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 .
Claims 1, 11-13, 15, 23-38 are presented for examination.
The amendments and remarks filed on 10/06/2025 have been received and entered.
Claims 32 and 35 are objected as being dependent on a rejected claim.
There has been an inadvertent mistake in citing the rejected claims as 1-3, 15 and 23-28. The correct numbering of the rejected claims as indicated on the coversheet and at the end of obviousness rejection in the rejection of 09/26/2024 is 1-13, 15 and 23-28.
Claims 32 and 35 are objected as being dependent on a cancelled claim.
Claim Rejections - 35 USC § 112
Claims 31 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.
Claim 31 is indefinite as to the phrase “therapeutic”, such phrase fails to set forth either a composition or a compound intended.
Claims dependent of claim 31 are also rejected as they have all the limitations of the rejected claim.
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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1, 11-13, 15, 29, 30-34 is/are rejected under 35 U.S.C. 103 as being unpatentable over
Santangelo al. (EP 0499882) in view of Catron al. (US 20100278905) and further in view of Clemons
(US 9,541,558) and Yaccobi (US Patent 6,416,777).
Santangelo et al. teach the use of N-acetyl ethyl, propyl and isopropyl ester in an ophthalmic
formulation for the treatment of cataract. See the abstract, page 2, page 6 and claims. Santangelo
makes clear that some of the claimed compounds have been previously used in an ophthalmic
formulation.
Catron teaches an orally deliverable pharmaceutical composition comprises a Bcl-2 family protein inhibitory compound, e.g., ABT-263, a heavier-chalcogen antioxidant and a substantially non-aqueous lipid carrier, wherein said compound and said antioxidant are in solution in the carrier. The composition is suitable for oral administration to a subject in need thereof for treatment of a disease characterized by overexpression of one or more anti-apoptotic Bcl-2 family proteins, for example cancer. See The abstract. Catron in para [0079] teaches that the composition is "orally deliverable", i.e., adapted for oral administration; however, such a composition can be useful for delivery of the drug to a subject in need thereof by other routes of administration, including without limitation parenteral, sublingual, buccal, intranasal, pulmonary, topical, transdermal, intradermal, ocular, otic, rectal, vaginal, intragastric, intracranial, intrasynovial and intra-articular routes. Catron teaches the use of N-acetylcysteine derivatives, such as, N-acetylcysteine, N-acetylcysteine butyl ester, N-acetylcysteine dodecyl ester, N-acetyl-cysteine ethyl ester, N-acetylcysteine methyl ester, N- acetylcysteine octyl ester, N-acetyl-cysteine propylester. See Para [0150] and claim 11. Santangelo and Catron differ from the claimed invention in acetylcysteine derivatives of claims 1, 11, 29, 30, 31 and the implant of claims 12, 13, 15, and 32-34.
Clemons teaches a cysteine hydrazine nicotinamide derivative having pyridine at the R2 position as it is
in the claimed invention. See claims. Yaacobi teaches a drug delivery device for a human eye, and
methods of delivery of a pharmaceutically active agent (i.e., therapeutic agent) to the posterior segment
of the human eye (e.g., abstract). The device includes a pharmaceutically active agent, and a geometry
that facilitates the implantation of the device on an outer surface of the sclera (and thus is in contact
with the sclera of the eye), with the pharmaceutically active agent disposed above the macula. See
column 2, lines 60-67 The device comprises an outer layer Surrounding an inner layer (e.g., see Fig. 9
and 10), with each layer comprising curvature at both surfaces (e.g., col. 5, lines 22-24 and 52- 57).
Yaacobi further teaches the device is preferably disposed directly on the outer surface of the sclera,
below Tenon's capsule for treatment of most posterior segment diseases or conditions (e.g., col. 4, lines
34-38).
Regarding claim 13, Yaacobi teaches the outer layer preferably comprises a biocompatible, non-
bioerodable polymeric composition; examples of suitable polymers comprises silicone, polyvinyl alcohol, ethylene vinyl acetate, polylactic acid, nylon, polypropylene, polycarbonate, cellulose, cellulose acetate,
polyglycolic acid, polylactic-glycolic acid, cellulose esters, polyether sulfone, acrylics, their derivatives.
See claim 7. Yaacobi teaches that Inner core may comprise any ophthalmic acceptable
pharmaceutically active agents suitable for localized delivery. See column 6 and claim 11. Yaacobi
teaches the disposing the device on outer surface of said sclera, beneath said inferior oblique muscle,
and with said pharmaceutically active agent disposed above said macula. See claims.
Regarding claim 24 and 25, Yaacobi discloses specific diseases of the eye which may be treated include
ARMD and diabetic retinopathy. See column 3, lines 1-5 and column 5, lines 15-21.
It would have been obvious to a person skilled in the art to use a nicotine or pyridine in a cysteine
composition and to use an implant for delivering the ophthalmic formulation motivated by the teachings
of Clemons, which teaches the substituents of nicotine and pyridine on cysteine as old and well known.
Yaccobi teaches the use of an implant for delivering ophthalmic formulations using any suitable drug. It
would have been obvious to use the claimed N-acetylcysteine alkyl esters, which are used in ophthalmic
formulations in the implant of the claimed composition, considering that Yaacobi teaches the use of
such implants for delivering ophthalmic pharmaceutical active ingredients to the eye as old and well
known.
The combination of relied upon references, make clear that the claimed N-acetyl alkyl ester having pyridine and a nicotine have been previously used in an pharmaceutical/ophthalmic formulations. Yaacobi et al. teach the use of the claimed implant for delivering ophthalmic formulations to the eye and treat conditions, such as macular degeneration and diabetic retinopathy.
Claims 23-28, 35, 36 and 37 are considered to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZOHREH A FAY/Primary Examiner, Art Unit 1617