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 1-15, 39-43 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the abstract idea of data analysis/model updating without significantly more. Claims 1, 9 and 39 recite(s) limitations such as "generate a blood pressure estimation" and "update one or more parameters of the adaptive predictive model in real-time". This judicial exception is not integrated into a practical application because the claims generally recite functional results more than technical implementation details – e.g., recite a specific technical improvement in signal processing or calibration that is supported by the specification, rather than only "adaptive predictive model" and "update one or more parameters". The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the added elements are recited at a high level of generality [e.g., no particular configuration]: "blood pressure monitoring device," "arterial pulse wave sensor," and "at least one processor". The dependent claims also do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6, 14, 41 and associated dependent claims are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 6 and 14, “one of a regression model, a machine learning model, or a classifier model” – it is unclear what is the boundary of these models and whether the different models can overlap. Clarification of the distinct boundaries relative to each other with support is requested.
Claim 41 recites the limitation "the limb or digit". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-15, 39-43 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Schmitt”, US Publication 20200229716, in view of “Mulligan”, US Publication 20150065826.
Regarding claim 1, Schmitt discloses a blood pressure monitoring system [0039], comprising:
a blood pressure monitoring device configured to obtain a blood pressure measurement from a subject [0039, 0059: blood pressure reference measurement unit 20, such as a non-invasive cuff device, configured to acquire blood pressure reference measurements 21];
an arterial pulse wave sensor configured to obtain arterial pulse wave data from the subject [0039: arterial pulse wave sensor 10, such as a PPG sensor, configured to acquire an arterial pulse wave sensor signal 11]; and
at least one processor [0039: apparatus 30 implemented as an appropriately programmed processor] configured to:
generate a blood pressure estimation for the subject via a predictive model using real-time arterial pulse wave data from the arterial pulse wave sensor [0043, 0053, 0059-0060: estimation unit 33 determines blood pressure estimation values from extracted features of the pulse wave signal using a mathematical model relating the feature to blood pressure];
receive a real-time blood pressure measurement from the blood pressure monitoring device [0043, 0059: receives blood pressure reference measurements 21 from the unit 20]; and
in response to receiving the real-time blood pressure measurement, update one or more parameters of the predictive model to improve blood pressure estimation accuracy of the predictive model [0043, 0050-0051, 0059, 0065: calibration unit 34 determines calibration parameters by fitting the modelled relation to the actual measured pairs of feature values and BP reference measurements, and recalibration is performed to update these parameters to account for intra-patient variability and improve estimation performance].
However, Schmitt does not explicitly disclose wherein the predictive model is an “adaptive” predictive model and wherein the updating of the parameters occurs “in real-time”.
Mulligan discloses a similar non-invasive blood pressure monitoring system that utilizes an adaptive predictive model that is updated in real-time [0105-0106: a prediction system that can predict future results and adapt the predictive model in real-time when data is received; 0093: direct measurements can be fed back into the model to update the model and thereby improve performance].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Schmitt with the teachings of Mulligan -- updating the predictive model in real-time as an adaptive predictive model, as taught by Mulligan, would enhance the base device of Schmitt by ensuring that the mathematical model adapts to physiological changes in the patient as soon as new reference data is available, thereby continuously maintaining high blood pressure estimation accuracy without requiring offline processing or delayed calibration cycles.
Regarding claim 2, Schmitt discloses wherein the at least one processor is further configured to: determine whether the generated blood pressure estimation is above or below one or more thresholds [0062: calibration trigger unit checks if the difference between the estimated BP and the BP of the latest reference measurement has exceeded a certain threshold ΔBP_max, which implicitly determines if the estimation is above or below the threshold relative to the reference]; and in response to determining that the generated blood pressure estimation is above or below the one or more thresholds, update the one or more parameters of the adaptive predictive model in real-time [0062, 65: if the threshold is exceeded, recalibration is triggered, which updates the calibration parameters; combined with Mulligan’s real-time updating as discussed above].
Regarding claim 3, Schmitt discloses wherein the at least one processor is further configured to, in response to receiving one or more subsequent real-time blood pressure measurements, update the one or more parameters of the adaptive predictive model in real-time [0065: recalibration is performed analogously to initial calibration, utilizing new BP reference measurements to update the calibration parameters; combined with Mulligan’s real-time updating as discussed above].
Regarding claim 4, Schmitt does not explicitly disclose wherein the at least one processor is further configured to send an alert to a remote device in response to determining that the generated blood pressure estimation is above or below a threshold. Mulligan discloses sending an alert to a remote device in response to determining that the generated blood pressure estimation is above or below a threshold [0098: if blood pressure trends are outside of the normal range, it sets off alarm conditions such as a message to a physician via electronic mail or text message]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Schmitt with the teachings of Mulligan -- sending an alert to a remote device when blood pressure is outside a threshold, as taught by Mulligan, would enhance the base device of Schmitt by ensuring that medical professionals or caregivers are immediately notified of potentially dangerous acute or chronic blood pressure changes, allowing for prompt medical intervention.
Regarding claim 5, Schmitt discloses wherein the at least one processor is further configured to request a blood pressure measurement from the blood pressure monitoring device in response to determining that the generated blood pressure estimation is above or below the one or more thresholds [0059, 62, 65: when the threshold is exceeded, recalibration is triggered, which implicitly requests and obtains new BP reference measurements from the blood pressure measurement device].
Regarding claim 6, Schmitt discloses wherein the adaptive predictive model comprises one of a regression model, a machine learning model, or a classifier model [0024, 52, 59: the calibration parameters are determined by fitting the modelled relation via linear or non-linear regression].
Regarding claim 7, Schmitt discloses wherein the arterial pulse wave sensor comprises a photoplethysmography (PPG) sensor [0039: the arterial pulse wave sensor comprises a photoplethysmography (PPG) sensor].
Regarding claim 8, Schmitt discloses wherein the blood pressure monitoring device comprises an inflatable cuff configured to be attached to a limb or digit of a subject [0059: the blood pressure reference measurement unit is a cuff device].
Regarding claim 9, Schmitt discloses a device comprising an automated inflatable cuff configured to be attached to a limb or digit of a subject, wherein the cuff is configured to generate a blood pressure measurement for the subject [0039, 59: blood pressure reference measurement unit 20, such as a cuff device]; an arterial pulse wave sensor configured to obtain arterial pulse wave data from the subject [0039: sensor 10]; and at least one processor [0039: apparatus 30] configured to generate a blood pressure estimation, receive a real-time blood pressure measurement from the cuff, and update parameters of the model [0043, 0059, 0065]. Schmitt further discloses that a means for attachment or positioning of the sensor and unit may be provided, such as a belt or sticker [0040].
However, Schmitt does not explicitly disclose wherein the device is a single integrated “wearable device” comprising all these components, nor does it explicitly disclose the “adaptive” predictive model updated “in real-time”.
Mulligan discloses a wearable device form factor for blood pressure monitoring [0056-58: a sensor device 105 designed to be worn on a patient’s wrist, comprising a cuff 125 and processing unit 145] and an adaptive predictive model updated in real-time [0093, 0105-0106].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Schmitt with the teachings of Mulligan -- integrating the components into a wearable device, as taught by Mulligan, would enhance the base device of Schmitt by providing a compact, ambulatory form factor that allows the patient to move freely while continuous blood pressure monitoring and recalibration are performed, thereby improving patient comfort and compliance. Furthermore, updating the predictive model in real-time as an adaptive predictive model, as taught by Mulligan, would enhance the base device of Schmitt by ensuring that the mathematical model immediately adapts to physiological changes.
Regarding claims 10-15, these claims depend from claim 9 and add additional limitations that are disclosed by the combination of Schmitt and Mulligan as explained above with respect to the corresponding limitations in claims 2-7.
Regarding claim 39, Schmitt in view of Mulligan discloses a blood pressure monitoring method comprising the steps performed by at least one processor of: generating a blood pressure estimation for a subject via an adaptive predictive model using real-time arterial pulse wave data from an arterial pulse wave sensor attached to the subject; receiving a real-time blood pressure measurement from a blood pressure monitoring device attached to the subject; and in response to receiving the real-time blood pressure measurement, updating one or more parameters of the adaptive predictive model in real-time to improve blood pressure estimation accuracy of the adaptive predictive model -- the rationale and citations to Schmitt and Mulligan are the same as those set forth above in the analysis of claim 1.
Regarding claims 40-43, these claims depend from claim 39 and add additional limitations that are disclosed by the combination of Schmitt and Mulligan as explained above with respect to the corresponding limitations in claims 7, 8, 2, and 3, respectively.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tse Chen whose telephone number is (571)272-3672. The examiner can normally be reached M-F 7-3 EST.
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/TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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