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
Applicant’s Request for Reconsideration dated July 21, 2026 is acknowledged.
Claims 1, 5-11, 13 and 14 are pending.
Claims 2-4 and 12 are cancelled.
Claim 1 is currently amended.
Claims 6 and 8-11 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions, there being no allowable generic or linking claim.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 July 21, 2026 are pending and under consideration to the extent of the elected species, e.g., the species of substrate is “stenfilcon”. In view of the amendment of the claims, a polymer of N,N-diethyl acrylamide is rejoined.
This action is made FINAL.
Withdrawn Objections / Rejections
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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Maintained Grounds of Rejection: 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, of record); Tamiya et al. (US 2015/0274854, published October 1, 2015, of record); and Chauhan et al. (WO 2019/070979, published April 11, 2019, of record).
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 evidenced 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 polymer consisting of poly(N,N-diethylacrylamide, 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 (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 have been fully considered but they are not persuasive.
Applicant argues at page 6 of the Remarks that the newly cited references are improperly combined with McCabe.
At pages 6-7 Applicant argues Vanderbilt is directed to two different polymers, argues Vanderbilt does not disclose poly(N,N-diethylacrylamide), and appears to argue removing one of the polymers of Vanderbilt would change the principle of operation of Vanderbilt.
This is unpersuasive because the claims do not stand rejected over Vanderbilt. That is, Vanderbilt is being used to modify McCabe. McCabe discloses a process as instantly claimed, the process of McCabe comprising inter alia “treating a polymerized ophthalmic lens with a wetting agent” selected from the group inclusive of polyacrylamides (e.g., claims 1, 8). Therefore, McCabe is in possession of methods comprising one polymer selected from the genus of polyacrylamides. In response to applicant's arguments against the references individually, 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).
Applicant at pages 7-8 argues poly(N,N-diethylacrylamide) has high adsorption power.
This is unpersuasive because adsorption power is merely an intrinsic physical property. See for example Shibai et al. (WO 2017/104520, as evidenced by US 2020/0263055) at paragraph [0007]:
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In view of Shibai, it is expected that amide polymers inclusive of those comprising N,N-diethylacrylamide (e.g., Shibai, claim 10) have “high hydrogen-bonding strength” and thus “high adhesion” to surfaces. Furthermore, because McCabe is in possession of methods comprising one polymer selected from the genus of polyacrylamides, McCabe is in possession of methods which result in high adsorption power.
At pages 8-9 Applicant argues Tamiya is directed to contact lens materials comprising silicone acrylamide polymers. Applicant concludes Tamiya is not directed to methods as instantly claimed and cites to case law for the proposition that there is no reason to consider Tamiya. Applicant further argues the disclosure of the poly-N,N-diethyl acrylamide wetting agent of Tamiya is one option among twenty candidates, none of which are used in any working examples. Applicant concludes the Examiner has not considered the references as a whole.
This is unpersuasive because the narrative of the rejection acknowledges Tamiya to disclose “silicone acrylamide copolymers suitable for ophthalmic lenses such as a contact lens”. Tamiya is relied upon in the rejection for the disclosure of art-recognized wetting agents for contact lenses because McCabe is in possession of methods comprising one polymer selected from the genus of polyacrylamides, the one polymer being a wetting agent. Of the twenty or so wetting agent candidates claimed by Tamiya, only three appear to fall within the genus of polyacrylamides. Selection of a known material from a list is presumptively obvious. See MPEP 2144.07.
At pages 9-11 Applicant argues Chauhan discloses both covalent and non-covalent interactions and argues Chauhan discloses polyacrylamide. Applicant concludes polyacrylamide is not poly(N,N-diethylacrylamide) and cites to the data within the instant specification and in particular to Comparative Example 2.
This is unpersuasive because it is understood that the usage of polyacrylamide by Chauhan encompasses a genus (e.g., abstract). The genus of polyacrylamides embraced by Chauhan encompasses N,N-dialkylacrylamides inclusive of N,N-diethyl-acrylamide (e.g. paragraph [0100]). This is important because Tamiya is relied upon for the disclosure that poly-N,N-diethyl acrylamide is a wetting agent and McCabe teaches methods of physically treating ophthalmic lenses with wetting agents under heat to improve comfort (e.g., title). Therefore, the Examiner maintains the combined teachings of the prior art render obvious methods as instantly claimed.
The data within the instant specification have already been considered and addressed on the written, public record. That different polymers can be characterized by different properties is not per se unexpected. See generally MPEP 716.02 for information regarding allegations of unexpected results. To be of any probative value, any secondary evidence must be related to the claimed invention. See MPEP 716.01(b). McCabe is already in possession of methods comprising the sole active method step as instantly claimed, the method employing one polymer selected from the genus of polyacrylamides. Applicant’s data do not outweigh the disclosure of McCabe because the entire point of McCabe that the wetting polymer “treats” the ophthalmic lens during heating thereby improving lens comfort upon use. See MPEP 716.01(d). Applicant’s position that different acrylamides are not identical is unpersuasive because it is expected that different polymers will have different properties. See, e.g., Zhang et al. “Study of polydimethylacrylamide- and polydiethylacrylamide-adsorbed coatings on fused silica capillaries and their application to genetic analysis,” Analytica Chimica Acta 507:179-184, 2004. Zhang evidence for a given surface two different acrylamides yield different properties. The issue is whether practice of the instantly claimed method with poly(N,N-diethylacrylamide) is drawn to a different invention that is non-obvious over McCabe in view of the prior art. The totality of evidence of record suggests it is not.
At pages 11 Applicant argues each applied reference has its own deficiencies and concludes a POSA would not modify McCabe by going against Vanderbilt or/and Tamiya.
This is not found persuasive because there is no need to “go against” either Vanderbilt or Tamiya in order to render obvious variants of the method of McCabe.
At pages 11-13 Applicant cites to the data within the instant specification in support of an allegation of unexpected results.
The data within the instant specification have already been considered and addressed on the written, public record. That different polymers can be characterized by different properties is not unexpected. See generally MPEP 716.02 for information regarding allegations of unexpected results. Applicant’s citation to the exemplary PVP wetting agent of McCabe remains unpersuasive for reasons of record. The exemplary process of McCabe remains identical to the exemplary processes within the instant specification. Specifically, McCabe selects a contact lens, selects a wetting polymer and amount thereof and sterilizes at 121 ºC for 30 minutes (e.g., Example 1). In Example 1 of the instant specification, Applicant selects a contact lens, selects a polymer and amount thereof and sterilizes in an autoclave at 121 ºC for 30 minutes (e.g., paragraph [0135]). The evidence of record demonstrates that the instant process as exemplified is drawn to an obvious variant of the method of McCabe.
Therefore, the rejection over McCabe is properly maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zhang et al. “Study of polydimethylacrylamide- and polydiethylacrylamide-adsorbed coatings on fused silica capillaries and their application to genetic analysis,” Analytica Chimica Acta 507:179-184, 2004
Shibai et al. (WO 2017/104520, published June 22, 2017, as evidenced by US 2020/0263055) teaches polymer layers comprising polymers comprising an amide group inclusive of N,N-diethylacrylamide; the polymers have high hydrogen bonding strength and thus exhibit high adhesion to a substrate and since amide groups (amide bonds) have high cohesion therebetween, the surface of the polymer layer was found to be less likely to have scratch marks even when rubbed with a hard product such as steel wool (title; abstract; claims, in particular 1, 10; paragraphs [0007], [0016], [0037], [0054]).
THIS ACTION IS MADE FINAL. 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 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
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