DETAILED ACTION
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 .1
Status of Claims
Claims 1-18 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Oct 15 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Terminal Disclaimer
A terminal disclaimer has not been filed with this response. The nonstatutory obviousness
double patenting rejections over US Patents 11,382,909, 11,890,277, 11,896,588, and 11,883,390
are maintained.
Response to Arguments
Applicant's arguments filed Oct 15 2025 have been fully considered but they are not
persuasive. See below maintained obviousness rejections (in view of Chia, Akorn PI and WoldeMussie) and maintained non-statutory double patenting rejections.
Maintained Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Chia (Atropine for the Treatment of Childhood Myopia: Safety and Efficacy of 0.5%, 0.1%, and 0.01% Doses (Atropine for the Treatment of Myopia 2), Ophthalmology Volume 119, Number 2, February 2012 – provided on 7/30/2024 IDS)), in view of Akorn Atropine Prescribing Information (PI) (Akorn Atropine Care™(atropine sulfate ophthalmic solution), NDA 206289 Product Label ,Revised July 2014 ) and WoldeMussie (U.S. 5,716,952 provided on IDS dated 8/30/24.). Chia (NPL Cite No. 024), and Akorn Atropine PI (NPL Cite No. 006 on IDS provided on 7/30/2024).
Pending claim 1 is directed to a stabilized ophthalmic composition for treating premyopia, myopia, or progression of myopia, comprising from about 0.00 l wt % to about 0.05 wt% of atropine or atropine sulfate, water, and between 0.4 wt% and 0.8 wt % of a buffering agent at a pH from about 4.4 to about 6.4, wherein the buffering agent comprises a citrate buffering agent or an acetate buffering agent, or a combination thereof. Claim 5 limits the composition to about 0.001 wt % to about 0.01 wt%. Similar to claim 1, claim 15 is directed to a similar method of administering to an eye of the individual an effective amount of an ophthalmic composition of claim 1.
Regarding claims 1, 5 and 15 concerning the limitations of treating myopia with an aqueous ophthalmic formulation of atropine 0.01% (eye drops), Chia discloses atropine eyedrops of 0.01% “has minimal side effects compared with atropine 0.1% and 0.5%, and retains comparable efficacy in controlling myopia progression.” See abstract. Chia teaches the concentration of 0.01 wt% of atropine where it notes in terms of efficacy “atropine 0.01 % also had significant clinical effects as evident by its effect on myopia progression, accommodation and pupil size.” See page 353, column 1. Chia teaches that “[o]verall, atropine-related adverse effects were uncommon at the 0.01% dose.” See page 353, column 2. Table 3 of Chia teaches reduced instances of adverse/severe adverse events at atropine 0.01 % when compared to higher concentrations 0.1% and 0.5%. See page 353 top of page, noting reduced adverse events of 0.01 % atropine in treating childhood myopia in terms of allergic conjunctivitis, dermatitis involving eyelids, etc. compared with 0.1% and 0.5%.
While Chia teaches treatment of myopia with 0.01% atropine sulphate as required by claims 1, 5 and 15, Chia does not recite an aqueous formulation or citrate buffers. However, one of ordinary skill in the art would have a reasonable expectation of success in formulating the atropine formulation of claims 1 and 5, as 1) as there are known aqueous formulations of atropine 2) and it would be routine for the skilled artisan to buffer the composition to the claimed pH via citrate buffer.
A person having ordinary skill in the art (PHOSITA), recognizing the capability
and purposes of buffers to maintain a stable pH would routinely do so as known in the art.
With regard to the water (aqueous solution) limitation, Akorn Atropine Sulfate Prescribing Information (Akorn Atropine PI) teaches atropine sulfate ophthalmic solution for topical application to the eye, where the solution comprises water. See page 1 and bottom of page 3. Regarding claim 1 and the limitation of a citrate buffer and the claimed pH range of pH from about 4.4 to about 6.4, WoldeMussie teaches the use of the buffering agents, such as phosphate, borate and citrate is taught in column 2, lines 23-29. Further, WoldeMussie teaches a pH adjustor to a pH of 4.5-7.5, see Table 1.
Chia teaches the advantages of atropine at 0.01% concentration for the effective treatment of myopia, as claimed, as discussed above. Akorn Atropine PI teaches an aqueous formulation for topical application to the eye as required by claims 1, 5 and 15.
The rationale to support the finding of obviousness are the teachings of known prior art elements (formulation of an aqueous atropine concentration of 0.01% with minimal adverse effects per Chia and Akorn Atropine PI, where claimed pH is achieved with citrate buffer per WoldeMussie) with a known method (treatment of myopia with atropine as per Chia) to predictably arrive at the claimed invention.
Regarding claim 2, Chia teaches treatment of myopic progression in children with tropicamide. See page 347, column 2. It would be prima facie obvious to combine two art known equivalents know for the same purpose, in this case, the medicines atropine and tropicamide to treat myopia. See MPEP 2144.06 I.2
Per claims 3-5 where atropine or sulfate salt is present at a concentration of from about 0.001 wt % to about 0.03 wt %, about 0.001 wt % about 0.02 wt %, or about 0.001 wt % to about 0.01 wt %, Chia teaches “atropine 0.01 % . . . had significant clinical effects as evident by its effect on myopia progression, accommodation and pupil size.” See page 353, column 1.
Regarding claim 6 and the limitation of where the composition of claim 1 further comprises a carbonate, organic or amino buffer, WoldeMussie teaches the use of the buffering agents, such as phosphate, borate and citrate (an organic buffer) is taught in column 2, lines 23-29. Further, WoldeMussie teaches a pH adjustor to a pH of 4.5-7.5, see Table 1.
Regarding claims 7-8’s limitations of a tonicity adjusting agent, a monovalent cation halide salt, such as NaCl, it is noted that sodium chloride is a known tonicity agent in aqueous solution. Akorn Atropine PI, at page 3 discloses hydrochloric acid and sodium hydroxide in aqueous solution. See page 3.
Regarding claims 9-10 disclosing a viscosity agent, hydroxypropyl methylcellulose (HPMC), Akorn Atropine PI teaches hypromellose (aka HPMC). See page 3, last full paragraph.
Regarding claims 11-13’s limitations of preservative and a concentration of about 0.0001% to about 1%, Akorn Atropine PI teaches benzalkonium chloride 0.1 mg (0.01%). See page 3, last full paragraph.
Regarding claim 14’s limitation wherein the composition is essentially free of procaine and benactyzine, Chia, Akorn and WoldeMussie are completely silent with regards to the composition possessing either procaine or Benactyzine.
Regarding claims 16-17 disclosing treating myopia (pre- and/or progression) with topical/instillation administration, Chia discloses treatment of myopia with atropine, see Abstract. Regarding the route of administration of topical/instillation; both of these routes of administration are via the eye.3 Note that Akorn teaches the administration of topical drops to the eye. See Dosage and Administration. Sections 2.1 and 2.2.
Regarding claim 18 disclosing an eye drop bottle, Chia discloses atropine eye drops in bottles, see page 348, column 1, and eye drop administration to test subjects. See abstract.
RESPONSE TO ATTORNEY ARGUMENTS:
The Attorney response states Chia does not teach a stabilized low-concentration atropine
composition (i.e. stabilized composition, citrate buffering agent or buffer capacity sufficient to
maintain the pH of solution between about 4.4 to about 6.4 for an extended period of time of at least 1 month).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response, as detailed above, Chia teaches treatment of myopia with 0.01% atropine sulphate as required by claims 1, 5 and 16. Further, a PHOSITA would have a reasonable expectation of success in formulating atropine formulation of claims 1 and 5, as 1) as there are known aqueous formulations of atropine 2) and it would be routine for the skilled artisan to buffer the composition to the claimed pH via citrate buffer, per Akorn Atropine PI) and WoldeMussie. Further, a person having ordinary skill in the art (PHOSITA), recognizing the capability of and purposes of buffers to maintain a stable pH would routinely do so to maintain the claimed pH.
The Attorney response states Akorn does not address stability in low-dose atropine formulations; MPP 2143, the discovery of a previously unknown problem by the patentee can support a finding of nonobviousness, where Akorn does not consider the problem of low-dose atropine stability, where the it is alleged the solutions in Akorn would not work in the claimed formulation.
As detailed above, Chia addresses the issue of low-dose atropine formulations, where Akorn Atropine Sulfate Prescribing Information (Akorn Atropine PI) teaches atropine sulfate ophthalmic solution for topical application to the eye, where the solution comprises water. See page 1 and bottom of page 3.
The claimed range of pH 4.4 to 6.5 is within the range of a known range of pH 4-5 to preserve aqueous atropine solutions. See Kondritzer and Zvirbilis, page 523, column 1.4 At higher concentrations, stable sterilized atropine sulfate solutions pH ranges were established in a range as wide 2.8-6.0, with distinct deterioration occurring at a pH of 7 or higher. Id. Kondritzer and Zvirbilis
The Attorney response states a PHOSITA would not expect the excipients of WoldeMussie to stabilize atropine (lists multiple active ingredients, but not atropine, atropine sulphate). The Attorney response states a PHOSITA would not have a reasonable expectation of success that WoldeMussie that its excipients would stabilize an atropine sulfate composition.
In response, a PHOSITA would have reasonable expectation of success to stabilize atropine based on general knowledge in the art and knowing the stability of atropine at the claimed pH levels (generally known in the art) and those taught by WoldeMussie, to predictably arrive at he claimed formulation for the claimed method.
Maintained Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory 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.
RESPONSE TO ATTORNEY ARGUMENTS:
The attorney requested the provisional double patenting rejections be held in abeyance
upon indication of allowable subject matter. A terminal disclaimer has not been filed with the Oct 2025 Attorney reply. In response, the rejections are maintained as detailed below.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 46-59 of copending Application No. 17721838 (reference application) in view of Akorn Atropine Prescribing Information (PI) (Akorn Atropine Care™((atropine sulfate ophthalmic solution), NDA 206289 Product Label (Revised July 2014)).
As discussed above, claims 1-18 are directed to a stabilized ophthalmic composition for treating premyopia, myopia, or progression of myopia, comprising from about 0.001 wt% to about 0.05wt% of atropine or atropine sulfate, water, and a buffering agent comprising citric acid, wherein the buffering agent has a pKa between 4.0 and 7.0.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are drawn to a method of treating myopia in an individual in need thereof. Regarding claims 1, 5 and 15, reference application claim 46 discloses the following.
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Reference claim 52 discloses a citrate buffer as required by claim 1.
With regard to claims 2-4, 6-14 and 16-18, reference application claims 47-59 are directed to embodiments of aqueous formulations with citrate buffer (also combinations of buffers, carbonate, organic amino acid buffers, etc.), including additional agents such as those claimed in claim 2, tonicity agents (comprising a halide); viscosity, HPMC; chitosan, povidone, etc., free of procaine and benactyzine; topical and instillation administration; an eye drop bottle as claimed. Further, Akorn teaches atropine eye drop formulations where similar to the claimed invention, are preserved with benzalkonium chloride.
Claims 1, 3-5, 7-9 and 13-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 49-68 of copending Application No. 17721831 (reference application). The disclosure of the rejected claims are discussed and incorporated herein. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are drawn to a method of treating myopia in an individual in need thereof. Regarding claims 1, 5 and 15, reference application claims 49-50 discloses the following.
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Claims 49 and 59 teach a method of treating myopia with a composition comprising atropine with overlapping wt% concentrations, as well as the composition per se.
Per claims 3-5 where atropine or sulfate salt is present at a concentration of from about 0.001 wt %to about 0.03 wt %, about 0.001 wt % about 0.02 wt %, or about 0.001 wt % to about 0.01 wt %, these limitations are taught by the reference application as discussed above.
Regarding claims 7-8’s limitations of a tonicity adjusting agent, a monovalent cation halide salt, such as NaCl, reference application claims 49 and 59 recites sodium chloride.
Regarding claim 9, the reference application discloses viscosity agents chitosan and povidone. See claims 49 and 59.
Regarding claim 13’s limitation of a preservative from about 0.0001% to about 1%, the reference application teaches glycerin, a known preservative, see claims 49 and 59.
Regarding claim 14 and the limitation of wherein the stabilized ophthalmic composition is essentially free of procaine and benactyzine, the reference application is completely silent with regards either procaine or Benactyzine.
Regarding claims 16-17’s limitations of treating myopia (pre- and/or progression) with topical/instillation administration, it would be obvious for PHOSITA to administer the eye drops of the reference application via topical/instillation administration.
Regarding claim 18 and the limitation of an eye drop bottle, it would routine for a PHOSITA to optimize the invention so as to have it administered via an eye dropper bottle.
Claims 1-2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 49-50 of copending Application No. 17721831 (reference application) in view of Chia (Atropine for the Treatment of Childhood Myopia: Safety and Efficacy of 0.5%, 0.1%, and 0.01% Doses (Atropine for the Treatment of Myopia 2), Ophthalmology Volume 119, Number 2, February 2012).
While claim 1 is disclosed by the teachings of the reference application alone (see above rejection), it is noted that the reference application 17721831 does not teach the particular species of claim 2. Regarding claim 2, Chia teaches treatment of myopic progression in children with tropicamide. See page 347, column 2. It would be prima facie obvious to combine two art known equivalents know for the same purpose, in this case, the medicines atropine and tropicamide to treat myopia. See MPEP 2144.06 I.5
Claims 1 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 49-50 of copending Application No. 17721831 (reference application) in view of WoldeMussie (U.S. 5,716,952).
While claim 1 is disclosed by the teachings of the reference application alone (see above rejection), it is noted that the reference application 17721831 does not teach the particular species of claim 6. Regarding claim 6 and the limitation of where the composition of claim 1 further comprises a carbonate, organic or amino buffer, WoldeMussie teaches the use of the buffering agents, such as phosphate, borate and citrate (an organic buffer) is taught in column 2, lines 23-29. Further, WoldeMussie teaches a pH adjustor to a pH of 4.5-7.5, see Table 1.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 46-49 and 51-59 of copending Application No. 17681560 (reference application). The disclosure of the rejected claims are discussed and incorporated herein. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are drawn to a method of treating myopia in an individual in need thereof. Regarding claims 1, 5 and 15, reference application claim 46 discloses the following.
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Claim 46 teaches a method of treating myopia with a buffered aqueous atropine composition of 0.01 wt% that falls within the claimed range of about 0.01 wt% to about 0.05 wt% atropine. Reference claim 51 discloses a citrate buffer as required by claim 1.
As required by the balance of claims 2-4, 6-14 and 16-19, reference application claims 47-49 and 51-59 are directed to embodiments of topically applied (via instillation, drop by drop and an eye drop bottle) ophthalmic aqueous formulations, citrate, carbonate, organic and amino acid buffers, tonicity agents (that comprise a halide salt of a monovalent cation), a viscosity agent (HPMC), a preservative (benzalkonium chloride) in claimed amounts that is essentially free of procaine benactyzine, etc.
Claims 1-5 and 7-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 8-19 of copending Application No. 17894882 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are drawn to a method of treating myopia in an individual in need thereof. Regarding claims 1, 5 and 15, reference application claim 1 discloses the following.
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As required by the balance of claims 2-4, 8-15 and 17-19, reference application claims 2-5 and 8-19 are directed to embodiments of topically applied (via instillation, drop by drop and an eye drop bottle) ophthalmic aqueous formulations, tonicity agents (that comprise a halide salt of a monovalent cation), a viscosity agent (HPMC), a preservative in amounts as claimed, such as benzalkonium chloride, is essentially free of procaine and benactyzine, etc.
Claims 1 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 49-50 of copending Application No. 17894882 (reference application) in view of WoldeMussie (U.S. 5,716,952).
While claim 1 is disclosed by the teachings of the reference application alone (see above rejection), it is noted that the reference application 17894882 does not teach the particular species of claim 6.
Regarding claim 6 and the limitation of where the composition of claim 1 further comprises a carbonate, organic or amino buffer, WoldeMussie teaches the use of the buffering agents, such as phosphate, borate and citrate (an organic buffer) is taught in column 2, lines 23-29. Further, WoldeMussie teaches a pH adjustor to a pH of 4.5-7.5, see Table 1.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 17894885 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are drawn to a method of treating myopia in an individual in need thereof. Regarding claims 1, 5 and 15, reference application claim 1 discloses the following.
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As required by the balance of claims 2-4, 6-14 and 16-18, reference application claims 2-18 are directed to embodiments of topically applied (via instillation, drop by drop and an eye drop bottle) ophthalmic aqueous formulations, citrate and acetate buffers, tonicity agents (that comprise a halide salt of a monovalent cation), a viscosity agent (HPMC), a preservative in amounts as claimed, such as benzalkonium chloride, is essentially free of procaine and benactyzine, etc.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18539823 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are drawn to a method of treating myopia in an individual in need thereof. Regarding claims 1, 5 and 15, reference application claim 1 discloses the following.
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Reference claim 6 discloses a citrate buffer as required by claim 1.
As required by the balance of claims 2-4, 6-14 and 16-18, reference application claims 2-20 are directed to embodiments of topically applied (via instillation, drop by drop and an eye drop bottle) ophthalmic aqueous formulations, citrate, carbonate, organic and amino acid buffers, tonicity agents (that comprise a halide salt of a monovalent cation), a viscosity agent (HPMC), a preservative in amounts as claimed, such as benzalkonium chloride, is essentially free of procaine and benactyzine, etc.
Claims 1-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-19 and 21 of copending Application No. 18784718 (reference application) in view of WoldeMussie (U.S. 5,716,952).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are drawn to a method of treating myopia in an individual in need thereof. Regarding claims 1, 5 and 16, reference application claim 1 discloses the following.
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Reference claim 21 discloses a buffer as required by claim 1.
Regarding claim 1 and the limitation of a citrate buffer and the claimed pH range of pH from about 4.4 to about 6.4, WoldeMussie teaches the use of the buffering agents, such as acetate (organic buffer), phosphate, borate and citrate is taught in column 2, lines 23-29. Further, WoldeMussie teaches a pH adjustor to a pH of 4.5-7.5, see Table 1.
Regarding claim 6 and the limitation of buffers as disclosed, WoldeMussie teaches buffers and use of multiple buffers, see above.
As required by the balance of claims 2-4, 6-14 and 16-18, reference claims 2-19 and 21 are directed to embodiments of topically applied (via instillation, drop by drop and an eye drop bottle) ophthalmic aqueous formulations, tonicity agents (that comprise a halide salt of a monovalent cation), a viscosity agent (HPMC), a preservative in amounts as claimed, such as benzalkonium chloride, is essentially free of procaine and benactyzine, etc.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 11382909. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are drawn to a method of treating myopia in an individual in need thereof. Regarding claims 1, 5 and 16, reference patent claim 1 discloses the following.
Reference patent claim 1. A method of treating progression of myopia or reducing the progression rate of myopia in an individual in need thereof, comprising administering to an eye of the individual a stabilized ophthalmic composition comprising from about 0.001 wt % to about 0.05 wt % of atropine or atropine sulfate and water, wherein the stabilized ophthalmic composition further comprises a buffering agent to provide a pH from about 4.8 to about 6.4, wherein the stabilized ophthalmic composition is a liquid, and wherein the stabilized ophthalmic composition comprises less than about 10% of a degradant formed from degradation of the atropine or atropine sulfate after an extended period of time of at least 2 weeks under a storage temperature of from about 20° C. to about 70° C. and relative humidity from about 50% to about 80%. Reference claim 7 discloses a buffer as required by claim 1.
As required by the balance of claims 2-4, 6-14 and 16-18, reference patent claims 2-25 are directed to embodiments of topically applied (via instillation, drop by drop and an eye drop bottle) ophthalmic aqueous formulations; borate (complexed or not), phosphate, citrate, acetate, carbonate, or amino acid buffers, or combinations thereof; tonicity agents (that comprise a halide salt of a monovalent cation), a viscosity agent (HPMC), a preservative in amounts as claimed, such as benzalkonium chloride, is essentially free of procaine and benactyzine, etc.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11883390. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are drawn to a method of treating myopia in an individual in need thereof. Regarding claims 1, 5 and 15, reference patent claim 1 discloses the following.
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Reference claim 6 discloses a buffer as required by claim 1.
As required by the balance of claims 2-4, 6-14 and 16-18, reference patent claims 2-20 are directed to embodiments of topically applied (via instillation, drop by drop and an eye drop bottle), ophthalmic aqueous formulations; acetate, citrate, carbonate, organic or amino acid buffers, or combinations thereof; tonicity agents (that comprise a halide salt of a monovalent cation), a viscosity agent (HPMC), a preservative in amounts as claimed, such as benzalkonium chloride, is essentially free of procaine and benactyzine, etc.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11890277. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are drawn to a method of treating myopia in an individual in need thereof. Regarding claims 1, 5 and 16, reference patent claim 1 discloses the following.
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Reference claim 7 discloses a buffer as required by claim 1.
As required by the balance of claims 2-4, 6-14 and 16-18, reference patent claims 2-20 are directed to embodiments of topically applied (via instillation, drop by drop and an eye drop bottle) ophthalmic aqueous formulations; acetate, citrate, carbonate, organic or amino acid buffers, or combinations thereof; tonicity agents (that comprise a halide salt of a monovalent cation), a viscosity agent (HPMC), a preservative in amounts as claimed, such as benzalkonium chloride, is essentially free of procaine and benactyzine, etc.
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11896588. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are drawn to a method of treating myopia in an individual in need thereof. Regarding claims 1, 5 and 16, reference patent claim 1 discloses the following.
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As required by the balance of claims 2-4, 6-14 and 16-18, reference patent claims 2-20 are directed to embodiments of topically applied (via instillation, drop by drop and an eye drop bottle) ophthalmic aqueous formulations; acetate, citrate, carbonate, organic or amino acid buffers, or combinations thereof; tonicity agents (that comprise a halide salt of a monovalent cation), a viscosity agent (HPMC), a preservative in amounts as claimed, such as benzalkonium chloride, is essentially free of procaine and benactyzine, etc.
Conclusion and Correspondence
In summary no claims are allowed. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM Y LEE/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
1 CONTINUING DATA
This application is a CON of 17/681,560 02/25/2022
17/681,560 is a CON of 16/677,538 11/07/2019 PAT 11382909
16/677,538 is a CON of 15/568,381 10/20/2017 PAT 10842787
15/568,381 is a 371 of PCT/US2016/029222 04/25/2016
PCT/US2015/037249 is a CIP of PCT/US2015/037249 06/23/2015
PCT/US2015/037249 is a CIP of 14/726,139 05/29/2015 PAT 9421199
PCT/US2015/037249 is a CIP of 14/726,139 05/29/2015 PAT 9421199
PCT/US2015/037249 has PRO 62/151,926 04/23/2015
PCT/US2015/037249 has PRO 62/151,926 04/23/2015
14/726,139 has PRO 62/151,926 04/23/2015
2 I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)
3 Looking to the specification for the definition of installation and topically; installation is after administration to a rabbit’s eye (paragraph 00408) topically is administered in the eye and ocular surface (paragraph 0277 and 0294).
4 Kondritzer and Zvirbilis Stability of Atropine in Aqueous Solution Journal of the American
Pharmaceutical Association Volume 46, Issue 9 September 1957 Pages 531-535.
5 I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)
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