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 7-15 and 17-21 are pending. Claims 6 and 16 are canceled. Claim 21 is newly added. Claims 1, 14-15 and 17-18 are amended.
Claims 4-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (pilocarpine (claim 4) and carbachol (claim 5)) when aceclidine is elected), there being no allowable generic or linking claim.
Claims 1-3 and 7-15 and 17-21 are examined on their merits in light of the elected species of myopia and aceclidine.
Rejections that were not necessitated by amendment have been made below and the Office Action is made Non-Final as a result.
Information Disclosure Statement
The IDS filed 8/12/2025 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Rejections and/or objections not reiterated from previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.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.
Objections Withdrawn
Objections to the Specification
In light of the amendments to the specification the objections to the specification are withdrawn.
Claim Objections – Duplicate Claim
In light of the amendments to the claims the objections to the claims are withdrawn.
Rejections Withdrawn
Claim Rejections - 35 USC § 103
The rejection of claims 1-3, 7-15 and 17-20 under 35 U.S.C. 103 over Prospectus/Technical Sheet for Glaucostat Josefa Valcarecel GLAUCOSTAT® 2% colirio (11/9/2023 IDS) 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 (11/9/2023 IDS) and Mayama et al. Myopia and Advanced-Stage Open Angle Glaucoma, Ophthalmology, 109, pp 2072-2077, 2002. (11/9/2023 IDS) and Yu et al US 2005/0196370 (9/8/2005) (11/9/2023 IDS) is withdrawn in view of the amendments to the claims and in favor of the new grounds of rejection below.
Double Patenting
In light of the abandonment of the application the provisional rejection of claims 1-3, 7-15 and 17-20 on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 5 of U.S. Patent Appn. No. 17/715369 in view of Yu et al US 2005/0196370 (9/8/2005) is withdrawn in view of the abandonment of the ‘369 application.
Upon further consideration the rejection of claims 1-3, 7-15 and 17-21 on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 14 of U.S. Patent No. 9320709 in view of Yu et al US 2005/0196370 (9/8/2005) is withdrawn.
Upon further consideration the rejection of claims 1-3, 7-15 and 17-21 on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4, 5, 7, 9 and 11 of U.S. Patent No. 10959990 in view of Yu et al US 2005/0196370 (9/8/2005) is withdrawn.
New Rejections/Rejections Maintained
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 of this title, 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 1-3, 7-15 and 17-21 are rejected under 35 U.S.C. 103 over Prospectus/Technical Sheet for Glaucostat Josefa Valcarecel GLAUCOSTAT® 2% colirio (11/9/2023 IDS) 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 (11/9/2023 IDS) and Mayama et al. Myopia and Advanced-Stage Open Angle Glaucoma, Ophthalmology, 109, pp 2072-2077, 2002. (11/9/2023 IDS) and Yu et al US 2005/0196370 (9/8/2005) (11/9/2023 IDS) as evidenced by the instant specification.
Glaucostat Technical Sheet (“Glaucostat”) discloses an ophthalmic solution that contains aceclidine hydrochloride, benzalkonium chloride, boric acid, sodium borate and water for injection. (See Glaucostat Translation page 1 Quantitative Composition). The Glaucostat technical sheet qdescribes the Glaucostat commercial product. In this product the only active agent is aceclidine and benzalkonium chloride is a surfactant. The Glaucostat sheet does not clearly indicate its date, although there is a “05/00” on page 1. If this is an indication of the date than this is a printed publication dated May of 2000 that describes a commercial product that has been available earlier than the instant application’s filing date of February 20. 2020. However, in the US 4906467 there is a reference to Glaucostat and this reference is dated March 6, 1990. This indicates that this product was on sale or at least publicly known (well enough to be almost synonymous with aceclidine) as early as March 6, 1990, the date of this reference. Aceclidine is the elected muscarinic agonist and is called for in instant claim 2. An aqueous solution is called for in instant claim 1.
Glaucostat also teaches that Glaucostat (aceclidine) is a parasympathomimetic agent, with marked cholinergic properties and minima; anticholinerestase activity. (See Glaucostat Translation page 1). Glaucostat teaches that it is indicated in ocular hypertonia such as chronic glaucoma, apthaic glaucoma, sub-acute and closed-angle glaucoma and child and juvenile glaucoma and pigmentary glaucoma. (See pages 1-2 of Machine Translation). While this indicates that it is intended for administration to the eyes of glaucoma patients, Glaucostat does not expressly teach the administration of aceclidine to the eyes of a patient with myopia. Glaucostat also does not teach polysorbate 80, hydroxypropylmethylcellulose, pH, tropicamide and brimonidine. These deficiencies are made up with the teachings of Romano, Mayama et al. and Yu et al.
Romano teaches the administration to the eye of Glaucostat in a study that compares the effects of the administration of Glaucostat with the simultaneous administration of pilocarpine to patients who all had glaucoma. (See Abstract and pages 1-2). Thus, Romano teaches a method of administering to a subject an opthalmological composition comprising aceclidine as called for in instant claim 1. Romano teaches that aceclidine was well tolerated by patients even when pilocarpine was not. (See Romano page 520).
All of the patients in Romano had glaucoma, but Romano is silent on whether the patients had myopia. (See page 2). Myopia is nearsightedness or where objects closer to the eye can be focused on but objects farther away can appear blurry. Nearsightedness is common in individuals with glaucoma and many individuals suffer from both conditions, as taught by Mayama et al. (See page 2072). Specifically, Mayama teaches that myopia is associated with higher intraocular pressure and occurs more often in glaucoma patients than in the normal population. (See page 2072, first paragraph). Thus at least some of the glaucoma patients in the Romano study had to have myopia and were subjects in need thereof a called for in instant claim 1.
Yu et al. (Yu) discloses an ophthalmic solution for treating dry eye that comprises aceclidine, mannitol, hydroxypropylmethyl cellulose, and a nonionic surfactant. Yu teaches that these excipients make for excellent formulations with several ophthalmic actives. (See Yu [0040], [0090],[0114], [0084], claim 4 and [0026]). Yu teaches that while its ophthalmic solution is for preventing dry eye, it is suitable for common ophthalmic actives to be added to it.
Mannitol is a polyol and it can be administered in the same composition as the aceclidine. Mannitol is taught to be a useful tonicity agent in Yu which can adjust the osmolality of the composition. (See [0084]). Yu teaches a pH of from 6.8-8.0. (See [0074]). This is about 6.0 as called for in instant claims 12 and 17.
Yu teaches ophthalmic compositions for treating dry eye comprising an oil-in-water emulsion containing a demulcent, which is preferably hydroxypropylmethylcellulose (see [0041]), an oil and a surfactant that can be a nonionic surfactant. (See Yu Abstract, [0041], [0090],[0115], [0016], [0084], claim 4, throughout and [0026]). Yu teaches a low surfactant to oil ratio that provides stability and performance. (See [0029], [0024], [0053]). Yu teaches viscosity agents as called for in claims 13 and 18 such as hydroxypropylmethylcellulose. (See [0142]). This is a cellulose derivative as called for in claim 20. Yu teaches that a second therapeutic agent may include tropicamide as called for in claim 9 and that it may be present in an amount of about 0.001%. (See [0116]). 0.001% falls within the from about 0.0001% to about 0.01% w/v called for in instant claim 8. Tropicamide is identified as a therapeutic agent so it is taught to be a results effective variable, so it would be no more than routine experimentation to experiment to arrive at the amount in claims 10 and 11.
Yu teaches that while its ophthalmic solution is for preventing dry eye, it is suitable for common ophthalmic actives to be added to it.
As stated in paragraph [0046]
Topical ophthalmic application forms of the present compositions include, without limitation, eye drops for dry eye treatment and for other treatments, forms for the delivery of drugs or therapeutic components into the eye and forms for caring for contact lenses. The present compositions are very useful for treating dry eye and similar conditions, and other eye conditions. In addition, the present compositions are useful in or as carriers or vehicles for drug delivery, for example, a carrier or vehicle for delivery of therapeutic components into or through the eyes.
Yu expressly teaches mixtures of ophthalmic actives and brimonidine is one such ophthalmic active ingredient. (See [0098]). Brimonidine is called for in instant claim 21. Brimonidine is an α-2 adrenergic agonist as evidenced by the instant specification at [0041]. A nonionic surfactant is called for in instant claim 19. The nonionic surfactant can be polysorbate 80 which is a polysorbate as called for in claim 19. The aceclidine can be present in an amount of about 0.01 to about 5%. (See [0116]). 0.01 to about 5% aceclidine overlaps with the from about 0.1% to about 4.0% called for in claim 1, the from about 0.3% to about 2% w/v as called for in instant claim 3 and overlaps with the about 1% to about 2% w/v called for in claim 15. Yu teaches that aceclidine is an effective therapeutic that treats glaucoma. (See [0114]).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to administer Glaucostat to treat glaucoma patients having myopia based on the teachings of Romano and Mayama in order to have a glaucoma treating composition that could reduce intraocular pressure but with the advantage of a smaller effect on accommodation and decrease of the depth of the anterior chamber as taught by Glaucostat as well as having good tolerance by patients as taught by Romano.
It would be prima facie obvious for a skilled artisan administering Glaucostat in view of Romano and Mayama method to add hydroxymethylcellulose for viscosity adjustment and control, polysorbate 80 for a nonionic surfactant and tropicamide and brimonidine as secondary ophthalmic therapeutic agents to the ophthalmic solution, and have the amount of aceclidine be between 0.01 and 5% as taught by Yu in order to have a stable composition that can effectively deliver ophthalmic actives as well as treat glaucoma as taught by Yu.
With respect to the limitation “wherein the administration of the composition treats one or more symptoms of the eye condition [myopia] in the subject’s eye”, the prior art is silent as to this property. The prior art, however, teaches all of the claimed components in the same amounts (at the overlap of the ranges) and also teaches all of the same steps as those claimed. Glaucostat in view of Romano, Mayama and Yu teach the administration of 0.01 to 5% aceclidine in aqueous solution with hydroxypropylmethylcellulose, polysorbate 80 and tropicamide and brimonidine to the eye of glaucoma patients having myopia, which is identical to the claimed method. The administration of this composition would necessarily treat one or more symptoms of myopia as evidenced by the specification in Example 18 in which subjects administered the claimed composition will have a symptom of myopia treated. A composition having the same components as those claimed will necessarily have the same properties as those claimed, See MPEP 2112.01[R-3]: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” In re Spada, 911 F2d 705, 709, 15 USQPQ2d 1655, 1658 (Fed. Cir. 1990).
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 1-3, 7-15 and 17-20 on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claims 16-20 of U.S. Patent No. 9314427 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 instant claims are directed to a method of treating myopia comprising administering to a subject in need thereof an ophthalmological composition comprising aceclidine, tropicamide and a nonionic surfactant and a viscosity agent.
The claim of U.S. Patent No. 9314427 is directed to a method of treating myopia comprising administering to a subject in need thereof an ophthalmological composition comprising aceclidine, a viscosity enhancer, a nonionic surfactant and a cryoprecipitate. The claims of U.S. Patent No. 9314427 differ from those of the instant application in that they do not recite tropicamide, polysorbate and hydroxypropyl ethylcellulose and brimonidine. These deficiencies are made up for with the teachings of Yu et al.
The teachings of Yu are described supra. It would be prima facie obvious for a skilled artisan following the method of the claims of U.S. Patent No. 9314427 to add tropicamide, hydroxypropylmethylcellulose, and polysorbate 80 to the ophthalmic solution as taught by Yu in order to have a stable composition that can effectively deliver mixtures of ophthalmic actives as taught by Yu.
The rejection of claims 1-3, 7-15 and 17-20 and newly applied to claim 21 are rejected on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claim 5 of U.S. Patent No. 10617763 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 myopia comprising administering to a subject in need thereof an ophthalmological composition comprising aceclidine, tropicamide and a nonionic surfactant and a viscosity agent.
The claims of U.S. Patent No. 10617763 are directed to a method of treating myopia 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 tropicamide or brimonidine. These deficiencies are made up for with the teachings of Yu et al.
The teachings of Yu are described supra. It would be prima facie obvious for a skilled artisan following the method of the claims of U.S. Patent No. 10617763 to add tropicamide and brimonidine, in the ophthalmic solution as taught by Yu in order to have a stable composition that can effectively deliver mixtures of ophthalmic actives as taught by Yu.
Claims 1-3, 7-15 and 17-21 are directed to an invention not patentably distinct from claim 5 of Patent No. 10617763 in view of Yu et al US 2005/0196370 (9/8/2005).
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between application or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned U.S. Patent No. 10617763, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualified as prior art under 35 U.S. C, 102(a)(2) and the patentably indistinct inventions were not commonly owner or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 101(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(v)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 USC 102(c) and 37 CFRR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
A showing that the invention were commonly owned or deemed to be commonly owned not later than the effective filing date under 35 USC 100(i) of the claimed invention will preclude a rejection under 35 USC 102 or 103 based upon the commonly assigned case. Alternative, applicant may take action to amend or cancel claims such that the applications, or the patent and the application, no longer contain claims directed to patentably indistinct inventions.
The rejection of claims 1-3, 7-15 and 17-20 and newly applied to claim 21 on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 12-13 and 16 of U.S. Patent No. 10052313 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 myopia comprising administering to a subject in need thereof an ophthalmological composition comprising aceclidine, tropicamide and a nonionic surfactant and a viscosity agent.
The claims of U.S. Patent 10052313 are directed to a method of treating myopia comprising administering to a subject in need thereof an ophthalmological composition comprising aceclidine, hydroxypropylmethylcellulose, brimonidine, a nonionic surfactant and mannitol. The claims of U.S. Patent No. 10052313 differ from those of the instant application in that they do not expressly recite treatment with a composition with a cellulose based viscosity agent. This deficiency is made up for with the teachings of Yu et al.
The teachings of Yu are described supra. It would be prima facie obvious for a skilled artisan making the composition of the claims of U.S. Patent No. 10052313 to add hydroxypropylmethylcellulose to the ophthalmic solution as taught by Yu in order to have a stable composition that can effectively deliver mixtures of ophthalmic actives as taught by Yu.
Claims 1-3, 7-15 and 17-21 are directed to an invention not patentably distinct from claim 1, 12-13 and 16 of Patent No. 10052313 in view of Yu et al US 2005/0196370 (9/8/2005).
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between application or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned U.S. Patent No. 10052313, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualified as prior art under 35 U.S. C, 102(a)(2) and the patentably indistinct inventions were not commonly owner or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 101(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(v)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 USC 102(c) and 37 CFRR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
The rejection of claims 1-3, 7-15 and 17-20 and newly applied to claim 21 on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 5-12 of U.S. Patent No. 9833441 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 myopia comprising administering to a subject in need thereof an ophthalmological composition comprising aceclidine, tropicamide and a nonionic surfactant and a viscosity agent.
The claims of U.S. Patent No. 9833441 are directed to a method of treating myopia comprising administering to a subject in need thereof an ophthalmological composition comprising aceclidine and tropicamide. The claims of U.S. Patent No. 9833441 differ from those of the instant application in that they do not expressly recite polysorbate 80, brimonidine and hydroxypropylmethylcellulose. This deficiency is made up for with the teachings of Yu et al.
The teachings of Yu are described supra. It would be prima facie obvious for a skilled artisan following the method of the claims of U.S. Patent No. 9833441 to add hydroxypropylmethylcellulose, brimonidine and polysorbate 80 to the ophthalmic solution as taught by Yu in order to have a stable composition that can effectively deliver mixtures of ophthalmic actives as taught by Yu.
Claims 1-3, 7-15 and 17-21 are directed to an invention not patentably distinct from claim 1 and 5-12 of Patent No. 9833441 in view of Yu et al US 2005/0196370 (9/8/2005).
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between application or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned U.S. Patent No. . 9833441, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualified as prior art under 35 U.S. C, 102(a)(2) and the patentably indistinct inventions were not commonly owner or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 101(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(v)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 USC 102(c) and 37 CFRR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
The rejection of claims 1-3, 7-15 and 17-21 on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 19 of U.S. Patent No. 9844537 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 myopia comprising administering to a subject in need thereof an ophthalmological composition comprising aceclidine, tropicamide and a nonionic surfactant and a viscosity agent.
The claims of U.S. Patent No. 9844537 are directed to a method of treating myopia comprising administering to a subject in need thereof an ophthalmological composition comprising aceclidine and a polyol. The claims of U.S. Patent No. 9844537 differ from those of the instant application in that they do not expressly recite polysorbate 80, hydroxypropylmethylcellulose, brimonidine and tropicamide. This deficiency is made up for with the teachings of Yu et al.
The teachings of Yu are described supra. It would be prima facie obvious for a skilled artisan following the method of the claims of U.S. Patent No. 9844537 to add tropicamide, hydroxypropylmethylcellulose, brimonidine and polysorbate 80 to the ophthalmic solution as taught by Yu in order to have a stable composition that can effectively deliver mixtures of ophthalmic actives as taught by Yu.
Claims 1-3, 7-15 and 17-21 are directed to an invention not patentably distinct from claim 1 and 19 of Patent No. 9844537 in view of Yu et al US 2005/0196370 (9/8/2005).
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between application or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned U.S. Patent No. . 9833441, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualified as prior art under 35 U.S. C, 102(a)(2) and the patentably indistinct inventions were not commonly owner or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 101(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(v)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 USC 102(c) and 37 CFRR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
Claims 1-3, 7-15 and 17-21 are rejected on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claims 1 and 14 of U.S. Patent No. 9320709 in view of Yu et al US 2005/0196370 (9/8/2005) as evidenced by the specification.
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 myopia comprising administering to a subject in need thereof an ophthalmological composition comprising aceclidine and a nonionic surfactant and a viscosity agent.
The claims of U.S. Patent No. 9320709 are directed to a method of treating presbyopia comprising administering to a subject in need thereof an ophthalmological composition comprising aceclidine and a nonionic surfactant and a viscosity agent. The claims of U.S. Patent No. 9320709 differ from those of the instant application in that they do not expressly recite polysorbate 80, brimonidine, hydroxypropylmethylcellulose, and tropicamide. This deficiency is made up for with the teachings of Yu et al.
The teachings of Yu are described supra. It would be prima facie obvious for a skilled artisan following the method of the claims of U.S. Patent No. 9320709 to add tropicamide, hydroxypropylmethylcellulose, brimonidine, and polysorbate 80 to the ophthalmic solution as taught by Yu in order to have a stable composition that can effectively deliver mixtures of ophthalmic actives as taught by Yu.
With respect to the limitation “wherein the administration of the composition treats one or more symptoms of the eye condition [myopia] in the subject’s eye”, the claims are silent as to this property. The claims of U.S. Patent No. 9320709 in light of Yu, however, teach all of the claimed components in the same amounts (at the overlap of the ranges) and also teaches all of the same steps as those claimed.
The claims of U.S. Patent No. 9320709 in light of Yu teach the administration of 0.25 to 2.0% aceclidine in aqueous solution with hydroxypropylmethylcellulose, polysorbate 80 and tropicamide and brimonidine to the eye of glaucoma patients having myopia, which is identical to the claimed method. The administration of this composition would necessarily treat one or more symptoms of myopia as evidenced by the specification in Example 18 in which subjects administered the claimed composition will have a symptom of myopia treated. A composition having the same components as those claimed will necessarily have the same properties as those claimed, See MPEP 2112.01[R-3]: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” In re Spada, 911 F2d 705, 709, 15 USQPQ2d 1655, 1658 (Fed. Cir. 1990).
Claims 1-3, 7-15 and 17-21 are directed to an invention not patentably distinct from claim 1 and 14 of Patent No. 9320709 in view of Yu et al US 2005/0196370 (9/8/2005).
The U.S. Patent and Trademark Office may not institute a derivation proceeding in the absence of a timely filed petition. The USPTO normally will not institute a derivation proceeding between application or a patent and an application having common ownership (see 37 CFR 42.411). Commonly assigned U.S. Patent No. . 9320709, discussed above, may form the basis for a rejection of the noted claims under 35 U.S.C. 102 or 103 if the commonly assigned case qualified as prior art under 35 U.S. C, 102(a)(2) and the patentably indistinct inventions were not commonly owner or deemed to be commonly owned not later than the effective filing date under 35 U.S.C. 101(i) of the claimed invention.
In order for the examiner to resolve this issue the applicant or patent owner can provide a statement under 35 U.S.C. 102(b)(2)(C) and 37 CFR 1.104(v)(4)(i) to the effect that the subject matter and the claimed invention, not later than the effective filing date of the claimed invention, were owned by the same person or subject to an obligation of assignment to the same person. Alternatively, the applicant or patent owner can provide a statement under 35 USC 102(c) and 37 CFRR 1.104(c)(4)(ii) to the effect that the subject matter was developed and the claimed invention was made by or on behalf of one or more parties to a joint research agreement that was in effect on or before the effective filing date of the claimed invention, and the claimed invention was made as a result of activities undertaken within the scope of the joint research agreement; the application must also be amended to disclose the names of the parties to the joint research agreement.
Claims 1-3, 7-15 and 17-21 are rejected on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4, 5, 7, 9 and 11 of U.S. Patent No. 10959990 in view of Yu et al US 2005/0196370 (9/8/2005) as evidenced by the specification.
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 myopia comprising administering to a subject in need thereof an ophthalmological composition comprising aceclidine and a nonionic surfactant and a viscosity agent.
The claims of U.S. Patent No. 10959990 are directed to a method of treating presbyopia comprising administering to a subject in need thereof an ophthalmological composition comprising aceclidine and a nonionic surfactant and a viscosity agent. The claims of U.S. Patent No. 10959990 differ from those of the instant application in that they do not expressly recite hydroxypropylmethylcellulose or brimonidine. This deficiency is made up for with the teachings of Yu et al.
The teachings of Yu are described supra. It would be prima facie obvious for a skilled artisan following the method of the claims of U.S. Patent No. 9320709 to add hydroxypropylmethylcellulose and brimonidine to the ophthalmic solution as taught by Yu in order to have a stable composition that can effectively deliver mixtures of ophthalmic actives as taught by Yu.
The claims of U.S. Patent No. 10959990 in light of Yu teach the administration of about 1.75 % aceclidine in aqueous solution with hydroxypropylmethylcellulose, polysorbate 80 and tropicamide and brimonidine to the eye of glaucoma patients having myopia, which is identical to the claimed method. The administration of this composition would necessarily treat one or more symptoms of myopia as evidenced by the specification in Example 18 in which subjects administered the claimed composition will have a symptom of myopia treated. A composition having the same components as those claimed will necessarily have the same properties as those claimed, See MPEP 2112.01[R-3]: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” In re Spada, 911 F2d 705, 709, 15 USQPQ2d 1655, 1658 (Fed. Cir. 1990).
The provisional rejection of claims 1-3, 7-15 and 17-20 and newly applied to claim 21 on the basis of nonstatutory obviousness-type double patenting as being unpatentable over claims 18-20 of U.S. Patent Appn. No. 17/730376 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 myopia comprising administering to a subject in need thereof an ophthalmological composition comprising aceclidine, tropicamide and a nonionic surfactant and a viscosity agent.
The claims of U.S. Patent Appn. No. 17/730376 are directed to a method of treating myopia comprising administering to a subject in need thereof an ophthalmological composition comprising aceclidine as the active agent. The claims of U.S. Patent Appn. No. 17/730376 differ from those of the instant application in that they do not recite polysorbate 80, brimonidine, hydroxymethylcellulose or tropicamide. These deficiencies are made up for with the teachings of Yu et al.
The teachings of Yu are described supra. It would be prima facie obvious for a skilled artisan following the method of the claims of U.S. Patent Appn. No. 17/730376 to add polysorbate 80, hydroxymethylcellulose, brimonidine and tropicamide to the ophthalmic solution as taught by Yu in order to have a stable composition that can effectively deliver mixtures of ophthalmic actives as taught by Yu.
The rejection is provisional because the claims are not yet issued.
Response to Arguments
Applicants’ arguments of August 12, 2025 have been fully considered and are found to be partly persuasive and partly unpersuasive.
Applicants note the amendments to the specification to address the objections to the claims and specification. The objections are withdrawn above.
Applicants argue that a prima facie obviousness case has not been made because while Mayama does recite that the intraocular pressure may be associated with myopia but provides no evidence that it is a symptom of myopia itself or that correcting intraocular pressure would treat myopia. Applicants note that Mayama describes the occurrence of myopia in glaucoma patients, but makes no suggestion that the treatment of glaucoma would cure one or more symptoms of myopia.
Additionally, Applicants argue that a skilled artisan reading Mayama and Romano would not be motivated to treat myopia with a muscarinic agonist, nor would they have an expectation of success in treating a myopic patient with a composition comprising about 0.1% to about 4.0% of a muscarinic agonist.
Applicants argue the amendments to the claims to recite an aqueous composition and note that claim 16 of US Patent No. 9314427 is directed to administration of a lyophilized composition and therefore is patentably distinct from the instant amended claims. This argument is found to be persuasive and the rejection is withdrawn above in light of the amendments to the claims.
Applicants argue the amendments to the claims to recite an aqueous composition and note that claim 16 of US Patent No. 9314427 is directed to administration of a lyophilized composition and therefore is patentably distinct from the instant amended claims.
Applicants note that U.S. Patent Appn. No. 17/715369 has been abandoned and argue that the nonstatutory obviousness-type double patenting should be withdrawn. This argument is found to be persuasive and the rejection has been withdrawn as moot.
Applicants request that the remaining obviousness-type double patenting rejections be held in abeyance.
The obviousness arguments have been carefully reviewed and are not found to be persuasive.
As described in the rejection above it would be prima facie obvious for a skilled artisan administering Glaucostat to treat glaucoma patients having myopia based on the teachings of Romano and Mayama in order to have a glaucoma treating composition that could reduce intraocular pressure but with the advantage of a smaller effect on accommodation and decrease of the depth of the anterior chamber as taught by Glaucostat as well as having good tolerance by patients as taught by Romano.
It would also be prima facie obvious for a skilled artisan administering Glaucostat in view of Romano and Mayama method to add hydroxymethylcellulose for viscosity adjustment and control, polysorbate 80 for a nonionic surfactant and tropicamide and brimonidine as secondary ophthalmic therapeutic agents to the ophthalmic solution, and have the amount of aceclidine be between 0.01 and 5% as taught by Yu in order to have a stable composition that can effectively deliver ophthalmic actives as well as treat glaucoma as taught by Yu.
With respect to claim 1’s property of treating a symptom of myopia, the prior art is silent as to this property. The prior art, however, teaches all of the claimed components in the same amounts (at the overlap of the ranges) and also teaches all of the same steps as those claimed. Glaucostat in view of Romano, Mayama and Yu teach the administration of 0.01 to 5% aceclidine in aqueous solution with hydroxypropylmethylcellulose, polysorbate 80 and tropicamide and brimonidine to the eye of glaucoma patients having myopia. The administration of this composition would necessarily treat one or more symptoms of myopia as evidenced by the specification in Example 18 in which subjects administered the claimed composition will have a symptom of myopia treated. Applicant is reminded that claiming the result of the identical method of the prior art, i.e., Glaucostat in view of Romano, Mayama and Yu supra, is tantamount only to finding a property in the old composition. A composition having the same components as those claimed will necessarily have the same properties as those claimed, See MPEP 2112.01[R-3]: “A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.” In re Spada, 911 F2d 705, 709, 15 USQPQ2d 1655, 1658 (Fed. Cir. 1990). Applicant has not distinguished the claimed process from the obvious process of the prior art, nor has applicant sufficiently undermined the rationale on which the current rejection relies by merely arguing the discovery of the result of the prior art’s process. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979).
Applicants’ argument that a skilled artisan reading Mayama and Romano would not be motivated to treat myopia with a muscarinic agonist, nor would they have an expectation of success in treating a myopic patient with a composition comprising about 0.1% to about 4.0% of a muscarinic agonist is not found to be persuasive. This argument is not persuasive because the ordinarily skilled artisan would be motivated to treat glaucoma patients having myopia with aceclidine and brimonidine, both of which are effective medications to lower intraocular pressure in individuals with open-angle glaucoma. Respectfully, Applicants are viewing the prior art only through the lens of the instant claims and the instant invention. However, those of ordinary skill in the art would not necessarily view the prior art through the same lens.
The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result is covered by applicant See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the inventor); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972)(discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert denied, 500 U.S. 904 (1991).
Applicant’s argument regarding the amendments to the claims to recite an aqueous composition and note that claim 16 of US Patent No. 9314427 is directed to administration of a lyophilized composition and therefore is patentably distinct from the instant amended claims is not found to be persuasive. Respectfully, claim 16 is not directed to administering a lyophilized powder to the eye, as this would simply not be feasible. Furthermore, the language in claim 16 suggests that a solution is being claimed. The claims recites that it is a composition comprising a lyophilized aceclidine at a w/v concentration and further recites the concurrent administration of a cycloplegic agent at a concentration from 0.025% to about 0.1% w/v wherein w/v denotes weight by volume. Additionally, the excipients recited in claim 16, such as a viscosity enhancer, surfactant and buffer, also imply that the composition is a solution. The obviousness-type double patenting rejection over US Patent No. 9314427 is maintained.
Applicants’ request to hold the double patenting rejection in abeyance until there is an indication of allowability of claims is noted. Applicants 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 REQUIREMENT AS TO FORM (see MPEP 37 CFR 1.111(b) and 714.02). Thus, the double patenting rejection is maintained (although adjusted to reflect the amendments to the claims) as no action regarding this rejection has been taken by applicants at this time.
Conclusion
No claims are allowed.
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SARAH CHICKOS
Examiner
Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619