DETAILED ACTION
The Examiner acknowledges the amendments received 15 July 2026. Claims 10-11 and 13 are cancelled; new claims 24-64 are entered; claims 1-9, 12 and 14-64 are pending.
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
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “light adjustment module” in claim 14.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The corresponding structure seems to read on hardware (one or more processors, logic devices, or circuits or processors, memory, and network interface, which would be essentially a computer, as disclosed in [0242]) and the algorithm is outlined in various parts of the specification throughout in adjusting light parameter associated with the visual signal, such as a frequency, amplitude, wavelength, intensity pattern or other parameter of the visual signal.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Response to Arguments
Applicant's arguments filed 15 July 2026 have been fully considered but they are not persuasive. The arguments pertain to the amendments to the claims and will therefore be addressed below in the prior art rejection.
Claim Objections
Claims 60-64 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim 59. See MPEP § 608.01(n). Accordingly, the claims 60-64 have not been further treated on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 25 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 25 requires “a pulse rate interval of about 0.012 seconds to about 0.05 seconds”. No support is provided in the accompanying arguments, and the Examiner cannot find this range in the Disclosure as originally filed.
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 59-64 are 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. Claims 59-64 recite “The device of any one of claims” with only one claim listed. It is unclear on which of the claims these claims depend.
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.
Claims 1, 12, 18, 20, 29-32 and 40-44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tass et al (U.S. 2010/0324631). Tass discloses (Figure 1) one or more light sources (11); a feedback sensor (par. 0085-0088); and one or more processors (10) individually or collectively programmed to execute a set of instructions comprising (par. 0120): (i) using the one or more light sources to generate a first light pulse; (ii) using the one or more light sources to generate a second light pulse; and (iii) emitting the first light pulse and the second light pulse, wherein the device is a non-invasive device (par. 0085 and 0151).
Regarding claim 12, Tass discloses (par. 0071) the set of instructions further comprises applying a phase offset to a plurality of the second light pulses, wherein the phase offset ranges from about 0 to about 180 degrees with respect to a plurality of the first light pulses.
Regarding claim 18, Tass discloses (par. 0153-0154) using a second device wirelessly and communicatively coupled to the device to: at least generate the first light pulse.
Regarding claim 20, Tass discloses (par. 0115) the feedback sensor is configured to perform image processing.
Regarding claim 29, Tass discloses (par. 0108) at least a laser diode.
Regarding claim 30, Tass discloses (par. 0108) one or more LEDs.
Regarding claim 31, Tass discloses (Fig. 1) a control unit (10) operatively coupled to the one or more light sources, wherein the control unit is configured to control one or more predetermined parameters.
Regarding claim 32, Tass discloses (par. 0117) the control unit controls at least pulse train duration.
Regarding claim 40, Tass discloses (par. 0098) the control unit is further configured to adjust the one or more predetermined parameters in response to feedback received from a subject.
Regarding claim 41, Tass discloses (par. 0085-0088) the control unit is further configured to adjust the one or more predetermined parameters in response to feedback received from the feedback sensor.
Regarding claim 42, Tass discloses (par. 0085-0088) the control unit is further configured to adjust the one or more predetermined parameters automatically based on at least physiological feedback.
Regarding claim 43, Tass discloses (par. 0045) the device is configured to treat, prevent, protect against or otherwise affect mild cognitive impairment or Alzheimer's disease or benefiting the cognitive function of the brain of the subject
Regarding claim 44, Tass discloses (par. 0100-0102) a filtering component operatively coupled to the one or more light sources, wherein the filtering component is configured to filter light from the one or more light sources to produce the first light pulse or the second light pulse.
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.
Claims 2-5, 15-17, 19, 24-28, 33-39 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Tass et al (U.S. 2010/0324631). Tass discloses a device for treating mild cognitive impairment treating the mild cognitive impairment or Alzheimer's disease recited in claim 1 as set forth above.
Regarding claims 2, 33 and 45, Tass discloses (par. 0028) the first light pulse emits a first plurality of light waves having one or more wavelengths ranging from 380 nanometers (nm) to 780 nanometers (nm). The Examiner notes that this is a similar range to the one claimed (750 nm as the upper limit versus 780 nm in the prior art). In both the Tass reference and in the instant application, several very long ranges that are similar are given. Par. 0247 of the Published Application reads “the light generation module 110 can instruct the visual signaling component 150 to generate visual signals comprising one or more light waves having one or more wavelength corresponding to one or more of ultraviolet (e.g., 10-380 nm); violet (e.g., 380-450 nm), blue (e.g., 450-495 nm), green (e.g., 495-570 nm), yellow (e.g., 570-590 nm), orange (e.g., 590-620 nm), red (e.g., 620-750 nm); or infrared (e.g., 750-1000000 nm). The wavelength can range from 10 nm to 100 micrometers. In some embodiments, the wavelength can be in the range of 380 to 750 nm.” The instant application does not disclose any criticality associated with the claimed range of wavelengths. Par. 0028 of Tass reads “The optical stimuli 12 applied by the respective stimulation units 11 can be individual stimuli 20, as shown in an exemplary fashion in FIGS. 2A to 2W, or can be made up of such individual stimuli 20. In FIGS. 2A to 2W, the intensity (y-axis) of the individual stimuli 20 is plotted in each case over time t (x-axis). The duration of an individual stimulus 20 can lie in the region of 1 ps to 200 ps, or more. The electromagnetic radiation making up the optical stimuli 12 can be visible light with wavelengths between 380 and 780 nm, or infrared radiation with wavelengths between 780 and 3000 nm (or up to 10 000 nm or more).” Both the largest range, and the claimed range are very similar, with the Tass range being only 30 nm larger and encompassing the claimed range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (see MPEP 2144.05(I)).
Regarding claim 3, Tass discloses (par. 0028) the first plurality of light waves does not comprise ultraviolet or infra-red light (“The electromagnetic radiation making up the optical stimuli 12 can be visible light with wavelengths between 380 and 780 nm”).
Regarding claim 4, Tass discloses (par. 0028) the second light pulse emits a second plurality of light waves having one or more wavelengths ranging from 380 nanometers (nm) to 780 nanometers (nm).
Regarding claim 5, Tass discloses (par. 0028) the second plurality of light waves does not comprise ultraviolet or infra-red light.
For claims 3-5, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists in the absence of any criticality associated with claimed ranges (see MPEP 2144.05(I)).
Regarding claims 15-17 and 24, the instant specification does not disclose any criticality for duration and frequency of stimulation as recited in claims 15-17 (see par. 0290 and 0645). Tass further teaches that stimulation parameters including duration and frequency of stimuli are varied in a demand-driven fashion based on the patient’s pathological activity (par. 0094 and 0095). As such, the duration and frequency of stimulation are result-effective variable that achieves a recognized result of providing appropriate therapy based on pathological activity of a patient. Therefore, it would have been obvious to one of ordinary skill in the art to discover the optimum workable range(s) of stimulation durations and frequencies of “1 hour per day”, “multiple sessions per day, wherein each session is less than 1 hour in duration”, and “once a day for a period of at least about one month” by normal optimization procedures known in the treatment of mild cognitive impairment treating the mild cognitive impairment or Alzheimer's disease.
Regarding claim 19, Tass discloses the claimed invention except for first and second light pulses each comprise a frequency of about 35 Hz to about 45 Hz. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide pulses of this range, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. For example, in the instant application, there is no one frequency value or range that is given criticality for the applied function (treating Alzheimer’s or mild cognitive impairment). See the Published Application at par. 0390 and 0506, which only lists values of frequencies, and does not provide a range, much less the range that is claimed.
Regarding claims 25-26 and 38, the instant specification does not disclose any criticality for pulse rate interval as recited (see par. 0252). Tass further teaches that stimulation parameters including duration and frequency of stimuli are varied in a demand-driven fashion based on the patient’s pathological activity (par. 0094-0095). As such, the pulse rate interval of stimulation is a result-effective variable that achieves a recognized result of providing appropriate therapy based on pathological activity of a patient. Therefore, it would have been obvious to one of ordinary skill in the art to discover the optimum workable range(s) of pulse rate intervals of “about 0.012 seconds to about 0.05 seconds” or “about 0.025 seconds” by normal optimization procedures known in the treatment of mild cognitive impairment treating the mild cognitive impairment or Alzheimer's disease. It is noted that at least in the case of claim 25, there is no disclosure in the Specification of this range at all, much less whether it is selected for a specific purpose (see above rejection under 35 USC 112).
Regarding claims 27-28 and 34-36, the instant specification does not disclose any criticality for pulse frequency as recited (see par. 0252). Tass further teaches that stimulation parameters including duration and frequency of stimuli are varied in a demand-driven fashion based on the patient’s pathological activity (par. 0094-0095). As such, the pulse frequency of stimulation is a result-effective variable that achieves a recognized result of providing appropriate therapy based on pathological activity of a patient. Therefore, it would have been obvious to one of ordinary skill in the art to discover the optimum workable range(s) of pulse frequencies of “about 20 Hertz (Hz) to about 80 Hz” or “about 40 Hz” by normal optimization procedures known in the treatment of mild cognitive impairment treating the mild cognitive impairment or Alzheimer's disease.
Regarding claims 37 and 39, the instant specification does not disclose any criticality for pulse width or duty cycle as recited (see par. 0252). Tass further teaches that stimulation parameters including duration and frequency of stimuli are varied in a demand-driven fashion based on the patient’s pathological activity (par. 0094-0095). As such, the pulse width or duty cycle of stimulation are result-effective variable that achieves a recognized result of providing appropriate therapy based on pathological activity of a patient. Therefore, it would have been obvious to one of ordinary skill in the art to discover the optimum workable range(s) of pulse width of “about 1 millisecond to about 10 milliseconds” or duty cycle “between about 10% and about 90%” by normal optimization procedures known in the treatment of mild cognitive impairment treating the mild cognitive impairment or Alzheimer's disease.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Tass et al (U.S. 2010/0324631) in view of Barclay et al (CN 105073190). Tass discloses (par. 0108) the claimed invention except for polychromatic light. Barclay, however, discloses therapeutic electromagnetic radiation device (Abstract). Barclay specifically teaches well known radiation sources including OLED for generating variable wavelength (polychromatic) device (p9, first full paragraph). 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 Tass’ processor device with Barclay polychromatic light sources in order to obtain a desired wavelength range of radiation source.
Claims 21-23 are rejected under 35 U.S.C. 103 as being unpatentable over Tass et al (U.S. 2010/0324631) in view of Neuvonen et al (U.S. 2015/0190635). Tass discloses the claimed invention except for a camera, though Tass discloses use of imaging (par. 0052). Neuvonen, however, discloses (Figure 2A) a sensing arrangement (202) for transcranial stimulation, which includes at least one camera (par. 0036). Both Tass and Neuvonen both disclose systems for treating cognition (par. 0002 of Neuvonen) via external stimulation. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to modify Tass’ light stimulation therapy with Neuvonen’s camera in order to generate a 3D map of the patient’s head for aid in stimulation placement.
Regarding claim 22, Neuvonen discloses (par. 0036) capturing an image of the subject.
Regarding claim 23, Neuvonen discloses (par. 0040) using the image to determine whether a subject is in proximity of the device.
Allowable Subject Matter
Claims 6 and 14 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.
Claims 46-58 are allowed.
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 DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792
Prosecution Insights