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
Claims 1-7 are currently pending and the claims filed on 05/12/2026 are acknowledged.
Election/Restriction
Applicant's election without traverse of Group I, claims 1-7 in the Reply filed on May 12, 2026 is acknowledged. Therefore, claims 1-7 are examined on the merits to which the following grounds of rejections are applicable.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/10/2023 was filed before the mailing date of the instant first action on the merits. The submission thereof is in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statement has been considered by the examiner, and signed and initialed copy is enclosed herewith.
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 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, 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 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 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Winterton (TW201138866, IDS of 11/10/2023, citation is obtained from its corresponding US2011/0217202A1) in view of Hung et al. “Recent advances in photodynamic therapy against fungal keratitis”, Pharmaceutics, 2021-11-26, pp. 1-21 (IDS of 11/10/2023).
Applicant claims the below claim 1 filed on 05/12/2026:
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For examination purpose, the limitation of “after the contact lens is exposed to white light for 0.01 hour to 16 hours, the photoactive solution continuously released by the contact lens produces singlet oxygen and reactive oxygen species, thereby inhibiting growth and activity of fungi” of instant claim 1 is an intended use/effect, and that is, such features are not structural limitations and but rather a natural result obtained from when the claimed contact lens having a photoactive solution is worn, and in addition, claims 4-5 further defining such features would also be non-structural limitations. Please note that the patentability of composition claims depends on the claimed structure, not on the use or purpose of that structure." Catalina Mktg. Int'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002), and thus, "recitation of a new intended use for an old product does not make a claim to that old product patentable." In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1977).
Consequently, when the prior art teaches the same contact lens comprising a contact lens and a photoactive solution as claimed, such intended use/effects would be implicit.
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02); and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Winterton discloses a lens care unit comprising a contact lens made of hydrogel or silicone hydrogel (e.g., [0014], [0016]-[0017]) which reads on the claimed contact lens material; a lens care solution containing a singlet oxygen generating agent capable of generating singlet oxygen under UV/visible light irradiation and including photosensitizer of Toluidine Blue O (TBO), Rose Bengal (RB), etc. for disinfecting the contact lenses (e.g., [0019], [0021], [0075] and claim 18 of prior art) which reads on the claimed rose bengal, wherein the term “disinfect” means the rendering non-viable of substantially all pathogenic microbes that are in vegetative state including germs such as fungi and bacterial (e.g., [0015]); the lens care solution further comprises microbicide in a concentration sufficient to effect the desired disinfection of a contact lens including hydrogen peroxide in an amount of 0.03% that is within the claimed range of 0.01 to 1.0% (e.g., [0058]. [0062], and the Examples including Table 4). MPEP2144.05 states that [I]n the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); the lens care solution further comprises buffering agent selected from tris buffer, phosphate-buffer (e.g., PBS), etc. (e.g., Example 1 and claim 7 of prior art) which reads on the claimed buffer solution; the lens care solution further comprises hydrophilic polymer polyvinylalcohol (PVA), etc. (e.g., [0043] and claim 8 of prior art) that reads on the claimed stabilizer; and the lens care unit does not require antifungal agent (see e.g., entire document) (instant claims 1 (in part), and claims 2-5); and the lens care unit is effective to disinfect contact lenses against a wide range of microorganisms including Fusarium solani, Candida albicans, etc. (e.g., [0068]) which reads on the claimed drug-resistant fungi as supported by the instant publication at [0036] (instant claims 6-7).
Winterton discloses the amount of photosensitizer TBO (250microgram/ml = 0.025%) (e.g., [0083]), and however, Winterton does not expressly teach the amount of RB of instant claim 1. The deficiency is cured by Huang.
Huang discloses photodynamic therapy (PDT) against fungal keratitis (abstract) using 0.1% Rose Bengal (RB) as a photosensitizer which is within the claimed rage of 0.01 to 1.0% (e.g., first para. and Table 2 on page 8) in which activation with green light has shown 72% success rate in infectious keratitis (IK) patients (the last third para. on page 2) and Table 2 discloses 0.1% RB is effective to treat Fusarium Spp. under green light LED (518 nm, 0.9J/cm2 to 1.8J/cm2) (instant claim 1 – amount of RB). MPEP2144.05 as noted above.
It would have been obvious to modify the teachings of Winterton with 0.1% RB under green light irradiation of Huang in order to enhance therapeutic effects against fungal infection as taught by Huang.
In addition, as noted above, the limitations of intended use/effects are natural results when the contact lens having a photoactive solution is worn since the applied art in combination achieves the claimed contact lens. That is, The claimed features are a natural result of the combination of elements. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008). (inherency is limited when applied to obviousness and is present only when the limitation at issue is the “natural result” of the combination of prior art elements; quoting In re Oelrich, 666 F.2d 578, 581 (CCPA 1981)). See also MPEP 2112. Persion Pharms. LLC v. Alvogen Malta Operations LTD., 945 F.3d 1184, 1191, 2019 USPQ2d 494084 (Fed. Cir. 2019), “where the court stated that a proper finding of inherency does not require that all limitations are taught in a single reference, and that inherency may meet a missing claim limitation when the limitation is “the natural result of the combination of prior art elements.” The court found that pharmacokinetic limitations of the asserted claims were inherently met by combining prior art references because the limitations were necessarily present in the prior art combination.
In light of the foregoing, instant claims 1-7 are obvious over Winterton in view of Huang.
In the alternative, even if the limitations of intended use/effects of instant claim 1 and white light elements of instant claims 4-5 are considered, the following references teach them.
Regarding claims 1-3 and 5-7, the limitations of claims 1-3 and 6-7 were taught by Winterton in view of Huang as noted above.
Winterton further discloses the lens care unit further comprises a light irradiation source for irradiating the singlet oxygen-generating agent for a period of time sufficient to produce a sufficient amount of singlet oxygen in the lens care solution to disinfect the contact lens (e.g., abstract, [0008], [0013]) wherein the time period can range from about 5 minutes and about 6 hours (e.g., [0020]) that is within the claimed range of 0.01 hour to 16 hours. MPEP2144.05 as noted above (instant claim 1 – intended use limitation).
However, Winterton does not expressly teach the light dose of instant claim 5. The deficiency is cured by Huang.
Huang discloses photodynamic therapy (PDT) against fungal keratitis (abstract) using 0.1% Rose Bengal (RB) as a photosensitizer (e.g., first para. and Table 2 on page 8) in which activation with green light has shown 72% success rate in infectious keratitis (IK) patients (the last third para. on page 2) and Table 2 discloses that 0.1% RB that is within the claimed range of 0.01 to 1.0% is effective to treat Fusarium Spp. under green light LED (518 nm, 0.9J/cm2 to 1.8J/cm2) which is within the claimed range of 0.01 J/cm2 to 200J/cm2 and a wavelength 495-570 nm of the green light (instant claim 5). MPEP2144.05 as noted above.
It would have been obvious to modify the teachings of Winterton with white light condition of Huang in order to enhance the inhibition of growth and activity of fungi under relatively low green light dose as taught by Huang.
Regarding instant claim 4, claim 4 is rejected by Winterton in view of Huang and further in view of Kim et al., “In Vitro Bactericidal Effects of 625, 525, and 425nm Wavelength (Red, Green, and Blue) Light-Emitting Diode Irradiation”, Photomedicine and Laser Surgery, vol. 31, no. 11, 2013, pp. 554-562.
Winterton in view of Huang does not expressly teach the light intensity of instant claim 4. The deficiency is cured by Kim.
Kim discloses green LED peak at 525 nm (spectra width 520-530nm) at power density of 6mW/cm2 which is within the claimed range of greater than or equal to 0.1mW/cm2 significantly reduced microbial viability (see abstract, 555, 557, and relevant Figs. 1-6) (instant claim 4).
It would have been obvious to modify the teachings of Winterton/Huang with light intensity of Kim in order to provide a proper microbicidal light intensity of green light source as taught by Kim.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Conclusion
All examined claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/ Primary Examiner, Art Unit 1613
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