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.
Claims 7-12 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. Independent claim 7 recites “a processor configured to receive a signal from the signal detection unit; analyze the signal and generate a feedback signal to the controller to control the light source until optimal results are obtained” in line 3-6. However, the scope of the claimed optimal results or to which it is relevant cannot be determined from the specification or the claim language. Therefore, this limitation renders claims 7-12 indefinite. In this Office Action, the recited limitation described above (i.e., optimal results) is regarded the stimulation optical radiation/energy exposed/directed to the brain tissue of the subject. Appropriate correction is required.
Claim 9 recites the limitation "the paths of the photons of the light" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. This limitation further renders the claim indefinite. Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or no obviousness.
Claims 7,8 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Pub. No. 2011/0144723 to Streeter et al. (hereinafter “Streeter”) in view of Wells et al., Pub. No. U.S 2011/0295331 (hereinafter “Wells”) .
Regarding claim 7, Streeter discloses a system for in vivo and transcranial stimulation of a brain tissue of a subject, the system comprising: at least one light source 40,340 spaces away from the scalp of the subject (see Figs. 1, 6A-6C, Fig. 13, and pars. 0097, 0148, 149); a controller 360 to control/energize operation of the light source 340 (par. 0148); a signal detecting unit (‘in certain embodiment, [a] logic circuit 110 is responsive to signal from a sensor monitoring at least one parameter of the treatment to control the applied light” see par. 0147) and a processor configured to receive a signal from the signal detecting unit (in certain embodiment, a programmable controller 126 comprises a clock 212 coupled to the logic circuit 210 is responsive to signals from the sensor to adjust the treatment parameters to optimize the phototherapy, see pars.0144-145). Streeter further teaches a biomedical sensors can provide real-time feedback information to a logic circuit 210 (par. 0147), but he does not teach to analyze the signal to generate a feedback signal to the controller to control the light source/treatment light as claimed. Wells disclose a laser-based nerve stimulating system and methods of use, the method comprising the step of detecting electrical signals of the nerves and using such signals to provide a feedback signal. Therefore, it would have been obvious the time applicant’s invention was filed to one of ordinary skill in the art to modify Streeter in view of Wells to analyze the detected signals in order to generate a feedback signal to the to the controller to better control the light source in order to deliver a desired/optimal radiation to the subject’s brain tissue as Wells suggested/indicated (see Par. 0343).
wherein the system includes a reflection module to receiving a light beam from the light source 342 and a galvanometer both coupled to the controller and one or more sets of mirrors
346 mounted on assembly 348/calculation module which is adjustable by a plurality of motors 350, wherein the mirrors are configured to generate one or more light beams and reflect the light beams to the subject’s brain (Fig. 14, par. 0040, 0149). Streeter teaches a signal detecting unit and a processor configured to receive a signal from a signal sensor (in certain embodiment, a programmable controller 126 comprises a clock 212 providing a timing signal, and a programmable controller 126 responsive to signals from the sensor to adjust the treatment parameters to optimize the phototherapy (Fig. 12 and pars.0144, 0227)). He further teaches a biomedical sensors can provide real-time feedback information to a logic circuit 210 (par. 0147), but he does not teach analyzing the signal and generate a feedback signal to the controller as claimed. Wells disclose a laser-based nerve stimulating system and methods of use, the method comprising the step of detecting electrical signals of the nerves and using such signals to provide a feedback signal to a controller to control stimulation laser light (see Par. 0343). Wells further teaches the use of a microprocessor that performs signal analysis using a fast Fourier Transform as claimed (see Pars. 0046). Hence, at the time applicant’s invention was filed, it would have been obvious to one of ordinary skill in the art to modify Streeter in view of Wells and use Fourier Transform as a means for processing the detected signals in order to generate the feedback control signal.
Regarding claim 8, Streeter discloses a calculation module/an assembly 348 including galvanometer 344 comprising reflection mirrors 346 which is communicatively and electrically connected with the light source, reflection mirrors, and controller 360 (Fig. 14 par. 0134, 0149).
Regarding claim 10, Streeter teaches the light source 340 is diode laser (see pars. 0129 0149)discloses that, at least in one embodiment, the light source provide light in the wavelength range between 800 nm to 815 nm, and irradiance of 20 mow/cm2 to 60 mow/cm2 (see pars. 0009, 0086, 0124, 0126, 0130 and claims 1 and 2).
Regarding claim 11, Streeter teaches detecting brain activity using alternative signal detectors including MRI device (par. 0227).
Regarding claim 12, Streeter discloses the use of a programmable controller for receiving and analyzing a feedback signal from the brain tissue for adjusting parameters of the stimulation light based on the analyzed feedback signal. Thus, in this Office Action, the programmable controller is treated to have a machine learning algorithm/code capability configured to learn and determine brain status as claimed.
Allowable Subject Matter
Claim 9 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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 AHMED M FARAH whose telephone number is (571)272-4765. The examiner can normally be reached Mon - Fri. 9:30AM -10:30 PM.
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/AHMED M FARAH/Primary Examiner, Art Unit 3792