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 Group I (claims 1-18) without traverse in the reply filed on 03/06/2026 is acknowledged. Claims 1-18 are pending and claims 19-25 are hereby withdrawn.
Additionally, Applicant's election with traverse of Subspecies 1A (Fig. 1), 2A (Fig. 5), 3A (Fig. 6), 4C (Fig. 13), 5B (Fig. 15), and 6B (Fig. 28) with traverse and that claims 1-25 encompass the elected subspecies in the reply filed on 03/06/2026 is also acknowledged.
The traversal is on the ground(s) that “the Office Action has not established a prima facie showing of a serious burden”. This is not persuasive because a requirement for restriction is permissible if there is a patentable difference between the species as claimed and there would be a serious search and/or examination burden on the examiner if restriction is not required (See MPEP § 803 and § 808.02).
The following is an example of what is materially different or distant in the first two species:
Species 1: conceptual diagram illustrating an example system that manages delivery of
stimulation to a patient:
1A: Fig. 1; [0049]: a conceptual diagram illustrating an example system 100 that manages delivery of neurostimulation includes an IMD 102 and a patient programmer 104 operably coupled to IMD 102.
1B: Fig. 2; [0053]: tibial nerve(s) stimulation system 150 includes an implantable tibial nerve stimulation device 152 and an external recharger 154, which is structurally different than the IMD 102 and patient programmer 104 of the example system 100 discussed above in subspecies 1A.
Species 2: conceptual diagram illustrating an example setup screen for managing stimulation
Amplitude
2A: Fig. 5; [0095]: includes menu 504 indicates the current stage in the setup and a “Guided Setup” process
[0095]: “FIG. 5, screen 502 has been entered to begin the “Guided Setup” process. Screen 502 allows for selection of stimulation amplitude. Menu 504 indicates the current stage in the setup, which is shown as “Stimulation” in FIG. 5”
2B: Fig. 8: includes the “CUSTOM SETUP” instead of the “GUIDED SETUP” in fig. 5 and does not include menu 504
Examiner notes that subspecies 2B (fig. 8) and 2C (fig. 9) do seem to be directed to the same subspecies, as evidenced by Applicant’s specification “FIG. 9 shows amplitude selection menu 510 displaying a stimulation amplitude of “1.0 mA,” which may be the result of the user pushing the “up” arrow button of amplitude selection menu 510 in FIG. 8” [0098], therefore, Applicant is only required to select between 2A and 2B, which consist of different features, as discussed above.
Since none of the arguments were found persuasive, the requirement is still deemed proper and is therefore made FINAL.
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 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 (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 instances of therapy delivery;
generate for output the modification to the programmed therapy schedule”.
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 limitation, “generate for output the modification to the programmed therapy schedule”, is directed to additional elements, specifically insignificant post solution activity (see MPEP 2106.05(g)).
The above recited limitations merely process information and then output the results of the above identified abstract ideas. Additionally, the recited “generate for output” 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 “output” is such that it substantially encompasses all applications of the recited exception (such as moving information).
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 amount to significantly more than the abstract idea itself. Accordingly, claims 1-18 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 § 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.
(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 1-4, 7, 10-13, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levine et al. (US 2020/0330760).
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]: each dose may be adjusted individually through a virtual control; 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);
determine, based upon the first set of information, a therapy usage pattern ([0167]: the patient adjusting a slider with their thumb will determine a new therapy usage pattern with updated dose times);
determine a modification to a programmed therapy schedule based on the therapy usage pattern ([0167]: modification to a programmed therapy schedule is the new schedule of doses that will be delivered); and
generate for output the modification to the programmed therapy schedule [0167]: patient receives doses at the new schedule).
In re claim 2, Levine discloses 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, Levine discloses wherein to determine the therapy usage pattern, the processing circuitry is configured to determine a pattern of skipped or adjusted therapy sessions ([0167]: multiple doses i.e. therapy sessions can be adjusted and would adjust the therapy usage pattern).
In re claim 4, Levine discloses wherein to determine the pattern of skipped or 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); and
a pattern of times when stimulation sessions of the programmed therapy schedule were skipped (optional).
In re claim 7, Levine discloses 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 ([0167-0168]: adjustments are provided as stimulation to the user).
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 instances of therapy delivery;
determining, via processing circuitry, based upon the first set of information, a therapy usage pattern;
determining, via processing circuitry, a modification to a programmed therapy schedule based on the therapy usage pattern; and
generating for output, via processing circuitry, the modification to the programmed therapy schedule”,
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 skipped or adjusted therapy sessions”, see in re claim 6 above.
In re claim 13, regarding the limitations, “wherein determining the pattern of skipped or 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”, see in re claim 7 above.
Claim Rejections - 35 USC § 102 / 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.
Claim 6 is rejected under 35 U.S.C. 102(a)(1) / 103 as being unpatentable over Levine et al. (US 2020/0330760) [in view of Lima et al. (US 20070233204)].
In re claim 6, Levine teaches 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 system of Levine need 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 system of Levine 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 system of Levine 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 under 35 U.S.C 103 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 Rejections - 35 USC § 103
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 Pilkington et al. (US 2017/0076060).
In re claim 5, Levine fails to disclose 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 Kothandaraman (US 2011/0257707).
In re claim 8, Levine fails to disclose 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 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
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
Yakovlev et al. (US 2020/0101291) discloses neuromodulation treatments for chronic pain [0003], wherein a display (abstract) provides a user with a user interface (abstract), which van evaluate therapy adherence (abstract).
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.
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, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RUMAISA RASHID BAIG/Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796
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