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 .
Response to Amendment
The original amendments to the claims filed 02 FEBRUARY 2024 with the heading “Docket No. 3290000046US01” have been received and are entered. This version of the claims is examined herein.
Specification
The use of the term BLUETOOTH®, which is a trade name or a mark used in commerce, has been noted in this application at [0077], [0078], and [0122]. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Drawings
The drawings are objected to because:
There are units missing on the x- and y-axes of Figure 17A and Figure 17B.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 13 (line 3) and Claim 14 (line 3) are objected because of the following informalities: the terms “subsequent AHE event” are suggested to be revised to “subsequent AHE event of the patient” for readability and consistency with the other recitations of the terms in the claims. 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 7 – 8 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 7 recites the limitation "detecting, by the processor, the one or more AHE events of the patient" in line 2. There is insufficient antecedent basis for this limitation in the claim. There is no previously-recited “or more AHE events of the patient”. The term in Claim 1 from which this claim depends is “detecting, by the processor, an AHE event of the patient”. For the purposes of examination, the term "detecting, by the processor, the one or more AHE events of the patient" is deemed to claim “"detecting, by the processor, the AHE event of the patient". Claim 8 is similarly rejected due to its dependence on Claim 7.
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 – 16 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.
Regarding Claim 1, the claim recites "an act or step, or series of acts or steps" and is therefore a process, which is a statutory category of invention (Step 1). The claims are then analyzed to determine whether it is directed to any judicial exception (Step 2A, Prong 1).
Each of Claims 1 – 16 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of Claims 1 – 16 recites at least one step or instruction for observations, evaluations, judgments, and opinions, which are grouped as a mental process under the 2019 PEG. The claimed invention involves making observations, evaluations, judgments, and opinions, which are concepts performed in the human mind under the 2019 PEG.
Accordingly, each of Claims 1 – 16 recites an abstract idea.
Specifically, Independent Claim 1 recite (underlined are observations, judgements, evaluations, or opinions, which are grouped as a mental process under the 2019 PEG) (additional elements bolded, see Step 2A, prong 2);
Claim
A method for adaptively detecting an Acute Hypotension Episode (AHE) event of a patient, comprising:
processing, by a processor, a signal relating to the patient to determine at least one mean arterial pressure (MAP) threshold value for the patient; and
detecting, by the processor, an AHE event of the patient based on the at least one MAP threshold value.
(observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
These underlined limitations describe a mathematical calculation and/or a mental process, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the limitations cannot be practically performed by a human with the aid of a pen and paper, or by using a generic computer as a tool to perform mathematical calculations and/or mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mathematical calculations and/or the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform mathematical calculations and/or mental process steps. For example, in Independent Claim 1, these limitations include:
Observation and judgment of at least one mean arterial pressure (MAP) threshold value for the patient
Observation and judgment of an AHE event of the patient based on the at least one MAP threshold value.
Similarly, Dependent Claims 2 – 16 include the following abstract limitations, in addition to the aforementioned limitations in Independent Claim 1 (underlined observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG):
determining at least one fluctuation of the signal from a baseline of the signal.
Observation and judgment of at least one fluctuation of the signal from a baseline of the signal.
comparing one or more MAP values of the signal against the at least one MAP threshold value.
Observation and judgment to compare one or more MAP values of the signal against the at least one MAP threshold value.
determining if a duration relating to the one or more MAP values is longer than a pre-configured threshold duration.
Observation and judgment if a duration relating to the one or more MAP values is longer than a pre-configured threshold duration.
determining if the at least one MAP threshold value is lower than a first pre- configured MAP threshold value.
Observation and judgment if the at least one MAP threshold value is lower than a first pre- configured MAP threshold value.
determining if a mean MAP value of a baseline of the signal is lower than a second pre-configured MAP threshold value.
Observation and judgment if a mean MAP value of a baseline of the signal is lower than a second pre-configured MAP threshold value.
detecting an onset and a duration of the AHE event of the patient based on the at least one MAP threshold value and the signal.
Observation and judgment of an onset and a duration of the AHE event of the patient based on the at least one MAP threshold value and the signal.
storing the onset and the duration of the AHE event of the patient, and one or more MAP values associated with the AHE event in a database.
Observation and judgment to store the onset and the duration of the AHE event of the patient, and one or more MAP values associated with the AHE event in a database.
receiving a MAP waveform,
Observation and judgment of a MAP waveform,
receiving at least one clinical data,
Observation and judgment of at least one clinical data,
determining, by the processor, a prediction of a subsequent AHE event of the patient based on the at least one MAP threshold value and the signal.
Observation and judgment of a prediction of a subsequent AHE event of the patient based on the at least one MAP threshold value and the signal.
receiving an input relating to a time frame
Observation and judgment of an input relating to a time frame
determining a MAP value of the subsequent AHE event, the MAP value relating to a severity level of the subsequent AHE event.
Observation and judgment of a MAP value of the subsequent AHE event, the MAP value relating to a severity level of the subsequent AHE event.
extracting at least one feature in the signal, wherein the determination of the prediction of the subsequent AHE event is based on the at least one feature of the signal.
Observation and judgment of at least one feature in the signal, wherein the determination of the prediction of the subsequent AHE event is based on the at least one feature of the signal.
determining two or more predictions based on the at least one feature extracted from a plurality of signals relating to a plurality of patients;
Observation and judgment of two or more predictions based on the at least one feature extracted from a plurality of signals relating to a plurality of patients;
comparing the two or more predictions
Observation and judgment of the two or more predictions
determine an optimal prediction of subsequent AHE events of the plurality of patients based on the at least one feature extracted from the plurality of signals,
Observation and judgment of an optimal prediction of subsequent AHE events of the plurality of patients based on the at least one feature extracted from the plurality of signals,
all of which are grouped as mental processes or mathematical algorithms under the 2019 PEG.
Accordingly, as indicated above, each of the above-identified claims recite an abstract idea.
Step 2A, Prong 2
The above-identified abstract ideas in each of Independent Claim 1 (and their respective Dependent Claims) are not integrated into a practical application under 2019 PEG because the additional elements (identified in Claims 1 – 16), either alone or in combination, generally link the use of the above-identified abstract ideas to a particular technological environment or field of use. More specifically, the additional elements of:
“processor”, “at least one processor”
“at least one memory”
Additional elements recited include “processor”, “at least one processor”, and “at least one memory”, in Independent Claim 1 (and their respective Dependent Claims). These components are recited at a high level of generality, , i.e., as a processor performing a generic function of processing data (the detecting, determining, and comparing); These generic hardware component limitations “processor”, “at least one processor”, and “at least one memory”, are no more than mere instructions to apply the exception using generic computer and hardware components. As such, these additional elements do not impose any meaningful limits on practicing the abstract idea.
Further additional elements from Claims 1 - 16 includes pre-solution activity limitations, such as:
processing, by a processor, a signal relating to the patient
wherein the signal comprises the MAP waveform.
the at least one clinical data comprising at least one of a blood composition, a urine composition, hemodynamic waveform data, demographic data, comorbidity data, a blood pressure, a central venous pressure, a frailty score and perioperative administration data, wherein the signal comprises the at least one clinal data.
the prediction comprises a prediction of an occurrence of the subsequent AHE event of the patient within the time frame.
at least one memory including computer program code
the optimal prediction being either one of or a combination of the two or more predictions, wherein the prediction of the subsequent AHE of the patient is based on the optimal prediction of the subsequent AHE events of the plurality of patients.
the at least one memory and the computer program code configured to, with at least one processor, cause the apparatus at least to perform the method according claim 1.
These pre-solution measurement elements are insignificant extra-solution activity, setting up the parameters of the system, and serve as data-gathering for the subsequent steps.
The “processor”, “at least one processor”, and “at least one memory”, as recited in Independent Claim 1 (and their respective Dependent Claims) are generically recited computer and hardware 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 ideas identified above in Independent Claim 1 (and their 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 method and system merely implements the above-identified abstract idea (e.g., mental process and certain method of organizing human activity) using rules (e.g., computer instructions) executed by a computer processor 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 their dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, Independent Claim 1 (and their dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B –
None of Claims 1 – 16 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: “processor”, “at least one processor”, and “at least one memory”, as recited in Independent Claim 1 (and their dependent claims).
The additional elements of the “processor”, “at least one processor”, and “at least one memory”, in Independent Claim 1 (and their dependent claims), as discussed with respect to Step 2A Prong Two, amounts to no more than mere instructions to apply the exception using generic computer and hardware components. The same analysis applies here in 2B, i.e., mere instructions to apply an exception using a generic computer component cannot integrate a judicial exception into a practical application at Step 2A or provide an inventive concept in Step 2B.
The above-identified additional elements are 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.
Per Applicant’s specification, the “processor” and “at least one processor” is described generically at [0010] and [0011] as part of the apparatus that processes a signal and detects an AHE event based on the signal processing; [0081] as “a physical device comprising at least one processor and at least one memory including computer program code.”; and [0143] as “processor 2204 for executing software routines…may include a multi-processor system”. The “processor” and “at least one processor” are shown as generic box element “Processor 2204” in Figure 22.
Per Applicant’s specification, the “at least one memory”, is described generically in [0058] with “The computer readable medium may include storage devices such as magnetic or optical disks, memory chips, or other storage devices suitable for interfacing with a computer” and [0144] as “main memory 2208” with examples given for generic types of storage. The “at least one memory” is shown as generic box element “Main memory 2208” in Figure 22.
Accordingly, in light of Applicant’s specification, the claimed terms “processor”, “at least one processor”, and “at least one memory”, are reasonably construed as a generic computing and hardware devices. 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 “processor”, “at least one processor”, and “at least one memory”, 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 Independent Claim 1 (and their dependent claims) 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 methods and apparatus of Claims 1 – 16 are 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 – 16 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 for Step 2A Prong 2 in Independent Claim 1 (and their 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 instruct the practitioner to 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 – 16 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 – 16 amounts to significantly more than the abstract idea itself. Accordingly, Claims 1 – 16 are not patent eligible and rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 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.
Claims 1 – 3, 9 – 12, 14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Genc, (United States Patent Application Publication US 2011/0245631 A1), hereinafter Genc.
Regarding Claim 1, Genc discloses A method for adaptively detecting an Acute Hypotension Episode (AHE) event of a patient ([Abstract]), comprising:
processing, by a processor ([0008] “execution with a processor…“), a signal relating to the patient ([0002] “Mean Arterial Pressure (MAP) measurements”; [0005] “reading heart rate data…mean arterial pressure data from the patent over the given time period“) to determine at least one mean arterial pressure (MAP) threshold value for the patient ([0032] “P is the AHE prediction threshold…If a positive AHE detection is found for P out of R repetitions, an AHE is declared and its onset time is known, at 60”; Fig 4; [0002] “AHE may be defined as…at least ninety percent…of Mean Arterial Pressure (MAP) measurements are at or below 60 mmHg.”)(Examiner notes that the initial threshold is based on the signals that indicate that the patient is a human being monitored for AHE, so a standard level is applied.); and
detecting, by the processor, an AHE event of the patient ([0005] “reporting the acute hypotensive episode and its onset time when detected.”; [0008]) based on the at least one MAP threshold value ([0032] “P is the AHE prediction threshold…If a positive AHE detection is found for P out of R repetitions, an AHE is declared and its onset time is known, at 60”; Fig 4; [0002] “AHE may be defined as…at least ninety percent…of Mean Arterial Pressure (MAP) measurements are at or below 60 mmHg.”)
Regarding Claim 2, Genc discloses as described above, The method according to claim 1. For the remainder of Claim 2, Genc discloses wherein the step of processing, by the processor, the signal to determine the at least one MAP threshold value for the patient (See citation in Claim 1 above) comprises:
determining at least one fluctuation ([0025] “…disturbance”) of the signal from a baseline of the signal ([0025] “disturbance may be added to MAP specifically d is added to the MAP prior to Neural 16.”);
Regarding Claim 3, Genc discloses as described above, The method according to claim 1. For the remainder of Claim 3, Genc discloses wherein the detecting, by the processor, the AHE event of the patient (See citation in Claim 1 above) comprises:
comparing one or more MAP values of the signal against the at least one MAP threshold value ([0028] “determination, at 32, is made whether the MAP is already below a certain level, such as 60 mmHg.. This level is selected because AHE has already started and is still the same AHE.”)
Regarding Claim 9, Genc discloses as described above, The method according to claim 1. For the remainder of Claim 9, Genc discloses further comprising:
receiving a MAP waveform (Fig 1, “MAP (mmHg)” the x axis for the drawn wave; [0024] “when MAP increases SNA decreases, as illustrated in graph 11.”; Fig 4 Block 40: “Read HR and MAP N-point time series data…”; [0025] “The input 14…eventual output of the effector portion 10 is the MAP, which is also an input 16 to the neural portion 12…”) wherein the signal comprises the MAP waveform ([0002] “Mean Arterial Pressure (MAP) measurements”; [0005] “reading heart rate data…mean arterial pressure data from the patent over the given time period“; Fig 1 “graph 11”)
Regarding Claim 10, Genc discloses as described above, The method according to claim 1. For the remainder of Claim 10, Genc discloses further comprising:
receiving at least one clinical data ([0005] “…mean arterial pressure data from the patent over the given time period“) , the at least one clinical data comprising at least one of a blood composition, a urine composition, hemodynamic waveform data, demographic data ([0007] “age of the patient…”), comorbidity data ([0007] “…total peripheral resistance”), a blood pressure ([0007] “…mean arterial pressure…”), a central venous pressure, a frailty score and perioperative administration data, wherein the signal comprises the at least one clinal data ([0005] “…mean arterial pressure data from the patent over the given time period“).
Regarding Claim 11, Genc discloses as described above, The method according to claim 1. For the remainder of Claim 11, Genc discloses further comprising:
determining, by the processor, a prediction of a subsequent AHE event of the patient ([0026] “probabilistic measure on occurrence of AHE in a prediction window is generated. If the probability is above a pre-specified value then the occurrence of the AHE is predicted and the onset time is output.”) based on the at least one MAP threshold value and the signal ([0002] “AHE may be defined as…at least ninety percent…of Mean Arterial Pressure (MAP) measurements are at or below 60 mmHg.”; Fig 5, information from “Sensor/Probes” fed into “Estimate model”, “Simulated Model”, and eventually to “Prediction Model”; [0036])
Regarding Claim 12, Genc discloses as described above, The method according to claim 11. For the remainder of Claim 12, Genc discloses further comprising:
receiving an input ([0037] “The period could be longer, where it may be defined by data that is available.”)(Examiner notes that the input is “data that is available”, which is received by the model and an input.) relating to a time frame ([0037] “estimate model 25 is provided a defined size of data collected over at least a thirty-minute period. “; [0026] “pre-specified prediction window.”), wherein the prediction comprises a prediction of an occurrence of the subsequent AHE event of the patient within the time frame (Fig 5, [0037] “the simulate model 35 has a prediction window size of more than thirty minutes.”; [0031] including “discrete prediction time…”; Fig 3 and Fig 4; [0032] “…AHE is within the prediction window…onset is recorded”)
Regarding Claim 14, Genc discloses as described above, The method according to claim 11. For the remainder of Claim 14, Genc discloses further comprising:
extracting at least one feature (Fig 4; [0031] “Conditioning…the MAP data for…determining an onset of an acute hypotensive episode”, “A mean and standard deviation of random coefficients of the nth (<N) order linear neural portion with a maximum likelihood estimator is calculated, at 44.”) in the signal ([0005] “…mean arterial pressure data from the patent over the given time period“) wherein the determination of the prediction of the subsequent AHE event is based on the at least one feature of the signal (Fig 5, Fig 3 and 4; [0031] – [0033] including “determination…whether an AHE is within the prediction window…onset it recorded, at 54” (of Figure 4)).
Regarding Claim 16, Genc discloses An apparatus for adaptively detecting an Acute Hypotension Episode (AHE) event of a patient ([Abstract]), comprising:
at least one processor ([0008] “execution with a processor…“); and
at least one memory including computer program code ([0018] “memory…appropriate program means for executing the method of the invention.”; [0021] “…program modules…memory storage devices”; [0022])
the at least one memory and the computer program code configured to, with at least one processor, cause the apparatus at least to perform the method ([0018] “memory…appropriate program means for executing the method of the invention.”; according claim 1 (See citations above in Claim 1).
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.
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.
Claims 4, 6 – 8, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Genc in view of Stapelfeldt et. al., (United States Patent Application Publication US 2014/0107504 A1), hereinafter Stapelfeldt.
Regarding Claim 4, Genc discloses as described above, The method according to claim 3. For the remainder of Claim 4, Genc discloses wherein the detecting, by the processor, the AHE event of the patient (See citation in Claim 1 above) comprises:
Genc does not specifically disclose determining if a duration relating to the one or more MAP values is longer than a pre-configured threshold duration.
Stapelfeldt teaches systems and methods for monitoring a patient during a procedure to record severity and duration of hypotension events based on MAP thresholds, determining a calculated risk metric for predicted adverse outcomes related to the procedure. Specifically for Claim 4, Stapelfeldt teaches determining if a duration relating to the one or more MAP values is longer than a pre-configured threshold duration ([0040] “duration of hypotensive periods of time spent below a range of mean arterial blood pressure (MAP) thresholds.”; [0019] “the risk metric can comprise a number of mean arterial blood pressure thresholds that were met for cumulative times exceeding certain predetermined values, Such as one minute or a certain number of minutes”; [0042])
Stapelfeldt provides a motivation to combine at [0023] with “system 30 can also be used to identify and stratify patients after the procedure for more intensive post procedure follow-up care due to risk portended by the severity and duration of aberrant levels of physiological parameters that were experienced during the procedure.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that documenting the duration of the hypotension events would be useful for determining patients that could require additional follow-up care due to risk predicted by the severity and duration of hypotension during a procedure.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the system for detecting and predicting the onset of an acute hypotensive episode from evaluating MAP readings against a threshold disclosed in Genc with the determination of the duration of hypotensive periods of time spent below MAP threshold taught by Stapelfeldt, creating a single hypotension detection and prediction device that can correlate duration of a hypotensive episode with a need for follow-up care to counteract the higher risk of post-procedural adverse events.
Regarding Claim 6, Genc discloses as described above, The method according to claim 1. For the remainder of Claim 6, Genc discloses wherein the detecting, by the processor, the AHE event of the patient (See citation in Claim 1 above) comprises:
determining if a mean MAP value of a baseline of the signal is lower than a second MAP threshold value ([0056] “changes in MAP with respect to time can be derived by subtracting the average of the MAP over the past five minutes, ten minutes, or other time durations, from the current value of the MAP.”; [0028] “…whether the MAP is already below a certain level, such as 60 mmHg”)(Examiner notes that the past value can be considered second MAP threshold in regard to determining a change in MAP (with the to the first MAP threshold set at 60 mmHg.)
Genc does not particularly disclose is lower than a second pre-configured MAP threshold value. Genc does broadly disclose that the MAP can be set at an exemplar level [0028] “such as 60 mmHg”, but is not limited to that level. Further, it broadly discloses evaluating MAP levels dynamically to other average MAP levels at [0056] with the “changes in MAP with respect to time…”
Stapelfeldt teaches determining if a mean MAP value of a baseline of the signal is lower than a second pre-configured MAP threshold value ([0034] “Intraoperative hypotension was common, with MAP dropping (for at least one minute) below 75 mm Hg in 92% of cases and below 45 mm Hg in 10% of cases
(FIG. 6).”)
Stapelfeldt provides a motivation to combine at [0034] with “Worsening hypotension (any amount of time spent below progressively lower MAP thresholds) was reflected by a progressive increase in the average cumulative amounts of time spent below each of the other thresholds across the entire array of MAP thresholds and, associated with this, a progressive increase in 30-day mortality.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that evaluating the MAP against progressively lower MAP thresholds would be useful to determine the severity of the hypotension event, which is useful for determining the risk of 30-day mortality after the hypotensive episode.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the system for detecting and predicting the onset of an acute hypotensive episode from evaluating MAP readings against a threshold disclosed in Genc with the comparing a patient’s MAP values against multiple, increasingly low pre-configured MAP threshold values taught by Stapelfeldt, creating a single hypotension detection and prediction device that can evaluate severity of the AHE by comparing against multiple, increasingly low pre-configured MAP threshold values in order to determine the risk of 30-day mortality after the hypotensive episode.
Regarding Claim 7, Genc discloses as described above, The method according to claim 1. For the remainder of Claim 7, Genc discloses wherein the detecting, by the processor, the one or more AHE events (Examiner notes the 112(b) interpretation above) of the patient comprises:
detecting an onset ([0032] “ a determination is made as to whether an AHE is within the prediction window and the onset is recorded, at 54.”) of the AHE event based on the at least one MAP threshold value and the signal ([0032] “P is the AHE prediction threshold…If a positive AHE detection is found for P out of R repetitions, an AHE is declared and its onset time is known, at 60”; Fig 4; [0002] “AHE may be defined as…at least ninety percent…of Mean Arterial Pressure (MAP) measurements are at or below 60 mmHg.”).
Genc does not specifically disclose and a duration of the AHE event of the patient based on the at least one MAP threshold value and the signal.
Stapelfeldt teaches and a duration of the AHE event of the patient based on the at least one MAP threshold value and the signal [0019] “…a number of mean arterial blood pressure thresholds that were met for cumulative times exceeding certain predetermined values, such as one minute or a certain number of minutes”; [0042] “…duration of hypotension below a wide range of commonly encountered MAP thresholds.” [0028] “blood pressure thresholds for monitoring hypotension…blood pressure values”).
The motivation for Claim 7 to combine Genc with Stapelfeldt is the same as that described in more detail in Claim 4. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the system for detecting and predicting the onset of an acute hypotensive episode from evaluating MAP readings against a threshold disclosed in Genc with the determination of the duration of hypotensive periods of time spent below MAP threshold taught by Stapelfeldt, creating a single hypotension detection and prediction device that can correlate duration of a hypotensive episode with a need for follow-up care to counteract the higher risk of post-procedural adverse events.
Regarding Claim 8, Genc in view of Stapelfeldt discloses as described above, The method according to claim 7. For the remainder of Claim 8, Genc discloses storing the onset of the AHE event of the patient ([0032] “ a determination is made as to whether an AHE is within the prediction window and the onset is recorded, at 54.”), and one or more MAP values associated with the AHE event in a database ([0021] “program modules may be located in both local and remote computer storage media including memory storage devices.”; [0035] “the records, or data collected…”; [0019])
Genc does not specifically disclose and the duration of the AHE event of the patient in a database.
Stapelfeldt teaches store… a duration of the AHE event of the patient ([0040] “duration of hypotensive periods of time spent below a range of mean arterial blood pressure (MAP) thresholds.”; …in a database ([0052] “…arterial blood pressure…The encounter server 122 can store information from such devices 130 data as part of a patient encounter in memory”)
The motivation for Claim 8 to combine Genc with Stapelfeldt is the same as that described in more detail in Claims 4 and 7. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the system for detecting and predicting the onset of an acute hypotensive episode from evaluating MAP readings against a threshold disclosed in Genc with the determination of the duration of hypotensive periods of time spent below MAP threshold taught by Stapelfeldt, creating a single hypotension detection and prediction device that can correlate duration of a hypotensive episode with a need for follow-up care to counteract the higher risk of post-procedural adverse events.
Regarding Claim 13, Genc discloses as described above, The method according to claim 11. For the remainder of Claim 13, Genc discloses wherein the determining, by the processor, the prediction of the subsequent AHE event of the patient (See citation in Claim 11) comprises:
determining a MAP value of the subsequent AHE event ([0026] “predict the MAP in simulate model 35…”)
Genc does not disclose the MAP value relating to a severity level of the subsequent AHE event.
Stapelfeldt teaches the MAP value relating to a severity level of the AHE event ([0035] “the severity of hypotension (the hypotensive MAP threshold exceeded)”; [0034] “MAP dropping (for at least one minute) below 75 mm Hg in 92% of cases and below 45 mm Hg in 10% of cases (FIG. 6)”, “…Worsening hypotension (any amount of time spent below progressively lower MAP thresholds)…”)
The motivation for Claim 13 to combine Genc with Stapelfeldt is the same as that described in more detail in Claim 6. In summary, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the system for detecting and predicting the onset of an acute hypotensive episode from evaluating MAP readings against a threshold disclosed in Genc with the comparing a patient’s MAP values against multiple, increasingly low pre-configured MAP threshold values taught by Stapelfeldt, creating a single hypotension detection and prediction device that can evaluate severity of the AHE by comparing against multiple, increasingly low pre-configured MAP threshold values in order to determine the risk of 30-day mortality after the hypotensive episode.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Genc in view of Schneider et. al., (United States Patent Application Publication US 2022/0400965 A1), hereinafter Schneider, further in view of Mathis et. al., “Preoperative Risk and the Association between Hypotension and Postoperative Acute Kidney Injury”, hereinafter Mathis.
Regarding Claim 5, Genc discloses as described above, The method according to claim 1. For the remainder of Claim 5, Genc discloses wherein the detecting, by the processor, the AHE event of the patient (See citation in Claim 1 above) comprises:
determining at least one MAP threshold, a first pre- configured MAP threshold value ([0028] “determination, at 32, is made whether the MAP is already below a certain level, such as 60 mmHg.. This level is selected because AHE has already started and is still the same AHE.”)
Genc does not disclose at least one MAP threshold is lower than a first pre-configured MAP threshold value. Genc does broadly disclose that the MAP can be set at an exemplar level [0028] “such as 60 mmHg”, but is not limited to that level. Further, it broadly discloses evaluating MAP levels dynamically to other average MAP levels at [0056] with the “changes in MAP with respect to time…”
Schneider teaches implementing a configurable MAP threshold to which the AHE prediction algorithm can adapt. Specifically for Claim 5, Schneider teaches at least one MAP threshold value different than a first pre- configured MAP threshold value ([0043] “an adjusted MAP threshold.”; [0042] “define the occurrence of hypotension with respect to a standard ( e.g., defined) MAP threshold, such as 65 mmHg or other pressure thresholds.”)(Examiner notes that the MAP threshold can be “adjusted´ to something other than the first pre-set value, 65 mmHg as taught by Schneider, or it would be 60 mmHg as disclosed by Genc.)
Schneider provides a motivation to combine at [0024] with “enabling dynamic adaptation of the model to an adjusted MAP threshold that may be based on training and expertise of medical personnel.“ A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that being able to adjust the MAP threshold for a patient would be useful for applying medical expertise and experience to set an effective MAP threshold for actually detecting hypotensive events, in cases where the standard value of 60 mmHg (disclosed in Genc) is less effective for the patient.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the system for detecting and predicting the onset of an acute hypotensive episode from evaluating MAP readings against a threshold broadly “such as 60 mmHg” disclosed in Genc with the particular accommodation to adjust the MAP threshold in a predictive AHE model taught by Schneider, creating a single hypotension detection and prediction device that can evaluate severity of the AHE by comparing against different settings of MAP threshold values in order to more accurately evaluate hypotensive events for patients.
Schneider does not specifically disclose how to determine an appropriate adjusted MAP threshold. Schneider is open to obtaining the adjusted MAP threshold through other means than direct user input at [0017] “accommodate the adjustable (e.g., user defined or otherwise adjusted) MAP threshold”, and it defers to medical
Mathis teaches determining different MAP thresholds on a patient-by-patient basis that are indicative of potential acute kidney injury based on the determined pre-operative risk level. Specifically for Claim 5, Mathis teaches determining if the at least one MAP threshold value is lower than a first pre- configured MAP threshold value (Figure 3 with MAP 60 – 64 mmHg, 50 – 59 mmHg, 50 – 54 mmHg, and <50 mmHg; [Page 2, “Results:” Section] “Patients with medium risk…associations between severe-range intraoperative hypotension (mean arterial pressure less than 50 mmHg) and acute kidney injury… patients with the highest risk, mild hypotension ranges (mean arterial pressure 55 to 59 mmHg) were associated with acute kidney injury”; [Page 12, “Conclusions” Section] “high-risk patients are sensitive to hypotension as mild as MAP of less than 65 mmHg, levels routinely tolerated in perioperative or critical care settings.“)(Examiner notes that the pre-configured MAP threshold can be the standard MAP threshold of a mean arterial pressure (MAP) of less than 65 mmHg.)
Mathis provides a motivation to combine at [Page 9, Bottom] with “The data presented establish the intuitive concept that the relationship between hypotension and AKI varies by underlying patient and procedural risk,” and [Page 8, Bottom] that describes differing levels of acute kidney injury risk based on the MAP range of less than 50 mmHg for persons with medium preoperative risk and 60 – 65 mmHg for persons with highest preoperative risk. A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that setting the MAP threshold based on the preoperative risk for the patient would be useful for having an appropriate level to minimize the risk of acute kidney injury for the particular patient. Genc in view of Schneider already includes the ability for a medical professional (or other means) to dynamically set the threshold. Mathis provides teaching of logic that could be used to determine what a threshold should be for a given patient.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the system for detecting and predicting the onset of an acute hypotensive episode from evaluating MAP readings against an adjustable MAP threshold disclosed in Genc in view of Schneider with the different MAP thresholds, lower and higher, depending on the overall preoperative risk levels taught by Mathis, creating a single hypotension detection and prediction device that can evaluate severity of the AHE by comparing against appropriate settings of MAP threshold values to minimize the risk of acute kidney injury for the particular patients of differing preoperative risk levels.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Genc in view of Rocha et. al., “Prediction of acute hypotensive episodes by means of neural network multi-models”, hereinafter Rocha.
Regarding Claim 15, Genc discloses as described above, The method according to claim 14. For the remainder of Claim 15, Genc discloses wherein the step of determining, by the processor, the prediction of the subsequent AHE of the patient (See citation in Claim 14 above) comprises:
determining two or more predictions based on the at least one feature extracted from a plurality of signals ([0005] “predicting (or determining) one or more occurrences of acute hypotensive episodes (AHE) prior to their onset.”)
Genc does not disclose relating to a plurality of patients; comparing the two or more predictions to determine an optimal prediction of subsequent AHE events of the plurality of patients based on the at least one feature extracted from the plurality of signals, the optimal prediction being either one of or a combination of the two or more predictions, wherein the prediction of the subsequent AHE of the patient is based on the optimal prediction of the subsequent AHE events of the plurality of patients.
Rocha teaches application of neural network multi-models to the prediction of adverse acute hypotensive episodes (AHE) occurring in intensive care units using data from multiple patients. Specifically for Claim 15, Rocha teaches determining two or more predictions based on the at least one feature extracted from a plurality of signals relating to a plurality of patients ([Page 882, Right Column, “2.1. Challenge Goal Section”, Paragraph 1 - 2])…” predict which patients in the available dataset (MIMIC-II) would experience an acute hypotensive episode…”; “challenge dataset…a time series of mean arterial blood pressure (MAP) at one-minute intervals…”; [Page 882, right column – Page 883, Left Column, “2.2. Mimic-II project” Section] – [Page 882, “2.3. Training and test datasets” Section] “…data from about 30,000 ICU patients to date, including recorded physiologic signals and time series,”, “…patient records from the MIMIC-II database…”);
determining two or more predictions based on the at least one feature extracted from a plurality of signals [Page 882, Right Column, “2.1. Challenge Goal Section”, Paragraph 1 - 2])…” predict which patients in the available dataset (MIMIC-II) would experience an acute hypotensive episode…”; “challenge dataset…a time series of mean arterial blood pressure (MAP) at one-minute intervals…”; [Page 882, right column – Page 883, Left Column “2.2. Mimic-II project” Section] – [Page 882, “2.3. Training and test datasets” Section] “…data from about 30,000 ICU patients to date, including recorded physiologic signals and time series,”, “…patient records from the MIMIC-II database…”));
comparing the two or more predictions to determine an optimal prediction of subsequent AHE events of the plurality of patients [Page 886, Left Column, “3.3.3. Prediction of MAP signals” Section, Paragraph 1 – Paragraph 5], “Given a new MAP testing signal, truncated at time instant To, the MAP forecast is done based on previous trained GRNN multi-models…“, “…a weighted average of the predictions performed by the M multi-models is computed…”; [Page 888, Left Column, 4th Full Paragraph] “The final MAP predicted signal is computed as the weighted average of all four estimated predictions, Eq. (14)“) based on the at least one feature extracted from the plurality of signal [Page 886, “3.3.3. Prediction of MAP signals” Section, Paragraph 1 – Paragraph 5]…“…stored MAP templates…”, [Page 888, Left Column, 4th Full Paragraph] “The final MAP predicted signal...weighted average of all fours estimated predictions…”), the optimal prediction being either one of or a combination of the two or more predictions [Page 886, Left Column “3.3.3. Prediction of MAP signals” Section, Paragraph 1 – Paragraph 5]…“…a weighted average of the predictions performed by the M multi-models is computed…”; [Page 888, Left Column, 4th Full Paragraph] “The final MAP predicted signal...weighted average of all fours estimated predictions…”), wherein the prediction of the subsequent AHE of the patient is based on the optimal prediction of the subsequent AHE events of the plurality of patients ([Page 882, Right Column, “2.1. Challenge Goal Section”, Paragraph 1 - 2])…” predict which patients in the available dataset (MIMIC-II) would experience an acute hypotensive episode…”; “challenge dataset…a time series of mean arterial blood pressure (MAP) at one-minute intervals…”; [Page 886, Left Column, “3.3.3. Prediction of MAP signals” Section, Paragraph 1 – Paragraph 5], “Given a new MAP testing signal, truncated at time instant To, the MAP forecast is done based on previous trained GRNN multi-models…“, “…a weighted average of the predictions performed by the M multi-models is computed…”; [Page 888, Left Column, 4th Full Paragraph] “The final MAP predicted signal...weighted average of all fours estimated predictions…”)
Rocha provides a motivation to combine at [Page 881, Left Column] with “early detection of AHE will give professionals enough time to select a more effective treatment, without exposing the patient to additional risks of delaying therapy” and [Page 881, Right Column, 1st Full Paragraph] “It is clinically accepted that if there exists enough patient’s clinical information, then a prediction system for hypotensive episodes, over a specific time period, can be developed.” A person having ordinary skill in the art before the effective filing date of the claimed invention would recognize that using neural network multi-models would be useful to analyze data from many patients to increase the accuracy of the prediction, as well as allow for predictions to be made for more than one patient, overall enabling early detection to select an effective treatment of the hypotension episode.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the system for make one or more predictions of the onset of an acute hypotensive episode from evaluating patient MAP data disclosed in Genc with Rocha’s taught neural network multi-models for predicting AHE using data from multiple patients and weighted optimization of the prediction, creating a single hypotension detection and prediction device that can predict AHE by incorporating data and predictions from many patients to increase the accuracy of the predictions and enabling early detection to select an effective treatment of the hypotension episode.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tsuji et. al., “Recurrent probabilistic neural network-based short-term prediction for acute hypotension and ventricular fibrillation” teaches a method to predict acute clinical deterioration triggered by hypotension, including machine learning to investigate data among many patients with hypotension.
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/MELISSA JO MONTGOMERY/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791