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 Arguments
Applicant’s arguments filed 06/30/2026 have been fully considered but are moot in view of new grounds of rejection or are not persuasive.
Applicant argues, “Even if claim 1 involves concepts that in a vacuum were to be characterized as abstract ideas, claim 1 is not directed to abstract ideas per se, much less "mental processes."5 Any inventive concept may be susceptible to physical or engineering abstraction that can be related to or characterized as involving abstract ideas or laws of nature.”
Examiner respectfully disagrees. Claim 1 recites the following mental processes:
“determine, based upon the first set of information, a therapy usage pattern of the actual therapy delivered to the patient over the plurality of past instances of therapy delivery” (mental process – person can evaluate and analyze data to determine a therapy usage pattern of a patient);
“determine a modification to a programmed therapy schedule based on the therapy usage pattern” (mental process – person can evaluate and analyze data a modification to scheduled therapy).
These limitations, under their broadest reasonable interpretation, cover concepts that can be practically performed in the human mind.
Applicant argues, “Claim 1 has been amended to recite that the processing circuitry is configured to perform "one or more of: receive an input accepting the programmed therapy schedule with the modification, and automatically update the programmed therapy schedule with the modification; and control delivery of actual therapy according to the programmed therapy schedule with the modification." In this way, amended claim 1 recites an element or combination of elements that "apply or use the recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition," and therefore "as a whole integrates the exception into a practical application of that exception."…claim 1 as a whole integrates the alleged judicial exception into a practical application.”
Examiner respectfully disagrees.
The limitations,
“one or more of:
receive an input accepting the programmed therapy schedule with the modification, and
automatically update the programmed therapy schedule with the modification”,
are directed to additional elements, specifically insignificant post solution activity (see MPEP 2106.05(g)).
The above recited limitations merely process information. Additionally, the recited limitations are neither particular enough to meaningfully limit the recited exception nor does it have more than a nominal relationship to the exception. In other words, the breadth of the recited limitations is such that it substantially encompasses all applications of the recited exception, and may be interpreted as moving information around.
Regarding the recited, “control delivery of actual therapy according to the programmed therapy schedule with the modification”, Examiner asserts that the limitation is not particular and instead provide instructions to apply the exception in a generic way (see factor ‘a’ in MPEP §2106.04(d)(2)). There is nothing in the claim which shows how the act of controlling delivery according to the programmed therapy schedule with the modification particularly and specifically treats a particular disorder or disease.
Applicant argues, “Even if, under Step 2A, claim 1 could be considered to recite insignificant extra solution activity or not be integrated into a practical application, which Applicant does not concede, the Office must reevaluate these conclusions under Step 2B.15 According to Step 2B, the Office is required to determine whether any element, or combination of elements, in the claim is sufficient to provide an inventive concept (i.e., whether the additional elements amount to significantly more than the exception itself)…”
Examiner respectfully disagrees. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than insignificant extra solution activity and generic computer components.
The same analysis applies here in 2B and does not provide an inventive concept.
Therefore, none of the claims 1-18 and 26 amount to significantly more than the abstract idea itself. Accordingly, claims 1-18 and 26 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
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 1-18 and 26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea without significantly more.
Step 1:
Independent claims 1 and 10 are directed a system and method, respectively. Thus, they are directed to statutory categories of invention.
Step 2A, Prong 1:
Claims 1 and 10 recite the following claim limitations which are directed to abstract ideas, specifically mental processes (see MPEP § 2106.04(a)(2)):
In re claim 1:
determine, based upon the first set of information, a therapy usage pattern of the actual therapy delivered to the patient over the plurality of past instances of therapy delivery (mental process – person can evaluate and analyze data to determine a therapy usage pattern of a patient);
determine a modification to a programmed therapy schedule based on the therapy usage pattern (mental process – person can evaluate and analyze data a modification to scheduled therapy).
In re claim 10, see above.
These limitations, under their broadest reasonable interpretation, cover concepts that can be practically performed in the human mind.
Therefore, the claim limitations fall within the 'mental processes' grouping of abstract ideas.
Step 2A, Prong 2:
Claims 1 and 10 recite the following additional elements:
In re claim 1,
“processing circuitry configured to:
receive a first set of information, the first set of information comprising information of actual therapy delivered to a patient over a plurality of past instances of therapy delivery;
one or more of:
receive an input accepting the programmed therapy schedule with the modification, and
automatically update the programmed therapy schedule with the modification; and
control delivery of actual therapy according to the programmed therapy schedule with the modification”.
In re claim 10, see above.
The following limitations: “processing circuitry configured to: receive a first set of information, the first set of information comprising information of actual therapy delivered to a patient over a plurality of instances of therapy delivery”, are pre-solution activities (see MPEP 2106.05(g)), because they’re used to obtain additional information used to determine a therapy usage pattern.
Additionally, the limitations,
“one or more of:
receive an input accepting the programmed therapy schedule with the modification, and
automatically update the programmed therapy schedule with the modification”,
are directed to additional elements, specifically insignificant post solution activity (see MPEP 2106.05(g)).
The above recited limitations merely process information. Additionally, the recited “receive an input” and “automatically update” is neither particular enough to meaningfully limit the recited exception nor does it have more than a nominal relationship to the exception. In other words, the breadth of the recited limitations is such that it substantially encompasses all applications of the recited exception, and may be interpreted, under broadest reasonable interpretation, such as moving information around.
Regarding the recited, “control delivery of actual therapy according to the programmed therapy schedule with the modification”, Examiner asserts that the limitation is not particular and instead provide instructions to apply the exception in a generic way (see factor ‘a’ in MPEP §2106.04(d)(2)). There is nothing in the claim which shows how the act of controlling delivery according to the programmed therapy schedule with the modification particularly and specifically treats a particular disorder or disease.
There is nothing in the claims which show how providing the above recited limitations integrates the judicial exception into a practical application.
Further, there is no evidence of record that would support the assertion that this step is an improvement to a computer or a technological solution to a technological problem.
Regarding the limitations,“ processing circuitry configured to…”, Examiner asserts that the above recited limitations amount to nothing more than mere instructions to apply the abstract idea using a generic computer (MPEP 2106.05(f), Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983).
Additionally, the above recited claims’ recitation of “processing circuitry” is merely reciting the computer components at a high-level of generality. In other words, the computer components are being used as a tool to carry out the system’s functions (See MPEP 2106.05(f)).
Thus, the abstract idea is not integrated into a practical application. The combination of these additional elements is no more than insignificant extra solution activity, and generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
Step 2B:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than insignificant extra solution activity and generic computer components.
The same analysis applies here in 2B and does not provide an inventive concept.
Therefore, none of the claims 1-18 and 26 amount to significantly more than the abstract idea itself. Accordingly, claims 1-18 and 26 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
Additionally, regarding claim 26, Examiner asserts that the recited, “wherein to control delivery of actual therapy, the processing circuitry is configured to output, to an implantable medical device (IMD), the programmed therapy schedule with the modification” is interpreted as additional elements, and would not amount to a particular prophylaxis. For instance, the limitations are not particular and instead provide instructions to apply the exception in a generic way (see factor ‘a’ in MPEP §2106.04(d)(2)). There is nothing in the claim which shows how the act of causing the implantable medical device to output the programmed therapy schedule with the modification particularly and specifically treats a particular disorder or disease. In other words, the recited “control delivery” may be interpreted as an output that does not result in a particular prophylaxis.
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 1-4, 7, 10-13, 16, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Levine et al. (US 2020/0330760) in view of Mishra et al. (WO 2022/047077).
In re claim 1, Levine discloses a system ([0167]: combination of user interface and implanted microstimulator) comprising: processing circuitry ([0167]: portion of implanted microstimulator that adjusts stimulation; [0163]) configured to:
receive a first set of information ([0167]: receives all adjustments made by a user); fig. 17A: 1701),
the first set of information comprising information of actual therapy delivered to a patient over a plurality of instances of therapy delivery ([0167]: each dose of a plurality of doses may be individually adjusted to be earlier or later than a scheduled time); and
control delivery of actual therapy according to the modification ([0167]: patient receives doses based on the adjustments).
Levine fails to disclose
the first set of information comprising information of actual therapy delivered to a patient over a plurality of past instances of therapy delivery;
determine, based upon the first set of information, a therapy usage pattern of the actual therapy delivered to the patient over the plurality of instances of therapy delivery;
determine a modification to a programmed therapy schedule based on the therapy usage pattern;
one or more of:
receive an input accepting the programmed therapy schedule with the modification, and
automatically update the programmed therapy schedule with the modification; and
control delivery of actual therapy according to the programmed therapy schedule with the modification.
Mishra teaches an implantable system [0007] for delivering electrical stimulation to a patient [0007], and teaches
receiving a first set of information comprising information of actual therapy delivered to a patient over a plurality of past instances of therapy delivery ([0360]: patient recording that they liked a particular stimulation paradigm and recording one that they did not like);
determine, based upon the first set of information, a therapy usage pattern of the actual therapy delivered to the patient over the plurality of past instances of therapy delivery ([0360]: therapy usage pattern is automatically updated to include a different stimulation paradigm that wasn’t previously included and to increase a duration of a stimulation paradigm that was liked by the patient);
determine a modification to a programmed therapy schedule based on the therapy usage pattern ([0360]: patient provides feedback regarding which stimulation paradigms they liked and didn’t like, which will be used to automatically adjust a schedule of future therapy);
automatically update the programmed therapy schedule with the modification ([0360]: automatically adjusts schedule of future therapy based on patient feedback); and
control delivery of actual therapy according to the programmed therapy schedule with the modification [0360].
Mishra further teaches that automatically updating a future therapy based on a patient’s preference of previously applied therapy allows the future therapy to test out new therapy while also extending a duration of a previous therapy that they liked [0360].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the system taught by Levine, to provide the first set of information comprising information of actual therapy delivered to a patient over a plurality of past instances of therapy delivery; determine, based upon the first set of information, a therapy usage pattern of the actual therapy delivered to the patient over the plurality of instances of therapy delivery; determine a modification to a programmed therapy schedule based on the therapy usage pattern; automatically update the programmed therapy schedule with the modification; and control delivery of actual therapy according to the programmed therapy schedule with the modification, as taught by Mishra, because doing so allows the programmed therapy schedule to be automatically updated based on a patient’s preference.
Such a modification would yield wherein the system of Levine, which teaches allowing a user to manually adjust timing of upcoming doses, to incorporate determining a therapy usage pattern of the actual therapy delivered to the patient over the plurality of instances of therapy delivery, determining a modification to a programmed therapy schedule based on the therapy usage pattern, automatically updating the programmed therapy schedule with the modification, and controlling delivery of actual therapy according to the programmed therapy schedule with the modification, as taught by Mishra which teaches automatically updating a programmed therapy schedule based on received patient preference information from previously applied therapy, so that the programmed therapy schedule will be adjusted based on patient preference.
In re claim 2, the proposed combination yields (all mapping directed to Levine unless otherwise stated) wherein the processing circuitry is further configured to:
access a second set of information ([0167]: scheduled time for each dose is a second set of information),
the second set of information comprising information of the programmed therapy schedule for the patient [0167]; and
compare the second set of information and the first set of information ([0167]: the scheduled doses are viewed by the patient so they can adjust each one based on a desired time for each dose to be delivered),
wherein to determine the therapy usage pattern, the processing circuitry is configured to determine the therapy usage pattern based upon comparison of the second set of information and first set of information ([0167]: new preferred schedule of doses is determined based on an adjustment of the scheduled doses times).
In re claim 3, the proposed combination yielded in re claim 1 above yields wherein to determine the therapy usage pattern, the processing circuitry is configured to determine a pattern of previously skipped or previously adjusted therapy sessions (Levine: [0167]: multiple doses i.e. therapy sessions can be adjusted and would adjust the therapy usage pattern; see also the proposed combination yielded in re claim 1 above, where a plurality of previously adjusted therapy sessions would be received, as taught by Mishra).
In re claim 4, Levine discloses wherein to determine the pattern of previously skipped or previously adjusted therapy sessions, the processing circuitry is configured to determine one or more of:
a pattern of times when one or more stimulation therapy parameters were adjusted relative to one or more stimulation therapy parameters of the programmed therapy schedule ([0167-0168]: pattern of adjusted therapy sessions would include the amount of doses that had their timing adjusted, see also the proposed combination yielded in re claim 1 above, where a plurality of previously adjusted therapy sessions were determined, as taught by Mishra); and
a pattern of times when stimulation sessions of the programmed therapy schedule were skipped (optional).
In re claim 7, the proposed combination yields (all mapping directed to Levine unless otherwise stated) wherein the processing circuitry is further configured to:
generate for output, on a display (fig. 18B: mobile phone has a display), a plurality of selectable therapy parameter control icons (fig. 18B: each of the times are doses which can be selected to adjust timing and would also include icons to adjust the timings; [0167-0168]),
generate for output, on the display, a plurality of selectable therapy schedule customization icons ([0167]: icons to adjust timing for each dose), and
responsive to receiving input via one or more of the plurality of selectable therapy control icons and via one or more of the plurality of selectable therapy schedule customization icons [0167-0168], control an implantable medical device (IMD) ([0167]: delivery of VNS from an implanted microstimulator on a vagus nerve) to deliver scheduled therapy according to the programmed therapy schedule with the modification ([0167-0168]: adjustments are provided as stimulation to the user, see also the proposed combination yielded in re claim 1 above).
In re claim 10, regarding the limitations, “a method comprising:
receiving, via processing circuitry, a first set of information, the first set of information comprising information of actual therapy delivered to a patient over a plurality of past instances of therapy delivery;
determining, via processing circuitry, based upon the first set of information, a therapy usage pattern of the actual therapy delivered to the patient over the plurality of past instances of therapy delivery;
determining, via processing circuitry, a modification to a programmed therapy schedule based on the therapy usage pattern;
one or more of:
receiving an input accepting the programmed therapy schedule with the modification, and
automatically updating the programmed therapy schedule with the modification; and
controlling delivery of actual therapy according to the programmed therapy schedule with the modification”,
see in re claim 1 above.
In re claim 11, regarding the imitations, “further comprising:
accessing, via processing circuitry, a second set of information,
the second set of information comprising information of the programmed therapy schedule for the patient; and
comparing, via processing circuitry, the second set of information and the first set of information,
wherein determining the therapy usage pattern comprises determining the therapy usage pattern based upon comparison of the second set of information and the first set of information”,
see in re claim 2 above.
In re claim 12, regarding the limitations, “wherein determining the therapy usage pattern comprises determining a pattern of previously skipped or previously adjusted therapy sessions”, see in re claim 3 above.
In re claim 13, regarding the limitations, “wherein determining the pattern of previously skipped or previously adjusted therapy sessions comprises determining one or more of:
a pattern of times when one or more stimulation therapy parameters were adjusted relative to one or more stimulation therapy parameters of the programmed therapy schedule; and
a pattern of times when stimulation sessions of the programmed therapy schedule were skipped”, see in re claim 4 above.
In re claim 16, regarding the limitations, “further comprising:
generating for output, on a display, via the processing circuitry, a plurality of selectable therapy parameter control icons,
generating for output, on the display, via the processing circuitry, a plurality of selectable therapy schedule customization icons, and
responsive to receiving input via one or more of the plurality of selectable therapy control icons and via one or more of the plurality of selectable therapy schedule customization icons, controlling an implantable medical device (IMD) to deliver scheduled therapy according to the programmed therapy schedule with the modification”,
see in re claim 7 above.
In re claim 26, the proposed combination yields (all mapping directed to Levine unless otherwise stated), wherein to control delivery of actual therapy [0168], the processing circuitry is configured to output, to an implantable medical device (IMD) [0020, 0162], the programmed therapy schedule with the modification [0168, 0163].
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Levine et al. (US 2020/0330760) in view of Mishra et al. (WO 2022/047077) [in view of Lima et al. (US 20070233204)].
In re claim 6, the proposed combination yields (all mapping directed to Levine unless otherwise stated) wherein the actual therapy delivered to the patient comprises therapy delivered to one or more of a vagus nerve [0004-0006] for inflammation therapy [0004-0006].
Regarding the limitations, “wherein the actual therapy delivered to the patient comprises therapy delivered to one or more of a sacral nerve or tibial nerve for incontinence therapy” the recited limitations are directed to functional language/intended use.
A recitation of the functional language of the claimed invention, such as the recitation of “therapy delivered to one or more of a sacral nerve or tibial nerve for incontinence therapy”, must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional language, then it meets the claim.
In this case, the proposed combination only be able to perform these functions in order to anticipate the claimed invention; see MPEP § 2114 (I) and In re Schreiber, 128 F.3d at 1478, 44 USPQ2d at 1432. Therefore, since the proposed combination has all of the necessary structure to deliver therapy to one or more of a sacral nerve or tibial nerve for incontinence therapy, it is therefore capable of and/or able to be configured to do the above limitations, see MPEP 2114 "[A]pparatus claims cover what a device is, not what a device does." See MPEP 2114.
Additionally, it would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the proposed combination in view of Liam to provide wherein the actual therapy delivered to the patient comprises therapy delivered to one or more of a sacral nerve or tibial nerve for incontinence therapy, as discussed below.
Thus, claim 6 is additionally rejected as follows.
Lima teaches a system for implantable treatment of a patient [0002], and teaches sacral nerve stimulation [0005] is an approved stimulation therapy for reducing urge incontinence [0005].
Lima further teaches that various nerves may be stimulated to target various conditions [0009], and that sending electrical impulses to the sacral nerve [0087] acts as a bladder toner [0087], which reduces or eliminates the patient’s urge incontinence [0087].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the system taught by Levine, to provide wherein the actual therapy delivered to the patient comprises therapy delivered to a sacral nerve for incontinence therapy, as taught by Lima, because various nerves may be stimulated to target various conditions, such as stimulating the sacral nerve to reduce the patient’s urge incontinence, since stimulating the sacral nerve acts as a bladder toner.
Claim 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Levine et al. (US 2020/0330760) in view of Mishra et al. (WO 2022/047077) in view of Pilkington et al. (US 2017/0076060).
In re claim 5, the proposed combination fails to yield wherein the processing circuitry is further configured to: generate for output, on a display, a therapy adherence metric indicative of a patient’s adherence to the programmed therapy schedule.
Pilkington teaches
managing a patient’s health [0006] through a medication dispensing device (fig. 1: 20; [0006, 0027] which comprises processing circuitry ([0027-0028]: medication dispensing device 20 may perform processing and calculations and therefore would have processing circuitry]),
wherein the processing circuitry is configured to: generate for output, on a display (fig. 1: 22; [0112]), a therapy adherence metric ([0112]: adherence scores are output) indicative of a patient’s adherence to programmed therapy schedule ([0104]: device 20 receives medication information regarding times doses of medication were missed or skipped; [0107-0108]: adherence score is generated over a period of time based on a medication dosage schedule and the amount of times the medication was taken by a patient; fig. 8: 800).
Pilkington further teaches that the adherence score reveals insight into factors that influence adherence [0111], especially once the reason for skipping the dose is obtained [0074, 0111].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the system taught by Levine, to provide wherein the processing circuitry is further configured to: generate for output, on a display, a therapy adherence metric indicative of a patient’s adherence to the programmed therapy schedule, as taught by Pilkington, because the adherence score reveals insight into factors that influence adherence, especially once the reason for skipping the dose is obtained.
In re claim 14, regarding the limitations, “further comprising: generating for output, on a display, via the processing circuitry, a therapy adherence metric indicative of a patient’s adherence to the programmed therapy schedule”, see in re claim 5 above.
Claim 8-9 and 17-18 is rejected under 35 U.S.C. 103 as being unpatentable over Levine et al. (US 2020/0330760) in view of Mishra et al. (WO 2022/047077) in view of Kothandaraman (US 2011/0257707).
In re claim 8, the proposed combination fails to yield wherein the plurality of selectable therapy parameter control icons comprises a plurality of amplitude adjustment icons.
Kothandaraman teaches an implantable [0037-0038] spinal cord stimulation system [0037], and teaches
a plurality of selectable therapy parameter control icons (fig. 10: 128, 130, 132, 134; [0063]) used to adjust stimulation [0063],
wherein the plurality of selectable therapy parameter control icons comprises
a plurality of amplitude adjustment icons (fig. 10: top and bottom side of 128 are interpreted as amplitude adjustment icons; [0063]),
a plurality of pulse width adjustment icons (fig. 10: left and right side of 130 are interpreted as pulse width adjustment icons; [0063]), and
a plurality of pulse rate adjustment icons (fig. 10: left and right side of 132 are interpreted as pulse rate adjustment icons; [0063]).
Kothandaraman further teaches that the icons allow a clinician to modify various characteristics of a stimulation energy [0063] by incrementally increasing or decreasing each characteristic [0063].
It would have been obvious to someone of ordinary skill in the art at the time the instant invention was filed to modify the system taught by Levine, to provide wherein the plurality of selectable therapy parameter control icons comprises a plurality of amplitude adjustment icons, as taught by Kothandaraman, because the icons allow a clinician to modify various characteristics of stimulation energy by incrementally increasing or decreasing each characteristic.
In re claim 9, regarding the limitations, “wherein the plurality of selectable therapy parameter control icons comprises
a plurality of amplitude adjustment icons,
a plurality of pulse width adjustment icons, and
a plurality of pulse rate adjustment icons”,
see the proposed combination yielded in re claim 8 above.
In re claim 17, regarding the limitations, “wherein the plurality of selectable therapy parameter control icons comprises a plurality of amplitude adjustment icons ”, see in re claim 8 above.
In re claim 18, regarding the limitations, “ wherein the plurality of selectable therapy parameter control icons comprises
a plurality of amplitude adjustment icons,
a plurality of pulse width adjustment icons, and
a plurality of pulse rate adjustment icons”,
see in re claim 9 above.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Levine et al. (US 2020/0330760) in view of Mishra et al. (WO 2022/047077) in view of Lima et al. (US 2007/0233204).
In re claim 15, regarding the limitations, “wherein the actual therapy delivered to the patient comprises therapy delivered to one or more of a sacral nerve or tibial nerve for incontinence therapy”, see the proposed combination yielded re claim 6 above.
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.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUMAISA R BAIG whose telephone number is (571)270-0175. The examiner can normally be reached Mon-Fri: 8am- 5pm.
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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