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 1-15 are pending in the instant application.
Claims 1-12 are presented for examination.
Claims 13-15 are withdrawn from examination.
The response to the restriction requirement of 09/04/2025 has been received and entered. Applicant elected claims 1-12 without traverse for examination purpose.
Claim Rejections - 35 USC § 112
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.
Claims 1 and 8 are 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.
Claims 1 and 8 are indefinite as to the phrase “including”. The phrase including renders the claim indefinite because it is not clear whether the limitation followed by the phrase “including” is part of the claimed invention. See MPEP 2173.05 (d).
The claims dependent on the rejected claims are also rejected, since they have all the limitations of the rejected claims.
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) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Thakur et al. (US 20180325812 submitted by the applicant) in view of Abe et al. (US 20120177717) and further in view of Beamish et al. (The Effects of Monoacrylated Poly (Ethylene Glycol) on Properties of Poly (Ethylene Glycol) Diacrylate Hydrogel Used for Tissue Engineering) (submitted by the applicant).
The claims are drawn to an ocular composition comprising:
at least 0.1% w/w of a therapeutic agent; b) 5 to 95% w/w of a photopolymerizable composition comprising 3 to 70% w/w of one or more compounds of formula I:
PNG
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58
230
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wherein Ri is hydrogen or a linear or branched C1-C3 alkyl; R2 is an acrylate or methacrylate group; n is 2 or 3 and m is equal or greater than 1, the weight percentage of the one or more compounds of formula I being based on the total weight of the photopolymerizable composition;
c) 0.1 to 40% w/w of a biodegradable polymer selected from the group consisting of lactide/glycolide copolymer (including poly(lactide-co-glycolide) (PLGA)), poly (L-lactide) (PLA), polyhydroxyalkanoates, including polyhydroxybutyrate, polyglycolic acid (PGA), polycaprolactone (PCL), poly (DL-lactide) (PDL), poly (D-lactide), lactide/caprolactone copolymer, poly-L-lactide-co-caprolactone (PLC) and mixtures, copolymers, and block copolymers thereof, and
d) a photoinitiator.
Regarding claim 1, Thakur et al. teach ocular composition comprising: 99 to 60% (w/w) of a photopolymerizable composition selected from the group of fragments or monomers consisting of polyalkylene glycol diacrylate and polyalkylene glycol dimethacrylate, wherein the photopolymerizable composition has a molecular weight in the range of 100 to 20,000 Dalton; a biodegradable polymer selected from the group consisting of aliphatic polyester-based polyurethanes, polylactides, polycaprolactones, polyorthoesters and mixtures, copolymers, and block copolymers thereof; a photoinitiator; and a therapeutic agent. See the abstract. Thakur et al. teach the biodegradable polymer is selected from the group lactide/glycolide co-polymer (PLGA), polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), lactide/caprolactone copolymer (PLC), poly (L-lactide) (PLLA) and mixtures, copolymers, and block copolymers thereof. See Para [0014]. Thakur et al. differs from the claimed invention in the use of polyethylene acrylates, such as polyethylene glycol methacrylate and the concentration of 3-70% of compound of formula I. Abe teaches the use of polyethylene glycol methacrylate (PEGMA) in a sustained drug delivery system. Polyethylene glycol diacrylate (PEGDA) is also taught in the drug delivery system by Abe et al. See Para [0108] and claim 8. It would have been obvious to substitute polyethylene methacrylate for acrylates of Thakur, motivated by the teachings of Abe, which teaches the use of polyethylene glycol methacrylate in a sustained drug delivery system for delivering ophthalmic formulations. The determination of optimum proportions or amounts are considered to be within skill of the artisan in the absence of evidence to the contrary. Applicant’s attention is drawn to In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Wherein the court states “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”.
Regarding claim 2, Abe et al. teach the use of poly (ethylene glycol) methacrylate in a sustained drug release system. See Para [0108] and claim 8.
Regarding claim 3, Abe teaches that PEGMA has been used in a sustained drug delivery system. See Para [0108] and claim 8.
Regarding claim 4, Abe does not teach the concentration of 5-60% w/w of compound of Formula I. However, the determination of optimum proportions or amounts are considered to be within skill of the artisan in the absence of evidence to the contrary.
Regarding claim 5, Thakur teaches the use of poly (ethylene glycol) diacrylate. See Paras [0131]-[0133]. The addition of such compound to polyethylene glycol methacrylate is taught by Beamish et al.
Regarding claim 6, Thakur teaches the use of PEGDA as photopolymerizable compound.
Regarding claim 7, Abe does not teach the concentrations of 40 to 75% w/w of the photopolymerizable composition. However, the determination of optimum proportions or amounts is considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 8, Thakur teach that the biodegradable polymer is selected from the group lactide/glycolide co-polymer (PLGA), polylactic acid (PLA), polyglycolic acid (PGA), polycaprolactone (PCL), lactide/caprolactone copolymer (PLC), poly (L-lactide) (PLLA) and mixtures, copolymers, and block copolymers thereof. See Para [0014].
Regarding claim 9, Thakur teaches the use of PLGA as a biodegradable polymer being used in a polymerizable composition. See para [0014].
Regarding claim 10, Thakur does not teach the use of poly (ethylene glycol) methacrylate (PEGMA). However, Abe et al. teach the use of poly (ethylene glycol) methacrylate (PEGMA) in a sustained drug delivery system. See Para [0108] and claim 8.
Regarding claim 11, Thakur does not teach the combination of poly (ethylene glycol) methacrylate and poly (ethylene glycol) diacrylate at specific concentrations and proportions. However, Abe teaches the use of PEGDA and PEGMA in a sustained drug delivery system. Furthermore, Beamish et al. teach the that the addition of PEGMA to photopolymerized PEGDA hydrogels similar to those used in tissue engineering applications enhanced the network cross-linking, as evidenced by a decreased swelling ratio, increased mechanical modulus, and an increase in the calculated S effective chains per cross-linking PEGDA molecule. See conclusion. The determination of optimum proportions or amounts are considered to be within the skill of artisan in the absence of evidence to the contrary. Thakur et el. Also teach he use of 1-[4-(2-hydroxyethoxy)-phenyl]-2-hydroxy-2-methyl-1-propanone as a photoinitiator. See Para [0039] and [0153].
Regarding claim 12, Thakur teaches the compositions or implants can deliver bioactive agents, a large molecular weight drug, such as, aflibercept, pegaptanib, or an antibody therapeutic, such as ranibizumab, bevacizumab, trastuzumab, rituximab, gentuzumab, ozagamicin or cetuximab. See Para [0211]. The use of timolol, latanoprost and dexamethasone is taught in Para [0210].
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