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 .
Status of Claims
Claims 1-18 are rejected.
Response to Arguments
Claim Rejections - 35 USC § 112
Applicant’s arguments, see Remarks, filed 5/1/26, with respect to claim 18 have been fully considered and are persuasive. The 112 rejection of claim 18 has been withdrawn.
Claim Rejections - 35 USC § 101
Applicant's arguments filed 5/1/26 have been fully considered but they are not persuasive.
Applicant asserts that claim 1 as amended herein includes sufficient structural and transformational limitations that integrate into a practical application and improve the technology in the art. However, the Examiner disagrees. An improvement to the abstract idea is still an abstract idea.
Applicant asserts that the claim invention recites a specific integrated medical system that obtains data real-time, processes data, generates treatment recommendations, presents those recommendations, receives clinician input, and updates outputs over time. However, the claim does not recite this being performed in real-time. Even if the claim did recite this, MPEP 2106.05(f) states:
Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).
The processing steps, generating treatment recommendations, presenting the recommendations, receiving clinician input, and updating the outputs over time are directed to the abstract idea.
Applicant asserts that the claims states generating two-dimensional physiological plots and continuously updating confidence levels based on time-varying clinical measurements. However, generating a plot can be done using pen and paper and is directed to the abstract idea. Updating the confidence levels is also directed to the abstract idea. In addition, the claim does not recite this being performed continuously.
Applicant asserts that the claim integrates the exception into a practical application through “one or more devices that measure or record a plurality of clinical parameters…including one or more hemodynamic parameters.” However, the one or more devices amount to pre-solution activity of data gathering and are a well-understood, routine, and conventional structure as evidenced below.
Applicant asserts that the claimed system does not operate on abstract data, but instead processes real-world physiological measurements from a patient. The Examiner notes that as shown in the rejection below, the measurements from the one or more devices amount to pre-solution activity of data gathering.
Applicant asserts the alleged abstract idea is integrated into a technological environment involving physiological sensors and patient monitoring, which the USPTO recognizes as indicative of a practical application. See MPEP 2106.05(d)(1). However, the physiological sensors in the claims amount to pre-solution activity of data gathering and are well-understood, routine, and conventional activity as evidenced below.
Applicant asserts that the system produces actionable outputs that guide medical treatment decisions, thereby transforming raw data into a clinically meaningful result. However, this is directed to the abstract idea as the claim does not positively recite the administration of medications and performance of medical procedures. A clinician can write down their selection based on a list of choices.
Applicant asserts that courts have repeatedly found eligibility where claims process real-world signals and product actionable outputs. See CardioNet, LLC v. InfoBionic, Inc., 955 F.3d 1358 (Fed. Cir. 2020). However, the judicial exception alone cannot provide the improvement. See MPEP 2106.05(a):
It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field.
Applicant asserts that it is not a generic display, but a specific, domain-tailored visualization of physiological state, directly tied to the underlying computational model. However, MPEP 2106.05(f) states:
Use of 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 integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit).
Applicant asserts that such a visualization improves a clinician’s ability to interpret patient condition, provides context for treatment recommendations, and enhances understanding of dynamic physiological changes. However, merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Applicant asserts that there is a closed-loop decision support system, where: 1) physiological data is collected, 2) recommendations are generated, 3) clinicians select interventions, and 4) the system continues updating outputs. However, the data collection amounts to pre-solution activity of data gathering. Steps 2-4 are directed to the abstract idea. See the rejection below for further details.
Applicant asserts that updating confidence levels: “over time as values of the plurality of clinical parameters change over time” reflects a continuous monitoring and adaptive processing system. However, the claim does not recite this being performed in real-time or continuously. Even if the claim did recite this, MPEP 2106.05(f) states:
Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).
Applicant asserts that the claim invention discloses non-conventional combination of elements including: physiological data acquisition, feature derivation, activation functions with defined mathematical properties, weighted aggregation, confidence-based ranking of rules, domain-specific visualization, and interactive clinician input. However, these limitations are directed to the abstract idea and are not additional elements.
Applicant asserts that the claimed invention discloses an improvement over conventional clinical practice. Specifically, the specification as originally filed explains that clinicians traditionally: manually collect disparate data, perform calculations, and apply inconsistent guidelines under time pressure. However, MPEP 2106.05(f) states:
Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. The limitation of “one or more devices that measure or record…patient” in claims 1-5 and 10-18 has been interpreted under 35 U.S.C. 112(f).
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
For “one or more devices” in claims 1-5 and 10-18, the specification discloses be a right heart catheter and an associated hemodynamic monitor, a central venous catheter, a sphygmomanometer, a laboratory information system, an electronic medical record system, a noninvasive cardiac output monitor, a ventricular assist device, a ventilator (see [0016] and [0017]), or any equivalents thereof.
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 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, specifically an abstract idea.
Step 1
The claimed invention in claims 1-18 are directed to statutory subject matter as the claims recite a shock detection and management system.
Step 2A, Prong One
Regarding claim 1, the recited steps are directed to mathematical concepts and a mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsections (I) and (III)).
Regarding claim 1, the limitations of “cardiac index, comprising the cardiac output divided by a body surface area of the patient; and systemic vascular resistance, comprising the cardiac output divided by the mean arterial pressure” are mathematical calculations of performing addition and division in order for shock detection and management.
Regarding claim 1, the limitations of “a plurality of features, each selected from or derived from the plurality of clinical parameters, wherein the plurality of features comprise one or both of cardiac output; and cardiac index, comprising the cardiac output divided by a body surface area of the patient; mean arterial pressure; and systemic vascular resistance, comprising the cardiac output divided by the mean arterial pressure; and, a multiplicity of rules, wherein each rule comprises a treatment recommendation; one or more activation functions associated with each rule, wherein each activation function of the one or more activation functions maps a value of a feature of the plurality of features into an activation function value; a weight associated with each activation function and with each rule; and a confidence function associated with each rule that maps values of the plurality of features into a confidence level that the treatment recommendation is beneficial for the patient, wherein the confidence function is calculated by applying an aggregation function to activation function values associated with each rule using the weight associated with each activation function and with each rule; calculate values of the plurality of features from the values of the plurality of clinical parameters; calculate the confidence level for each rule of the multiplicity of rules using the confidence function associated with each rule; select a plurality of recommended rules from the multiplicity of rules that have highest confidence levels; update the plurality of recommended rules and associated confidence levels as values of the plurality of clinical parameters change over time; wherein each of the plurality of recommended rules correspond to clinical interventions comprising one or more of administration of medications and performance of medical procedures; generate one or more plots of the physiological status of the patient based on the plurality of features, including a two-dimensional plot of cardiac index and systemic vascular resistance, and receive input…indicating selection of one or more of the plurality of recommended rules by said one or more clinicians, each corresponding to a clinical intervention” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional selecting features including one or both of cardiac output and cardiac index, mean arterial pressure, systemic vascular resistance, and a multiplicity of rules. Next, mapping a value of a feature of the plurality of features into an activation function value on paper. Next, determining a weight with each activation function and each rule, and a confidence function associated with each rule that maps values of the plurality of features into a confidence level that the treatment recommendation is beneficial for the patient, wherein the confidence function is calculated by applying an aggregation function to activation function values associated with each rule using the weight associated with each activation function and with each rule. Next, calculating values of the plurality of features from the values of the plurality of clinical parameters; calculating the confidence level for each rule of the multiplicity of rules using the confidence function associated with each rule; selecting a plurality of recommended rules from the multiplicity of rules that have highest confidence levels; and updating the plurality of recommended rules and associated confidence levels over time as values of the plurality of clinical parameters change over time. The updating continues as values of the plurality of clinical parameters change over time. Then, writing down a two-dimensional plot of the physiological status of the patient on paper. Lastly, having the clinician write down their choice of one or more of the plurality of recommended rules.
Step 2A, Prong Two
For claim 1, the judicial exception is not integrated into a practical application. In particular, claim 1 recites “a processor, a display, a user interface, one or more devices, a memory, and transmitting steps.” The one or more devices amount to nothing more than pre-solution activity of data gathering. The processor, display, user interface, and memory are recited at a high-level of generality and amount to nothing more than parts of a generic computer. The transmitting steps and displaying plots amounts to post-solution activity. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into
a practical application, the additional element of the one or more devices amounts to nothing more than mere pre-solution activity of data gathering, which does not amount to an inventive concept. Moreover, the one or more devices are recited at a high level of generality and are well-understood, routine, and conventional structures as evidenced by US 20210290085 (¶2-conventional barometric sphygmomanometer), US 20020019592 (¶2-conventional wrist sphygmomanometers), and US 20160228661 (¶6-a conventional mechanical ventilator). Further, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known to the industry, as discussed in Alice Corp., 573 U.S. at 225, 110 USPQ2d at 1984 (see MPEP § 2106.05(d)).
Regarding dependent claims 2-18, the limitations of claim 1 further define the limitations already indicated as being directed to the abstract idea.
Claim 2 is further directed to the abstract idea as indicated above for claim 1.
Claim 3 is further directed to the abstract idea as indicated above for claim 1.
Claim 4 is further directed to the abstract idea as indicated above for claim 1.
Claim 5 is further directed to the abstract idea as indicated above for claim 1.
Regarding claim 6, wherein the one or more devices comprise a right heart catheter and an associated hemodynamic monitor amount to pre-solution activity of data gathering and are well-understood, routine, and conventional activity as evidenced by: US 20190142284 (¶15-conventional hemodynamic monitors), US 20220061799 (¶41-a routine right heart catheter), and US 20080221460 (¶26-conventional right heart catheter).
Regarding claim 7, wherein clinical parameters measured by the right heart catheter comprise the cardiac output, the cardiac index, the systemic vascular resistance, pulmonary catheter wedge pressure, central venous pressure, and pulmonary vascular resistance amounts to pre-solution activity of data gathering and are well-understood, routine, and conventional activity as evidenced by: US 20220061799 (¶41-a routine right heart catheter), US 20080221460 (¶26-conventional right heart catheter), and US 20220061804 (¶65-a conventional Swan-Ganz catheter).
Regarding claim 8, wherein the one or more devices further comprise one or more of a central venous catheter; a sphygmomanometer; a laboratory information system; an electronic medical record system; and, a noninvasive cardiac output monitor amounts to pre-solution activity of data gathering and are well-understood, routine, and conventional activity as evidenced by: US 20210290085 (¶2-conventional barometric sphygmomanometer), US 20020019592 (¶2-conventional wrist sphygmomanometers), and US 20210233629 (¶16-a conventional electronic medical records system).
Regarding claim 9, wherein the one or more devices further comprise one or more of a ventricular assist device; and, a ventilator, amount to pre-solution activity of data gathering and are well-understood, routine, and conventional activity as evidenced by: US 20160228661 (¶6-a conventional mechanical ventilator), US 20130032149 (¶3-conventional ventilators), and US 20090229611 (¶37- conventional ventilator).
Regarding claim 10, “a processor and a user interface” are recited at a high-level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Regarding claim 11, the limitation of “wherein the one or more clinicians can further enter notes that explain acceptance or rejection of one or more of the plurality of recommended rules” is a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, this limitation is nothing more than a medical professional writing down notes that explain acceptance or rejection of one or more of the plurality of recommended rules. A “user interface” is recited at a high-level of generality and amount to nothing more than parts of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Regarding claim 12, the limitations of “perform an analysis of the notes and the acceptance or rejection of one or more of the plurality of recommended rules; and modify the multiplicity of rules based on this analysis” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional reviewing notes and accepting or rejecting one or more of the plurality of recommended rules; and modifying the multiplicity of rules based on this analysis.
Regarding claim 13, the limitation of “wherein the aggregation function comprises a weighted average using the weight associated with each activation function and with each rule” is a mathematical calculation of performing addition and division in order for shock detection and management.
Claim 14 is further directed to the abstract idea as indicated above for claim 1.
Claim 15 is further directed to the abstract idea as indicated above for claim 1.
Regarding claim 16, the limitation of “generate one or more plots of the physiological status of the patient based on values of the plurality of features” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, this limitation is nothing more than a medical professional drawing on paper one or more plots of the physiological status of the patient based on values of the plurality of features. Additionally, the transmitting step amounts to post-solution activity.
Regarding claim 17, the limitation of “wherein the one or more plots of the physiological status of the patient comprise a two-dimensional plot of a value of the cardiac index on one axis and a value of the systemic vascular resistance on a second axis” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, this limitation is nothing more than a medical professional drawing on paper one or more plots of the patient comprising a two-dimensional plot of a value of the cardiac index on one axis and a value of the systemic vascular resistance on a second axis.
Regarding claim 18, the limitations of “generate a training dataset comprising samples having the values of the plurality of features as inputs and treatments performed as outputs; generate the confidence function associated with each rule based of the multiplicity of rules; and generate the confidence function of the each rule of the multiplicity of rules based on the plurality of features, and use the confidence function associated with the each rule of the multiplicity of rules to calculate a confidence level for the each rule of the multiplicity of rules” are a process, as drafted, covers performance of the limitation that can be performed by a human mind (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard. For example, these limitations are nothing more than a medical professional taking the inputs and outputs based on received data and making a determination of the confidence function associated with each rule and features. The receiving steps amount to pre-solution activity of data gathering. Applicant includes a machine learning system/a supervised learning model which is nothing more than the computer implementation/automation of an abstract mental process of screening a patient, which is what a physician typically does with a patient in a diagnostic setting.
Examiner’s Note
Claims 1-18 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office action.
Regarding claim 1, the scope of a plurality of features, each selected from or derived from the plurality of clinical parameters, wherein the plurality of features comprise one or both of cardiac output; and cardiac index, comprising the cardiac output divided by a body surface area of the patient; mean arterial pressure; and systemic vascular resistance, comprising the cardiac output divided by the mean arterial pressure; and, a multiplicity of rules, wherein each rule comprises a treatment recommendation; one or more activation functions associated with each rule, wherein each activation function of the one or more activation functions maps a value of a feature of the plurality of features into an activation function value; select a plurality of recommended rules from the multiplicity of rules that have highest confidence levels; and update the plurality of recommended rules and associated confidence levels over time as values of the plurality of clinical parameters change over time were not found in the prior art alone or in combination with one another to be obvious over the prior art of record. The closest prior art of record is US 20170053077; however it fails to recite a multiplicity of rules, wherein each rule comprises a treatment recommendation; one or more activation functions associated with each rule, wherein each activation function of the one or more activation functions maps a value of a feature of the plurality of features into an activation function value; select a plurality of recommended rules from the multiplicity of rules that have highest confidence levels; and update the plurality of recommended rules and associated confidence levels over time as values of the plurality of clinical parameters change over time.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20240090779: it may be desirable to never deliver a shock to a conscious subject (¶50) and determine whether to deliver one or more treatment shocks via the plurality of treatment electrodes to treat the identified treatable arrhythmia using the confidence level for the identified treatable arrhythmia (claim 18).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA HODGE whose telephone number is (571) 272-7101. The examiner can normally be reached M-F: 8:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, UNSU JUNG can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.N.H./Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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