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
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.
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 and 20 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) a first light source (11); a second light source (11); a filtering component (par. 0100-0102); 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 first light source to generate a first light pulse; (ii) using the second light source to generate a second light pulse; and (iii) emitting the first light pulse and the second light pulse to the subject, thereby treating the mild cognitive impairment or Alzheimer's disease or benefiting the cognitive function of the brain of the subject (par. 0045).
Regarding claim 12, Tass discloses (par. 0071) the instructions further comprising applying a phase offset to a plurality of the second light pulse, wherein the phase offset ranges from about 0 to about 180 degrees with respect to a plurality of the first light pulse.
Regarding claim 18, Tass discloses (par. 0153-0154) using a second device wirelessly and communicatively coupled to the stimulus-emitting 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.
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, and 19 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 claim 2, 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, 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.
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.
Conclusion
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.
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792