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 .
Election/Restrictions
Claims 14-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Groups II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on April 24th, 2026.
Applicant’s election without traverse of Group I (Claims 1-13) in the reply filed on April 24th, 2026 is acknowledged.
Abstract
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
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).
Claim Objections
Claims 6, 10-11, and 13 are objected to because of the following informalities:
Claim 6 recites “administration of a clinical intervention” in line 2, but should read “administration of the clinical intervention”
Claim 10 recites “a profiling parameter over” in line 17, but should read “a profile parameter of the plurality of profiling parameters”
Claim 11 recites “administration of a critical care intervention” in lines 1-2, but should read “administration of the critical care intervention”
Claim 13 recites “administration of a critical care intervention” in line 2, but should read “administration of the critical care intervention”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-13 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.
Claim 1 recites “a patient” in line 13. It is unclear as to whether this limitation is referring to the previously recited “a patient” from line 1 of Claim 1, or a separate element. Clarification is requested.
Claim 2 recites “one or more of” in line 2. Further in line 3, Claim 2 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 3 recites “the stored data segment” in line 1. It is unclear as to whether this limitation is referring to one of the “plurality of stored data segments from a database” previously recited in Claim 1, one of the “plurality of stored data segments satisfying threshold similarity criteria” previously recited in Claim 1, or a separate element. Clarification is requested.
Claim 5 recites “a clinical intervention” in line 2. It is unclear as to whether this limitation is referring to the “clinical intervention” previously recited in Claim 4, or a separate element. Clarification is requested.
Claim 8 recites “a plurality of patients” in line 2. It is unclear as to whether this limitation is meant to include the “patient” previously recited in Claim 1, or not. Clarification is requested.
Claim 9 recites “the patient” in line 2. It is unclear as to whether this limitation is referring to the “patient” previously recited in Claim 1, one of the “plurality of patients” previously recited in Claim 8, or a separate element. Clarification is requested.
Claim 10 recites “a plurality of profiling parameters” in line 11. It is unclear as to whether this limitation is referring to the “plurality of profiling parameters” previously recited in Claim 1, or a separate element. Clarification is requested.
Claim 10 recites “the fixed period of time” in lines 17 and 19. It is unclear as to whether this limitation is referring to the “fixed time period” previously recited in line 16 of Claim 10, or a separate element. Clarification is requested.
Claim 11 recites the limitation "the administration one or more critical care interventions" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the similar data segments" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the hardware processor" in line 1. There is insufficient antecedent basis for this limitation in the claim. Although Claim 1 previously recited “an integrated hardware unit” and a “system processor”, this is the first recitation of a “hardware processor”.
Claim 13 recites the limitation "the calculated probability" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Each of Claims 1-13 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 1
Claims 1-13 recite a system for identifying physiological states of a patient. Thus, the claims are directed to a machine, which is one of the statutory categories of invention.
Step 2A, Prong 1
Each of Claims 1-13 recites at least one step or instruction for identifying physiological states of a patient, which is grouped as a mental process under the 2019 PEG. Claim 1 recites an abstract idea in the form of a mental process, as consistent with Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012). If a claim, under its broadest reasonable interpretation, covers performance in the mind but for the recitation of generic computer components, then it is still in the mental processes category unless the claim cannot practically be performed in the mind, see Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016). Comparing patient data to stored data segments from a database and identifying physiological states of a patient are assessments that may be performed by a human. This applies for all claims dependent on claim 1. Accordingly, each of Claims 1-13 recites an abstract idea.
Specifically, Claim 1 recites the abstract idea of: “generate hemodynamic data corresponding to an arterial pressure waveform of the patient based on the adjusted pressure within the inflatable blood pressure bladder over the period of time; perform waveform analysis of the hemodynamic data to determine a plurality of profiling parameters; extract a patient data segment comprising a patient data set for a first profiling parameter of the plurality of profiling parameters; compare the patient data segment to a plurality of stored data segments from a database, each of the plurality of stored data segments having an associated stored discrete state data set indicative of whether a clinical intervention was administered and a stored data set for the first profiling parameter; identify a plurality of stored data segments satisfying threshold similarity criteria with respect to the patient data segment”.
Examiner notes that the step of adjusting a pressure is considered pre-solution activity and the step of displaying is considered data-outputting. The manner in which the signals are obtained is considered data-gathering, Both pre-solution activity and data-gathering/data-outputting are considered insignificant extra-solution activity, which is separate from the abstract idea.
Further, dependent Claims 2-13 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed. Accordingly, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claim 1 (and its dependent Claims 2-13) is not integrated into a practical application under 2019 PEG because the additional elements, either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the claims recite the additional elements of: “a non-invasive blood pressure sensor comprising an inflatable blood pressure bladder, a pressure controller pneumatically connected to the inflatable blood pressure bladder, and an optical transmitter and an optical receiver that are electrically connected to the pressure controller; and an integrated hardware unit comprising: a system processor; a system memory; a display comprising a user interface” in claim 1 and “hardware processor” in claim 13. These additional elements are either considered as data-gathering/data-outputting elements or generically recited computer elements which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claim 1 (and its dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed system merely implements the above-identified abstract idea (e.g., mental process) using rules (e.g., computer instructions) executed by a computer (e.g., “integrated hardware unit” as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claim 1 (and its dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claim 1 (and its dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 1-13 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “a non-invasive blood pressure sensor comprising an inflatable blood pressure bladder, a pressure controller pneumatically connected to the inflatable blood pressure bladder, and an optical transmitter and an optical receiver that are electrically connected to the pressure controller; and an integrated hardware unit comprising: a system processor; a system memory; a display comprising a user interface” in claim 1 and “hardware processor” in claim 13. The above-identified additional elements are either considered as data-gathering/data-outputting elements or generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by Applicant’s specification (e.g. paragraphs [0062-0080]) which discloses that the processor(s) comprise generic computer components that are configured to perform the generic computer functions (e.g. generating, performing, extracting, comparing, and identifying) that are well-understood, routine, and conventional activities previously known to the pertinent industry; and wherein the additional elements comprise generic components that are configured to perform pre-solution activity, data-gathering steps, and data-outputting steps; the Applicant’s Background in the specification; and the cited prior art.
Accordingly, in light of Applicant’s specification, the claimed term “integrated hardware unit” is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “integrated hardware unit”. 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 computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are 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, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 1-13 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the system of Claims 1-13 is directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 1-13 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claim 1 (and its dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 1-13 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1-13 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1-13 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Theran et al (U.S. Publication No. 2014/0058273; cited by Applicant) in view of Borgos et al (U.S. Publication No. 2011/0021931) and Najarian et al (U.S. Publication No. 2015/0374300).
Regarding Claim 1, Theran discloses a system for identifying physiological states of a patient, the system (Apparatus, systems and methods analyzing pressure and volume waveforms in the vasculature; Abstract) comprising:
a sensor (a detection device may be used to obtain a waveform, e.g., a PG waveform or pressure waveform; [0121]); and
an integrated hardware unit comprising: a system processor (The processing unit(s) of the present disclosure generally include means, e.g., hardware, firmware and/or software, for carrying out one or more of the disclosed methods/processes of calibration/normalization; [0121-0123]); a system memory ([0125-0127]); a display comprising a user interface (A display and/or other feedback means may also be included/provided to convey detected/processed data. Thus, in exemplary embodiments, index values may be displayed, e.g., on a monitor. The display and/or other feedback means may be stand-alone or may be included as one or more components/modules of the processing unit(s) and/or system; [0123]); wherein the system memory includes instructions that, when executed by the system processor (Software/firmware may, e.g., advantageously include processable instructions, i.e., computer readable instructions, on a suitable storage medium for carrying out one or more of the disclosed methods/processes; [0122]), are configured to:
generate hemodynamic data corresponding to an arterial pressure waveform of the patient ([0072]);
perform waveform analysis of the hemodynamic data to determine a plurality of profiling parameters ([0076]);
extract a patient data segment comprising a patient data set for a first profiling parameter of the plurality of profiling parameters ([0077]);
display, on the user interface, a predicted discrete state indicator of the patient ([0048 and 0123]).
Theran fails to specifically disclose a non-invasive blood pressure sensor comprising an inflatable blood pressure bladder, a pressure controller pneumatically connected to the inflatable blood pressure bladder, and an optical transmitter and an optical receiver that are electrically connected to the pressure controller; adjust a pressure within the inflatable blood pressure bladder with the pressure controller to maintain a constant volume of an artery of a patient for a period of time based on a feedback signal generated by the optical transmitter and the optical receiver; generate hemodynamic data corresponding to an arterial pressure waveform of the patient based on the adjusted pressure within the inflatable blood pressure bladder over the period of time.
In a similar technical field, Borgos teaches a vital sign measurement device including a sensor fixation device, a sensor frame, an optical sensing system, and an output unit (Abstract), specifically comprising a non-invasive blood pressure sensor comprising an inflatable blood pressure bladder (As shown in FIG. 4, a sensor fixation device 102 can be an inflatable cuff 120 having an inflatable bladder 122; [0042]), a pressure controller pneumatically connected to the inflatable blood pressure bladder (The bladder 122 in such a device 102 can be pneumatically connected to a pump 124 via a hose 116, as is the case in FIG. 4. In some implementations such as that shown in FIG. 4, a pneumatically inflatable cuff can be inflated (e.g., via a pump 124) and deflated (e.g., via a valve 126) to adjust the pressure applied to a portion of a subject's body 112. In some implementations, a system can include an inflation controller 452, such as is included in the output unit 106 as shown in FIG. 12, to control the inflation and deflation of the cuff; [0043]), and an optical transmitter and an optical receiver that are electrically connected to the pressure controller (The sensor fixation device 102 holds the sensor frame 200 and applies it against an anatomical location of a subject 112, within which is an artery 118. In the FIG. 1, for example, the anatomical location 112 is an upper arm of a human patient. The sensor frame 200 can be positioned so that the optical sensing system 104 senses movement corresponding to an arterial pulse when the sensor frame 200 is placed against the anatomical location 112 of the subject…the optical sensing system 104 employs what may be referred to as an optical power modulation method to detect and measure arterial pulses. An example optical sensing system that implements such an optical power modulation method, referring in particular to FIG. 5C, includes an optical waveguide 212 held by the sensor frame 200, an optical source 202 positioned to supply optical energy to a first end of the optical waveguide 212, and an optical detector 240 positioned to detect an amount of optical energy exiting a second, opposite end of the optical waveguide 212; [0038-0039]);
adjust a pressure within the inflatable blood pressure bladder with the pressure controller to maintain a constant volume of an artery of a patient (The sensor fixation device 102 holds the sensor frame 200 and applies it against an anatomical location of a subject 112, within which is an artery 118; [0038]; [0044]) for a period of time based on a feedback signal generated by the optical transmitter and the optical receiver (The sensor fixation device can hold the sensor frame 200 adjacent to an anatomical location of a subject 112 at a predetermined sensor fixation pressure or at an adjustable sensor fixation pressure…a pneumatically inflatable cuff can be inflated (e.g., via a pump 124) and deflated (e.g., via a valve 126) to adjust the pressure applied to a portion of a subject's body 112; [0041-0043]);
generate hemodynamic data corresponding to an arterial pressure waveform of the patient based on the adjusted pressure within the inflatable blood pressure bladder over the period of time (the output unit receives signals (e.g., electrical signals) representative of an amount of optical energy (e.g., light) exiting the second end of the optical waveguide and thus detected by the optical detector 240. These signals can be transmitted via electrical wires 108. In some implementations, the output unit 106 can also receive other data. For example, as shown in FIG. 4, wires 108 can transmit data in the form of signals (e.g., electrical signals) from a pressure transducer in the bladder 122 of a cuff 120 to the output unit 106 to allow the output unit 106 to determine an amount of pressure applied to an anatomical location of a patient; [0054]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the inflatable cuff teachings of Borgos into those of Theran in order to adjust the pressure applied to a portion of a subject's body (Borgos [0041-0043]).
Theran and Borgos fail to specifically disclose comparing the patient data segment to a plurality of stored data segments from a database, each of the plurality of stored data segments having an associated stored discrete state data set indicative of whether a clinical intervention was administered and a stored data set for the first profiling parameter; and identifying a plurality of stored data segments satisfying threshold similarity criteria with respect to the patient data segment.
In a similar technical field, Najarian teaches early detection of hemodynamic decompensation using taut-string transformation for classification for physical conditions of a subject based on monitored physiologic signal data (Abstract), comprising comparing the patient data segment to a plurality of stored data segments from a database, each of the plurality of stored data segments having an associated stored discrete state data set indicative of whether a clinical intervention was administered and a stored data set for the first profiling parameter (The pre-processed raw signal data is then provided to a signal decomposition and analysis stage 106, which identifies features in the received data, features that correlate to analyzing and identifying medical conditions. The size of extracted features may vary. Some features may be window sized, some sub-window sized, while others may be larger than the size of the window. In the examples discussed herein, the features are extracted only from each window and not across multiple windows, i.e., the window size has been set to be large enough to allow for one or more features to be extracted each window. The features may be determined continuously as the raw signal data is buffered and transmitted to the stage 106. Feature extraction may occur based on this windowed signal data alone or by comparing the data with other stored data, such as historical data, collected from previous operations of the system 100 or from other databases, e.g., databases of physical sensor (monitor) data, population data, subject-specific physiological data (age, weight, height, blood pressure and other vital signs, medications, past and current medical/surgical history, mechanisms of injury etc.); [0036]); and
identifying a plurality of stored data segments satisfying threshold similarity criteria with respect to the patient data segment (After feature extraction on each window, the computed feature set (containing one or more features) from stage 106 is then applied to a machine learning stage 108, which develops diagnostic models, and in some instances, predictive models using a variety of machine learning techniques…after feature extraction on each window, the computed feature set (containing one or more features) from stage 106 is then applied to a machine learning stage 108, which develops diagnostic models, and in some instances, predictive models using a variety of machine learning techniques; [0038-0042]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the comparison teachings of Najarian into those of Theran and Borgos in order to compare the data with other stored subject-specific physiological data from a database in order to provide an accurate physiological trajectory of the patient in terms of dynamic cardiovascular health (Najarian [0037-0038]).
Regarding Claim 2, Theran discloses wherein the plurality of profiling parameters comprises hemodynamic parameters including one or more of a systolic blood pressure, diastolic blood pressure, standard mean arterial pressure, stroke volume, heart rate, respiration, and cardiac contractibility (a pressure waveform reflective of systolic and/or diastolic blood pressure (BP) (e.g., generated using a non-invasive blood pressure monitor) may correlate to peaks and/or valleys of the PG signal, respectively… relative compliance indexes may be determined by comparing a combined waveform derived from the arterial and venous pressure waveforms to the PG signal; [0076-0077]).
Regarding Claim 3, Theran and Borgos fail to disclose wherein the patient data segment and the stored data segment each comprise a fixed time period over which the first profiling parameter is determined for a plurality of time points taken at regular intervals to produce the patient data set for the first profiling parameter and the stored data set for the first profiling parameter.
In a similar technical field, Najarian teaches early detection of hemodynamic decompensation using taut-string transformation for classification for physical conditions of a subject based on monitored physiologic signal data (Abstract), wherein the patient data segment and the stored data segment each comprise a fixed time period over which the first profiling parameter is determined for a plurality of time points taken at regular intervals to produce the patient data set for the first profiling parameter and the stored data set for the first profiling parameter (the system 100 may be trained to process and predict the most useful portions of the signal data using a certain fixed data sized window…as raw signal data is continuously acquired, 20 second intervals of the raw signal data may be separately buffered and sent to the processing algorithm. The windowing stage 102 may apply a certain window size (e.g., anywhere between 10 s to 60 s) when filtering the signal data; [0027-0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the fixed window teachings of Najarian into those of Theran and Borgos in order to best filter the raw signal data in windows of a particular size that may be buffered and analyzed as discrete blocks of data (Najarian [0027]).
Regarding Claim 4, Najarian further teaches wherein the patient data segment further comprises an associated discrete state indicative of whether a clinical intervention was administered during the patient data segment (Feature extraction may occur based on this windowed signal data alone or by comparing the data with other stored data, such as historical data, collected from previous operations of the system 100 or from other databases, e.g., databases of physical sensor (monitor) data, population data, subject-specific physiological data (age, weight, height, blood pressure and other vital signs, medications, past and current medical/surgical history, mechanisms of injury etc.); [0036]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the subject-specific physiological data (including vital signs, medications, past and current medical/surgical history) teachings of Najarian into those of Theran and Borgos in order to best compare the current data with other stored data, such as databases of physical sensor (monitor) data, population data, subject-specific physiological data (Najarian [0027]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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/CHANEL J YOON/Examiner, Art Unit 3791
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