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 without traverse of species II, i.e. claims 5-13 & 17-20 in the reply filed on August 27, 2025 is acknowledged.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 1, 2026 has been entered.
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, 5, 13 & 17, specifically independent claims 1 & 13, are directed to an abstract idea without significantly more. Please see the below analysis providing the details as to why the invention is directed towards non-statutory subject matter.
Step 1:
Claim 1 is directed to a system, i.e. a product, a statutory category of invention.
Claim 13 is directed to a method, a statutory category of invention.
Step 2A, Prong 1:
Claim 1 recites the method steps of (via a control circuit):
“…receive physical activity information…”
“…receive a prescribed treatment…”
“…determine an indication of patient…”
“…determine an indication of patient condition…”
“…provide the determined indication of patient compliance…”
“…control transition of a state of an indicator…”
Claim 13 recites the method comprises:
“…detecting physical activity of a patient…”
“…receiving physical activity information…”
“…receiving a prescribed treatment…”
“…determining an indication of patient…”
“…determining an indication of patient condition…”
“…providing the determined indication of patient compliance…”
“…controlling transition of a state of an indicator…”
These limitations, under the broadest interpretation, fall within the mental processes (i.e. detecting, receiving, determining, providing and controlling) grouping of an abstract idea. It would be practical, but for the recitation “a control circuit” to perform the steps in a human’s mind, or with a pen and paper, to utilize the claimed signals.
Step 2A, Prong 2:
The claims as a whole fails to integrate the abstract idea into a practical application. Claims 1 & 13 recites the following additional elements, which for the reasons set forth below, do not integrate the abstract idea into a practical application.
“…a motion sensor…” which is directed to data gathering, see MPEP 2106.05(g).
“…a control circuit…” which is directed to mere instructions to apply an exception, see MPEP 2106.05(f).
Therefore, the claims fail to integrate the abstract idea into a practical application. The examiner also notes that the additional elements recited in claims 1 & 13 do not apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition. The claims are also silent to providing any treatment at all to a patient.
Step 2B:
The claims as a whole fails to recite an inventive concept. The additional elements, when considered individually and in combination, do not recite significantly more than the abstract idea for the reasons as set forth above in Step 2A, Prong 2. Upon re-evaluating the limitation that was previously identified as insignificant extra-solution activity in Step 2A, Prong 2, the following evidence to show that the limitation is well-understood, routine and conventional:
real-time discrete data obtained from a medical device/data previously collected from a medical device (i.e. body surface/unipolar electrodes) Presenting offers and gathering statistics, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93; Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network).
producing at said computer processor a human-readable output (i.e. processor) of the analysis of the gathered data, this is also WURC, as evidenced by Electric Power Group, LLC v. Alstom S.A., 830F.3d 1350, 119 USPQ2d 1739 (Fed.Cir. 2016), which discusses “conventional computer, network, and display technology” and states that “nothing in the patent contains any suggestion that the displays needed for that purpose are anything but readily available. We have repeatedly held that such invocations of computers and networks that are not even arguably inventive are “insufficient to pass the test of an inventive concept in the application” of an abstract idea”.” Similarly, there is nothing in Applicant’s specification that indicates that the device that is “producing at said computer processor a human-readable output indicating” the findings of the analysis is anything but readily available.
Therefore, the claims fail to recite significantly more than the abstract idea and claims 1, 8 & 15 are rejected under 35 U.S.C 101.
The examiner also notes that limitations of the dependent claims 5 & 17 further define the steps of determining indication of patient compliance, which further limits the claim limitations already indicated above as being directed to an abstract idea. Therefore, claims 5 & 17 are also directed to patient-ineligible subject matter.
Response to Arguments
Applicant's arguments filed June 1, 2026 have been fully considered but they are not persuasive. The applicant argues the following points in which the examiner provides a reason(s) as to why the arguments are not persuasive:
The examiner notes and agrees that the amendments overcome the prior art rejection in view of Treacy et al. (US 2018/0261066), previously applied in this application. Accordingly, the prior art rejections have been withdrawn.
However, the applicant argument’s regarding subject matter eligibility are not persuasive.
The examiner acknowledges that claims 1 & 13 have been amended to recite:
controlling a transition of a state of an indicator based on at least one of a determined indication of patient compliance or a determined indication of patient condition. The examiner further acknowledges that the amendment more closely addresses the eligibility concerns identified in the prior office action. Nevertheless, the amendment does not alter the conclusion that claim 1 remains directed to a judicial exception that is not integrated into a practical application.
The applicant argues that the claimed indicator-state transition constitutes a technological improvement and a practical application. This argument is not persuasive. The claims continue to receive physical activity information, determine patient compliance and patient condition, provide the results of those determinations, and control a state transition of an indicator based upon those results. The claimed indicator-state transition merely communicates or presents the outcome of the claimed analysis and does not improve the functioning of the motion sensor, control circuit, indicator, patient monitoring system or any other technology.
The applicant further relies upon specification paragraphs [0103]-[0105] and [0110]. While the specification describes embodiments involving control of therapy components, therapy adjustment and modification of treatment parameters, such features are not presently recited in independent claims 1 & 13. The presently claimed invention is limited to controlling a transition of a state of an indicator and does not require controlling therapy delivery, modifying treatment parameters, or otherwise improving operation of a medical device.
The examiner notes that the amendments add hardware-related limitations and more closely reflect embodiments described in the specification. The presently claimed indicator-state transition remains an output of the claimed determinations rather than a technological operation that meaningfully integrates the judicial exception into a practical application.
Accordingly, the rejection under 35 U.S.C. § 101 is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796
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