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 .
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. {See MPEP 609.05(b)} Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
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 121-124 and 129-140 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 121 and 129 recite an apparatus and are thus directed towards statutory categories of invention.
Step 2A Prong 1:
Claims 121 and 129 recite the following limitations:
therapy parameters being selected from a plurality of predefined profiles determined by an aggregation learning algorithm;
adjust the therapy parameters based on the measured physiological data from the therapy session;
and optimize the adjusted therapy parameters by a learning algorithm based on an individual database, the learning algorithm predicting a modified outcome based on the individual database which includes an aggregation of physiological data and satisfaction data from multiple therapy sessions for the user.
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 determining therapy parameters and adjusting therapy parameters, a human could reasonably evaluate the determinations to identify and adjust parameters to optimize treatment. 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 121 and 129 recite the following additional elements:
one or more electrodes configured to generate electric stimulation signals based on therapy parameters
one or more sensors configured to detect physiological data, wherein the one or more sensors are operably connected to the wearable neurostimulation device;
and one or more hardware processors configured to: perform a therapy session with the therapy parameters; measure physiological data from the one or more sensors
The limitations of “collecting” and “measuring” are merely insignificant pre-solution activity (See MPEP 2106.05(g) and gathering of data from a generic sensor is a step of mere data gathering).
The limitations of “the aggregation learning algorithm predicting a plurality of outcomes for the user based on a plurality of predefined profiles, the plurality of predefined profiles being based on features extracted from data for a plurality of users” and “the learning algorithm predicting a modified outcome based on the individual database which includes an aggregation of physiological data and satisfaction data from multiple therapy sessions for the user”, while not mental processes comprise steps that are merely implementation on a generic system, such as a processor. A generic system amounts to no more than the implementation of a mental process on a generic computer. Further, these 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 in the medical therapies, where it is common to have algorithms on generic computer devices to calculate, measure and update data as a conventional function. Thus by MPEP 2106.05(d) these steps do not comprises integration of the mental process into practical application.
Accordingly, even in combination, these additional elements noted above (electrodes, sensors and processors) 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 “therapy parameters being selected from a plurality of predefined profiles determined by an aggregation learning algorithm; adjust the therapy parameters based on the measured physiological data from the therapy session; and optimize the adjusted therapy parameters by a learning algorithm based on an individual database, the learning algorithm predicting a modified outcome based on the individual database which includes an aggregation of physiological data and satisfaction data from multiple therapy sessions for the user”.
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 is considered executing a mental process by using a generic computer component (processor).
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 mere instructions to apply the exception using generic components (sensors and electrodes) for data gathering and generic computer components (processor). The same analysis applies here in 2B and does not provide an inventive concept.
NOTE: Claim 125 recites the additional limitation “and perform another therapy session with the optimized therapy parameters, wherein the device is a wearable transcutaneous device”. This limitation is a practical application of an abstract idea. As such, claim 125 and dependent claims 126-128 are not rejected under 35 U.S.C. 101.
Dependent claims:
Claims 122-124 and 130-140 are dependent claims that further limit the apparatus with collecting and determining data and parameters. Accordingly, these claims do not integrate the abstract idea into a practical application for similar reason to the extra solution activity of claims 121 and 129. These limitations comprise well-understood, routine and conventional activity in the medical monitor space, where it is common to have sensors, electrodes and computer devices. Thus by MPEP 2106.05(d) these steps do not comprises integration of the mental process into practical application.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E 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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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796