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 .
Claims 1, 5, 14, 16 and 17 have been amended. Claims 2, 7, 12, 13 and 18 have been cancelled. Claims 21-25 are new.
Claims 1, 3-6, 8-11, 14-18 and 20-25 are pending.
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, 3-6, 8-11, 14-18 and 20-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1
Claims 1, 3-6, 8-11, 14-15 and 21-23 are drawn to a method for guided neuromodulation therapy, which is within the four statutory categories (i.e. process). Claim 16 is drawn to a non-transitory medium for guided neuromodulation therapy, which is within the four statutory categories (i.e. manufacture). Claims 17, 19-20 and 24-25 are drawn to a system for guided neuromodulation therapy which is within the four statutory categories (i.e. machine).
Step 2A | Prong One
Claim 1 of Group I (Claims 1, 3-6, 8-11, 14-15 and 21-23) recites a method, comprising:
receiving a medication schedule from a patient associated with neuromodulation therapy delivered by a medical device;
sending queries related to symptoms and side effects experienced by the patient;
receive a response from the patient in response to the queries;
determine, based on the received response, a parameter for a period of time of medication efficacy, wherein the parameter comprises one of: an average on-time for each dose administered to the patient, an average on-time percentage per waking hour, or a daily average on-time;
determine a change in the parameter for the period of time;
compare the change in the parameter to an average parameter for the patient; and
in response to the change in the parameter exceeding a threshold change, program the medical device to change the neuromodulation therapy delivered to the patient.
Claim 16 further recites a non-transitory computer-readable medium storing instructions executable by a processor (MPEP § 2106.05(f), apply it, MPEP § 2106.05(g), insignificant extra-solution activity).
Claim 17 further recites a processing system configured to deliver stimulation therapy to a patient (MPEP § 2106.05(f), apply it); and a memory coupled to the processing system, the memory storing instructions (MPEP § 2106.05(f), apply it, 2106.05(g), insignificant extra-solution activity).
The bolded limitations, given the broadest reasonable interpretation, cover a certain method of organizing human activity because it recites fundamental economic practices, commercial or legal interactions, and/or managing personal behavior or relationships or interactions between people. Any limitations not identified above as part of the abstract idea are underlined and are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for Claims 16 (Group II) and 17, 19-20 and 24-25 (Group III) is identical as the abstract idea for Claims 1-15 (Group I), they are just directed towards different statutory categories.
Dependent Claims 3-6, 8-11, 14-15, 18 and 20-25 include other limitations, for example, Claim 3 recites sending at least one query associated with determining a percentage of time while the patient was awake during a period of time that the patient experienced a change in side effects or symptoms, Claim 4 recites sending the queries related to the symptoms and the side effects at specified time intervals, Claim 5 recites in response to the change in the parameter exceeding the threshold change, sending additional queries to the patient to refine the determination of the change in the parameter, Claims 6 and 18 recite identifying patterns in the parameter of the medication efficacy during different periods of time, Claim 8 recites receiving a sleep schedule from the patient, Claim 9 recites the queries at least 1 hour before the patient goes to bed, Claim 10 recites sending the queries every other week, Claim 11 recites sending the queries once a month for patients who are not administered medication, Claim 12 recites receiving a response from the patient in response to the queries, Claim 13 recites wherein the received response is used to determine one of: an average on-time for each dose administered to the patient, an average on- time percentage per waking hour, or a daily average on-time, Claim 14 recites wherein the received response is used to determine one of: a weekly average on-time, a monthly average on-time, or a variance of each recording from a determined average, Claim 15 recites providing a recommendation based on a response to the queries that indicates the patient is trending in a positive direction or a negative direction, and Claim 20 recites wherein the processing system is configured for use to communicate with a caregiver of the patient to receive caregiver feedback regarding the medication efficacy of the patient, Claims 21 and 24 recite wherein programming the medical device comprises adjusting at least one of an amplitude, a frequency, a pulse width, an electrode configuration, a polarity, or a current fractionalization of the neuromodulation therapy delivered by the medical device, Claims 22 and 25 recite comparing the change in the parameter to an average parameter for the patient, and setting a trigger when the change in the parameter is outside a threshold difference from the average parameter, and Claim 23 recites wherein programming the medical device comprises decreasing a stimulation amplitude during an anticipated medication wash-in period and returning the stimulation amplitude to a base level after a specified period of time, but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent Claims 1, 16 and 17.
Step 2A | Prong Two
Furthermore, Claims 1, 3-6, 8-11, 14-18 and 20-25 are not integrated into a practical application because the additional elements (i.e. the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of recites a non-transitory computer-readable medium, a processor, a processing system, and a memory coupled to the processing system, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see paragraphs [0094-0096] and [0102] of the present Specification, see MPEP 2106.05(f); and
add insignificant extra-solution activity to the abstract idea – for example, the recitation of storing data, which amounts to an insignificant application, see MPEP 2106.05(g).
Step 2B
Furthermore, the Claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e. the elements other than the abstract idea) amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The Specification expressly disclosing that the additional elements are well-understood, routine, and conventional in nature:
paragraphs [0094-0096] and [0102] of the Specification discloses that the additional elements (i.e. non-transitory computer readable medium, processor, memory) comprise a plurality of different types of generic computing systems that are configured to perform generic computer functions (i.e. storing data) that are well-understood, routine, and conventional activities previously known to the pertinent industry (i.e. healthcare);
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
Storing and retrieving information in memory, e.g. see Versata Dev. Group, Inc. v. SAP Am., Inc. – similarly, the current invention recites storing programming data in a database and/or electronic memory, and retrieving the data from storage in order to execute the claimed limitations.
Dependent Claims 3-6, 8-11, 14-15, 18 and 20-25 include other limitations, but these merely further narrow the recited abstract of the independent claims and do not contain any additional elements beyond those found in the independent claims.
Thus, taken alone, the additional elements do not amount to “significantly more” than the above-identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 1, 3-6, 8-11, 14-18 and 20-25 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Arguments
Applicant's arguments filed 06/22/2026 have been fully considered.
§§ 102 & 103 Rejections
Applicant’s arguments with respect to section 102 rejection has been withdraw in view of the amendments. The closest prior art of record, Litvak (U.S. Pub. No. 2022/0266023 A1), Crowder (U.S. Pub. No. 2013/0172774 A1), Shouldice (U.S. Pub. No. 2025/0134451 A1) and Cederlund (U.S. Pub. No. 2015/0193597 A1), do not disclose or render obvious the limitations of “determining, based on the received response, a parameter for a period of time of medication efficacy, wherein the parameter comprises one of: an average on-time for each dose administered to the patient, an average on-time percentage per waking hour, or a daily average on-time; and determining a change in the parameter for the period of time; determining that the change in the parameter exceeds a threshold change; and in response to the parameter exceeding the threshold change, recommending an adjustment to the neuromodulation therapy, and programming the medical device to change the neuromodulation therapy delivered to the patient based on the recommended adjustment” in combination with the other limitations found in the independent claims. Claims 3-6, 8-11, 14-15 and 21-23 are free from prior art as they depend from claim 1.
The prior art rejection for claims 16 and 17 is withdrawn for the same reasons as described above with respect to claim 1. Claims 18, 20 and 24-25 are free from prior art as they depend from claim 17.
§ 101 Rejection
Applicant's asserts that the amendments overcome the 101 rejection. The rejection is maintained as the programming of the medical device is considered part of the abstract idea, and therefore, does not result in a practical application.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachelle Reichert whose telephone number is (303)297-4782. The examiner can normally be reached M-F 9-5 MT.
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/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
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