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 .
Response to Arguments
Regarding the 112b rejection of claim 8, applicant’s amendments have rendered this rejection moot and it is hereby withdrawn.
Regarding the 101 rejection of claims 6 and 8, applicant’s amendments have rendered this rejection moot and it is hereby withdrawn.
Regarding the 102 rejection of claims 6-8, applicant’s amendments and related arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding Tsubota, it is emphasized that the reference teaches the claimed power density (see at least Pars 0047, Example 5, Tables 1 and 2), but is silent to the specific “duration of one to five hours per day for at least two weeks”. However, Tsubota recognizes that the duration of exposure can be longer or shorter; “When a person is exposed to light for a long period of time for the purpose of myopia prevention, the irradiance relates to exposure time as well, and may be increased if the time is short, but is preferably decreased if the time is long” (Par 0047). The examiner considers this optimization of a result effective variable; MPEP 2144.05. It is emphasized that applicant’s themselves have no criticality or unexpected results for this duration (“For humans, however, as long as there is no interference with normal daily life, the time is not particularly limited and examples include several hours per day (one to five hours, for example). A duration may range from a few weeks (two to eight weeks, for example) to a few months (two to six months, for example)” Par 0021 of applicant’s specification.). Therefore, while Tsubota fails to anticipate the newly claimed amendments, the examiner contends that the reference renders obvious the claim language; see new 103 below.
To emphasize the examiner’s position, the examiner has found a new prior art reference (US 2016/0067087 to Tedford et al.) that clearly establishes the duration and frequency of ophthalmic light therapy as a result effective variable; “The treatment can be repeated multiple times per day or multiple times per week. The length of treatment time and frequency of treatment periods can depend on several factors, including the functional recovery of the subject and the results of imaging analysis of the injury, the disease or condition being treated, the use of pulsed or continuous light, the irradiance of the light, the number of light sources used, or the sequence or pattern of the treatment” Par 0165; see new 103 below.
Additionally, the examiner has included a new 103 rejection with a new primary reference (WO 2019/181967 to Kobashi). It is noted that this reference is published 9/26/2019 which is before the effective filing date of the current application, and the presence of the Kobashi inventor on the prior art reference (who is not listed as an inventor on the current application) makes it so that it is not readily apparent that this is an inventor-originated disclosure and therefore the exception does not apply; If, however, the application names fewer joint inventors than a publication (e.g., the application names as joint inventors A and B, and the publication names as authors A, B and C), it would not be readily apparent from the publication that it is an inventor-originated disclosure and the publication would be treated as prior art under AIA 35 U.S.C. 102(a)(1) unless there is evidence of record that an exception under AIA 35 U.S.C. 102(b)(1) applies (MPEP 2153.01a). See new 103 for additional explanation.
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, 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.
Claims 6 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0129204 to Tsubota et al. (provided by applicant on the IDS submitted 2/28/2024) or, in the alternative, under 35 U.S.C. 103 as obvious over Tsubota in view of US 2016/0067087 to Tedford et al.
[Claim 6] Tsubota discloses a choroidal thinning inhibiting method comprising:
emitting violet light having a wavelength within a range from 360 nm to 400 nm (at least Abstract; Pars 0006-11 and 0039) to inhibit thinning of a choroid of an eye (MPEP 2112.02 states “under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.”; “when the claim recites using an old composition or structure and the ‘use’ is directed to a result or property of that composition or structure, then the claim is anticipated.”)
controlling an irradiance of the violet light at a power density of 0.01 to 5 mW/cm2 (at least Pars 0047, Example 5, Tables 1 and 2) for a duration.
While Tsubota discloses a duration of 6 hours (or longer) per day for one week, and therefore fails to explicitly teach 1-5 hours per day for at least two weeks, the reference clearly contemplates shorter durations (When a person is exposed to light for a long period of time for the purpose of myopia prevention, the irradiance relates to exposure time as well, and may be increased if the time is short, but is preferably decreased if the time is long; Par 0047). The examiner considers this an optimization of a result effective variable; "[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." MPEP 2144.05. Therefore, it would have been obvious to try different shorter durations per day and for a longer overall duration, e.g. at least two weeks, as this is merely routine optimization. It is emphasized that applicant themselves have no criticality for the claimed duration.
If applicant disagrees that Tsubota alone renders the claimed duration obvious, then Tedford makes it clear that the duration and frequency of ophthalmic light therapy is a result effective variable. Specifically, Tedford discloses “the treatment may be terminated after one treatment period, while in other embodiments, the treatment may be repeated for at multiple treatment periods. The time between subsequent treatment periods can be at least five minutes, at least two in a 24-hour period, at least 1 to 2 days, or at least one week. The treatment can be repeated multiple times per day or multiple times per week. The length of treatment time and frequency of treatment periods can depend on several factors, including the functional recovery of the subject and the results of imaging analysis of the injury, the disease or condition being treated, the use of pulsed or continuous light, the irradiance of the light, the number of light sources used, or the sequence or pattern of the treatment. In at least some embodiments, the timing parameters can be adjusted in response to a feedback signal from a sensor or other device (e.g., biomedical sensor, magnetic resonance imaging device) monitoring the subject.” (Par 0165). Therefore, it would have been obvious to one of ordinary skill in the art to modify the method of Tsubota to try a duration of 1-5 hours per day for at least two weeks, as the duration and frequency of eye light therapy depends on many factors, as taught by Tedford; this is considered routine optimization.
[Claim 8] The examiner takes the position that by teaching the method step recited in claim 6, this limitation is inherently met; “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.” MPEP 2112.02. If applicant disagrees, see alternative 103 rejection, below.
[Claim 9-12] As discussed above, Tsubota teaches the claimed power densities (at least Pars 0047, Example 5, Tables 1 and 2). Regarding the duration, Tedford makes it clear that the duration and frequency of the eye therapy treatments are based on numerous factors. Therefore, a POSITA would take all of these factors into consideration when deciding/trying how long to perform the treatments.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Tsubota OR Tsubota and Tedford as applied to claim 6 above, and further in view of “Myopia (Nearsightedness)”.
Tsubota discloses treatment of myopia, but is silent regarding any of the specific conditions/symptoms claimed. However, eye strain, headaches (pain) are known symptoms of myopia. Additionally, myopia is known to lead to other eye conditions, including cataracts and glaucoma. Therefore, it would have been obvious to one of ordinary skill in the art to target individuals with eye strain, headaches/pain, cataracts and/or glaucoma with the violet light taught by Tsubota, as these are known symptoms and complications of myopia with the understanding that preventing myopia, as taught by Tsubota, would alleviate the symptoms and prevent future complications associated with myopia.
Claims 6 and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/181967 to Kobashi et al. (provided on the previous 892 mailed 6/26/25) or, in the alternative, under 35 U.S.C. 103 as obvious over Kobashi in view of US 2016/0067087 to Tedford et al.
[Claim 6] Kobashi discloses a choroidal thinning inhibiting (scleral strengthening) method comprising:
emitting violet light having a wavelength within a range from 360 nm to 400 nm (at least Abstract. “The violet light can be said to be all or part of the wavelength within the range of 360 to 400 nm”) to inhibit thinning of a choroid of an eye (strengthening of the sclera; at least Abstract. MPEP 2112.02 states “under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.”; “when the claim recites using an old composition or structure and the ‘use’ is directed to a result or property of that composition or structure, then the claim is anticipated.”)
controlling an irradiance of the violet light at a power density of 0.01 to 5 mW/cm2 (0.1-1mW/cm2; Abstract) for a duration of 1-5 hours per day (Abstract).
While Kobashi discloses a duration of 1-5 hours per day for one week (“This was done for one week (7 days).”), and therefore fails to explicitly teach “for at least two weeks”. The examiner considers this an optimization of a result effective variable; "[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." MPEP 2144.05. Therefore, it would have been obvious to try a longer overall duration, e.g. at least two weeks, as this is merely routine optimization. It is emphasized that applicant themselves have no criticality for the claimed duration.
If applicant disagrees that Kobashi alone renders the claimed duration obvious, then Tedford makes it clear that the duration and frequency of ophthalmic light therapy is a result effective variable. Specifically, Tedford discloses “the treatment may be terminated after one treatment period, while in other embodiments, the treatment may be repeated for at multiple treatment periods. The time between subsequent treatment periods can be at least five minutes, at least two in a 24-hour period, at least 1 to 2 days, or at least one week. The treatment can be repeated multiple times per day or multiple times per week. The length of treatment time and frequency of treatment periods can depend on several factors, including the functional recovery of the subject and the results of imaging analysis of the injury, the disease or condition being treated, the use of pulsed or continuous light, the irradiance of the light, the number of light sources used, or the sequence or pattern of the treatment. In at least some embodiments, the timing parameters can be adjusted in response to a feedback signal from a sensor or other device (e.g., biomedical sensor, magnetic resonance imaging device) monitoring the subject.” (Par 0165). Therefore, it would have been obvious to one of ordinary skill in the art to modify the method of Kobashi to try applying light therapy for at least two weeks, as the duration and frequency of eye light therapy depends on many factors, as taught by Tedford; this is considered routine optimization.
[Claim 8] The examiner takes the position that by teaching the method step recited in claim 6, this limitation is inherently met; “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process.” MPEP 2112.02.
[Claim 9-12] As discussed above, Kobashi teaches the claimed power densities (Abstract). Regarding the duration, Tedford makes it clear that the duration and frequency of the eye therapy treatments are based on numerous factors. Therefore, a POSITA would take all of these factors into consideration when deciding/trying how long to perform the treatments.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David 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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/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796