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 .
Applicant’s election without traverse of Group I, claims 1-2, 5, 6, 8 and 10-15 in the reply filed on 01/12/2026 is acknowledged.
Claims 16, 17, 19, 22, 23, 24, 26, 30, 32, 35-37 and 40 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/12/2026.
Claim Rejections - 35 USC § 102
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 5, 6, 8 and 14 is/are rejected under 35 U.S.C. 102 (a)(1)/(a)(2) as being anticipated by Ali et al. (US 8,388,995 submitted by the applicant).
Regarding claim 1, Ali teaches a systems and methods of time released ophthalmic drug delivery using contact lenses. See column 1, lines 55-58. Ali teaches a contact lens comprising a recognitive, weakly cross-linked polymeric hydrogel matrix having between about 0.1% to 20% moles cross-linking monomer and/or macromer species per total moles of all monomer and/or macromer species present with complexing memory sites that complex a comfort agent and release the comfort agent from the weakly cross-linked hydrogel matrix over time while in contact with a surface of an eye, wherein the weakly cross-linked polymeric hydrogel is formed by the steps of generating a solution comprising amounts of a bio-template, a functionalized monomer or macromer, and a cross-linking monomer, complexing the functionalized monomer or macromer and the bio-template through non-covalent interactions, initiating copolymerization of the functionalized monomer or macromer and the cross-linking monomer, and loading the comfort agent into the memory sites. See claim 1. Ali teaches that the invention is directed to both corrective and refractive contact lenses as well as non-corrective and non-refractive contact lenses. See column 3, lines 25-27. The elastic modulus is the inherent property of the contact delivery system of Ali et al., considering that Ali uses the same silicone hydrogel contact lens with a cross-linked polymeric hydrogel matrix with the same functional monomers and crosslinking agents. Applicant’s attention is drawn to In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990), where the court states “Products of identical chemical composition cannot have mutually exclusive properties”. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claim 2, Ali teaches the contact lens drug delivery system comprising cross-linked hydrogel matrix comprises silicone-based or silicone-containing macromer or polymer chains. See Claim 2. Ali teaches that a hydrogel matrix that is formed from silicon-based cross-linking monomers, carbon based or organic-based monomers, macromers or a combination thereof. Suitable cross-linking monomers include but are not limited to Polyethylene glycol (200) dimethacrylate (PEG200DMA), ethylene glycol dimethacrylate (EGDMA), tetraethyleneglycol dimethacrylate (TEGDMA), N,N'-Methylene-bis-acrylamide and polyethylene glycol (600) dimethacrylate (PEG600DMA). Suitable silicon-based cross-linking monomers can include tris(trimethylsiloxy)silyl propyl methacrylate (TRIS) and hydrophilic TRIS derivatives such as tris(trimethylsiloxy)silyl propyl vinyl carbamate (TPVC), tris(trimethylsiloxy)silyl propyl glycerol methacrylate (SIGMA), tris(trimethylsiloxy)silyl propyl methacryloxyethylcarbamate (TSMC); polydimethylsiloxane (PDMS) and PDMS derivatives, such as methacrylate end-capped fluoro-grafted PDMS crosslinker, a methacrylate end-capped urethane-siloxane. See column 3, lines 34-55.
Regarding claim 5, Ali teaches the cross linking agents being Polyethylene glycol (200) dimethacrylate (PEG200DMA), ethylene glycol dimethacrylate (EGDMA), tetraethyleneglycol dimethacrylate (TEGDMA), N,N'-Methylene-bis-acrylamide and polyethylene glycol (600) dimethacrylate (PEG600DMA). See column 3, lines 38-42.
Regarding claim 6, Ali teaches that the drugs that can be delivered by the system and method of the present invention include, but are not limited to, Anti-bacterials, Anti-infectives, Anti-microbial Agents, such as anti-fungal agents (all of which generally referred to as antibiotics) such as Penicillins (including Aminopenicillins and/or penicillin as in conjunction with penicillinase inhibitor and anti-fungal agents), Cephalosporins (and the closely related cephamycins and carbapenems), Fluoroquinolones, Tetracyclines, Macrolides, Aminoglycosides. See column 6, lines 23-39. The use of the ophthalmic drugs delivered by the claimed contact lens system is taught in column 6, line 47-67 and column 7, lines 1-2.
Regarding claim 8, Ali teaches the use of anti-inflammatory agents, such as dexamethasone and dexamethasone sodium phosphate, diclofenac sodium and antibiotics, such as fluoroquinolone and cephalosporine. See column 6, lines 31-60.
Regarding claim 14, the claim is drawn to a composition that is formed by a process. When a claim is drawn to a product by process, such claim will be examined to the extent that reads on the product. Ali teaches a composition contact lens comprising a recognitive, weakly cross-linked polymeric hydrogel matrix having between about 0.1% to 20% moles cross-linking monomer and/or macromer species per total moles of all monomer and/or macromer species present with complexing memory sites that complex a comfort agent and release the comfort agent from the weakly cross-linked hydrogel matrix over time while in contact with a surface of an eye, wherein the weakly cross-linked polymeric hydrogel is formed by the steps of generating a solution comprising amounts of a bio-template, a functionalized monomer or macromer, and a cross-linking monomer, complexing the functionalized monomer or macromer and the bio-template through non-covalent interactions, initiating copolymerization of the functionalized monomer or macromer and the cross-linking monomer, and loading the comfort agent into the memory sites. See claim 1.
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, 2, 5, 6, 8 and 10-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ali et al. (US 8,338,995 submitted by the applicant).
The claims are drawn a contact lens delivery system containing ocular therapeutic agents,
comprising:
a silicone hydrogel contact lens comprising a cross-linked polymeric hydrogel matrix comprising
functional monomers and low molecular weight crosslinking agents, and
wherein the cross-linked polymeric hydrogel matrix has macromolecular memory sites that
complex an ocular therapeutic agent and release the ocular therapeutic agent from the
hydrogel matrix over time while in contact with a surface of an eye,
wherein the cross-linked polymeric hydrogel matrix contains an effective amount of the at least
one ocular therapeutic agent, and
wherein the silicone hydrogel contact lens are afocal, multi-focal, vision correcting or non-
correcting, plano, or bandage lenses having no vision correction and having an elastic
modulus between about 0.5 mPa and about 2.0 MPa.
Regarding claim1, Ali teaches a systems and methods of time released ophthalmic drug delivery using contact lenses. See column 1, lines 55-58. Ali teaches a contact lens comprising a recognitive, weakly cross-linked polymeric hydrogel matrix having between about 0.1% to 20% moles cross-linking monomer and/or macromer species per total moles of all monomer and/or macromer species present with complexing memory sites that complex a comfort agent and release the comfort agent from the weakly cross-linked hydrogel matrix over time while in contact with a surface of an eye, wherein the weakly cross-linked polymeric hydrogel is formed by the steps of generating a solution comprising amounts of a bio-template, a functionalized monomer or macromer, and a cross-linking monomer, complexing the functionalized monomer or macromer and the bio-template through non-covalent interactions, initiating copolymerization of the functionalized monomer or macromer and the cross-linking monomer, and loading the comfort agent into the memory sites. See claim 1. Ali teaches that the invention is directed to both corrective and refractive contact lenses as well as non-corrective and non-refractive contact lenses. See column 3, lines 25-27. The elastic modulus is the inherent property of the contact delivery system of Ali et al., considering that it uses the same silicone hydrogel contact lens with a cross-linked polymeric hydrogel matrix with the same functional monomers and crosslinking agents. Applicant’s attention is drawn to In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990), where the court states “Products of identical chemical composition cannot have mutually exclusive properties”. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claim 2, Ali teaches the contact lens drug delivery system comprising cross-linked hydrogel matrix comprises silicone-based or silicone-containing macromer or polymer chains. See Claim 2. Ali teaches that a hydrogel matrix is formed from silicon-based cross-linking monomers, carbon based or organic-based monomers, macromers or a combination thereof. Suitable cross-linking monomers include but are not limited to Polyethylene glycol (200) dimethacrylate (PEG200DMA), ethylene glycol dimethacrylate (EGDMA), tetraethyleneglycol dimethacrylate (TEGDMA), N,N'-Methylene-bis-acrylamide and polyethylene glycol (600) dimethacrylate (PEG600DMA). Suitable silicon-based cross-linking monomers can include tris(trimethylsiloxy)silyl propyl methacrylate (TRIS) and hydrophilic TRIS derivatives such as tris(trimethylsiloxy)silyl propyl vinyl carbamate (TPVC), tris(trimethylsiloxy)silyl propyl glycerol methacrylate (SIGMA), tris(trimethylsiloxy)silyl propyl methacryloxyethylcarbamate (TSMC); polydimethylsiloxane (PDMS) and PDMS derivatives, such as methacrylate end-capped fluoro-grafted PDMS crosslinker, a methacrylate end-capped urethane-siloxane. See column 3, lines 34-55.
Regarding claim 5, Ali teaches the cross linking agents being Polyethylene glycol (200) dimethacrylate (PEG200DMA), ethylene glycol dimethacrylate (EGDMA), tetraethyleneglycol dimethacrylate (TEGDMA), N,N'-Methylene-bis-acrylamide and polyethylene glycol (600) dimethacrylate (PEG600DMA). See column 3, lines 38-42.
Regarding claim 6, Ali teaches that the drugs that can be delivered by the system and method of the present invention include, but are not limited to, Anti-bacterials, Anti-infectives, Anti-microbial Agents, such as anti-fungal agents (all of which generally referred to as antibiotics) such as Penicillins (including Aminopenicillins and/or penicillin as in conjunction with penicillinase inhibitor and anti-fungal agents), Cephalosporins (and the closely related cephamycins and carbapenems), Fluoroquinolones, Tetracyclines, Macrolides, Aminoglycosides. See column 6, lines 23-39. The use of the ophthalmic drugs delivered by the claimed contact lens system is taught in column 6, line 47-67 and column 7, lines 1-2.
Regarding claim 8, Ali teaches the use of anti-inflammatory agents, such as, dexamethasone and dexamethasone sodium phosphate, diclofenac sodium and antibiotics, such as fluoroquinolone and cephalosporine. See column 6, lines 31-60.
Regarding claim 10, Ali does not teach the concentration of 20 ug to about 500 ug drug in the cross-linked polymer hydrogel matrix. However, the determination of optimum proportions or amounts are considered to be within the skill of 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 claim11, Ali does not teach the concentration of silicone or siloxane monomers
or macromers, methacryloxypropyl-tris-(trimethylsiloxy) silane (TRIS), and/or N,N dimethyl
acrylamide (DMA) in the cross-linked polymer hydrogel matrix. However, the determination of optimum proportions or amounts are considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 12, Ali does not teach wherein the crosslinking agents comprise ethylene
glycol dimethacrylate (EGDMA) and/or polyethylene glycol 200 dimethacrylate (PEG200DMA)
in an amount of from about 0.5 wt.-% to about 15 wt.-%. Ali teaches that the cross-linked polymeric hydrogel matrix having between 0.15 to 20% crosslinking monomer. See claim 1. The amount overlaps with the claimed amounts. Furthermore, the determination of optimum proportions or amounts are considered to be within the skill of artisan in the absence of evidence to the contrary.
regarding claim 13, Ali teaches the use of azobisisobutyronitrile (AIBN), 2,2-dimethoxy-2-phenyl acetophenone (DMPA), 1-hydroxycyclohexyl phenyl ketone (Irgacure 184), 2,2-dimethoxy-1,2-diphenylethan-1-one (Irgacure 651), ammonium persulfate, iniferter such as tetraethylthiuram disulfide, or combinations thereof as initiators. See column 4, lines 41-55. The concentration of initiator is taught to be 0.1-30 wt.%. See column 4, lines 1-2. Such concentrations overlaps with the claimed concentrations of 0.01 to about 5 wt.%. Furthermore, the determination of optimum proportions or amounts are considered to be within the skill of artisan in the absence of evidence to the contrary.
Regarding claim 14, the claim is drawn to a composition that is formed by a process. When a claim is drawn to a product by process, such claim will be examined to the extent that reads on the product. Ali teaches a composition contact lens comprising a recognitive, weakly cross-linked polymeric hydrogel matrix having between about 0.1% to 20% moles cross-linking monomer and/or macromer species per total moles of all monomer and/or macromer species present with complexing memory sites that complex a comfort agent and release the comfort agent from the weakly cross-linked hydrogel matrix over time while in contact with a surface of an eye, wherein the weakly cross-linked polymeric hydrogel is formed by the steps of generating a solution comprising amounts of a bio-template, a functionalized monomer or macromer, and a cross-linking monomer, complexing the functionalized monomer or macromer and the bio-template through non-covalent interactions, initiating copolymerization of the functionalized monomer or macromer and the cross-linking monomer, and loading the comfort agent into the memory sites. See claim 1.
Regarding claim 15, Ali teaches statistics that indicates a quality that the comfort of wearing and the oxygen permeability of the silicone hydrogel is in agreement with conventional contact lenses. See column 16, lines 45-50. Ali does not teach the oxygen permeability of 50 Barrer. However, Ali teaches the oxygen permeability of the silicone hydrogel contact lens is in agreement with conventional contact lenses. Furthermore, the determination of hydrogen permeability of a contact lens is considered to be within the skill of artisan in the absence of evidence to the contrary.
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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/ZOHREH A FAY/Primary Examiner, Art Unit 1617