Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 2-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 2-11 and 12-21 are drawn to respective systems, each of which is within the four statutory categories.
Step 2A(1)
Claim 1 recites, in part, performing the steps of
for each of a plurality of different physiological parameters of the patient:
based at least in part on physiological data, determine a plurality of different physiological parameter features, each feature associated with physiological phenomena that affect measurement of the physiological parameter, wherein the plurality of physiological parameter features is configured to allow accurate measurement of risk associated with the physiological parameter;
for each of the plurality of physiological parameter features:
determine a risk associated with the physiological parameter feature based on whether the physiological parameter feature is changing; and
determine a risk weight associated with the physiological parameter feature based on sensitivity of the physiological parameter feature risk to changes in the physiological parameter feature;
determine the risk associated with the physiological parameter based on each of the weighted physiological parameter feature risks; and
determine a risk weight associated with the physiological parameter based on sensitivity of total risk associated with the patient to changes in the physiological parameter;
determine the total risk associated with the patient based on each of the weighted physiological parameter risks, wherein the total risk indicates a level of urgency in clinical treatment and care of the patient.
These elements fall within the scope of concepts performed within the human mind, and therefore recite an abstract idea in the form of a mental process. Fundamentally the process is that of evaluating the risk associated with physiological parameters of a patient based on features of each parameter and the sensitivity of the risk associated with each feature, and a total risk for the patient indicating urgency of care based on the risks posed by each parameter and the sensitivity of the risk of each parameter. Each of the steps enumerated above can be performed by a clinician observing a patient’s physiological data and making judgements regarding the relative risks posed by different parameters and features of the parameters before rendering an opinion on the urgency with which the patient must be treated.
Claim 12 recites, in part, performing the steps of
for each of a plurality of different physiological parameters of the patient:
based at least in part on a physiological signal, determine a plurality of different physiological parameter features, the plurality of physiological parameter features configured to allow accurate measurement of risk associated with the physiological parameter;
for each of the plurality of physiological parameter features:
determine a contribution to the physiological parameter risk based on a risk associated with the physiological parameter feature and a risk weight associated with the physiological parameter feature, wherein the physiological parameter feature risk is based on whether the physiological parameter feature is changing, and wherein the physiological parameter feature risk weight is based on sensitivity of the physiological parameter risk to changes in the physiological parameter feature; and
determine a contribution to a total risk associated with the patient based on a determined risk associated with the physiological parameter and a risk weight associated with the physiological parameter, wherein the physiological parameter risk is based on the contributions of each physiological parameter feature, and wherein the physiological parameter risk weight is based on sensitivity of the total risk to changes in the physiological parameter;
determine the total risk associated with the patient based on the contributions of each physiological parameter, wherein the total risk indicates a likelihood of serious illness or debilitation of the patient, and a change in risk derived from one or more of the plurality of physiological parameters of the patient.
These elements fall within the scope of concepts performed within the human mind, and therefore recite an abstract idea in the form of a mental process. Fundamentally the process is that of evaluating the risk associated with changes in physiological parameters of a patient based on features of each parameter and the sensitivity of the risk associated with each feature, and a total risk for the patient indicating urgency of care based on the risks posed by each parameter and the sensitivity of the risk of each parameter. Each of the steps enumerated above can be performed by a clinician observing a patient’s physiological data and making judgements regarding the relative risks posed by different parameters and features of the parameters before rendering an opinion on the likelihood of serious illness or debilitation of the patient.
In addition to a mental process, elements above such as a) determining a contribution to the physiological parameter risk based on a risk associated with the physiological parameter feature and a risk weight associated with the physiological parameter feature, wherein the physiological parameter feature risk is based on whether the physiological parameter feature is changing, and wherein the physiological parameter feature risk weight is based on sensitivity of the physiological parameter risk to changes in the physiological parameter feature, b) determining a contribution to a total risk associated with the patient based on a determined risk associated with the physiological parameter and a risk weight associated with the physiological parameter, wherein the physiological parameter risk is based on the contributions of each physiological parameter feature, and wherein the physiological parameter risk weight is based on sensitivity of the total risk to changes in the physiological parameter, and c) determining the total risk associated with the patient based on the contributions of each physiological parameter may also be construed as mathematical concepts in the form of mathematical calculations.
Step 2A(2)
This judicial exception is not integrated into a practical application because the additional elements within the claims only amount to:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
Claim 1 recites additional elements of a) a physiological sensor comprising a plurality of LEDs and a detector, the plurality of LEDs configured to emit light at one or more wavelengths at a measurement site of a patient, the detector configured to generate physiological data associated with the one or more light wavelengths after attenuation by tissue at the measurement site of the patient, b) one or more hardware processors recited as performing the subsequent data analysis functions, and c) a display recited as displaying a visual indicator associated with the total risk for visualization by a caregiver such that the caregiver is alerted for immediate attention to a condition of the patient.
Claim 12 recites additional elements of a) a physiological sensor having a plurality of LEDs configured to emit light of one or more wavelengths at a measurement site of a patient and at least one detector configured to generate at least one physiological signal associated with the one or more light wavelengths after attenuation by tissue at the measurement site of the patient, b) one or more hardware processors recited as in communication with the physiological sensor and used to perform the subsequent data analysis functions, and c) a display recited as displaying a visual indicator associated with the total risk to dynamically change responsive to the change in risk such that a caregiver is alerted for immediate attention to a change in condition of the patient.
Paragraph 57 provides a description of an optical sensor having LED emitters on one side of a fingertip and at least one detector positioned on the opposite side of the fingertip, and that the sensor produces a signal responsive to attenuation of the emitted light wavelengths by the tissue of the fingertip. Paragraph 57 discusses the LEDs emitting wavelengths that allow determining a ratio of oxyhemoglobin and deoxygemoglobin in the pulsatile blood perfused tissue in the fingertip, as well as emitting light so as to resolve other hemoglobin components, but does not provide further explicit description of the physiological data generated. Examiner notes that the above arrangement describes the components and functioning of a pulse oximeter, and that paragraph 6 of Applicant’s disclosure describes measurements such as hemoglobin and blood oxygen content as being produced by pulse oximeters. Given that a) the elements both recited and disclosed correspond to those of a pulse oximeter, b) that the physiological sensor is only recited as producing “physiological data” in claim 1 and a “physiological signal” in claim 12, and c) the only use of these information in the claim is determining the plurality of physiological parameter features “based at least in part on” the physiological data/physiological signal, the physiological sensor is construed as encompassing a blood sensor such as a pulse oximeter.
Paragraph 28 describes a system having a risk engine, an “optional personalization,” and an output processor. Paragraphs 58 and 59 additionally describe a “digital signal processor” and instrument manager as receiving digital data input and physiological parameter information. No further description of the hardware associated with these elements or disclosure of a “hardware processor” is provided however. The hardware processor is construed accordingly as encompassing generic computer processing components.
Paragraph 59 further describes I/O devices 1490, including touch screens, as well as visual indicators and displays for displaying physiological parameters and risk displays. Figures 10A and 10B show screens displaying a total risk score in the form of a graph on a graphical user interface element. No further disclosure is provided of the display or visual indicator. The display and visual indicator are construed accordingly as encompassing generic computer display hardware as well as graphical interface elements.
The above elements only amount to mere instructions to implement functions within the abstract idea using computing elements as tools. For example, the hardware processor is only recited at a high level of generality as configured to perform the subsequent data analysis steps and control the display, and is only broadly described in the disclosure. The display is likewise only recited at a high level of generality as used to display the visual indicator, with the visual indicator only recited as associated with the total risk and only disclosed as graphical elements. These elements are therefore not sufficient to integrate the abstract idea into a practical application.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of:
A. Instructions to Implement the Judicial Exception. MPEP 2106.05(f)
As explained above, claims 2 and 12 only recite the physiological sensor, one or more hardware processors, and display as tools for performing the steps of the abstract idea, and mere instructions to perform the abstract idea using a computer is not sufficient to amount to significantly more than the abstract idea. MPEP 2106.05(f).
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually.
Depending Claims
Claims 3 and 13 recite wherein the plurality of physiological parameters includes one or more of at least: oxygen saturation, respiration rate, pulse rate, pulse rate variability index, and perfusion index. These limitations fall within the scope of the abstract idea as set out above.
Claims 4 and 14 recite wherein the plurality of physiological parameter features includes one or more of at least: a physiological parameter baseline, a physiological parameter instability, and an average slope associated with the physiological parameter. These limitations fall within the scope of the abstract idea as set out above.
Claims 5 and 15 recite determining the physiological parameter baseline as riding near a top of a physiological parameter waveform over a period of time. These limitations fall within the scope of the abstract ideas as set out above.
Claims 5 and 15 further recite the additional element of the one or more hardware processors as configured to perform the subsequent data processing steps.
Paragraph 28 describes a system having a risk engine, an “optional personalization,” and an output processor. Paragraphs 58 and 59 additionally describe a “digital signal processor” and instrument manager as receiving digital data input and physiological parameter information. No further description of the hardware associated with these elements or disclosure of a “hardware processor” is provided however. The hardware processor is construed accordingly as encompassing generic computer processing components.
The recited hardware processor only amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the hardware processor is only recited at a high level of generality as configured to perform the subsequent data analysis steps, and is only broadly described in the disclosure. This element is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract ideas.
Claims 6 and 16 recite determining the physiological parameter instability based on a plurality of deviations of a physiological parameter waveform from the physiological parameter baseline over a period of time. These limitations fall within the scope of the abstract ideas as set out above.
Claims 6 and 16 further recite the additional element of the one or more hardware processors as configured to perform the subsequent data processing steps.
Paragraph 28 describes a system having a risk engine, an “optional personalization,” and an output processor. Paragraphs 58 and 59 additionally describe a “digital signal processor” and instrument manager as receiving digital data input and physiological parameter information. No further description of the hardware associated with these elements or disclosure of a “hardware processor” is provided however. The hardware processor is construed accordingly as encompassing generic computer processing components.
The recited hardware processor only amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the hardware processor is only recited at a high level of generality as configured to perform the subsequent data analysis steps, and is only broadly described in the disclosure. This element is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract ideas.
Claims 7 and 17 recite determining the average slope of the physiological parameter based on slopes of adjacent samples on a physiological parameter waveform over a period of time. These limitations fall within the scope of the abstract ideas as set out above.
Claims 7 and 17 further recite the additional element of the one or more hardware processors as configured to perform the subsequent data processing steps.
Paragraph 28 describes a system having a risk engine, an “optional personalization,” and an output processor. Paragraphs 58 and 59 additionally describe a “digital signal processor” and instrument manager as receiving digital data input and physiological parameter information. No further description of the hardware associated with these elements or disclosure of a “hardware processor” is provided however. The hardware processor is construed accordingly as encompassing generic computer processing components.
The recited hardware processor only amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the hardware processor is only recited at a high level of generality as configured to perform the subsequent data analysis steps, and is only broadly described in the disclosure. This element is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract ideas.
Claims 8 and 18 recite determining a physiological parameter feature risk based on whether the physiological parameter feature is changing in a certain direction. These limitations fall within the scope of the abstract ideas as set out above.
Claims 8 and 18 further recite the additional element of the one or more hardware processors as configured to perform the subsequent data processing steps.
Paragraph 28 describes a system having a risk engine, an “optional personalization,” and an output processor. Paragraphs 58 and 59 additionally describe a “digital signal processor” and instrument manager as receiving digital data input and physiological parameter information. No further description of the hardware associated with these elements or disclosure of a “hardware processor” is provided however. The hardware processor is construed accordingly as encompassing generic computer processing components.
The recited hardware processor only amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the hardware processor is only recited at a high level of generality as configured to perform the subsequent data analysis steps, and is only broadly described in the disclosure. This element is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract ideas.
Claims 9 and 19 recite determining a physiological parameter feature risk based on whether a physiological parameter feature value is either increasing or decreasing. These limitations fall within the scope of the abstract idea as set out above.
Claims 9 and 19 further recite the additional element of the one or more hardware processors as configured to perform the subsequent data processing steps.
Paragraph 28 describes a system having a risk engine, an “optional personalization,” and an output processor. Paragraphs 58 and 59 additionally describe a “digital signal processor” and instrument manager as receiving digital data input and physiological parameter information. No further description of the hardware associated with these elements or disclosure of a “hardware processor” is provided however. The hardware processor is construed accordingly as encompassing generic computer processing components.
The recited hardware processor only amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the hardware processor is only recited at a high level of generality as configured to perform the subsequent data analysis steps, and is only broadly described in the disclosure. This element is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract ideas.
Claims 10 and 20 recite determining one or more risk factors based on received patient data associated with the monitored patient. These limitations fall within the scope of the abstract ideas as set out above.
Claims 10 and 20 further recite the additional element of the one or more hardware processors as configured to perform the subsequent data processing steps.
Paragraph 28 describes a system having a risk engine, an “optional personalization,” and an output processor. Paragraphs 58 and 59 additionally describe a “digital signal processor” and instrument manager as receiving digital data input and physiological parameter information. No further description of the hardware associated with these elements or disclosure of a “hardware processor” is provided however. The hardware processor is construed accordingly as encompassing generic computer processing components.
The recited hardware processor only amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the hardware processor is only recited at a high level of generality as configured to perform the subsequent data analysis steps, and is only broadly described in the disclosure. This element is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract ideas.
Claims 11 and 21 recite updating one or more physiological parameter risks based on the one or more risk factors. These limitations fall within the scope of the abstract ideas as set out above.
Claims 11 and 21 further recite the additional element of the one or more hardware processors as configured to perform the subsequent data processing steps.
Paragraph 28 describes a system having a risk engine, an “optional personalization,” and an output processor. Paragraphs 58 and 59 additionally describe a “digital signal processor” and instrument manager as receiving digital data input and physiological parameter information. No further description of the hardware associated with these elements or disclosure of a “hardware processor” is provided however. The hardware processor is construed accordingly as encompassing generic computer processing components.
The recited hardware processor only amounts to mere instructions to implement functions within the abstract idea using computing elements as tools. Specifically, the hardware processor is only recited at a high level of generality as configured to perform the subsequent data analysis steps, and is only broadly described in the disclosure. This element is therefore not sufficient to integrate the abstract idea into a practical application or to amount to significantly more than the abstract ideas.
Claims 2-21 are therefore rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 5 and 15 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.
With respect to claims 5 and 15, Examiner is unable to determine the metes and bounds of the respective claims based on the recitation of “determine the physiological parameter baseline as riding near a top of a physiological parameter waveform…”.
Initially, it is not clear what function is being recited by “determin[ing]” the physiological parameter baseline in the context of the above limitation. The claim is ambiguous as to whether “determine” corresponds to calculating the physiological parameter baseline value based on the criteria of “riding near a top of a physiological parameter waveform,” or a different function such as simply displaying the physiological parameter baseline near a top of a physiological parameter waveform.
Furthermore, the term “near” is a relative term which renders the claim indefinite. The term “near” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. While paragraphs 35 and 38 use the term in the same context as the respective claims, and Figure 5A shows a line in proximity to the top of a waveform, it is not clear how one would determine whether a particular value for the physiological parameter baseline would qualify as “near” the top.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rothman et al (US Patent Application Publication 2009/0105550) discloses a system which calculates a health score by determining a risk associated with each of a plurality of vital sign parameters, assigning weights to the parameters based on the relative contribution of each parameter to the patient’s risk, and summing the weighted risk series (see e.g. [74]-[83], [118]-[129], and [131]).
Wu et al (US Patent Application Publication 2010/0106524) discloses a system which calculates a health risk for different medical events by determining a risk associated with particular levels of each of a plurality of patient parameters, assigning weights to the parameters based on the relative contribution of each parameter to the risk posed by that event, and summing the weighted risk series (see e.g. [37]-[39], [57]-[69], and Tables 1-3);
Al-Ali et al (US Patent Application Publication 2006/0220881) discloses a monitoring system including a physiological sensor comprising a plurality of LEDs configured to emit light at one or more wavelengths at a measurement site of a patient, and a detector configured to generate physiological data associated with the one or more light wavelengths after attenuation by tissue at the measurement site of the patient, and a display showing indicators of patient risk (see e.g. Figures 1 and 4, [36], [41], and [92]-[94]);
Tarassenko et al, Biosign™: Multi-Parameter Monitoring For Early Warning Of Patient Deterioration;
Saeed et al (US Patent Application Publication 2008/0214904);
Hopenfeld (US Patent Application Publication 2011/0040199);
Lynn (US 6,223,064);
Sampath (US Patent Application Publication 2009/0119330).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM G LULTSCHIK whose telephone number is (571)272-3780. The examiner can normally be reached 9am - 5pm.
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/Gregory Lultschik/Examiner, Art Unit 3682