DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
In light of the amendment filed 23 October 2025, the rejection under §112(a) has been withdrawn and the prior art rejection has been modified.
Terminal Disclaimer
The terminal disclaimer filed 23 October 2025 was approved on 27 October 2025. Therefore, the double patenting rejection has been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6 and 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regard to claims 6 and 23, the specification as originally presented does not contain explicit support for the limitation of wherein the at least one of a carboxylic acid and a salt thereof is present in an amount of “0.1 to 1 wt%” and “from 0.45 wt.% to 5 wt.%.” At best, the specification teaches that the at least one of a carboxylic acid and a salt thereof is present in an amount of from 0.1 wt.% to 5 wt.%. See [0029].
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 4, 6-11, 13, 21 and 23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pickard (WO 86/05401) in view of Sakanishi et al. (WO 2004037302 with reliance upon English-language machine translation; hereinafter “Sakanishi”).
In regard to claims 1, 7 and 21, Packard discloses a contact lens disinfecting solution formed by dissolving a solid composition with a main component of tap water comprising: hydrogen peroxide (formed in the created solution from a precursor; see lines 4-31 of page 4) and at least one of a carboxylic acid and a salt thereof (an acid such as citric or malic acid which are organic carboxylic acids of the recited composition; see lines 4-10 of page 6) which comprises a hydroxyl group and a carboxyl group that are bonded to one carbon atom.
Pickard does not explicitly disclose wherein water is provided as purified or distilled water as Pickard teaches that tap water is used.
Sakanishi discloses a contact lens disinfecting solution which uses a hydrogen peroxide based composition. Sakanishi discloses that the solution is aqueous with tap water, purified water and distilled water being acceptable forms of water as a main component of the solution. See page 5 of the machine translation.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have substituted the purified or distilled water as disclosed by Sakanishi for the tap water of Pickard without creating any new or unexpected results as providing distilled or purified water instead of tap water would produce predictable results of forming a contact lens disinfecting solution. The prior art can be modified or combined to reject claims as prima facie obvious as long as there is a reasonable expectation of success. See In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (see MPEP § 2143.02).
In regard to claim 2, Packard discloses wherein the contact lens disinfecting solution has a pH of from 6 to 8 (5.5 to 8.0 or 6.0 to 7.5). See lines 4-7 of page 6.
In regard to claims 4 and 8, Packard discloses that the hydrogen peroxide is present in the created disinfecting solution at a concentration of 0.5 to 3.0%, 0.5% to 1.5%, or about 6% which significantly overlaps with and anticipates the claimed ranges of 1 to 10 and 2 to 6 wt%. See lines 15-19 of page 4.
In regard to claims 3, 6 and 23, Pickard is silent in regard to the concentration at which the organic acid is present in the solution. It is noted that Pickard discloses that the acid is provided to provide the solution with a pH in the range of especially 6.0 to 7.5 which is wholly encapsulated by the preferred range of 6 to 8 of the instantly disclosed invention. It is further noted that the instant disclosure does not provide criticality of the claimed range of concentrations. Therefore, it would have been within the ambit of one of ordinary skill in the art before the effective filing date of the claimed invention to have determined the optimum or workable range of the concentration of the organic acid in the contact lens disinfecting solution by routine experimentation and without producing any new or unexpected results as the solutions are provided in the same range of pH levels. “[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.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
In regard to claim 9, Packard discloses that the solution can contain at least one chelating (“sequestering”) agent such as EDTA or a salt thereof (“ethylene-diamine tetraacetic acid and its salts”). See lines 11-15 of page 5.
In regard to claim 10, Packard discloses wherein the chelating agent is present in the contact lens disinfecting solution at a concentration in the range of from 0.01 to 0.5 wt.% as it is disclosed that 0.01 to 0.1 g can be added to 10 mL of tap water which would produce a weight percentage of 0.01 to 0.1. See lines 16-19 of page 5.
In regard to claims 11 and 13, Packard discloses wherein the solution further comprises a surfactant such as polyethylene glycol ethers of higher alcohols (polyethylene glycol monocetyl ethers). See lines 11-27 of page 6.
Claims 11-13 and 22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pickard in view of Sakanishi and Hong et al. (US 2004/0121924; hereinafter “Hong”).
In regard to claims 11-13, Pickard and Sakanishi are silent in regard to a nonionic tonicity agent and wherein the surfactant can be polyethylene glycol esters of fatty acids, poloxamers or poloxamines.
Hong discloses a contact lens care solution which can disinfect a contact lens using hydrogen peroxide ([0048]) which includes tonicity adjusting agents, such as the nonionic agents of glycerol or saccharides (sorbitol or mannitol), and surfactants such as polyethylene glycol ethers of fatty acids (which would inherently include higher fatty acids), poloxamines or poloxamers. See [0043] and [0047].
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have substituted the tonicity agent compositions and/or surfactant component compositions of Hong for the respective component compositions in Pickard without creating any new or unexpected results. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
In regard to claim 22, Pickard and Sakanishi are silent in regard to an alkaline pH adjusting agent. Pickard does disclose wherein a buffer can be included so that the resultant solution has the required pH. See page 6, lines 8-10.
Hong discloses examples of suitable buffering agents which may be incorporated into the composition. Hong teaches that the buffering agents can be alkaline metal salts, such as potassium or sodium carbonates, or sodium hydroxide. See [0046]. It is noted that the instant specification discloses sodium hydroxide as an example of an alkaline agent in [0030].
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have used the alkaline buffering agents of Hong as the buffer in the composition of Pickard as one of ordinary skill in the art would have been motivated to have looked to the prior art in order to determine appropriate buffer compositions.
Response to Arguments
Applicant's arguments filed 23 October 2025 have been fully considered but they are not persuasive.
Applicant argues that it would not have been obvious to have used Pickard’s composition with purified or distilled water as it would change the principal of operation of the reference. Applicant further argues that the carboxylic acid component of Pickard is added to lower the pH of tap water to within a desired range and there would have been no reason to include the carboxylic acid component in the event that the dissolving solution is purified or distilled water. The Examiner respectfully disagrees. The Examiner contends that it still would have been obvious to one of ordinary skill in the art to have used purified or distilled water with the composition of Pickard as such forms of water would still work to form the desired contact solution as evidenced by the disclosure of Sakanishi. The additional components present in the composition of Pickard would not adversely react with purified or distilled water, but they merely function to further enable tap water to be used in addition to purified or distilled water. In regard to the argument that the carboxylic acid is used to lower the pH of the tap water to a desired pH and “there would have been no reason to include this carboxylic acid component in the event that the dissolving solution is purified or distilled water,” the Examiner respectfully disagrees with the argument. It is noted that Pickard explicitly discloses that the “composition may contain other components conventionally present in disinfection solutions” such as “an acid (to adjust the pH)” wherein the acid is the aforementioned carboxylic acid. See page 5, line 33 through page 6 line 10 of Pickard. Therefore, it is clearly indicated by Pickard that the carboxylic acid is “conventionally used” and not a component which is merely added to account for the use of tap water.
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 TIMOTHY C CLEVELAND whose telephone number is (571)270-5041. The examiner can normally be reached M-F 9:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Claire Wang can be reached on (571) 270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY C CLEVELAND/Primary Examiner, Art Unit 1774
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