DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
1. Applicant’s arguments filed in the reply on January 18, 2026 were received and fully considered. Claim 13 was amended. Please see corresponding rejection headings and response to arguments section below for more detail.
Continued Examination Under 37 CFR 1.114
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 3, 2026 has been entered.
Claim Rejections - 35 USC § 101
3. 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.
4. Claims 13, 14, and 17-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 13 follows.
Regarding claim 13, the claim recites a method for identifying one or more correlations within contextual blood pressure analysis. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“A method for identifying one or more correlations within contextual blood pressure analysis, the method comprising… computing one or more blood pressure values and/or blood pressure related values, based on the signal representing the waveform…analyzing the one or more computed blood pressure values and/or blood pressure related values in association with one or more corresponding time values and with the one or more subject awareness parameters and/or the one or more physiologic parameters; automatically identifying one or more correlations between the computed blood pressure values and the one or more subject awareness parameters; and providing, based on the one or more correlations, a diagnosis related to blood pressure, cardiac activity and/or related disorder.”
These limitations describe a mathematical calculation. Furthermore, the limitations also describe a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, or using simple pen/paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“…obtaining, continuously, from a wearable pressure sensor configured to directly sense pressure at a peripheral artery of a subject, a signal representing a waveform of blood pressure of the subject wearing the pressure sensor… obtaining, from one or more subject awareness sensors and/or medical or non- medical user sources, signal(s) indicative of one or more subject awareness parameters and/or one or more physiologic parameters of the subject…”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant extra-solution activity, e.g., mere data gathering steps necessary to perform the identified judicial exception. See MPEP 2106.05g, which establishes that mere data gathering does not integrate a judicial exception into a practical application.
The additional limitations also do not add significantly more to the identified judicial exception because they relate to widely-understood, routine, and conventional components for obtaining known types of physiological data.
Dependent claims 14 and 17-23 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, claims 13, 14, and 17-23 are not patent eligible under 35 USC 101.
Claim Rejections – 35 USC § 103
5. 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 (i.e., changing from AIA to pre-AIA ) 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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
6. Claims 13, 14, 17, 18, and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Klaassen et al., (US PG Pub. No. 2017/0293727 A1) (hereinafter “Klaassen”) in view of Waller et al. (US PG Pub. No. 2017/0238819 A1) (hereinafter “Waller”).
Klaassen was applied in the previous office action.
With respect to claim 13, Klaasen teaches a method for identifying one or more correlations within contextual blood pressure analysis (see title “Intelligent Blood Pressure Monitoring”; par.0044 “contextual data… with the blood pressure measurements… to aid a physician or user in diagnosing blood pressure issues”), the method comprising: obtaining, or more subject awareness sensors and/or medical or non- medical user sources, signal(s) indicative of one or more subject awareness parameters and/or one or more physiologic parameters of the subject (HR sensor 126 obtains physiologic parameters of the subject; see Fig. 1; see also par.0044 “a sound sensor (e.g., microphone) to detect the ambient noise level, location sensor to detect the user’s current location, and/or other sensors to detect other user context information, as described above”); analyzing the one or more computed blood pressure values and/or blood pressure related values in association with one or more corresponding time values and with the one or more subject awareness parameters and/or the one or more physiologic parameters (data from BP sensor and HR sensor and/or other sensors are analyzed by a doctor, with respect to a time/temporal component, in order to provide a diagnosis of postural hypotension or other postural blood pressure anomaly; see par.0020 “determine the most suitable times for measuring a user’s blood pressure; see also par.0022, 0025, 0027, 0032-33, par.0044, Fig. 1).
However, Klaassen does not explicitly teach obtaining, continuously, a signal representing a waveform of blood pressure of the subject wearing the pressure sensor.
Waller teaches obtaining, continuously, a signal representing a waveform of blood pressure of the subject wearing the pressure sensor (par.0084 “many uses for continuous blood pressure measurement on a wrist-worn wearable monitoring device”).
Therefore, it would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Klaassen to continuously obtain a signal representing a waveform of blood pressure for the purpose of identifying various wellness/medical conditions including pre-hypertension, hypertension, hydration status, stress level, fitness metrics, a user’s hydration status, etc., as evidence by Waller (par.0084).
Although Klaassen does not explicitly teach automatically identifying one or more correlations between the computed blood pressure values and the one or more subject awareness parameters; and providing, based on the one or more correlations, a diagnosis related to blood pressure, cardiac activity and/or related disorder, further modification to incorporate this feature would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed for the following reasons.
First, Klaassen expressly discloses:
[0044] In some implementations, blood pressure monitor 122 can initiate a blood pressure measurement in response to user input. For example, the user of wearable device 120 may feel faint and initiate a blood pressure measurement by providing input to wearable device 120. In response to the user input, blood pressure monitor 122 can measure the user’s blood pressure using blood pressure sensor 124 and/or the user’s heart rate using heart rate sensor 126. In some implementations, blood pressure monitor 122 can collect contextual data in response to the user initiating a blood pressure measurement. For example, blood pressure monitor 124 can use a sound sensor (e.g., microphone) to detect the ambient noise level, location sensor to detect the user’s current location, and/or other sensors to detect other user context information, as described above. For example, blood pressure monitor 124 can use a motion sensor (e.g., accelerometer) to detect the user’s movements and/or posture at the time the blood pressure measurement was taken. The user’s posture can be useful, for example, for a doctor to diagnose a postural hypotension or other postural blood pressure anomaly. This contextual data can be stored in correlation with the blood pressure measurements (e.g., in blood pressure database 116 and/or 126) to aid a physician or user in diagnosing blood pressure issues.
Accordingly, Klaassen suggests a diagnosis related to blood pressure that takes into consideration user’s blood pressure as well as contextual data, of which the two data sets can be stored as a correlation. It is understood that storing correlation of blood pressure measurements with contextual data would also serve the purpose for aiding in future/additional blood pressure related diagnosis. As such, providing future/additional blood pressure related diagnosis would impliedly require first identifying the stored correlation that is relevant (e.g. identifying blood pressure values that are correlated to sleep would lead to a different diagnosis versus BP values that are correlated to high stress, exercise, etc.). While Klaassen does not explicitly teach automatically identifying one or more correlations, such a modification would have been prima facie obvious to PHOSITA when the invention was filed since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
Moreover, Waller further discloses the well-known nature utilizing correlations in the manner recited (see at least par. 21, 26, 35-36, 38, 44, 52). Examiner also previously cited additional references that demonstrate the well-known nature of identifying one or more correlations in the manner recited. Please see prior art of record section at the end of the previous and current office actions for example teachings.
With respect to claim 14, Klaassen teaches the contextual blood pressure data comprises a circadian pattern of blood pressure values along with respective subject awareness parameters (par.0025, 0027, 0032-33).
With respect to claim 17, Klaassen teaches based on the one or more correlations, identifying a hazardous situation (par.0044 “a postural hypotension or other postural blood pressure anomaly” equates to a hazardous situation).
With respect to claim 18, Klaassen teaches providing a blood pressure alert prior to initiation of the hazardous situation (par.0033 “indicates the user may be stressed”).
With respect to claim 20, Klaassen teaches measuring the one or more subject awareness parameters, utilizing the one or more subject awareness sensors, before, during and/or after obtaining the blood pressure waveform signal utilizing the pressure sensor (par.0044).
With respect to claim 21, Klaassen teaches wherein the one or more computed blood pressure values comprise Systolic, Diastolic, Mean, momentary arterial blood pressure or any combination thereof; and/or wherein the one or more computed blood pressure related values comprise heart rate and/or breathing rate (par.0035).
With respect to claim 22, Klaassen teaches wherein the one or more physiologic parameters comprise one or more present and/or past (historic) physiologic parameters selected from the group consisting of: the subject’s activity and/or length/intensity thereof, orientation, posture, sleep vs. awake, heart rate, respiration rate, skin humidity/sweat level, or any combination thereof (par.0045 “user context… motion data, sleep state”; par.0058 “historical data… user behavioral patterns”).
With respect to claim 23, Klaassen teaches wherein the one or more medical and non-medical user sources comprise health Apps, social platforms, calendars, fitness Apps, communication Apps or any combination thereof (par.0022, 0036-37, 0055).
7. Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Klaassen, as applied to claim 15 above, in further view of Hwang et al. (US PG Pub. No. 2019/0200865 A1) (hereinafter “Hwang”).
Hwang was applied in the previous office action.
With respect to claim 19, Klaassen teaches a method for contextual blood pressure analysis, as established above.
However, Klaassen does not explicitly teach the limitations further recited in claim 19.
Regarding claim 19, Hwang teaches utilizing machine learning algorithms, learning one or more of the habits of the subject based on the one or more correlations, and predicting behavior of the subject’s blood pressure in a defined situation (par.0039 “Algorithms may be used to analyze the data and determine which information to provide to the user… machine learning algorithms”; par.0073 “The combination of data from… sensors… combined with data from… heart rate, respiratory rate, temperature, and/or blood pressure monitor may be used to indicate or predict sepsis and shock”).
Therefore, it would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed to modify Klaassen to incorporate machine learning algorithms in order to analyze multiple sets of physiological data to provide information to the user including prediction of sepsis and shock, as evidence by Hwang (par.0039, 0073).
Prior Art of Record
8. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Previously cited:
US PG Pub. No. 2018/0008206 A1, see par.0071,74
US PG Pub. No. 2020/0008685 A1, see par.0043
US PG Pub. No. 2016/0157782 A1, see par.0023, 33
US PG Pub. No. 2018/0153476 A1, see par.0040, 80
US PG Pub. No. 2015/0305675 A1, see par.0052
US PG Pub. No. 2012/0289791 A1, see par.0214
Response to Arguments
9. Applicant’s arguments filed with respect to the 35 USC 101 rejections raised in the previous office action were fully considered, but they are not persuasive. Applicant sets forth the following main arguments, which Examiner will address in turn:
The claims are not directed to an abstract idea alone (remarks, pg. 9);
Examiner respectfully disagrees. As set forth in the corresponding rejection heading above, Examiner identifies limitations that recite an abstract idea (“computing one or more blood pressure values… analyzing the one or more computed blood pressure values… automatically identifying one or more correlations… providing, based on the one or more correlations, a diagnosis related to blood pressure”). More specifically, Examiner maintains that these limitations correspond to mathematical relationships and/or mental process. While the claims also recite “a wearable pressure sensor”, this additional limitation merely amounts to extra-solution activity and does not integrate the claims into a practical application. See MPEP 2106.05(g), mere data gathering does not integrate claims into a practical application.
The claims include significantly more than conventional activity (remarks, pgs. 9-10);
Applicant more specifically contends that the use of the wearable pressure sensor, acquisition of contextual and physiological data from subject awareness sensors and user sources, time-based analytical processing, and diagnostic step does not relate to conventional activity. Examiner respectfully disagrees. The use of a generically claimed “wearable pressure sensor” does not constitute significantly more. Rather, Examiner maintains that the wearable pressure sensor is merely being utilized in a conventional manner (to obtain known pressure data). Moreover, obtaining data from other generically claimed “awareness” sensors does not constitute significantly more for similar reasons. Finally, Examiner identifies that “analyzing the one or more computed blood pressure values… in association with one or more… time values” and “providing a diagnosis” are limitations that were identified as being part of the abstract idea. As the “significantly more” test applies to additional (e.g. structural) limitations, applicant’s arguments that these abstract idea limitations recite significantly more are moot.
The claims are integrated into a practical application (remarks, pgs. 10-11).
Examiner respectfully disagrees and maintains that the claims recite an abstract idea that is not integrated into a practical application; and the additional limitations do not recite significantly more. Moreover, the purported improvement to the technology appears to lie within the judicial exception itself1.
Therefore, claims 13, 14, and 17-23 remain rejected via 35 USC 101. Please see corresponding rejection heading above for more detail.
10. Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action have been fully considered. Applicant sets forth the following main arguments, which Examiner will address in turn:
Klaassen does not disclose or suggest continuous waveform acquisition from a wearable at a peripheral artery (remarks, pg. 12);
Examiner respectfully disagrees. However, and solely for the purposes of compact prosecution, Examiner introduces a new secondary reference (Waller) which expressly discloses continuous waveform acquisition from a wearable sensor for blood pressure. Examiner also argues that Klaassen’s blood pressure sensor 124 within smart watch 120 provides sensing at a peripheral artery2. Examiner further adds that sensing blood pressure, via wearable wrist watch, is widely known. Please see prior art section above for more detail, updated citations, and updated obviousness rationale.
Klaassen does not teach computing BP values based on waveform analysis (remarks, pg. 12);
Examiner respectfully disagrees. Klaassen expressly discloses that blood pressure monitor 122 measures/computes BP based on values/waveform obtained from BP sensor 124 (par.0042 “blood pressure monitor 122 can automatically measure the user’s blood pressure”; see Fig. 11). Fig. 10 also depicts waveforms corresponding a user’s recorded blood pressure measurement(s). As such, Klaassen teaches that BP is determined based on waveform analysis.
Klaassen does not provide a diagnostic output based on analyzed correlation (remarks, pgs. 12-13).
Examiner respectfully disagrees and reiterates that this limitation is obvious for the following reasons:
First, Klaassen expressly discloses:
[0044] In some implementations, blood pressure monitor 122 can initiate a blood pressure measurement in response to user input. For example, the user of wearable device 120 may feel faint and initiate a blood pressure measurement by providing input to wearable device 120. In response to the user input, blood pressure monitor 122 can measure the user's blood pressure using blood pressure sensor 124 and/or the user's heart rate using heart rate sensor 126. In some implementations, blood pressure monitor 122 can collect contextual data in response to the user initiating a blood pressure measurement. For example, blood pressure monitor 124 can use a sound sensor (e.g., microphone) to detect the ambient noise level, location sensor to detect the user's current location, and/or other sensors to detect other user context information, as described above. For example, blood pressure monitor 124 can use a motion sensor (e.g., accelerometer) to detect the user's movements and/or posture at the time the blood pressure measurement was taken. The user's posture can be useful, for example, for a doctor to diagnose a postural hypotension or other postural blood pressure anomaly. This contextual data can be stored in correlation with the blood pressure measurements (e.g., in blood pressure database 116 and/or 126) to aid a physician or user in diagnosing blood pressure issues.
Accordingly, Klaassen suggests a diagnosis related to blood pressure that takes into consideration user’s blood pressure as well as contextual data, of which the two data sets can be stored as a correlation. It is understood that storing correlation of blood pressure measurements with contextual data would also serve the purpose for aiding in future/additional blood pressure related diagnosis. As such, providing future/additional blood pressure related diagnosis would impliedly require first identifying the stored correlation that is relevant (e.g. identifying blood pressure values that are correlated to sleep would lead to a different diagnosis versus BP values that are correlated to high stress, exercise, etc.). While Klaassen does not explicitly teach automatically identifying one or more correlations, such a modification would have been prima facie obvious to PHOSITA when the invention was filed since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
Moreover, Waller further discloses the well-known nature of identifying one or more correlations in the manner recited (see at least par. 21, 26, 35-36, 38, 44, 52). Examiner also previously cited additional references that demonstrate the well-known nature of identifying one or more correlations in the manner recited. Please see prior art of record section at the end of the previous and current office actions for example teachings.
Therefore, claims 13, 14, and 17-23 remain rejected via 35 USC 103. Please see prior art section above for more detail, updated citations, and updated obviousness rejections.
Conclusion
11. No claim is allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
1 MPEP 2106.05(a) “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements.”
2 Note: Klaassen’s pressure sensor 124 within a smart watch 120 senses pressure at the wrist, of which is location of two main peripheral arteries: the radial artery and the ulnar artery
Prosecution Insights