DETAILED ACTION
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/03/2024 and 10/23/2024 has been considered by the examiner.
Preliminary Amendment
Preliminary Amendment that was filed on 09/03/2024 is entered.
Claim Objections
Claims 1 and 7 are objected to because of the following informalities: the term “a degree 1, 2 and 3” should read “a degree of change 1, 2 and 3” for clarity.
Appropriate correction is required.
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 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 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.
Claims 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over NG et al. (US PUB 2015/0272439; herein after “NG”) in view of Cohen-Tannoudji et al. (US PUB 2014/0320806; herein after “Cohen”).
NG and Cohen disclose the measure the relative light characteristics of the at least two light beams. Therefore, they are analogous art.
Regarding claim 1, NG teaches a method of determining characteristics of light (see Abstract, para. [0070]), comprising: a relationship acquisition step of, with respect to a subject (a patient, para. [0016]… subject's eye, para. [0081], FIG. 3), obtaining in advance a relationship 1 between a wavelength and irradiance (incidence) of light that decides whether or not a morphological change of an ocular cell (i.e., an ocular structure of interest, para. [0071]) is caused and a relationship 2 between the wavelength and irradiance of the light that decides whether or not migration of the ocular cell is changed (i.e., an ocular structure of interest may depend to some extent on the directional changes which light employed by the measurement technique undergoes while passing through any ocular structures preceding the structure of interest, para. [0071] and … refractive indices are functions of wavelengths, a dispersion curve is used to calculate the change in refractive index given a specific wavelength of source light rays used, para. [0117], also see para. [0023], [0024], [0077] and [0078]); a relationship selection step of selecting at least any of the relationship 1 and the relationship 2 depending on a degree 1 (a degree of polarization, para. [0041]) that is required for the morphological change (para. [0041]) and a degree 2 that is required for the cell migration (i.e., a software includes a) Correction of optical distortions from preceding surfaces b) recovery of refractive index from dispersion curve of ocular tissue (cell) using another optical measurement of another wavelength or by resolving the discrepancy in curvature or distance when compared to another optical measurement of similar wavelength, para. [0149], also see para. [0018] and [0031]; and a determination step of determining a wavelength and irradiance of light to be incident on the subject's eye based on the selected relationship (i.e., As refractive indices are functions of wavelengths, a dispersion curve is used to calculate the change in refractive index given a specific wavelength of source light rays used, para. [0117], also see para [0039], [0074] to [0077] and [0149]).
NG teaches all limitations except for explicit teaching of a wavelength and irradiance of light that decides whether or not a morphological and migration change of an ocular cell.
However, in a related field of endeavor Cohen teaches a filter "selectively inhibits" a range of wavelengths if it inhibits at least some transmission of wavelengths within the range, while having little or no effect on the transmission of visible wavelengths outside the range, unless specifically configured to do so, para. [0063].
Indeed, the phototoxicity on RPE cells using a primary cell model of AMD, Stargardt disease, retinitis pigmentosa, Best's disease, it was discovered by the inventors that light was toxic to RPE cells at wavelengths of visible light centered at around 435 nm. In experimental studies, toxicity to RPE cells was demonstrated for 10 nm bandwidths of light stretching from 415 nm to 455 nm, para. [0025].
Therefore, 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 device of NG such that the phototoxicity on RPE cells using a primary cell model of AMD, where a range of wavelengths if it inhibits at least some transmission of wavelengths within the range, while having little or no effect on the transmission of visible wavelengths outside the range (e.g., wavelength and irradiance of light for change of an ocular cell) as taught by Cohen, thereby having a reduced effect of visual color distortion and improved scotopic vision.
Regarding claim 6, NG fails to teach the ocular cell is a lens epithelial cell, a cell retinal pigment epithelial cell, a corneal endothelial cell, a corneal epithelial stem cell, or a subconjunctival fibroblast.
However, in a related field of endeavor Cohen teaches the influence of light in retinal pigment epithelium (RPE), para. [0104].
Therefore, 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 device of NG such that the ocular cell is a lens epithelial cell, a cell retinal pigment epithelial cell etc. as taught by Cohen, thereby improve scotopic vision.
Allowable Subject Matter
Claims 2-5 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 2, the prior art does not teach, or renders obvious, regarding the relationship 1 is a plot 1 that decides whether or not a morphological change of the ocular cell is caused in a relation between the wavelength and irradiance of the light, and the relationship 2 is a plot 2 that decides whether or not the migration of the ocular cell is changed in the relation between the wavelength and irradiance of the light.
Claims 3-5 depend upon allowable claim 2.
Allowable Subject Matter
Claims 7-15 are allowed.
The following is an examiner's statement of reasons for allowance: The prior art taken either singularly or in a combination fails to anticipate or fairly suggest the limitations of the independent claims, in such a manner that rejection under 35 U.S.C. 102 or 103 would be proper. The prior art fails to teach a combination of all the claimed features as presented in independent claim 7, for example a method of determining characteristics of light, where a relationship selection step of selecting at least any of the relationship 1, the relationship 2, and the relationship 3 depending on at least any of a degree 1 that is required for the morphological change, a degree 2 that is required for the cell migration, and a degree 3 that is required for the invasion; and a determination step of determining a wavelength and irradiance of light that is to be incident on the subject's eyes based on the selected relationship.
Claims 8-15 depend upon allowable claim 7.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance”.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Tedford et al. (US PUB 2016/006708) teaches “An ophthalmic phototherapy device and associated treatment methods to expose an eye to selected multi-wavelengths of light to promote the healing of damaged or diseased eye tissue.”, see Abstract.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MUSTAK CHOUDHURY whose telephone number is (571)272-5247. The examiner can normally be reached on M-F 8AM-5PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ricky Mack can be reached on (571)272-2333. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MUSTAK CHOUDHURY/Primary Examiner, Art Unit 2872
June 9, 2026
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