DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 6/15/2026 has been entered.
Acknowledgments
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1, 5-9, 21-22, 25-28 are pending.
This action is Non-Final.
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, 5-9, 21-22, 25-28 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s):
Claim 1: a system for managing a blood-pressure variation of a patient, comprising:
determine a target sleeping blood pressure of the patient based on the received waking blood pressure of the patient and the received nocturnal blood pressure dip of the patient (mental process, mathematical concepts);
determine, based on the determined target sleeping blood pressure, a target exercise intensity for the patient (mathematical concept, mental process, methods of organizing human activity);
determine a target exercise timing for the patient, comprising either: (i) predicting, based on the received measure of the circadian rhythm of the patient, a timing of melatonin onset for the patient, and processing the predicted timing of melatonin onset in accordance with one or more target exercise timing determination algorithms to determine the target exercise timing for the patient, or (ii) comparing the received measure of the circadian rhythm of the patient with a threshold value, and, based on a result of the comparing, determining the target exercise timing to be in either a time window after waking or a time window before sleeping (mathematical concept, mental process, methods of organizing human activity)
Claim 28: a system for prescribing a patient's target exercise intensity and target exercise timing to manage blood-pressure variation of the patient, comprising:
determine a target sleeping blood pressure of the patient based on the received waking blood pressure of the patient and the received nocturnal blood pressure dip of the patient (mental process, mathematical concepts);
determine, based on the determined target sleeping blood pressure, a target exercise intensity for the patient (mathematical concept, mental process, methods of organizing human activity);
determine a target exercise timing for the patient, comprising either: (i) predicting, based on the received measure of the circadian rhythm of the patient, a timing of melatonin onset for the patient, and processing the predicted timing of melatonin onset in accordance with one or more target exercise timing determination algorithms to determine the target exercise timing for the patient, or (ii) comparing the received measure of the circadian rhythm of the patient with a threshold value, and, based on a result of the comparing, determining the target exercise timing to be in either a time window after waking or a time window before sleeping (mathematical concept, mental process, methods of organizing human activity);
These claim limitations fall within the identified groupings of abstract ideas:
Mathematical Concepts:
mathematical relationships
mathematical formulas or equations
mathematical calculations
Mental Processes
concepts performed in the human mind (including an observation, evaluation, judgment, opinion)
Certain Methods Of Organizing Human Activity
managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions)
This judicial exception is not integrated into a practical application because:
Under the step 2A, analysis is conducted on the additional features of the claim. Under this analysis, the additional features beyond the judicial exception are:
Claim 1
a wearable device adapted to be worn by the patient, the wearable device comprising a blood pressure sensor and a circadian rhythm sensor, wherein the blood pressure sensor is configured to measure: (i) a waking blood pressure of the patient; and (ii) a nocturnal blood pressure dip of the patient; and wherein the circadian rhythm sensor is configured to measure a circadian rhythm of the patient;
a smart device, the smart device configured to wirelessly receive blood pressure measurements from the blood pressure sensor and circadian rhythm measurements from the circadian rhythm sensor of wearable device, the smart device comprising a processor configured to:
generate an output signal representative of the determined target exercise intensity and the determined target exercise timing; and
a user interface of either the wearable device or the smart device, the user interface configured to provide the output signal representative to the patient.
Claim 28
a wearable device adapted to be worn by the patient, the wearable device comprising a bloo0d pressure sensor and a circadian rhythm sensor, wherein the blood pressure sensor is configured to measure: (i) a waking blood pressure of the patient; (ii) a nocturnal blood pressure dip of the patient; and wherein the circadian rhythm sensor is configured to measure a circadian rhythm of the patient;
a smart device configured to wirelessly receive blood pressure measurements from the PPG and circadian rhythm measurements from the circadian rhythm sensor of wearable device, the smart device comprising a processor configured to:
generate an output signal representative of the determined target exercise intensity and the determined target exercise timing;
a user interface of either the wearable device or the smart device, the user interface configured to provide the output signal representative to the patient; and
a remote client device associated with a clinician and in communication with the smart device and configured to receive one or more of: (i) the output signal representative of the determined target exercise intensity and the determined target exercise timing; (ii) the blood pressure measurements; and (iii) the circadian rhythm measurements.
The additional features of claims 1 and 28 amount to pre and post insignificant extra solution activities to the claimed judicial exception, including data gathering, transmitting, and outputting signals, and to generically claimed processing structures of a wearable device, a smart device, and server used to receive, process, and output data used by the exceptions and which are claimed as tools to implement the exceptions or merely receive the exceptions and do not add anything significantly more to the claimed exceptions.
These features in the claim do not integrate the exception into a practical application of the exception as the additional elements in the claim do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is no more than a drafting effort designed to monopolize the exception.
Limitation concepts that are indicative of integration into a practical application:
Improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a)
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c)
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception - see MPEP 2106.05(e) and Vanda Memo
Limitation concepts that are not indicative of integration into a practical application:
Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f)
Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g)
Generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h)
Under Step 2B, the claim limitations are evaluated for an inventive concept. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, when considered separately and in combination, they do not add significantly more to the exception. Analyzing the additional claim limitations individually, the additional limitation that is not directed to the abstract idea are the same as those identified above in step 2a. Such limitations related to the obtaining of data are recognized by the courts as routine data gathering in order to input data to the exceptions (i.e. mathematical algorithm), and thus, do not add a meaningful limitation to the apparatus as it would be routinely used by those of ordinary skill in the art in order to apply the exceptions (i.e. mathematical algorithm). The computer structures cited above are claimed as performing generic computer functions routinely used in computer applications. Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. The additional limitations recited in the dependent claims are directed to further data gathering, further computer structures, further details and additional features which recite exceptions (A more specific abstraction is still an abstraction), generically claimed routine sensors for the expected data gathering from such conventional sensors (see for example Jang et al. (Jang, US 2010/0267520) Shimuta (US 2018/0263518) as discussed in prior claim 6 art rejections), including known systems of wearable, smart devices, and servers (see US 2007/0265533, US 2008/0146892, US 2008/0220941, US 2011/0245633, US 2014/0085077, US 2016/0360980) where additional computer technology and generic portability of the computer system which are additional routine uses of computer systems common in the art. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Therefore, analyzing the claims as an ordered combination under the Mayo/Alice analysis the features claimed are directed to patent ineligible limitations.
Response to Arguments
The examiner acknowledges applicant’s submission of amendments to the claims filed 6/15/2026.
Applicant’s arguments regarding the claim objections have been fully considered and are persuasive due to the amendments to the claims; the objections are withdrawn.
Applicant’s arguments regarding the rejections under 35 U.S.C. 112(a) have been fully considered and are persuasive due to the amendments to the claims. The rejections are withdrawn.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 101 have been fully considered but are not persuasive. Applicant’s arguments are that the claims do not recite any judicial exceptions. However, counter to the extensive arguments, Office examples are non-precedential guidance and do not sway that exceptions are not recited in the claims. Counter to the hypothetical limitations provided by the Office, the instant claims have claim limitations recited that a panel of Judges on appeal have agreed that the claims recite judicial exceptions. The controlling analysis is that of the Mayo/Alice analysis and not Office examples, which the panel also provided in addition to the Examiner’s rejections. It is settled that the claims recite judicial exceptions based on the current prosecution history. In order for the recited exceptions to be patent eligible under 101, the additional limitations viewed in the claim as a whole are evaluated to see if the exceptions are integrated into a practical application or recite significantly more than the claimed exceptions. The differences between the Board decision and the present claims are the structures recited for performing the exceptions, and pre and post solution features. Applicant’s argument is that the claims are to a physical system that utilizes modern technology to convey functionality. However, machine or transformation is a tool and not a brightline indicator of patent eligibility. Nothing in the claims amounts to a novel configuration of sensors or data gathering. The claims uses generic sensors to gather patient data and then does nothing more than process that data to produce a signal, and extra solution activities of outputting and displaying data. The claims amount to nothing more data processing and using generic computer structures conventional/well-known in modern technology, as tools for implementation. The additional features of claims 1 and 28 amount to pre and post insignificant extra solution activities to the claimed judicial exception, including data gathering, transmitting, and outputting signals, and to generically claimed processing structures of a wearable device, a smart device, and server used to receive, process, and output data used by the exceptions and which are claimed as tools to implement the exceptions or merely receive the exceptions and do not add anything significantly more to the claimed exceptions. The rejections are respectfully maintained.
Conclusion
No prior art rejections have been applied, but the claims are not in condition for allowance due to the rejections of the claims under 35 U.S.C. 101/112.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 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, Robert (Tse) Chen can be reached at (571)272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791
Prosecution Insights