DETAILED ACTION
Status of Claims
This action is in reply to the application filed on 15 May, 2024.
Claims 1 – 13 have been amended; and Claims 14 – 20 have been added by an amendment filed on 15 May, 2024.
Claims 1 – 20 are currently pending and have been examined.
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 .
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 – 9 and 11 - 20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea), and does not include additional elements that either: 1) integrate the abstract idea into a practical application, or 2) that provide an inventive concept – i.e. elements that amount to significantly more than the abstract idea. The Claims are directed to an abstract idea because, when considered as a whole, the plain focus of the claims is on an abstract idea.
Claim 1 is representative. Claim 1 recites:
A computer-implemented method, the method comprising:
receiving patient data, the patient data comprising data about a patient's blood pressure over time,
analyzing the patient data and identifying one or more signs of a hypertensive crisis in the patient data, and
providing a notification to the patient, the notification comprising information about the identified one or more signs of the hypertensive crisis and a request for the patient to perform an action.
Claim 13 recites medium with instructions executed by a processor, and Claim 12 recites a system that executes the steps of the method recited in Claim 1.
STEP 1
The claims are directed to a system, a method and non-transitory computer readable medium, which are included in the statutory categories of invention.
STEP 2A PRONG ONE
The claims, as illustrated by Claim 1, recite limitations that encompass an abstract idea including:
receiving patient data, the patient data comprising data about a patient's blood pressure over time,
analyzing the patient data and identifying one or more signs of a hypertensive crisis in the patient data, and
providing a notification to the patient, the notification comprising information about the identified one or more signs of the hypertensive crisis and a request for the patient to perform an action.
The claims, as illustrated by Claim 1, recite limitations that encompass an abstract idea within the “mental processes” grouping – concepts performed in the human mind including observation, evaluation, judgment and opinion. The claims recite receiving patient blood pressure data over time; analyzing the data to identify signs of a hypertensive crisis; and providing a notification to the patient comprising information about the identified signs of the hypertensive crisis, and a request to perform an action.
Collecting information, including when limited to particular content, is within the realm of abstract ideas, and analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, are mental processes within the abstract idea category (Electric Power Group v. Alstom S.A. (Fed Cir, 2015-1778, 8/1/2016).
The specification discloses that patient blood pressure may be measured by any method. (@ 0034 as published – see US PGPUB 2025/0006371 A1) The data may be received at a computer by entering the data via an input unit (@ 0107), or by transmitting the data from sensors over known short-range communication technology. (@ 0118) The blood pressure data may be analyzed to identify a sign of hypertensive crisis, by comparing the measured value for the patient to a threshold. (@ 0051) The specification defines a “hypertension crisis” as being one of a “hypertensive urgency” or a “hypertensive emergency”, indicating that both may occur “when blood pressure becomes “very high”. (@ 0003) The specification discloses that the thresholds defined for hypertensive urgency or hypertensive emergency: are known in the art (@ 0052); may be arbitrarily derived numbers (@ 0054); may be determined by a physician (@ 0055); or may be determined automatically based on the patient data or risk. (@ 0056)
A notification is provided to the patient via the patient’s smart phone. The notification includes “information about the identified signs of the hypertension crisis” - i.e. information indicating that the measured blood pressure exceeds the threshold. The notification may further include “a request for the patient to perform an action”. The specification discloses that requested actions may include an action performed by the patient that acknowledges the notification, such as pressing a switch on a computer, swiping a graphic on a touch-sensitive display, issue a command by voice or any other action that shows that the patient has received and understood the communication. (@ 0084) The patient may also be requested to take an action such as: “answer one or more questions” (@ 0086); or to: “remain calm, lie down, take a medication, call an emergency physician”, etc. (@ 0092-0093).
Analyzing a patient’s blood pressure measurements, taken over time, identify a sign of hypertensive crisis, including by comparing the measured values for the patient to a threshold is a process that can be performed in the human mind. As such, the claims recite an abstract idea within the mental process grouping.
The claims, as illustrated by Claim 1, recite limitations that encompass an abstract idea within the “certain methods of organizing human activity” grouping –
managing personal behavior or relationships or interactions between people including social activities, teaching, and following rules or instructions.
The claims recite receiving patient blood pressure data over time; analyzing the data to identify signs of a hypertensive crisis; and providing a notification to the patient comprising information about the identified signs of the hypertensive crisis, and a request to perform an action. This process is typical in medicine, where blood pressure measures are taken over time to determine if any diagnosis of hypertensive crisis is indicated, and is process that merely organizes this human activity. (See MPEP 2016.04 (a)(2) II C finding that “a mental process that a neurologist should follow when testing a patient for nervous system malfunctions” is a method of organizing human activity, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982). As such, the claims recite an abstract idea within the certain methods of organizing human activity grouping.
STEP 2A PRONG TWO
The claims recite limitations that include additional elements beyond those that encompass the abstract idea above including:
A computer-implemented method;
receiving patient data;
providing a notification to the patient.
However, these additional elements do not integrate the abstract idea into a practical application of that idea in accordance with the MPEP. (see MPEP 2106.05)
The computer that executes the method is recited at a high level of generality such that it amounts to no more than instructions to apply the abstract idea using a generic computer component – i.e. “a computer system comprising a processor and memory”; “a desktop or a laptop computer a tablet computer and/or a smartphone” (@ 0064, 0117). These elements merely add instructions to implement the abstract idea on a computer, and generally link the abstract idea to a particular technological environment.
In addition to being a part of the abstract “receiving and analyzing”, receiving patient data is an extra-solution activity – i.e. a data gathering step. Similarly, providing notifications, while ancillary to the abstract idea itself, is also an extra-solution activity that does not add a meaningful limitation to the abstract idea.
Nothing in the claim recites specific limitations directed to an improved technology or technological process. Similarly, the specification is silent with respect to these kinds of improvements. A general purpose computer that applies a judicial exception by use of conventional computer functions, as is the case here, does not qualify as a particular machine, nor does the recitation of a generic computer impose meaningful limits in the claimed process. (see Ultramercial, Inc. v. Hulu, LLC, 772 F.3d 709, 716-17 (Fed. Cir. 2014)). As such, the additional elements recited in the claim do not integrate the abstract hypertensive crisis identification process into a practical application of that process.
STEP 2B
The additional elements identified above do not amount to significantly more than the abstract hypertensive crisis identification process. Receiving information and requesting information, for example over a network, is a well-understood, routine and conventional computer function – i.e. receiving or transmitting data over a network as in Symantec, TLI, OIP and buySAFE. Displaying the results of the abstract process, such as via a notification, is an ancillary part of the abstract process itself as in Electric Power Group.
The additional structural elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than a recitation of generic computer structure (i.e. a computer/processor and memory, computer-readable medium). Each of the above components are disclosed in the specification as being purely conventional and/or known in the industry. Because the specification describes these additional elements in general terms, without describing particulars, Examiner concludes that the claim limitations may be broadly, but reasonably construed, as reciting well-understood, routine and conventional computer components and techniques. The specification describes the elements in a manner that indicates that they are sufficiently well-known that the specification does not need to describe the particulars in order to satisfy U.S.C. 112. Considered as an ordered combination the limitations recited in the claims add nothing that is not already present when the steps are considered individually. As such, the additional elements recited in the claim do not provide significantly more than the abstract hypertensive crisis identification process, or an inventive concept.
The dependent claims add additional features including:
those that merely serve to further narrow the abstract idea above such as:
further limiting the signs of hypertensive crisis (Claim 2, 3, 14, 15);
further limiting the content of second notifications (Claim 9);
those that recite additional abstract ideas such as:
determining thresholds individually for the patient (Claim 4, 16);
adjusting the rate of measurement based on the degree of change of the measurement (Claim 5, 17);
provide a reminder or second notification based on various conditions (Claim 6 – 8, 18 - 20);
receiving a predicted blood pressure value, compare to a threshold, and provide a notification or reminder (Claim 11);
those that recite well-understood, routine and conventional activity or computer functions such as:
inputting patient data into a trained machine learning model and receiving a predicted blood pressure or probability of hypertensive crisis from the model (apply it) (Claim 11);
those that recite insignificant extra-solution activities; or those that are an ancillary part of the abstract idea.
With respect to Claim 11, in particular, the claimed machine learning model replaces the knowledge and experience of a physician by applying established methods of machine learning to an abstract hypertension crisis identification process in a new data environment – i.e. applying a trained model to the blood pressure information. The specification generically discloses the machine learning model – no particular algorithm such as a neural network, support vector machine, etc. are disclosed. The model may be trained to detect a hypertensive crisis using the patient’s blood pressure information; using any suitable model and correctly labelled information (@ 0068 - 0069). Machine learning limitations reciting broad, functionally described, well-known techniques executed by generic and conventional computing devices, does not provide a practical application of the abstract diagnostic process. “Today we hold only that patents that do no more than claim the application of generic machine learning to new data environments, without disclosing improvements to the machine learning models to be applied, are patent ineligible under §101.” (Recentive Analytics, Inc. v. Fox Corp. (Fed. Cir. 2025)).
Therefore, the limitations recited in the dependent claims, in combination with those recited in the independent claims add nothing that integrates the abstract idea into a practical application, or that amounts to significantly more. As such, the additional element do not integrate the abstract idea into a practical application, or provide an inventive concept that transforms the claims into a patent eligible invention.
The apparatus claims are no different from the method claims in substance. “The equivalence of the method, system and media claims is readily apparent.” “The only difference between the claims is the form in which they were drafted.” (Bancorp). The method claims recite the abstract idea implemented on a generic computer, while the apparatus claims recite generic computer components configured to implement the same idea. Specifically, Claims 12 – 20 merely add the generic hardware noted above that nearly every computer will include. The apparatus claim’s requirement that the same method be performed with a programmed computer does not alter the method’s patentability under U.S.C. 101 (In re Grams). Therefore, the claims are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
CLAIM 10 is not encompassed in the rejection above. Claim 10 recites: “a medication dispensing device is triggered to automatically administer a medication”. The medication disclosed and claimed is not “specifically identified” and therefore, is not a “particular treatment or prophylaxis. (see MPEP 2106.04(d)(2). Nonetheless, triggering a medication dispensing device to administer a medication “to lower the blood pressure”; even a dispensing device that is disclosed as being known in the art; provides a practical application of the abstract hypertensive crisis identification process.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 4, 7, 10, 12 – 14, 16 and 19 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Manda: (US PGPUB 2011/0190692 A1).
CLAIMS 1, 12 and 13
Manda discloses a system and method for administering a vasodilator to a patient based on blood pressure, that includes the following limitations:
A computer-implemented method; (Manda Abstract, 0005); the method comprising:
receiving patient data, the patient data comprising data about a patient's blood pressure over time; (Manda Abstract, 0019, 0037, 0041, 0081);
analyzing the patient data and identifying one or more signs of a hypertensive crisis in the patient data; (Manda Abstract, 0019, 0042 – 0045, 0083); and
providing a notification to the patient, the notification comprising information about the identified one or more signs of the hypertensive crisis and a request for the patient to perform an action; (Manda 0019, 0025, 0037, 0043, 0045, 0048).
Manda discloses a system and method for administering a vasodilator to a patient based on blood pressure, that includes a programmer/computer receiving patient data, including blood pressure measurements, taken over time. The blood pressure measurements are compared to a threshold (i.e. analyzing), and if the threshold is traversed (i.e. one or more signs of a hypertensive crisis), an alarm, alert or notification is sent to the patient, for example by text, e-mail or a graphical alert, or using an audible or vibration alert. The alert may include “triggering an action” automatically or manually. For example, the system may be configured to operate in a closed loop configuration or in an open loop configuration. In a closed loop configuration the alert automatically adjusts the therapy; while in an open loop, the alert is provided to the patient, but the system does not take an automatic action. The system provides means for the patient to adjust therapy parameters using the programmer. An alert, in an open loop configuration, inherently includes a request for the patient to perform an action.
CLAIMS 2, 4, 7, 10, 14, 16 and 19
Manda discloses a system and method for administering a vasodilator to a patient based on blood pressure, that includes the following limitations:
wherein the one or more signs of the hypertensive crisis comprise one or more measured and/or predicted blood pressure values exceeding one or more pre-defined thresholds; (Manda Abstract, 0019, 0042 – 0045, 0083);
wherein the one or more pre-defined thresholds were determined individually for the patient; (Manda 0043, 0054);
wherein a reminder is provided to the patient and/or a second notification is provided to another person, if the patient's blood pressure exceeds the one or more pre-defined thresholds; (Manda Abstract, 0019, 0042 – 0045, 0083);
wherein a medication dispensing device is triggered to automatically administer a medication, if the patient's blood pressure exceeds the one or more pre-defined thresholds, and/or if the patient's blood pressure does not fall below the one or more pre-defined thresholds within the pre-defined time period, and/or if the patient does not perform the requested action; (Manda Abstract, 0017 - 0019, 0063).
Manda discloses determining when one or more blood pressure values exceeds a threshold, and issues an alert/alarm/notification to the patient or a physician (i.e. a reminder). Threshold are determined based on patient information (i.e. determined individually for the patient). Manda discloses automatically triggering a medication dispensing device if the patient’s blood pressure exceeds the threshold.
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 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 6, 8, 9, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Manda: (US PGPUB 2011/0190692 A1) in view of Walker et al.: (US PGPUB 2014/0257852 A1).
CLAIMS 6, 8, 9, 18 and 20
Manda discloses the limitations above relative to Claims 1 and 12 respectively. With respect to the following limitations:
wherein a reminder is provided to the patient and/or a second notification is provided to another person, if the patient does not perform the requested action within a pre-defined time period; (Walker 0050, 0055, 0058, 0060);
wherein a second notification is provided to another person, if the patient's blood pressure does not fall below the one or more pre-defined thresholds within a pre-defined time period; wherein the second notification comprises one or more of the following: actual blood pressure of the patient, the patient's blood pressure history, geo-coordinates of the patient, information about actions performed and/or not performed by the patient; (Walker 0007, 0050, 0055, 0058, 0062, 0067).
Manda discloses notifications for blood pressure measurements traversing a high or low threshold, but does not disclose second notifications for non-compliance or for ineffective treatments. Walker discloses an interactive healthcare application for patient care that includes patient reminders and second notifications to another person if the patient does not perform the requested action – i.e. is not compliant. Further, a second notification is sent to another person, such as a doctor, if the patient’s blood pressure does not fall below the threshold, for example after a treatment is administered. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the blood pressure monitoring system of Manda so as to have included notifications for non-compliance or ineffective treatments, in accordance with the teaching of Walker, in order to allow for effective management of the patient’s condition.
Claims 3, 11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Manda: (US PGPUB 2011/0190692 A1) in view of Peters: (US PGPUB 2023/0200664 A1).
CLAIMS 3 and 15
Manda discloses the limitations above relative to Claims 1 and 12 respectively. With respect to the following limitations:
wherein the one or more signs of the hypertensive crisis comprise a probability value exceeding pre-defined thresholds, the probability value indicating the probability of occurrence of the hypertensive crisis within a pre-defined imminent time period; (Peters 0018, 0039, 0045, 0101, 0125).
Manda discloses a system and method for administering a vasodilator to a patient based on blood pressure, but does not expressly disclose a probability value of the occurrence of a hypertensive crisis. Peters discloses a system and method for cardiac health assessment that includes determining the likelihood of pulmonary hypertension (i.e. a probability value indicating the occurrence of a hypertensive crisis), using a trained model. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the blood pressure monitoring system of Manda so as to have included determining the probability of hypertension, in accordance with the teaching of Peters, in order to allow for effective management of the patient’s condition.
CLAIM 11
Manda discloses the limitations above relative to Claim 1. Additionally, Manda the following limitations:
comparing the predicted blood pressure value / the probability value with a pre-defined threshold; (Manda Abstract, 0019, 0042 – 0045, 0083); and
in case the predicted blood pressure value / the probability value exceeds the pre-defined threshold: providing the first notification to the patient and/or providing a reminder to the patient and/or providing a second notification to another person; (Manda 0019, 0025, 0037, 0043, 0045, 0048).
Manda discloses a system and method for administering a vasodilator to a patient based on blood pressure, that includes a programmer/computer receiving patient data, including blood pressure measurements, taken over time. The blood pressure measurements are compared to a threshold, and if the threshold is traversed (i.e. one or more signs of a hypertensive crisis), an alarm, alert or notification is sent to the patient, for example by text, e-mail or a graphical alert, or using an audible or vibration alert.
With respect to the following limitations:
inputting the patient data into a trained machine learning model, receiving from the trained machine learning model i) a predicted blood pressure value, the predicted blood pressure value indicating the expected patient's blood pressure that will be reached for a defined period in the immediate future, or ii) a probability value, the probability value indicating the probability of occurrence of the hypertensive crisis within a pre-defined imminent time period; (Peters 0012, 0015, 0031, 0039, 0045, 0050, 0101, 0124)
Manda discloses a system and method for administering a vasodilator to a patient based on comparing a measured blood pressure to a threshold. Manda does not expressly disclose comparing a predicted blood pressure, determined using a trained machine learning model, to the threshold; however, Peters does. Peters discloses a system and method for cardiac health assessment that includes determining the likelihood of pulmonary hypertension (i.e. a probability value indicating the occurrence of a hypertensive crisis), using a trained machine learning model. The predicted blood pressure is used to adjust medical treatment. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the blood pressure monitoring system of Manda so as to have included determining the probability of hypertension, in accordance with the teaching of Peters, in order to allow for effective management of the patient’s condition.
Claims 5 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Manda: (US PGPUB 2011/0190692 A1) in view of Tichauer: (US PGPUB 2012/0277602 A1).
CLAIMS 5 and 17
Manda discloses the limitations above relative to Claims 1 and 12 respectively. With respect to the following limitations:
wherein the rate at which blood pressure measurements are taken is automatically adjusted over time to the degree of change of the patient's blood pressure; (Tichauer 0002, 0050 - 0052).
Manda discloses blood pressure measurement, but does not disclose adjusting the rate of measurement based on the change in measurements. Tichauer discloses a blood pressure monitoring system to assess the health of an individual, prescribe medication, and encourage actions, such as exercise, if blood pressure readings are higher than normal values based on patient characteristics. Tichauer can identify patients at risk of kidney failure, stroke, heart attack or other serious risks. In particular, Tichauer discloses adjusting the rate of measurements based on the measurements for optimal accuracy. A sliding window may be adjusted to increase or decrease the measurement rate based on the degree of change in blood pressure. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing data of the claimed invention, to have modified the blood pressure monitoring system of Manda so as to have included adjusting a measurement rate based on the degree of change in the measurement, in accordance with the teaching of Tichauer, in order to allow for more accurate detection of acute changes in blood pressure.
CONCLUSION
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US PGPUB 2010/0056883 A1 to Meschisen et al. discloses vital sign monitors that provide an alarm if a blood pressure reading is either above or below a respective threshold.
US PGPUB 2015/0356701 A1 to Gandy et al. discloses a patient monitoring system for blood pressure, and determining compliance with prescribed actions.
US PGPUB 2017/0360379 A1 to Yang et al. discloses monitoring blood pressure and issuing a notification is the measurement is likely to exceed a threshold.
US PGPUB 2023/0395265 A1 to Ikezoe et al. discloses predicting the probability of hypertension based on blood pressure measurements.
Any inquiry of a general nature or relating to the status of this application or concerning this communication or earlier communications from the Examiner should be directed to John A. Pauls whose telephone number is (571) 270-5557. The Examiner can normally be reached on Mon. - Fri. 8:00 - 5:00 Eastern. If attempts to reach the examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert Morgan can be reached at (571) 272-6773.
Official replies to this Office action may now be submitted electronically by registered users of the EFS-Web system. Information on EFS-Web tools is available on the Internet at: http://www.uspto.gov/patents/process/file/efs/guidance/index.jsp. An EFS-Web Quick-Start Guide is available at: http://www.uspto.gov/ebc/portal/efs/quick-start.pdf.
Alternatively, official replies to this Office action may still be submitted by any one of fax, mail, or hand delivery. Faxed replies should be directed to the central fax at (571) 273-8300. Mailed replies should be addressed to “Commissioner for Patents, PO Box 1450, Alexandria, VA 22313-1450.” Hand delivered replies should be delivered to the “Customer Service Window, Randolph Building, 401 Dulany Street, Alexandria, VA 22314.”
/JOHN A PAULS/Primary Examiner, Art Unit 3683
Date: 6 February, 2026