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 January 28, 2026 have been fully considered but they are not persuasive. Applicant has amended the independent claims 1, 13 and 17 to include the limitation of “stimulating a patient using an electrical stimulation system”. Applicant argues that ““stimulating a patient using an electrical stimulation system” is a necessary step in the recited process and the remainder of the steps cannot be performed without “stimulating a patient using an electrical stimulation system”.” (page 6 of Remarks). However, the examiner respectfully disagrees that this recitation is sufficient to overcome the rejection under 35 U.S.C. 101 because the limitation of “stimulating a patient using an electrical stimulation system” is merely insignificant pre-solution activity. {See MPEP 2106.05(g)} The stimulation of a patient is insignificant pre-solution activity due to the limitation not imposing meaningful limits on the claim with the recitation of a generic “electrical stimulation system”. Since the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering). MPEP 2106.05(g).
As such, the claims remain rejected under 35 U.S.C. 101 as detailed below.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Following is an analysis of subject matter eligibility according to MPEP 2106:
Step 1:
Independent claims 1, 13 and 17 recite a method, and are thus directed towards statutory categories of invention.
Step 2A Prong 1:
Claims 1, 13 and 17 recite the following limitations:
obtaining or determining i) a therapeutic effects value and a side effects value for a first set of stimulation parameter values or ii) a therapeutic effect threshold value or side effect threshold value for an electrode selection of the first set of stimulation parameter values;
performing clinical effects determinations in response to the stimulation for at least the first set of stimulation parameter values at a plurality of points in time extending over at least one week;
evaluating, by a processor, the clinical effects determinations to identify any difference from the therapeutic effects value, the side effects value, the therapeutic effect threshold value, or the side effect threshold value over time;
and when the difference from the therapeutic effects value, the side effects value, the therapeutic effect threshold value, or the side effect threshold value meets or exceeds a threshold, recommending or implementing, by the processor and without human intervention, a new set of stimulation parameter values based on previous clinical effects determinations.
These limitations, under their broadest reasonable interpretation, cover concepts that can be practically performed in the human mind, i.e., using pen and paper. With obtaining or determining a set of values and performing a determination based on values at plurality of points in time extending over at least one week, a human could reasonably evaluate the determinations to identify and differences from the value. This concept aligns with MPEP 2106.04(a)(2). Mental process where claims reciting: “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016)”, were determined to comprise “a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions.” Thus, the present claims recite limitations which fall within the 'mental processes’ grouping of abstract ideas.
Step 2A Prong 2:
Claims 1, 13 and 17 recite the following additional elements:
stimulating a patient using an electrical stimulation system
evaluating, by a processor, the subsequent therapeutic effects values or subsequent therapeutic threshold values to identify a difference from the first therapeutic effects value or first therapeutic threshold value, respectively;
and when the difference from the first therapeutic effects value or first therapeutic threshold value exceeds a threshold, recommending or implementing, by the processor and without human intervention, a new set of stimulation parameter values based on previous clinical effects determinations.
The limitation of “stimulating a patient using an electrical stimulation system” is merely insignificant pre-solution activity. {See MPEP 2106.05(g)} The stimulation of a patient is insignificant pre-solution activity due to the limitation not imposing meaningful limits on the claim with the recitation of a generic “electrical stimulation system”. Since the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering). MPEP 2106.05(g)
Furthermore, the limitations of “evaluating” data and “recommending or implementing” an updated data set comprise method steps that are merely implementation of a method on a generic system, such as a processor. The implementation of a mental process on a generic computer (in this case, once the mental process cited above is performed, one can readily ascertain how the mentally calculated data may be entered in a generic processor for evaluation and recommendation or implementation based on the data) provide no improvement to the functioning of a computer system as known in the medical art, thus as noted in MPEP 2106.05(a) the limitations do not amount to an improvement in the functioning of a computer. Similarly, these limitations comprises well-understood, routine and conventional activity with a processor, where it is common to have computer devices receive , evaluate and make “recommendations” or “implement” a change based on the data. Thus by MPEP 2106.05(d) these steps do not comprises integration of the mental process into practical application. Accordingly, even in combination, the additional element noted above (processor) 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. There is no recitation of an additional element (or combination of elements) that integrate the abstract idea of a mental process into a practical application. The claimed limitations merely “recommending or implementing” “a new set of stimulation parameter values” based on previous determinations (ex. “recommending or implementing, by the processor and without human intervention, a new set of stimulation parameter values based on previous clinical effects determinations”). There is no improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a); Or applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2). Thus, the limitations of updating data, by a processor in a closed-loop manner (without human intervention) is considered executing a mental process by using a generic computer component (processor). As discussed with respect to Step 2A Prong Two, the additional element in the claim are mere instructions to apply the exception using a generic computer component (processor). The same analysis applies here in 2B and does not provide an inventive concept.
Dependent claims:
Claims 2-12, 14-16 and 18-20 are dependent claims that further limit the method into steps relating to monitoring and revising the data through a mental process. Accordingly, these claims do not integrate the abstract idea into a practical application for similar reason to claims 1, 13 and 17. These limitations comprise well-understood, routine and conventional activity in the medical diagnostic and treatment devices, where it is common to have computer devices evaluate and “recommend or implement” changes to treatment based on the sensed data. Thus by MPEP 2106.05(d) these steps do not comprises integration of the mental process into 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 ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796