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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 27, 2025 has been entered.
Status of Application
Receipt of Applicant’s arguments and amended claims filed on October 27, 2025 is acknowledged.
Claims 20-27 and 29-40 are pending in this application.
Claims 1-19 and 28 have been cancelled.
Claims 20, 29 and 33 have been amended. Claim 40 is new.
All pending claims are under examination in this application.
Withdrawn Rejections
Claim Rejections - 35 USC § 112
The rejection of claims 20-39 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement because claim 20 recites “where the solution is formulated to gradually release the therapeutic agent in a controlled manner when exposed to an aqueous medium” and there is no disclosure in the instant specification how a non-aqueous solution can be formulated to gradually release the therapeutic agent in a controlled manner when exposed to an aqueous medium has been withdrawn in view of the amendment to claim 20 to include a solubilizing excipient.
Newly Applied Rejections
Claim Rejections - 35 USC § 112
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 40 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 40 recites “where the solution is formulated to for a partially water insoluble mass when placed in an aqueous medium, that gradually release the therapeutic agent in a controlled manner.” While the instant specification disclosed in paragraph 0016 “the preparation is preferably formulated to controllably release the therapeutic agent into the patient area to be treated. The preparation is formulated to controllably release the agent over “a period of time” and “where the preparation is formulated to form a partially water insoluble mass when placed in an aqueous medium, that gradually releases the drug into the aqueous medium in a controlled manner” in paragraph 0076-0077, it is disclosed this preparation is in the form a viscous liquid, semi solid, or a paste. As noted below, the specification does not disclose the mass is a viscous liquid, semi-solid, or paste, there is no disclose of a partially water insoluble mass having the claimed properties.
The instant specification does not disclose how said preparation is “formulated to gradually release the therapeutic agent in a controlled manner when exposed to an aqueous medium”. The Examiner is unable to locate support or a teaching of how the preparation is formulated to have said functionality when exposed to an aqueous medium. Paragraph 00271 discloses lidocaine in an EGCG:propylene glycol paste and paragraph 00273 discloses tannic acid:propylene glycol paste, however, the instant claims do no recite propylene glycol is a component and its only disclosed as an alternative in instant claim 29. The use of propylene glycol appears to be a critical element to the functioning of the formulation as claimed.
Therefore, there is no disclosure in the instant specification how a non-aqueous solution can be formulated to gradually release the therapeutic agent in a controlled manner when exposed to an aqueous medium.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 40 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 40, the claim recites “is formulated to form a partially water insoluble mass”, however, it is unclear what type of “mass” is formed. A review of the specification does not define what would constitute a “mass”. Therefore, it is unclear what additional components would be necessary or permissible to meet the limitation of “formulated to form a partially water-insoluble mass”. For purposes of prosecution, the Examiner has interpreted “mass” to include any type of formulation that has a mass, including liquids, gases, and solids or semi-solids.
Allowable Subject Matter
Claims 20-27 and 29-40 are free of the prior art. The closest prior art is that of Memarzadeh et al. (US 2008/0103103) which discloses compositions for treating an ocular condition by administration to an effective amount of a catechin or polyphenol (abstract).
Epigallocatechin gallate (EGCG) is used (paragraph 0007-0008). The composition can additionally comprise chemotherapeutic agents, antibiotics, antibiotics, anesthetics, anti-inflammatory agents (paragraph 0041), for example.
The compositions are disclosed to be aqueous solutions or suspensions (paragraph 0042).
A drug containing depot can be administered to the ocular tissue. A depot can take a variety of forms so long as the composition containing a catechin or polyphenol can be provided in sufficient concentration levels therein and is releasable therefrom and that the depot is not readily removed from the eye. A depot generally remains for at least about 30 minutes after administration, in particular at least 2 hours and can be at least 4 hours (paragraph 0046).
Memarzaheh differs from the instant claims in that it is drawn to an aqueous solution or suspension instead of a non-aqueous solution as recited in the instant claims.
Additionally, while Memarzadeh discloses therapeutic agents which may be water insoluble. There is no teaching within the prior art that it is limited to those agents. Additionally, there is no motivation within the art to limit the drug depot, as taught by Memarzadeh to water insoluble therapeutic agents.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615