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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/26/25 has been entered.
Claim Rejections - 35 USC § 102
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)(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.
Claim(s) 1, 5-19, and 21-24 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Dinsmoor (US 20240075286 A1).
For claim(s) 1, 18, and 19, Dinsmoor teaches A method, comprising:
receiving a trigger signal indicative of a trigger to evaluate sensing capabilities of sensing-capable electrodes; [¶¶52-56]
responding to the received trigger signal by measuring an impedance corresponding to each of at least one of the sensing-capable electrodes, [¶¶57-60 and ¶¶64-75]
and evaluating the measured impedance against threshold values to assess or reassess which of the sensing-capable electrodes are available to be activated for sensing evoked compound action potentials (ECAPs), [selection in ¶¶68-71 means that unselected electrodes are unused and thus ‘disabled’ from providing input for subsequent calculations]
wherein a controller is configured to remove at least one electrode from the sensing-capable electrodes that are available to be activated or add at least one electrode to the sensing-capable electrodes that are available to be activated based on the evaluating the measured impedance against the threshold values; [selection (a form of activation) in ¶¶67-71 then ¶¶101-112]
activating at least one of the sensing-capable electrodes that are available to be activated and sensing the ECAPs using the activated at least one of the sensing-capable electrodes. [selection (a form of activation) in ¶¶67-71]
For claim 5, Dinsmoor teaches The method of claim 1,
further comprising receiving a user-input via a user input,
wherein the trigger signal is indicative of the user input. [¶¶67-71]
For claim 6, Dinsmoor teaches The method of claim 1,
further comprising accessing a scheduled programmed in a memory, wherein the trigger signal is provided in accordance with the programmed schedule. [¶¶90-92]
For claim 7, Dinsmoor teaches The method of claim 1,
further comprising using at least one sensor to sense at least one physiological parameter and providing the trigger signal based on the sensed at least one physiological parameter. [¶88, ¶109]
For claim 8, Dinsmoor teaches The method of claim 1,
further comprising monitoring the sensed ECAPs and providing the trigger signal based on the monitored sensed ECAPs. [¶109]
For claim 9, Dinsmoor teaches The method of claim 1,
further comprising reconfiguring sensing configurations to create a different differential pair when at least one electrode in an existing differential pair is to be removed. [pairing in ¶¶100-112 in view of ¶¶67-71]
For claim 10, Dinsmoor teaches The method of claim 1,
further comprising reconfiguring sensing configurations to automatically replace a single electrode when another single electrode is removed. [relative selection in ¶94 is replacing of electrodes]
For claim 11, Dinsmoor teaches The method of claim 1,
further comprising generating a sensing map report that identifies at least one electrode added to the sensing-capable electrodes that are available to be activated for sensing ECAPs. [¶94, ¶¶101-112]
For claim 12, Dinsmoor teaches The method of claim 1,
further comprising generating a sensing map report that identifies at least one electrode removed from the sensing-capable electrodes that are available to be activated for sensing ECAPs. [¶¶101-112]
For claim 13, Dinsmoor teaches The method of claim 1,
further comprising generating a sensing map report that identifies the sensing-capable electrodes that are available to be activated for sensing ECAPs. [¶¶101-112]
For claim 14, Dinsmoor teaches The method of claim 1,
wherein the evaluating the sensing capabilities of the sensing-capable electrodes includes measuring impedance for individual ones of the sensing capable electrodes. [individual impedance measurements is/are central inventive feature(s) detailed throughout the majority (if not the entirety) of the disclosure of Dinsmoor, see at least ¶¶101-112]
For claim 15, Dinsmoor teaches The method of claim 1,
wherein the evaluating the sensing capabilities includes comparing a measured impedance correspond to an electrode to threshold values for the electrode. [¶67, ¶94, ¶108, ¶115]
For claim 16, Dinsmoor teaches The method of claim 15,
wherein the evaluating the sensing capabilities further includes recording a violation when the measured impedance is outside of the threshold values, determining that recorded violations break a rule for allowable violations, and updating the sensing-capable electrodes that are available to be activated for sensing ECAPs. [¶67, ¶94, ¶108, ¶115]
For claim 17, Dinsmoor teaches The method of claim 16,
wherein the evaluating the sensing capabilities further includes updating a sensing electrode distribution record. [¶¶101-114]
For claim 21, Dinsmoor teaches The system of claim 19,
wherein the controller is configured to update a sensing electrode distribution record including the sensing-capable electrodes that are allowed to be active, active ones of the sensing capable electrodes, and a sensing configuration of the active ones of the sensing-capable electrodes. [¶¶101-114]
For claim 22, Dinsmoor teaches The system of claim 21,
wherein the sensing electrode distribution record further includes when the evaluating occurred and when an electrode status changes being disabled from being active and enabled to be active. [¶¶100-115]
For claim 23, Dinsmoor teaches The method of claim 17,
wherein the sensing electrode distribution record includes:
the sensing-capable electrodes that are allowed to be active; active ones of the sensing capable electrodes; and a sensing configuration of the active ones of the sensing-capable electrodes. [¶¶100-115]
For claim 24, Dinsmoor teaches The method of claim 23,
wherein the sensing electrode distribution record further includes when the evaluating occurred and when an electrode status changes being disabled from being active and enabled to be active. [¶¶100-115]
In consideration of Examiner’s interpretation and citation for a controller receiving a trigger signal to evaluate sensing capabilities, and in earnest and good faith advancement of prosecution, claim(s) 1, 5-7, and 18-19 is/are alternately rejected under 35 U.S.C. 103 as being unpatentable over Dinsmoor in view of Sawchuk (US 20090299421 A1).
If (arguendo) Dinsmoor fails to teach a trigger signal to a controller to evaluate sensing capabilities via user input, a schedule, or a physiological parameter, then:
Sawchuk teaches a system controller for evaluating sensing capabilities of leads [lead assessment with the IMD is/are central inventive feature(s) detailed throughout the majority (if not the entirety) of the disclosure of Sawchuk — see esp. ¶¶29-40] including via a trigger signal from a user input [¶¶45-59], a schedule [¶165], and/or via a physiological parameter determination [¶¶145-148 Fig(s). 8 Fig(s). 11]
It would have been obvious to one of ordinary skill at the time the invention was filed to modify the controller of Dinsmoor to incorporate the automated trigger conditions of Sawchuk in order to ensure sensor lead integrity and reliability. As motivated by Sawchuk ¶¶2-11.
Response to Arguments
Applicant's 11/26/25 arguments with respect to the prior art have been fully considered but they are not persuasive.
Applicant argues in remarks p. 6-8 that Dinsmoor fails to teach claim(s) 1 as in Dinsmoor a clinician inputs operating parameters instead of a controller as recited in claim(s) 1. Examiner respectfully disagrees. Dinsmoor ¶¶69-70 details that a clinician may review the displayed results from electrode testing and then program the device to utilize certain of the electrodes. That a user initiates the electronics of the device (e.g., the controller) to perform the activation of electrodes from the results does not preclude a user initiating such steps. The claims do not recite any language that requires the controller operate the selection without any user input via a display interface.
Applicant argues in remarks p. 8 that Dinsmoor fails to teach claim(s) 5. Examiner respectfully disagrees. Dinsmoor ¶71 details that the clinician can request sensed impedance values to determine which electrodes to use. Examiner suggests further amending the ‘input’ which is merely limited as an ‘input’ per se to specify a form and/or manner of input for the initiating of the evaluating in order to distinguish from Dinsmoor.
The same issue of breadth arises with Applicant’s arguments for claim(s) 6-7. In each instance, the ‘schedule’ and ‘physiological parameter’ are recited at a level of breadth that Dinsmoor teaches at least some form of each even if only in an initializing step that is triggered before the electrode impedance evaluation step which still meets the BRI of the ‘trigger’ in question as evidenced further in Dinsmoor Fig(s). 7. Examiner generally suggests further defining the ‘schedule’ and the ‘parameter’ to distinguish from Dinsmoor (e.g., to distinguish from a basic electrode activation sequence detailed throughout Dinsmoor that meets the BRI of ‘schedule’ and/or to distinguish from the bone sensing detailed throughout Dinsmoor that meets the BRI of ‘parameter’).
Applicant then argues in remarks p. 9 that Dinsmoor has a different solution than the present application — however such an argument does not clearly link to any specific claim language.
In any event, in earnest advancement of prosecution, a new alternate grounds of rejection has been provided for which the arguments are moot.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN S MELHUS whose telephone number is (571)272-5342. The examiner can normally be reached Monday - Friday | 9:00 AM - 5:00 PM.
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, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/BENJAMIN S MELHUS/
Primary Examiner, Art Unit 3791
Prosecution Insights