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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/21/26 has been entered.
Status of Claims
Claims 1-18 are rejected.
Response to Arguments
Claim Rejections - 35 USC § 101
Applicant's arguments filed 7/29/26 have been fully considered but they are not persuasive.
Applicant asserts that the amendments do not merely add data gathering or insignificant extra-solution activity (Remarks, page 13). However, the Examiner disagrees. The amendments are further directed to the abstract idea and insignificant extra-solution activity as indicated in the rejection below.
Applicant asserts that the mathematical processing is therefore integrated into operation of a computerized physiological decision-support system rather than being performed in the abstract (Remarks, page 14). However, the Examiner disagrees. Applicant asserts that the processor applies the mathematical processing (Remarks, page 14). The processor is recited at a high-level of generality and amounts to nothing more than a part of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Applicant asserts that the plots improve the operation of the computerized clinical decision-support system by continuously integrating incoming physiological measurements into both confidence calculations and correlated physiological visualizations (Remarks, page 15). However, the plots are directed to the abstract idea. In addition, merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Applicant asserts that the claimed invention cannot practically be performed as a mental process (Remarks, page 15). However, the Examiner disagrees. 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 claimed mathematical processing is inseparably integrated with computerized acquisition of physiological measurements, derivation of physiological features, generation of continuously updated confidence calculations, generation of correlated physiological-state visualizations, and computerized presentation of the resulting technical outputs for clinical decision support (Remarks, page 15). However, the Examiner disagrees. Applicant asserts that the processor applies the mathematical processing (Remarks, page 14). The processor is recited at a high-level of generality and amounts to nothing more than a part of a generic computer. Merely including instructions to implement an abstract idea on a computer does not integrate a judicial exception into practical application.
Applicant asserts that the technical operations improve the manner in which computerized physiological data are processed, organized, correlated, and presented during management of patients at risk for shock (Remarks, page 16). 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).
Claim Objections
Claim 1 is objected to because of the following informalities: line 5 is missing “and” in between the last two structural elements of a memory and a processor. Applicant is encouraged to amend “and” after a memory. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: line 54 is missing “and” in between the last two steps the processor is configured to perform. Applicant is encouraged to amend “and” after the generating step and before the transmitting step. Appropriate correction is required.
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 claim 1 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 claim 1, the specification discloses 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 ¶16 and ¶17), 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 “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; one or more activation functions associated with each rule, wherein each activation function maps a value of a feature of the plurality of features into an activation function value, wherein each activation are mathematical calculations of performing addition, division, ratios, etc. in order for shock detection and management (see ¶12, ¶41-43, and ¶47 of the specification).
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 maps a value of a feature of the plurality of features into an activation function value, wherein each activation 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, and systemic vascular resistance. In addition, receiving a multiplicity of rules, wherein each rule comprises a treatment recommendation. Next, mapping a value of a feature of the plurality of features into an activation function value on paper, which is selected from the group consisting of a monotonically nondecreasing function, a monotonically nonincreasing function, and a piecewise linear function. 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, wherein each confidence level changes gradually and continuously as values of the plurality of features change over time. Then, writing down a two-dimensional plot of the physiological status of the patient on paper where the cardiac index is on one axis and a value of the systemic vascular resistance on a second axis. The confidence levels associated with the plurality of recommended rules are correlated with the one or more plots. The plots aid the clinician and provide a method of which of the plurality of recommended rules are applicable in which patient physiological states. 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, 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, 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.
Claim 16 is further directed to the abstract idea as indicated above for claim 1.
Claim 17 is further directed to the abstract idea as indicated above for claim 1.
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.
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).
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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/LAURA HODGE/Examiner, Art Unit 3792
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