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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/30/2024 are in accordance with the provisions of 37 CFR 1.97 and are considered by the Examiner.
Priority
Claim foreign priority app# 10 2023 114 373.5 is acknowledged.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Claim 1-15 terms data analysis unit, and control unit are interpreted as invoke 35 U.S.C. 112(f).
The claim limitation 'data analysis unit' is interpreted under 35 U.S.C. 112(f) because the term 'unit' is a generic placeholder that does not impart sufficient structure to perform the recited function of 'analyzing the data elements and providing an analysis result'. The claim language does not provide the physical structure or specific steps (algorithm) necessary to perform this function. Therefore, this element is construed to cover the corresponding structure described in the specification and equivalents thereof.
"The claim limitation 'control unit' is interpreted under 35 U.S.C. 112(f) because the term 'unit' is a generic placeholder that does not impart sufficient structure to perform the recited function of 'coordinating the interface, the output unit, the data storage unit and the data analysis unit [and] using the analysis result to select at least one instruction'. The claim language does not provide the physical structure or specific steps (algorithm) necessary to perform this function. Therefore, this element is construed to cover the corresponding structure described in the specification and equivalents thereof."
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-15 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Because terms ‘control unit’ and ‘data analysis unit’ do not have a defined structure in the specification for the full scope of the claimed functions. Refer to paragraphs 0159-0162 it is disclosed as both hardware and software.
Note: Referenced applicant language comes from public application number-> US 20240404662 A1.
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.
Claim 1-15 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.
Because terms ‘control unit’ and ‘data analysis unit’ do not have a defined structure in the specification for the full scope of the claimed functions. Refer to paragraphs 0159-0162 it is disclosed as both hardware and software.
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.
Non-Statutory Rejection
The claimed invention is directed to non-statutory subject matter. Claim 15 does not fall within any of the four statutory categories (process, machine, manufacture, composition) because:
Under BRI, the phrase "A computer program or computer program product ... comprising a program code" encompasses software per se. Software per se is a non-statutory category because it represents mere information or functional descriptive material that is not a machine, manufacture, composition of matter, or process. Although the claim recites a "tangible, non-transitory computer-readable medium," the broadest reasonable interpretation of a "computer program" independent of structural components remains directed to software per se; therefore Step 1 = NO.
The specification supports this interpretation, stating: "The program code may preferably be executed on a computer, a processor or a programmable hardware component," which describes the program as a set of instructions or "program code" that is functionally independent of the physical medium (Spec., para. [0159]).
Note: Referenced applicant language comes from public application number-> US 20240404662 A1.
Subject Matter eligibility Rejection 35 U.S.C 101
Claims 1-15 are rejected under 35 U.S.C. § 101 because the claimed subject matter is directed to a judicial exception (an abstract idea) without reciting elements that integrate the exception into a practical application or provide an inventive concept amounting to significantly more than the exception itself.
Step 1: Statutory Categories Analysis
The claims are directed to statutory subject matter, encompassing the following statutory categories:
Machine (Claims 1-9): The language reciting "A support system... comprising: an interface arrangement... a data storage unit... an output unit; and a control unit" describes a concrete thing consisting of parts, aligning with the definition of a machine in MPEP § 2106.03.
Process (Claims 10-14): The language reciting "A process... comprising the steps of: providing... reading in... evaluating... selecting... issuing... reading in... evaluating" defines a series of acts or steps, aligning with the definition of a process in MPEP § 2106.03.
Manufacture (Claim 15): The language reciting "A computer program or computer program product provided with a tangible, non-transitory computer-readable medium" describes a tangible article given a new form through artificial efforts, aligning with the definition of a manufacture in MPEP § 2106.03 and non-statutory category “A computer program or computer program product“, therefore are rejected under non-statutory category, however analysis is continue with the purpose of compact prosecution in view of future amendments.
Having developed the statutory subject matter analysis, the analysis proceeds to Step 2A Prong one.
Step 2A, Prong One: Judicial Exception Analysis
Step 2A, Prong One is to verify if a claim recites a specific judicial exception before determining if that exception is actually integrated into a practical application under prong two.
The whole invention is related to the "basic idea ... to involve the patient more closely in communication ... to promote faster recovery" by evaluating "patient measurements and the device status" to select "verbal instructions ... delivered to the patient" (Spec., para. [0021]-[0022]). Refer to Specification paragraphs [0021]-[0024] for further details.
More specifically, the claims 1-15 are directed to a judicial exception because they recite the abstract idea of collecting information, analyzing physiological status, and managing patient behavior through communication. Because under broadest reasonable interpretation (BRI) the claims recite a feedback loop of analyzing data to select an instruction and modifying that instruction based on the patient's reaction. This is directed to a judicial exception because the steps of analyzing data and selecting content based on that analysis are mental processes, and the step of instructing a patient to modify their state is a method of organizing human activity (managing personal behavior).
Independent Claims Recites the following non-bold parts:
Claim 1.
A support system for assisting a patient during medical diagnostics or therapy, the support system comprising:
an interface arrangement comprising one or more interfaces configured to receive at least one data element from a group of data elements;
a data storage unit for storing instructions, or for storing groups of instructions or for storing instruction families, wherein the instructions stored in the data storage unit are configured to address at least one of the human senses including at least one of the sense of hearing, sense of sight, sense of taste, sense of smell, sense of touch or sense of feel;
an output unit; and
a control unit with an associated data analysis unit,
wherein the control unit is configured to coordinate the interface, the output unit, the data storage unit and the data analysis unit,
wherein the data analysis unit is configured to analyze the data elements and to provide an analysis result,
wherein the control unit is configured to use the analysis result to select at least one instruction from the group of instructions or instruction families stored in the data storage unit and to provide the at least one selected instruction to the output unit,
wherein the output unit is configured to address or issue the at least one selected instruction to the patient,
wherein the interface arrangement is configured to detect at least one confirmation address from a group of confirmation addresses,
wherein the at least one confirmation address indicates a reaction or feedback from the patient to the at least one instruction previously addressed to or issued to the patient or changes in the therapy or treatment environment, in a patient care situation or in the environment of the patient compared to a time before the instruction was addressed to or issued to the patient,
wherein during operation of the support system the control unit is configured to continuously select or adapt the instructions based on the data elements and the confirmation addresses and to coordinate the provision of the instructions to the output unit.
Note: The bolded portions represent additional elements evaluated in Prong Two and Step 2B. The non-bolded portions represent the abstract idea. Referenced applicant language comes from public application number-> US 20240404662 A1.
Claim Abstract Classification Rational
Under their Broadest Reasonable Interpretation (MPEP § 2111), the independent claims 1, 10, and 15 abstract idea recite collecting patient data, mentally analyzing it to determine a medical condition, selecting a communication instruction, and adapting the communication based on human feedback. This process aligns with the following abstract idea categories:
Mental Process (MPEP § 2106.04(a)(2)(III)): Concepts performed in the human mind, such as observation, evaluation, judgment, and opinion. The independent claims 1, 10, and 15 recite "analyze the data elements," "provide an analysis result," and "use the analysis result to select at least one instruction." These limitations describe the cognitive steps of interpreting information and making a decision based on that interpretation. When comparing the MPEP 2111 interpretation of the selected independent claims limitations, the process of recognizing a "critical situation" and selecting an "instruction" based on that diagnosis fits the definition of a mental process in MPEP 2106. The specification supports this, stating: "From an analysis of physiological data ... critical situations can be recognized and predicted in advance" (Spec., para. [0023]). This paragraph is relevant because it explicitly characterizes the "analysis" as a recognition and prediction process, which are fundamental cognitive functions.
Certain Method of Organizing Human Activity (MPEP § 2106.04(a)(2)(II)): Managing interactions between people, or between a person and a machine, to achieve a specific behavior. The independent claims 1, 10, and 15 recite "issue the at least one selected instruction to the patient" and "continuously select or adapt the instructions based on ... confirmation addresses." This describes a managed workflow of interaction, which falls under the sub-category of Managing Personal Behavior or Relationships. Under BRI, the claims manage the patient's behavior during therapy by issuing prompts and monitoring compliance. The specification supports this, stating: "The basic idea behind the invention is to involve the patient more closely in communication ... to promote faster recovery" and "asking them to breathe in and out more deeply. If the patient cooperates ... [they] increase their own comfort" (Spec., para. [0021], [0023]). This paragraph is relevant because it confirms the system's objective is to manage the patient's personal behavior and cooperation through a controlled communication cycle.
Manual Replication Scenario (Human Equivalence)
The abstract nature of the claims is reinforced because the entire process is analogous to fundamental human activities. Even when performed by a computer for efficiency or speed, MPEP 2106.04(a) clarifies that if a process can be performed by a human, even with a pen and paper, it remains an abstract idea. The automation of a nurse-patient interaction does not change its character.
Step-by-step human analogy:
"receive at least one data element": A nurse observes a patient and reads their heart rate monitor (gathering data).
"analyze the data elements... provide an analysis result": The nurse evaluates in their mind whether the heart rate is too high (cognitive evaluation).
"select at least one instruction": The nurse decides that the patient needs to be calmed down (decision-making).
"issue... instruction to the patient": The nurse says to the patient, "Please try to relax and breathe slowly" (sensory communication).
"detect at least one confirmation address": The nurse continues to watch the patient's reaction and monitor the heart rate (gathering feedback).
"continuously select or adapt": If the patient's heart rate stays high, the nurse decides to repeat the request or change their tone to be more firm (adapting behavior management).
Dependent Claims Analysis
The dependent claims 2-9 and 11-14 are also directed to an abstract idea.
Claims 2, 4, 7, 9, 11, 13: These claims recite under BRI specific types of data (e.g., "physiological parameters," "video data," "mood state") or specific feedback variables, which is a Mental Process (Evaluation of specific data). Under BRI, these claims merely specify the particular information being gathered and analyzed; however, specifying the subject of the information (e.g., blood pressure vs. mood) does not move the claim out of the abstract idea of analyzing information to reach a conclusion.
Claims 3, 12: These claims recite under BRI specific types of instructions (e.g., "text modules," "music," "pictograms"), which is a Certain Method of Organizing Human Activity (Managing Behavior). These are simply different modes of communication used to manage the patient interaction; choosing a "pictogram" versus a "word" is a decision about the content of the management message.
Claims 5, 6: These claims recite under BRI "prioritization" or "classification" of instructions, which is a Mental Process. Under BRI, ranking tasks or classifying data based on importance is a fundamental cognitive act of organization that occurs in the mind of a human.
Claim 8: This claim recites under BRI that the system receives data from specific medical devices (e.g., "ventilator," "MRI"), which is Gathering Data for use in a Mental Process. While hardware is mentioned, the underlying act is the receipt of information from those sources to feed the abstract analysis, which is inherent to the data analysis process itself.
The analysis now proceeds to Step 2A, Prong Two to evaluate if these additional elements integrate the judicial exception into a practical application.
Step 2A, Prong Two: Integration into a Practical Application
Step 2A Prong Two determines whether the claim as a whole integrates the abstract idea into a practical application by imposing a meaningful limit on the judicial exception. The claims' additional elements (interface arrangement, data storage unit, control unit, data analysis unit, output unit) do not overcome Prong Two because they merely describe a generic computer environment invoked to implement the abstract idea.
Evaluation of Independent Claims 1, 10, and 15 Additional Elements
Interface arrangement, Data Storage Unit, Control Unit, Data Analysis Unit, Output Unit: The recitation of these units fails to integrate the abstract idea because:
Under the Broadest Reasonable Interpretation (MPEP § 2111), the interface arrangement, control unit, data analysis unit, storage, and output unit are generic components invoked solely to automate the abstract mental process. As established in MPEP § 2106.05(f), implementing an abstract idea on a computer is not an integration. Furthermore, MPEP § 2106.05(a) clarifies that using a computer as a tool without improving it fails to save the claim. Limiting this to the medical field (MPEP § 2106.05(h)) is insufficient. Thus, the additional elements do not overcome Prong Two.
When viewed as a whole, the combination of these elements does not integrate the abstract idea. The claim describes a generic arrangement performing the abstract analysis, which does not transform the abstract idea into an eligible application.
Dependent Claims Analysis
The dependent claims add only minor limitations that fail to provide the necessary integration.
Claims 2, 4, 7, 9, 11, 13: These claims add specific data types (e.g., physiological parameters, video data) and feedback types, which are abstract ideas explained in prong one.
Claims 3, 12: These claims add specific forms of instructions (e.g., text, music, pictograms), which are abstract ideas explained in prong one.
Claims 5, 6: These claims add prioritization and classification, which is a Mental Process (analysis). Adding more abstract mental steps does not integrate the primary abstract idea.
Claim 8: This claim recites the receipt of data from specific medical hardware including a "ventilator," "anesthesia device," "physiological patient monitor," "X-ray device," and "MRI device." Under BRI, connecting to these devices serves solely as a precursor step to gather the data elements required for the abstract analysis. Gathering data from specific sources does not integrate the analysis into a practical application. These devices merely link the abstract idea to the medical field. This "field-of-use" limitation does not meaningfully limit the claim or provide an inventive concept.
Claim 14: This claim adds a "computer program or computer program product provided with a tangible non-transitory computer-readable medium comprising a program code." The computer-readable medium and program code represent a generic software implementation that merely provides instructions to automate the abstract idea without improving computer functionality.
When viewed as a whole, the combination of these elements in the dependent and independent claims does not integrate the abstract idea because they merely define the specific medical context for the abstract analysis without improving the technical tool used.
Because the claims are directed to an abstract idea without integrating it into a practical application, the analysis proceeds to Step 2B.
Step 2B: Inventive Concept Analysis
Step 2B determines whether the claim limitations, individually or in combination, provide an inventive concept by verifying if the additional elements are more than "well-understood, routine, and conventional" (WRC) activities in the field. The additional elements identified in Prong Two do not overcome Step 2B because they recite generic computer and medical components used in a high-level manner.
Evaluation of Independent Claims 1, 10, and 15 Additional Elements
Interface arrangement, Data Storage Unit, Control Unit, Data Analysis Unit, Output Unit: The interface arrangement, data storage, control, analysis, and output units fail to provide an inventive concept as they represent generic computer components performing standard data gathering via networks (Spec. para [0128]), high-level information retention in databases (Spec. para [0173]), mere instructions for logical processing on a processor (Spec. para [0159]), and post-solution communication via auditory peripherals (Spec. para [0022]). Automating an abstract idea using such generic hardware lacks significantly more per MPEP § 2106.05(f) and (a), while the medical environment (MPEP § 2106.05(h)) constitutes a mere field-of-use limitation.
When viewed as a whole, the combination of additional elements is not enough. The specification admits the system is an aggregation of known devices ("ventilator," "monitor," "computer") communicating via known protocols to perform the data analysis, which is a conventional arrangement of hardware.
Dependent Claims Analysis
Claims 2, 4, 7, 9, 11, 13: These claims add specific data types (e.g., physiological parameters, video data) and feedback types, which are abstract ideas explained in prong one.
Claims 3, 12: These claims add specific forms of instructions (e.g., text, music, pictograms), which are abstract ideas explained in prong one.
Claims 5, 6: These claims add prioritization and classification, which is a Mental Process (analysis). Adding more abstract mental steps does not integrate the primary abstract idea.
Claim 8: The medical hardware, like a "ventilator," "anesthesia device," or "MRI," represents insignificant extra-solution activity (MPEP § 2106.05(g)). These devices serve solely as a "precursor step to gather the data elements required for the abstract analysis," and the specification identifies them as generic "data sources" used "to compare data" (Spec., para. [0128], [0195]). As these elements "merely link the abstract idea to the medical field," they function as a "field-of-use" limitation that fails to provide significantly more than the exception.
Claim 14: This claim recites a generic computer-readable medium and program code, which are conventional tools for executing instructions on a standard processor and lack significantly more (MPEP § 2106.05(f)).
When viewed as a whole, the combination of dependent claims and additional elements is not enough because applying the abstract analysis to standard medical data collected from standard medical devices and displaying results via standard audio/video means represents a conventional assembly of components performing their expected functions.
The claims are directed to an abstract idea and lack an inventive concept. Therefore, Claims 1-15 are rejected under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-6, 8-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cates- US-11382563
Cates teaches Claim 1.
A support system for assisting a patient during medical diagnostics or therapy, the support system comprising: (Cates, Col. 1, ll. 54-60; Col. 10, ll. 1-10; Col. 8; ll. 15-30)
Cates describes a computational and hardware-integrated monitoring arrangement that intervenes during patient care by providing a patient-monitoring system configured to prompt patients to breathe when the system detects ventilatory depression.
an interface arrangement comprising one or more interfaces configured to receive at least one data element from a group of data elements; (Cates, Col. 10, ll. 30-55; Col. 11, ll. 60-65, fig. 2)
Cates describes a hardware and communication configuration utilizing wires or wireless communication to gather data elements from various patient sensors into a central data receiver. Where Cates utilizes a wireless communication transceiver 57 to communicate sensor data to the data input device 51, the prior art functionally describes the interface arrangement.
a data storage unit for storing instructions, or for storing groups of instructions or for storing instruction families, wherein the instructions stored in the data storage unit are configured to address at least one of the human senses including at least one of the sense of hearing, sense of sight, sense of taste, sense of smell, sense of touch or sense of feel; (Cates, Col. 3, ll.34-49, Col. 10, ll. 10-35; Col. 21, ll. 50-60; Col. 18, ll. 5-15, Col. 8, ll. 55-65, Col.15, ll. 50-65)
Cates describes a digital storage environment where a software program 27 resides in memory 25 to trigger verbal prompts and tactile stimulus directed at a patient's hearing and touch/feel. Because Cates stores a recorded voice and configurations for a tactile stimulator in memory to address the patient's senses.
an output unit; (Cates, Col. 10, ll. 10-20, Col. 8, ll. 30-45, fig.3)
Cates describes hardware components dedicated to delivering stimuli, specifically disclosing a speaker 18 and a tactile stimulator 38. Since these components deliver the audio prompts and tactile stimulus to the patient, the output unit is disclosed.
and
a control unit with an associated data analysis unit, (Cates, Col. 10, ll. 30-35; Col. 10, l. 60 - Col. 11, ll.10;)
Cates describes a computational core where a processor 29 executes logic to interpret data via a data processing system. Where Cates employs specialized modules like the ventilation detection module 41 to evaluate sensor signals, the prior art discloses the control and analysis unit combination.
wherein the control unit is configured to coordinate the interface, the output unit, the data storage unit and the data analysis unit, (Cates, Col. 10, ll. 10-35; Col. 10, ll. 55-65)
Cates describes a central manager where the processor 29 interacts with the data receiver and software modules to evaluate patient conditions and trigger prompting. Since the processor dictates when the audio prompts are retrieved from memory and sent to the speaker based on interpreted data, the coordination function is taught.
wherein the data analysis unit is configured to analyze the data elements and to provide an analysis result, (Cates, Col. 13, l. 50 - Col. 14, l. 10; Col. 15, ll. 5-10)
Cates describes a logic layer that evaluates sensor readings to produce a classification of the patient's ventilation status. Because Cates generates a specific identification of a ventilation problem (analysis result) from raw sensor data, the analysis unit configuration is disclosed.
wherein the control unit is configured to use the analysis result to select at least one instruction from the group of instructions or instruction families stored in the data storage unit and to provide the at least one selected instruction to the output unit, (Cates, Col. 15, ll. 25-45; Col. 8, ll. 51-67)
Cates describes a workflow where the determination of a ventilation problem triggers the selection of a prompting stimulus from a predefined protocol. Since Cates routes audible or tactile cues to the patient hardware based on the breathing status analysis, the selection and provision requirement is met.
wherein the output unit is configured to address or issue the at least one selected instruction to the patient, (Cates, Col. 10, ll. 15-20; Col. 21, ll. 50-55)
Cates describes hardware that provides the selected instructions (prompts) to the human subject. Because the system generates and issues an audible prompt or vibration through the speaker or stimulator, the issuing function is taught.
wherein the interface arrangement is configured to detect at least one confirmation address from a group of confirmation addresses, (Cates, Col. 21, ll. 50-55; Col. 15, ll.15-30, l. 65 - Col. 16, l. 5, Figs. 8A/8B)
Cates describes a feedback mechanism where sensor data is analyzed to determine the patient's response to a specific prompt. Where Cates detects at least one breath as a feedback signal via the interface, the prior art describes detecting a confirmation address.
wherein the at least one confirmation address indicates a reaction or feedback from the patient to the at least one instruction previously addressed to or issued to the patient or changes in the therapy or treatment environment, in a patient care situation or in the environment of the patient compared to a time before the instruction was addressed to or issued to the patient, (Cates, Col. 15, l. 65 - Col. 16, l. 10; Col. 21, ll. 50-55, fig. 8A, Col.16, ll. 1-15)
Cates describes a feedback loop where spontaneous breathing (reaction) is detected following the audible prompt. Because Cates uses sensor data to verify that the patient responded compared to the inadequate ventilation state prior to the prompt, the indication of a reaction or change is taught.
wherein during operation of the support system the control unit is configured to continuously select or adapt the instructions based on the data elements and the confirmation addresses and to coordinate the provision of the instructions to the output unit. (Cates, abstract, Col. 8, ll. 60-65; Col. 15, l. 65 - Col. 18, l. 25, Col.9, ll. 35-45, Col. 21, ll. 45-55)
Cates describes a dynamic control loop where the level of prompting is escalated or maintained based on system sensors measuring the patient's response. Since Cates personalizes the stimulus by adapting the intensity (decibel level or vibration) based on breath responsiveness (confirmation), the prior art describes continuous adaptation and coordination.
Cates teaches Claim 2.
A support system according to claim 1,
wherein the at least one data element is configured as an element from a group of data elements and is based on measured variables or variables derived from measured variables, parameters, information, planning data, calendar data, and/or time data, (Cates, Col. 10, ll. 30-45; Col. 12, ll. 55-65)
Cates describes a processing architecture that ingests raw patient sensor inputs and applies mathematical filters to interpret data. Where Cates utilizes a data processing system to transform raw accelerometer signals sampled at 100 Hz into usable monitoring metrics, the prior art describes measured and derived variables.
wherein the group of data elements comprises at least one of the following data elements:
data elements which indicate physical, pathological, physiological or psychological situations of the patient; (Cates, Col. 13, l. 50 - Col. 14, l. 10; Col. 9, ll. 30-40)
Cates describes classifying a patient's state as unconscious or suffering from ventilatory depression based on sensor inputs. Since Cates identifies a specific ventilation problem type (pathological situation), the prior art describes data indicating patient situations.
data elements which indicate a parameter of the upper airways, the lower airways or the lungs, a respiratory physiological parameter or a ventilation parameter, including pressure levels, breathing or ventilation frequencies, flow rates, volumes, compositions of inhaled or exhaled gases, wherein the data elements indicate an exceedance of the parameter of the upper airways, the lower airways or the lungs, of the respiratory physiological parameter or ventilation parameter above a predetermined threshold value for a predetermined period of time or for a predetermined number of times, or wherein the data elements indicate a shortfall of the parameter of the upper airways, the lower airways or the lungs, the respiratory physiological parameter or the ventilation parameter below a predetermined threshold value for a predetermined period of time or for a predetermined number of times; (Cates, Col. 19, ll. 65-68; Col. 10, ll. 45-50)
Cates describes a monitoring logic where Prompting begins if the respiratory rate (RR) falls below a limit like 6 breaths per minute for a duration of 60 seconds. Because Cates monitors for a shortfall below a predetermined threshold for a ventilation parameter, the prior art describes this element.
data elements which indicate a neurological parameter, wherein the data elements indicate an exceeding of the neurological parameter above a predetermined threshold value for a predetermined period of time or for a predetermined number of times, or wherein the data elements indicate a falling below of the neurological parameter below a predetermined threshold value for a predetermined period of time or for a predetermined number of times; (Cates, Col. 9, ll. 30-40; Col. 11, ll. 25-30; Col. 19, ll. 60-65)
Cates describes data elements indicating a neurological parameter by evaluating whether a patient is conscious or unconscious (state of mind/neurological state). The system detects a falling below... a predetermined threshold for a predetermined period of time by identifying a sufficient lack of motion and depressed ventilation for at least 30 seconds. Since Cates uses these measured shortfalls to determine the neurological state of unconsciousness, the prior art describes the monitoring of neurological parameters against temporal thresholds.
data elements which indicate a physical parameter, wherein the data elements indicate an exceeding of the physical parameter above a predetermined threshold value for a predetermined period of time or for a predetermined number of times, or wherein the data elements indicate a falling below of the physical parameter below a predetermined threshold value for a predetermined period of time or for a predetermined number of times; (Cates, Col. 11, ll. 1-10; Col. 18, ll. 35-45)
Cates describes evaluating patient motion and electrical stimulation levels against specific time and magnitude limits. Because the system adapts its behavior based on physical parameters crossing these thresholds (e.g., 10 mA increments or lack of motion), the prior art describes the physical parameter thresholds.
data elements which indicate a parameter of the cardiovascular system or of the blood circulation, vascular or lymphatic system, including indicating pressure levels or flow or volume situations, wherein the data elements indicate an exceedance of the parameter of the cardiovascular system or of the blood circulation, vascular or lymphatic system above a predetermined threshold value for a predetermined period of time or for a predetermined number of times, or wherein the data elements indicate that the parameter of the cardiovascular system falls below a predetermined threshold value for a predetermined period of time or for a predetermined number of times; (Cates, Col. 2, ll. 1-10; Col. 20, ll. 15-25)
Cates describes evaluating blood oxygenation (SpO2) against a safety limit. Where Cates initiates an alarm because oxygen saturation drops below 90%, the prior art describes a cardiovascular parameter falling below a predetermined threshold.
data elements characterizing a physiologically or psychologically induced situation of pain, anxiety or panic, based on an increase in the heart rate within a predetermined time interval above a predetermined threshold value, an increase in skin moisture within a predetermined time interval above a predetermined threshold value, an increase in respiratory rate within a predetermined time interval above a predetermined threshold value, a change in muscle tone, an increase in systolic or diastolic blood pressure; (Cates, Col. 11, ll. 15-25; Col. 19, ll. 60-68)
Cates describes a system that evaluates an increase in respiratory rate to determine the success of a prompting protocol. Because the system identifies a shift in physiological status based on RR crossing a defined threshold, the prior art describes at least one alternative in the group.
data elements which indicate alarm situations during medical therapies, diagnosis, care measures or during a regular clinical daily routine; (Cates, Col. 2, ll. 1-10; Col. 11, ll. 35-45)
Cates describes a monitoring system that triggers a low SpO2 alarm or an emergency rescue alert when patient safety thresholds are breached. Because these signals represent alarm situations occurring within a post-operative care environment, the prior art describes the limitation.
data elements which indicate situations with activities of the patient in the patient's environment or movement events in connection with the patient in a therapy or treatment environment or in patient care situations; (Cates, Col. 11, ll. 1-10; Col. 19, ll. 20-25)
Cates describes using accelerometers to identify patient movement. Because the system utilizes a motion detection system to evaluate if a patient is moving during patient care, the prior art describes movement events.
data elements which indicate situations or events in a therapy or treatment environment of the patient during the performance of medical therapies, diagnoses, care measures or the regular routine in the clinical daily routine; (Cates, Col. 3, ll. 5-15; Col. 15, ll. 30-35; Col. 1, ll. 30-35, Col. 5, ll. 50-67)
Cates describes data elements that identify situations or events in the treatment environment, specifically identifying the post-operative period and physical therapy. The system monitors these situations to determine when a snooze function or interruption of monitoring is required. Because the system's operation is predicated on identifying these specific clinical daily routines (like trips to the restroom or care measures), the prior art describes the limitation.
data elements which are based on two-dimensional or three-dimensional image or video data and indicate status data of the patient or events in relation to the patient's environment;(Cates, Col.: 13 ll.: 1–10)
Cates describes data elements that are based on two-dimensional or three-dimensional image data by disclosing the use of electrical impedance tomography (EIT). Since the Applicant’s specification (Franz para [0048]) explicitly defines EIT as a source of images, the tomographic method for displaying lung movement in Cates constitutes image-based data. This data is used to indicate status data of the patient by detecting breathing and ventilation. Because Cates employs EIT to generate a visual/image-based representation of physiological status, the prior art describes the limitation under the broadest reasonable interpretation consistent with the specification.
data elements which are based on two-dimensional or three-dimensional image or video data and indicate situations of potential changes in location of the patient;
data elements which are based on two-dimensional or three-dimensional image or video data and indicate situations of potential disconnections of the patient from patient connection lines or patient access lines;
data elements which indicate status data or alarms of other patients or events; (Cates, Col. 14, ll. 35–55)
Cates describes a monitoring system that processes rotation events and generates breathing assessment results (status data). Because the prior art describes identifying specific clinical events and status data, the limitation is anticipated under the broadest reasonable interpretation.
and
data elements which indicate status data or alarm situations of the patient or events in relation to the patient, the data elements being based on audio data including alarm signals from a direct therapy or treatment environment or a spatially close environment of the patient. (Cates, Col. 12, l. 65 - Col. 13, l. 5; Col. 14, ll. 25-35)
Cates describes a microphone used to detect the sound of air flowing or snoring. Since Cates identifies the patient's respiration status using sound identified by the system, the prior art describes audio-based status data.
Cates teaches Claim 3.
A support system according to claim 1,
wherein the group of instructions stored in the data storage unit contains or comprises at least one of the following instructions: intentions, text modules, sentence modules, sentence fragments, speech sequences, words, syllables, audio sequences, speech cues, sound reproductions, music reproductions, sound reproductions, sound reproductions, text representations, graphic representations, visualizations, film or video sequences, individual images, individual image sequences, diagrams, symbols, pictograms. (Cates, Col. 8, ll. 60-65; Col. 20, ll. 50-60; Col. 10, ll. 1-5)
Cates describes a system that uses digitized verbal prompts consisting of phrases and words to intervene with a patient. Since Cates specifically identifies the use of speech sequences like “Mr. Jones, take a deep breath” and visualizations on a touch screen display, the prior art describes the content of the instructions stored in the data unit under the broadest reasonable interpretation.
Cates teaches Claim 4.
A support system according to claim 1,
wherein the at least one confirmation address is formed as an element from the group of confirmation addresses and is based on mental, physical, physical, neurological, physiological or metrologically determined data or information, (Cates, Col. 10, ll. 30-55; Col. 3, ll. 10-20; Col. 9, ll. 30-40)
Cates describes a confirmation address (feedback) through the data processing system which interprets signals from various patient sensors. This data is metrologically determined and physiological in nature, as it includes continuous ventilation and SpO2 monitoring. Furthermore, the system identifies if a patient is likely either unconscious, which constitutes a neurological or mental state evaluation. Therefore, Cates provides the required data foundation.
wherein the group of confirmation addresses includes or comprises at least one of the following confirmation addresses:
confirmation addresses which indicate physical, pathological, physiological or psychological situations of the patient; (Cates, Col. 13, ll. 50- Col. 14, ll. 10, col. 16, ll. 1-13)
Cates utilizes confirmation addresses that indicate physiological or pathological situations by classifying respiration events and identifying the type of ventilation problem (pathological condition). The feedback loop specifically asks if spontaneous breathing resumed, which is a direct indication of a physiological situation resulting from the instruction.
confirmation addresses which indicate an upper airway, lower airway or lung parameter, a respiratory physiology parameter or a ventilation parameter relative to a time prior to issuing the instruction to the patient; (Cates, Co. 19, ll. 60- Col. 20, ll.5; Col. 21, ll. 50-60)
Cates describes using confirmation addresses such as RR (respiratory rate) and breath sensor data to evaluate the patient's state relative to a time prior. The system establishes a Baseline and then determines from the breath sensor data if the patient responded to the prompt. Because the system evaluates the resumption of breaths compared to the pre-prompt Baseline, it teaches a ventilation parameter relative to a time prior.
confirmation addresses which indicate a parameter of the lungs, the cardiovascular system or a parameter of the blood circulation, vascular or lymphatic system including heart rate, heart rate variability, systolic blood pressure, diastolic blood pressure, wherein the confirmation addresses indicate a change in the cardiovascular system parameter or the circulatory or vascular system parameter from a time prior to the issuance of the instruction to the patient; (Cates, col. 19, ll. 60- col. 20, ll.25)
Cates describe confirmation addresses indicating a cardiovascular system parameter via SpO2 (oxygen saturation). The system explicitly monitors for a change... from a time prior by determining if the SpO2 increases > 4 percentage points following the initiation of prompting. Since this increase is measured from the nadir or baseline established before or during the event, the prior art describes the cardiovascular change requirement.
confirmation addresses which indicate physiologically or psychologically induced situations by a change in heart rate, skin hydration, respiratory rate or muscle tone compared to a time before the instruction was issued to the patient; (Cates, Col. 20, ll. 1-15; Col. 21, ll. 45-57)
Cates teaches confirmation addresses indicating a physiologically induced situation (resumed breathing) evidenced by a change in respiratory rate (RR). The system monitors whether the prompt results in a breath detected, which is a direct comparison of the breathing pattern compared to a time before the prompt was issued.
confirmation addresses which indicate events or situations, status data during medical therapies, diagnoses, care measures or during a regular routine, in a clinical daily routine, (Cates, Col. 3, ll. 5-15; Col. 13-33)
Cates describes capturing status data and confirmation addresses (breath/SpO2 response) during medical therapies and care measures, specifically identified as the post-operative period. Monitoring for opioid-induced ventilatory depression constitutes an event within the clinical daily routine of surgical recovery.
confirmation addresses which indicate situations with movement events in a therapy or treatment environment, in the care situation or in the patient's environment; (Cates, Col. 11, ll. 1-15, Col. 11, ll. 23-37)
Cates teaches confirmation addresses indicating movement events through a motion detection module 42 and accelerometer. These components detect hand and/or body motion as feedback to determine if the patient is alert or still conscious during the care situation. This motion data serves as a confirmation of the patient's physical state in the treatment environment.
confirmation addresses which indicate situations with activities in the patient's environment, movement events in connection with the patient in the therapy or treatment environment or in care situations; (Cates, Col. 11, ll. 1 - Col. 12, ll.13)
Cates utilizes movement events in connection with the patient as a confirmation address. The system specifically evaluates if movement is sufficient to classify the patient's alertness within the care situation, functionally satisfying the requirement for activity-based feedback.
confirmation addresses which are based on two-dimensional or three-dimensional image or video data and indicate situations with respect to the status of patient connection lines or patient access lines with respect to a point in time before the instruction is issued to the patient,
confirmation addresses which indicate situations based on two-dimensional or three-dimensional image or video data of potential changes in location of the patient relative to a time prior to the issuance of the instruction to the patient;
and
confirmation addresses which indicate changes in alarm situations compared to a point in time before the instruction was issued to the patient. (Cates, Col. 20, ll. 1-31, Col. 2, ll. 1-21)
Cates describes confirmation addresses that indicate changes in alarm situations. The system sounds a low SpO2 alarm when levels drop; following the prompting protocol, the system monitors for an increase to above 90 %. When this occurs, prompting ceases, which represents a change in the alarm situation (resolution of the low-oxygen state) compared to a point in time before (the alarm state) the instruction was successful.
Cates teaches Claim 5.
A support system according to claim 1, wherein the control unit is configured to assign a prioritization to the instructions and to configure the temporal sequence of issuing instructions to the patient on the basis of the prioritization. (Cates, Col. 8, ll. 53-65; Col. 15, l. 45 - Col. 16, l. 7)
Cates describes an escalation hierarchy where the level of prompting is determined by the patient's immediate risk and previous response. Since Cates dictates a sequence where prompts increase in intensity and allows for immediate escalation based on critical SpO2 levels, the prior art functionally describes prioritization and temporal configuration.
Cates teaches Claim 6. A support system according to claim 1, wherein the control unit is configured to determine an effect of the instructions based on instruction information and to classify the instruction or classify an effect of the instructions and to configure the output of further instructions to the patient based on the classification. (Cates, Col. 8, ll. 53-67; Col. 4, ll. 1-11)
Cates describes a system that personalizes stimulus based on how a patient responds to specific levels of stimulus. Because Cates evaluates responsiveness (effect) to identify the proper level of the next prompt, the prior art describes configuring further instructions based on the classification of the effect.
Cates teaches Claim 8.
A support system according to claim 1,
wherein the interface arrangement receives the at least one data element and/or the at least one confirmation address from a medical device, a diagnostic device, a therapy device, a ventilator or an anesthesia device, a medical measuring device, a physiological patient monitor, a blood gas analyzer, an electroimpedance tomography device, an ultrasound imaging device an X-ray device, a mammography device, a heart sound contraction recorder, a computer tomography device, a magnetic resonance imaging device, an imaging or camera system, a thermometer for recording body temperatures, devices for measuring carbon dioxide saturation or oxygen saturation in the blood, devices for determining the carbon dioxide concentration in respiratory gases, including a capnometer or oxy-capnometer, a heat therapy device, including a warming bed or incubator, or
wherein the support system is provided as a part or as a component of a medical device, a diagnostic device, a therapy device, a ventilator or an anesthesia device, a medical measuring device, a physiological patient monitor, an electroimpedance tomography device, an ultrasound imaging device an X-ray device, a mammography device, a computer tomography device, a magnetic resonance imaging device, an imaging or camera system, a thermometer for detecting body temperatures, a device for measuring oxygen saturation or carbon dioxide concentration in respiratory gases, including a capnometer or oxy-capnometer, a heat therapy device, including a warming bed or incubator. (Cates, Col. 11, ll. 45–50; Col. 10, ll. 1–3)
Cates describes a system integrated with a capnometry sensor and pulse oximeter to monitor patient status. Since Cates explicitly utilizes these specific medical measuring devices to generate the data processed by the support system
Cates teaches Claim 9.
A support system according to claim 1,
wherein the control unit is configured to continuously select the instructions based on the data elements and/or based on the confirmation addresses during operation of the support system, generating, filtering or adapting the instructions, (Cates, Col. 8, ll. 61 – Col. 9, ll. 5 When a prompt is successful... the level of prompting is not escalated. If, however, a prompt is not successful, the level of prompting is escalated. ... Col. 4, ll. 1-5 response to different types and levels of stimulus... is used identify the proper level of prompting required)
Cates describes a dynamic escalation protocol where the level of prompting is modified based on patient responsiveness. Since Cates utilizes measured responses to personalize and identify the proper level of the next instruction, the prior art describes the configuration to adapt instructions.
wherein the control unit is configured to include in the selection, generation, filtering or adaptation of the instructions at least one patient-specific criterion from a group of patient-specific criteria comprising:
name, nationality, mother tongue, gender, sexual orientation, religion; (Cates, Col. 20, ll. 51-53 Verbal prompts include the patient's name in phrases such as “Mr. Jones, take a deep breath)
language, mother tongue, dialect, sign language; (Cates, Col. 4, ll. 60-65; Col. 5, ll. 30-50)
age, height, weight, body mass index; (Cates, Col. 4, ll. 60-65; Col. 5, ll. 30-50)
mood, state of mind; (Cates, Col. 4, ll. 60-65; Col. 9, ll. 30-40)
Cates describes a control unit that personalizes its interaction based on the patient's alertness and familiarity with the stimulus (using relatives' voices).
clinical picture, diagnosis, medication, anesthesia; (Cates, Col. 4, ll. 50-55; Col. 12, ll. 15-25; Col. 5, ll. 1-10, system... identifies and distinguishes among drug-induced ventilation problem types, including central apnea, bradypnea, obstructive apnea... volunteers receiving the sedative propofol and the opioid remifentanil... identify the proper level of prompting required)
therapy situation, care situation, degree of therapy, degree of care, duration of therapy;(Cates, Col.2, ll. 60-67, Col. 3, ll. 1-15; Col. 1, ll. 50-55; Col. 11, ll. 45-55, ventilation of patients in general wards or outpatient settings may not be monitored... provide a fundamental change in the management of high-risk patients. system of the invention may also include a snooze function... for patient trips to the restroom, for physical therapy...)
physical, pathological, physiological or psychological situations of the patient; (Cates, Col. 9, ll. 30-40; Col. 14, ll. 1-10; Col. 2, ll. 60-65, fig. 6)
type and balance of diet related to fats and carbohydrates;(Cates, Col. 2, ll. 15-20; Col. 11, ll. 40-50)
dietary arrangements including special diets; (Cates, Col. 2, ll. 15–20; Col. 11, ll. 40–50 , Artifacts from hand motion such as when the patient eats, adjusts their blanket or any myriad of minor activities, also cause the pulse oximeter to produce false alarms regularly.
)
Cates teaches the identification of a patient's dietary status by recognizing the specific activity of when the patient eats. Under BRI, identifying that a patient is currently engaged in the act of consuming a diet allows the system to distinguish between a physiological event and a motion artifact. Since Cates accounts for the situational context of eating to reject motion artifacts and reduce false alarms, the prior art describes the monitoring of a dietary arrangement.
information from a nutrition and fluid management system;
length of stay in a therapy or treatment environment; (Cates, Col. 2, ll. 25-35; Col. 20, ll. 30-35)
and
privacy in the therapy or treatment environment.(Cates, Col. 4, ll. 60-65; Col. 5, ll. 50-60; Col. 15, ll. 30-35)
Cates teaches Claim 14.
A process according to claim 10, further comprising providing a computer program or computer program product provided with a tangible non-transitory computer-readable medium comprising a program code for performing one or more of the repeating sequence of process steps. (Cates, Col. 10, ll. 1–35; Col. 3, ll. 1–10).
Notes: Because Claim 10 it is substantially same under BRI than Claim 1, then Cates also taught claim 10.
Cates describes a computer software patient monitoring program stored in internal memory that drives the processor to execute the monitoring logic. Because the memory serves as the tangible non-transitory medium for the programmed logic that performs the method steps
Note: Claim 10-13, and 15 are rejected with claims 1-4 for being very similar under Broadest Reasonable interpretation (BRI).
Claim Rejections - 35 USC § 103
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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cates- US-11382563, and further in view of Rodgers- US-20070162304.
Cates teaches Claim 7.
A support system according to claim 1, wherein the confirmation addresses are based on two-dimensional or three-dimensional image or video data or on audio data,
; (Cates, Col. 10, ll. 10-20; Col. 12, ll. 65-67; Col. 13. ll.1-15, Col. 24, ll. 5-10)
Cates describes hardware for capturing sensory feedback, specifically a microphone for audio recording. Since Cates uses the sound of air flowing detected by these interfaces to confirm a breath response (confirmation address), the prior art describes the data basis for the feedback.
a patient's mood state based on audio data, which includes sounds or sounds produced by the patient that indicate psychological or physiological situations including anxiety or panic; (Cates, Col. 14, ll. 25-35; Col. 15, ll. 1-5)
Cates describes an analysis unit that interprets sound from a microphone to identify clinical events. Because the system detects sound identified as snoring to classify the patient's ventilation problem, it functionally describes using sounds produced by the patient to indicate a physiological situation.
Cates teaches the limitation a support system wherein the confirmation addresses are based on audio data, describing a system that uses a microphone to detect sounds produced by the patient such as snoring to identify physiological situations (Col. 14, ll. 23-40; Col. 15, ll. 1-15). However, Cates fails to disclose the specific Missing Element: confirmation addresses based on two-dimensional or three-dimensional image or video data comprising a facial expression or a spatial situation.
Rodgers teaches the Missing Element, describing the use of image or video data to determine a spatial situation and patient's mood state (pain/wellness) based on a facial expression, specifically disclosing a "controller mounted camera 1016 … provides a direct facial view of the patient" (Rodgers, Col. 30, ll. 46-67) and using video analysis to monitor "patient wellness," "pain level," and "detect movements or behaviors that may lead to unassisted Support exiting" (Rodgers, Col. 4, ll. 1-37;).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Cates with Rodgers because both references address the shared purpose of automated patient monitoring to "prevent harm to a patient" (Cates, Col. 2, ll. 54-67; Rodgers, Col. 3, ll. 10-25). The integration of Rodgers' video-based facial and spatial monitoring into Cates' audio-respiratory monitoring system provides a comprehensive verification mechanism to address Cates' recognized problem of "false alarms" caused by motion artifacts (Cates, Col. 2, ll. 15-20), allowing the system to visually confirm distress detected by the audio sensors.
A person of ordinary skill in the art would have been motivated to integrate the video-based facial and spatial analysis from Rodgers into the system of Cates to achieve the benefit of higher accuracy in event detection, as Rodgers teaches that using such profile-based analysis "reduces the incidence of false positives and false negatives... and may reduce staff response times to critical clinical events" (Rodger, Col. 4, ll. 55-67).
A PHOSITA would have had a reasonable expectation of success in combining the references because the modification required only ordinary skill and routine experimentation. Both references disclose computer-implemented monitoring systems utilizing sensors and logic modules (Cates, Fig. 1-3; Rodgers, Fig. 1-3), and the integration of camera data streams into a sensor fusion algorithm is a straightforward technical application of known elements.
Conclusion
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/JOSHUA DAMIAN RUIZ/Examiner, Art Unit 3684
/Shahid Merchant/ Supervisory Patent Examiner, Art Unit 3684