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 .
Status of the Claims
Per Applicant’s amendment to the claims, submitted on 08/28/2025, claim 46 is amended, claim 59 is canceled, and claims 60-61 are newly added. Currently, claims 46-58 and 60-61 are pending in the instant application.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/28/2025 has been entered.
Claim Rejections - 35 USC § 103 – Withdrawn
Rejections of claims 46-59:
In light of Applicant’s amendment to the claims, the rejections are hereby withdrawn. Claim 46 has been amended to include a limitation regarding potency post-storage for two weeks at 60C. Applicant alleges unexpected results in the form of stability data. Provided in support is Table 26A from Specification page 95:
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Applicant contends that the pH range of the composition recited in claim 1 (4.5-6.0) is critical to the stability of said composition, and that the criticality of the range is predicated on an unexpected increase in stability of formulation which is not present at pH levels higher than 6.0. As Woldemussie teaches a pH range of 4.5-7.0, and makes no indication of varying stability effects across the indicated pH range, Applicant’s argument is acceptable.
Double Patenting – Maintained
Claims 46-58 and 60-61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 46-49 and 51-59 of copending Application No. 17/681,560 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both are directed towards the treatment of myopia by administering essentially the same composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 46-58 and 60-61 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-5 and 8-19 of copending Application No. 17/894,885 (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 towards treating myopia by administering a composition, while the claims of the reference application are directed towards a composition which is materially the same.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Rejections over copending application 17/681,560:
Applicant’s arguments are not persuasive, the rejections are hereby maintained. Applicant contends that the amendment to claim 46 creates a patentable distinction between the instant claims and the claims of the ‘560 application. Claim 46 has been amended to include a limitation wherein the composition “comprises a potency of at least 90% after at least 2 weeks at 60°C”, however the amendment is insufficient to overcome the double patenting rejection. The outstanding double patenting rejection is predicated on the lack of patentable distinction between the claims due to their overlapping scope. Currently, claim 46 of the ‘560 application has also been amended, however the claim is still drawn to a method of treating myopia by administering a composition comprising 0.01% atropine at pH 4.5-6.0. While the claim of the ‘560 application contains limitations about stabilized pH after storage, and the claim of the instant application recites a limitation about atropine stability/potency after storage, the difference in these functional descriptions of the respective compositions are not sufficient to provide patentable distinction. The reason being that the methods of each of these claims are still drawn to methods of treating the same conditions by administering compositions having overlapping limitations with regards to constituency. When the claims of each are taken as a whole, there is not only overlap in the treatment of myopia, identical pH range, and the inclusion of at least atropine, benzalkonium chloride, and a buffering agent.
Rejections over copending application 17/894,885:
Applicant’s arguments are not persuasive, the rejections are hereby maintained. Applicant contends that the amendment to claim 46 creates a patentable distinction between the instant claims and the claims of the ‘885 application. Claim 46 has been amended to include a limitation wherein the composition “comprises a potency of at least 90% after at least 2 weeks at 60°C”, however the amendment is insufficient to overcome the double patenting rejection. Likewise to the maintained rejection over the ‘560 application, the rejections over the ‘885 application are maintained to due to overlapping claim scope which has not been ameliorated by the amendment to the instant claims. Claim 1 of the ‘885 application recites a composition comprising 0.001-0.05% atropine in water with a buffering agent, and a pKa between 4.0 and 7.0. claim 16 of the ‘885 application further recites a method of use of said composition for the treatment of myopia. Claim 46 of the instant application recites a method of treating myopia by administering a composition comprising 0.01% atropine, water, and benzalkonium chloride, in a pH range of 4.5-6.0, wherein the composition comprises a potency of at least 90% after 2 weeks at 60C. The main differences between the claims of the instant application and the ‘885 application are the recitations in regards to the pH range, pKa range, and potency after storage. As explained in the previous Office Action, the buffering agent of the instant application includes citrate buffer, which is known to form a buffer system comprising citric acid in aqueous solution, and provides multiple pKa values between 4 and 7. With regards to the potency after storage, this functional language does not overcome the overlap in constituency of composition between the claims.
Double Patenting – New Grounds of Rejection
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 46-58 and 60-61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 10842787. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the claims are significantly overlapping.
Claim 46 of the instant application recites the following:
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Claim 1 of the ‘787 patent recites the following:
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Claims 12 and 13 of the ‘787 patent recite the following:
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Claim 19 of the ‘787 patent recites the following:
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As can be seen from the above exemplified claims, the inventions of the instant application and the ‘787 patent are overlapping in scope. The composition of claim 46 of the instant application appears to fall within the bounds of composition recited in claim 1 of the ‘787 patent, having an atropine content of 0.01%, an overlapping pH range, and 90% atropine potency after storage at 60C. The main differentiating factor between the two claims is that the claim of the instant application recites benzalkonium chloride. However, the presence of benzalkonium chloride does not remove the composition from the bounds of claim 1 of the ‘787 patent because the composition of the ‘787 patent comprises it’s recited constituents. Furthermore, claims 12 and 13 of the ‘787 patent indicate the inclusion of preservatives including benzalkonium chloride. In addition, claim 19 of the ‘787 patent indicates a method of use in treating myopia by administering the atropine composition of claim 1. As the claims at hand are so similar in scope and content, the inventions cannot be considered as patentably distinct from one another.
Conclusion
Claims 46-61 are rejected.
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/ERIC TRAN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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