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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The intended result of increasing expression of at least one gene selected from the listed group fails to provide a clear-cut indication of the scope of the subject matter. It appears to merely recite the problem to be solved, without reciting the actual steps necessary to bring about such an outcome (see MPEP 2173.05(g)). If the desired feature does not result from the steps already disclosed in claim 1, then the steps necessary to bring about such an outcome must be recited. If the desired result is considered inherent with practice of the method set forth in claim 1, then the claim fails to further limit claim 1.
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 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Dilmanian (Pub. No. 2020/0276457).
Regarding claim 1, see at least the abstract.
Regarding claims 2 and 3, see par. 0081.
Claim(s) 1-10, 12, 14, 17, 19, 21 and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Johnson et al. (Johnson: Pub. No. 2021/0308482).
Regarding claim 1, Johnson discloses a method for treating and/or preventing a disorder in a subject in need thereof, comprising: irradiating light of a specific wavelength to the subject (see abstract), wherein the disorder is selected from the group consisting of demyelination disorder, neuro-degenerative disorder, tumor, central neurological disorder, and a symptom associated with myelinogenesis (see, for example, title of invention, par. 0003, claim 3, etc.).
Related comments apply to claims 2, 3 and 10, wherein the treatment and prevention of demyelination diseases by irradiating light of a specific wavelength to the subject by a light irradiating apparatus, results in promotion of regeneration or an increase in myelin, given that Johnson includes wavelengths associated with violet light to treat demyelination.
Regarding claim 4, see par. 0006 (continuous or pulsed/blinking mode). A controller is inherently required to enact said modes (see par. 0007).
Regarding claim 5, see abstract, par. 0003, etc.
Regarding claims 6-9, further limitations on the various optional disorders listed in claim 1 fail to distinguish over the Johnson reference which includes at least one of the viable options listed in claim 1. Johnson therefore reads on claims 6-9 as the claims are not limited to only the particular disorder recited in the claim.
Regarding claim 12, see par. 0005.
Regarding claim 14, the recited wavelength of 400 nm includes violet light (violet light ranging from 380 to 450 nm).
Regarding claims 17 and 19, as indicated above, Johnson includes continuous (i.e., 0 Hz blinking rate) or pulsed frequencies.
Regarding claim 21, Johnson discloses that a light source may be installed nearby or in front of the eye/face (see abstract).
Regarding claim 22, see par. 0036.
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.
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.
Claim(s) 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Malchano et al. (Malchano: Pub. No. 2023/0111776).
Regarding claim 13, note the rejection of said claim under §112 above. While Johnson does not explicitly refer to increasing gene expression of at least one gene selected from the recited group, such increase in gene expression would be inherent in any method of irradiating light of a specific wavelength effective to treat one of the disorders listed in claim 1, where the irradiating light falls within the violet light range. While Johnson does not explicitly disclose the recited range or a particular wavelength within the recited range in the violet light spectrum. Malchano, however, discloses a related device also suitable for treating or preventing neurological disorders including neuro-degenerative disorder and demyelination (see pars. 0010, 0013, 0082), wherein the treatment may include violet light in the 380 to 450 nm wavelength (par. 0205). Given that it is known to use such light in the treatment of neurological degenerative disorders, and given the limited number of wavelength bands suitable for human application, those of ordinary skill in the art would have considered the exact wavelengths employed to be a matter of routine clinical experimentation, dependent upon the individual patient’s condition. As stated, such a method would result in an inherent increase in the expression of at least one of the listed genes in an area of the CNS.
Regarding claim 14, while the examiner considers Johnson to disclose the use of violet light (400 nm wavelength), out of an abundance of caution, the examiner includes rejection under §103. As already argued above, Malchano discloses a related method wherein violet light is specifically stated as suitable to treating and preventing neurological disorders. The use violet light would have been considered a matter of obvious design for the same reasons presented in the previous paragraph.
Regarding the limitations of claims 15 and 16, note the comments above in the discussion of claim 13. Concerning specific use of the 380 nm wavelength, again as stated above, treatment with violet light in the 380 to 450 nm band is known in the art. The applicant gives no criticality to a wavelength of 380 nm, merely expressing a variety of wavelength options in an exemplary manner (see par. 0037). The exact wavelength used would have thus been considered a matter of routine experimentation and user prerogative.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Johnson.
Regarding claim 20, Johnson discloses that a controller may be used to provide the necessary dosage of light (par. 0007), at a dosage/irradiation time of between 30 seconds and 5 minutes (par. 0042). While it is not explicitly stated that the controller controls the time of application per se, the use of controllers to control dosage times in medical devices is old and well-known. Such a feature allows for precise, predictable, controlled treatment times, without needing to rely upon human intervention, thus avoiding potentially inconsistent application or excessive and/or ineffective treatment resulting from human error. Lacking any criticality, automation of previously manual activity has further been considered by the courts to constitute a matter of obvious design (see MPEP 2144.04).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Shanks discloses a light therapy device and method employing visible light from 400-760 nm.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNEDY SCHAETZLE whose telephone number is (571)272-4954. The examiner can normally be reached 2nd Monday of the biweek and W-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E. Hamaoui can be reached at 571 270 5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
August 17, 2026
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