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 .
Election/Restrictions
Applicant’s election without traverse of Group I (directed to claims 1-9) in the reply filed on 07/06/2026 is acknowledged.
Information Disclosure Statement
The Information Disclosure Statements (IDS) dated 1/27/2025, 05/28/2025, and 08/19/2025 have been considered by the Examiner.
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.
(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 1-5 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hershey et al (US 20170143972 A1).
Regarding claim 1, Hershey teaches a method for photobiomodulation (Fig. 9), the method comprising:
emitting light from a lead (214) implanted in a patient (see [0007]; implantable neuromodulation device) using a light source according to a first delivery program to photobiomodulate the patient (see [0048]; neuromodulation device 104 is configured to deliver neuromodulation energy in the form of light, such as using an optical stimulator, Fig. 9, [0084-0085]; at 902 delivering neuromodulation to a tissue site, at 904 controlling the delivery using a neuromodulation parameter set);
monitoring at least one biomarker to monitor at least one effect of the photobiomodulation (see Fig. 9, [0086]; at 906 sensing biomarker parameter(s) associated with the tissue site)
determining, by a processor, whether the monitoring of the at least one biomarker meets a change condition (see Fig. 9, [0087]; at 907 comparing each of the biomarker parameters to a reference value);
when the monitoring of the at least one biomarker meets a change condition, determining, by the processor, a change to the first delivery program to produce a second delivery program (see Fig. 9, [0088]; at 910 adjusting the neuromodulation parameter set using an outcome of the comparison); and
emitting light from the implanted lead according to the second delivery program (see [0005]; the control circuit may be configured to control the delivery of the neuromodulation using the neuromodulation parameter set and adjust one or more parameters of the neuromodulation parameter set using the biomarker parameter).
Regarding claim 2, Hershey teaches the method of claim 1, wherein the change condition comprises a magnitude or a rate of the biomarker (see [0051]; one or more biomarker sensors 110 can each be configured for sensing one or more biomarker parameters associated with a tissue site, including a measure of the biomarker or a measure of a derivative of the biomarker).
Regarding claim 3, Hershey teaches the method of claim 1, wherein the change condition comprises a magnitude or a rate of a change in a magnitude of the biomarker (see [0051]; one or more biomarker sensors 110 can each be configured for sensing one or more biomarker parameters associated with a tissue site, including a measure of the biomarker or a measure of a derivative of the biomarker).
Regarding claim 4, Hershey teaches the method of claim 1, wherein the monitoring comprises monitoring the at least one biomarker using at least one sensor (see [0051]; biomarker sensors 110).
Regarding claim 5, Hershey teaches the method of claim 4, wherein at least one of the at least one sensor is an implanted sensor (see [0051]; biomarker sensors 110 may include one or more implantable biomarker sensors).
Regarding claim 9, Hershey teaches the method of claim 1, wherein the emitting comprises emitting the light for neural protection, neural survival, or neural growth (see [0057]; the neuromodulation may be delivered in the form of optical stimulation wherein one or more light emitters is configured to apply near-IR energy to the tissue site such as to reduce inflammation and promote neuro-proliferation and neuro-regeneration).
Claims 1-5 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al (US 20180369607 A1).
Regarding claim 1, Zhang teaches a method for photobiomodulation, the method comprising:
emitting light from a lead (403) implanted in a patient using a light source (411) according to a first delivery program to photobiomodulate the patient (see [0071]; light is emitted to the target stimulation location(s) via the one or more light emitters);
monitoring at least one biomarker to monitor at least one effect of the photobiomodulation (see [0077]; the size and shapes of the activation volumes obtained using a given set of stimulation parameters can be sensed using sensing electrodes);
determining, by a processor, whether the monitoring of the at least one biomarker meets a change condition (see [0078-0079]; changes in the sensed signals may correspond to one or more disorders or conditions of interest, the feedback system 450 may sense a change in the amount or quality of a signal);
when the monitoring of the at least one biomarker meets a change condition, determining, by the processor, a change to the first delivery program to produce a second delivery program (see [0079]; the closed-loop feedback subsystem 450 can be used to adjust one or more parameters or the emitted light based on the conditions of the sensed electrical signals, e.g. sensing a new signal, sensing a change in the amount or quality of a signal, the disappearance of a signal, etc.); and
emitting light from the implanted lead according to the second delivery program (see [0079]; the parameters of the emitted light are adjusted).
Regarding claims 2 and 3, Zhang teaches the method of claim 1 wherein the change condition comprises a magnitude or a rate of the biomarker or rate of a change in a magnitude of the biomarker (see [0077-0079]; sensing electrodes can sense a level of neuronal activation, neuronal firing rates, a change in the amount of quality of a signal, etc.).
Regarding claims 4 and 5, Zhang teaches the method of claim 1, wherein the monitoring comprises monitoring the at least one biomarker using at least one implanted sensor (see Fig. 4, [0066]; sensing electrodes 434 are disposed along the distal portion of the implantable lead).
Regarding claim 7, Zhang teaches the method of claim 1, wherein the monitoring or the determining is performed at a regular periodic interval (see [0052]; any processor can be used that may produce optical stimulation at a regular interval and/or be capable of receiving and interpreting instructions from an external programming unit that allows for modification of stimulation characteristics).
Claims 1 and 4-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Howard (US 20220111212 A1).
Regarding claim 1, Howard teaches a method for photobiomodulation, the method comprising:
emitting light from a lead implanted in a patient (see [0010]; an implanted device providing optical stimulation) using a light source according to a first delivery program to photobiomodulate the patient (see [0010]; the methods may comprise applying stimulation based on a first version of stimulation parameters);
monitoring at least one biomarker to monitor at least one effect of the photobiomodulation (see [0010]; sensing results of the applied stimulation);
determining, by a processor, whether the monitoring of the at least one biomarker meets a change condition (see [0010]; sensing results of the applied stimulation to form patient treatment results data);
when the monitoring of the at least one biomarker meets a change condition, determining, by the processor, a change to the first delivery program to produce a second delivery program (see [0010]; modifying the first version of stimulation parameters using the patient treatment results data to form a second version of stimulation parameters); and
emitting light from the implanted lead according to the second delivery program (see [0010]; applying stimulation based on the second version of stimulation parameters).
Regarding claim 4, Howard teaches method of claim 1, wherein the monitoring comprises monitoring the at least one biomarker using at least one sensor (see [0010]; a plurality of sensing devices may comprise at least one of an electroencephalogram device or an implanted device providing one or both of electrical and optical sensing).
Regarding claim 5, Howard teaches the method of claim 4, wherein at least one of the at least one sensor is an implanted sensor (see [0010]; implanted device providing one or both of electrical and optical sensing).
Regarding claim 6, Howard teaches the method of claim 4, wherein at least one of the at least one sensor is a worn or wearable sensor (see Fig. 1; BCCS earbuds externally monitor vitals/EEG).
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.
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 nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al (US 20180369607 A1) in view of Deligianni et al (US 20180193663 A1).
Regarding claim 8, Zhang teaches the method of claim 1. Hershey is silent regarding wherein the biomarker comprises dopamine or acetylcholine.
Deligianni teaches a probe for neural stimulation using an implantable lead which emits light and comprises sensing means for recording the neural response and resulting neurochemical release of dopamine (Deligianni [0043-0044]).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Zhang’s method for photobiomodulation, which monitored the effects of the stimulation by the resulting neural electrical response via sensing electrodes with Deligianni’s carbon electrode sensors which allow for electrochemically recording neurotransmitters as a result of optical stimulation. One of ordinary skill in the art would have been motivated to make this modification in order to activate neurons using optical stimulation, record resulting neural electrical activity, and resulting neurochemistry in the extracellular or intracellular space, with a single probe (Deligianni [0043]).
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Serrano Carmona (US 20180110971 A1) which teaches neural electrical stimulation methods with optical observation.
Chabrol et al (US 20210178175 A1) which teaches an illuminating device implantable in a living being.
Clark et al (US 20200376262 A1) which teaches systems and methods for making and using implantable electrical/optical stimulation leads and systems.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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/A.J.S./Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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