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 .
Status of Claims
Claims 1-3 and 5-19 are pending in the current application.
Claims 1, 5, and 11 are amended in the current application.
Claim 4 is canceled in the current application.
Response to Arguments
Applicant's remarks and amendments filed on April 3, 2026 have been fully considered.
Applicant requests withdrawal of the rejection under 35 USC 112(b) set forth in the previous office action.
The rejection under 35 USC 112(b) set forth in the previous office action is withdrawn due to the present claim amendments.
Applicant argues that Ito teaches that when a vinyl ester of a lower fatty acid is replaced with hydrophilic monomers then properties of oxygen permeability, excellent wettability, lipid contamination resistance, flexibility, and shape recovery cannot be achieved; therefore, Ito would teach away from compositions comprising hydrophilic monomers.
This is not persuasive for the following reasons. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Ito is not relied upon alone to render obvious the claimed invention. Note that while Ito does not disclose all the features of the presently claimed invention, Ito is used as a teaching reference, and therefore, it is not necessary for this secondary reference to contain all the features of the presently claimed invention, In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973), In re Keller 624 F.2d 413, 208 USPQ 871, 881 (CCPA 1981). Rather this reference teaches a certain concept, and in combination with the other applied prior art establishes a prima facie case of obviousness over the presently claimed invention. Ito teaches that it is well known and well within the abilities of those skilled in the art to utilize fluoroalkyl acrylate monomers having a perfluoroalkyl group of 4 carbon atoms to form polymers for silicone-based ophthalmic contact lenses to attain flexibility, wettability, sufficient oxygen permeability, and lipid-stain resistance (Ito, [0068]-[0069]).
Moreover, Ito’s results presented in Tables 1-5 do not establish that a combination of a silicone-containing monomer, a hydrophilic monomer, and a compatibilizing monomer result in failure to achieve the aforementioned properties. Ito provides inventive examples formed of a monomer mixture of siloxane macromonomer (A), a vinyl ester of a lower fatty acid monomer (B), a silicon-containing monomer (C), and a fluorine-containing compatibilizing monomer (D) in Table 1; and comparative examples formed of siloxane macromonomer (A), a silicon-containing monomer (C), and other hydrophilic monomers such as 2-hydroxyethyl methacrylate. None of Ito’s examples test embodiments simultaneously comprising a silicone-containing monomer, a fluorine-containing compatibilizing monomer, and a hydrophilic monomer such as 2-hydroxyethyl methacrylate. Therefore, one skilled in the art would not be able to verify Applicant’s assertions based upon the teachings and data provided by Ito. It is noted that “the arguments of counsel cannot take the place of evidence in the record,” see MPEP 2145, I. It is the examiner’s position that the arguments provided by the applicant regarding a monomer mixture of a hydrophilic monomer and a compatibilizing monomer failing to achieve the aforementioned properties must be supported by objective evidence, a declaration, or an affidavit. As set forth in MPEP 716.02(g), “the reason for requiring evidence in a declaration or affidavit form is to obtain the assurances that any statements or representations made are correct, as provided by 35 U.S.C. 24 and 18 U.S.C. 1001.”
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 1-3 and 5-19 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.
Claim 1 is indefinite as the recitation of possible elements is not properly claimed in the alternative. Treatment of claims reciting alternatives is not governed by the particular format used (e.g., alternatives may be set forth as "a material selected from the group consisting of A, B, and C" or "wherein the material is A, B, or C"). See, e.g., the Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications ("Supplementary Guidelines"), 76 Fed. Reg. 7162, 7166 (February 9, 2011). Alternative expressions are permitted if they present no uncertainty or ambiguity with respect to the question of scope or clarity of the claims. A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group "consisting of" (rather than "comprising" or "including") the alternative members. Abbott Labs., 334 F.3d at 1280, 67 USPQ2d at 1196. If a Markush grouping requires a material selected from an open list of alternatives (e.g., selected from the group "comprising" or "consisting essentially of" the recited alternatives), the claim should generally be rejected under 35 U.S.C. 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim. If a claim is intended to encompass combinations or mixtures of the alternatives set forth in the Markush grouping, the claim may include qualifying language preceding the recited alternatives (such as "at least one member" selected from the group), or within the list of alternatives (such as "or mixtures thereof"). Id. at 1281. See MPEP 2173.05(h).
For the purposes of examination, claim 1 is interpreted as reciting “the hydrophilic monomer (a-3) is selected from the group consisting of hydroxyethyl (meth)acrylate, …, and 1-methyl-3-methylene-2-pyrrolidinone.” Alternatively, claim 1 could be amended to recite “the hydrophilic monomer (a-3) is selected from hydroxyethyl (meth)acrylate, …, or 1-methyl-3-methylene-2-pyrrolidinone” to overcome the aforementioned deficiency. Correction is required.
Claims 2, 3, and 5-19 are also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, since these claims depend from claim 1 as rejected above and do not remedy the aforementioned deficiency.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-3, 5-16, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Vanderlaan et al. (US 2010/0280146 A1) in view of Ito et al. (US 2004/0054106 A1).
Regarding Claim 1, Vanderlaan teaches a polymer composition (material) for ophthalmic contact lenses comprising a silicone containing monomer component, a hydrophilic monomer component (a polymerizable mixture containing monomer components (a) that include (a-1) and (a-3)), a high molecular weight hydrophilic polymer (a hydrophilic polymer component (b)), and a compatibilizing agent (Vanderlaan, [0002], [0006]-[0016]). Vanderlaan teaches the silicone containing monomer component (a-1) is a monomer that contains a siloxane bond and is free of hydroxyl groups (Vanderlaan, [0031]-[0033], [0044]-[0060]). Vanderlaan teaches the hydrophilic component (a-3) includes hydrophilic monomers that include 2-hydroxyethyl acrylate (Vanderlaan, [0062]-[0067]). Vanderlaan teaches the polymer composition (material) for ophthalmic contact lenses has a water content of greater than about 17%, and preferably greater than about 25% by weight (Vanderlaan, [0062], [0083]). Vanderlaan’s water content falls within the claimed range of 11 mass% or more, and therefore, satisfies the claimed range (MPEP 2131.03).
Vanderlaan remains silent regarding a compatibilizing monomer (a-2) having a hydrogen bonding proton-containing group (such as a hydroxyl group) and being free of any silicon atoms, where the compatibilizing monomer (a-2) has four or more carbon atoms (excluding carbon atoms contained in a polymerizable functional group) and has a solubility of less than 0.03 g/mL in water at 25oC.
Ito, however, teaches a polymer composition (material) for ophthalmic contact lenses comprising a silicone containing monomer, a hydrophilic monomer, and a fluorine-containing monomer (Ito, [0001], [0009]-[0057], [0063]-[0071]). Ito discloses the fluorine-containing monomer is preferably a fluoroalkyl acrylate as depicted below having an R’1 as a perfluoroalkyl preferably of 4-6 carbon atoms to impart flexibility, wettability, sufficient oxygen permeability, and lipid-stain resistance (Ito, [0068]-[0069]). Ito’s fluoroalkyl acrylate having a perfluoroalkyl group of 4 carbon atoms is identical to the compatibilizing monomer (a-2) example in the specification as originally filed on page 60 having solubility of less than 0.01 g/mL in water at 25oC (Spec, Pg 60). "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). 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. Id. In view of the foregoing, Ito’s fluoroalkyl acrylate having a perfluoroalkyl group of 4 carbon atoms is considered to inherently exhibit a solubility of less than 0.01 g/mL in water at 25oC and exhibit compatibilizing properties. It would have been obvious to one of ordinary skill in the art to have selected and to have tried Ito’s fluoroalkyl acrylate having a perfluoroalkyl group of 4 carbon atoms from the finite list of viable fluorine-containing monomers, and moreover, to impart flexibility, wettability, sufficient oxygen permeability, and lipid-stain resistance with a predictable and reasonable expectation of success (Ito, [0068]-[0069]; MPEP 2143).
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Ito – Fluoroalkyl acrylate
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Specification – C4F9CH2CH(OH) CHMA
Since Vanderlaan and Ito both disclose polymer compositions comprising silicone-based components for ophthalmic contact lenses, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added Ito’s fluoroalkyl acrylate having a perfluoroalkyl group of 4 carbon atoms into Vanderlaan’s composition to yield a polymer that exhibits flexibility, wettability, sufficient oxygen permeability, and lipid-stain resistance as taught by Ito (Ito, [0068]-[0069]).
Regarding Claim 2, modified Vanderlaan teaches the fluorine-containing monomer having a perfluoroalkyl group R’1 of 4 carbon atoms has six or more carbon atoms excluding the carbon atoms in the polymerizable functional group (Ito, [0068]-[0069]).
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Ito – Fluoroalkyl acrylate
Regarding Claim 3, modified Vanderlaan teaches the polymer composition (material) can include a compatibilizing agent with at least one polymerizable group (i.e., a compatibilizing monomer (a-2)) that can be included in an amount of about 0 to about 5 wt% of the polymer composition (Vanderlaan, [0013], Claim 9). Vanderlaan’s compatibilizing monomer (a-2) content overlaps the claimed range of 5-50 mass%, and therefore, establishes a prima facie case of obviousness over the claimed range (MPEP 2144.05, I).
Regarding Claim 5, modified Vanderlaan teaches the high molecular weight hydrophilic polymer (a hydrophilic polymer component (b)) is included in a preferred amount of about 3-15 wt% based upon the total of all reactive components (Vanderlaan, [0068]-[0070]). Modified Vanderlaan’s range is completely encompassed within the claimed range of 1-30 mass%, and therefore, satisfies the claimed range (MPEP 2131.03).
Regarding Claim 6, modified Vanderlaan teaches the fluoroalkyl acrylate having a perfluoroalkyl group of 4-6 carbon atoms (a-2) has an acrylate polymerizable functional group, an intermediate portion containing a hydroxyl group, and the perfluoroalkyl group of 4-6 carbon atoms as a hydrophobic terminal group (Ito, [0068]-[0069]).
Regarding Claim 7, modified Vanderlaan teaches the fluoroalkyl acrylate having a perfluoroalkyl group of 4-6 carbon atoms (a-2) can have a branched hydrocarbon group such as 3-(perfluoro-3-methylbutyl)-2-hydroxypropyl (meth)acrylate (Ito, [0065]-[0069]).
Regarding Claim 8, modified Vanderlaan teaches the fluoroalkyl acrylate having a perfluoroalkyl group (a-2) has a Z (meth)acryloyl group, an A divalent atomic group containing a hydroxyl group (a hydrogen bonding proton-containing group), and a B hydrocarbon group having 3-15 carbon atoms, where a total number of carbon atoms in A+B is 4 or more (Ito, [0065]-[0069]).
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Ito – Fluoroalkyl acrylate
Regarding Claims 9 and 10, modified Vanderlaan teaches the fluoroalkyl acrylate having a perfluoroalkyl group (a-2) has the A divalent group satisfying formula (i) of claim 9, where X is -O-; Ra1 can be an alkylene group of 3 carbon atoms and a hydroxyl group (-CH2-CH(OH)-CH2-); and r1, r2, r3, and r4 are 0 (Ito, [0065]-[0069]).
Regarding Claim 11, modified Vanderlaan teaches the polymer composition (material) can include a copolymerizable dye (i.e., a polymerizable dyestuff) (Vanderlaan, [0077]).
Regarding Claim 12, modified Vanderlaan teaches the fluoroalkyl acrylate having a perfluoroalkyl group (a-2) has a hydroxyl group (a hydrogen bonding proton-containing group) (Ito, [0065]-[0069]).
Regarding Claim 13, modified Vanderlaan teaches the silicone containing component (a-1) is a monomer that contains a siloxane bond, is free of hydroxyl groups, and contains a nitrogen atom (Vanderlaan, [0060], Formulae IX & X).
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Vanderlaan – Formula IX
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Vanderlaan – Formula X
Regarding Claim 14, modified Vanderlaan teaches the high molecular weight hydrophilic polymer (hydrophilic polymer component (b)) has a weight average molecular weight of no less than 100,000 (Vanderlaan, [0068]). Modified Vanderlaan’s range is identical to the claimed range, and therefore, satisfies the claimed range (MPEP 2131.03).
Regarding Claims 15 and 16, modified Vanderlaan teaches the high molecular weight hydrophilic polymer (hydrophilic polymer component (b)) can be a polyvinyl amide such as preferably poly-N-vinyl pyrrolidone (Vanderlaan, [0068]-[0071]).
Regarding Claims 18 and 19, modified Vanderlaan teaches ophthalmic medical contact lenses comprising the polymer composition as discussed above for claim 1 (Vanderlaan, [0002], [0009], [0014]-[0015], [0083]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Vanderlaan et al. (US 2010/0280146 A1) in view of Ito et al. (US 2004/0054106 A1) as applied to claim 1 above, and further in view of Satake et al. (US 2016/0289368 A1).
Regarding Claim 17, modified Vanderlaan teaches the polymer composition (material) for ophthalmic contact lenses as discussed above for claim 1. Modified Vanderlaan teaches the polymer composition can exhibit modulus ranging from 64±4 psi to 118.4±7.3 psi (60 psi to 125.7 psi; 0.41 MPa to 0.87 MPa) (Vanderlaan, [0096], [0142]-[0146], Tables 5 & 8).
Modified Vanderlaan remains silent regarding a Young’s modulus of from 0.05 MPa to 2.0 MPa.
Satake, however, teaches a polymer for an ophthalmic contact lens having a Young’s modulus of from 0.3 MPa to 1.0 MPa to achieve excellent wearing comfort, sufficiently high flexibility, and adequate degree of deformation recovery property (Satake, [0010]-[0012], [0025]-[0026]). Satake’s Young’s modulus range is completely encompassed within the claimed range of 0.05-2.0 MPa, and therefore, satisfies the claimed range (MPEP 2131.03). Satake teaches the polymer comprises a polysiloxane-based monomer and a hydrophilic monomer (Satake, [0015]-[0017], [0038]-[0054]).
Since modified Vanderlaan and Satake both disclose polymer compositions comprising silicone-based components for ophthalmic contact lenses exhibiting similar modulus properties, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have adjusted and optimized Vanderlaan’s composition Young’s modulus between 0.3 MPa to 1.0 MPa to yield a polymer that achieves excellent wearing comfort, sufficiently high flexibility, and adequate degree of deformation recovery property as taught by Satake (Satake, [0010]-[0012], [0025]-[0026], MPEP 2144.05, II).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELI D STRAH whose telephone number is (571)270-7088. The examiner can normally be reached M-F 9 am - 7 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Aaron Austin can be reached on 571-272-8935. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Eli D. Strah/Primary Examiner, Art Unit 1782
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