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
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on Dec 10 2025 has been entered.
Status of Claims
Claims 1-19 and 22-23 are pending. Claims 3,8-10,13-14 and 17 are withdrawn. Claims 1-2,4-7,11-12,15-16,18-19 and 22-23, are under examination as being directed to elected Formulation 52 (see paragraph 39 of the specification).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Dec 10 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant’s cancellation of claim 21, filed Dec. 10, 2025 with respect to the objection of claim 21 has been fully considered and is persuasive. Applicant’s cancellation of claim 21, filed Dec. 10, 2025 with respect to the rejection of claim 21 under 35 USC 112(a) has been fully considered and is persuasive. Therefore, the objection and rejection of claim 21 has been withdrawn.
Applicant’s arguments and amendment of claim 1, filed Dec 10 2025, with respect to the rejection of claims 1-2, 4-7, 11-12, 15-16, 18-19, and 23 are rejected under 35 U.S.C. 103 as unpatentable over Chia, Ophthalmology Volume 119, Number 2, February 2012)), in view of Akorn Atropine Prescribing Information (PI) (Revised July 2014 ), have been considered. In response and in light of the amendment of claim 1, an obviousness rejection over the same prior art has been issued below.
Claim Rejections - 35 U.S.C. § 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 1-2,4-7,11-12,15-16,18-19 and 22-23 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)), in view of Akorn Atropine Prescribing Information (PI) (Akorn Atropine Care™((atropine sulfate ophthalmic solution), NDA 206289 Product Label (Revised July 2014 )))). 3
Examined amended claim 1 is directed to a method of treating myopia in an individual in need thereof, comprising administering to an eye of the individual an ophthalmic composition comprising from about 0.01 wt% to about 0.05 wt% atropine or atropine sulfate, water, and tropic acid, and wherein the composition comprises less than 10 % of tropic acid based on the concentration of atropine or atropine sulfate after storage at a temperature of about 25°C for at least 2 weeks..
Similar to claim 1, claim 15 is directed to a similar method of administering the same composition of amended claim 1 to a subject in need, but also includes other conditions such as pre-myopia or progression of myopia, as well as myopia.
Similar to claim 1, claim 23 is directed to a similar method of treating myopia in an individual in need thereof, comprising administering to an eye of the individual an ophthalmic composition comprising from about 0.01 wt% to about 0.05 wt% atropine or atropine sulfate, water, and tropic acid, and wherein the topic acid is present in the composition in an amount less than 10% based on the concentration of atropine or atropine sulfate after storage at a temperature of about 25°C for at least 2 weeks. For claims 1, 15 and 23, a tropic acid range of less than 10% that that of atropine, would have a broad and reasonable interpretation of 0% tropic acid in the ophthalmic composition.
Regarding claims 1, 15 and 23 and 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.4 Per MPEP 2144.05, where the claimed ranges overlap or lie inside prior art ranges, a prima facie case of obviousness exists.
As required by claims 1, 15 and 23, Chia does not teach the presence of tropic acid in its atropine sulfate formulations.
While Chia teaches treatment of myopia with 0.01% atropine sulphate as required by claims 1, 15 and 23, Chia does not recite an aqueous formulation, nor is there an explicit teaching of tropic acid of less than 10% of atropine after storage at 25°C for at least 2 weeks.
However, a person having ordinary skill in the art (PHOSITA) would have had a reasonable expectation of success in formulating the atropine ophthalmic formulation of Chia into known atropine aqueous formulations in known concentrations as cited in the art and also achieving the tropic acid less than 10 % of atropine/atropine sulfate after storage 25°C for at least 2 weeks.
Further, with regard to the limitation of claims 1, 15 and 23 of tropic acid under 10% of atropine/atropine sulfate after storage at a temperature of about 25°C for at least 2 weeks, “ a PHOSITA would have a reasonable expectation that such stability limitation would be present in formulations of the prior art. Storage of the claimed atropine formulation under vacuum conditions, at an optimal pH to ensure stability with various excipients would lead a PHOSITA to have the reasonable expectation the claimed compositions would be stable as claimed.
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. While Akorn Atropine PI does teach tropic acid as metabolite formed by enzymatic hydrolysis of the liver in the body of a subject (see page 8), it does not teach the presence of tropic acid in the atropine formulation to be administered to the subject as claimed.
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 and 5.
A PHOSITA following the teachings of Chia would have found it prima facie obvious to treat the myopia with aqueous formulations of atropine sulfate known to be commercially available and FDA approved in the art, that is absent any amounts of tropic acid.
The rationale to support a finding of obviousness are the known prior art elements of atropine formulated at a concentration of 0.01% to treat myopia in combination with known method, use of an aqueous formulation, to predictably arrive at the claimed invention. It would be routine for a PHOSITA to optimize a method treating myopia as claimed with aqueous formulations of such as the cited prior art discloses such methods per Chia and where a commercial and FDA approved atropine formulation is an aqueous formulation.
Claims 2 and 16 and the limitation of atropine sulphate concentration of about 0.01 wt% is taught by Chiba. 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.
As per claims 4-6 and 18-19 and the limitation of topical administration to the eye, via instillation (drop by drop to the eye), administered at least once a day, Chia teaches its child subjects were administered 0.01% atropine once nightly. See abstract. See also Akorn Atropine PI that discloses atropine sulfate ophthalmic solution for topical application to the eye, administered 1 drop topically to the eye, up to twice daily as needed. See page 1.
As required by claim 7 and the limitation of a tonicity adjusting agent, it is noted that sodium chloride is a known tonicity agent in aqueous solution as per Akorn Atropine PI, where page 3 notes hydrochloric acid and sodium hydroxide in aqueous solution. See page 3.
Regarding claims 11-12 and the limitations of the preservative benzalkonium chloride, Akorn Atropine PI teaches a benzalkonium chloride at a concentration of 0.01 % of its formulation is also taught. See page 3, reproduced in part below.
PNG
media_image1.png
50
660
media_image1.png
Greyscale
Similar to claims 1, 15 and 23, claim 22 is directed to a method of treating myopia in an individual in need comprising administering an ophthalmic composition comprising from about 0.01 wt% to about 0.05 wt% atropine or atropine sulfate, water, and tropic acid, and wherein the composition comprises less than .005 % of tropic acid.
RESPONSE TO ATTORNEY ARGUMENTS:
The Attorney response states the prior art of Chia and Akon fail to teach each and every element of claim 1, with emphasis on the functional descriptive language of “ after storage at a temperature of about 25°C for at least 2 weeks.”
The Attorney response cites to MPEP 2112 Part IV, to state that the degradation of atropine to naturally degrade into the tropic acid impurity/degrading when atropine is left in solution” would NOT be inherently present.
In response, with regard to the limitation of claims 1, 15 and 23 of tropic acid under 10% of atropine/atropine sulfate after storage at a temperature of about 25°C for at least 2 weeks, “ a PHOSITA would have a reasonable expectation that such stability limitation would be present in formulations of the prior art. Storage of the claimed atropine formulation under vacuum conditions, at an optimal pH to ensure stability with various excipients would lead a PHOSITA to have the reasonable expectation the claimed compositions would be stable as claimed.
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:
With regard to all the obviousness type double patenting rejections, Applicant requested they be held in abeyance. In response, the double patenting rejections remain in place.
Claims 1, 2, 4-7, 11-12, 15, 16, 18-19 and 22-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 46-59 of copending Application No. 17721838 (reference application)
claims 49-68 of copending Application No. 17721831 (reference application) in view of Akorn PI
claims 46-49 and 51-59 of copending Application No. 17681560 (reference application)
claims 1-5 and 8-19 of copending 17/894882 (reference application)
claims 1-18 of copending Application No. 17894884 (reference application)
claims 1-5 and 8-19 of copending Application No. 17894885 (reference application)
claims 24-69 of copending Application No. 19235538 (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 directed of treating myopia and/or pre-myopia or reduce the progression of myopia via administration of atropine sulfate as per claims 1, 15 and 22-23, where the reference application teaches a similar pH and/or buffered atropine ophthalmic composition.
Similar to claim 1, claim 23 is directed to a similar method of treating myopia in an individual in need thereof, comprising administering to an eye of the individual an ophthalmic composition comprising from about 0.01 wt% to about 0.05 wt% atropine or atropine sulfate, water, and tropic acid, and wherein the topic acid is present in the composition in an amount less than 10% based on the concentration of atropine or atropine sulfate after storage at a temperature of about 25°C for at least 2 weeks. It is noted that claims 1, 15 and 22-23 are interpreted to include formulations that have no amounts of tropic acid.
The ‘838 Application
Regarding claims 1, 15 and 22-23, reference application claim 46 discloses a method of treating progression of myopia in an individual in need thereof, comprising administering to an eye of the individual, a composition comprising 0.01wt% atropine/atropine sulfate, water, benzalkonium chloride, pH between 4.5 and 6.0.
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. MPEP 2144.05 (overlapping ranges). One of ordinary skill in the art would predictably look to the reference application to arrive at the claimed invention.
While the reference application is silent with regard to amounts of tropic acid, as claims 1, 15 and 22-23 are broadly and reasonably interpreted to include formulations where tropic acid is at zero percent of the atropine amounts, i.e., not present, the reference application claims teach and suggest such compositions missing tropic acid.
A PHOSITA would have found it prima facie obvious based on the teachings of the reference application to arrive at a tropic acid free formulation of atropine or atropine sulfate at 0.01 wt % intended to treat myopia, in a water carrier
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%, free of tropic acid) with a known method (treatment of myopia with atropine as per the reference application) to predictably arrive at the claimed invention.
With regard to claims 2 and 16, directed to 0.01 wt% atropine sulfate; claim 7 requiring a tonicity agent (for example NaCl); and claims 11-12 requiring the preservative benzalkonium chloride, these are taught by reference application claim 46 as noted above (with regard to aqueous atropine solution and benzalkonium) and the balance of reference claims below.
Reference Claims 47-59 are directed embodiments of aqueous formulations, tonicity agents (sodium chloride), chitosan, povidone, etc. as claimed.
With regard to claims 4-6 and 18-19 and the topical administration to the eye for treatment of myopia and related conditions at least once a day via instillation (drop by drop) are not explicitly recited in the reference claims. While these limitations are not expressly taught by the reference application claims, it would be routine for a PHOSITA to treat myopia and related conditions via drop by drop instillation at least once a day.
The ‘831 Application
Regarding claims 1, 15 and 22-23, reference application claims 49 and 59, teach atropine, citrate buffered formulations in a pH range as detailed below.
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.
While the reference application is silent with regard to amounts of tropic acid, as claims 1, 15 and 22-23 are broadly and reasonably interpreted to include formulations where tropic acid is at zero percent of the atropine amounts, i.e., not present, the reference application claims teach and suggest such compositions missing tropic acid.
A PHOSITA would have found it prima facie obvious based on the teachings of the reference application to arrive at a tropic acid free formulation of atropine or atropine sulfate at 0.01 wt % intended to treat myopia, in a water carrier
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%, free of tropic acid) with a known method (treatment of myopia with atropine as per the reference application) to predictably arrive at the claimed invention.
With regard to claims 2 and 16, directed 0.01 wt% atropine sulfate; claim 7 requires a tonicity agent (for example NaCl); and claims 11-12 requiring the preservative benzalkonium chloride, these are taught by reference claims 49 and 59, or the balance of reference claims as follows. Reference Claims 50-68 are directed embodiments of aqueous formulations, tonicity agents (sodium chloride), chitosan, povidone, etc. as claimed.
With regard to claims 4-6 and 18-19 and the topical administration to the eye for treatment of myopia and related conditions at least once a day via instillation (drop by drop) are not explicitly recited in the reference claims. However, it would be in the skill and expertise of one of ordinary skilled in the art to do so as the reference claims are all directed ophthalmic aqueous formulations of atropine, known to be administered to the eye subject as per Akorn Atropine PI, see page 1.
The ’560 Application
Regarding claims 1, 15 and 22-23, reference application claim 46 is as follows.
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.
One of ordinary skill in the art would predictably look to the reference application to arrive at the claimed invention.
While the reference application is silent with regard to amounts of tropic acid, as claims 1, 15 and 22-23 are broadly and reasonably interpreted to include formulations where tropic acid is at zero percent of the atropine amounts, i.e., not present, the reference application claims teach and suggest such compositions missing tropic acid.
A PHOSITA would have found it prima facie obvious based on the teachings of the reference application to arrive at a tropic acid free formulation of atropine or atropine sulfate at 0.01 wt % intended to treat myopia, in a water carrier
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%, free of tropic acid) with a known method (treatment of myopia with atropine as per the reference application) to predictably arrive at the claimed invention.
With regard to claims 2 and 16, directed 0.01 wt% atropine sulfate; claims 4-6 and 18-19 and the topical administration to the eye for treatment of myopia and related conditions at least once a day via instillation (drop by drop); claim 7 requires a tonicity agent (for example NaCl); and claims 11-12 requiring the preservative benzalkonium chloride, these are taught by reference 46, or the balance of reference claims as follows.
Reference Claims 47-49 and 51-59 are directed embodiments of topically applied (via instillation, drop by drop), ophthalmic aqueous formulations, tonicity agents (sodium chloride), chitosan, povidone, etc. as claimed.
The ‘882 Application
Regarding claims 1, 15 and 22-23, reference application claim 1, teaches atropine, buffered formulations in a pH range (via citrate buffer) known to reduce tropic acid degradation as follows:
While the reference application is silent with regard to amounts of tropic acid, as claims 1, 15 and 22-23 are broadly and reasonably interpreted to include formulations where tropic acid is at zero percent of the atropine amounts, i.e., not present, the reference application claims teach and suggest such compositions missing tropic acid.
A PHOSITA would have found it prima facie obvious based on the teachings of the reference application to arrive at a tropic acid free formulation of atropine or atropine sulfate at 0.01 wt % intended to treat myopia, in a water carrier
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%, free of tropic acid) with a known method (treatment of myopia with atropine as per the reference application) to predictably arrive at the claimed invention.
With regard to claims 2 and 16, directed 0.01wt% atropine sulfate; claims 4-6 and 18-19 and the topical administration to the eye for treatment of myopia and related conditions at least once a day via instillation (drop by drop); claim 7 requires a tonicity agent (for example NaCl); and claims 11-12 requiring the preservative benzalkonium chloride, these are taught by reference 1, or the balance of reference claims as follows.
Reference Claims 2-5 and 8-19 are directed embodiments of topically applied (via instillation, drop by drop), ophthalmic aqueous formulations, tonicity agents (sodium chloride), chitosan, povidone, etc. as claimed.
The ‘884 Application
Regarding claims 1, 15 and 22-23, reference application claim 1 is as follows.
Claim 1 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 One of ordinary skill in the art would predictably look to the reference application to arrive at the claimed invention.
While the reference application is silent with regard to amounts of tropic acid, as claims 1, 15 and 22-23 are broadly and reasonably interpreted to include formulations where tropic acid is at zero percent of the atropine amounts, i.e., not present, the reference application claims teach and suggest such compositions missing tropic acid.
A PHOSITA would have found it prima facie obvious based on the teachings of the reference application to arrive at a tropic acid free formulation of atropine or atropine sulfate at 0.01 wt % intended to treat myopia, in a water carrier
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%, free of tropic acid) with a known method (treatment of myopia with atropine as per the reference application) to predictably arrive at the claimed invention.
With regard to claims 2 and 16, directed 0.01wt% atropine sulfate; claims 4-6 and 18-19 and the topical administration to the eye for treatment of myopia and related conditions at least once a day via instillation (drop by drop); claim 7 requires a tonicity agent (for example NaCl); and claims 11-12 requiring the preservative benzalkonium chloride, these are taught by reference 1, or the balance of reference claims as follows. Reference Claims 2-19 are directed embodiments of topically applied (via instillation, drop by drop), ophthalmic aqueous formulations, tonicity agents (sodium chloride), chitosan, povidone, etc. as claimed.
The ‘885 Application
Regarding claims 1, 15 and 22-23, reference application claim 1 is as follows.
Claim 1 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 One of ordinary skill in the art would predictably look to the reference application to arrive at the claimed invention.
While the reference application is silent with regard to amounts of tropic acid, as claims 1, 15 and 22-23 are broadly and reasonably interpreted to include formulations where tropic acid is at zero percent of the atropine amounts, i.e., not present, the reference application claims teach and suggest such compositions missing tropic acid.
A PHOSITA would have found it prima facie obvious based on the teachings of the reference application to arrive at a tropic acid free formulation of atropine or atropine sulfate at 0.01 wt % intended to treat myopia, in a water carrier
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%, free of tropic acid) with a known method (treatment of myopia with atropine as per the reference application) to predictably arrive at the claimed invention.
With regard to claims 2 and 16, directed 0.01wt% atropine sulfate; claims 4-6 and 18-19 and the topical administration to the eye for treatment of myopia and related conditions at least once a day via instillation (drop by drop); claim 7 requires a tonicity agent (for example NaCl); and claims 11-12 requiring the preservative benzalkonium chloride, these are taught by reference 1, or the balance of reference claims as follows. Reference Claims 2-19 are directed embodiments of topically applied (via instillation, drop by drop), ophthalmic aqueous formulations, tonicity agents (sodium chloride), chitosan, povidone, etc. as claimed.
The ’538 Application
Regarding claims 1, 15 and 22-23, reference application claim 24 is as follows.
Reference claim 24 is directed to a method of treating myopia (progression), reducing progression in an individual thereof, comprising administering to the eye an aqueous solution (pH about 6.2 to about 7.5), comprising about 0.0001 wt% to about 0.05 wt% atropine/sulfate, and a buffering agent.
While the reference application is silent with regard to amounts of tropic acid, as claims 1, 15 and 22-23 are broadly and reasonably interpreted to include formulations where tropic acid is at zero percent of the atropine amounts, i.e., not present, the reference application claims teach and suggest such compositions missing tropic acid.
A PHOSITA would have found it prima facie obvious based on the teachings of the reference application to arrive at a tropic acid free formulation of atropine or atropine sulfate at 0.01 wt % intended to treat myopia, in a water carrier
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%, free of tropic acid) with a known method (treatment of myopia with atropine as per the reference application) to predictably arrive at the claimed invention.
With regard to claims 2 and 16, directed 0.01wt% atropine sulfate; claims 4-6 and 18-19 and the topical administration to the eye for treatment of myopia and related conditions at least once a day via instillation (drop by drop); claim 7 requires a tonicity agent (for example NaCl); and claims 11-12 requiring the preservative benzalkonium chloride, these are taught by reference 1, or the balance of reference claims as follows
Dependent reference claims 25-69 are directed to species of atropine concentration, species of buffering agents, tonicity adjusting agents, viscosity agents, times administered, stabilizing agent, preservative, etc.
Conclusion and Correspondence
No claims are allowed. 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM Y LEE/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
1 This application is a CON of 17/894,885 filed 08/24/2022. 17/894,885 is a CON of 17/681,560 filed 02/25/2022. 17/681,560 is a CON of 16/677,538 filed 11/07/2019 and issued as US PAT 11382909. 16/677,538 is a CON of 15/568,381 filed 10/20/2017 and issued as US PAT 10842787.
15/568,381 is a 371 of PCT/US16/29222 filed 04/25/2016.
PCT/US16/29222 is a CIP of PCT/US15/37249 filed 06/23/2015.
PCT/US16/29222 is a CIP of 14/726,139 filed 05/29/2015 issued as US PAT 9421199.
PCT/US15/37249 is a CIP of 14/726,139 filed 05/29/2015 issued as US PAT 9421199.
PCT/US16/29222 has PRO 62/151,926 filed 04/23/2015.
14/726,139 has PRO 62/151,926 filed 04/23/2015.
PCT/US15/37249 has PRO 62/151,926 filed 04/23/2015.
As discussed in the previous office action, now canceled claim 21 and the limitation of tropic acid therein, can only claim priority to amended claim 1 of Sept 4 2024. See below.
2 Formulation 5 (see Specification, para. [00393], Table 23A) as the species for substantive examination. Formulation 5 comprises (%w/v) 0.01 Atropine sulfate monohydrate, 0.04 Citric Acid, 0.9 Sodium Chloride, 0.01 Benzalkonium Chloride (BAK), and Q.S. H 20. Tropic acid concentration of Formulation 5 is provided at least at para. [00381 ], Table 25A.
3 Chia (NPL No. 024), and Akorn Atropine PI (NPL No. 006) are cited on the July 30, 2024 IDS.
4 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%.