DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 20 2025 has been entered.
Receipt of Arguments/Remarks filed on October 20 2025 is acknowledged. Claim 2 and 4 were/stand cancelled. Claim 1 was amended. Claims 1, 3 and 5-10 are pending. Claims 6-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made with traverse in the reply filed on January 14 2025. Claims 1, 3, 5 and 9-10 are directed to the elected invention.
The examiner notes that the response filed October 20 2025 appears to withdraw claim 9, but claim 9 was previously examined and is examined herein.
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 .
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, 3, 5 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Turcu et al. (Nanomaterials, 2017) in view of Claret et al. (USPGPUB No. 20180147283) and Zhang (USPGPUB No. 20110046033).
Applicant Claims
The instant application claims a contact lens product having a cornea repair function, comprising a composition and a contact lens immersed in the composition, wherein the composition includes gold nanoparticles and alpha-lipoic acid, and, wherein the gold nanoparticles are present in an effective concentration from 0.01 ppm to 3000 ppm and have an average particle size from 0.01 nm to 100 nm, and the alpha-lipoic acid is present in an amount from 0.05 wt% to 3wt% based on the composition being 100 wt% and wherein the contact lens is configured to transfer the gold nanoparticles and the α-lipoic acid to an eye surface area for corneal tissue regeneration.
As claimed the composition has a pH from 6 to 8 and an osmotic pressure from 240 osmol/kg to 400 osmol/kg.
Claim 9 is interpreted as further limiting as the claim requires lipoic acid or dihydrolipoic acid bonded to the gold nanoparticles whereas claim 1 merely requires both to be present in the composition. Lipoic acid and dihydrolipoic acid are a redox pair with lipoic acid being the oxidized form and dihydrolipoic acid being the reduced form. Therefore, the recitation alpha-lipoic acid is interpreted as encompassing both the oxidized and reduced form.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
Turcu et al. is directed to lipoic acid gold nanoparticles functionalized with organic compounds as bioactive materials. Gold nanoparticles (Au NPs) are increasingly exploited for the design and development of novel nanomedicines due to their ease of synthesis, characterization and surface functionalization. Different studies demonstrate their antimicrobial properties with a large spectrum including gram-positive and gram-negative bacterial (page 1). Biomolecules bound on the surface of nanoparticles can simultaneously play several essential roles like preserving the size of the main core, acting as a stabilizing ligand and making further functionalization steps possible (page 2, second paragraph). One kind of chemical reaction is based on the affinity of gold for thiol groups. Lipoic acid (LA) is a disulfide that is a well-known antioxidant and it is reduced at intracellular levels into dihydrolipoic acid which as strong antioxidant properties. It is used in medicine in many diseases due to its antioxidant activity (page 2). LA Au NPs were obtained (section 2.2). Fully coated Au NPs with an average size of 16 nm were obtained which clearly show dihydrolipoic acid functionalized on the nanoparticles (section 3.1, figure 1). Table 1 shows the MIC of sample I which is the LA coated Au NPs. The gold nanoparticles were biocompatible at concentrations lower than 50 µg/mL (conclusions). Serial two-fold dilutions of compounds ranging between 1000 and 1.95 µg/mL performed in a 200 µL volume of broth (section 2.5).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.02)
Turcu et al. does not teach the use of the antioxidant Au NPs with a contact lens or specify the claimed pH and osmotic pressure or lipoic acid. However, these deficiencies are cured by Claret et al. and Zhang.
Claret et al. is directed to an ophthalmic composition comprising lipoic acid and a mucomimetic polymer. Claimed is a composition comprising a mucomimetic polymer and lipoic acid (claim 1). The amount of lipoic acid ranges from 0.01 to 0.02% by weight (claim 5). Lipoic acid is known for its antioxidant properties. Its antimicrobial properties have also been described for use in contact lens cleanings solution. A variety of patent application describe the use of ophthalmic or cosmetic composition comprising lipoic acid as antioxidant agent (paragraph 0003). The use of a buffer to stabilize the pH at an acceptable value is taught (paragraph 0030). The pH of the composition is between 6 and 7 (paragraph 0036). Sterile compositions are taught (paragraph 0037). Claret et al. directs the readers attention to US Patent No. 6162393 which teach the use of lipoic acid in contact lens cleaning solutions (paragraph 0003).
De Bruiju et al. is directed to contact lens and ophthalmic solutions. It is taught that natural plant compounds show antimicrobial and cleaning activity. It has been discovered that some of these anti-microbial compounds act in a synergistic or complementary manner with other anti-microbial compound and thus enhance their-antimicrobial actions. These natural plant compounds include lipoic acid (column 5, lines 22-38). These naturally occurring microbial compound is used in ophthalmic solutions at 10 to 10,000 parts per million (claim 13;43).
Zhang is directed to a multipurpose lens care solution with benefits to corneal epithelial barrier function. Multipurpose contact lens solutions (MPSs) are used in the cleaning and disinfection of contact lenses. MPSs consist of antimicrobial agent for disinfectant and preservative qualities, a surfactant, a chelator which may have antibiotic properties, wetting agents, and a buffering agent to maintain pH of the solution (paragraph 0005). The lens care solutions will typically have an osmolality in the range of at least about 200 mOsmol/kg for example, about 300 or about 350 to about 400 mOsmol/kg (paragraph 0065). The contact lens care solutions will very likely include a buffer system. By the terms “buffer” or “buffer system” is meant a compound that, usually in combination with at least one other compound, provides a buffering system in solution that exhibits buffering capacity, that is, the capacity to neutralize, within limits, either acids or bases (alkali) with relatively little or no change in the original pH. The buffer capacity is measured from a starting pH of 6 to 8, preferably from 7.4 to 8.4 (paragraph 0034-0035). MPSs can be used to clean and disinfect contact lenses. In general, the contact lens solutions can be used as a daily or every other day care regimen known in the art as a “no-rub” regimen. This procedure includes removing the contact lens from the eye, rinsing both sides of the lens with a few milliliters of solution and placing the lens in a lens storage case. The lens is then immersed in fresh solution for at least two hours (paragraph 0070).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Turcu et al., Claret et al., De Bruiju et al., and Zhang et al. and utilize the gold nanoparticles of Turcu et al. with lipoic acid in a multipurpose contact lens solution. One skilled in the art would have been motivated to utilize the combination of gold nanoparticles of Turcu et al. with lipoic acid in a multipurpose contact lens solution as these are known to contain antimicrobials and Turcu et al. and Claret et al. suggest the antimicrobial properties of the gold nanoparticles and lipoic acid. Since lipoic acid is known to be used in disinfecting solutions as taught by Claret et al. there is a reasonable expectation of success.
Regarding the claimed contact lens, Zhang teaches that a contact lens can be immersed in the cleaning and disinfecting solution.
Regarding the claimed “wherein the contact lens is configured to transfer the gold nanoparticles and the alpha-lipoic acid to an eye surface area for corneal tissue regeneration”, the instant specification teaches when the contact lens is immersed in the package solution beneficial ingredients in the package solution would enter the contact lens or adhere onto the contact lens. Therefore, when the contact lens is put on the eye of a person, the beneficial ingredients can be transferred to an eye surface area from the contact lens (paragraph 0046). This suggest that merely placing the contact lens in a solution that contains the gold nanoparticles and lipoic acid would necessarily result in transfer of some of the solution to the eye. Since immersion of a contact lens in the cleaning/disinfecting solution is obvious for the reasons et forth above, this would suggest that when the contact lens is transferred to the eye, it would necessarily transfer some of the gold nanoparticles and alpha-lipoic acid to an eye surface area.
Regarding the claimed concentration of lipoic acid and gold nanoparticles in claims 1 and 3, Turcu et al. teaches a total concentration of between 1.95 and 1000 µg/mL which corresponds to 1.95 and 1000 ppm (i.e. 0.0002 to 0.1%) for the gold/lipoic acid. Bruiju et al. teaches a concentration of 10 to 10,000 ppm which corresponds to 0.001 to 1 wt% which overlaps the instant claims. Furthermore, both the gold nanoparticles and the lipoic acid are taught as antimicrobial, therefore, one skilled in the art would manipulate the concentration in order to achieve the desired antimicrobial effect.
Regarding claim 5, Figure 1 of Turcu et al. shows OH on the surface.
Regarding the particle size of the gold nanoparticles in claims 1 and 3, Turcu et al. teaches 16 nm which falls within the scope claimed. Turcu et al. teaches solutions of the Au NPs.
Regarding claim 9, Turcu et al. teaches dihydrolipoic acid bonded thereon (figure 1).
Regarding claim 10, Claret et al. teaches a pH from 6-7 and Zhang teaches a pH of 6 to 8, preferably from 7.4 to 8.4. Zhang teaches the cleaning solution has an osmolality in the range of at least about 200 mOsmol/kg for example, about 300 or about 350 to about 400 mOsmol/kg. Therefore, when using lipoic acid and the gold nanoparticles of Turcu et al. in a cleaning and disinfecting solution one skilled in the art would have been motivated to utilize a pH from 6-8 and a osmolality in the range of at least about 200 mOsmol/kg as taught by Zhang.
Response to Arguments
Applicants’ arguments filed October 20 2025 have been fully considered but they are not persuasive.
Applicants argue that (1) Turcu does not provide any teaching or suggestion of combining alpha-lipoic acid with gold nanoparticles and is silent on transferring the combination to an eye surface. It is argued a person of ordinary skill in the art would not arrive at the subject matter as claimed.
Regarding Applicants first argument, firstly, the examiner cannot agree that Turcu does not teach the combination of alpha-lipoic acid with gold nanoparticles. The literal title of the reference is lipoic acid gold nanoparticles. Secondly, while Turcu does not teach the functionalized gold nanoparticles being transferred to an eye surface, the examiner cannot agree that this is not unobvious. Turcu et al. expressly states in the conclusions that the functionalized gold nanoparticles are novel antimicrobial agents. Therefore, it would have been obvious to utilize the combination in any composition wherein an antimicrobial agent(s) is desired. The secondary references, specifically Claret et al. and De Bruiju et al., suggest the use of antimicrobials in contact lens solutions. This provides the motivation to combine the teachings of the references and arrive at the claimed invention.
Applicants argue that (2) the concentration of alpha-lipoic acid in Claret does not overlap with the instant claims. Neither Claret nor Zhang provides any teaching or suggest that gold nanoparticles and alpha-lipoic acid are used in combination in a composition be transferred to an eye surface.
Regarding Applicants’ second argument, while Claret does not teach a concentration of lipoic acid falling within the claims as amended, Claret does direct the readers’ attention to De Bruiju et al. which clearly teaches an overlapping range. Furthermore, the gold and lipoic acid are taught as antimicrobial, one skilled in the art would manipulate the amount in order to achieve the desired antimicrobial effect. None of Applicants arguments establish the instantly claimed amount is unexpected or critical.
Regarding the transferring to an eye surface, as set forth in the rejection above, the instant specification teaches when the contact lens is immersed in the package solution beneficial ingredients in the package solution would enter the contact lens or adhere onto the contact lens. Therefore, when the contact lens is put on the eye of a person, the beneficial ingredients can be transferred to an eye surface area from the contact lens (paragraph 0046). This suggest that merely placing the contact lens in a solution that contains the gold nanoparticles and lipoic acid would necessarily result in transfer of some of the solution to the eye. Since immersion of a contact lens in the cleaning/disinfecting solution is obvious for the reasons set forth above, this would suggest that when the contact lens is transferred to the eye, it would necessarily transfer some of the gold nanoparticles and alpha-lipoic acid to an eye surface area.
Conclusion
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/ABIGAIL VANHORN/Primary Examiner, Art Unit 1636