DETAILED ACTION
This action is responsive to the “AMENDMENT and/or RESPONSE under 37 C.F.R. § 1.111” filed 24 August 2026. The Examiner acknowledges the amendments to claims 1-15, as well as the addition of new claims 16-20. Claims 1-20 are pending.
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 .
Information Disclosure Statement
The IDS filed 26 April 2024 cites U.S. Patent Application Publication 20170267592, wherein the Applicant cites the name of the Patentee or Applicant of the cited document as “Maltz”. However, the Examiner notes that US-20170267592-A1 has an Applicant/Inventor of Charles H. Bell, JR. and an Assignee of Crispy Crete, LLC [the Examiner further notes that the cited document is directed towards a system for processing unhardened concrete]. As such, the cited document is considered to be improperly cited. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Specification
The disclosure is objected to because of the following informalities:
The amendment filed 26 April 2024 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure [“This application is the U.S. National Phase application under 35 U.S.C. §371 of International Application NO. PCT/EP2022/079239, filed on October 20, 2022, which claims the benefit of International Application No. 21204644.5 filed on October 26, 2021. These applications are hereby incorporated by reference” (emphasis applied)]. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: incorporation(s) by reference to foreign priority document(s) when added by amendment at the time of entry to the national stage is/are considered new matter [An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)) (MPEP § 608.01(p)(I)(B)); An international application designating the U.S. has two stages (international and national) with the filing date being the same in both stages. Often the date of entry into the national stage is confused with the filing date. It should be borne in mind that the filing date of the international stage application is also the filing date for the national stage application (MPEP § 1893.03(b))]]. Applicant is required to cancel the new matter in the reply to this Office Action. The Examiner suggests amending the cited portion of the Specification to read “This application is the U.S. National Phase application under 35 U.S.C. §371 of International Application NO. PCT/EP2022/079239, filed on October 20, 2022, which claims the benefit of International Application No. 21204644.5 filed on October 26, 2021.
Appropriate correction is required.
Claim Objections
Claim(s) 1, 9, 13, and 18-19 is/are objected to because of the following informalities:
The functions performed by the processing unit of each of claims 1, 9, 13, and 18 should be tabbed to the right once [lines 11-29 in claim 1; lines 3-9 of claim 9; lines 23-41 in claim 13; lines 3-6 in claim 19].
Claim 13 should read “the subject’s blood pressure” [line 38].
Claim 19 should read “wherein the processing unit is configured to control” [line 2].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Each claim has been analyzed to determine whether it is directed to any judicial exceptions.
Representative claim(s) 13 [representing all independent claims] recite(s):
A system for calibrating a blood pressure (BP) surrogate for use in monitoring blood pressure of a subject, the system comprising:
a pressure-delivery system comprising a cuff configured to be attached to a body part of the subject and to deliver a pressure to the subject's body part by inflating the cuff;
a pressure sensor configured to measure time-dependent cuff pressure values during inflation of a-the cuff of the pressure-delivery system attached to the subject's body part and to acquire or infer a BP measurement value;
a first sensor configured to be attached to a first site of a body of the subject and to measure a first time-dependent sensor signal related to a heartbeat of the subject during the inflation of the cuff;
a second sensor configured to be attached to a second site of the subject's body and to measure a second time-dependent sensor signal related to the subject's heartbeat during the inflation of the cuff; and
a device for computing one or more calibration parameters for calibrating a BP surrogate from the BP measurement value, the time-dependent cuff pressure values and the first and second time-dependent sensor signals, the device comprising:
a BP input configured to receive the time-dependent cuff pressure values and the BP measurement value from the pressure sensor;
a sensor input configured to receive the first and second time-dependent sensor signals from the first and second sensors; and
a processing unit configured to:
control the pressure-delivery system using a control signal to repeatedly inflate the cuff in directly consecutive partial inflations, wherein in each repetition of a partial inflation the cuff is inflated up to a cuff pressure below a latest measured mean BP of the subject,
compute pulse-related values from the first and second time-dependent sensor signals, measured during the repeated directly consecutive partial inflations of the cuff, using a first feature in the first time-dependent sensor signal and a second feature in the second time-dependent sensor signal, the pulse-related values being pulse arrival time (PAT) values or pulse transit time (PTT) values,
compute a calibration parameter for a BP surrogate from the BP measurement value and pairs of the pulse-related values and corresponding cuff pressure values, computed from the first and second time-dependent sensor signals measured during the repeated directly consecutive partial inflations of the cuff, a pair comprising a pulse-related value and a corresponding, temporally related cuff pressure value, and
calibrate the BP surrogate in accordance with the calibration parameter for monitoring the subjects' blood pressure,
wherein, for computing the calibration parameter for the BP surrogate, only pairs of pulse-related values and corresponding cuff pressure values are used for which the cuff pressure value is below the latest measured mean BP.
(Emphasis added: abstract idea, additional element)
Step 2A Prong 1
Representative claim(s) 13 recites the following abstract ideas, which may be performed in the mind or by hand with the assistance of pen and paper:
“compute pulse-related values from the first and second time-dependent sensor signals, measured during the repeated directly consecutive partial inflations of the cuff, using a first feature in the first time-dependent sensor signal and a second feature in the second time-dependent sensor signal, the pulse-related values being pulse arrival time (PAT) values or pulse transit time (PTT) values” – may be performed by merely applying known or derived mathematical formulas/equations using at least a limited amount of data or by observing known or previously collected data and drawing mental conclusions therefrom under no particular time constraints [see Applicant’s Specification p. 10:27-30, which defines PAT as a time interval between points in time, as well as a sum of values; see Applicant’s Specification p. 10:31-34, which defines PTT as a length of time]; wherein the Examiner notes that the recitation of “the first and second time-dependent sensor signals, measured during the repeated directly consecutive partial inflations of the cuff” merely defines the type of data observed/collected
“compute a calibration parameter for a BP surrogate from the BP measurement value and pairs of the pulse-related values and corresponding cuff pressure values, computed from the first and second time-dependent sensor signals measured during the repeated directly consecutive partial inflations of the cuff, a pair comprising a pulse-related value and a corresponding, temporally related cuff pressure value” and “wherein, for computing the calibration parameter for the BP surrogate, only pairs of pulse-related values and corresponding cuff pressure values are used for which the cuff pressure value is below the latest measured mean BP” – may be performed by merely applying known or derived mathematical formulas/equations or employ known relationships/correlations on at least a limited amount of data and drawing mental conclusions therefrom under no particular time constraints [Applicant’s Specification p. 8:22-27, which discloses the use of mathematical operations to compute the calibration parameter]; wherein the recitation of “wherein, for computing the calibration parameter for the BP surrogate, only pairs of pulse-related values and corresponding cuff pressure values are used for which the cuff pressure value is below the latest measured mean BP” merely limits the type of data utilized in the mental process
“calibrate the BP surrogate in accordance with the calibration parameter for monitoring the subjects' blood pressure” – may be performed by merely performing known or derived mathematical formulas/equations or employ known relationships/correlations on at least a limited amount of data [Applicant’s Specification p. 11:6-25, which discloses the use of mathematical operations to “calibrate” the BP surrogate]
If a claim, under BRI, covers performance of the limitations in the mind but for the mere recitation of extra-solutionary activity (and otherwise generic computer elements) then the claim falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea under Step 2A Prong 1 of the Mayo framework as set forth in the 2019 PEG.
No limitations are provided that would force the complexity of any of the identified evaluation steps to be non-performable by pen-and-paper practice.
Alternatively or additionally, these steps describe the concept of using implicit mathematical formula(s) [i.e., “compute pulse-related values from the first and second time-dependent sensor signals, measured during the repeated directly consecutive partial inflations of the cuff, using a first feature in the first time-dependent sensor signal and a second feature in the second time-dependent sensor signal, the pulse-related values being pulse arrival time (PAT) values or pulse transit time (PTT) values” (Applicant’s Specification p. 10:27-34); “compute a calibration parameter for a BP surrogate from the BP measurement value and pairs of the pulse-related values and corresponding cuff pressure values, computed from the first and second time-dependent sensor signals measured during the repeated directly consecutive partial inflations of the cuff, a pair comprising a pulse-related value and a corresponding, temporally related cuff pressure value,… wherein, for computing the calibration parameter for the BP surrogate, only pairs of pulse-related values and corresponding cuff pressure values are used for which the cuff pressure value is below the latest measured mean BP” (Applicant’s Specification p. 8:22-27); “calibrate the BP surrogate in accordance with the calibration parameter for monitoring the subjects' blood pressure” (Applicant’s Specification p. 11:6-25)] to derive a conclusion based on input of data, which corresponds to concepts identified as abstract ideas by the courts [Diamond v. Diehr. 450 U.S. 175, 209 U.S.P.Q. 1 (1981), Parker v. Flook. 437 U.S. 584, 19 U.S.P.Q. 193 (1978), and In re Grams. 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989)]. The concept of the recited limitations identified as mathematical concepts above is not meaningfully different than those mathematical concepts found by the courts to be abstract ideas.
The dependent claims merely include limitations that either further define the abstract idea [e.g. limitations relating to the data gathered or particular steps which are entirely embodied in the mental process] and amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they are merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Thus, these concepts are similar to court decisions of abstract ideas of itself: collecting, displaying, and manipulating data [Int. Ventures v. Cap One Financial], collecting information, analyzing it, and displaying certain results of the collection and analysis [Electric Power Group], collection, storage, and recognition of data [Smart Systems Innovations].
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Independent claims 1, 13, and 14 as individual wholes fail to amount to significantly more than the judicial exception at Step 2B. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of extra-solutionary activity [i.e., generic computer function, pre-solution data gathering as a necessary precursor for the mental analyses] and generic computer elements cannot amount to significantly more than an abstract idea [MPEP § 2106.05(f)] and is/are further considered to merely implement an abstract idea on a generic computer [MPEP § 2106.05(d)(II) establishes computer-based elements which are considered to be well understood, routine, and conventional when recited at a high level of generality].
For the independent claim portions and dependent claims which provide additional elements of extra-solutionary data gathering, MPEP § 2106.05(g) establishes that mere data gathering for determining a result does not amount to significantly more. The extra-solutionary activity of processor steps [acquiring (see BP input and sensor input of claim 13) storing signals, etc.] as presently recited, cannot provide an inventive concept which amounts to significantly more than the recited abstract idea.
For the independent claims as well as the dependent claims merely reciting generic computer elements and functions [processing unit of a device of claim 1 recited at a high level of generality; BP input, sensor input, and processing unit, each recited at a high level of generality in claim 13; and corresponding functions of each of the generic computer elements of claims 1, 13, and 15], MPEP § 2106.05(d)(II) establishes computer-based elements which are considered to be well understood, routine, and conventional when recited at a high level of generality.
Accordingly, the generic computer elements and corresponding functions thereof as presently limited, cannot provide an inventive concept since they fall under a generic structure and/or function that does not add a meaningful additional feature to the judicial exception(s) of the claim(s).
Claim 13 recites a combination of “a pressure-delivery system comprising a cuff configured to be attached to a body part of the subject and to deliver a pressure to the subject's body part by inflating the cuff; a pressure sensor configured to measure time-dependent cuff pressure values during inflation of a-the cuff of the pressure-delivery system attached to the subject's body part and to acquire or infer a BP measurement value; a first sensor configured to be attached to a first site of a body of the subject and to measure a first time-dependent sensor signal related to a heartbeat of the subject during the inflation of the cuff; a second sensor configured to be attached to a second site of the subject's body and to measure a second time-dependent sensor signal related to the subject's heartbeat during the inflation of the cuff” and wherein the processing unit is configured to “control the pressure-delivery system using a control signal to repeatedly inflate the cuff in directly consecutive partial inflations, wherein in each repetition of a partial inflation the cuff is inflated up to a cuff pressure below a latest measured mean BP of the subject”; claim 1 is considered to recite similar subject matter of “a BP input configured to measure time-dependent cuff pressure values…”, “a cuff of a pressure-delivery system”, “a sensor input configured to measure a first time-dependent sensor signal and a second time-dependent sensor signal” [wherein the Examiner notes that the BP “input” and the sensor “input” of claim 1 are described as having different functionality from the BP “input” and sensor “input” of claim 13], and wherein a processing unit is configured to “control the pressure-delivery system using a control signal to repeatedly inflate the cuff in directly partial inflations…” similar to claim 13; claims 4-10 and 17-19 are further considered to limit independent claim 1 by limiting the level or speed of inflation of the cuff of the pressure-delivery system; claim 14 recites “- obtaining time-dependent cuff pressure values during inflation of a cuff of a pressure-delivery system attached to a body part of the subject; - obtaining a BP measurement value; - measuring a first time-dependent sensor signal and a second time-dependent sensor signal, each related to a heartbeat of the subject and measured at different sites of a body of the subject during inflation of the cuff” and “controlling the pressure-delivery system to repeatedly inflate the cuff in directly consecutive partial inflations” similar to claim 13. Such a combination of a pressure-delivery system [and control thereof], pressure sensor, first sensor, and second sensor is considered well-understood, routine, and conventional, as known by at least:
Applicant’s disclosure is not particular regarding the particular structure of the generically claimed elements of the combination of the pressure-delivery system, pressure sensor, first sensor, and second sensor, and recites the elements at a high level of generality [The system 1 comprises a pressure-delivery system 10 comprising a cuff 11 configured to be attached to the subject's body part and to deliver a pressure to the subject's body part by inflating the cuff. Such a pressure-delivery system 10 comprising a cuff 11 that can be attached to an extremity of the subject, in particular the upper arm, upper leg or wrist, is generally known in the art of NIBP measurement. Generally, it comprises a pressure generating unit, e.g. a pump or pressure reservoir, that is configured to inflate the cuff 11, a valve that is configured to deflate the cuff 11, and a processor that is configured to control the pressure generating unit and the valve and to determine the subject's blood pressure based on the measured cuff pressure (Applicant’s Specification p. 13:36-14:8); The pressure sensor 20, e.g. in the form of a pressure transducer, may thus be integrated into the cuff and may be implemented by a conventional BP sensor. Other means to apply an external pressure and to detect cuff pressure, such as a Shellcuff design, are possible as well (Applicant’s Specification p. 14:13-16); The first sensor 30 may be an ECG sensor for acquiring an ECG signal. The first site may e.g. be the subject's chest or torso at which ECG electrodes are preferably attached for ECG measurements (Applicant’s Specification p. 14:19-21); The second sensor 40 may be a PPG sensor, e.g. a contact PPG sensor (such as a pulse oximetry sensor comprising one or more LEDs emitting light in the visible and/or infrared range, e.g. red and infrared light) or a remote PPG sensor (such as a camera or photo detector, as e.g. known from Verkruysse et al., “Remote plethysmographic imaging using ambient light”, Optics Express, 16(26), 22 Dec. 2008, pp. 21434-21445). PPG generally refers to the optical measurement of volume changes of an organ or a body part and in particular to the detection of volume changes due to a cardio-vascular pulse wave traveling through the body of a subject with every heartbeat. Radiation reflected by or transmitted through a skin region of the subject can be detected (Applicant’s Specification p. 14:24-32)]. This lack of disclosure is acceptable under 35 U.S.C. 112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the medical technology arts. Thus, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the field of blood pressure and heartbeat related signal measurements. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional element because it describes such an additional element in a manner that indicates that the additional element is sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. 112(a) [see Berkheimer memo from April 19, 2018, Page 3, (III)(A)(1), not attached]. Adding hardware that performs “well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible [TLI Communications].
Pantelopoulos (US-20170209053-A1, previously presented) [Another aspect of the disclosure relates to methods for calibrating a blood pressure measuring system including an inflatable cuff. The system also includes a calibration blood pressure device for measuring blood pressure, one or more sensors for measuring pulse transit time, a memory, and one or more processors. The method involves: (a) applying an external pressure to a person using the inflatable cuff; (b) obtaining a measurement of internal blood pressure of a person with the calibration blood pressure device, wherein the calibration blood pressure device does not rely on pulse transit time to measure the blood pressure; (c) obtaining a transmural blood pressure level from the measurement of internal blood pressure and the external pressure; (d) obtaining proximal pulse wave data and distal pulse wave data from the one or more sensors; (e) obtaining a pulse transit time using the proximal pulse wave data and the distal pulse wave data; (f) repeating (a)-(e) one or more times when applying one or more different external pressures, thereby obtaining two or more calibration data points corresponding to two or more transmural blood pressure levels and two or more pulse transit times; and (g) fitting a model to data points including the two or more calibration data points, wherein the model relates transmural blood pressure to pulse transit time (Pantelopoulos ¶0021); In some implementations, the inflatable cuff includes a pressure sensor, and the method further includes determining the external pressure using the pressure sensor (Pantelopoulos ¶0022); In some implementations, the at least one first biometric sensor is selected from the group consisting of: a photoplethysmorgraphy (PPG) sensor, an ECG sensor,… and any combinations thereof (Pantelopoulos ¶0023); In some implementations, the at least one second biometric sensor is selected from the group consisting of: a photoplethysmorgraphy (PPG) sensor, an ECG sensor,… and any combinations thereof (Pantelopoulos ¶0024)]
Cho (US-20100130876-A1) [Blood pressures of six persons were measured at heart level using a cuff-based upper arm blood pressure monitor (A&D, UA-767) and a cuff-based wrist blood pressure monitor (Citizen, CH-656C). For each person at the same position, a PWV is measured from the ECG signals of both hands and a PPG signal of a finger measured by a transmissive optical sensor (Cho ¶0047); The structure of the PWV measurer 730 will be described in detail with reference to FIGS. 8 and 9. FIG. 8 illustrates a wrist-type blood pressure measuring apparatus. Three electrodes 731a, 731b and 731c for measuring an EGC signal are added to a conventional blood pressure monitor cuff 770. An optical sensor 732 for measuring a PPG signal is provided inside a cuff 770 that contacts a wrist aorta portion or is provided in an additional device 800 that wraps around a finger (Cho ¶0055)]
Zhou (US-20090118628-A1) [Inflation-based oscillometric blood pressure measurements can be preferable from the patient's point of view, as they are typically faster and more comfortable than conventional deflation-based oscillometric measurements. Such measurements typically use a mechanical pump to rapidly inflate a cuff worn of a patient's arm, and a solenoid value to then slowly deflate the cuff while a pressure sensor measures a pressure waveform. In an inflation-based oscillometric measurement, like the one described herein, the mechanical pump slowly inflates the cuff, during which the control system within the body-worn sensor measures and processes the pressure waveform (Zhou ¶0023); In addition to making occasional inflation-based oscillometric measurements, the above-described system can continuously measure blood pressure from the patient using a technique based on a `pulse transit time` determined from three ECG electrodes 5a-c attached to the patient's chest, and an optical sensor 15 attached to the patient's thumb (Zhou ¶0025)]
Examiner’s Note Regarding Particular Treatment or Prophylaxis: Claim(s) 1-20 fail to recite any subject matter that may be considered to be a particular treatment or prophylaxis, as none of the identified claims positively recite or include language that is considered to be a particular treatment or prophylaxis as an additional element to integrate the judicial exception into a practical application or allow the identified claims to amount to significantly more than the judicial exception [MPEP § 2106.04(d)(2)].
Accordingly, the claim(s) as whole(s) fail amount to significantly more than the judicial exception under Step 2B.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1 and 13-16 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 9 and 14-15 of copending Application 18/705,335, hereinafter Muehlsteff, in view of Pantelopoulos (US-20170209053-A1, previously presented).
Conflicting claim 9 of Muehlsteff is considered to anticipate almost each and every limitation of instant claim 1 [see comparison below], except for the limitations wherein the control signal is used to control the pressure-delivery system to “repeatedly inflate the cuff in directly consecutive partial inflations, wherein in each repetition of a partial inflation the cuff is inflated up to a cuff pressure equal to or below a latest measured mean BP of the subject”, wherein the computed pulse-related values are based on the first and second time-dependent sensor signals as “measured during the repeated directly consecutive partial inflations of the cuff”, and the function of the processing unit to “calibrate the BP surrogate in accordance with the calibration parameter for monitoring the subject’s blood pressure”.
Pantelopoulos discloses systems and methods for estimating blood pressure using pulse transit time, wherein Pantelopoulos discloses performing directly consecutive partial inflations to gather a plurality of data points of blood pressure levels and corresponding pulse transit time values to calibrate a BP surrogate [The system also includes a calibration blood pressure device for measuring blood pressure, one or more sensors for measuring pulse transit time, a memory, and one or more processors. The method involves: (a) applying an external pressure to a person using the inflatable cuff; (b) obtaining a measurement of internal blood pressure of a person with the calibration blood pressure device, wherein the calibration blood pressure device does not rely on pulse transit time to measure the blood pressure; (c) obtaining a transmural blood pressure level from the measurement of internal blood pressure and the external pressure; (d) obtaining proximal pulse wave data and distal pulse wave data from the one or more sensors; (e) obtaining a pulse transit time using the proximal pulse wave data and the distal pulse wave data; (f) repeating (a)-(e) one or more times when applying one or more different external pressures, thereby obtaining two or more calibration data points corresponding to two or more transmural blood pressure levels and two or more pulse transit times; and (g) fitting a model to data points including the two or more calibration data points, wherein the model relates transmural blood pressure to pulse transit time (Pantelopoulos ¶0021); In some implementations, the process decides whether in the calibration data points have been collected. See block 410. If more calibration data points are necessary, the process loops back to block 402. The previous operations may be repeated one or more times to obtain one or more additional calibration data points. When enough calibration data points have been collected, the process proceeds to fit the model to the calibration data points. See block 412. The model relates blood pressure to PTT (Pantelopoulos ¶0138), wherein the model relating BP to PTT is considered to “calibrate” a surrogate BP based on PTT and corresponding BP measurement values].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Muehlsteff to employ wherein the control signal is used to control the pressure-delivery system to “repeatedly inflate the cuff in directly consecutive partial inflations, wherein in each repetition of a partial inflation the cuff is inflated up to a cuff pressure equal to or below a latest measured mean BP of the subject”, wherein the computed pulse-related values are based on the first and second time-dependent sensor signals as “measured during the repeated directly consecutive partial inflations of the cuff”, and the function of the processing unit to “calibrate the BP surrogate in accordance with the calibration parameter for monitoring the subject’s blood pressure”, so as to gather a sufficient amount of data for relating the measurement BP to computed PTT, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [repeat steps to partially inflate the cuff to obtain more or a sufficient amount of data] [MPEP § 2143(I)(D)].
Conflicting claim 9 as modified by Pantelopoulos is further considered to render obvious instant claim 16.
Claim 1 of the Instant Application
Claim 9 of Conflicting Patent Application No. 18/705,335, hereinafter Muehlsteff, which is considered to incorporate the subject matter of claim 1 therein
A device for calibrating a blood pressure (BP) surrogate for use in monitoring blood pressure of a subject, the device comprising:
A device for calibrating a blood pressure (BP) surrogate for use in monitoring a subject’s blood pressure, comprising: [claim 1, lines 1-2]
a BP input configured to measure time-dependent cuff pressure values during inflation of a cuff of a pressure-delivery system attached to a body part of the subject and a BP measurement value;
a BP sensor configured to obtain time-dependent cuff pressure values during inflation of a cuff of a pressure-delivery system attached to a subject’s body part and to obtain a BP measurement value [claim 1, lines 3-5]
a sensor input configured to measure a first time-dependent sensor signal and a second time-dependent sensor signal, each related to a heartbeat of the subject and measured at different sites of a body of the subject during the inflation of the cuff; and
a first sensor configured to obtain a first time-dependent sensor signal; and a second sensor configured to obtain a second time-dependent sensor signal, wherein both said first time-dependent sensor signal and said second time-dependent sensor signal are related to the subject’s heartbeat and are measured at different sites of the subject’s body during the inflation of the cuff [claim 1, lines 6-10]
a processing unit configured to:
a processing unit configured to: [claim 1, line 11]
control the pressure-delivery system using a control signal to repeatedly inflate the cuff in directly consecutive partial inflations, wherein in each repetition of a partial inflation the cuff is inflated up to a cuff pressure equal to or below a latest measured mean BP of the subject,
wherein the processing unit is configured to compute a control signal, the control signal controlling the pressure-delivery system to fully inflate the cuff for acquisition of the BP measurement value, and to only partly inflate the cuff for acquisition of the first time dependent sensor signal and the second time-dependent sensor signal [claim 9, lines 1-5]
compute pulse-related values from the first and second time-dependent sensor signals, measured during the repeated directly consecutive partial inflations of the cuff, using a first feature in the first time-dependent sensor signal and a second feature in the second time-dependent sensor signal, the pulse-related values being pulse arrival time (PAT) values or pulse transit time (PTT) values,
compute, during inflation of the cuff, pulse-related values from the first and second time-dependent sensor signals using a first feature in the first time-dependent sensor signal and a second feature in the second time-dependent sensor signal, the pulse-related values being pulse arrival time (PAT) values or pulse transit time (PTT) values [claim 1, lines 12-16]
compute a calibration parameter for a BP surrogate from the BP measurement value and pairs of the pulse-related values and corresponding cuff pressure values, computed from the first and second time-dependent sensor signals measured during the repeated directly consecutive partial inflations of the cuff, a pair comprising a pulse-related value and a corresponding, temporally related cuff pressure value, and
select pairs of pulse-related values and corresponding cuff pressure values for computing a calibration parameter for a BP surrogate, a pair comprising a pulse-related value and a corresponding, temporally related cuff pressure value [claim 1, lines 17-19]
compute a calibration parameter for a BP surrogate from the BP measurement value and the selected pairs of pulse-related values and corresponding cuff pressure values [claim 1, lines 25-27]
calibrate the BP surrogate in accordance with the calibration parameter for monitoring the subjects' blood pressure,
wherein, for computing the calibration parameter for the BP surrogate, only pairs of pulse-related values and corresponding cuff pressure values are used for which the cuff pressure value is below the latest measured mean BP.
wherein only pairs of pulse-related values and corresponding cuff pressure values are selected for which the cuff pressure value is below: (i) the subject’s latest measured diastolic BP; (ii) the subject’s latest measured mean BP; or (iii) a set threshold cuff pressure [claim 1, lines 19-24]
Conflicting claim 9 of Muehlsteff is considered to anticipate almost each and every limitation of instant claim 13 [see comparison below], except for “a pressure-delivery system comprising a cuff configured to be attached to a body part of the subject and to deliver a pressure to the subject's body part by inflating the cuff” [conflicting claim 1 of Muehlsteff is considered to fail to positively recite the “pressure-delivery system” (lines 3-5)], “a device for computing one or more calibration parameters for calibrating a BP surrogate from the BP measurement value, the time-dependent cuff pressure values and the first and second time-dependent sensor signals, the device comprising: a BP input configured to receive the time-dependent cuff pressure values and the BP measurement value from the pressure sensor; a sensor input configured to receive the first and second time-dependent sensor signals from the first and second sensors”, wherein the device further comprises the processing unit, wherein the control signal is used to control the pressure-delivery system to “repeatedly inflate the cuff in directly consecutive partial inflations, wherein in each repetition of a partial inflation the cuff is inflated up to a cuff pressure equal to or below a latest measured mean BP of the subject”, wherein the computed pulse-related values are based on the first and second time-dependent sensor signals as “measured during the repeated directly consecutive partial inflations of the cuff”, and the function of the processing unit to “calibrate the BP surrogate in accordance with the calibration parameter for monitoring the subject’s blood pressure”.
Pantelopoulos discloses systems and methods for estimating blood pressure using pulse transit time, wherein Pantelopoulos discloses the use of a pressure-delivery system comprising a cuff configured to be attached to a body part of a subject and to deliver a pressure to the subject’s body part by inflating the cuff [Process 700 is implemented on a system including an inflatable cuff, a calibration blood pressure device for measuring blood pressure, one or more sensors for measuring pulse transit time, a memory, and one or more processors. Similar to process 400, the calibration blood pressure device does not rely on pulse transit time to measure blood pressure. In some implementations, the inflatable cuff includes a pressure sensor. Process 700 starts by applying an external pressure to a person using the inflatable cuff. See block 704. In some implementations, the system determines the external pressure using the pressure sensor in the inflatable cuff (Pantelopoulos ¶¶0149-0150)], and performing directly consecutive partial inflations to gather a plurality of data points of blood pressure levels and corresponding pulse transit time values to calibrate a BP surrogate [Pantelopoulos ¶¶0021, 0138, wherein the model relating BP to PTT is considered to “calibrate” a surrogate BP based on PTT and corresponding BP measurement values]. Pantelopoulos further discloses a device that is operably coupled to a BP sensor and sensors configured to measure time-dependent sensor signals related to a heartbeat of the subject, and wherein the device comprises a processor configured to perform computations using measured values [The functionality discussed herein may be provided using a number of different approaches. For example, in some implementations a processor may be controlled by computer-executable instructions stored in memory so as to provide functionality such as is described herein. In other implementations, such functionality may be provided in the form of an electrical circuit. In yet other implementations, such functionality may be provided by a processor or processors controlled by computer-executable instructions stored in a memory coupled with one or more specially-designed electrical circuits (Pantelopoulos ¶0162); In some implementations, the wearable biometric monitoring device integrates a plurality of biometric sensors. FIG. 8B is a block diagram showing components of a biometric monitoring device in such an implementation. The biometric monitoring device includes a processor, a display element, communication circuitry, and a plurality of biometric sensors that are communicatively linked and contained in a housing structure. In some implementations, instead of enclosed in a housing, one or more of the sensors may be integrated into auxiliary structure connected to the housing structure. For example, the PPG sensor may be integrated into a wristband that is attached to a housing, providing a device with a form similar to a wrist-watch that can be worn on the wrist. See FIG. 13A. The plurality of the biometric sensors in the example illustrated in FIG. 8B includes a PPG sensor, an ECG sensor, an inertial or motion sensor, a temperature sensor, and an altimeter (Pantelopoulos ¶0165); Embodiments of biometric monitoring devices may include one or more processors. Figures. For example, an independent application processor may be used to store and execute applications that utilize sensor data acquired and processed by one or more sensor processors (processor(s) that process data from physiological, environmental, and/or activity sensors). In the case where there are multiple sensors, there may also be multiple sensor processors. An application processor may have sensors directly connected to it as well. Sensor and application processors may exist as separate discrete chips or exist within the same packaged chip (multi-core). A device may have a single application processor, or an application processor and sensor processor, or a plurality of application processors and sensor processors (Pantelopoulos ¶0286)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Muehlsteff to employ “a pressure-delivery system comprising a cuff configured to be attached to a body part of the subject and to deliver a pressure to the subject's body part by inflating the cuff” and “a device for computing one or more calibration parameters for calibrating a BP surrogate from the BP measurement value, the time-dependent cuff pressure values and the first and second time-dependent sensor signals, the device comprising: a BP input configured to receive the time-dependent cuff pressure values and the BP measurement value from the pressure sensor; a sensor input configured to receive the first and second time-dependent sensor signals from the first and second sensors”, wherein the device further comprises the processing unit, in order to define a system, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [positive incorporation of a pressure-delivery system comprising a cuff to determine a BP of a subject and incorporation of a “device” operably coupled to sensors and comprising a processing unit to perform the claimed functionality of the processing unit] [MPEP § 2143(I)(D)]; and further obvious to have modified the system Muehlsteff to employ wherein the control signal is used to control the pressure-delivery system to “repeatedly inflate the cuff in directly consecutive partial inflations, wherein in each repetition of a partial inflation the cuff is inflated up to a cuff pressure equal to or below a latest measured mean BP of the subject”, wherein the computed pulse-related values are based on the first and second time-dependent sensor signals as “measured during the repeated directly consecutive partial inflations of the cuff”, and the function of the processing unit to “calibrate the BP surrogate in accordance with the calibration parameter for monitoring the subject’s blood pressure”, so as to gather a sufficient amount of data for relating the measurement BP to computed PTT, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [repeat steps to partially inflate the cuff to obtain more or a sufficient amount of data] [MPEP § 2143(I)(D)].
Claim 13 of the Instant Application
Claim 9 of Conflicting Patent Application No. 18/705,335, hereinafter Muehlsteff, which is considered to incorporate the subject matter of claim 1 therein
A system for calibrating a blood pressure (BP) surrogate for use in monitoring blood pressure of a subject, the system comprising:
A device for calibrating a blood pressure (BP) surrogate for use in monitoring a subject’s blood pressure, comprising: [claim 1, lines 1-2]
[wherein the Examiner notes that while conflicting claims 1/9 are directed towards a “device”, whereas instant claim 13 is directed towards a “system”, instant claim 1 and conflicting claims 1/9 are both considered to be directed towards the same statutory category of “machine”]
a pressure-delivery system comprising a cuff configured to be attached to a body part of the subject and to deliver a pressure to the subject's body part by inflating the cuff;
a pressure sensor configured to measure time-dependent cuff pressure values during inflation of a-the cuff of the pressure-delivery system attached to the subject's body part and to acquire or infer a BP measurement value;
a BP sensor configured to obtain time-dependent cuff pressure values during inflation of a cuff of a pressure-delivery system attached to a subject’s body part and to obtain a BP measurement value [claim 1, lines 3-5]
a first sensor configured to be attached to a first site of a body of the subject and to measure a first time-dependent sensor signal related to a heartbeat of the subject during the inflation of the cuff;
a first sensor configured to obtain a first time-dependent sensor signal [claim 1, line 6]
wherein both said first time-dependent sensor signal and said second time-dependent sensor signal are related to the subject’s heartbeat and are measured at different sites of the subject’s body during the inflation of the cuff [claim 1, lines 8-10]
a second sensor configured to be attached to a second site of the subject's body and to measure a second time-dependent sensor signal related to the subject's heartbeat during the inflation of the cuff; and
a second sensor configured to obtain a second time-dependent sensor signal, wherein both said first time-dependent sensor signal and said second time-dependent sensor signal are related to the subject’s heartbeat and are measured at different sites of the subject’s body during the inflation of the cuff [claim 1, lines 7-10]
a device for computing one or more calibration parameters for calibrating a BP surrogate from the BP measurement value, the time-dependent cuff pressure values and the first and second time-dependent sensor signals, the device comprising:
a BP input configured to receive the time-dependent cuff pressure values and the BP measurement value from the pressure sensor;
a sensor input configured to receive the first and second time-dependent sensor signals from the first and second sensors; and
a processing unit configured to:
a processing unit configured to: [claim 1, line 11]
control the pressure-delivery system using a control signal to repeatedly inflate the cuff in directly consecutive partial inflations, wherein in each repetition of a partial inflation the cuff is inflated up to a cuff pressure below a latest measured mean BP of the subject,
wherein the processing unit is configured to compute a control signal, the control signal controlling the pressure-delivery system to fully inflate the cuff for acquisition of the BP measurement value, and to only partly inflate the cuff for acquisition of the first time dependent sensor signal and the second time-dependent sensor signal [claim 9, lines 1-5]
compute pulse-related values from the first and second time-dependent sensor signals, measured during the repeated directly consecutive partial inflations of the cuff, using a first feature in the first time-dependent sensor signal and a second feature in the second time-dependent sensor signal, the pulse-related values being pulse arrival time (PAT) values or pulse transit time (PTT) values,
compute, during inflation of the cuff, pulse-related values from the first and second time-dependent sensor signals using a first feature in the first time-dependent sensor signal and a second feature in the second time-dependent sensor signal, the pulse-related values being pulse arrival time (PAT) values or pulse transit time (PTT) values [claim 1, lines 12-16]
compute a calibration parameter for a BP surrogate from the BP measurement value and pairs of the pulse-related values and corresponding cuff pressure values, computed from the first and second time-dependent sensor signals measured during the repeated directly consecutive partial inflations of the cuff, a pair comprising a pulse-related value and a corresponding, temporally related cuff pressure value, and
select pairs of pulse-related values and corresponding cuff pressure values for computing a calibration parameter for a BP surrogate, a pair comprising a pulse-related value and a corresponding, temporally related cuff pressure value [claim 1, lines 17-19]
compute a calibration parameter for a BP surrogate from the BP measurement value and the selected pairs of pulse-related values and corresponding cuff pressure values [claim 1, lines 25-27]
calibrate the BP surrogate in accordance with the calibration parameter for monitoring the subjects' blood pressure,
wherein, for computing the calibration parameter for the BP surrogate, only pairs of pulse-related values and corresponding cuff pressure values are used for which the cuff pressure value is below the latest measured mean BP.
wherein only pairs of pulse-related values and corresponding cuff pressure values are selected for which the cuff pressure value is below: (i) the subject’s latest measured diastolic BP; (ii) the subject’s latest measured mean BP; or (iii) a set threshold cuff pressure [claim 1, lines 19-24]
Conflicting claim 14 of Muehlsteff is considered to anticipate almost each and every limitation of instant claim 14 [see comparison below], except “controlling the pressure-delivery system to repeatedly inflate the cuff in directly consecutive partial inflations, wherein in each repetition of a partial inflation the cuff is inflated up to a cuff pressure below a latest measured mean BP of the subject” [Muehlsteff does recite claim language indicating that relevant cuff pressure values are below the subject’s latest measured mean BP (claim 14, lines 18-22)], wherein the computed pulse-related values are based on the first and second time-dependent sensor signals as “measured during the repeated directly consecutive partial inflations of the cuff”, and the step of “calibrating the BP surrogate in accordance with the calibration parameter for monitoring the subject’s blood pressure”.
Pantelopoulos discloses systems and methods for estimating blood pressure using pulse transit time, wherein Pantelopoulos discloses performing directly consecutive partial inflations to gather a plurality of data points of blood pressure levels and corresponding pulse transit time values to calibrate a BP surrogate [Pantelopoulos ¶¶0021, 0138, wherein the model relating BP to PTT is considered to “calibrate” a surrogate BP based on PTT and corresponding BP measurement values].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Muehlsteff to employ “controlling the pressure-delivery system to repeatedly inflate the cuff in directly consecutive partial inflations, wherein in each repetition of a partial inflation the cuff is inflated up to a cuff pressure below a latest measured mean BP of the subject”, wherein the computed pulse-related values are based on the first and second time-dependent sensor signals as “measured during the repeated directly consecutive partial inflations of the cuff”, and the step of “calibrating the BP surrogate in accordance with the calibration parameter for monitoring the subject’s blood pressure”, so as to gather a sufficient amount of data for relating the measurement BP to computed PTT, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [repeat steps to partially inflate the cuff to obtain more or a sufficient amount of data] [MPEP § 2143(I)(D)].
Conflicting claim 15 as modified by Pantelopoulos is further considered to render obvious instant claim 15.
Claim 14 of the Instant Application
Claim 14 of Conflicting Patent Application No. 18/705,335, hereinafter Muehlsteff
A method for calibrating a blood pressure, BP, surrogate for use in monitoring blood pressure of a subject, the method comprising:
A method for calibrating a blood pressure (BP) surrogate for use in monitoring a subject’s blood pressure, comprising: [claim 14, lines 1-2]
- obtaining time-dependent cuff pressure values during inflation of a cuff of a pressure-delivery system attached to a body part of the subject;
obtaining, using a pressure sensor, time-dependent cuff pressure values during inflation of a cuff of a pressure-delivery system attached to a subject’s body part [claim 14, lines 3-4]
- obtaining a BP measurement value;
obtaining a BP measurement value [claim 14, line 5]
- measuring a first time-dependent sensor signal and a second time-dependent sensor signal, each related to a heartbeat of the subject and measured at different sites of the subject's a body of the subject during the inflation of the cuff;
obtaining, using a first sensor, a first time-dependent sensor signal; and obtaining, using a second sensor, a second time-dependent sensor signal, wherein said first time-dependent sensor signal and said second time-dependent sensor signal are both related to the subject’s heartbeat and are measured at different sites of the subject’s body during the inflation of the cuff [claim 14, lines 6-10]
- controlling the pressure-delivery system to repeatedly inflate the cuff in directly consecutive partial inflations, wherein in each repetition of a partial inflation the cuff is inflated up to a cuff pressure below a latest measured mean BP of the subject;
inflation of a cuff of a pressure-delivery system attached to a subject’s body part [claim 14, lines 3-4]
wherein only pairs of pulse-related values and corresponding cuff pressure values are selected for which the cuff pressure value is below: (i) the subject’s latest measured diastolic BP; (ii) the subject’s latest measured mean BP; or (iii) a set threshold cuff pressure [claim 14, lines 18-22]
- computing pulse-related values from the first and second time-dependent sensor signals, measured during the repeated directly consecutive partial inflations of the cuff, using a first feature in the first time-dependent sensor signal and a second feature in the second time-dependent sensor signal, the pulse-related values being pulse arrival time (PAT) values or pulse transit time (PTT) values;
computing, during inflation of the cuff and using a processor, pulse-related values from the first and second time-dependent sensor signals using a first feature in the first time-dependent sensor signal and a second feature in the second time-dependent sensor signal, the pulse-related values being pulse arrival time (PAT) values or pulse transit time (PTT) values [claim 14, lines 11-15]
- computing a calibration parameter for a BP surrogate from the BP measurement value and pairs of the pulse-related values and corresponding cuff pressure values, computed from the first and second time-dependent sensor signals measured during the repeated directly consecutive partial inflations of the cuff, a pair comprising a pulse-related value and a corresponding, temporally related cuff pressure value of the same time instant; and
selecting, by the processor, pairs of pulse-related values and corresponding cuff pressure values for computing a calibration parameter for a BP surrogate, a pair comprising a pulse-related value and a corresponding, temporally related cuff pressure value, wherein only pairs of pulse-related values and corresponding cuff pressure values are selected for which the cuff pressure value is below: (i) the subject’s latest measured diastolic BP; (ii) the subject’s latest measured mean BP; or (iii) a set threshold cuff pressure [claim 14, lines 16-22]
computing, by the processor, a calibration parameter for a BP surrogate from the BP measurement value and the selected pairs of pulse-related values and corresponding cuff pressure values [claim 14, lines 23-25]
calibrating the BP surrogate in accordance with the calibration parameter for monitoring the subjects' blood pressure,
wherein, for computing the calibration parameter for the BP surrogate, only pairs of pulse-related values and corresponding cuff pressure values are used for which the cuff pressure value is below the latest measured mean BP.
selecting, by the processor, pairs of pulse-related values and corresponding cuff pressure values for computing a calibration parameter for a BP surrogate, a pair comprising a pulse-related value and a corresponding, temporally related cuff pressure value, wherein only pairs of pulse-related values and corresponding cuff pressure values are selected for which the cuff pressure value is below: (i) the subject’s latest measured diastolic BP; (ii) the subject’s latest measured mean BP; or (iii) a set threshold cuff pressure [claim 14, lines 16-22]
This is a provisional nonstatutory double patenting rejection.
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.
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.
Claim(s) 1, 4, 7-9, 11-15, and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banet (US-20100160798-A1, cited by Applicant, previously presented) in view of Pantelopoulos (US-20170209053-A1, previously presented) and Ogura (US-5649536-A).
Regarding claim 1, Banet teaches
A device for calibrating a blood pressure (BP) surrogate for use in monitoring blood pressure of a subject, the device comprising:
a BP input configured to measure time-dependent cuff pressure values during inflation of a cuff of a pressure-delivery system attached to a body part of the subject and a BP measurement value [The cuff includes an air bladder which, when pressurized with a pneumatic system, applies a pressure 107 to an underlying artery 102, 102' (Banet ¶0061); This means calibration can be performed with a single, inflation-based measurement that typically takes between 40-60 seconds. At a recommended inflation rate (approximately 3-10 mmHg/second, and most preferably about 5 mmHg/second) this typically yields between 5-15 data points. These are the data points analyzed with the linear regression model to determine the patient-specific slope. Blood pressure values (SYS.sub.INDEX, MAP.sub.INDEX, and DIA.sub.INDEX) and the ratios between them (R.sub.SYS=SYS.sub.INDEX/MAP.sub.INDEX; R.sub.DIA=DIA.sub.INDEX/MAP.sub.INDEX) determined during the inflation-based measurement are also used in this calculation, and then for subsequent pressure-free measurements (Banet ¶0065); During an actual pressure-dependent indexing measurement, the body-worn monitor collects data like that shown in FIGS. 2A and 2B, for an individual patient. During a measurement, the microprocessor analyzes the variation between applied pressure and PTT, shown graphically in FIG. 2A, to estimate the relationship between blood pressure and PTT (Banet ¶0068), wherein the pneumatic system as operably coupled to the cuff applying a known pressure for the microprocessor to measure and analyze is considered to read on a pressure input as claimed];
a sensor input configured to measure a first time-dependent sensor signal and a second time-dependent sensor signal, each related to a heartbeat of the subject and measured at different sites of a body of the subject during the inflation of the cuff [An electrical system featuring at least 3 electrodes coupled to an amplifier/filter circuit within cabling attached to the wrist-worn transceiver measures an ECG waveform 104, 104' from the patient. Three electrodes (two detecting positive and negative signals, and one serving as a ground) are typically required to detect the necessary signals to generate an ECG waveform with an adequate signal-to-noise ratio. At the same time, an optical system featuring a transmissive or, optionally, reflective optical sensor measures a PPG waveform 105, 105' featuring a series of `pulses`, each characterized by an amplitude of AMP.sub.1/2, from the patient's artery. The preferred measurement site is typically near small arteries in the patient's thumb, such as the princeps pollicis artery. A microprocessor and analog-to-digital converter within the wrist-worn transceiver detects and analyzes the ECG 104, 104' and PPG 105, 105' waveforms (Banet ¶0061)]; and
a processing unit configured to:
control the pressure-delivery system using a control signal to inflate the cuff [When this criterion is met the pump is automatically inflated, and the patient-specific slope is then determined as described above (Banet ¶0067); The Composite Method performs an indexing measurement once every 4-8 hours using inflation-based oscillometry. During the indexing measurement, a linear regression model is used to relate the pressure applied by the cuff to an `effective MAP` (referred to as MAP*(P) in FIG. 3A) representing a mean pressure in the patient's arm (Banet ¶0065); When an oscillometric measurement is rejected, a NULL value is returned, and the body-worn monitor instructs the pneumatic system to re-inflate the cuff, and the measurement is repeated (Banet ¶0084), wherein ¶0084 is cited to highlight the operative connection between the system of Banet and the cuff to automatically inflate the cuff to a determined level],
compute pulse-related values from the first and second time-dependent sensor signals, measured during the inflation of the cuff, using a first feature in the first time-dependent sensor signal and a second feature in the second time-dependent sensor signal, the pulse-related values being pulse arrival time (PAT) values or pulse transit time (PTT) values [Banet ¶0061; During an actual pressure-dependent indexing measurement, the body-worn monitor collects data like that shown in FIGS. 2A and 2B, for an individual patient. During a measurement, the microprocessor analyzes the variation between applied pressure and PTT, shown graphically in FIG. 2A, to estimate the relationship between blood pressure and PTT (Banet ¶0068)],
compute a calibration parameter for a BP surrogate from the BP measurement value and pairs of the pulse-related values and corresponding cuff pressure values, computed from the first and second time-dependent sensor signals measured during the inflation of the cuff, a pair comprising a pulse-related value and a corresponding, temporally related cuff pressure value [Using parameters such as heart rate and initial estimated blood pressure, the first pressure-dependent indexing measurement (step 182a) determines a relationship between PTT and blood pressure as described above. This measurement takes about 40 seconds, and may occur automatically (e.g., after about 1 minute), or may be driven by the medical professional (e.g., through a button press). The microprocessor then uses this relationship and a measured value of PTT to determine blood pressure during the following pressure-free measurement (step 181b). This measurement step typically proceeds for a well-defined period of time (e.g., 4-8 hours), during which it continuously determines blood pressure (Banet ¶0101), wherein the Examiner notes that the determined relationship between PTT and blood pressure is considered to read on the broadest reasonable interpretation of a “calibration parameter for a BP surrogate”, as the relationship is used to determine BP following pressure-free measurements of PTT], and
calibrate the BP surrogate in accordance with the calibration parameter for monitoring the subjects' blood pressure [Banet ¶101, wherein the determined BP based on the relationship between BP and PTT and a measured PTT is considered to define the calibrated BP surrogate].
However, Banet fails to explicitly disclose wherein the pressure-delivery system is controlled repeatedly inflate the cuff in directly consecutive partial inflations, wherein in each repetition of a partial inflation the cuff is inflated up to a cuff pressure equal to or below a latest measured mean BP of the subject; wherein the first and second time-dependent sensor signals are measured during the repeated directly consecutive partial inflations of the cuff; and wherein, for computing the calibration parameter for the BP surrogate, only pairs of pulse-related values and corresponding cuff pressure values are used for which the cuff pressure value is below the latest measured mean BP.
Pantelopoulos discloses systems and methods for estimating blood pressure using pulse transit time, wherein Pantelopoulos discloses performing directly consecutive partial inflations to gather a plurality of data points of blood pressure levels and corresponding pulse transit times [Another aspect of the disclosure relates to methods for calibrating a blood pressure measuring system including an inflatable cuff. The system also includes a calibration blood pressure device for measuring blood pressure, one or more sensors for measuring pulse transit time, a memory, and one or more processors. The method involves: (a) applying an external pressure to a person using the inflatable cuff; (b) obtaining a measurement of internal blood pressure of a person with the calibration blood pressure device, wherein the calibration blood pressure device does not rely on pulse transit time to measure the blood pressure; (c) obtaining a transmural blood pressure level from the measurement of internal blood pressure and the external pressure; (d) obtaining proximal pulse wave data and distal pulse wave data from the one or more sensors; (e) obtaining a pulse transit time using the proximal pulse wave data and the distal pulse wave data; (f) repeating (a)-(e) one or more times when applying one or more different external pressures, thereby obtaining two or more calibration data points corresponding to two or more transmural blood pressure levels and two or more pulse transit times; and (g) fitting a model to data points including the two or more calibration data points, wherein the model relates transmural blood pressure to pulse transit time (Pantelopoulos ¶0021); In some implementations, the process decides whether in the calibration data points have been collected. See block 410. If more calibration data points are necessary, the process loops back to block 402. The previous operations may be repeated one or more times to obtain one or more additional calibration data points. When enough calibration data points have been collected, the process proceeds to fit the model to the calibration data points. See block 412. The model relates blood pressure to PTT (Pantelopoulos ¶0138)].
Ogura discloses systems and methods for measuring blood pressure of a subject, wherein Ogura discloses performing repeated partial inflations and deflations using a pressure cuff, wherein Ogura discloses that in each repetition of a partial inflation the cuff is inflated up to a cuff pressure below a latest measured mean BP of the subject [a pressure changing device which increases the pressure of the cuff to a prescribed value lower than a mean blood pressure of the subject, and subsequently decreases the cuff pressure from the prescribed value, in each of a plurality of periodic cycles (Ogura Col 9:38-42); Since the rate of change .theta. is determined based on the data obtained while the cuff pressure P.sub.c is changed in a low pressure range from atmospheric pressure to the hold pressure P.sub.CH, the BP monitor operation of the apparatus 500 does not cause the subject to feel discomfort due to the pressing of the inflated cuff 510 (Ogura Col 46:29-34)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Banet to employ wherein the pressure-delivery system is controlled repeatedly inflate the cuff in directly consecutive partial inflations, wherein in each repetition of a partial inflation the cuff is inflated up to a cuff pressure equal to or below a latest measured mean BP of the subject; wherein the first and second time-dependent sensor signals are measured during the repeated directly consecutive partial inflations of the cuff, so as to gather additional data for relating the measured blood pressure to calculated pulse transit time at a pressure that does not cause discomfort to the subject, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [repeat steps to partially inflate the cuff to a non-discomforting pressure to obtain more data] [MPEP § 2143(I)(D)]. Based on the modification of Banet in view of Pantelopoulos and Ogura to employ wherein the partial inflations are to a cuff pressure below a latest measured mean BP of the subject [Ogura Col 9:38-42], the limitation “wherein, for computing the calibration parameter for the BP surrogate, only pairs of pulse-related values and corresponding cuff pressure values are used for which the cuff pressure value is below the latest measured mean BP” is considered to be rendered obvious, as all the measurements of the first and second time-dependent sensor signals used to compute the pulse-related values are considered to have been measured when the cuff pressure value was below the latest measured mean BP.
Regarding claim 4, Banet in view of Pantelopoulos and Ogura teaches
The device as claimed in claim 1,
wherein the processing unit is configured to compute the control signal for controlling the pressure-delivery system to inflate the cuff in the partial inflations up to a latest measured diastolic BP of the subject, up to a latest measured mean BP of the subject, or up to a set threshold cuff pressure below the latest measured mean BP [See § 103 modification of claim 1 above; Ogura Col 9:38-42].
Regarding claim 7, Banet in view of Pantelopoulos and Ogura teaches
The device as claimed in claim 1,
wherein the processing unit is configured to compute the control signal for controlling the pressure-delivery system to inflate the cuff in the partial inflations up to a cuff pressure at which an amplitude of the second time-dependent signal exceeds an amplitude threshold, in particular an absolute amplitude threshold or a relative amplitude threshold [Banet ¶0061, wherein any measured second time-dependent signal may be considered to be relative to a non-particular “relative amplitude threshold”].
Regarding claim 8, Banet in view of Pantelopoulos and Ogura teaches
The device as claimed in claim 1,
wherein the processing unit is configured to compute the control signal for controlling the pressure-delivery system to inflate the cuff in the partial inflations at a predetermined inflation speed [See § 103 modification of claim 1 above; Banet ¶0065].
Regarding claim 9, Banet in view of Pantelopoulos and Ogura teaches
The device as claimed in claim 1,
wherein the processing unit is configured to:
compute the control signal for controlling the pressure-delivery system to deflate the cuff after each iteration of a partial inflation [FIGS. 4A and 4B show actual PTT vs. MAP*(P) and MAP data, measured for a single patient, during a pressure-dependent measurement that uses inflation (FIG. 4A) and deflation (FIG. 4B) (Banet ¶0073); wherein based on the § 103 modification of claim 1 above, as the partial inflation to determine PTT and corresponding pressure values is repeated, the corresponding deflation is repeated].
However, Banet in view of Pantelopoulos and Ogura fails to explicitly disclose wherein the processing unit is configured to compute, for each iteration, one or more calibration parameters from pairs of pulse-related values and corresponding cuff pressure values obtained in the respective iteration using separate regressions, and average the respective calibration parameters computed for two or more iterations into one or more averaged calibration parameters for use by the BP surrogate.
As Banet is already considered to teach computing, for a single inflation, one or more calibration parameter from pairs of pulse-related values and corresponding cuff pressure values obtained using a regression [Banet ¶0065], it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Banet in view of Pantelopoulos and Ogura to employ wherein the processing unit is configured to compute, for each iteration, one or more calibration parameters from pairs of pulse-related values and corresponding cuff pressure values obtained in the respective iteration using separate regressions, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [apply a regression to each iterated inflation] [MPEP § 2143(I)(D)]; and as Pantelopoulos separately notes that determining an average is a known statistical analysis [Pantelopoulos ¶0094], it would have been further obvious to employ the processing unit to average the respective calibration parameters computed for two or more iterations into one or more averaged calibration parameters for use by the BP surrogate, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [statistical analysis of a data set of a same type of separately calculated values] [MPEP § 2143(I)(D)].
Regarding claim 11, Banet in view of Pantelopoulos and Ogura teaches
The device as claimed in claim 1.
However, while Banet applies a linear regression model to determine the calibration parameter [Banet ¶0065], Banet in view of Pantelopoulos and Ogura fails to explicitly disclose wherein the processing unit is configured to control how many iterations of partial inflation are conducted based on a comparison of a regression error to a regression error threshold.
Pantelopoulos discloses ensuring that a sufficient amount of calibration data points are collected to relate BP and PTT, and further discloses obtaining estimates of model parameters to minimize the distance between the calibration data points and the model prediction [In some implementations, the process decides whether in the calibration data points have been collected. See block 410. If more calibration data points are necessary, the process loops back to block 402. The previous operations may be repeated one or more times to obtain one or more additional calibration data points. When enough calibration data points have been collected, the process proceeds to fit the model to the calibration data points. See block 412. The model relates blood pressure to PTT. In some implementations, the model includes a linear mathematical relationship, a general linear model, a non-linear model, or a neural network model. In some implementations, the non-linear model describes blood pressure as a nonlinear function of PTT as shown in equation (7). In other implementations, the linear model describes blood pressure as a decreasing linear function of PTT. In some implementations, fitting the model to the calibration data points involves obtaining estimates of model parameters to minimize the distance between the calibration data points and the model prediction. In some implementations, fitting the model to the calibration data points involves obtaining estimates of model parameters to maximize the likelihood of the model. FIG. 5 illustrates an example of multiple calibration data points and a relationship of a model that describes BP as a non-linear function of PTT, such as that of equation (7). In alternative implementations, a linear model may be fit to the same calibration data points showing the figure (Pantelopoulos ¶0138, Fig. 5), wherein the distance between the calibration data points and the model as disclosed by Pantelopoulos is considered to read on the broadest reasonable interpretation of “regression error”].
As Pantelopoulos discloses ensuring collection of a sufficient amount of data points and subject matter directed towards minimizing a distance between data points and a model, which is considered to be equivalent to attempting to reduce a regression error, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified wherein the processing unit is configured to control how many iterations of partial inflation are conducted based on a comparison of a regression error to a regression error threshold, to maximize accuracy of the regression.
Regarding claim 12, Banet in view of Pantelopoulos and Ogura teaches
The device as claimed in claim 1,
wherein the processing unit is configured to determine BP values when no pressure is delivered to the subject's body part by the pressure-delivery system by use of the computed BP surrogate and the measured first and second time-dependent sensor signals measured at different sites of the subject's body when no pressure is delivered to the subject's body part [Banet ¶0101].
Regarding claim 13, Banet teaches
A system for calibrating a blood pressure (BP) surrogate for use in monitoring blood pressure of a subject, the system comprising:
a pressure-delivery system comprising a cuff configured to be attached to a body part of the subject and to deliver a pressure to the subject's body part by inflating the cuff [The cuff includes an air bladder which, when pressurized with a pneumatic system, applies a pressure 107 to an underlying artery 102, 102' (Banet ¶0061)];
a pressure sensor configured to measure time-dependent cuff pressure values during inflation of a-the cuff of the pressure-delivery system attached to the subject's body part and to acquire or infer a BP measurement value [This means calibration can be performed with a single, inflation-based measurement that typically takes between 40-60 seconds. At a recommended inflation rate (approximately 3-10 mmHg/second, and most preferably about 5 mmHg/second) this typically yields between 5-15 data points. These are the data points analyzed with the linear regression model to determine the patient-specific slope. Blood pressure values (SYS.sub.INDEX, MAP.sub.INDEX, and DIA.sub.INDEX) and the ratios between them (R.sub.SYS=SYS.sub.INDEX/MAP.sub.INDEX; R.sub.DIA=DIA.sub.INDEX/MAP.sub.INDEX) determined during the inflation-based measurement are also used in this calculation, and then for subsequent pressure-free measurements (Banet ¶0065); During an actual pressure-dependent indexing measurement, the body-worn monitor collects data like that shown in FIGS. 2A and 2B, for an individual patient. During a measurement, the microprocessor analyzes the variation between applied pressure and PTT, shown graphically in FIG. 2A, to estimate the relationship between blood pressure and PTT (Banet ¶0068), wherein the pneumatic system as operably coupled to the cuff applying a known pressure for the microprocessor to measure and analyze is considered to read on a pressure input as claimed];
a first sensor configured to be attached to a first site of a body of the subject and to measure a first time-dependent sensor signal related to a heartbeat of the subject during the inflation of the cuff [An electrical system featuring at least 3 electrodes coupled to an amplifier/filter circuit within cabling attached to the wrist-worn transceiver measures an ECG waveform 104, 104' from the patient. Three electrodes (two detecting positive and negative signals, and one serving as a ground) are typically required to detect the necessary signals to generate an ECG waveform with an adequate signal-to-noise ratio (Banet ¶0061)];
a second sensor configured to be attached to a second site of the subject's body and to measure a second time-dependent sensor signal related to the subject's heartbeat during the inflation of the cuff [an optical system featuring a transmissive or, optionally, reflective optical sensor measures a PPG waveform 105, 105' featuring a series of `pulses`, each characterized by an amplitude of AMP.sub.1/2, from the patient's artery. The preferred measurement site is typically near small arteries in the patient's thumb, such as the princeps pollicis artery. A microprocessor and analog-to-digital converter within the wrist-worn transceiver detects and analyzes the ECG 104, 104' and PPG 105, 105' waveforms (Banet ¶0061)]; and
a device for computing one or more calibration parameters for calibrating a BP surrogate from the BP measurement value, the time-dependent cuff pressure values and the first and second time-dependent sensor signals, the device comprising:
a BP input configured to receive the time-dependent cuff pressure values and the BP measurement value from the pressure sensor [Banet ¶¶0065, 0068, wherein operable electronic coupling between the microprocessor and the pressure sensor to read pressure signals is considered to read on the claimed BP input];
a sensor input configured to receive the first and second time-dependent sensor signals from the first and second sensors [Banet ¶0061, wherein operable electronic coupling between the microprocessor and the first and second sensor for reading sensor signals is considered to read on a sensor input as claimed]; and
a processing unit configured to:
control the pressure-delivery system using a control signal to inflate the cuff [When this criterion is met the pump is automatically inflated, and the patient-specific slope is then determined as described above (Banet ¶0067); The Composite Method performs an indexing measurement once every 4-8 hours using inflation-based oscillometry. During the indexing measurement, a linear regression model is used to relate the pressure applied by the cuff to an `effective MAP` (referred to as MAP*(P) in FIG. 3A) representing a mean pressure in the patient's arm (Banet ¶0065); When an oscillometric measurement is rejected, a NULL value is returned, and the body-worn monitor instructs the pneumatic system to re-inflate the cuff, and the measurement is repeated (Banet ¶0084), wherein ¶0084 is cited to highlight the operative connection between the system of Banet and the cuff to automatically inflate the cuff to a determined level],
compute pulse-related values from the first and second time-dependent sensor signals, measured during the inflation of the cuff, using a first feature in the first time-dependent sensor signal and a second feature in the second time-dependent sensor signal, the pulse-related values being pulse arrival time (PAT) values or pulse transit time (PTT) values [Banet ¶0061; During an actual pressure-dependent indexing measurement, the body-worn monitor collects data like that shown in FIGS. 2A and 2B, for an individual patient. During a measurement, the microprocessor analyzes the variation between applied pressure and PTT, shown graphically in FIG. 2A, to estimate the relationship between blood pressure and PTT (Banet ¶0068)],
compute a calibration parameter for a BP surrogate from the BP measurement value and pairs of the pulse-related values and corresponding cuff pressure values, computed from the first and second time-dependent sensor signals measured during the inflation of the cuff, a pair comprising a pulse-related value and a corresponding, temporally related cuff pressure value [Using parameters such as heart rate and initial estimated blood pressure, the first pressure-dependent indexing measurement (step 182a) determines a relationship between PTT and blood pressure as described above. This measurement takes about 40 seconds, and may occur automatically (e.g., after about 1 minute), or may be driven by the medical professional (e.g., through a button press). The microprocessor then uses this relationship and a measured value of PTT to determine blood pressure during the following pressure-free measurement (step 181b). This measurement step typically proceeds for a well-defined period of time (e.g., 4-8 hours), during which it continuously determines blood pressure (Banet ¶0101), wherein the Examiner notes that the determined relationship between PTT and blood pressure is considered to read on the broadest reasonable interpretation of a “calibration parameter for a BP surrogate”, as the relationship is used to determine BP following pressure-free measurements of PTT], and
calibrate the BP surrogate in accordance with the calibration parameter for monitoring the subjects' blood pressure [Banet ¶101, wherein the determined BP based on the relationship between BP and PTT and a measured PTT is considered to define the calibrated BP surrogate].
However, Banet fails to explicitly disclose wherein the pressure-delivery system is controlled repeatedly inflate the cuff in directly consecutive partial inflations, wherein in each repetition of a partial inflation the cuff is inflated up to a cuff pressure equal to or below a latest measured mean BP of the subject; wherein the first and second time-dependent sensor signals are measured during the repeated directly consecutive partial inflations of the cuff; and wherein, for computing the calibration parameter for the BP surrogate, only pairs of pulse-related values and corresponding cuff pressure values are used for which the cuff pressure value is below the latest measured mean BP.
Pantelopoulos discloses systems and methods for estimating blood pressure using pulse transit time, wherein Pantelopoulos discloses performing directly consecutive partial inflations to gather a plurality of data points of blood pressure levels and corresponding pulse transit times [Another aspect of the disclosure relates to methods for calibrating a blood pressure measuring system including an inflatable cuff. The system also includes a calibration blood pressure device for measuring blood pressure, one or more sensors for measuring pulse transit time, a memory, and one or more processors. The method involves: (a) applying an external pressure to a person using the inflatable cuff; (b) obtaining a measurement of internal blood pressure of a person with the calibration blood pressure device, wherein the calibration blood pressure device does not rely on pulse transit time to measure the blood pressure; (c) obtaining a transmural blood pressure level from the measurement of internal blood pressure and the external pressure; (d) obtaining proximal pulse wave data and distal pulse wave data from the one or more sensors; (e) obtaining a pulse transit time using the proximal pulse wave data and the distal pulse wave data; (f) repeating (a)-(e) one or more times when applying one or more different external pressures, thereby obtaining two or more calibration data points corresponding to two or more transmural blood pressure levels and two or more pulse transit times; and (g) fitting a model to data points including the two or more calibration data points, wherein the model relates transmural blood pressure to pulse transit time (Pantelopoulos ¶0021); In some implementations, the process decides whether in the calibration data points have been collected. See block 410. If more calibration data points are necessary, the process loops back to block 402. The previous operations may be repeated one or more times to obtain one or more additional calibration data points. When enough calibration data points have been collected, the process proceeds to fit the model to the calibration data points. See block 412. The model relates blood pressure to PTT (Pantelopoulos ¶0138)].
Ogura discloses systems and methods for measuring blood pressure of a subject, wherein Ogura discloses performing repeated partial inflations and deflations using a pressure cuff, wherein Ogura discloses that in each repetition of a partial inflation the cuff is inflated up to a cuff pressure below a latest measured mean BP of the subject [a pressure changing device which increases the pressure of the cuff to a prescribed value lower than a mean blood pressure of the subject, and subsequently decreases the cuff pressure from the prescribed value, in each of a plurality of periodic cycles (Ogura Col 9:38-42); Since the rate of change .theta. is determined based on the data obtained while the cuff pressure P.sub.c is changed in a low pressure range from atmospheric pressure to the hold pressure P.sub.CH, the BP monitor operation of the apparatus 500 does not cause the subject to feel discomfort due to the pressing of the inflated cuff 510 (Ogura Col 46:29-34)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Banet to employ wherein the pressure-delivery system is controlled repeatedly inflate the cuff in directly consecutive partial inflations, wherein in each repetition of a partial inflation the cuff is inflated up to a cuff pressure equal to or below a latest measured mean BP of the subject; wherein the first and second time-dependent sensor signals are measured during the repeated directly consecutive partial inflations of the cuff, so as to gather additional data for relating the measured blood pressure to calculated pulse transit time at a pressure that does not cause discomfort to the subject, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [repeat steps to partially inflate the cuff to a non-discomforting pressure to obtain more data] [MPEP § 2143(I)(D)]. Based on the modification of Banet in view of Pantelopoulos and Ogura to employ wherein the partial inflations are to a cuff pressure below the latest measured mean BP of the subject [Ogura Col 9:38-42], the limitation “wherein, for computing the calibration parameter for the BP surrogate, only pairs of pulse-related values and corresponding cuff pressure values are used for which the cuff pressure value is below the latest measured mean BP” is considered to be rendered obvious, as all the measurements of the first and second time-dependent sensor signals used to compute the pulse-related values are considered to have been measured when the cuff pressure value was below the latest measured mean BP.
Regarding claim 14, Banet teaches
A method for calibrating a blood pressure, BP, surrogate for use in monitoring blood pressure of a subject, the method comprising:
- obtaining time-dependent cuff pressure values during inflation of a cuff of a pressure-delivery system attached to a body part of the subject [The cuff includes an air bladder which, when pressurized with a pneumatic system, applies a pressure 107 to an underlying artery 102, 102' (Banet ¶0061); This means calibration can be performed with a single, inflation-based measurement that typically takes between 40-60 seconds. At a recommended inflation rate (approximately 3-10 mmHg/second, and most preferably about 5 mmHg/second) this typically yields between 5-15 data points. These are the data points analyzed with the linear regression model to determine the patient-specific slope. Blood pressure values (SYS.sub.INDEX, MAP.sub.INDEX, and DIA.sub.INDEX) and the ratios between them (R.sub.SYS=SYS.sub.INDEX/MAP.sub.INDEX; R.sub.DIA=DIA.sub.INDEX/MAP.sub.INDEX) determined during the inflation-based measurement are also used in this calculation, and then for subsequent pressure-free measurements (Banet ¶0065); During an actual pressure-dependent indexing measurement, the body-worn monitor collects data like that shown in FIGS. 2A and 2B, for an individual patient. During a measurement, the microprocessor analyzes the variation between applied pressure and PTT, shown graphically in FIG. 2A, to estimate the relationship between blood pressure and PTT (Banet ¶0068), wherein the pneumatic system as operably coupled to the cuff applying a known pressure for the microprocessor to measure and analyze is considered to read on a pressure input as claimed];
- obtaining a BP measurement value [Banet ¶¶0065, 0068];
- measuring a first time-dependent sensor signal and a second time-dependent sensor signal, each related to a heartbeat of the subject and measured at different sites of the subject's a body of the subject during the inflation of the cuff [An electrical system featuring at least 3 electrodes coupled to an amplifier/filter circuit within cabling attached to the wrist-worn transceiver measures an ECG waveform 104, 104' from the patient. Three electrodes (two detecting positive and negative signals, and one serving as a ground) are typically required to detect the necessary signals to generate an ECG waveform with an adequate signal-to-noise ratio. At the same time, an optical system featuring a transmissive or, optionally, reflective optical sensor measures a PPG waveform 105, 105' featuring a series of `pulses`, each characterized by an amplitude of AMP.sub.1/2, from the patient's artery. The preferred measurement site is typically near small arteries in the patient's thumb, such as the princeps pollicis artery. A microprocessor and analog-to-digital converter within the wrist-worn transceiver detects and analyzes the ECG 104, 104' and PPG 105, 105' waveforms (Banet ¶0061)];
- controlling the pressure-delivery system to inflate the cuff [When this criterion is met the pump is automatically inflated, and the patient-specific slope is then determined as described above (Banet ¶0067); The Composite Method performs an indexing measurement once every 4-8 hours using inflation-based oscillometry. During the indexing measurement, a linear regression model is used to relate the pressure applied by the cuff to an `effective MAP` (referred to as MAP*(P) in FIG. 3A) representing a mean pressure in the patient's arm (Banet ¶0065); When an oscillometric measurement is rejected, a NULL value is returned, and the body-worn monitor instructs the pneumatic system to re-inflate the cuff, and the measurement is repeated (Banet ¶0084), wherein ¶0084 is cited to highlight the operative connection between the system of Banet and the cuff to automatically inflate the cuff to a determined level];
- computing pulse-related values from the first and second time-dependent sensor signals, measured during the inflation of the cuff, using a first feature in the first time-dependent sensor signal and a second feature in the second time-dependent sensor signal, the pulse-related values being pulse arrival time (PAT) values or pulse transit time (PTT) values [Banet ¶0061; During an actual pressure-dependent indexing measurement, the body-worn monitor collects data like that shown in FIGS. 2A and 2B, for an individual patient. During a measurement, the microprocessor analyzes the variation between applied pressure and PTT, shown graphically in FIG. 2A, to estimate the relationship between blood pressure and PTT (Banet ¶0068)];
- computing a calibration parameter for a BP surrogate from the BP measurement value and pairs of the pulse-related values and corresponding cuff pressure values, computed from the first and second time-dependent sensor signals measured during the inflation of the cuff, a pair comprising a pulse-related value and a corresponding, temporally related cuff pressure value of the same time instant [Using parameters such as heart rate and initial estimated blood pressure, the first pressure-dependent indexing measurement (step 182a) determines a relationship between PTT and blood pressure as described above. This measurement takes about 40 seconds, and may occur automatically (e.g., after about 1 minute), or may be driven by the medical professional (e.g., through a button press). The microprocessor then uses this relationship and a measured value of PTT to determine blood pressure during the following pressure-free measurement (step 181b). This measurement step typically proceeds for a well-defined period of time (e.g., 4-8 hours), during which it continuously determines blood pressure (Banet ¶0101), wherein the Examiner notes that the determined relationship between PTT and blood pressure is considered to read on the broadest reasonable interpretation of a “calibration parameter for a BP surrogate”, as the relationship is used to determine BP following pressure-free measurements of PTT]; and
calibrating the BP surrogate in accordance with the calibration parameter for monitoring the subjects' blood pressure [Banet ¶101, wherein the determined BP based on the relationship between BP and PTT and a measured PTT is considered to define the calibrated BP surrogate].
However, Banet fails to explicitly disclose controlling the pressure-delivery system to repeatedly inflate the cuff in directly consecutive partial inflations, wherein in each repetition of a partial inflation the cuff is inflated up to a cuff pressure below a latest measured mean BP of the subject; wherein the first and second time-dependent sensor signals are measured during the repeated directly consecutive partial inflations of the cuff; wherein, for computing the calibration parameter for the BP surrogate, only pairs of pulse-related values and corresponding cuff pressure values are used for which the cuff pressure value is below the latest measured mean BP.
Pantelopoulos discloses systems and methods for estimating blood pressure using pulse transit time, wherein Pantelopoulos discloses performing directly consecutive partial inflations to gather a plurality of data points of blood pressure levels and corresponding pulse transit times [Another aspect of the disclosure relates to methods for calibrating a blood pressure measuring system including an inflatable cuff. The system also includes a calibration blood pressure device for measuring blood pressure, one or more sensors for measuring pulse transit time, a memory, and one or more processors. The method involves: (a) applying an external pressure to a person using the inflatable cuff; (b) obtaining a measurement of internal blood pressure of a person with the calibration blood pressure device, wherein the calibration blood pressure device does not rely on pulse transit time to measure the blood pressure; (c) obtaining a transmural blood pressure level from the measurement of internal blood pressure and the external pressure; (d) obtaining proximal pulse wave data and distal pulse wave data from the one or more sensors; (e) obtaining a pulse transit time using the proximal pulse wave data and the distal pulse wave data; (f) repeating (a)-(e) one or more times when applying one or more different external pressures, thereby obtaining two or more calibration data points corresponding to two or more transmural blood pressure levels and two or more pulse transit times; and (g) fitting a model to data points including the two or more calibration data points, wherein the model relates transmural blood pressure to pulse transit time (Pantelopoulos ¶0021); In some implementations, the process decides whether in the calibration data points have been collected. See block 410. If more calibration data points are necessary, the process loops back to block 402. The previous operations may be repeated one or more times to obtain one or more additional calibration data points. When enough calibration data points have been collected, the process proceeds to fit the model to the calibration data points. See block 412. The model relates blood pressure to PTT (Pantelopoulos ¶0138)].
Ogura discloses systems and methods for measuring blood pressure of a subject, wherein Ogura discloses performing repeated partial inflations and deflations using a pressure cuff, wherein Ogura discloses that in each repetition of a partial inflation the cuff is inflated up to a cuff pressure below a latest measured mean BP of the subject [a pressure changing device which increases the pressure of the cuff to a prescribed value lower than a mean blood pressure of the subject, and subsequently decreases the cuff pressure from the prescribed value, in each of a plurality of periodic cycles (Ogura Col 9:38-42); Since the rate of change .theta. is determined based on the data obtained while the cuff pressure P.sub.c is changed in a low pressure range from atmospheric pressure to the hold pressure P.sub.CH, the BP monitor operation of the apparatus 500 does not cause the subject to feel discomfort due to the pressing of the inflated cuff 510 (Ogura Col 46:29-34)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Banet to employ wherein the pressure-delivery system is controlled repeatedly inflate the cuff in directly consecutive partial inflations, wherein in each repetition of a partial inflation the cuff is inflated up to a cuff pressure equal to or below a latest measured mean BP of the subject; wherein the first and second time-dependent sensor signals are measured during the repeated directly consecutive partial inflations of the cuff, so as to gather additional data for relating the measured blood pressure to calculated pulse transit time at a pressure that does not cause discomfort to the subject, and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [repeat steps to partially inflate the cuff to a non-discomforting pressure to obtain more data] [MPEP § 2143(I)(D)]. Based on the modification of Banet in view of Pantelopoulos and Ogura to employ wherein the partial inflations are to a cuff pressure below a latest measured mean BP of the subject [Ogura Col 9:38-42], the limitation “wherein, for computing the calibration parameter for the BP surrogate, only pairs of pulse-related values and corresponding cuff pressure values are used for which the cuff pressure value is below the latest measured mean BP” is considered to be rendered obvious, as all the measurements of the first and second time-dependent sensor signals used to compute the pulse-related values are considered to have been measured when the cuff pressure value was below the latest measured mean BP.
Regarding claim 15, Banet in view of Pantelopoulos and Ogura teaches
The method of claim 14.
However, Banet in view of Pantelopoulos and Ogura fails to explicitly disclose wherein the method as claimed in claim 14 may be employed as a non-transitory computer readable medium storing code that, when executed by a computer, causes the computer to carry out the method as claimed in claim 14.
Pantelopoulos discloses implementation of method steps as computer-executable instructions stored in memory [The functionality discussed herein may be provided using a number of different approaches. For example, in some implementations a processor may be controlled by computer-executable instructions stored in memory so as to provide functionality such as is described herein. In other implementations, such functionality may be provided in the form of an electrical circuit. In yet other implementations, such functionality may be provided by a processor or processors controlled by computer-executable instructions stored in a memory coupled with one or more specially-designed electrical circuits (Pantelopoulos ¶0162)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Banet in view of Pantelopoulos and Ogura as claimed in claim 14 to be employed as a non-transitory computer readable medium storing code that, when executed by a computer, causes the computer to carry out the method as claimed in claim 14, as this modification would amount to mere application of a known technique to a known device (method, or product) to yield predictable results [execute computer/processor related steps as computer-executable instructions stored in memory] [MPEP § 2143(I)(D)].
Regarding claim 17, Banet in view of Pantelopoulos and Ogura teaches
The device as claimed in claim 1, wherein the processing unit is configured to compute the control signal for controlling the pressure-delivery system to inflate the cuff in the partial inflations at an inflation speed dependent on one or more of a heart rate, a diastolic BP, a mean BP, and a systolic BP of the subject [Banet ¶0065, wherein the inflation being at a rate defined by Banet as being a recommended rate to result in a “unique” set of MAP*(P)/PTT paired data points that may be extracted for each heartbeat as the applied pressure ramps from DIA to SYS, the inflation rate is considered to be based on one or more of heart rate, diastolic BP, and systolic BP].
Regarding claim 18, Banet in view of Pantelopoulos and Ogura teaches
The device as claimed in claim 1,
wherein the processing unit is configured to:
compute the control signal for controlling the pressure-delivery system to deflate the cuff after each iteration of a partial inflation [See § 103 modification of claim 1 above; Ogura Col 9:38-42], and
compute one or more calibration parameters from pairs of pulse-related values and corresponding cuff pressure values obtained in two or more iterations in a single regression [Banet ¶0065; wherein based on the § 103 modification of claim 1 above, as Banet ¶0065 discloses the use of a single regression using a plurality of data points, the data points may be considered to come from the iterative partial inflations].
Regarding claim 19, Banet in view of Pantelopoulos and Ogura teaches
The device as claimed in claim 1,
wherein the processing unit is configured control when a full inflation of the cuff is conducted according to a fixed schedule or a variable schedule [The Composite Method performs an indexing measurement once every 4-8 hours (Banet ¶0065)], or according to when one or more calibration parameters changed by more than 10 percent in a last computation.
Claim(s) 2-3, 10, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banet in view of Pantelopoulos, as applied to claims 1 and 14 above, in further view of Donehoo (US-20100249616-A1, previously presented).
Regarding claim 3 [written in longhand format to include the subject matter of claim 2, from which claim 3 depends from, therein], Banet in view of Pantelopoulos and Ogura teaches
The device as claimed in claim 1.
However, Banet in view of Pantelopoulos and Ogura fails to explicitly disclose wherein the processing unit is configured to compute the control signal for controlling the pressure-delivery system to inflate the cuff in the partial inflations as long as a peripheral BP varies by less than 10 percent; and wherein the processing unit is configured to determine when the peripheral BP is substantially constant based on the first time-dependent sensor signal and/or the second time-dependent sensor signal by determining a period during which an amplitude of the second time-dependent signal varies by less than 10 percent with respect to a previously acquired average value.
Donehoo discloses systems and methods for determining blood pressure, wherein Donehoo discloses that a level of inflation of a cuff affects a peripherally measured pulse waveform, and wherein the cuff is inflated while the peripherally measured pulse waveform is substantially constant and deflated when the peripherally measured pulse waveform is no longer substantially constant [Referring back to FIG. 3, the plethysmograph waveform 60 includes a series of pulses 62 that each represent a beat of the patient's heart. In the graph of FIG. 3, the waveform 60 is illustrated as the blood pressure cuff on the patient is inflated to ultimately occlude the brachial artery. The occlusion of the brachial artery occurs following the final pulse 63 of FIG. 3. After the final pulse 63, the waveform 60 falls dramatically and no additional pulses 62 are detected. No additional pulses are detected since the brachial artery has been fully occluded and no additional blood flow reaches the finger probe sensor of the pulse monitor. FIG. 3 further illustrates an acceleration waveform 65 which is a second derivative of the plethysmograph waveform 60. The acceleration waveform 65 includes a series of acceleration peaks 66 that each correspond to the rapidly rising portion of the plethysmograph waveform 60 that occurs at the beginning of each of the pulses 62. The individual peaks 66 of the acceleration waveform 65 occur at the same frequency as the patient's heart rate, as clearly illustrated in FIG. 3. When the blood pressure cuff begins to occlude the brachial artery, the pulses 62 begin to disappear following the final pulse 63. Since the pulses 62 disappear after the complete occlusion of the brachial artery, the acceleration waveform flattens out after the final acceleration peak 68. The flattened portion of the acceleration signal 65 is shown by reference numeral 72. The flattened portion 72 indicates that the brachial artery has been fully occluded by the blood pressure cuff, indicating that the NIBP monitoring system has inflated the blood pressure cuff above the systolic pressure for the patient and that no further inflation is needed (Donehoo ¶¶0031-0033, Fig. 3), wherein the finger probe sensor of the pulse monitor of Donehoo is considered to be equivalent to the instantly claimed second time-dependent sensor and the PPG sensor as positioned at the patient’s thumb of Banet (Banet ¶0061), and wherein the Examiner notes that as depicted in Donehoo Fig. 3, the pulses 62 and acceleration waveform 65 are each considered to vary to a non-particular degree prior to inflation of the cuff to the patient’s systolic pressure, and significantly vary (begin to disappear/flatten out) upon occlusion of the patient’s brachial artery upon inflation of the cuff beyond the patient’s systolic pressure].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Banet in view of Pantelopoulos and Ogura to employ wherein the processing unit is configured to compute the control signal for controlling the pressure-delivery system to inflate its cuff in the partial inflations as long as a peripheral BP is substantially constant, wherein the processing unit is configured to determine if the peripheral BP is substantially constant based on the first and/or second time-dependent sensor signal, in particular by determining the period during which an amplitude of the second time-dependent signal is substantially constant, in particular varies by less than a predetermined amount with respect to a previously acquired average value, as the level of inflation prior to the level of the patient’s systolic pressure allows for generally constant measurable peripheral pulse waves for additional analysis, and at the level of inflation above the patient’s systolic pressure, blood flow is occluded from reaching the area of the second time-dependent signal to prevent measurable peripheral pulse waves.
However, while the level of inflation of the cuff is considered to be a result effective variable [Donehoo ¶¶0031-0033, wherein the level of inflation of the cuff results in a measurable level of peripheral pulse waves] and as depicted in Donehoo Fig. 3, the level of inflation of the cuff results past the patient’s systolic pressure results in measurable peripheral pulse waves varying by an non-particular degree, Banet in view of Pantelopoulos, Ogura, and Donehoo fails to explicitly disclose wherein the peripheral BP being substantially constant refers to the peripheral BP varying by less than 10 percent, and wherein the amplitude of the second time-dependent sensor signal being substantially constant refers to the amplitude of the second time-dependent signal varying by less than 10 percent with respect to a previously acquired average value.
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454 456, 105 USPQ 233 235 (CCPA 1955); MPEP § 2144.05(II). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the monitored variation in each of the peripheral BP and amplitude of the second time-dependent signal.
“The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims… [I]n such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575 1578 (Fed. Cir. 1990). Criticality is shown by some noticeable difference in the qualities. In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933). Nothing in the specification leads one of ordinary skill in the art to understand that the range(s) recited in claims 2-3 is/are somehow ‘critical’ or lead to unexpected results [Applicant’s Specification p. 4:14-22, wherein the Applicant notes that other reasonable values may be used].
Regarding claim 10, Banet in view of Pantelopoulos and Ogura teaches
The device as claimed in claim 1.
However, while Banet in view of Pantelopoulos and Ogura discloses inflating the cuff to obtain a time-dependent BP reference measurement for use in monitoring the subject’s BP using the BP surrogate [Banet ¶¶0065, 0101; See § 103 modification of claim 1 above, wherein iterations of the partial inflation are performed], Banet in view of Pantelopoulos and Ogura fails to explicitly disclose wherein the processing unit is configured to compute the control signal for controlling the pressure-delivery system to inflate the cuff in a full inflation beyond the subject' a systolic BP of the subject before and/or after one or more iterations of partial inflation to obtain a time-dependent BP reference measurement for use in monitoring the subject's BP using the BP surrogate.
Donehoo discloses systems and methods for determining blood pressure, wherein a full inflation is performed to allow for measurement of a subject’s mean arterial pressure, systolic blood pressure, and diastolic blood pressure [During normal operation of the NIBP monitoring system 10 shown in FIG. 1, the blood pressure cuff 12 is initially placed on the patient 16, typically around the subject's upper arm 14 over the brachial artery. At the inception of the measuring cycle, the blood pressure cuff 12 is inflated to a target inflation pressure that fully occludes the brachial artery, i.e., prevents blood from flowing through the brachial artery at any time in the heart cycle. In FIG. 2, the target inflation pressure is illustrated by reference number 40 (Donehoo ¶0022, Fig. 2); As the cuff pressure decreases from the initial inflation pressure, the NIBP monitoring system detects the cuff pressure oscillations 44 and records the pressure oscillation amplitudes for the current cuff pressure. The central processor within the NIBP monitoring system can then calculate the MAP 46, systolic pressure 48 and diastolic pressure 50 (Donehoo ¶0025)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Banet in view of Pantelopoulos and Ogura to employ wherein the processing unit is configured to compute the control signal for controlling the pressure-delivery system to inflate the cuff in a full inflation beyond the subject' a systolic BP of the subject before and/or after one or more iterations of partial inflation to obtain a time-dependent BP reference measurement for use in monitoring the subject's BP using the BP surrogate, as this modification would amount to mere application of a known technique to a known device (method, or product) to yield predictable results [enable determination of mean arterial pressure, systolic pressure, and diastolic pressure] [MPEP § 2143(I)(D)].
Regarding claim 20, Banet in view of Pantelopoulos and Ogura teaches
The method as claimed in claim 14.
However, Banet in view of Pantelopoulos and Ogura fails to explicitly disclose wherein the pressure-delivery system is controlled to inflate the cuff in the partial inflations as long as a peripheral BP varies by less than 5 percent.
Donehoo discloses systems and methods for determining blood pressure, wherein Donehoo discloses that a level of inflation of a cuff affects a peripherally measured pulse waveform, and wherein the cuff is inflated while the peripherally measured pulse waveform is substantially constant and deflated when the peripherally measured pulse waveform is no longer substantially constant [Donehoo ¶¶0031-0033].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Banet in view of Pantelopoulos and Ogura to employ wherein the pressure-delivery system is controlled to inflate the cuff in the partial inflations as long as a peripheral BP is substantially constant, as the level of inflation prior to the level of the patient’s systolic pressure allows for generally constant measurable peripheral pulse waves for additional analysis, and at the level of inflation above the patient’s systolic pressure, blood flow is occluded from reaching the area of the second time-dependent signal to prevent measurable peripheral pulse waves.
However, while the level of inflation of the cuff is considered to be a result effective variable [Donehoo ¶¶0031-0033, wherein the level of inflation of the cuff results in a measurable level of peripheral pulse waves] and as depicted in Donehoo Fig. 3, the level of inflation of the cuff results past the patient’s systolic pressure results in measurable peripheral pulse waves varying by an non-particular degree, Banet in view of Pantelopoulos, Ogura, and Donehoo fails to explicitly disclose wherein peripheral BP being substantially constant refers to varying by less than 5 percent.
“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454 456, 105 USPQ 233 235 (CCPA 1955); MPEP § 2144.05(II). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the monitored variation in the peripheral BP.
“The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims… [I]n such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575 1578 (Fed. Cir. 1990). Criticality is shown by some noticeable difference in the qualities. In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933). Nothing in the specification leads one of ordinary skill in the art to understand that the range(s) recited in claim 20 is/are somehow ‘critical’ or lead to unexpected results [Applicant’s Specification p. 4:14-22, wherein the Applicant notes that other reasonable values may be used].
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banet in view of Pantelopoulos and Ogura, as evidenced by McCombie (US-20160143546-A1, previously presented).
Regarding claim 5, Banet in view of Pantelopoulos and Ogura teaches
The device as claimed in claim 1.
However, Banet in view of Pantelopoulos and Ogura fails to explicitly disclose calibrating the BP surrogate based on a PAT, such that the combination fails to explicitly disclose wherein the processing unit is configured to compute the control signal for controlling the pressure-delivery system to inflate the cuff in the partial inflations up to a cuff pressure at which the PAT exceeds an absolute PAT threshold or a relative PAT threshold compared to a baseline PAT.
McCombie discloses systems and methods for calibrating a blood pressure, BP, surrogate for use in monitoring a subject’s blood pressure based on a pulse arrival time [To account for patient-dependent properties, such as arterial compliance, pulse pressure wave-based measurements of blood pressure are typically ‘calibrated’ using a conventional blood pressure cuff. Typically during the calibration process the blood pressure cuff is applied to the patient, used to make one or more blood pressure measurements, and then left on the patient. Going forward, the calibration blood pressure measurements are used, along with a change in PTT or PWV to determine the patient's blood pressure and blood pressure variability (McCombie ¶0006); The inflatable cuff is configured to cover a portion of the vascular path of length (L.sub.c), and transmit to the processing component a waveform indicative of cuff pressure on the patient's extremity during inflation. The processing component calculates a series of PAT as a function of cuff pressure during inflation of the inflatable cuff to above the patient's systolic blood pressure, wherein the inflation causes a compliance change in the vascular path of length L.sub.c, thereby causing the PAT measured by the sensor device to lengthen as cuff pressure is increased (McCombie ¶0012); determining using the processing component one or more coefficients which relate PWV to mean arterial pressure (MAP) by modeling the series of PATs measured as a function of cuff pressure as a nonlinear relationship (McCombie ¶0015)], wherein McCombie identifies pulse transit time as a physical property of the cardiac cycle [the PAT defined as a time difference between ventricular depolarization occurring in a cardiac cycle, and arrival of a pressure wave at the first point resulting from blood flow caused by the ventricular depolarization through a vascular path of length (L.sub.t) (McCombie ¶0015)].
As such, as Banet in view of Pantelopoulos and Ogura teaches wherein the processing unit is configured to compute the control signal for controlling the pressure-delivery system to inflate its cuff in the partial inflations up to a cuff pressure [Banet ¶¶0061, 0065; Pantelopoulos ¶¶0021, 0138; Ogura Col 9:38-42; See § 103 modification above], each cuff pressure is considered to be a cuff pressure at which a PAT may exceed any non-particular, undefined relative PAT threshold as compared to a baseline PAT.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banet in view of Pantelopoulos and Ogura, as evidenced by McCombie, as applied to claim 5 above, in further view of McCombie.
Regarding claim 6, Banet in view of Pantelopoulos and Ogura, as evidenced by McCombie, teaches
The device as claimed in claim 5.
However, Banet in view of Pantelopoulos and Ogura fails to explicitly disclose wherein the processing unit is configured to compute the baseline PAT by averaging PAT measurements over a period in the range of 10 s to 5 min.
McCombie discloses systems and methods for calibrating a blood pressure, BP, surrogate for use in monitoring a subject’s blood pressure based on a pulse arrival time [McCombie ¶¶0006, 0012, 0015], wherein McCombie discloses determining a baseline PAT for determining the BP surrogate [In certain embodiments, the processing component can determine a baseline pulse arrival time (PAT.sub.cal) from the first and second time-dependent waveforms indicative of one or more contractile properties of the patient's heart obtained in the absence of pressure being applied by the inflatable cuff device, and a systolic pressure (SYS.sub.cal), diastolic pressure (DIA.sub.cal), and mean arterial pressure (MAP.sub.cal) from the waveform indicative of cuff pressure on the patient's extremity obtained during inflation (McCombie ¶0017)].
Banet does disclose averaging PTT measurements over a period, in particular a period in the range of 10 s to 5 min [In embodiments, the indexing measurement is performed once every 4 hours or more, and a PTT-based cNIBP measurement is performed once every 1 second or less. Typically, PTT values are averaged from a set of values collected over a time period between, typically ranging from 10 to 120 seconds. The average is typically a `rolling average` so that a new value, determined over the averaging period, can be displayed relatively frequently (e.g. every second) (Banet ¶0018)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Banet in view of Pantelopoulos and Ogura, as evidenced by McCombie, so as to employ wherein the processing unit is configured to compute the baseline PAT by averaging PAT measurements over a period in the range of 10 s to 5 min, as PAT is considered to be indicative of blood pressure, and as this modification would amount to mere application of a known technique to a known device (method, or product) to yield predictable results [apply statistical techniques to data to obtain statistical information] [MPEP § 2143(I)(D)].
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banet in view of Pantelopoulos and Ogura, as applied to claim 1 above, in further view of McCombie (US-20160143546-A1, previously presented).
Regarding claim 16, Banet in view of Pantelopoulos and Ogura teaches
The device as claimed in claim 1.
However, Banet in view of Pantelopoulos and Ogura fails to explicitly disclose wherein, for computing the pulse-related values from the first and second time-dependent sensor signals, the pulse-related values are PAT values.
McCombie discloses systems and methods for calibrating a BP surrogate for use in monitoring a subject’s blood pressure based on a pulse arrival time [McCombie ¶0006, 0012, 0015].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Banet in view of Pantelopoulos to employ wherein, for computing the pulse-related values from the first and second time-dependent sensor signals, the pulse-related values are PAT values, as this modification would amount to mere application of a known technique to a known device (method or product) ready for improvement to yield predictable results [use of PAT to calibrate a BP surrogate] [MPEP § 2143(I)(D)].
Response to Arguments
Applicant's arguments, see Applicant’s Remarks p. 11, filed 24 August 2026, with respect to the previously presented Specification Objections have been fully considered but they are not entirely persuasive.
The objection to the abstract has been overcome and withdrawn.
Regarding the previously presented objection to the Specification regarding new matter, the Applicant asserts that the “Cross-Reference to Prior Applications” cannot add new matter because the present application claims the benefit of the previous applications, and therefore contains the identical subject matter, such that the amended “Cross-Reference to Prior Applications” does not make substantive changes to the present application that can be considered new matter. The Applicant further notes that the “Cross-Reference to Prior Applications” is encouraged practice to provide clarity and to ensure that any inadvertently omitted material from the PCT application is incorporated by reference under 37 CFR 1.57(b) back to the appropriate priority date. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that the previously presented objection is not directed towards the entire cited portion of the Specification, but specifically the language that incorporates the foreign application by reference. The Examiner further notes that as the Applicant has a valid priority claim, the incorporation by reference for inadvertently omitted subject matter is applicable; however, the amendment to the Specification is a blanket incorporation which is potentially more than what was inadvertently omitted and is thus ineffective.
Applicant’s arguments, see Applicant’s Remarks p. 11, with respect to the claim objections have been fully considered and are persuasive. The objections to claims 1-15 have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 12, with respect to the previously presented claim interpretations have been fully considered and are persuasive. The claim interpretation regarding intended use has been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 12, with respect to the previously applied rejections under § 112(b) have been fully considered and are persuasive. The rejections of claims 2-3, 9, and 13 under § 112(b) have been withdrawn.
Applicant's arguments, see Applicant’s Remarks p. 13-22, with respect to the previously applied rejections under § 101 have been fully considered but they are not persuasive.
Regarding Step 2A Prong 1, the Applicant asserts that the amended claims necessarily incorporate actual measurements, signal processing responsive to measurements, and automated control that cannot be practically performed in the human mind in light of the amendments to the BP input measuring time-dependent cuff pressure values, sensor input measuring first and second time-dependent sensor signals, and processing unit controlling the pressure delivery system. The Examiner acknowledges the amendments to claims 1, 13, and 14 to positively recite performing actual measurements and automated control, which the Examiner notes at Step 2A Prong 1 are not considered to be directed towards mental processes. However, the Examiner notes that each argued element is still further analyzed under Step 2A Prong 2 and Step 2B, and further that while the signal processing responsive to measurements is recited as being performed by a processing unit of a device in claim 1, such language is considered to merely implement an abstract idea on a generic computer [MPEP § 2106.05(d)(II) establishes computer-based elements which are considered to be well understood, routine, and conventional when recited at a high level of generality].
Furthermore, regarding the identified mathematical concepts, the Applicant asserts that claim 1 does not expressly recite any mathematical relationships, mathematical formulas or equations, or mathematical calculations, and the recitations at most are arguably based on or involve mathematical concepts, but do not recite the mathematical concepts themselves. However, the Examiner notes that the argued analysis at Step 2A Prong 1 was noted as being in addition to or in the alternative to the previous analysis that still identified the argued limitations as being directed towards mental processes regardless of the implicit use of mathematical formulas.
Regarding Step 2A Prong 2, the Applicant asserts that any potential abstract idea recited in claim 1 is incorporated into at least the practical application of using a BP input to measure-time dependent cuff pressure values, using a sensor input to measure first and second time-dependent sensor signals, controlling the pressure delivery system, computing a calibration parameter, and calibrating the BP surrogate in accordance with the calibration parameter for monitoring the subject’s blood pressure. However, the Examiner disagrees with the Applicant’s argument, as the Examiner notes that based on the Step 2A Prong 2 analysis, the use of a BP input and sensor input as claimed is considered to be extra-solution activity of pre-solution data gathering as a necessary precursor for the mental analyses, such that the BP input and the sensor input fail to integrate the abstract idea into a practical application. Furthermore, the processing unit functions to compute a calibration parameter and calibrate the BP surrogate were previously identified as being directed towards abstract ideas of mental processes, such that these limitations are not further considered at Step 2A Prong 2. The limitation of controlling the pressure delivery system, while not specifically being an extra-solution activity at Step 2A Prong 2, is further analyzed at Step 2B, wherein the limitation is considered to be well-understood, routine, and conventional activity based on the Applicant’s disclosure and cited references.
The Applicant further asserts that the claimed process is an improvement to the technical field of medical testing and diagnosis, specifically non-invasive blood pressure measuring systems, wherein the technical problem addressed by the claimed process is inherent inaccuracies in determining blood pressure values using conventional non-invasive blood pressure measuring systems, as well as the need for accurate calibration [Applicant’s Specification p. 1:14-22, 2:3-6, 18-19, 12:1-2]. The Applicant also notes that in the claims, a computer-implemented method is employed to improve calibration of a BP surrogate used for non-invasive blood pressure monitoring, thus defining an improvement to computer functionality [Applicant emphasizes Ex Parte Desjardins]. Regarding Step 2B, the Applicant asserts that the claims amount to significantly more than the abstract idea itself, based on the improvements as discussed in the Applicant’s remarks with respect to the Step 2A Prong 2 analysis. The claimed invention is not considered to be patent eligible under 35 U.S.C. 101, as while the Applicant asserts that the claimed invention is for improving “other technology or technical field”, the improvement is recited within limitations that have been identified as being abstract ideas implemented on a generic computer with additional elements that are considered to be well-understood, routine, and conventional. The “improvements” are not considered to be additional elements, as the computation of a calibration parameter for a BP surrogate and calibration of the BP surrogate for monitoring the subject’s blood pressure are identified as being abstract ideas. As such, under MPEP 2106.05(a), "an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology". Specifically, the "improvements" analysis in Step 2A determines whether the claim pertains to an improvement to the functioning of a computer or to another technology without reference to what is well-understood, routine, conventional activity [MPEP § 2106.04(d)(1)]. It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception [MPEP § 2106.05(a)]. As such, the claims do not recite additional elements that may integrate the abstract ideas into a practical application of the abstract ideas, and thus the claimed invention is not considered to improve other technology or technical field. In light of the December 5, 2025 memo, the Examiner notes that revised MPEP § 2106.04(d)(1) recites “In short, first the specification should be evaluated to determine if the disclosure provides sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement in the functioning of a computer, or an improvement to other technology or a technical field… Conversely, if the specification explicitly sets forth an improvement but only in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine that the claim improves technology or a technical field. Second, if the specification sets forth an improvement in technology or a technical field, the claim must be evaluated to ensure that the claim itself reflects the disclosed improvement… See, e.g., Ex Parte Desjardins, Appeal No. 2024-000567 (PTAB September 26, 2025, Appeals Review Panel Decision) (precedential), in which the specification identified the improvement to machine learning technology by explaining how the machine learning model is trained to learn new tasks while protecting knowledge about 2 previous tasks to overcome the problem of “catastrophic forgetting,” and that the claims reflected the improvement identified in the specification. Indeed, enumerated improvements identified in the Desjardins specification included disclosures of the effective learning of new tasks in succession in connection with specifically protecting knowledge concerning previously accomplished tasks; allowing the system to reduce use of storage capacity; and the enablement of reduced complexity in the system. Such improvements were tantamount to how the machine learning model itself would function in operation and therefore not subsumed in the identified mathematical calculation.” As such, the Examiner notes that the Applicant’s arguments related to the Applicant’s noted improvements [the computation of a calibration parameter for a BP surrogate and calibrating the BP surrogate for the purposes of non-invasive blood pressure monitoring (Applicant’s Specification p. 1:14-22, 2:3-6, 18-19, 12:1-2)] are not considered to be directed towards the functioning of a computer or technology and are considered conclusory, as the Applicant fails to provide necessary details as to how the alleged improvement improves the functioning of a computer or technology [the Examiner notes that in a similar fashion to the improvements analysis outlined above, the computation of the calibration parameter and calibration of the BP surrogate is/are directed to analysis considered to be embodied in representative claim 13 as a judicial exception of an abstract idea that may be performed in the mind or by hand, as the computation and calibration may be performed by merely applying known or derived mathematical formulas/equations or employ known relationships/correlations on at least a limited amount of data and drawing mental conclusions therefrom under no particular time constraints].
Applicant's arguments, see Applicant’s Remarks p. 22, with respect to the previously applied provisional rejections under Non-Statutory Double Patenting have been fully considered but they are not persuasive.
The Applicant requests withdrawal of the obviousness-type double patenting rejections of claims 1 and 12-15, as the Applicant submits that the rejection is premature as the Examiner has not indicated that all claims would be allowable if Applicants submits a Terminal Disclaimer, and as the Examiner has presented additional rejections [§ 103] that would not be overcome by merely filing the Terminal Disclaimer. However, the Examiner notes that the provisional non-statutory double patenting rejections will be maintained until patentable subject matter is identified in either the instant or co-pending applications.
Applicant’s arguments, see Applicant’s Remarks p. 22-25, with respect to the rejection(s) of claim(s) 1, 14, and those dependent therefrom under § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Banet (US-20100160798-A1, cited by Applicant, previously presented) in view of Pantelopoulos (US-20170209053-A1, previously presented) and Ogura (US-5649536-A).
The Applicant asserts that there is no disclosure in Banet that mentions inflating the cuff to a pressure that is specifically equal to or below a certain blood pressure, or that the certain blood pressure is specifically the subject’s latest measured mean blood pressure, as recited in claim 1. The Applicant further asserts that in light of the amendment to claim 1 to recite “wherein for computing the calibration parameter for the BP surrogate, only pairs of pulse-related values and corresponding cuff pressure values are used for which the cuff pressure value is below the latest measured mean BP”, the reliance of Pantelopoulos for the proposition of repeatedly inflating the cuff in directly consecutive partial inflations, wherein in each repetition of a partial inflation the cuff is inflated up to a cuff pressure equal to or below a latest measured mean BP of the subject [Pantelopoulos ¶¶0021, 0138] is not sufficient to teach limiting the repeated inflations to pressures below the latest mean BP, or computing the calibration parameter for the BP surrogate using only pairs of pulse-related values and corresponding cuff pressure values for which the cuff pressure value is below the latest measured mean BP, or computing the calibration parameter for the BP surrogate using only pairs of pulse-related values and corresponding cuff pressure values for which the cuff pressure value is below the latest measured mean BP, as amended in claim 1, as the Applicant notes that the cited portions of Pantelopoulos teach merely repeating measurements at “different external pressures” to generate additional calibration points [Pantelopoulos ¶0021], which is a broader set of pressure levels, generally, and fails to restrict the calibration procedure to a low-pressure subset of the latest measured mean BP. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1, 13, and 14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Banet is presently modified in view of Pantelopoulos and Ogura (US-5649536-A), wherein the Examiner notes that Ogura is relied upon regarding the argued subject matter of inflating the cuff to a pressure that is specifically equal to or below a certain blood pressure, or that the certain blood pressure is specifically the subject’s latest measured mean blood pressure [Ogura Col 9:38-42, 46:29-34].
The Applicant also asserts that the proposed combination of Banet in view of Pantelopoulos is improper in that there is no rational basis for combining the respective teachings, and no reasonable expectation of success in doing so, as the Applicant notes that Banet discloses performing a single inflation-based measurement [Banet ¶¶0065, 0108], such that there is no rational basis for combining the teaching of Pantelopoulos of repeating the blood pressure measurements at different pressures, as the repeated cuff inflations would change the principle operation of Banet. However, in response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the Examiner notes that Pantelopoulos is relied upon to provide the motivation to modify Banet, as Pantelopoulos discloses repeating the partial inflations in order to measure a sufficient amount of data points to relate the measured BP and a calculated PTT [Pantelopoulos ¶0138].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
