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 .
DETAILED ACTION
A second 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 27, 2026 has been entered.
Claims 1, 5-11, 13 and 14 are pending.
Claims 2-4 and 12 are cancelled.
Claim 1 has been amended to delete the copolymer and the elected embodiment thereof and to include the limitations of claim 4.
Claims 6 and 8-11 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claims 1, 5, 7, 13 and 14 as filed on January 15, 2026 are pending and under consideration to the extent of the elected species, e.g., the species of (co)polymer of a (meth)acrylamide having two substituents each having 2 or more carbon atoms on a nitrogen atom is “(meth)acrylic acid / N,N-diethyl (meth)acrylamide” and the species of substrate is “stenfilcon”. In view of the amendment of the claims, a polymer of N,N-diethyl (meth)acrylamide is rejoined.
Withdrawn Objections / Rejections
In view of the amendment of the claims, all previous claim rejections under 35 USC 103 over McCabe are withdrawn and all previous double patenting rejections over U.S. Patent No. 12,433,970 are withdrawn.
Applicant’s arguments have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 5, 7, 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over McCabe et al. (US 2007/0010595, published January 11, 2007, of record) as evidenced by Lotrafilcon A product information, printed 2025, of record in view of Vanderbilt et al. (US 2008/0151180, published June 26, 2008); Tamiya et al. (US 2015/0274854, published October 1, 2015); and Chauhan et al. (WO 2019/070979, published April 11, 2019).
McCabe teaches a method of treating a polymerized ophthalmic / contact lens with a wetting agent (hydrophilic polymer) selected from inter alia poly(meth)acrylamides such as N,N-dimethylacrylamide, wherein treating comprises heating the lens in an aqueous packaging solution comprising the wetting agent and a borate buffer (title; abstract; claims, in particular 1-8, 20; paragraphs [0001]-[0028], in particular [0011]-[0014]), as required by instant claim 13. The term “treating” refers to physical methods of contacting the wetting agent and the lens (paragraph [0009]). The concentration of the wetting agent is about 100 to 3000 ppm (0.01 to 0.3 wt%) (claim 17; paragraph [0016]). Ophthalmic lenses include soft contact lenses made from silicone hydrogels (paragraph [0007]), as required by instant claim 5. The ophthalmic lens is selected from inter alia lotrafilcon (silicone hydrogel, does not comprise inter alia epoxy groups as evidence by the product information) (claims 23-27; paragraph [0007]), as required by instant claims 5, 7, 14. Heating encompasses sterilization conditions (paragraphs [0009], [0011]-[0012]; Examples). McCabe further teaches the treatment improves the comfort of the lens (whole document, e.g., title). In the exemplary embodiment drawn to PVP wetting agents, the PVP incorporates into the matrix of the lens (not covalently bonded) (paragraph [0017]; Figure).
McCabe does not specifically teach autoclave sterilization, a poly(meth)acrylamide having two substituents each having 2 or more carbon atoms, a final pH of the solution of 6.1 to 8.0, and the formation of a 1 to 100 nm hydrophilic polymer layer not covalently bonded to the substrate as required by claim 1.
McCabe does not specifically teach stenfilcon as required by the elected embodiment of claim 7.
These deficiencies are made up for in the teachings of Vanderbilt, Tamiya and Chauhan.
Vanderbilt teaches coatings and solutions for contact lenses comprising a first polymer and a second polymer such as PVP, buffers inclusive of borate and having a pH of about 6 to 8 (the same as the final pH because a buffer by definition prevents changes in pH); the second polymer is adsorbed (not covalently bonded) on the contact lens and improves initial comfort of the lens (title; abstract; claims, in particular 1, 4, 9; paragraphs [0081], [0085], [0087], [0089]). Vanderbilt further teaches a method comprising placing the contact lens and the solution into a package and autoclaving (claims 24, 25). Autoclaving encompasses sterilization at temperatures of about 120 ºC or higher (paragraphs [0079]).
Tamiya teaches silicone acrylamide copolymers suitable for ophthalmic lenses such as a contact lens (title; abstract; claims). Tamiya further teaches wetting agents inclusive of poly-N,N-diethyl acrylamide (having two substituents each having 2 carbon atoms) (claims 25-30; paragraphs [0003], [0086]).
Chauhan teaches a contact lens having improved comfort comprising a lubricious surface layer comprising a polyacrylamide; the contact lens may be a silicone hydrogel lens such as lotrafilcon or stenfilcon (title; abstract; claims; paragraphs [0003], [0120], [0121], [0161], [0162]), as required by instant claim 7. The polyacrylamide may covalently or non-covalently interact with the contact lens (paragraph [0098]). The polyacrylamide may be a homopolymer formed from N,N-dialkylacrylamides such as N,N-diethylacrylamide (paragraphs [0099], [0100]). The surface layer has a thickness from about 0.1 to 5 microns, such as about 0.1 micron (100 nm) (paragraphs [0105]-[0108], [0148]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of McCabe to comprise autoclave sterilization as taught by Vanderbilt because autoclaving encompasses sterilization.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the aqueous, borate buffered packaging solutions of McCabe to have a pH of about 6 to 8 (the same as the final pH because a buffer by definition prevents changes in pH) as taught by Vanderbilt because this pH is suitable for packaging solutions for coating 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 modify the poly(meth)acrylamide wetting agent of the aqueous, borate buffered packaging solutions of McCabe to comprise poly-N,N-diethyl acrylamide as taught by Tamiya because poly-N,N-diethyl acrylamide is an art-recognized wetting agent for ophthalmic lenses such as contact lenses. One would have been motivated to do so because such polyacrylamides are expected to impart improved comfort in view of Chauhan.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that practice of the method of McCabe in view of Vanderbilt, Tamiya and Chauhan would result in adsorption of the polymeric wetting agents of McCabe in view of Tamiya and Chauhan because Vanderbilt teaches polymers to adsorb on a contact lens when packaged together with the lens and autoclaved.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adsorbed polymeric wetting agents of McCabe in view of Tamiya, Chauhan and Vanderbilt to have a surface layer thickness from about 0.1 to 5 microns such as about 0.1 micron as taught by Chauhan because this thickness imparts improved comfort due to the presence of a lubricous surface layer comprising a polyacrylamide. Regarding the specification of the thickness in a dry state, Chauhan does not expressly disclose this parameter, however, if the thicknesses of Chauhan are reported in a dry state then they overlap and fall within the instantly claimed range, sufficient to establish prima facie obviousness. See MPEP 2144.05. If they are reported in a wet state, then it necessarily follows Chauhan renders obvious thicknesses of less than about 0.1 microns because the thickness will decrease when the water is removed from the layer.
Regarding claim 7, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute contact lenses as taught by Chauhan inclusive of stenfilcon for the contact lens in the method of McCabe in view of Vanderbilt, Tamiya and Chauhan because simple substitution of functionally equivalent elements yields predictable results, absent evidence to the contrary. One of ordinary skill in the art would have been motivated to make the substitution because stenfilcon lenses would benefit from improved comfort due to the presence of the adsorbed acrylamide wetting agent.
Response to Arguments: Claim Rejections - 35 USC § 103
Applicant’s arguments of December 10, 2025, January 14, 2026 and January 15, 2026 have been fully considered but they are not persuasive.
With regard to arguments of December 10, the Remarks drawn to art applied in the previous rejection drawn to the previous embodiment of the claims are moot.
Applicant’s repeated citation to the Examples within the instant specification and repeated allegation of unexpected results remains unpersuasive for all of the reasons already of record. Applicant’s disagreement articulated at page 7 that Examples 14 and 15 are closer to the examples of McCabe because they appear to be drawn to the same contact lens and to substantially the same process steps is unpersuasive. That is, if one actually wanted to demonstrate the effect of the polymer, one skilled in the art would choose the example where all other conditions were the same. Applicant’s note at page 7 that McCabe does not disclose the claimed polymer is unpersuasive because McCabe is relied upon to render obvious the claimed process and to render obvious the genus of (meth)acrylamide wetting polymers. Applicant’s repeated position that they need not make a comparison to McCabe because the Comparative Examples within the instant specification have been deemed more appropriate by Applicant remains unpersuasive. See MPEP 716.02. Applicant’s repeated citation to Comparative Example 15 at page 8 remains unpersuasive for reasons of record. While Comparative Example 15 may comprise PVP, it does not comprise the same substrate as employed by McCabe. At best, Comparative Example 15 illustrates the effect of the substrate. Applicant’s repeated citation to Example 5 is moot as the copolymer is no longer claimed. Applicant’s repeated citation to Comparative Example 16 at page 9 remains unpersuasive for reasons of record. Applicant’s broad allegation that N,N-dimethylacrylamide does not form a layer is not supported by data for a single example. Applicant’s reproduction of Tables 5 and 2 at pages 9-11 is acknowledged. Applicant’s allegation at page 12 that the friction coefficient data are unexpected is unpersuasive because it is expected that a polyacrylamide coating will decrease friction as evidenced at least by McCabe and by Chauhan et al. (WO 2019/070979). Applicant is reminded that which is expected or unexpected can only be determined in comparison to the prior art in a manner commensurate in scope with that which is actually claimed. See MPEP 716.02. Applicant’s disagreement at page 13 that Applicant has not demonstrated anything unexpected within the meaning of MPEP 716.02 is unpersuasive.
With regard to arguments of January 14, Applicant at pages 12-13 introduces another allegation that Example 1 versus Comparative Example 3 establishes a critical distinction. This is unpersuasive because the claims are no longer drawn to a copolymer. Applicant’s allegation at page 13 that the claimed substituents are essential is unpersuasive because the data are limited to poly (N,N-diethylacrylamide) (e.g., Examples 2, 4, 6, 7, 9, 11, 13, 15) and the data (e.g., Table 2) appear to illustrate the effect of the substrate and the other process parameters. That the practice of different methods will result in different products having different properties is entirely expected.
With regard to arguments of January 15, Applicant’s statement that claim 3 is cancelled is acknowledged.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISSA PROSSER whose telephone number is (571)272-5164. The examiner can normally be reached M - Th, 10 am - 6 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, DAVID BLANCHARD can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALISSA PROSSER/Examiner, Art Unit 1619
/BENNETT M CELSA/Primary Examiner, Art Unit 1600