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 3 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 term “approximately” in claim 3 is a relative term which renders the claim indefinite. The term “approximately” 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.
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 1-7 and 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over Schiff (USPN 11,730,951) in view of Zhang (ZHANG et al., "Suppression of epileptic seizures via Anderson localization," JR Soc Interface, Vol. 14, No. 127: 30 pages (Feb. 2017), as provided by Applicant).
Regarding claim 1, Schiff discloses the claimed method of suppressing a spreading depolarization in a brain comprising:
determining a location of the spreading depolarization in the brain (e.g. detection of SD in the brain; Claim 5);
providing a stimulation signal to the brain focused on a volume of the brain at and surrounding the determined location of the spreading depolarization (e.g. administering stimulation to the brain to modulate spreading depression; Claim 1).
Schiff does not expressly disclose randomly varying an amplitude and focal point of the stimulation signal to suppress the spreading depolarization. Zhang discloses that it was well known in the art of suppressing the spreading of depolarization occurring during epileptic seizures to randomly varying stimulation by achieving an Anderson localization (e.g. as disclosed on pages 2-3). It would have been obvious to one having ordinary skill in the art to include the randomization of Zhang in the method of Schiff since such a modification would provide the predictable results of a reliable means of stopping depolarization spread.
Regarding claim 2, Zhang additionally discloses wherein the amplitude and the focal point of the stimulation signal are varied in accordance with a normal distribution (e.g. section 3.3).
Regarding claim 3, as best the claim can be understood, Zhang additionally discloses 3. wherein the volume of the brain on which the stimulation is focused is approximately 1cm3 in volume (e.g. step size of 14mm as disclosed in section 5, which is approximately 1cm3).
Regarding claim 4, Zhang additionally teaches wherein the amplitude and focal point are changed at a minimum every 130ms (e.g. change in time of 0.1ms, which is at greater than 130ms; as disclosed in section 4).
Regarding claim 5, Zhang additionally teaches wherein location of the focal point is varied from the location of the spreading depolarization a maximum of 1cm (e.g. step size of 14mm as disclosed in section 5, which is approximately 1cm3).
Regarding claim 6, Schiff additionally teaches amplitude of the stimulation signal is varied in a range between 0-2mA (e.g. Col.5, lines 25-35).
Regarding claim 7, Zhang additionally teaches wherein the amplitude is varied in accordance with a Gaussian normal random process with 0 mean and 1mA standard deviation (e.g. Gaussian white noises as taught in section 3.1).
Regarding claim 11, Schiff additionally teaches wherein the stimulation signal comprises one or more electric fields delivered by one or more electrodes (e.g. electrical stimulation and electrode disclosed in Col. 5, lines 5-30).
Regarding claim 12, Schiff additionally teaches wherein the stimulation signal is delivered by transcranial electrical stimulation (e.g. electrodes can be external as disclosed in Col. 5, lines 5-25).
Regarding claim 13, Schiff additionally teaches wherein the transcranial electrical stimulation is high-density electrical current stimulation (e.g. as disclosed in Col. 5, lines 5-25).
Regarding claim 14, Zhang additionally teaches wherein the stimulation signal is ultrasonic and is delivered by two or more transducers (e.g. ultrasonic stimulation as disclosed in section 1).
Regarding claim 15, Schiff additionally teaches wherein membrane potentials in the brain are altered by the stimulation signal (e.g. as disclosed in Col. 13, lines 10-25).
Regarding claim 16, Zhang additionally teaches wherein random variation of the amplitude and focal point of the stimulation signal randomizes the cortical medium through which the spreading depolarization wave passes, thereby suppressing the spreading depolarization (e.g. as disclosed in the Abstract).
Regarding claim 17, Zhang additionally teaches wherein the random variation of the amplitude and focal point of the stimulation signal causes an Anderson localization to form in the cortical medium of the brain (e.g. as disclosed in section 1).
Regarding claim 18, Zhang additionally teaches wherein the Anderson localization causes a randomization of the calcium conductance in the intracellular spaces of the brain (e.g. as disclosed in section 1).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Schiff and Zhang in further view of Reiss (US 5,512,057).
Regarding claims 8-10, Schiff and Zhang disclose the claimed invention but do not expressly disclose wherein the focal point is steered using spatial and/or temporal interference techniques, wherein the spatial interference technique includes using constructive and destructive interference of two or more sources of the stimulation signal to change the focal point of the stimulation signal and wherein the temporal interference technique uses frequency differentials between pairs of sources of the stimulation signal to change the focal point of the stimulation signal. Reiss teaches that it was known in the art of stimulation to apply interferential stimulation to change the location and strength of a stimulation signal (e.g. as disclosed in claim 1). It would have been obvious to one having ordinary skill in the art to include the interferential capabilities of Reiss in the method of Schiff and Zhang since such a modification would provide the system with the predictable results of a reliable means of controlling the focal point of the stimulation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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/Amanda K Hulbert/Primary Examiner, Art Unit 3792
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