DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Herein, “the previous Office action” refers to the Non-Final Rejection filed 4/9/2025.
Priority
As detailed on the Filing Receipt filed 3/19/2021, the instant application claims priority to as early as 3/10/2020. At this point in prosecution, all claims are accorded the earliest claimed priority date.
Claim Status
Claims 1-20 are pending, and examined herein.
Withdrawn Objections/Rejections
The objection to claim 1 is hereby withdrawn in view of Applicant’s amendments to relatively indent lines reciting processor functions and thereby clarify the nesting of claim elements in accordance with 37 CFR 1.75(i).
The rejection of claims 5 and 15 under 35 USC §12(b), as being indefinite, is hereby withdrawn in view of Applicant’s persuasive argument that the scope of the isolated term “monitor” may be understood in light of the specification (remarks filed 7/8/2025 at pg. 10, para. 2 – pg. 11, para. 2).
Claim Objections
Claims 2 and 18-20 are objected to because of the following informalities:
With respect to claim 2, the lines reciting processor functions (i.e., “segment…” at line 5, “extract…” at line 8) should be indented relative to the lines reciting components of the apparatus (i.e., lines 1-4) to make the nesting of claim elements clear.
Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation… There may be plural indentations to further segregate subcombinations or related steps (MPEP 608.01(m), referencing 37 CFR 1.75(i)).
Additionally, the recited “extracted features,.” (line 11) should be amended to “extracted features.” to remove the extraneous comma.
With respect to claims 18-20, the recited term “the waveforms” should read “the waveform”, to accord with antecedent recitation of “a waveform” (singular) in claims 1, 6 and 11.
Appropriate correction is required.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language, in light of the specification, as it would be understood by one of ordinary skill in the art (MPEP 2111-2111.01). This section documents the examiner’s
interpretation of certain recited claim language.
Claims 1, 6, 8-9, 11 and 13-14 recite the term “trained artificial intelligence”. This term is understood as encompassing a trained machine-learning algorithm.
Claim 1 recites the term “electrocardiogram monitor”, while claims 5 and 15 recite the term “monitor”. In the remarks filed 7/8/2025, Applicant highlights distinction in the as-filed specification between a depicted “monitor 155”and an “ECG monitor 101” (cited remarks at pg. 10, para. 2 – pg. 11, para. 2). The specification describes the former as an "electronic monitor that displays visualizations of images and data", e.g., a computer monitor, mobile device display, or television (specification at para. 0024), and indicates the latter as a source of processed ECG signals (para. 0025). In light of the highlighted portions of the specification, the term “electrocardiogram monitor” (or “ECG monitor”) is understood as referring to a specialized device that provides ECG signals while the isolated term “monitor” (as recited in claims 5 and 15) is understood as referring to an electronic display device.
Response to Arguments - Claim Rejections Under 35 USC § 101
In the remarks filed 7/8/2025, Applicant traverses the rejection under 35 USC § 101 and presents supporting arguments.
Applicant notes amendment of the claims to recite steps of “outputting an alert warning… and based on the alert warning, instructing a user on treatments to avoid and/or to treat the hemodynamic instability”, and alleges that the amended claims apply or use the alleged judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition (pg. 11, para. 9 – pg. 12, para. 2; pg. 13, para. 3).
“[I]n order to qualify as a ‘treatment’ or ‘prophylaxis’ limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition… If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the ‘treatment or prophylaxis’ consideration.” (MPEP 2106.04(d)(2)).
The cited treatment-related step provides treatment recommendations but does not affirmatively effect a particular treatment. It therefore amounts to mere indication of a field of use in which to apply the judicial exceptions, and as such is considered insufficient to integrate the judicial exceptions into a practical application (MPEP 2106.05(h)).
Applicant further alleges the amended claims improve the functioning of a computer system or technical field because the issuance of an alert warning allows for early intervention and treatment, as discussed in para. 0082 of the specification (pg. 12, para. 4 – pg. 13, para. 3).
The claims do not recite active steps of intervention or treatment, but rather recite steps that provide treatment recommendations to a user. Analysis of subject matter eligibility solely regards what is claimed, and integration of a judicial exception into a practical application can only be provided by recited additional elements. Applicant has not pointed to technical features among the recited additional elements that provide improvements over conventional technology employed in the field, thus the argument of technological improvement is found unpersuasive.
For the above reasons, the arguments are found unpersuasive and the rejection is maintained.
Claim Rejections - 35 USC § 101
35 USC § 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 USC § 101 because the claimed invention is directed to abstract ideas and natural phenomena without significantly more (i.e., non-statutory subject matter). The new grounds of rejection presented herein were necessitated by Applicant’s amendment of the claims (filed 7/8/2025).
"Claims directed to nothing more than abstract ideas, natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 § I).
Abstract ideas include mathematical concepts (including formulas, equations and calculations), certain methods of organizing human activity, and mental processes (processes that may be performed in the human mind, e.g., procedures for evaluating, analyzing or organizing information). See MPEP 2106.04(a)(2).
Laws of nature and natural phenomena include principles, relations, and products that are naturally occurring or do not have markedly different characteristics compared to what occurs in nature. See MPEP 2106.04(b).
The claims as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea and a natural phenomenon.
Step 1: The Four Categories of Statutory Subject Matter (MPEP 2106.03)
The claims are directed to an apparatus (claims 1-5 and 18), method (claims 6-10 and 19), and non-transitory computer readable storage medium (claims 11-17 and 20), which fall under categories of statutory subject matter.
Step 2A, Prong One: Whether the Claims Set Forth or Describe a Judicial Exception (MPEP 2106.04 § II.A.1)
‘Mathematical concepts’ are relationships between variables and numbers, numerical formulas or equations, or acts of calculation, which need not be expressed in mathematical symbols (MPEP 2106.04(a)(2) § I). The claims recite elements which encompass mathematical concepts, at least under their broadest reasonable interpretation, including:
“extract[ing] features of the heart beats in each of the first temporal windows” (claims 1, 6 and 11), i.e., calculating descriptive features from waveform data, wherein:
“extracting features of the heart beats… comprises: extracting heart rate variability” (claim 10), i.e., a particular descriptive feature; and
“generat[ing], based on the first extracted features from a waveform, generated features across a second temporal window” (claims 1, 6 and 11), i.e., calculating summary statistics based on descriptive features, wherein:
“the generated features across the second temporal window are based additionally on… second extracted features” (claims 2 and 7), i.e., calculation is further based on additional descriptive features;
“extract[ing] features of the arterial blood pressure waves in each of the first temporal windows” (claims 2, 7 and 12), i.e., deriving additional descriptive features;
“apply[ing] trained artificial intelligence to the generated features” (claims 1, 6 and 11), i.e., evaluating an optimized algorithm for input feature data.
The recited acts of calculation constitute mathematical concepts.
‘Mental processes’ are processes that can be performed in the human mind at least with use of a physical aid, e.g., a slide rule or pen and paper (MPEP 2106.04(a)(2) § III). The recited acts of calculation are practicably performable in the human mind, at least with physical aid and under their broadest reasonable interpretation, rendering them as mental processes. Additionally, the claims recite elements that encompass further processes that are practicably performable in the human mind, at least with physical aid and under their broadest reasonable interpretation, including:
“identify[ing] a plurality of heart beats from electrocardiogram waves” (claims 1, 6 and 11), i.e., identifying patterns in waveforms;
“separat[ing] the plurality of heart beats into first temporal windows” (claims 1, 6 and 11), i.e., dividing waveforms into segments;
“predict[ing] hemodynamic instability for the patient based on applying the trained artificial intelligence to the generated features” (claims 1, 6 and 11), i.e., making a prediction based on algorithm output;
“output[ting] an alert warning of the hemodynamic instability based on predicting the hemodynamic instability” (claims 1, 6 and 11), e.g., writing down a warning based on a prediction, wherein:
“the alert includes a projection in advance of when the patient will enter a phase of hemodynamic instability based on an estimated likelihood passing a predetermined threshold” (claims 3 and 16), i.e., a specific prediction;
“segment[ing] arterial blood pressure wave… into individual pulse cycles, wherein the first temporal windows each include a plurality of the individual pulse cycles” (claims 2, 7 and 12), i.e., dividing waveforms into segments;
“continuously identify the plurality of heart beats from the electrocardiogram waves for a plurality of the first temporal windows in the second temporal window” (claim 4), i.e., repeated pattern identification;
“label[ling] each of the plurality of heart beats with one of a plurality of predetermined labels based on characteristics of each of the plurality of heart beats” (claims 8 and 13);
“excluding at least one heartbeat of the plurality of heart beats from application of the trained artificial intelligence based on applying a noise filter to the plurality of heart beats” (claims 8 and 13), i.e., pre-filtering input data according to a noise filter;
“identifying at least one individual pulse cycle as abnormal” (claims 9 and 14), i.e., labelling data; and
“excluding the at least one individual pulse cycle identified as abnormal from application of the trained artificial intelligence” (claims 9 and 14), i.e., pre-filtering input data according to a particular label.
The recited steps of evaluating information, which are practicably performable in the human mind, constitute mental processes.
Mathematical concepts and mental processes constitute enumerated groupings of abstract ideas (MPEP 2106.04(a)(2) §§ I and III). Hence, the claims recite elements that, individually and in combination, constitute an abstract idea.
Furthermore, the claims recite functions of predicting hemodynamic instability based on manipulation of electrocardiogram (ECG) and arterial blood pressure (ABP) wave data, i.e., physiological measurements. Claims 18-20 expressly require that “the waveform[] is an ECG waveform and/or arterial blood pressure (ABP) waveform”. These physiological measurements are observations of naturally occurring phenomena (e.g., naturally-occurring sinus rhythms and pulse cycles resulting from heartbeats), and the claimed determination of hemodynamic instability is mere observation that these measurements fall within particular relative parameters (i.e., that the natural phenomena have particular characteristics).
Determining an advance projection of hemodynamic instability (claims 3 and 16) likewise relies upon natural correlations between current cardiac cycle characteristics and likelihood of future cardiac cycle characteristics. These correlations constitute laws of nature. Hence, the claims recite elements that, individually and in combination, constitute a natural phenomenon (MPEP 2106.04(b)).
The claims must therefore be examined further to determine whether they integrate these judicial exceptions into a practical application (MPEP 2106.04(d)).
Step 2A, Prong Two: Whether the Claims Contain Additional Elements that Integrate the Judicial Exception(s) into a Practical Application (MPEP 2106.04 § II.A.2)
The claims recite additional elements that constitute computer hardware for performing claimed functions and/or require performance of claimed functions using computer hardware, including:
“a first interface [that interfaces] at least one electrocardiogram monitor” (claims 1, 6 and 11), i.e., a computer hardware interface;
“a memory that stores instructions” (claim 1), wherein:
“when executed by the processor, the instructions… cause the apparatus to” perform claimed functions (claims 1-2 and 4);
“a processor that executes the instructions” (claim 1);
“a second interface [that interfaces] an arterial blood pressure monitor” (claims 2, 7 and 12), i.e., a computer hardware interface;
“a monitor adapted to display the alert” (claim 5); and
“A tangible non-transitory computer readable storage medium that stores a computer program” (claim 11), wherein:
“the computer program, when executed by a processor… caus[es] [a] system that includes the tangible non-transitory computer readable storage medium to” perform claimed functions (claim 11-14);
“the tangible non-transitory computer readable storage medium is… a component of a monitor that displays the alert” (claim 15).
The specification states that “The processor may be a general-purpose processor” (para. 0074), i.e., computer hardware having conventional capabilities.
The claims do not describe any specific computational steps by which computer hardware performs or carries out functions drawn to the judicial exceptions, nor do they provide any details of how specific structures of the computer hardware are used to implement these functions. The claims state nothing more than that computer hardware performs functions drawn to the judicial exceptions, and are therefore mere instructions to apply the judicial exceptions using computer hardware. As such, the claims do not integrate the judicial exceptions into a practical application (see MPEP 2106.04(d) § I and 2106.05(f)).
The claims further recite the following additional elements, which implement necessary data gathering:
performing functions on electrocardiogram wave data “received via [the] first interface from the at least one electrocardiogram monitor” (claims 1 and 11);
performing functions on arterial blood pressure wave data “received via [the] second interface from the arterial blood pressure monitor” (claims 2 and 12);
“receiving, via [the] first interface… a plurality of electrocardiogram waves” (claim 6); and
“receiving, via [the] second interface… arterial blood pressure waves” (claim 7).
Necessary data gathering is considered to be insignificant pre-solution activity, thus the data gathering functionality of the interfaces and measurement devices is insufficient to integrate the judicial exceptions into a practical application (MPEP 2106.05(g), see also MPEP 2106.05(b) § III).
The claims further recite the following additional element, which provides treatment recommendations based on the output of prior functions:
“based on the alert warning, instruct[ing] a user on treatments to avoid and/or to treat the hemodynamic instability” (claims 1, 6 and 11).
The recited treatment-related step does not effect a particular treatment, and therefore amounts to mere indication of a field of use in which to apply the judicial exceptions (MPEP 2106.04(d)(2)). Field-of-use limitations are insufficient to integrate the judicial exceptions into a practical application (MPEP 2106.05(h)).
No further additional elements are recited.
When the claims are considered as a whole: they do not improve the functioning of a computer, other technology, or technical field (MPEP 2106.04(d)(1) and 2106.05(a)); they do not apply the judicial exceptions to effect a particular treatment or prophylaxis for a disease or medical condition (MPEP 2106.04(d)(2)); they do not implement the judicial exceptions with, or in conjunction with, a particular machine (MPEP 2106.05(b)); they do not effect a transformation or reduction of a particular article to a different state or thing (MPEP 2106.05(c)); and they do not apply or use the judicial exceptions in some other meaningful way beyond linking the use of the judicial exceptions to a particular technological environment and/or field of use (e.g., automated cardiac monitoring; MPEP 2106.05(e) and 2106.05(h)).
Therefore, the claims do not integrate the judicial exceptions into a practical application. See MPEP 2106.04(d) § I.
Because the claims recite an abstract idea and a natural phenomenon, and do not integrate those judicial exceptions into a practical application, the claims are directed to those judicial exceptions. Claims that are directed to judicial exceptions must be examined further to determine whether the additional elements besides the judicial exceptions render the claims significantly more than the judicial exceptions. Additional elements besides the judicial exceptions may constitute inventive concepts that are sufficient to render the claims significantly more (MPEP 2106.05).
Step 2B: Whether the Claims Contain Additional Elements that Amount to an Inventive Concept (MPEP 2106.05)
As noted above, several recited additional elements amount to insignificant extra-solution activity. Mere addition of insignificant extra-solution activity does not amount to an inventive concept that would render the claims significantly more than the recited judicial exceptions, particularly when the activities are well-understood or conventional (MPEP 2106.05(g)). The conventionality of recited additional elements that amount to insignificant extra-solution activity must be further considered.
Recited additional elements amounting to insignificant extra-solution activity encompass processes that are indicated as well-understood, routine and conventional by relevant prior art. The cited reference book by Baura (Medical Device Technologies, Academic Press; published 2012) reviews medical device technologies, including sensor devices that measure physiologic conditions as electrical signals, which undergo digital conversion and transmission for processing (pg. 5, para. 4 – pg. 6, para. 1).
Baura discusses modern ECG instruments, which measure cardiac voltages and output signals to a processor for analysis, and consensus standards for ECG measurement (pg. 52, paras. 3-5; pg. 56, para. 4). Baura further discusses intraarterial blood pressure (IAP) sensors, which convert measured pressure to voltages (pg. 16, para. 3 - pg. 17, para. 3), and consensus standards for IAP measurement (pg. 160, para. 2; pg. 161, paras. 2-3). Baura additionally depicts ECG wave output (pg. 46) and blood pressure wave output (pg. 148, Fig. 7.2). Baura thus provides evidence for conventionality of receiving measured ECG and ABP wave data from monitors in the field of the invention.
Additionally, recited additional elements amounting to insignificant extra-solution activity encompass the following computer-implemented functions, which the courts have held as coextensive with a general-purpose computer and/or well-understood, routine and conventional:
Receiving and storing data (In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1316 (Fed. Cir. 2011); EON Corp. IP Holdings LLC v. AT&T Mobility LLC, 785 F.3d 616, 622 (Fed. Cir. 2015));
Receiving or transmitting data over a network (buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355 (Fed. Cir. 2014); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363 (Fed. Cir. 2015));
Storing and retrieving information in memory (OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363 (Fed. Cir. 2015); Versata Dev. Group, Inc. v. SAP America, Inc., 793 F.3d 1306, 1334 (Fed. Cir. 2015)); and
Selecting information for display (Electric Power Group, LLC v. Alstom S.A., 830 F.3d 1350, 1354-55 (Fed. Cir. 2016)).
Hence, the encompassed extra-solution activity is considered well-understood, routine and conventional. Well-understood, routine and conventional activity is insufficient to constitute an inventive concept that would render the claims significantly more than judicial exceptions (MPEP 2106.05(d)).
Mere instructions to implement judicial exceptions using a computer are, when considered individually, similarly insufficient to constitute an inventive concept that would render the claims significantly more than said judicial exceptions (see MPEP 2106.05(f)).
When the claims are considered as a whole, they do not integrate the judicial exceptions into a practical application; they do not confine the use of the judicial exceptions to a particular technology; they do not solve a problem rooted in or arising from the use of a
particular technology; they do not improve a technology by allowing the technology to
perform a function that it previously was not capable of performing; and they do not
provide any limitations beyond generally linking the use of the judicial exceptions to a particular technological environment and/or field of use (e.g., automated cardiac monitoring; MPEP 2106.05(e) and 2106.05(h)).
Therefore, the claims do not provide an inventive concept and/or significantly more than the judicial exceptions themselves. See MPEP 2106.05.
Conclusion: Claims are Directed to Non-statutory Subject Matter
For these reasons, the claims, when the limitations are considered individually and as a whole, are directed to judicial exceptions and lack an inventive concept. Hence, the claimed invention does not constitute significantly more than the judicial exceptions, so the claims are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
Response to Arguments - Claim Rejections Under 35 USC § 102
In the remarks filed 7/8/2025, Applicant traverses the rejection under 35 USC § 102 and highlights particular points of alleged distinction between the amended claims and the teachings of Najarian.
Applicant alleges that Najarian fails to disclose the amended claim feature of predicting hemodynamic instability before its occurrence, instead (at paras. 0038 and 0073) providing for assessment of hemodynamic decomposition based on a compensatory reserve index (CRI) model (pg. 15, para. 1 – pg. 16, para. 2).
Najarian expressly discusses application of the disclosed methodology to predicting hemodynamic decompensation (para. 0021), and presents the function of predicting subject physical condition(s) in the alternative to functions of analyzing and diagnosing subject physical condition(s) (para. 0024).
Najarian also states that disclosed classification models include predictive models, and are designed to provide a physiologic trajectory of a patient based on extracted features (para. 0038). Najarian specifically exemplifies classifications that predict the onset or likelihood of sepsis prior to the overt onset of sepsis (para. 0038). It is clear from the disclosure of Najarian that the discussed function of predicting is not limited to assessment of present state but rather includes prediction prior to occurrence of a condition. Thus, the presented argument of deficiency in the disclosure of Najarian is found unpersuasive.
Applicant alleges that Najarian fails to disclose the amended claim feature of displaying an alert warning of hemodynamic instability based on predicting the hemodynamic instability, instead (at para. 0042) generally providing for displaying an alarm condition (para. 16, para. 3 – pg. 17, para. 2).
Najarian discusses application of the disclosed methodology to predicting hemodynamic decompensation (para. 0021). In the referenced paragraph (para. 0042), Najarian further discusses performance by an illustrated stage 108 (see Fig. 1) of the following processes: production of a health report and/or alarm condition as a visual or tactile alert; and provision of output data to a treatment system for responsive control of treatment delivery. Najarian is therein discussing various applications of output data, wherein output data can include a prediction of hemodynamic decompensation. In this way, Najarian is considered to disclose displaying an alert based on predicting hemodynamic instability. Thus, the presented argument of deficiency in the disclosure of Najarian is found unpersuasive.
For the above reasons, the arguments are found unpersuasive and the rejection is maintained.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 USC §§ 102 and 103 is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 USC § 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 USC §§ 102(a)(1) and 102(a)(2) as being anticipated by Najarian et al (US 2015/0374300; effectively filed 6/27/2014; analogous to WO 2015/200750 listed on IDS filed 10/22/2021; previously cited). The new grounds of rejection presented herein were necessitated by Applicant’s amendment of the claims (filed 7/8/2025).
Claim 1 recites an apparatus comprising: a first interface that interfaces with at least one electrocardiogram monitor monitoring a patient; a memory that stores instructions; and a processor that executes the instructions.
The claim further requires that the instructions, when executed, cause the apparatus to perform functions of: identifying a plurality of heartbeats from electrocardiogram (ECG) waves received via the first interface; separate the heart beats into first temporal windows; extract features of the heartbeats in each of the first temporal windows; generate features across a second temporal window that includes a plurality of the first temporal windows; apply trained artificial intelligence to the generated features; predict hemodynamic instability for the patient; output an alert warning of the hemodynamic instability; and based on the alert warning, instruct a user on treatments to avoid and/or to treat the hemodynamic instability.
With respect to claim 1, Najarian discloses an apparatus (para. 0017; Fig. 8) comprising: a first interface that interfaces at least one electrocardiogram monitor monitoring a patient (paras. 0075 and 0077; 424 and 416 in Fig. 8); a memory that stores instructions (para. 0076, 406 and 410 in Fig. 8); and a processor that executes the instructions (para. 0075; 408 in Fig. 8).
Najarian further discloses processor-implemented functions including: receiving ECG waves via an interface from an ECG monitor and decomposing the signal into a plurality of heartbeats (paras. 0026, 0033 and 043-44; Fig. 6a-6c; see description of figures at para. 0015); filtering the signal into discrete windows based on a fixed time interval (para. 0027); extracting features from each window (para. 0036); determining statistical features, such as mean, sum and standard deviation of frequencies, along a domain across multiple windows, i.e., across a second temporal window that includes a plurality of the first temporal windows (para. 0037); developing diagnostic models by applying machine learning techniques to features, i.e., applying trained artificial intelligence to the generated features (para. 0038); providing a disease severity classification that predicts onset of a physical condition such as hemodynamic decompensation / instability (paras. 0038 and 0073); producing a health report and/or alarm condition as a visual or tactile alert (para. 0042); and further providing output data to a treatment system for control of treatment delivery in response to received data (para. 0042; Fig. 9).
Najarian further discusses embodiments of the disclosed apparatus implemented in communication with a medical treatment network, comprising health care professional terminals, for use as part of a decision assist system (para. 0076). Najarian therein indicates express contemplation of applications involving instruction of a user (e.g., a healthcare professional) regarding treatment.
With respect to claim 2, Najarian discloses applying the discussed decomposition and feature extraction steps to a variety of signal types (para. 0023), and exemplifies interfacing with arterial blood pressure (ABP) sensors to gather and extract features from ABP waveforms (paras. 0025 and 0077).
With respect to claim 3, Najarian discloses reporting results as a visual or tactile alert (para. 0042), and characterizes disclosed classification models as providing a physiologic trajectory, i.e., projection in advance, of a patient in terms of dynamic cardiovascular health (para. 0038).
Najarian further discloses producing classifications that predict the likelihood of disease onset prior to overt onset (para. 0038), and exemplifies a classification scheme wherein a particular derived value of less than 0.3, i.e., passing a predetermined threshold, is considered indicative of onset of hemodynamic instability (para. 0073).
In this way, Najarian discloses embodiments wherein the alert includes an advance projection of when the patient will enter a phase of hemodynamic instability based on an estimated likelihood passing a predetermined threshold.
With respect to claim 4, Najarian discloses embodiments wherein signal data is continuously acquired and processed (paras. 0027 and 0045).
With respect to claim 5, Najarian discloses producing an alarm condition as a visual alert using the display, i.e., electronic monitor, of a signal processing device (para. 0042).
Claims 6-7 are directed to a method comprising process steps of substantive similarity to those recited as functional limitations of the apparatus of claims 1-2. The disclosure of Najarian is considered to apply to the process limitations of claims 6-7 in the same manner as detailed regarding the functional limitations of claims 1-2.
With respect to claim 8, Najarian discloses pre-processing signal data with various statistical models to remove baseline drift effects, including high-pass filtering with a pre-selected cutoff frequency and phase response (paras. 031-33). High-pass filtering retains signal data that passes above a low frequency threshold and excludes data that falls below the threshold (i.e., noise).
Najarian further discloses first detecting QRS complexes in the ECG signal and characterizing intervals of interest as part of baseline drift removal (para. 033). In this way, Najarian discloses labelling heartbeats based on characteristics and excluding at least one heartbeat based on applying a noise filter.
With respect to claim 9, Najarian discloses that the discussed signal processing techniques, including filtering, are input signal agnostic and can be applied to a variety of signal types measured by various classes of sensors including ABP sensors (paras. 0023-25). High-pass filtering of pulse cycle data, with a pre-selected cutoff frequency and phase response, is viewed as equivalent to identifying and excluding abnormal pulse cycle(s).
With respect to claim 10, Najarian discloses Stockwell transformation of windowed signal data to extract primary features including heart rate variability (paras. 0023 and 0043-45).
Claims 11-12 and 16-17 are directed to a tangible non-transitory computer readable storage medium comprising functional limitations of substantive similarity to those of the apparatus of claims 1-4. Najarian discloses implementation of their methodology as a computer system configured by software instructions embodied on a machine-readable medium (para. 0080). Najarian presents embodiment on a machine-readable medium in the alternative to embodiment in a transmission signal (para. 0080), and thus discloses embodiment on a tangible, non-transitory computer readable medium. The disclosure of Najarian is considered to apply to the functional limitations of claims 11-12 and 16-17 in the same manner as detailed regarding the functional limitations of claims 1-4.
Claims 13-14 recite functional limitations of substantive similarity to the process steps of the method of claims 8-9. The disclosure of Najarian is considered to apply to the functional limitations of claims 13-14 in the same manner as detailed regarding the process steps of claims 8-9.
With respect to claim 15, Najarian discloses producing an alarm condition as a visual alert using the display, i.e., electronic monitor, of a signal processing device (para. 0042).
With respect to claims 18-20, Najarian discloses applying the discussed decomposition and feature extraction steps to a variety of signal types (para. 0023), and exemplifies interfacing with arterial blood pressure (ABP) sensors to gather and extract features from ABP waveforms (paras. 0025 and 0077).
In this way, the disclosure of Najarian anticipates the limitations of claims 1-20. Thus, the claimed invention is anticipated.
Conclusion
At this point in prosecution, no claims are allowed.
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 Theodore C. Striegel whose telephone number is (571)272-1860. The examiner can normally be reached Mon-Fri 12pm-8pm ET.
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/T.C.S./Examiner, Art Unit 1685
/JESSE P FRUMKIN/Primary Examiner, Art Unit 1685 October 15, 2025