DETAILED ACTION
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 information disclosure statement filed 26 April 2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because 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 abstract of the disclosure is objected to because the abstract exceeds 150 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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”, see emphasized portion]. 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.
Appropriate correction is required.
Claim Objections
Claim(s) 1-15 is/are objected to because of the following informalities:
Claim 1 should read “A device” [line 1] and claims 2-12 should each read “The device” [line 1 in each of claims 2-12]; claim 13 should read “A [line 1]; claim 14 should read “A [line 1]; claim 15 should read “A [line 1], wherein the Examiner directs attention to MPEP § 608.01(IV) regarding claim format.
Claim 2 should read “[[its]] the cuff of the pressure-delivery system” [lines 3]. The Examiner notes that claims 4 [line 3], 5 [line 3], 7 [line 3], 8 [line 3], 9 [lines 3-4], and 10 [line 3] each similar subject matter that is objected to mutatis mutandis.
Claim 15 should read “A non-transitory computer-readable medium having stored therein a program for causing a computer to carry out the steps of the method as claimed in claim 14 when said computer program is carried out on the computer” [lines 1-3] to avoid a claim to a signal per se [see Applicant’s Specification p. 3:20-22 regarding written description support for the proposed amendment].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
Examiner Notes Regarding Intended Use Limitations: Claim 1 recites the limitation(s) “compute a control signal for controlling the pressure-delivery system to repeatedly inflate its 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 the subject’s mean BP” [lines 10-12, see emphasized portion], which is considered to define an intended use of the computed control signal, wherein the Examiner notes that as the pressure-delivery system and cuff are each also not positively recited [See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"), wherein the Examiner notes that while the cited portion of the MPEP is directed towards the preamble, the cited portion is similarly applicable to ; To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim (MPEP § 2111.02(II))]. The Examiner notes that claims 2-10 and 14 recite similar intended use limitations for controlling a/the pressure-delivery system, which are similarly interpreted as intended use(s) of the corresponding control signal of each claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 2-3, 9, and 13 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance: claim 2 recites the broad recitation “by less than 10 percent” [line 4], and the claim also recites “less than 5 percent” [line 4] which is the narrower statement of the range/limitation; claim 3 recites the broad recitation “by less than 10 percent” [line 5], and the claim also recites “less than 5 percent” [line 5] which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 9 recites the limitation “the two or more iterations” [lines 7-8 and 10], which is considered to lack antecedent basis, as claims 1 and 9 fail to specifically recite that the iteration comprises two or more iterations. For examination purposes, the Examiner has interpreted the limitation lacking antecedent basis to further limit the amount of repeated partial inflations as recited in claim 1.
Claim 13 recites the limitation “the subject’s body part” [lines 3-4], which is considered to lack antecedent basis, as claim 13 fails to previously define a subject’s body part. The Examiner notes that due to the order of the limitations of claim 13, the device of claim 1, which may provide antecedent basis for a subject’s body part [claim 1, line 4], is not recited prior to the recitation of the limitation lacking antecedent basis. For examination purposes, the Examiner has interpreted the subject’s body part to refer to the subject’s body part as recited in claim 1.
Claim 13 recites the limitation “a cuff of the pressure-delivery system attached to the subject’s body” [line 6], which is considered indefinite, as it is not clear whether the recited cuff of the pressure-delivery system is meant to be different from the previously recited cuff configured to be attached to the subject’s body part of the pressure-delivery system [lines 3-4] or not. For examination purposes, the Examiner has interpreted the indefinite limitation to read “[[a]] the cuff of the pressure-delivery system”.
Examiner’s Note Regarding Subjective and Relative Terminology: The Examiner notes that claims 2, 3, and 11 recite language [“substantially constant” in claims 2-3; “substantially changed” in claim 11], however each identified claim is considered to recite language within each respective claim that provides a standard for ascertaining the requisite degree, such that one of ordinary skill in the art would be reasonably be apprised of the scope of the invention.
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) 1-15 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) 1 [representing all independent claims] recite(s):
Device for calibrating a blood pressure, BP, surrogate for use in monitoring a subject’s blood pressure, the device comprising:
a BP input 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 a BP measurement value;
a sensor input configured to obtain a first time-dependent sensor signal and a second time-dependent sensor signal, both related to the subject’s heartbeat and measured at different sites of the subject’s body during the inflation of the cuff; and
a processing unit configured to:
- compute a control signal for controlling the pressure-delivery system to repeatedly inflate its 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 the subject’s mean BP,
- 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, and
- 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.
(Emphasis added: abstract idea, additional element)
Step 2A Prong 1
Representative claim(s) 1 recites the following abstract ideas, which may be performed in the mind or by hand with the assistance of pen and paper:
“obtain time-dependent cuff pressure values during inflation of a cuff of a pressure-delivery system attached to a subject’s body part and a BP measurement value” – may be performed by merely observing known or previously collected data; wherein the Examiner notes that the limitation as recited fails to positively recite “a cuff of a pressure-delivery system attached to a subject’s body part” or a step of measuring a time-dependent cuff pressure values or blood pressure to define a data gathering step, such that the values being defined as “values during inflation of a cuff of a pressure-delivery system attached to a subject’s body part” merely define the type of data observed/collected
“obtain a first time-dependent sensor signal and a second time-dependent sensor signal, both related to the subject’s heartbeat and measured at different sites of the subject’s body during the inflation of the cuff” – may be performed by merely observing known or previously collected data; wherein the Examiner notes that the limitation as recited fails to positively recite a step of measuring a first time-dependent sensor signal or a second time-dependent sensor signal to define a data gathering step, such that the sensor signals being defined as “related to the subject’s heartbeat and measured at different sites of the subject’s body during the inflation of the cuff” merely define the type of data observed/collected
“compute a control signal for controlling the pressure-delivery system to repeatedly inflate its 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 the subject’s mean BP” – may be performed by merely performing known or derived mathematical formula/equations using at least a limited amount of data under no particular time constraints [see Applicant’s Specification p. 8:7-10, wherein the Examiner notes that the computed signal is not recited as having any particular form beyond a value or level of inflation]; wherein the Examiner notes that the recitation “for controlling the pressure-delivery system to repeatedly inflate its 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 the subject’s mean BP” does not positively recite a step of controlling the [also not positively recited] pressure-delivery system, such that the identified recitation is considered to define an intended use of the computed control signal; however, for the sake of compact prosecution the Examiner notes that similar claim language directed towards use of the pressure-delivery system as claimed is considered at Step 2B below, such that use of a cuff as recited in claim 1 would be rejected for similar reasons
“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 performing 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” fails to positively recite a step of measuring the first time-dependent sensor signal or the second time-dependent sensor signal to define a data gathering step, such that the sensor signals being defined as “measured during the repeated directly consecutive partial inflations of the cuff” merely define 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” – may be performed by merely performing known or derived mathematical formula/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]
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”, “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”] 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 2A Prong 2
The judicial exception is not integrated into a practical application.
Representative claim 1 only recites additional elements of extra-solutionary activity – in particular, extra-solution activity [generic computer function] – without further sufficient detail that would tie the abstract portions of the claim into a specific practical application (2019 PEG p. 55 – the instant claim, for example does not tie into a particular machine, a sufficiently particular form of data or signal collection – via the claimed extra-solution activity, or a sufficiently particular form of display or computing architecture/structure).
Dependent claim(s) 2-12 merely add detail to the abstract portions of the claim but do not otherwise encompass any additional elements which tie the claim(s) into a particular application/integration [the dependent claim(s) recite generic ‘units’ of ‘steps’ which encompass mere computer instructions to carry out an otherwise wholly abstract idea].
Dependent claim(s) 15 encounter substantially the same issues as the independent claim(s) from which they depend in that they encompass further generic extra-solutionary activity [generic data gathering] and/or generic computer elements [storage, memory per se].
Accordingly, the claim(s) are not integrated into a practical application under Step 2A Prong 2.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Independent claims 1 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] and generic computer elements cannot amount to significantly more than an abstract idea [MPEP § 2106.05(f)] and is 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 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 recited at a high level of generality and corresponding functions], 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, 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 1 recites “a BP input” and “a sensor input”. Such inputs is/are 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 inputs, and recites the inputs at a high level of generality [The inputs 51 and 52 may thus e.g. be (wired or wireless) communication interfaces or data interfaces, such as a Bluetooth interface, WiFi interface, LAN interface, HDMI interface, direct cable connect, or any other suitable interface allowing signal transfer to the device 50 (Applicant’s Specification p. 15:28-30)]. 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 data communication. 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].
Claim 13 recites “a pressure-delivery system comprising a cuff 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” [see Examiner’s note regarding recitation of the pressure-delivery system and computing a control as recited in claim 1]. Such a pressure-delivery system 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 pressure-delivery system, and recites the pressure delivery system 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)]. 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 non-invasive blood pressure 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].
Claim 13 recites “a pressure sensor configured to acquire time-dependent cuff pressure values during inflation of a cuff of the pressure delivery system attached to the subject’s body part and to acquire or infer a BP measurement value”. Such a pressure 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 pressure sensor, and recites the pressure sensor at a high level of generality [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)]. 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 non-invasive blood pressure 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].
Claim 13 recites “a first sensor configured to be attached to a first site of the subject’s body and to acquire a first time-dependent sensor signal related to the subject’s heartbeat during the inflation of the cuff”. Such a 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 first sensor, and recites the first sensor at a high level of generality [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)]. 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 heartbeat detection. 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].
Claim 13 recites “a second sensor configured to be attached to a second site of the subject’s body and to acquire a second time-dependent sensor signal related to the subject’s heartbeat during the inflation of the cuff”. Such a 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 second sensor, and recites the second sensor at a high level of generality [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 heartbeat detection. 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].
Examiner’s Note Regarding Particular Treatment or Prophylaxis: Claim(s) 1-15 fail to recite any subject matter that may be interpreted as 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.
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Claim(s) 1 and 12-15 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1 and 13-15 of copending Application No. 18/705,335, hereinafter Muehlsteff, in view of Pantelopoulos (US-20170209053-A1).
Conflicting claim 1 of Muehlsteff is considered to anticipate each and every limitation of instant claim 1 [see comparison below], except for the limitation wherein the processing unit is configured to “compute a control signal for controlling the pressure-delivery system to repeatedly inflate its 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 the subject’s mean BP”, such that the computed pulse-related values from the first and second time-dependent sensor signals, are measured during “the repeated directly consecutive partial inflations of the cuff”.
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 (Pantetopoulos ¶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)].
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 the processing unit to be configured to compute a control signal for controlling the pressure-delivery system to repeatedly inflate its 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 the subject’s mean BP; 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, 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 data] [MPEP § 2143(I)(D)].
Dependent conflicting claims 12-13, based on the modification of conflicting claim 1 above, is considered to further render obvious instant claims 12-13. Instant independent claim 14 is considered to be similarly anticipated by conflicting independent claim 14, based on a similar comparison as identified between conflicting claim 1 and instant claim 1, as modified by Pantetopoulos mutatis mutandis. Dependent conflicting claim 15, based on the modification of conflicting claim 14, is considered to further render obvious instant claim 15.
Claim 1 of the Instant Application
Claim 1 of Conflicting Patent Application No. 18/705,335, hereinafter Muehlsteff
Device for calibrating a blood pressure, BP, surrogate for use in monitoring a subject’s blood pressure, the device comprising:
Device for calibrating a blood pressure, BP, surrogate for use in monitoring a subject’s blood pressure, the device comprising: [lines 1-2]
a BP input 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 a BP measurement value;
a BP input 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 [lines 3-5]
a sensor input configured to obtain a first time-dependent sensor signal and a second time-dependent sensor signal, both related to the subject’s heartbeat and measured at different sites of the subject’s body during the inflation of the cuff; and
a sensor input configured to obtain a first time-dependent sensor signal and a second time-dependent sensor signal, both related to the subject's heartbeat and measured at different sites of the subject's body during the inflation of the cuff [lines 6-8]
a processing unit configured to:
a processing unit configured to: [line 9]
- compute 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, and
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 [line 10-13]
- 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, a pair comprising a pulse-related value and a corresponding, temporally related cuff pressure value.
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, wherein only pairs of pulse-related values and corresponding cuff pressure values are selected for which one or more predetermined conditions with respect to BP and/or cuff pressure are fulfilled, and 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 [line 14-24]
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, and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banet (US-20100160798-A1, cited by Applicant) in view of Pantelopoulos (US-20170209053-A1).
Regarding claim 1, Banet teaches
Device for calibrating a blood pressure, BP, surrogate for use in monitoring a subject’s blood pressure, the device comprising:
a BP input 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 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); 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)];
a sensor input configured to obtain a first time-dependent sensor signal and a second time-dependent sensor signal, both related to the subject’s heartbeat and measured at different sites of the subject’s body 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 to determine both PTT.sub.1 and PTT.sub.2 (from the pressure-dependent measurement) (Banet ¶0061)]]; and
a processing unit configured to:
- compute a control signal for controlling the pressure-delivery system to inflate its cuff to a cuff pressure equal to or below the subject’s mean BP [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 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 [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)], and
- 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 partial 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].
However, Banet fails to explicitly disclose that the computed control signal is for controlling the pressure-delivery system to repeatedly inflate its 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 the subject’s mean BP; wherein the first and second time-dependent sensor signals are measured during the repeated directly consecutive partial inflations of the cuff.
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 (Pantetopoulos ¶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 (Pantetopoulos ¶0138)].
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 that the computed control signal is for controlling the pressure-delivery system to repeatedly inflate its 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 the subject’s mean BP; 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, 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 data] [MPEP § 2143(I)(D)].
Regarding claim 4, Banet in view of Pantelopoulos teaches
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 its cuff in the partial inflations up to the subject's diastolic BP, in particular the subject's latest measured diastolic BP, up to the subject's mean BP, in particular the subject's latest measured mean BP, or up to a set threshold cuff pressure equal to or below the subject's mean BP [Banet ¶0065; see § 103 modification of claim 1 above].
Regarding claim 7, Banet in view of Pantelopoulos teaches
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 its 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 teaches
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 its cuff in the partial inflations at a predetermined inflation speed [Banet ¶0065; see § 103 modification of claim 1 above] or an inflation speed dependent on one or more of the subject's heart rate, the subject's diastolic BP, the subject's mean BP, and the subject's systolic BP.
Regarding claim 9, Banet in view of Pantelopoulos teaches
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 its 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],
- i) compute, for each iteration, the 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 the two or more iterations into one or more averaged calibration parameters for use by the BP surrogate, or
ii) compute the one or more calibration parameters from pairs of pulse-related values and corresponding cuff pressure values obtained in the 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 12, Banet in view of Pantelopoulos teaches
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 in view of Pantelopoulos teaches
System for calibrating a blood pressure, BP, surrogate for use in monitoring a subject's blood pressure, the system comprising:
a pressure-delivery system comprising a cuff 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 [During a measurement, the patient wears a body-worn monitor attached to a disposable cuff and collection of optical, electrical, motion, and temperature sensors (Banet ¶0060); 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 acquire time-dependent cuff pressure values during inflation of a 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 sensor as claimed];
a first sensor configured be attached to a first site of the subject's body and to acquire a first time-dependent sensor signal related to the subject's heartbeat 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 be attached to a second site of the subject's body and to acquire 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 (Banet ¶0061)]; and
a device as claimed in of the preceding 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 [see § 103 modification of claim 1 above].
Regarding claim 14, Banet teaches
Method for calibrating a blood pressure, BP, surrogate for use in monitoring a subject's blood pressure, the method comprising:
- obtaining time-dependent cuff pressure values during inflation of a cuff of a pressure-delivery system attached to a subject's body part [During a measurement, the patient wears a body-worn monitor attached to a disposable cuff and collection of optical, electrical, motion, and temperature sensors (Banet ¶0060); 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)];
- obtaining a BP measurement value [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)];
- obtaining a first time-dependent sensor signal and a second time-dependent sensor signal, both related to the subject's heartbeat and measured at different sites of the subject's body 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 to determine both PTT.sub.1 and PTT.sub.2 (from the pressure-dependent measurement) (Banet ¶0061)]];
- computing a control signal for controlling the pressure-delivery system to inflate its cuff up to a cuff pressure equal to or below the subject's mean BP [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 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 [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)], and
- 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 partial 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].
However, Banet fails to explicitly disclose wherein the computed control signal is for controlling the pressure-delivery signal to repeatedly inflate its 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 the subject’s mean BP; wherein the first and second time-dependent sensor signals are measured during the repeated directly consecutive partial inflations of the cuff.
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 (Pantetopoulos ¶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 (Pantetopoulos ¶0138)].
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 computed control signal is for controlling the pressure-delivery signal to repeatedly inflate its 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 the subject’s mean BP; 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, 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 data] [MPEP § 2143(I)(D)].
Regarding claim 15, Banet in view of Pantelopoulos teaches
The method as claimed in claim 14.
However, Banet in view of Pantelopoulos fails to explicitly disclose wherein the method as claimed in claim 14 to be employed as a computer program comprising program code means for causing a computer to carry out the steps of the method when said computer program is carried out on the computer.
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 as claimed in claim 14 to be employed as a computer program comprising program code means for causing a computer to carry out the steps of the method when said computer program is carried out on the computer, 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)].
Claim(s) 2-3 and 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banet in view of Pantelopoulos, as applied to claim 1 above, in further view of Donehoo (US-20100249616-A1).
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 teaches
Device as claimed in claim 1.
However, Banet in view of Pantelopoulos fails to explicitly disclose 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, in particular varies by less than 10 percent or less than 5 percent; 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 10 percent or less than 5 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].
Banet discloses the use of an average of values as a form of statistical analysis [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 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 and Donehoo fails to explicitly disclose wherein peripheral BP being substantially constant, particularly refers to the peripheral BP varying by less than 10 percent or less than 5 percent, and wherein the amplitude of the second time-dependent signal being substantially constant, particularly refers to the amplitude of the second time-dependent signal varying by less than 10 percent or less than 5 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).
“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 teaches
Device as claimed in claim 1.
However, while Banet in view of Pantelopoulos 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 of claim 1 above, wherein iterations of the partial inflation are performed], Banet in view of Pantelopoulos fails to explicitly disclose wherein the processing unit is configured to compute the control signal for controlling the pressure-delivery system to inflate its cuff in a full inflation beyond the subject's systolic BP 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 to employ wherein the processing unit is configured to compute the control signal for controlling the pressure-delivery system to inflate its cuff in a full inflation beyond the subject's systolic BP 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 11, Banet in view of Pantelopoulos teaches
Device as claimed in claim 1,
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 and/or to control if and when an inflation is conducted according to a fixed or variable schedule [The Composite Method performs an indexing measurement once every 4-8 hours using inflation-based oscillometry (Banet ¶0065), wherein one every 4-8 hours defines a fixed schedule] or if one or more calibration parameters substantially changed in the last computation, in particular changed by more than 10 percent.
However, while Banet in view of Pantelopoulos discloses conducting an inflation according to a fixed schedule, Banet in view of Pantelopoulos fails to explicitly disclose wherein the inflation is a full inflation.
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 [Donehoo ¶¶0022-0025, Fig. 2].
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 the inflation is a full inflation, 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)].
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Banet in view of Pantelopoulos, as applied to claim 1 above, as evidenced by McCombie (US-20160143546-A1).
Regarding claim 5, Banet in view of Pantelopoulos teaches
Device as claimed in claim 1.
However, Banet in view of Pantelopoulos fails to explicitly disclose calibrating a blood pressure, BP, surrogate for use in monitoring a subject’s blood pressure based on a pulse arrival time, 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 at which the PAT exceeds a PAT threshold, in particular 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 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; 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, as evidenced by McCombie, as applied to claim 5 above, in further view of McCombie.
Regarding claim 6, Banet in view of Pantelopoulos, as evidenced by McCombie, teaches
Device as claimed in claim 5.
However, Banet in view of Pantelopoulos fails to explicitly disclose wherein the processing unit is configured to compute the baseline PAT by averaging PAT measurements over a period, in particular 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, 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 particular 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)].
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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