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
Applicant's arguments filed 11/17/2025 have been fully considered but they are not persuasive.
Applicant first argues on page 6:
“One of ordinary skill in the art would understand the intensity of light therapy needed, and sufficient, to treat a motor-related neurological condition or a symptom of a motor-related neurological condition. The specification provides three examples…”
Examiner respectfully disagrees. The examples are instances of what wavelengths can be used, while ¶0042 specifically recites any above /below ambient level can be used (See also definition of ambient level in ¶0031). A “sufficient” amount can be interpreted broadly and in view of specification to include every level of light, including examples cited by examiner. Hence the claim is indefinite as to what the sufficient amount means or defines.
Applicant first argues on page 7-8:
“Pederson does not expressly or inherently describe a method for treating or preventing a motor-related neurological condition. Instead, Pederson specifies that the device thereof treats "light deficient disorders including Seasonal Affective Disorder (SAD), circadian sleep disorders, fatigue and circadian disruptions associated with jet-lag, shift-work, PMS and eating disorders… the emission spectrum of the device is sufficient to address SAD, jet lag, PMS, Delayed Sleep Phase Syndrome, and fatigue management,”
Examiner respectfully disagrees. Examiner has noted that the claimed, i.e. to prevent or treat a motor-related neurological condition is the intended use of the light therapy using the claimed wavelength, and sufficient intensity. The limitations as claimed, simply re-recites the preamble statement, and does not result in any manipulative difference between the claimed invention and the prior art. There is no response as to why this would not be an intended use of the administering step, and hence no manipulative difference as noted in the Office Action.
Applicants arguments on page 10 are similar to that discussed above and are not persuasive for same reasons.
Applicant argues on page 11:
“Willis teaches the use of therapies that block … Willis does not, however, teach or suggest "administering light consisting of blue and green spectrum light to a subject." Nor does Willis teach or suggest that blue and/or green light therapy could antagonize melatonin secretion by a subject.
Savage teaches administering blue and green spectrum light. … Savage, paragraph [0050]. Savage does not teach or suggest that blue or green light could be used to prevent or treat a motor-related neurological condition, as recited by claims 24 and 40, or at least one symptom of the motor-related neurological condition, as recited by claim 40.”
Examiner respectfully disagrees. In response to applicant's arguments against the references individually, one cannot show non obviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this case, applicant is individually addressing the references as applied by the examiner, while not considering the combination and reasons as discussed in Office Action pages 7-8. As of current record, examiner has correctly applied an obviousness type rejection and the arguments against the individual references are not persuasive.
Note: As noted in the response section of the Office Action of 03/29/2024, the limitation “consisting of blue and green spectrum”, is interpreted as described in the applicant remarks for pre-appeal brief of 10/24/2023, page 4. i.e., light (blue and green) anywhere between 400 nm and 600 nm. This interpretation has been incorporated into this Office Action as well, as previously done.
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.
Claims 24-26, 28-31, 40-42, 64-69, 75-77 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.
Claim 24 recites “in an amount sufficient to” in lines 3-4. This is indefinite for the following reasons. Firstly, the term “sufficient to” in claim 24 is a relative term which renders the claim indefinite. The term “sufficient to” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Secondly, application refers to multiple levels of intensities to provide treatment like 50 lux, 500 lux, 1000 lux, etc. Further, applicant spec. ¶0042 recites “Light therapy that employs ambient or below-ambient levels of blue-green and/or green wavelengths is also within the scope of the present invention.” Hence the scope of the invention involves every intensity of light, and it is not understood what a sufficient amount means. For prosecution advancement, examiner interprets sufficient to mean as above ambient or above 500 lux.
Claims 25-26, 28-31, 40-42, 64-69, 75-77 recites or encompasses similar limitations and are rejected for same reasons as above.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 24-26, 28-29, 40-42 rejected under 35 U.S.C. 102 (a) (1) and 102 (a) (2) as being anticipated by Pederson [US 20050073839 A1].
As per claim 24, Pederson teaches a method for treatment and/or prophylaxis of a motor-related neurological condition, comprising:
administering light (Pederson ¶0026 “hand-held ocular light therapy device for treatment or prevention”)
consisting of blue and green spectrum light to a subject (In view of interpretation of section 4 above, ¶0032 “The light emitted by the light emitting … can be selected to have a peak in the blue to green wavelengths of 400 to 600 nm and in one embodiment 450 to 550 nm”)
in an amount sufficient (In view of 112 (b) rejection above, Pederson ¶0037, ¶0038, “2500 lux” is > 500 lux, and is a sufficient amount)
to address a motor-related neurological condition experienced by the subject (This is intended use of the light therapy using the claimed wavelength, and sufficient intensity, does not result in any manipulative difference between the claimed invention and the prior art).
As per claim 25, Pederson further teaches wherein administering the blue and green spectrum light comprises pulsing the blue and green spectrum light (LEDs are digital devices that inherently uses pulses as switching on and off).
As per claim 26, Pederson further teaches wherein pulsing the blue and green spectrum light comprises pulsing the blue and green spectrum light from one pulse per second to one pulse per 20 minutes (Pederson ¶0083 “Treatment times for SAD are typically 15-60 minutes/day”, pulse range is included).
As per claim 28, Pederson further teaches wherein pulsing the blue and green spectrum light comprises pulsing the blue and green spectrum light for a duration of one second to 20 minutes (Pederson ¶0083 “Treatment times for SAD are typically 15-60 minutes/day”, pulse range is included).
As per claim 29, Pederson further teaches wherein administering the blue and green spectrum light comprises ocularly administering the blue and green spectrum light (Pederson ¶0027).
As per claims 40-42, they have limitations similar to claims 24-26, 28-29 and are rejected for same reasons as above.
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.
Claims 30-31, 64-69, 75-77 rejected under 35 U.S.C. 103 as being unpatentable over Pederson as applied to claim 24 above, and further in view of Bhaskar [Effect Of L-dopa on visual evoked potential in patients with Parkinson's disease, NEUROLOGY 1986;36:1119-1121].
As per claims 30-31, Pederson teaches claim 24 as discussed above. Pederson does not expressly teach administering a dopamine replacement to the subject, wherein administering the dopamine replacement comprises administering the dopamine replacement in separately from the light therapy.
Bhaskar in a similar field of visually evoked potentials, teaches a dopamine replacement to the subject, wherein administering the dopamine replacement comprises administering the dopamine replacement in separately from the light therapy (Bhaskar page 1119 LHS, providing VEP and L-dopa. VEP is provided before and after L-dopa).
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify method in Pederson by using L-dopa. The motivation would be to get improvements in parkinsonian states (Bhaskar abstract).
As per claims 64-69, 75-77, have limitations similar to claims 30-31and are rejected for same reasons as above in view of Pederson in view of Bhaskar. Further Note, the application for a period of 3 months of L-Dopa, and VEP before and after. This whole application of VEP and drug can be interpreted as a combination. Additionally, there are the only two ways that the different treatment can be provided, i.e. separately or as combination, with a reasonable expectation of success. Hence, it is also obvious as described in section 2143.I.E of MPEP (choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success).
Claims 24-26, 28-29, 40-42 rejected under 35 U.S.C. 103 as being unpatentable over Willis [US 20020068692 A1] in view of Savage [US 20050159795 A1].
As per claim 24, Willis teaches a method for treatment and/or prophylaxis of a motor-related neurological condition, comprising administering light in an amount sufficient to prevent or treat the motor-related neurological condition experienced by the subject (Willis ¶0138, light therapy for Parkinson’s Disease, at 1500 lux).
Willis does not expressly recite the light consisting of blue and green spectrum.
Savage in a related field of ocular light therapy teaches administering light consisting of blue and green spectrum (Savage ¶0034 “Another embodiment comprises the use of lamps that provide ... for a combination of the green and blue light ranges”/ ¶0050 “Alternately, the LEDs 84 may provide light in the green light range of 490-520 nm, alone or together with blue light”. ¶0041, sufficient intensities also discussed).
Willis directed to light therapy using melatonin suppression, for treatment of several disorders including motor-related neurological condition. Savage discloses LEDs and light combinations capable of regulating /suppressing melatonin (Savage ¶0003, ¶0050), to treat seasonal affective disorder, depression, chronobiological disorders, mood and sleep disorders (Savage ¶0003 and ¶0044). Mood disorders, depression and sleep disorders are secondary symptoms of and mood and sleep disorders (Applicant spec. ¶0007, ¶0013). Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify method in Willis by integrating light boxes as in Savage. The motivation would be to provide a light therapy unit capable of being individually tailored to achieve optimal treatment for different disorders (Savage ¶0054), including those directed to utilizing regulation / suppression or melatonin, as in Willis.
As per claim 25, Willis in view of Savage further teaches wherein administering the blue and green spectrum light comprises pulsing the blue and green spectrum light (Savage ¶0049-¶0050, use of LEDs. LEDs are digital devices that inherently uses pulses as switching on and off).
As per claim 26, Willis in view of Savage further teaches wherein pulsing the blue and green spectrum light comprises pulsing the blue and green spectrum light from one pulse per second to one pulse per 20 minutes (Savage ¶0024 “a therapeutic dosage of light is delivered during a period of about 15 to 25 minutes”, implies pulses in this range of time)
As per claim 28, Willis in view of Savage further teaches wherein pulsing the blue and green spectrum light comprises pulsing the blue and green spectrum light for a duration of one second to 20 minutes (Savage ¶0024 “a therapeutic dosage of light is delivered during a period of about 15 to 25 minutes”, implies pulses in this range of time).
As per claims 29, 40-42, have limitations similar to claims 24-26, 28 and are rejected for same reasons as above in view of Willis in view of Savage.
Claims 30-31, 64-69, 75-77 rejected under 35 U.S.C. 103 as being unpatentable over Willis in view of Savage as applied to claim 24 above, and further in view of Bhaskar [Effect Of L-dopa on visual evoked potential in patients with Parkinson's disease, NEUROLOGY 1986;36:1119-1121].
As per claims 30-31, Willis in view of Savage teaches claim 24 as discussed above. Willis in view of Savage does not expressly teach administering a dopamine replacement to the subject, wherein administering the dopamine replacement comprises administering the dopamine replacement in separately from the light therapy.
Bhaskar in a similar field teaches a dopamine replacement to the subject, wherein administering the dopamine replacement comprises administering the dopamine replacement in separately from the light therapy (Bhaskar page 1119 LHS, providing VEP and L-dopa. VEP is provided before and after L-dopa ).
Before the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to modify method in Willis in view of Savage by using L-dopa. The motivation would be to get improvements in parkinsonian states (Bhaskar abstract).
As per claims 64-69, 75-77, have limitations similar to claims 30-31and are rejected for same reasons as above in view of Willis in view of Savage and Bhaskar. Further Note, the application for a period of 3 months of L-Dopa, and VEP before and after. This whole application of VEP and drug can be interpreted as a combination. Additionally, there are the only two ways that the different treatment can be provided, i.e. separately or as combination, with a reasonable expectation of success. Hence, it is also obvious as described in section 2143.I.E of MPEP (choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success).
Conclusion
THIS ACTION IS MADE FINAL. 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 OOMMEN JACOB whose telephone number is (571)270-5166. The examiner can normally be reached 8:00-4:00.
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/Oommen Jacob/ Primary Examiner, Art Unit 3797