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 .
Information Disclosure Statement
The information disclosure statements filed 11 September 2025 and 30 October 2025 fail to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because no IDS fee was paid. They have been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in these information disclosure statements or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 3-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The originally filed disclosure fails to provide adequate written description for determining a level of confidence based on a determined correspondence between neural activity and an action. The specification does not provide an adequate description of how a level of confidence is determined. Paragraph [0069] of the filed specification states “A confidence level may be determined from the model situation, based on the behavioral paradigm.”, but fails to provide details of how the confidence level is determined. Paragraph [0070] discloses using a machine learning algorithm to determine what electrical activity corresponds to an action, and implies that somehow a mapping of an electrode is deemed “reliable”, but fails to describe how the mapping of the electrode is deemed reliable (“Since the electrical activity corresponded to speaking, the mapping of the electrode is deemed reliable” does not describe how the mapping of the electrode is deemed reliable). Paragraphs [0072-0073] appear to attempt to describe determining whether electrode positions are correct, but they, too, fail to describe determining a level of confidence based on a determined correspondence between neural activity and an action.
Further regarding claim 1, the claim recites that the method for cortical mapping comprises repositioning the electrode array to a second position on the cortical surface in response to a level of confidence falling short of a predetermined threshold. As best understood by the specification (sections [0065-0073] of the published specification), the repositioning of the electrode array in response to a confidence level falling short of a predetermined threshold is performed after cortical mapping has been performed. While sections [0065], [0067], and [0071-0073] mention repositioning the electrode array based on the “strength and fidelity” of a signal acquired from the electrode array, there is no clear discussion of, during cortical mapping, determining a level of confidence based on a decoded correspondence between neural activity and an action, and repositioning an electrode array in response to the determined level of confidence falling short of a predetermined threshold.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 3-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 recites that an electrode array is implanted both proximate to a brain of a patient and on a cortical surface. It is unclear how an electrode array would be implanted both proximate to a brain of a patient and on a cortical surface. For the purpose of examination, the claim is being interpreted such that the electrode array is implanted either proximate to the brain of the patient or at a first portion on a cortical surface.
Claims not explicitly rejected above are rejected due to their dependence on a rejected base claim.
Examiner’s Note
The following is a reason for the lack of prior art rejections against the claims: None of the prior art discloses or suggests, either alone or in combination, a method for cortical mapping comprising implanting an electrode array both proximate to the brain of a patient and on a cortical surface, in combination with the other claimed steps. Furthermore, none of the prior art discloses or suggests, either alone or in combination, a method for cortical mapping comprising repositioning an electrode array to a second position on a cortical surface response to a level of confidence falling short of a predetermined threshold, in combination with the other claimed elements.
Response to Arguments
Applicant's arguments filed 21 November 2025 have been fully considered and they are not persuasive.
Regarding the rejection of the claims under 35 U.S.C. 112(a), Applicant argues that paragraphs [0034] and [0080] provide adequate written description for how the claimed level of confidence is determined. The Examiner respectfully disagrees. Paragraph [0034] states that “the level of confidence is based on the correspondence”, but fails to detail how. Paragraph [0080] states that “The level of confidence may be based on the correspondence. For example, in the monitoring stage 220, software may determine a level of confidence. The level of confidence may be based on the correspondence between the neural activity relating to the action performed in step 306 such as speaking, moving a foot, moving an arm, or the like.” None of the three sentences in paragraph [0080] describe how the level of confidence is determined. A person of ordinary skill in the art, having read the entire specification, would not be enabled to make and use the claimed invention as it is entirely unclear as to how to determine the claimed level of confidence.
Regarding the rejections of claims 8 and 11 under 35 U.S.C. 112(b), Applicant’s amendments have obviated the rejections. However, as noted in paragraph 6 above, the amendments to claim 1 have warranted a new rejection under 35 U.S.C. 112(b).
Regarding the rejection of the claims under 35 U.S.C. 101, the amendments to the claims have overcome the rejection. The recitation of implanting and repositioning an electrode array through a cranial slit provides an improvement to the current technology.
Regarding the rejections of the claims in view of the previously cited prior art, the amendments to the claims have overcome the rejections.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ho et al. (The Layer 7 Cortical Interface:…) provides motivation to implant an electrode array comprising a flexible substrate and a plurality of electrodes through a cranial slit onto a cortical surface. Arya et al.’061 (WO 2021/174061 – previously cited) in view of Cogan et al.’805 (US Pub No. 2022/0370805 – previously cited), as discussed in the Non-Final Rejection mailed out 21 August 2025, discloses a method for cortical mapping of a brain of a patient comprising implanting an electrode array proximate to the brain of the patient at a first position, wherein the electrode array comprises a flexible substate and a plurality of electrodes arranged on the flexible substrate, monitoring electrophysiological activity by prompting the patient to perform or imagine performing an action over a period of time, recording neural activity exhibited by the patient, decoding the neural activity to determine a correspondence between the neural activity and the action, determining a level of confidence based on the correspondence, and recording in a map both the level of confidence and the correspondence between the neural activity and the action. Pallud et al. (Direct electrical bipolar electrostimulation… – previously cited) teaches that is known in the art to perform cortical mapping of a brain of a patient while the patient is awake, wherein the cortical mapping includes recording neural activity from different cortical sites while the patient performs specific tasks (see section 6.4 Intraoperative functional cortical mapping beginning on page 169). Wu et al.’457 (US Pub No. 2016/0120457 – previously cited) teaches removing implanted electrodes that are used for brain mapping after a target region of the brain has been accurately identified. Brunner et al.’264 (US Pub No. 2022/0218264 – previously cited) teaches recording, via an implantable electrode array, neural activity of a patient for the purposes of cortical mapping, the recording lasting for “around one week according to clinical indications”. Uy et al. (Stability of Maps… – previously cited) teaches performing cortical mapping for at least seven days. Ogawa et al. (Rapid and Minimum Invasive… – previously cited) teaches performing cortical mapping during awake craniotomy.
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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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791