DETAILED ACTION
Notices to Applicant
This communication is a final rejection. Claims 1-2, as filed 03/11/2026, 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.
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, (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]);
--providing to the patient, by a webserver through the PWD ([0162]), reminders to take a medication and instructions for taking the medication (“remind patients about their medication schedule,” [0346]; “Rules and thresholds for defining when to give notifications concerning the pharmaceutical product and different kind of issues, e.g. possible adverse events, possible side effects, change dosage regimen, possible interaction of other prescribed drugs etc. These have to be carefully developed and take notice of possible combination between different questions, the evolvement of the answers from patients over time, other possibly used medication, etc”), 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]);
--gathering in real-time from the patent, by the webserver through the PWD (handheld device communicating through the web or cloud in [0039] and FIGS. 4-5), (i) patient feedback about effects of the medication and side-effects of the medication, (ii) a survey on each patient’s health, (iii) health check-in information (“One aspect of the invention is to 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,” [0037]; the Examiner notes that Cederlund’s questionnaire responses are gathered in real-time and are thus capable of detecting adverse events; “A set of questions specific for the pharmaceutical product. The set of questions is implemented in a questionnaire giving the respondent the ability to choose any of a number of possible answers to each question or enter a number representing a test value. The questions may relate to the following, the list being illustrative and non-exhaustive: Side effects and adverse events, such as adverse drug effects…General, such as quality of life; feeling of support from family, friends, caregiver,” [0072]-[0085]; gathering data in real time with mobile internet in [0209]) 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),” [0056]; TABLE 2 on page 11).
Cederlund’s patient feedback information is captured with a handheld device such as a PDA or mobile telephone (Cederlund [0039]) but not that the patient wearable device is a watch as is suggested throughout the instant specification such as in [0066]: “The watch communicates using JAVA REST APIs to the webserver 106” and [0067]: “the PWD functions as a wrist watch”.
Tran teaches a smart watch as a patient monitoring 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).
One of ordinary skill in the art would have been motivated before the effective filing date to expand the patient monitoring of Cederlund to include the smart watch of Tran because a watch is “convenient, unobtrusive, [and] private” (Tran [0024]).
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]).
Response to arguments
Applicant's arguments filed 03/11/2026 have been fully considered and are discussed below.
Applicant argues that the claimed invention amounts to significantly more than any abstract idea (Step 2B) because gathering in real-time patient data by way of a wireless communication interface “solves the problem of a health care provider not being able to monitor an elderly or disabled patient continuously to record and document, for example, issues related to effects and side effects of the medication…e.g., using toilet facilities”. Remarks pages 3-4. This is not persuasive because the asserted improvement describes the usefulness of the abstract idea rather than any improvement to the functioning of a computer or other technology. Using a computer as a tool to perform existing processes does not integrate the abstract idea into a practical application. MPEP 2106.05(f). The “real-time” modifier describes when the data is gathered, not how the technology is improved. A POSITA would know how to implement data gathering in real time without further technical explanation precisely because it is the result routine computer functions. The fact that this occurs in a clinical trial is also insufficient under 2106.05(h) because this context is simply field-of-use. Applicant does not describe particular technical problems with implementing patient monitoring in clinical trials that are solved with the invention. Therefore the 101 rejections are maintained.
Regarding the prior art rejections, Applicant argues that Cederlund’s gathering of behavioral data is not in real-time, and this deficiency is not cured by Tran. Remarks pages 4-5. This is not persuasive. Cederlund’s system is designed to provide “early indications” of side effects ([0037]) and thus it provides timely, i.e., real-time, transmission of patient responses from the device to the server via mobile internet ([0209]). Because the claims do not rely upon a special definition of “real-time”, the term receives it broadest reasonable interpretation which encompasses the immediate data transmission of Cederlund’s internet-connected mobile device that provides data quickly enough to a sever to provide early indications of side effects. Applicant has not identified any structural or temporal limitations in the claims that would require something beyond Cederlund’s disclosure. Therefore the 103 rejections are maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/JOSHUA B BLANCHETTE/ Primary Examiner, Art Unit 3624