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 .
Election/Restrictions
Applicant’s election without traverse of Group 1, claims 1-9, in the reply filed on May 20, 2026 is acknowledged.
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant’s election was made without traverse in the reply filed on 05/20/2026.
Priority
Claims 1-9 are deemed to have an effective filing date of August 11, 2023.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 24, 36, 30 (Fig. 1); 303, 358 (Fig. 3); 560 (Figs. 5A-5B).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 305 (paragraph [0046]), 310 (paragraph [0045]), 550b (paragraphs [0060], [0062]-[0065], [0069] and [0072]-[0073]).
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: Paragraphs [0046], [0051], and [0053] refer to “memory 305”. Fig. 3 illustrates a memory designated by reference numeral 303. It is unclear if another memory 305 should be illustrated, or, if memory 305 in Fig. 3 should be memory 303 as shown in Fig. 3.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-9 claim a method (process). Therefore, the claims fall within the statutory categories.
Step 2A, Prong 1:
Claims 1-9 recite indicating on the graph a current setting of each of the at least one adjustable stimulation parameter and a range around the current setting. This limitation, as drafted, describe a process that, under its broadest reasonable interpretation, includes performance of the limitations in the mind or with pen and paper. Dependent claim 7 adds the limitation of querying which also can be practically performed in the human mind. See MPEP 2106.04(a) and 2106(a)(2) III.
Step 2A, Prong 2:
Claims 1-9 recite receiving a request to modify stimulation (extra-solution activity of data gathering), displaying a graph for at least one adjustable parameter (extra-solution activity of data outputting), receiving a selection of a new setting (not directed to the judicial exception), and modifying the stimulation according to the selection (not directed to the judicial exception). The judicial exception is not integrated into a practical application because neither the receiving a selection of a new setting and modifying the stimulation according to the selection integrates the judicial exception of mental process into a practical application as both additional elements are tangential to the extra-solution activity of data gathering (receiving a request) and do nothing to integrate the mental processes of indicating on a graph a current setting and a minor or major change of the abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims, taken as a whole, do not integrate the recited judicial exception into a practical application. Thus, the above-identified claims are directed to the judicial exception.
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)(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.
Claims 1-4 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2023/0149723 to Schmeling et al. (hereinafter referred to as “Schmeling”).
Regarding claim 1, Schmeling discloses a method for operation of a stimulation system (e.g., abstract: systems and techniques for controlling electrical stimulation), the method comprising: receiving a request to modify stimulation (e.g., paragraph [0009]: a target-amplitude widget configured to receive first user input indicating a desired changed in the target amplitude of the electrical stimulation; [0068]: the GUI of the therapy-management application running on external processor 150 informs and guides a user how to modify stimulation therapy parameters, as needed – which implies receiving a request to manually modify such parameters); displaying a graph for at least one adjustable stimulation parameter (e.g., paragraphs [0009]: GUI displays a stimulation-amplitude graph; [0127]-[0128] and Figs. 6D and 6E – where the adjustable stimulation parameter is the location of the electrode); indicating on the graph a current setting of each of the at least one adjustable stimulation parameter and a range around the current setting of at least one of the at least one adjustable stimulation parameter which represents at least one of a minor change in the stimulation based on a predefined minor change criteria or a moderate change in the stimulation based on a predefined moderate change criteria (e.g., paragraphs [0127]-[0128] and Figs. 6D and 6E – where the current setting of electrodes 620 and 622 is indicated as well as a range/region which 628A, 628B would necessarily represent a minor or major change; and [0056] and [0059]: techniques for adjusting stimulation parameters for pulses are based on comparing ECAP signals to a target or range of values; and paragraph [0145]: when the parameter to be modified is a gain setting, a selectable range of values can be received to update/modify the stimulation); receiving a selection of a new setting for at least one of the at least one adjustable stimulation parameter (e.g., paragraph [0085]: the reaction-threshold ECAP characteristic value is selected from a range of approximately 10 µV to approximately 20µV and [0145] as above); and modifying the stimulation according to the selection (e.g., paragraph [0031]: the GUI may enable a user to select and/or confirm ECAP signals to adjust stimulation parameters where the GUI receives user input selecting one or more of the ECAP thresholds to adjust one or more stimulation parameters of subsequent stimulation).
With respect to claim 2, Schmeling discloses the method of claim 1, wherein the indicating comprises indicating on the graph both the range representing the minor change and the range representing the moderate change (the region 628A would have both a minor change and a moderate change from the set location as shown in Fig. 6D).
As to claim 3, Schmeling discloses the method of claim 1, wherein the indicating comprises indicating on the graph at least one previous setting for at least one of the at least one adjustable stimulation parameter (e.g., Fig. 6D where the set location (large circle 1) is illustrated/indicated).
With respect to claim 4, Schmeling discloses the method of claim 3, wherein, for at least one of the at least one previous setting, the indication signifies an assessment of the stimulation provided by the previous setting (where the electrodes 622 are sensing electrodes and electrodes 620 are stimulation electrodes as shown in Fig. 6C).
As to claim 6, Schmeling discloses the method of claim 3, further comprising displaying a medication state for either the current setting or at least one of the at least one previous setting (e.g., paragraph [0102]: in other examples, the therapy may include medication).
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.
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.
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Schmeling in view of US Patent Application Publication No. 2023/0138098 to Telfort et al. (hereinafter referred to as “Telfort”).
With respect to claim 5, Schmeling discloses the method of claim 3, but does not expressly disclose that the indicating further comprises indicating on the graph an estimated disliked range based on a one of the at least one previous setting that has been assessed as providing disliked stimulation. However, Telfort, in the stimulation art, teaches that it was known in the stimulation art to provide/receive and display physiological parameters where the display can include numerical indication, graphs, etc. and include assessed acceptable and unacceptable ranges for the physiological parameters (e.g., paragraphs [0198]-[0199]). Thus, one of ordinary skill in the art would have recognized the benefits of indicating on the graph the ranges in view of the teachings of Telfort. Consequently, one of ordinary skill in the art would have modified the method of Schmeling so that its graph of stimulation parameters includes a dislike range (unacceptable) based on one of the at least one previous setting in view of the teachings of Telfort that such was a known engineering expedient in the stimulation art, and because the combination would have yielded a predictable result.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2019/0001135 to Yoo et al. (hereinafter referred to as “Yoo”).
With respect to claim 7-8, Schmeling discloses the method of claim 6, but does not expressly disclose querying whether the modified stimulation is acceptable after providing the modified stimulation for a predefined period of time and continuing the modified stimulation when a response to the query indicates that the modified stimulation is acceptable. However, Yoo, in a related art: electrical stimulation, teaches that it was known in the stimulation art to assess/query/evaluate impedance and/or connection status of an electrode connection to ensure that the impedance is within a normal operating range for stimulation treatment to be provided as intended, the impedance is tested after providing the stimulation for a predefined period of time and continues when a response to the query indicates that the stimulation is acceptable, and stopping/halting the stimulation if a bad/unacceptable coupling stimulation is determined (e.g., paragraph [0070] of Yoo). Thus, one of ordinary skill in the art would have recognized the benefits querying whether the stimulation is acceptable or unacceptable in view of the teachings of stimulation is acceptable or unacceptable. Consequently, one of ordinary skill in the art would have modified the method of Schmeling so that the modified stimulation is queried after providing the modified stimulation for a period of time, continuing the stimulation when a response to the query indicates that the modified stimulation is acceptable, and halting the modified stimulation when the response to the query indicates that the stimulation is not acceptable in view of the teachings of Yoo that such was a known engineering expedient in the stimulation art, and because the combination would have yielded a predictable result.
As to claim 9, Schmeling in view of Yoo teaches the method of claim 7, but does not expressly teach returning to the previous stimulation when the response to the query indicates that the modified stimulation is not acceptable. Yoo does teach that impedance is assessed to ensure that the impedance is within a normal operating range for stimulation treatment to be provided as intended (e.g., paragraph [0070] of Yoo). One of ordinary skill in the art would return to the previous acceptable stimulation when the query indicates that the modified stimulation is not acceptable as a matter of common sense.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application Publication No. 2021/0402190 to Zhang et al. teaches that a sensitivity setting and sensing electrode vector (parameters) programmed in the ICD may be indicated in a graph/table where indication of acceptable control parameter settings may be made in the GUI 500 by generating the display of times to detect VF in the corresponding data cells in a stylized font, bolded, underlined or other distinguishing characteristic as well as unacceptable control parameter settings by red font, strike through or other distinguishing display characteristic (e.g., paragraph [0271]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 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, Unsu Jung can be reached at 571 272-8506. 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.
/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792
Prosecution Insights