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 03/06/2026, has been entered. The examiner notes claims 33-46 are pending.
Response to Arguments
Applicant should submit an argument under the heading “Remarks” pointing out disagreements with the examiner’s contentions. Applicant must also discuss the references applied against the claims, explaining how the claims avoid the references or distinguish from them.
Election/Restrictions
Newly submitted claims 45 and 46 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: claims 45 and 46 are drawn to a kit for monitoring implantation of neural interface of a brain, which was not originally disclosed.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 45-46 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 41 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 “remote” in claim 41 line 2 is a relative term which renders the claim indefinite. The term “remote” 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. The distance the target region is from an object cannot be determined. Thus, the scope of the claim cannot be determined, rendering the claim indefinite.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 33-44 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Independent Claim 33 recites:
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;
deploying, using the endovascular delivery device, the neural interface comprising an electrode array configured to measure neural activity in the brain of the individual;
monitoring a position status of advancing the endovascular delivery device or deploying the neural interface;
measuring neural activity based on the position status with respect to the target brain region and a functional responsiveness to a task or stimulus to determine an association between the target brain region and the neural activity; and
performing at least one procedural action comprising: (…) confirming completion of implantation.
Step 1:
The examiner finds independent claim 33 is drawn to a method.
Step 2A Prong 1:
The above claim limitations constitute an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019.
“A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words ….” October 2019 Update: Subject Matter Eligibility, II. A. i. “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.” Id. at II. A. ii. “[A] claim does not have to recite the word “calculating” in order to be considered a mathematical calculation.” Id. at II. A. iii. See for example, SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018).
The claimed steps of “monitoring” and “confirming” recite mental processes. The examiner notes the steps of “advancing”, “deploying”, and “measuring” steps in claim 33 are found to be insignificant pre-solution activities.
The step of “monitoring a position status” in independent claim 33 is a mental process capable of being performed in the human mind. For example, the human mind is capable of monitoring the position of an object as it moves through space from one location to another. The step of “confirming completion” is a mental process capable of being performed in the human mind. For example, the human mind can confirm that a printer is finished printing job by confirming the motors have stopped running and paper has stopped being output.
The claimed steps of monitoring and confirming can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
“[T]he ‘mental processes’ abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions.” MPEP 2106.04(a)(2) III. The pending claims merely recite steps for estimation that include observations, evaluations, and judgments.
Examples of ineligible claims that recite mental processes include:
• a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind,
Electric Power Group, LLC v. Alstom, S.A.;
• claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind,
University of Utah Research Foundation v. Ambry Genetics Corp.
• a claim to collecting and comparing known information, which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
Regarding the dependent claims 34-44, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
Step 2A Prong 2:
This judicial exception (abstract idea) in Claims 18-23 and 25 is not integrated into a practical application because:
• The abstract idea amounts to simply implementing the abstract idea on a computing device. For example, the recitations regarding the generic computing components for measuring merely invoke a computer as a tool.
• The data-gathering step (measuring) and the data-output step do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
• There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computing device that is used as a tool for monitoring and confirming.
• The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to estimate bio-information.
• The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computing device for monitoring and confirming. The claims do not apply the obtained prediction to a particular machine. Rather, the data is merely output in a post-solution step.
Step 2B:
The additional elements are identified as follows: neural interface, an electrode array located on a microwire, microcatheter.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
• Applicant’s specification (e.g. paragraph [0008]) which discloses that neural interfaces are conventional to the field of endeavor.
• Nicolelis (US 20030093129 A1) which discloses the use of an electrode array located on a microwire as conventional ([0090] “Conventional neurosurgical techniques can be employed to implant microwire electrode arrays in appropriate brain areas”);
• Kaethner (US 20210298772 A1) which discloses the use of microcatheters are known in the art [0033 “…robotic catheter systems are known by which a (semi)automatic advance of a (micro)catheter and/or guidewire in a cavernous organ of a patient may be effected…”];
• Applicant’s Background in the specification.
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
Furthermore, the court decisions discussed in MPEP § 2106.05(d)(lI) note the well-understood, routine and conventional nature of such additional generic computer components as those claimed. See option III. A. 2. in the Berkheimer memorandum.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the units associated with the steps do not add meaningful limitation to the abstract idea. A computer, processor, memory, or equivalent hardware is merely used as a tool for executing the abstract idea(s). The process claimed does not reflect an improvement in the functioning of the computer.
When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Examiner’s Note
The examiner notes that, under BRI, the inclusion of the optional procedural action of “confirming completion of implantation” renders the 35 USC 101 rejection of claims 33-44 proper. However, the procedural actions of “adjusting a position of the endovascular delivery device” and/or “repositioning the neural interface” would integrate the judicial exception into a practical application if they were not optional limitations.
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 33, 41, and 43-44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oxley (WO 2013049887 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 [page 16 lns. 7-9, claim 33, Fig. 9, “advancing” is being interpreted as moving forward from one location to another];
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 a functional responsiveness 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”]; and
performing at least one procedural action comprising: adjusting a position of the endovascular delivery device based on the neural activity, repositioning the neural interface [page 19 lns. 11-15 “If a new location of the intravascular device is desired, the stent with intravascular device may be withdrawn back into the micro- tube 22, and the system 2 moved to a desired region where redeployment of the stent with intravascular device may then take place”], or confirming completion of implantation.
Regarding claim 41, Oxley teaches the method of claim 33, wherein advancing comprises advancing the neural interface into a remote location within the brain [page 16 lns. 7-9, claim 33, Fig. 9, “advancing” is being interpreted as moving forward from one location to another].
Regarding claim 43, Oxley teaches 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 teaches the method of claim 33, further comprising mapping the task or stimulus to one or more regions of the brain [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 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.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Oxley as applied to claim 33 above, and further in view of Morales (US 20220202486 A1).
Regarding claim 34, Oxley teaches 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 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 and Morales as applied to claim 34 above, and further in view of Mazar (US 20090076401 A1).
Regarding claim 35, Oxley 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 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 as applied to claim 33 above, and further in view of Dolev (US 20180014772 A1).
Regarding claim 36, Oxley teaches the method of claim 33, wherein monitoring a status comprises monitoring during the operative procedure [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 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 as applied to claim 33 above, and further in view of Ludvig (US 20070060973 A1) and Dolev.
Regarding claim 37, Oxley teaches the method of claim 33, further comprising administering a substance associated 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 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 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, 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, 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, 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 as applied to claim 33 above, and further in view of Hendler (US 20140148657 A1).
Regarding claim 40, Oxley teaches 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 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 as applied to claim 33 above, and further in view of Hartig (US 20170136238 A1).
Regarding claim 42, Oxley teaches 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 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
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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571)272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN M HANEY/Examiner, Art Unit 3791
/JUSTIN XU/Primary Examiner, Art Unit 3791
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