DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-14, in the reply filed on 6/25/2026 is acknowledged.
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/25/2026.
Examiner’s Note: The restriction requirement mailed on 4/29/2026 identified invention I as claims 1-15 as a system for monitoring arterial pressure and invention II as claims 16-20 as a method of monitoring arterial pressure. There was a typographical error which was obvious in view of the content of the restriction requirement, in that group I should have been identified as claims 1-14 as those claims are drawn to the system and invention II should have been identified as claims 15-20 as those claims are drawn to the method. Further, the applicant’s response to the restriction requirement identified claims 9-13 as being drawn to group II for the method. For the purpose of advancing prosecution, the examiner will examine claims 1-14, as those are the claims that are clearly drawn to group I as identified in the restriction requirement mailed on 4/29/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 8/6/2024 was received and placed in the record on file. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
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.
No claim limitations of the instant invention are being interpreted as invoking a 35 USC 112(f) interpretation.
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 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding claims 1-14; independent claim 1 is the exemplary claim and is directed to a machine (Step 1: Yes) and recites a judicial exception regarding an abstract idea (Step 2A, Prong 1: Yes). The abstract idea is bolded and italicized in the recreated claims below:
Claim 1:
A system for monitoring arterial pressure of a patient and providing a warning to medical personnel of nociception of the patient, the system comprising:
a hemodynamic sensor that produces hemodynamic data representative of an arterial pressure waveform of the patient;
a system memory that stores nociception software code;
a user interface that includes a sensory alarm that provides a sensory signal to warn the medical personnel of a nociception event of the patient; and
a hardware processor that is configured to execute the nociception software code to:
perform waveform analysis of the hemodynamic data to determine a plurality of signal measures;
extract detection input features from the plurality of signal measures that are indicative of the nociception event of the patient;
extract hemodynamic drug detection input features from the plurality of signal measures that are indicative of a hemodynamic drug administration event of the patient;
extract hemodynamic drug prediction input features from the plurality of signal measures that are predictive of effects to the patient from a future hemodynamic drug administration event;
extract stable detection input features from the plurality of signal measures that are indicative of a stable episode of the patient;
determine a first probability based on the hemodynamic drug prediction input features and the stable detection input features, wherein the first probability represents a probability of the patient experiencing effects from the future hemodynamic drug administration event;
determine a second probability based on the detection input features and the hemodynamic drug detection input features, wherein the second probability represents a probability of the patient experiencing the current nociception event versus the current hemodynamic drug administration event;
determine a third probability based on the detection input features and the stable detection input features, wherein the third probability represents a probability of the patient experiencing the current nociception event versus the stable episode;
compare the third probability with the first probability and the second probability to determine an output probability of the current nociception event of the patient; and
invoke the sensory alarm of the user interface in response to the output probability satisfying a predetermined detection criterion.
The independent claim encompasses an abstract idea drawn to a mental process that can be done in the human mind and/or by hand using pen and paper. If a claim, under its broadest reasonable interpretation, covers performance in the mind but for the recitation of generic computer components, then it is still in the mental processes category unless the claim cannot practically be performed in the mind, see Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016). In this case, the steps of: performing waveform analysis of the hemodynamic data to determine a plurality of signal measures; extracting detection input features from the plurality of signal measures that are indicative of the nociception event of the patient; extracting hemodynamic drug detection input features from the plurality of signal measures that are indicative of a hemodynamic drug administration event of the patient; extracting hemodynamic drug prediction input features from the plurality of signal measures that are predictive of effects to the patient from a future hemodynamic drug administration event; extracting stable detection input features from the plurality of signal measures that are indicative of a stable episode of the patient; determining a first probability based on the hemodynamic drug prediction input features and the stable detection input features, wherein the first probability represents a probability of the patient experiencing effects from the future hemodynamic drug administration event; determining a second probability based on the detection input features and the hemodynamic drug detection input features, wherein the second probability represents a probability of the patient experiencing the current nociception event versus the current hemodynamic drug administration event; determining a third probability based on the detection input features and the stable detection input features, wherein the third probability represents a probability of the patient experiencing the current nociception event versus the stable episode; and comparing the third probability with the first probability and the second probability to determine an output probability of the current nociception event of the patient are drawn to mental processes. In other words, the limitations as currently recited are drawn to the mental process that includes observation (analyzing the waveform), evaluation (extracting input features from the analysis), judgement and opinion (determining probabilities from input features and comparing of the probabilities).
Further, the claims do not recite additional elements that integrate the judicial exception into a practical application (Step 2A, Prong 2: No). The claims fail to recite additional elements or combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes meaningful limitations on the judicial exception. In the instant claim, the identified additional elements of: a hemodynamic sensor that produces hemodynamic data representative of an arterial pressure waveform; a system memory that stores nociception software code; a user interface that includes a sensory alarm that provides a sensory signal to warn the medical personal of a nociception event of the patient; and a hardware processor that is configured to execute the nociception software code, do not integrate the judicial exception into a practical application. Rather the additional elements of the instant claims amount to adding insignificant extra solution activity to the judicial exception (in this case, mere data gathering and output through use of a generic sensor recited at a high level of generality for obtaining/collecting the data and patient interface for outputting a result of the abstract idea analysis recited at a high level of generality); or amount to mere instructions for “applying the judicial exception by including the instruction to implement on a computer, or merely using a computer as a tool to perform the abstract idea” (in this case recitation of generic system memory for storing nociception software code containing the abstract idea and generic hardware processor configured to execute the nociception software code consisting of the abstract idea, both of which are recited at a high level of generality). Further, the additional elements, considered individually and as a whole, with the abstract idea: do not result in an improvement in the functioning of a computer or improvement in technology or technological field (the specification does not support or describe the improvement of the functioning of a computer or improvement in technology); do not apply the judicial exception to effect a particular treatment or prophylaxis (no treatment or prophylaxis is recited); do not implement the judicial exception in conjunction with a particular machine or manufacture which is integral to the claim (wherein the examiner notes that the machines/manufactures of the hemodynamic sensor, system memory, user interface and hardware processor as currently recited are all recited at a high level of generality and/or are conventional); do not affect the transformation or reduction of a particular article to a different state (wherein the data set being analyzed is not an article); and do not apply the judicial exception in a meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception (wherein the additional elements are recited a high level of generality and aren’t implemented in a meaningful way beyond carrying out the abstract idea).
Finally, the claims as a whole, do not include additional elements that are sufficient to amount to significantly more than the judicial exception (Step 2B: No). Specifically, the additional elements of: a hemodynamic sensor that produces hemodynamic data representative of an arterial pressure waveform; a system memory that stores nociception software code; a user interface that includes a sensory alarm that provides a sensory signal to warn the medical personal of a nociception event of the patient; and a hardware processor that is configured to execute the nociception software code; do not amount to or contribute to the inventive concept recited in the abstract idea. The additional elements, considered individually and as a whole, amount to merely implementing the abstract idea on a computer (through reciting the software code stored on a system memory and a hardware processor for executing the code recited at a high level of generality) and carrying out mere extra-solution activity (data collection and output via generic sensors and display/interface recited at a high level of generality) that do not attempt to meaningfully limit the abstract idea. Therefore, the additional elements, considered individually and as a whole, do not amount to more than the abstract idea.
Accordingly, claim 1 is rejected as non-statutory as being directed to a judicial exception without significantly more.
Furthermore, the dependent claims 2-14, do not recite any additional elements that implement the abstract idea into a practical application or amount to significantly more than the abstract idea.
Regarding claim 2-5; the claims merely recite further steps of the abstract idea by further defining what determined the input features from claim 1 wherein eligibility cannot be furnished by the unpatentable abstract idea itself (MPEP 2106.04 II, A, 2); and furthermore wherein claims 2-5 are not positively recited, and merely provide a statement of fact for how the features that are extracted for claim 1 were determined (i.e. they don’t materially affect or limit the claim, see the 35 USC 112(b) rejection below)
Regarding claims 6-10, the claims merely recite further steps of the abstract idea by further defining the mental process identified in claim 1; wherein eligibility cannot be furnished by the unpatentable abstract idea itself (MPEP 2106.04 II, A, 2).
Regarding claims 11 and 12; the claims further define the generically recited hemodynamic sensor recited in independent claim 1, however the examiner notes that non-invasive hemodynamic sensor that is attachable to an extremity of a patient (claim 11) and a minimally invasive arterial catheter based hemodynamic sensor (claim 12) are both conventional, well understood and routine hemodynamic sensors that produce hemodynamic data representative of arterial pressure waveforms of the patient as evidenced by Rogers et al US 2021/0386300 A1 which discloses in paragraph [0204] that hemodynamic waveforms are known to be measured by known pressure measurement sensors including non-invasive BP cuffs wrapped around limbs or a patient or continuous catheter based arterial line pressure sensors.
Regarding claims 13 and 14; the claims further define the signal produced by the hemodynamic sensor as an analog signal (claim 13) and the additional element of an analog to digital converter for converting the analog signal into a digital signal (claim 14); however the examiner takes official notice that sensor collecting analog signals and the use of an analog-to-digital converter to convert an analog signal to a digital signal for analysis by a computer system are conventional, well-known and routine elements. Accordingly, the additional elements of claims 13 and 14 do not amount to significantly more than the abstract idea as they are conventional, routine and well-known elements.
Examiner’s Note: the examiner notes that the subject matter of claims 2-5 could overcome the 35 USC 101 rejection if they were amended to recite the claims limitations as active steps of training a machine learning model via detection machine training the additional elements of the machine learning model and the active steps of the detection machine training would amount o significantly more than the abstract idea as the human mind cannot reasonable perform the machine learning model training via detection machine training as recited in claims 2-5. The examiner invites the applicant to amend the claims or set up an interview with the examiner to discuss possible amendments to overcome the 35 USC 101 rejection.
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 2-5 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.
Specifically, as currently recited, it is unclear how claims 2-5 materially affect the scope of the system and software code of independent claim 1. Specifically, claims 2-5 passively recite that input features of the nociception software code are determined by detection machine training, hydrodynamic drug detection machine training, hemodynamic drug prediction machine training, and stable detection machine training. However, there is no active step of providing or developing a machine learning model for which the detection machine training is performed on. In the absence of such model or active step/function in the software execution, the limitation reads as a statement of fact, rather than the function of the system and is disconnected from the independent claim nociception software. As such, the scope of claims 2-5 are indefinite as its unclear what is required for the a prior art reference to meet the instant claim limitations. The examiner encourages the applicant to amend the independent claim to recite that the software develops a machine learning model and performs machine detection training on the model to determine the input features or to recite such limitations within the each dependent claims that requires it in order to overcome the 35 USC 112(b) rejection.
Allowable Subject Matter
Claims 1-14 are currently rejected under 35 USC 101 as being directed to non-statutory subject matter or under 35 USC 112(b) as indefinite (claims 2-5). However, the claims are currently recited are indicated as allowable over the prior art of record (which is subject to further consideration based on amendments to the claims which may alter the scope of the claims).
The following is a statement of reasons for the indication of allowable subject matter: The instant invention discloses a novel system for monitoring arterial pressure of a patient and providing a warning to medical personnel of nociception of the patient, wherein the system utilizes a hemodynamic sensor to product data representative of an arterial pressure waveform of the patient, and the system utilizes software code to analyse the waveform to determine a plurality of signal measures, extract input features from the signal measures that are indicative of a nociception event, effects of the hemodynamic drug administration, predicative of effects on the patient from a future hemodynamic drug administration event, and indicative of a stable episode of the patient, and then determines a first, second and third probability from the extracted input features that represent the probability the patent is experiences effects from future hemodynamic drug administration event, probability the patient is experiencing a current nociception event versus a current hemodynamic drug administration event, and the probability the patient is experiencing the current nociception event versus a stable episode, respectively; and compare the probabilities with each other to determine the output probability of the current nociception event for the patient is a nociception event, an effect from a drug administered to the patient, or a stable episode to allow the medical personel to effectively treat the patient with analgesic or similar drug during a procedure.
The closest prior art of record is drawn to Zuckerman Stark et al (US 2018/0310877 A1) which discloses a system for monitoring pain in user wherein the system receives signal representing a physiological parameter from sensors including arterial blood pressure sensors, performs analysis on the signal to extract features, and then performs filtering, leveling and/or weighting to the physiological signal and/or features extracted from the physiological signal to compensate for changes in the physiological signal caused by administration of drug or a pain stimulus and compares it to reference values to classify an event in the signal no nociception, mild nociception, moderate nociception, and/or sever nociception or regression into a numerical scale and triggers an alarm and displays information based on the classification and if the calculation nociception score exceeds a predetermined threshold (paragraphs [0073]-[144]; figures 1-5). However, while Zuckerman Stark accounts for the weighting due to the administration of drugs and/or a pain stimulus in order to help classify an event in the signal, it does not discloses or make obvious extracting and determining a probability representing the probability the patient experience effect from future hemodynamic drug administration effects or the use of comparison between the three determined probabilities as claimed in the classification/determination of the event and invocation of the alarm. Additional reference of interest which monitor a physiological signal to determine, classify and output a score representing a nociception event or similar system are also cited in the references cited by not relied up section of the Conclusion below and the PTO-892 notice of references cited provided with this office action.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2022/0015696 A1 to Addison et al; discloses nociception stimulus feedback control for drug titration during surgery.
US 2005/0272984 A1 to Huiku; discloses a system for monitoring pain-related responses of a patient.
US 2018/0193650 A1 to Srivastava et al; discloses a pain management system based on cardiovascular parameters.
US 2018/0206784 A1 to Jensen et al; disclose a device and method for assessing the level of consciousness, pain and nociception during wakefulness, sedation and general anesthesia.
US 2006/0217628 A1 to Huiku; discloses a system for determination of the anesthetic state of a patient.
US 2023/0309841 A1 to Addison et al; discloses a device with sensors for nociception stimulus feedback for use in analgesic drug titration.
US 2024/0374810 A1 to Martinez Vazquez et al; discloses a system and method for administering anesthetic agents to a patient.
US 2024/0008749 A1 to Lee et al; discloses a hemodynamic monitor with nociception prediction and detection.
US 12,665,061 B2 to Addison et al; discloses a nociception event identification based on relative change in nociception parameter.
WO 2022/208120 A1 to Ruiz Nolasco; discloses a system and non-invasive monitoring of nociception and consciousness levels of sedated and anesthetized patients.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM J EISEMAN whose telephone number is (571)270-3818. The examiner can normally be reached Monday - Friday (7:00 AM - 4:00 PM).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
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