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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/20/2026 has been entered.
Response to Arguments
Applicant’s arguments, see Remarks page 6, filed 07/20/2026, with respect to the 35 USC 112(b) rejection of claim 41 has been fully considered and is persuasive. The applicant has amended claim 41 to resolve the 35 USC 112(b) rejection. The 35 USC 112(b) rejection of claim 41 has been withdrawn.
Applicant’s arguments, see Remarks pages 6-7, filed 07/20/2026, with respect to the 35 USC 101 rejection of claims 33-44 have been fully considered and are persuasive. The examiner notes the claims are drawn into eligible subject matter at step 2B of the Alice/Mayo test, as the amended step of “post-operatively detecting neural activity at the target brain region, wherein the individual actively controls an external device based on the post-operatively detected neural activity of the target brain region” cannot reasonably be interpreted as well-understood, routine, or conventional. The 35 USC 101 rejection of claims 33-44 has been withdrawn.
Applicant’s arguments, see Remarks pages 7-9, filed 07/20/2026, with respect to the rejection(s) of claim(s) 33-44 under 35 USC 102/103 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 Therefore, the rejection has been withdrawn.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 Waziri (US 20210236037 A1), Cinbis (US 20130027186 A1), and Digiovanna (US 20100137734 A1).
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 33, 41, and 43-44 are rejected under 35 U.S.C. 103 as being unpatentable over Oxley (WO 2013049887 A1) in view of Waziri (US 20210236037 A1), Cinbis (US 20130027186 A1), and Digiovanna (US 20100137734 A1).
Regarding claim 33, Oxley teaches a method of monitoring implantation of a neural interface in a brain of an individual, the method comprising:
advancing an endovascular delivery device through a vasculature of the individual to position the endovascular delivery device in a cerebral vessel adjacent a target brain region during an operative procedure [page 16 lns. 7-9, claim 33, Fig. 9, “advancing” is being interpreted as moving forward from one location to another, the examiner notes that “placement into an animal vessel” requires and “operative procedure”, see also Fig . 9];
deploying, using the endovascular delivery device, the neural interface comprising an electrode array configured to measure neural activity in the brain of the individual [page 28 lns. 20-22];
monitoring a position status of advancing the endovascular delivery device or deploying the neural interface [page 18 lns. 4-6];
measuring neural activity based on the position status with respect to the target brain region and responsive to a task or stimulus to determine an association between the target brain region and the neural activity [page 13 lns. 20-22 “The method may comprise sensing changes in electrical activity in the pre central gyrus resulting from attempted movement of natural, absent, or artificial body parts”].
Oxley teaches measuring neural activity but fails to explicitly teach measuring neural activity during the operative procedure using a monitoring device.
Waziri teaches measuring neural activity during the operative procedure [0048-0049 “…the implantable electrode array and/or the system as described herein can be used to: a. measure brain activity during an endovascular procedure…”] using a monitoring device [0048 “electrode array”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Oxley and incorporate the teachings of Waziri to include measuring neural activity during the operative procedure using a monitoring device. Doing so configures the system to monitor the patient undergoing the procedure to prevent/minimize injury during any point of the operation.
The combination of Oxley and Waziri teach measuring neural activity during the operative procedure but fails to explicitly teach confirming completion of implantation based on the measuring neural activity.
Cinbis teaches confirming completion of implantation of an implant [0055 “…a continuous beacon signal listening mode is enabled only prior to and up to implantation of the device (…) such that communication may be initiated with the sensing device 12 when needed to perform calibration operations, perform implant testing and measurements, and/or confirm a desired implant location”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the teachings of Oxley and Waziri to include the teachings of Cinbis to include confirming completion of implantation based on the measuring neural activity. Doing so ensures the system to placed in an optimal location to provide accurate results and minimize patient discomfort/injury.
Oxley teaches deploying a neural interface in the brain of an individual but fails to teach post-operatively detecting neural activity at the target brain region, wherein the individual actively controls an external device based on the post-operatively detected neural activity of the target brain region.
Digiovanna teaches post-operatively detecting neural activity at the target brain region [0007 “…a Brain Machine Interface (BMI) agent, that when operatively coupled to a subject during a mental task by the subject to control a prosthetic device, monitors one or more states of neural activity of the subject…”], wherein the individual actively controls an external device based on the post-operatively detected neural activity of the target brain region [0007 “…a mental task by the subject to control a prosthetic device…”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Oxley and incorporate the teachings of Digiovanna to include post-operatively detecting neural activity at the target brain region, wherein the individual actively controls an external device based on the post-operatively detected neural activity of the target brain region. Doing so configures the system to receive “…feedback (e.g. reward) associated with a behavior of the prosthetic device responsive to the control, learns a functional mapping between the mental task and the behavior in view of the feedback, and applies control actions to the prosthetic device in accordance with the learned functional mapping to maneuver the prosthetic device for a targeted behavior”, as recognized by Digiovanna par. 0007.
Regarding claim 41, Oxley, Waziri, Cinbis, and Digiovanna teach the method of claim 33, wherein advancing comprises advancing the neural interface into the cerebral vessel adjacent the target brain region [Oxley page 20 lns. 12-14 “Depending on its location and function, neural tissue of the brain adjacent the intravascular device may be stimulated, or electrical activity in this tissue may be changed…”].
Regarding claim 43, Oxley, Waziri, Cinbis, and Digiovanna teach the method of claim 33, wherein deploying the neural interface comprises positioning a plurality of neural interfaces within a plurality of vessels in the brain surrounding the target brain region [Oxley page 9 lns. 8-11 “The system may comprise multiple intravascular devices retained at various regions in one or more animal vessels. Thus, electrical activity of various regions of neural tissue proximate the intravascular devices may be sensed or stimulated”].
Regarding claim 44, Oxley, Waziri, Cinbis, and Digiovanna teach the method of claim 33, further comprising mapping the task or stimulus to one or more regions of the brain [Oxley page 12 lns. 16-19 “The method may comprise mapping quantities or properties of sensed or stimulated neural tissue. A property may comprise function. Thus, the method may comprise mapping the function of sensed or stimulated neural activity”].
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Oxley, Waziri, Cinbis, and Digiovanna as applied to claim 33 above, and further in view of Morales (US 20220202486 A1).
Regarding claim 34, Oxley, Waziri, Cinbis, and Digiovanna teach the method of claim 33, wherein Oxley teaches an endovascular delivery device, but fails to teach the endovascular delivery device comprises a microcatheter, wherein the microcatheter restrains an electrode portion of the neural interface until deployed.
Morales teaches the endovascular delivery device comprises a microcatheter [col. 132 “microcatheter”], wherein the microcatheter restrains an electrode portion of the neural interface until deployed [0137 “…the advanced functionality catheter may be used to perform intracranial transvascular direct brain access procedures (e.g., biopsy, electrode placement…”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Oxley, Waziri, Cinbis, and Digiovanna and incorporate the teachings of Morales to include the endovascular delivery device comprises a microcatheter, wherein the microcatheter restrains an electrode portion of the neural interface until deployed. Doing so configures the method to be minimally invasive to the patient while having a delivery system with enhanced navigation through complex vascular systems, reducing the risk of vessel damage and improving procedural safety.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Oxley, Waziri, Cinbis, Digiovanna, and Morales as applied to claim 34 above, and further in view of Mazar (US 20090076401 A1).
Regarding claim 35, Oxley, Waziri, Cinbis, Digiovanna, and Morales teach the method of claim 34, wherein Oxley further teaches deploying the neural interface [page 30 lns. 9-10 “…the intravascular device 4 is retained in a location within a vessel for testing”], but fails to teach applying a current to transform the electrode portion to anchor the neural interface.
Mazar teaches applying a current to transform the electrode portion to anchor the neural interface [0054 “The injectable system may contain one of the following features to facilitate subsequent extraction: an isodiametric profile, a breakaway anchor, a bioabsorbable material, coatings to limit tissue in-growth, and an electrically activated or fusable anchor”, see also 0057 “…an injectable detecting system 12 that includes a plurality of sensors 14 and/or electrodes…”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Oxley, Waziri, Cinbis, Digiovanna, and Morales and incorporate the teachings of Mazar to include applying a current to transform the electrode portion to anchor the neural interface. Doing so configures the system to deploy the anchor with reduced procedural risk by providing precise electro-controlled deployment that lowers the likelihood of paravalvular leakage or anchor displacement.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Oxley, Waziri, Cinbis, and Digiovanna as applied to claim 33 above, and further in view of Dolev (US 20180014772 A1).
Regarding claim 36, Oxley, Waziri, Cinbis, and Digiovanna teach the method of claim 33, wherein monitoring a status comprises monitoring during the operative procedure [Oxley page 19 lns. 26-27 “…for short term recording and monitoring during the angiography procedure”], but fails to teach the monitoring is specifically neural activity of the brain during a procedure.
Dolev teaches measuring neural activity during the procedure [0011 “… measuring a neural activity response to the examinatorial stimulation includes obtaining electroencephalogram (EEG) measurements indicative of a neural activity in the brain of the user during and/or after inducing the examinatorial stimulation”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Oxley, Waziri, Cinbis, and Digiovanna and incorporate the teachings of Dolev to include measuring neural activity during the procedure. Doing so configures the system to provide feedback to the physician/team during the procedure to detect changes in neural function which may aid in the prevention of irreversible neural damage to the patient.
Claims 37 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Oxley, Waziri, Cinbis, and Digiovanna as applied to claim 33 above, and further in view of Ludvig (US 20070060973 A1) and Dolev.
Regarding claim 37, Oxley, Waziri, Cinbis, and Digiovanna teach the method of claim 33, further comprising administering a substance into the target brain region [Oxley page 18 lns. 7-26], but fails to explicitly teach monitoring neural signals before, during, and after administration of the substance.
Ludvig teaches measuring the neural activity before the medical procedure [0049 “…base line cortical EEG activity for the test subject (e.g., a monkey) is recorded while none of the abnormal brain activity to be treated is present (e.g., before administering an agent designed to bring on a specific abnormal brain activity (e.g., an epileptogenic agent such as penicillin))”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Oxley, Waziri, Cinbis, and Digiovanna and incorporate the teachings of Ludvig to include measuring the neural activity before the medical procedure. Doing so configures the system to record a baseline measurement to be used as a comparison during and/or after treatment/assessment.
Dolev teaches measuring neural activity during and after the procedure [0011 “… measuring a neural activity response to the examinatorial stimulation includes obtaining electroencephalogram (EEG) measurements indicative of a neural activity in the brain of the user during and/or after inducing the examinatorial stimulation”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Oxley, Waziri, Cinbis, and Digiovanna and incorporate the teachings of Dolev to include measuring neural activity during and after the procedure. Doing so configures the system to provide feedback to the physician/team during the procedure to detect changes in neural function which may aid in the prevention of irreversible neural damage to the patient.
Regarding claim 39, Oxley, Waziri, Cinbis, Digiovanna, Ludvig, and Dolev teach the method of claim 37, wherein the combination of Oxley and Dolev further teach measuring the neural activity with the neural interface [Dolev 0011 “… measuring a neural activity response to the examinatorial stimulation includes obtaining electroencephalogram (EEG) measurements indicative of a neural activity in the brain of the user during and/or after inducing the examinatorial stimulation”] after administering the substance [Oxley page 18 lns. 7-26].
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Oxley, Waziri, Cinbis, and Digiovanna, Ludvig, and Dolev as applied to claim 37 above, and further in view of Pile-Spellman (Pile-Spellman, John M.D., Adenosine-induced Cardiac Pause for Endovascular Embolization of Cerebral Arteriovenous Malformations: Technical Case Report. Neurosurgery 44(4): p 881-886, April 1999).
Regarding claim 38, Oxley, Waziri, Cinbis, Digiovanna, Ludvig, and Dolev teach the method of claim 37, wherein Oxley teaches injecting a substance, but fail to teach the substance is an anesthetic injected into an artery targeted for embolization.
Pile-Spellman teaches the substance is an anesthetic injected into an artery targeted for embolization [page 6/15 para. 1].
It would have been obvious to one of ordinary skill before the effective filling date of the claimed invention to modify the injectable substance of Oxley to be an anesthetic for injecting an anesthetic into an artery targeted for embolization, because doing so may help patients harboring cerebral arteriovenous malformations (AVMs), as recognized by Pile-Spellman [pg 3/15, second paragraph under Conclusion], and to reduce patient discomfort caused during embolization.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Oxley, Waziri, Cinbis, and Digiovanna as applied to claim 33 above, and further in view of Hendler (US 20140148657 A1).
Regarding claim 40, Oxley, Waziri, Cinbis, and Digiovanna teach method of claim 33, wherein Oxley teaches measuring neural activity, but fails to teach indicating a brain region in which a task-related activity occurs based on the neural activity.
Hendler teaches indicating a brain region in which a task-related activity occurs based on the neural activity [0065 “…a frequency and time function of electrical signal measured from a set of locations in the subject's brain corresponding to a certain brain condition (e.g. in response to stimulus), the predetermined signature being indicative of a spatial neural activation of one or more regions in a subject brain corresponding to individual functions of the brain while under the certain brain condition and thus corresponding to a predicted certain activity state related to a certain brain condition…”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Oxley, Waziri, Cinbis, and Digiovanna and incorporate the teachings of Hendler to include indicating a brain region in which a task-related activity occurs based on the neural activity. Doing so configures the system to diagnose and/or monitor a patient’s abnormalities to aid in the tracking of the patient’s disease progression.
Claim 42 is rejected under 35 U.S.C. 103 as being unpatentable over Oxley, Waziri, Cinbis, and Digiovanna as applied to claim 33 above, and further in view of Hartig (US 20170136238 A1).
Regarding claim 42, Oxley, Waziri, Cinbis, and Digiovanna teach the method of claim 33, wherein Oxley teaches advancing the neural interface into the target brain region, but fails to teach the target brain region is associated with at least one cytoarchitecture region of the brain.
Hartig teaches the target brain region is associated with at least one cytoarchitecture region of the brain [0075 “Based on the cytoarchitecture of the layers in the ventro-dorsal plane, the insular cortex 300 is sub-divided into three zones that form concentric layers, namely the rostroventral agranular zone, the caudodorsal granular zone, and the intermediate dysgranular zone”, see also abstract “An electrode lead is surgically implanted in a region of the insular cortex to deliver electrical stimulation”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Oxley, Waziri, Cinbis, and Digiovanna and incorporate the teachings of Hartig to include the target brain region is associated with at least one cytoarchitecture region of the brain. Doing so configures the system to offer a more comprehensive understanding of the brain’s architecture and pathology, which leads to a more accurate diagnosis and/or treatment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HANEY whose telephone number is (571)272-0985. The examiner can normally be reached Monday through Friday, 0730-1630 ET.
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/JONATHAN M HANEY/Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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