rejected.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621