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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/08/2026 has been entered.
DETAILED ACTION
Notices to Applicant
This communication is a non-final rejection. Claims 1-2, as filed 06/08/2026, are currently pending and have been considered below.
Priority is generally acknowledged as shown on the filing receipt. This application is a DIV of 17/138,363 (12/30/2020), 17/138,363 is a DIV of 15/158,770 (05/19/2016), 15/158,770 has PRO 62/164,307 (05/20/2015).
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon and the rationale supporting the rejection would be the same under either status.
The Examiner notes that, while the currently-presented claims are not patentable for the reasons described below, certain features of the instant specification when viewed in combination may be patentable: passive capture of behavioral data by the PWD (“the PWD may collect a substantial number of real-time behavioral data points every day, to be analyzed by an Early Warning Predictive Analytics (EWPA) machine learning system within the coordinated care platform to alert the caregiver (via our mobile app) in case of any behavioral anomaly,” [0152] of the specification as filed); tap timestamps (“When the patient taps the screen, timestamps associated with the taps are recorded and sent to the predictive analytics engine,” [0089]); interval sampling of movement/wear/charging ([0153]-[0160]); indices with EWMA computation (“analyzing the behavioral data includes determining a compliance index and an engagement index using an exponential weighted moving average,” [0031]; [0164]); engagement index from response delay ([0163]-[0168]); and caregiver alert based on anomalies and historical data (“If the patient scores 10 for both it is great. If, however the patient starts missing medicines and alerts need to be raised, then the compliance value will be some value less than 10, which triggers an alert to be sent to the caregiver,” [0168]).
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 1-2 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter 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
The claim(s) recite(s) subject matter within a statutory category as a process, machine, and/or article of manufacture which recite:
1. A method of enhancing a clinical trial outcome, comprising:
equipping each patient of the clinical trial with a patient wearable device (PWD) (abstract idea, certain methods of organizing human activity, namely, the process caregivers follow to remotely monitor patients; to the extent that the PWD might go beyond an abstract idea, it amounts to insignificant extra-solution activity);
providing to the patient, by a webserver through the PWD, reminders to take a medication and instructions for taking the medication, and timely intervention messages composed to motivate patients to increase therapeutic adherence (abstract idea, certain methods of organizing human activity, namely, the process caregivers follow to remotely monitor patients and encourage medication compliance; to the extent that the PWD and webserver might go beyond an abstract idea, they amount to merely applying the abstract idea using computers as tools);
gathering in real-time from the patent, by the webserver through the PWD, (i) patient feedback about effects of the medication and side-effects of the medication, reported by the patient when the effects and/or side-effects occur, in response to experiencing the effects and/or side-effects of the medication, (abstract idea – certain methods of organizing human activity, namely patients self-reporting and caregivers remotely monitoring them; the details of when and why the human reports information is part of the method of organizing human activity because a patient typically tells providers about side effects while the effects are experienced)
(ii) a survey on each patient’s health, (iii) health check-in information, and (iv) vitals information generated by one or more vitals testing devices and collected, by way of a wireless communication interface, by the PWD (abstract idea, certain methods of organizing human activity, namely, the process caregivers follow to remotely monitor patients; to the extent that the vitals testing devices and wireless communication interface might go beyond an abstract idea, they amount to applying the abstract idea using computers as tools; a person watching a patient visually would gather data in real-time with his eyes and ears).
2. The method of claim 1, further comprising providing, by a webserver through each PWD, medication reminders and/or communication from a caregiver (abstract idea, certain methods of organizing human activity, namely, the process caregivers follow to remotely monitor patients; to the extent that the webserver and PWD might go beyond an abstract idea, they amount applying the abstract idea using computers as tools).
Step 2A Prong One
The broadest reasonable interpretation of these steps includes certain methods of organizing human activity, namely, the process caregivers follow to remotely monitor patients. The steps of gathering data from a patient over time and advising a patient on treatment (e.g., reminders to take medication) are technologically agnostic processes that a caregiver would perform when monitoring a patient. For example, the caregiver could call the patient every day to ask about current blood pressure, remind the patient to take a medication for bed, and generally discuss health check-in information. The other computer-focused terminology amounts to merely applying this monitoring process with generic computing equipment.
The dependent claim recites additional subject matter which further narrows or defines the abstract idea embodied in the claims because providing medication reminders and communication from the caregiver are both part of the remote monitoring process identified in claim 1. Providing these medication reminders and communications with a PWD and webserver amounts to merely applying the abstract idea with a computer.
Step 2A Prong Two
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception (such as recitation of providing patients by a webserver through the PWD reminder and intervention messages and gathering data from patients via vitals testing devices, wireless communication, and the PWDF which amount to invoking computers as a tool to perform the abstract idea, see applicant’s specification [0047] and [0108], see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of equipping patient with a PWD behavioral data associated with the patient and gathering patient data from the PWD to the webserver which amounts to mere data gathering and selecting a particular data source or type of data to be manipulated, see MPEP 2106.05(g))
Dependent claim 2 recites subject matter which amount to limitations consistent with the additional elements in the independent claims such as further abstract ideas, i.e., patient monitoring, and merely applying the idea with a computer, i.e., by a webserver through each PWD. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which: amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields such as receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i), performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii), and electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Claim Rejections - 35 USC § 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Cederlund (US20130304502A1) in view of and Tran (US20140104059A1).
Regarding claim 1, Cederlund discloses: A method of enhancing a clinical trial outcome (“clinical trials” [0066]; “The purpose of this type of feedback is, for instance, to motivate the patient to continuous improvements. Illustrations of how the patient's health status is evolving in comparison to the evolvement of earlier patients using the same pharmaceutical product, for example patients in clinical trials,” [0103]), comprising:
--equipping each patient of the clinical trial with a (“The technical realization and implementation of the CPP in the three studies is illustrated in FIG. 10. The patients were first registered in the system by the health care personnel and after that the patients could download, via mobile internet, the mobile phone application to their mobile phones. The mobile phone application could process, handle and present the questions and answers to the patient. The CPP also consisted of a web client application which was the primary user interface for the health care personnel,” [0209]; [0039]);
--providing to the patient, by a webserver through the PWD ([0162]; [0039]; [0209]), reminders to take a medication and instructions for taking the medication (“remind patients about their medication schedule,” [0346]; “guide the user to change or cease the administration or dosage regimen according to guidelines based on the information about side effects, or to contact the treating physician if advised,” [0114]), and timely intervention messages composed to motivate patients to increase therapeutic adherence (“Such messages may include recommendations, suggestions or information intended to motivate the respondent, e.g. to continue the prescribed dosage regimen although symptoms have disappeared or are less pronounced,” [0091]; [0099]);
--gathering in real-time from the patent, by the webserver through the PWD (handheld device communicating through the web or cloud in [0039]; “The patients were first registered in the system by the health care personnel and after that the patients could download, via mobile internet, the mobile phone application to their mobile phones,” [0209]),
--(i) patient feedback about effects of the medication and side-effects of the medication (“Side effects and adverse events, such as adverse drug effects,” [0073]; “Treatment, such as if the treatment is perceived as working well,” [0083]), reported by the patient when the effects and/or side-effects occur, in response to experiencing the effects and/or side-effects of the medication (The Examiner interprets this in light of the specification [00124]: Real-time Customizable Interventions - Occasional questions multiple times a day (such as YES/NO, side effects, pain levels) to assess patient’s physical and emotional health. Cederlund discloses: “some were “spontaneous”, i.e., always available for the patient to answer,” [0217]; [0233]; [0266]; Tables 3, 8, 16; “how much eczema do you have right now,” Table 7; “give the user early indications of the occurrence or development of a possible adverse event and/or side effect, by including questions relating to occurrence or development of a possible adverse event and/or side effect.. making each user of the pharmaceutical product aware of the occurrence or development of a possible adverse event and/or side effect and also facilitates that this may be reported directly to medical staff,” [0037])
--(ii) a survey on each patient’s health (“The term “set of questions” is a questionnaire with predetermined questions or items shown to a respondent to get answers for feedback purposes,” [0056]; “General, such as quality of life; feeling of support from family, friends, caregiver,” [0085]),
--(iii) health check-in information (“daily morning questions” in Table 16; “at what time of day the questions will show up for the respondents to answer them,” [0090]) and
--(iv) vitals information generated by one or more vitals testing devices and collected, by way of a wireless communication interface, by the PWD (“The questions may however also have an undefined number of answers, such as a value of a test parameter (e.g. blood pressure, blood glucose level, body temperature, weight) or free text,” [0086]; “Information from other products and systems, such as administration systems, laboratory data, personal patient devices such as watches, heart rate monitors, scales, mobile phone applications, pedometers, glucose meters, thermometers, audiometers, inhalers, ultrasound devices, electrocardiography devices, etc. Such information can be automatically collected by or transferred to the computer program product by different means,” [0119]-[0120]).
Thus, Cederlund discloses spontaneous questions (no scheduled time) and always-available questions that the patient answers for present-tense symptoms (e.g., “How much eczema do you have right now” in Table 7). Answers to the questions are transmitted with mobile internet to a server ([0209]).
Cederlund does not expressly disclose but Tran teaches:
--a patient wearable device (“The patient 30 may wear one or more wearable patient monitoring appliances such as wrist-watches or clip on devices or electronic jewelry to monitor the patient. One wearable appliance such as a wrist-watch includes sensors 40, for example devices for sensing ECG, EKG, blood pressure, sugar level, among others,” [0080]; “The watch and the base station is part of a mesh network that may communicate with a medicine cabinet to detect opening or to each medicine container 1391 to detect medication compliance,” [0166]; FIG. 6);
--vitals information generated by one or more vitals testing devices and collected, by way of a wireless communication interface, by the PWD (“One wearable appliance such as a wrist-watch includes sensors 40, for example devices for sensing ECG, EKG, blood pressure, sugar level, among others. In one embodiment, the sensors 40 are mounted on the patient's wrist (such as a wristwatch sensor) and other convenient anatomical locations. Exemplary sensors 40 include standard medical diagnostics for detecting the body's electrical signals emanating from muscles (EMG and EOG) and brain (EEG) and cardiovascular system (ECG),” [0080]; “a monitoring system includes one or more wireless nodes forming a wireless mesh network; a user activity sensor including a wireless mesh transceiver adapted to communicate with the one or more wireless nodes using the wireless mesh network; and a digital monitoring agent coupled to the wireless transceiver through the wireless mesh network to request assistance from a third party based on the user activity sensor,” [0017]; “. The watch and the base station is part of a mesh network that may communicate,” [0166]).
One of ordinary skill in the art would have been motivated before the effective filing date to expand the phone-based patient monitoring of Cederlund to include the smart watch mesh system of Tran because a watch is “convenient, unobtrusive, [and] private” (Tran [0024]) and because Cederlund contemplates collecting patient information from “devices such as watches, heart rate monitors” in [0120].
Additionally, one of ordinary skill in the art would have recognized that the only difference between the combination of Cederlund and claim 1 is the patient wearable device being a watch. Tran teaches this. One of ordinary skill in the art before the effective filing date could have substituted Cederlund’s mobile telephone with Tran’s smart watch. The results would have been predictable, namely, the information input, output, and processing that would otherwise be performed by the device of Cederlund would be performed on the smart watch.
Regarding claim 2, Cederlund further discloses: providing, by a webserver through each PWD, medication reminders and/or communication from a caregiver (“The patient can receive messages from the healthcare personnel as well through the computer program product, as a result of the feedback given to them,” [0106]; “remind patients about their medication schedule” in [0346]).
Response to arguments
Applicant's arguments filed 06/08/2026 have been fully considered and are discussed below.
Applicant argues that the claimed invention improves a technology as in Enfish because gathering in real-time patient data by way of a wireless communication interface is a “technological process of efficiently and automatedly collecting clinical data”. Remarks pages 3-4. This is not persuasive because the asserted improvement describes a result (i.e., efficiently and automatically collecting data) being performed on generic devices. Unlike Enfish where the claim changed how the computer database operated, Applicant recites no mechanism by which a device or networking protocol operates differently or better. Benefits such as improved speed or caregiver burden are not technical improvements. The data being collected in real-time or when an effect is occurring describes when the data gathering is performed, not how any technology is improved.
Regarding the prior art rejections, Applicant argues that a POSITA would have recognized that gathering data in real time as in claim 1 requires the data gathering to occur at the same time that the effect or side-effect is occurring which is distinct from Cederlund where the patient answers questionnaires “which will evince a natural lag between when the question is presented and when the response is provided.” Remarks page 4. While the Examiner accepts Applicant’s interpretation of “real-time”, this argument not persuasive because it argues against Cederlund’s scheduled questionnaires rather than its spontaneous questionnaires which are posed at no scheduled time and are always available for a patient to answer ([0217]; [0233]; [0266]; Tables 3, 8, 16). These questionnaires are phrased in the present tense, e.g., “How much eczema do you have right now?” in Table 7 and allow caregivers to track early indications of possible side effects in [0037]. There is no lag between when the question is presented and when the answers are transmitted for these spontaneous questionnaires.
Applicant separately argues that the amended claims are distinct from Cederlund and Tran because the combination does not teach all four types of data being collected. Remarks page 5. This is not persuasive because Cederlund’s spontaneous questionnaires involve no prompting and are present tense. To the extent that Applicant is asserting that real-time data collection cannot occur within a questionnaire framework, the Examiner disagrees because the BRI of the amended limitation includes any patient report occasioned by the experienced effect and made while they effect is currently being perceived.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BLANCHETTE whose telephone number is (571)272-2299. The examiner can normally be reached on Monday - Thursday 7:30AM - 6:00PM, EST.
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/JOSHUA B BLANCHETTE/ Primary Examiner, Art Unit 3624
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