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 .
Response to Amendment
The amendment filed on 06/02/2026 has been entered. Claim 1-20 remain pending in the application. Applicant’s amendment to the Claims have overcome the 112(b) rejection previously set forth in the Non-final Office Action mailed on 04/28/2026.
Response to Arguments
Claim Objections:
Applicant's claim amendment/remarks have successfully overcome the previous objections for claim 1-2, 16, 17, and 20. Those objections are withdrawn.
Applicant's arguments/remarks concerning Claim 13 have been fully considered but are not persuasive. The objection is maintained. Claim 13 recites, “stimulation is electronic, …”, “electrical stimulation” is a common term of art for stimulation that delivers electrical energy, whereas there is no generally understood meaning of “electronic stimulation”. Applicants remark is that “For consistency with the Specification, the Applicant has not amended claim 13”, however in the specification (Para 8, 44) has mention of “electrical stimulation”.
Rejection under 35 U.S.C § 112:
The previous rejection of Claim 14 and 16-20 under 112(b) is withdrawn in view of the amendment to the claims.
Rejection under 35 U.S.C § 103:
Applicant’s arguments, see page 6-7, filed on 06/02/2026, with respect to the rejection(s) of claim(s) 1, 5, 14, and 17 under 35 U.S.C § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of newly found prior art reference(s).
Claim Objections
Claim 13 objected to because of the following informalities:
In claim 13, “electronic” should recite “electric” or “electrical”.
Appropriate correction is required.
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 1 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 “stimulation via low-resistivity or highly conductive pathways” in claim 1 is a relative term which renders the claim indefinite. The term “low-resistivity” and “highly conductive” 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.
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(s) 1, 5, and 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20140214120 A1 to Simon et al. (hereinafter “Simon”) in view of KR 102499241 B1 to Yoon (hereinafter “Yoon”).
Regarding Claim 1, Simon teaches a method (see Abstract and Para 17) comprising: placing one or more electrodes on an exterior surface of a skull or scalp of a subject;
placing one or more electrodes into a cavity in a head of the subject transnasally or transorally but not in contact with a brain of the subject (see Para 17: “advanced an electrode lead or leads transnasally to a target site at or adjacent to a nerve within the patient. In preferred embodiment, the electrode lead(s) are delivered through one or both nostrils of the patient to the nasopharyngeal mucosa posterior to the middle turbinate adjacent to the SPG”, and Para 46-49, Fig 3-4); and
delivering stimulation via low-resistivity or highly conductive pathways (see Para 49: “through the nasal cavity and sphenoid sinus in FIG. 5”) defined in the head of the subject to a target brain structure using the exterior and interior electrodes (see Para 45: “use electrical stimulation to modulate, stimulate, reversibly inhibit and/or block activity of the SPG or other branches of cranial nerves.”, also Para 18: “a stimulation device comprises one or more electrodes”, and Para 47-52, Fig 3-6B).
Simon teaches placing one or more electrode into a cavity (nasal cavity) transnasally to deliver stimulation to a targeted are. However, does not teach placing one or more electrodes on skull or scalp.
Another reference, Yoon teaches an invention related to an electrode device configured to allow insertion of electrodes at desired locations within the nasal cavity (see Abstract), where placing one or more electrodes on an exterior surface of a skull or scalp of a subject (see Attached doc: “the scalp electrode 1 located on the skull”, also Fig. 1 and 7);
placing one or more electrodes into a cavity in a head of the subject transnasally or transorally but not in contact with a brain of the subject (see Attached doc: “the implantable electrode device 2 in the nasal cavity of the present invention can measure an electroencephalogram signal or an electrical impedance signal in parallel with the scalp electrode 1 located on the skull”, also Fig. 1 and 6).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant's effective filing date to modify the disclosure of Simon with the teaching of Yoon to combine scalp electrodes with transnasal electrodes to improve signal acquisition from deep brain structure, also to enhance stimulation coverage and improve targeting while utilizing electrode configurations. Signals from deep brain structures can be more accurately measured in parallel with the electrode deposed on the scalp.
Regarding Claim 5, Simon teaches a method wherein at least some of the transnasally/transorally-placed electrodes are placed in the olfactory cleft (see Para 49: “the stimulator is advanced on a path through the nostril and along the superior border of the middle turbinate, until it reaches the posterior wall of the nasopharynx in the vicinity of the SPG.”). However, does not specify the placement of the electrode with in the olfactory but pass through the path.
However, Yoon teaches an invention related to an electrode device configured to allow insertion of electrodes at desired locations within the nasal cavity (see Abstract), wherein at least some of the transnasally/transorally-placed electrodes are placed in the olfactory cleft (see Attached doc: “the intranasal implantable electrode device 2 of the present invention may be positioned close to the ethmoid plate (Cribriform plate of ethmoide bone). There is an ethmoid plate, which is a perforated structure for connecting the olfactory nerve, in the skull between the nasal cavity and the brain, and when electrodes are placed in this area, there is an advantage in that signals can be measured with high conductivity (the olfactory cleft is close proximity to cribriform plate of ethmoide bone)”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date to modify the disclosure of Simon and combine with Yoon to place at least some transnasally placed electrode within the olfactory cleft. Such modification of selective anatomical placement location for electrode would improve electrical conductivity, signal measurement, and delivering stimulation due to the proximity to olfactory nerve.
Regarding Claim 9, Simon further teaches the modified method of claim above, wherein the transnasally/transorally-placed electrodes are battery powered or powered wirelessly (see Para 18: “a stimulation device comprises one or more electrodes … the power source may also be implanted with the stimulation device or at another location … the energy that is used to produce the impulses is received wirelessly by a dipole or other type of antenna that is also part of the stimulator”, also Para 19, 58-59, 69).
Regarding Claim 10, Simon further teaches the modified method of claim above, wherein the stimulation is an electric field (see Para 20: “The stimulator is configured to … produce an electric field in the vicinity of the nerve …”, also Para 79, 101).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Yoon as applied to claim 1 above, and further in view of US 20120323214 A1 to Shantha (hereinafter “Shantha”).
Regarding Claim 2, Simon in view of Yoon, teach the modified method as discussed above, but fails to teach at least some of the transnasally/transorally-placed electrodes are placed under the cribriform plate.
However, Shantha teaches a method for treating diseases of the central nervous system (CNS) (see Para 1) wherein at least some of the transnasally/transorally-placed electrodes are placed under the cribriform plate (see Para 166: “FIG. 1 is the diagram of the lateral and medial wall of the nasal cavity 100, presenting the area covered by the olfactory regions mucosa (ORE) all the way to the cribriform plate of the ethmoid bone 8. It illustrates the ORE with various nerve structures (shown in black surface with white lines) that therapeutic agents and electrical impulses come in contact with,”, also Para 169: “The delivery of therapeutic agents pass through the olfactory bulb 35 transported by the olfactory mucosa and olfactory nerves 105 passing through the cribriform plate of the ethmoid bone 8”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date to combine the modified disclosure of Simon with the teaching of Shantha to have therapeutic agents and electrical impulses to come in contact with the treatment area.
Regarding Claim 3, Simon in view of Yoon, teach the modified method as discussed above, but fails to teach electrodes placed under the cribriform plate direct energy along pathways defined by foramina in the cribriform plate.
However, Shantha teaches a method for treating diseases of the central nervous system (CNS) (see Para 1) wherein electrodes placed under the cribriform plate direct energy along pathways defined by foramina in the cribriform plate (see Para 175: “This positioning between the sphenoid sinus 524 and the nasal balloon 519 will keep the Iontophoresis stimulating part and the therapeutic agents delivery part of the device 520 located firmly in the desired location i.e. on the olfactory nerve mucosa close to the cribriform plate of the ethmoid bone”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date to combine the modified disclosure of Simon with the teaching of Shantha to direct therapeutic energy in desired location along the defined pathways.
Regarding Claim 4, Simon in view of Yoon, teach the modified method as discussed above, but fails to teach at least some of the transnasally/transorally-placed electrodes direct energy along pathways defined by foramina in the skull base.
However, Shantha teaches a method for treating diseases of the central nervous system (CNS) (see Para 1) wherein at least some of the transnasally/transorally-placed electrodes direct energy along pathways defined by foramina in the skull base (see Para 175: “This positioning between the sphenoid sinus 524 and the nasal balloon 519 will keep the Iontophoresis stimulating part and the therapeutic agents delivery part of the device 520 located firmly in the desired location i.e. on the olfactory nerve mucosa close to the cribriform plate of the ethmoid bone as shown in the diagram. The electrical impulses delivered to create Iontophoresis also pass (spillover effect) from this device to the sphenopalatine ganglion 110 and to the anterior ethmoidal nerve 107 and sphenoid sinus neural components.”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date to combine the modified disclosure of Simon with the teaching of Shantha to direct therapeutic energy along the pathways in desired location.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Yoon as applied to claim 1 above, and further in view of US 20100010564 A1 to Simon. (hereinafter “Simon2”).
Regarding Claim 6, Simon in view of Yoon, teach the modified method as discussed above, but fails to teach at least some of the transnasally/transorally-placed electrodes are placed in one or more of the frontal, ethmoidal and sphenoid sinuses.
However, Simon2 teaches a method for treating nerve disorders (see Abstract) wherein at least some of the transnasally/transorally-placed electrodes are placed in one or more of the frontal, ethmoidal and sphenoid sinuses (see Para 59: “an electrode is introduced through the nostril 922 of the patient and advanced into one of the sinus cavities such as the front sinus 904 or the sphenoid sinus 908.”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date to combine the modified disclosure of Simon with the teaching of Simon2 to place the electrodes in one or more sinus cavity for delivering the appropriate electrical impulse from the sinus cavities to the target location in the brain (see Para 59).
Regarding Claim 7, Simon in view of Yoon, teach the modified method of claim 1 as discussed above, but fails to teach the transnasally/transorally-placed electrodes are disposed on a balloon that can be inflated after insertion into the cavity.
However, Simon2 teaches a method for treating nerve disorders (see Abstract) wherein the transnasally/transorally-placed electrodes are disposed on a balloon (see Para 13: “a balloon, is introduced into a sinus cavity … the electrical energy is applied to an electrode positioned within the balloon … the electrode comprises part or all of the balloon's outer wall”) that can be inflated after insertion into the cavity (see Para 16: “a balloon, that is movable from a deflated position for introduction through one of the patient's nostrils into a sinus cavity to an inflated position wherein at least a portion of the outer wall of the balloon contacts target tissue within sinus.”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date to combine the modified disclosure of Simon with the teaching of Simon2 to allows the balloon to conform to tissue within the sinus cavity also in the inflated position, has a larger tissue contact area than the electrode, which allows the device to be applied to a larger tissue treatment area (see Para 16).
Claims 8, 11-12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Yoon as applied to claim 1 and 10 above, and further in view of US 20230075205 A1 to Moran et al. (hereinafter “Moran”).
Regarding Claim 8, Simon in view of Yoon, teach the modified method of claims as discussed above, but fails to teach that the transnasally/transorally-placed electrodes are configured as a 2-dimensional or 3-dimensional array.
However, Moran teaches a system including intra-calvarial implants capable of stimulating (see Abstract) wherein the transnasally/transorally-placed electrodes are configured as a 2-dimensional or 3-dimensional array (see Para 15: “the implants include a 2D array of electrodes including a plurality of current passing (stimulating and or inhibiting) electrodes”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date to combine the modified disclosure of Simon with the teaching of Moran to allow stimulation/inhibition of quite small and well-defined volumes and the implants may be able to reduce undesired stimulation/inhibition (see Para 107).
Regarding Claim 11, Simon in view of Yoon, teach the modified method as discussed above, but fails to teach the electric field is steerable after insertion of the electrodes.
However, Moran further teaches a system including intra-calvarial implants capable of stimulating (see Abstract) wherein electric field is steerable after insertion of the transnasally/transorally-placed electrodes (see Para 12: “an intra-calvarial implant performing current steering through the calvarial bone (or the inner table of the calvarial bone) with an electrode array that is not in contact with the cortical target regions to be stimulated”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date to combine the modified disclosure of Simon with the teaching of Moran to deliver stimulating currents fitted to the detected position of the stimulation target (see Para 12).
Regarding Claim 12, Simon in view of Yoon, teach the modified method as discussed above, but fails to teach the electric field is steered using a beamforming process.
However, Moran teaches a system including intra-calvarial implants capable of stimulating (see Abstract) wherein the electric field is steered using a beamforming process (see Para 21: “processing the recorded electrical signals to compute spatial parameters representing the spatial distribution of the magnitude of … the cortical region to be stimulated, … including a plurality of simulated current spatial distribution data sets or datasets derived from the plurality of simulated current spatial distribution sets, a matched data set of stimulation parameters to be applied to the plurality of stimulating electrodes responsive to the spatial parameters representing the spatial distribution of the at least one biomarker computed in the step of processing, and applying to the cortical region stimulating electrical signals using the matched set of stimulation parameters selected in the step of selecting.”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date to combine the modified disclosure of Simon with the teaching of Moran to predict which areas are depolarized (activated) or hyperpolarized (inhibited) which in turn predicts which areas are activated (see Para 161).
Regarding Claim 15, Simon in view of Yoon, teach the modified method as discussed above, but fails to teach the electrodes are also used for sensing a response to the stimulation.
However, Moran teaches a system including intra-calvarial implants capable of stimulating (see Abstract) wherein the transnasally/transorally-placed electrodes are also used for sensing a response to the stimulation (see Para 12: “the present invention is the first to implement current steering methods in combination with in-situ sensing of cortical electrical signals to detect dynamic time dependent changes in neural network anatomical location”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date to combine the modified disclosure of Simon with the teaching of Moran to be capable of acquiring and processing locally sensed electrical signals (see Para 181).
Claims 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Yoon as applied to claim 1 above, and further in view of US 20210267523 A1 to Donoghue et al. (hereinafter “Donoghue”).
Regarding Claim 13, Simon in view of Yoon, teach the modified method as discussed above, but fails to teach wherein the stimulation is electronic, magnetic, light, thermal or ultrasound.
However, Donoghue teaches a method directed to treating a patient brain disorder (see Para 4) wherein the stimulation is electronic, magnetic, light, thermal or ultrasound (see Para 21: “at least one stimulation element can be configured to deliver stimulation in a form selected from the group consisting of: electrical energy; magnetic energy; … light energy; … thermal energy; … ultrasound energy; … and combinations thereof.”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date to combine the modified disclosure of Simon with the teaching of Donoghue to be configured to deliver stimulation from multiple stimulation elements to the patient.
Regarding Claim 16, Simon in view of Yoon, teach the modified method as discussed above, but fails to teach the transnasally/transorally-placed probes are used for delivering light, ultrasound, to the brain or cranial nerves.
However, Donoghue teaches a method directed to treating a patient brain disorder (see Para 4) wherein the transnasally/transorally-placed probes are used for delivering light, ultrasound, to the brain or cranial nerves (see Para 114: “sensor 160 comprises … a stimulation delivery element (e.g. an element configured to deliver stimulation energy). … sensor 160 comprises one or more electrodes configured to … and deliver electrical energy to tissue. … sensor 160 is configured to provide stimulation by delivering to tissue a form of energy selected from the group consisting of: electrical energy; magnetic energy; … light energy; … ultrasonic sound energy; … and combinations of these. … Energy (e.g. stimulation energy) can be delivered to various tissue locations of the patient, such as brain tissue (e.g. cortex of the brain, deep brain nuclei) and other nerve tissue (e.g. vagal nerve tissue)”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date to combine the modified disclosure of Simon with the teaching of Donoghue to provide stimulation by delivering electrical energy to tissue in a form of energy selected from the group (see Para 114).
Claims 14 is rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Yoon as applied to claims 1 above, also in view of “Accessibility of cortical regions to focal TES: Dependence on spatial position, safety, and practical constraints” to Saturnino et al. (hereinafter “Saturnino”) and further in view of CN 106345056 A to Wang et al. (hereinafter “Wang”).
Regarding Claim 14, Simon teaches transnasally placed electrode system to deliver electrical stimulation to neural tissue but does not teach optimizing the placement and activation of the electrode using machine learning.
However, Saturnino disclose a method for computational optimization of transcranial electrical stimulation by determining optimal electrode location and current injection patterns to maximize stimulation (see attached doc), wherein placement and activation of the externally-placed electrodes and the transnasally/transorally-placed electrodes are optimized using machine learning models (see attached doc: “efficiency of the optimization algorithms, together with the practically meaningful and intuitive input parameters in our optimizations, allowed us to perform an extensive mapping of the optimizations and test the effect of various constraints and parameter choices across the entire cortex … the optimization of multi-electrode TES montages on a fine electrode grid (up to ~300 electrodes, Suppl. Figs. S2–S7), so that the optimization procedure can do fine adjustments of the positions of the active electrodes in order to obtain the most focal and intense electric fields …”).
Another reference, Wang disclose a deep brain stimulation electrode array optimizing system based on machine learning (see Abstract), where placement and activation of the externally-placed electrodes and the transnasally/transorally-placed electrodes are optimized using machine learning models (see attached doc “a machine learning-based deep brain stimulating electrode array optimization system … simulation electrode array at different space positions of three-dimensional nerve tissue conductivity model generating different intensity of the stimulation field … The invention introduces electrode array structure, by adjusting different on-off mode of electrode array …”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date to combine the modified disclosure of Simon with the teaching of electrode placement and stimulation/activation optimization algorithm taught by Saturnino and further implementing those optimization using machine learning based optimization system taught by Wang. This would enable automated and specific optimization of electrode placement and activation, thereby improve the effectiveness and precision of electrical brain stimulation by improving targeting accuracy and therapeutic efficacy.
Claims 17 is rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Yoon as applied to claims 1 above, and further in view of “A miniaturized wireless neural implant with body-coupled power delivery and data transmission” to Lee et al. (hereinafter “Lee”).
Regarding Claim 17, Simon teaches transnasally placed electrode system for neuromodulation and the stimulation device may be powered wirelessly by receiving electromagnetic energy from an external source through antenna associated with the stimulation device. However, does not expressly teach using transnasal electrode as part of a system for delivering wireless power to a brain implant.
Another reference Lee teaches a neural interface that operates wirelessly in power delivery and data transmission (see attached doc), wherein the transnasally/transorally placed electrodes are used for delivering power wirelessly to a brain implant (see attached doc: “a wireless neural implant that uses body-coupled (BC) power delivery and data transmission [Fig. 1(b)]. It exploits the body and brain as a wireless power/data transmission channel that experiences much less propagation loss in body tissues than the conventional RF telemetry. The unique property of the BC scheme allows the neural implant to require only small electrodes for both wireless power delivery and data transmission. In addition, the neural implant is compatible with different types of electrodes without the need for additional components, resulting in a small form factor …”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date to combine the modified disclosure of Simon with the teaching of wireless power delivery by Lee to have a minimally invasive neural stimulation systems employing implanted electrode. By incorporating the wireless power transfer technique would predictably enable the transnasal electrode to wirelessly deliver power to a brain implant, thereby eliminating wired connection, improving patient comfort and increasing longevity of implantable neuromodulation system.
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Yoon and Moran as applied to claims 1 and 11 above, and further in view of US 20230158314 A1 to Ahsan et al. (hereinafter “Ahsan”).
Regarding Claim 18, Simon in view of Yoon, teach the modified method as discussed above, but fails to teach that the stimulation may be directed to specific voxels within a brain.
However, Ahsan teaches a method for minimally invasive deep brain simulation (DBS) involves obtaining a target location for the DBS (see Abstract) wherein the stimulation may be directed to specific voxels within a brain (see Para 59: “the imported geometry of the human head model consists of 362×434×362 voxel values. Each voxel is a cell with dimensions of 0.05 cm×0.05 cm×0.05 cm, which translates to an overall spatial size of 18.1 cm×21.7 cm×18.1 cm for the human head model. The model provides tissue segmentation of voxels into the following 11 tissue types: CSF, grey matter, white matter, fat, muscle, muscle/skin, skull, vessels, connective tissue (around fat), dura mater, and bone marrow. Each voxel contains a value that corresponds to the tissue that contributes most to that voxel. Each voxel is assigned with its material properties of μ, ϵ, σ, ρ, C, k, and ω.sub.b.”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date to combine the modified disclosure of the method with the teaching of Ahsan to obtaining a target location for the DBS.
Regarding Claim 19, Simon in view of Yoon, teach the modified method as discussed above, but fails to teach that intensity of the stimulation may be optimized for a specific voxel within a brain.
However, Ahsan teaches a method for minimally invasive deep brain simulation (DBS) involves obtaining a target location for the DBS (see Abstract) wherein intensity of the stimulation may be optimized for a specific voxel within a brain (see Para 61: 2D simulation was first performed on that transversal slice to understand the effect of different antenna locations and optimizations on the intensity and focality of envelope signal stimulation. Next, more resource intensive 3D simulations were performed to verify the final design”, also see Para 70 and 78).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date to combine the modified disclosure of the method with the teaching of Ahsan to stimulate a targeted deep brain location.
Regarding Claim 20, Simon in view of Yoon, teach the modified method as discussed above, but fails to teach that focality of the stimulation may be optimized for a specific voxel within a brain.
However, Ahsan teaches a method for minimally invasive deep brain simulation (DBS) involves obtaining a target location for the DBS (see Abstract) wherein focality of the stimulation may be optimized for a specific voxel within a brain (see Para 61: 2D simulation was first performed on that transversal slice to understand the effect of different antenna locations and optimizations on the intensity and focality of envelope signal stimulation. Next, more resource intensive 3D simulations were performed to verify the final design” also Para 70-71 and 78).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date to combine the modified disclosure of the method with the teaching of Ahsan to drive neural activity in targeted deep brain regions.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 6922590 B1 – “systems and methods for introducing one or more stimulating drugs and/or applying electrical stimulation to one or more areas of the brain”.
US 20220117540 A1 – “Intracalvarial BCIs including electrodes and electrode arrays for implantation within the calvarial bone of a skull for recording electrical activity from brain tissues underlying the calvarial bone and/or for electrically stimulating brain tissues underlying the calvarial bone for treating numerous neuropsychiatric diseases”.
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.
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/I.J./Examiner, Art Unit 3792
/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
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