DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2 April 2025.
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 1-6 and 8-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for “one of an organic carboxylic acid and a salt thereof into the disinfecting solution, the organic carboxylic acid having a structure in which a hydroxyl group and a carboxyl group are bonded to one carbon atom”, does not reasonably provide enablement for “one of an organic acid and a salt thereof” or “wherein the organic acid is a carboxylic acid.” The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims. The breadth of “organic acid” and “carboxylic acid” is much larger than the teaching in the specification of “the organic carboxylic acid having a structure in which a hydroxyl group and a carboxyl group are bonded to one carbon atom” and other acid compositions would likely be incompatible with a contact lens disinfecting solution as the solution must not cause irritation or damage to the eye when the treated contact lens is used. Thus, the nature of the invention and level of predictability of the art would not allow for many organic acids to acceptably. Additionally, the inventor has provided several specific working examples of compositions and has provided direction that only the organic carboxylic acid having a structure in which a hydroxyl group and a carboxyl group are bonded to one carbon atom are acceptable. Thus, the additional breadth of the scope of the limitations would require undue experimentation to make or use the invention based on the content of the disclosure as the compositions would require testing on living beings with the possibility of causing harm to the eye of the being.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-2, 4-5, 7-11 and 13 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Pickard (WO 86/05401).
In regard to claims 1, 5 and 7, Packard discloses a contact lens disinfecting solution formed by dissolving a solid composition with 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 an organic acid and a salt thereof (an acid such as citric or malic acid which are organic carboxylic acids; see lines 4-10 of page 6).
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 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.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 3 and 6 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pickard.
In regard to claims 3 and 6, 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.).
Claims 11-13 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pickard in view of Hong et al. (US 2004/0121924; hereinafter “Hong”).
In regard to claims 11-13, Pickard is 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.).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,427,488. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims encapsulates the scope of the patent claims. Additionally, the claims would not have been restricted if concurrently presented with the claims of the patent as the contact lens disinfecting solution is a subcomponent of the system. It would have been within the ambit of one of ordinary skill in the art to have determine the optimum or workable range of organic acid or salt thereof as recited in instant claims 3 and 6 without creating any new or unexpected results. It is noted that a nonionic tonicity agent as recited in instant claim 11 would be a well-known and obvious agent to use to create an osmotic pressure of the range recited by the patented claim 1.
Claims 1-8, 11 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-3, 8, 10 and 12 of U.S. Patent No. 10,137,218. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims encapsulates the scope of the patent claims as the limitations of the instant claims are present within the patented claims. Additionally, the claims would not have been restricted if concurrently presented with the claims of the patent as the contact lens disinfecting solution is a subcomponent of the system.
Claims 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-9, 11 and 13 of U.S. Patent No. 11,331,404. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims encapsulates the scope of the patent claims as the limitations of the instant claims are present within the patented claims. Additionally, the claims would not have been restricted if concurrently presented with the claims of the patent as the contact lens disinfecting solution is a subcomponent of the system. It would have been within the ambit of one of ordinary skill in the art to have determine the optimum or workable range of chelating agent as recited in instant claim 10 without creating any new or unexpected results.
Claims 1-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 and 18 of U.S. Patent No. 12,042,567. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims encapsulates the scope of the patent claims as the limitations of the instant claims are present within the patented claims. Additionally, the claims would not have been restricted if concurrently presented with the claims of the patent as the contact lens disinfecting solution is a subcomponent of the system.
Conclusion
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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/TIMOTHY C CLEVELAND/Primary Examiner, Art Unit 1774