DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-15 are pending.
This communication is in response to the communication filed November 7, 2025.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite systems, apparatuses, or methods for visually conveying future state of physiological state of patients, which are statutory categories of inventions.
Specifically, the independent claims, taking claim 1 as exemplary, recite accessing a stream of measured values, visually conveying a future state of the physiological parameter using the graphical representation of the patient by using a prediction technique to, based on the stream of measured values, generating, a prediction of a value of the physiological parameter at least one future time instance, thereby obtaining at least one predicted value of the physiological parameter; providing a modified version of each different set of graphical elements and selecting the modified version of a set of graphical elements for display based on the predicted value of the physiological parameter, wherein the modified version of the set of graphical elements is modified with respect to the set of graphical elements by a visual attribute of the set of graphical elements having been modified.
The dependent claims recite limitations directed to rendering styles, determining a confidence of the prediction of the value, prediction is determined based on an average of sensitivity and specificity, determining if the predicted value of the physiological parameter crosses a physiological threshold, determining a degree of criticality of the predicted value, conveying the degree of criticality, determining the degree of criticality, providing the modified version of the set of graphical elements simultaneously with set of graphical elements, omitting a numerical visualization, modified version of each set of graphical elements is selected, and physiological parameters.
The claims are interpreted as being grouped within the “certain methods of organizing human activity” grouping of abstract ideas because in this case, the claims involve a series of steps for displaying acquired information of physiological parameters. See MPEP 2106.04. The social activity at issue was the social activity of "’providing information to a person without interfering with the person’s primary activity.’" 896 F.3d at 1344, 127 USPQ2d 1553 (citing Interval Licensing LLC v. AOL, Inc., 193 F. Supp.3d 1184, 1188 (W.D. 2014)). The patentee claimed an attention manager for acquiring content from an information source, controlling the timing of the display of acquired content, displaying the content, and acquiring an updated version of the previously-acquired content when the information source updates its content. 896 F.3d at 1339-40, 127 USPQ2d at 1555. The Federal Circuit concluded that "[s]tanding alone, the act of providing someone an additional set of information without disrupting the ongoing provision of an initial set of information is an abstract idea," observing that the district court "pointed to the nontechnical human activity of passing a note to a person who is in the middle of a meeting or conversation as further illustrating the basic, longstanding practice that is the focus of the [patent ineligible] claimed invention." 896 F.3d at 1344-45, 127 USPQ2d at 1559.Accordingly, the claims recite an abstract idea.
This judicial exception is not integrated into a practical application. Integration into a practical application requires an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the exception. Here, the additional elements of the claims include computer elements: computer, display, non-transitory computer readable medium, input interface, display interface, and processor subsystem and a patient monitor.
The claims merely use the additional elements as tools to perform abstract ideas and generally link the use of a judicial exception to a particular technological environment. The use of the additional elements as tools to implement the abstract idea and generally to link the use of the abstract idea to a particular technological environment does not render the claim patent eligible, because it requires no more than a computer performing functions that correspond to acts required to carry out the abstract idea. Specifically, the computer elements perform the steps or functions of inputting, processing, storing, outputting, and displaying data. The invention may use a device or apparatus that may be a general-purpose device or apparatus, such as a workstation or a computer and may also be an application-specific device or apparatus, such as a patient monitor. (specification p. 18). The computer elements and the patient monitor are recited a high level of generality.
The additional elements do not show an improvement to the functioning of a computer or to any other technology, rather the additional elements perform general computing functions and do not indicate how the particular combination improves any technology or provides a technical solution to a technical problem. See Apple v. Ameranth, 842 F.3d 1229, 1240 (Fed. Cir. 2016). The additional elements do not use the exception to affect a particular treatment or prophylaxis for a disease, do not apply the exception using particular machines, and do not effect a transformation or reduction of a particular article to a different state or thing, rather the computer elements are generally stated as to their structure and function and are only used to make visualization of physiological state instead of directly providing specific treatment or prophylaxis. Therefore, the additional elements do not impose any meaningful limits on practicing the abstract idea and the additional limitations are not indicative of materializing into a practical application. Accordingly, the claim is directed to an abstract idea.
Generic computer elements recited as performing generic computer functions that are well-understood, routine, or conventional activities amount to no more than implementing the abstract idea with a computerized system (Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network and performing repetitive calculations); Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims."); See MPEP 2106.05(d) and July 2015 Update: Section IV). Here, the claim limitations directed to generating predictions and accessing values, are similar to receiving and sending information over a network and performing repetitive calculations.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as discussed above with respect to integration of the abstract idea into a practical application, the use of additional elements to perform the steps of the claims amount to no more than using computer related devices to automate or implement the abstract idea of visually conveying future state of physiological state of patients.
The use of a computer or processor to merely automate or implement the abstract idea cannot provide significantly more than the abstract idea itself. (See MPEP 2106.05(f) where mere instructions to apply an exception does not render an abstract idea patent eligible). There is no indication that the additional limitations alone or in combination improves the functioning of a computer or any other technology, improves another technology or technical field, or effects a transformation or reduction of a particular article to a different state or thing. Therefore, the claims are not patent eligible.
In conclusion, the claims are directed to the abstract idea of visually conveying future state of physiological state of patients. The claims do not provide an inventive concept, because the claims do not recite additional elements or a combination of elements that amount to significantly more than the judicial exception of the claims. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and the collective functions merely provide conventional computer implementation. Therefore, whether taken individually or as an order combination, the claims are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-2 and 9-15 are rejected under 35 U.S.C. 103 as being unpatentable over Hong (IDS Reference) in view of Tscholl (IDS Reference).
As per claim 1, Hong teaches
A computer-implemented method for visually conveying a physiological state of a patient, comprising: accessing a stream of measured values of at least one physiological parameter of the patient, wherein the measured values are obtained at consecutive time instances; (Hong par. 173 teaches application 210 may, for example, an application to receive user input or patient data for use in determining predicted patient parameters)
establishing a graphical representation of the patient on a display, wherein the graphical representation is configured to visually convey a current state of the physiological parameter using a set of graphical elements, wherein the set of graphical elements is selected from a predetermined number of different sets of graphical elements, which different sets of graphical elements each represent a different state of the physiological parameter, based on a current measured value of the physiological parameter; (Hong par. 173 teaches textual and graphical user interfaces to receive patient data as input and display output including predicted patient parameters for a given patient. Here the graphical representation of the patient on display is interpreted as displaying patient values on a screen.)
wherein the method further comprises visually conveying a future state of the physiological parameter using the graphical representation of the patient by: using a prediction technique to, based on the stream of measured values, generating a prediction of a value of the physiological parameter at least one future time instance, thereby obtaining at least one predicted value of the physiological parameter; (Hong claim 1 teaches processing past patient vital signs data for each patient using a vital signs prediction model derived from at least one machine learning process to output for each patient a respective time series of predicted vital signs values)
X does not specifically teach the following limitations met by Y, providing a modified version of each different set of graphical elements and selecting the modified version of a set of graphical elements for display based on the predicted value of the physiological parameter, wherein the modified version of the set of graphical elements is modified with respect to the set of graphical elements by a visual attribute of the set of graphical elements having been modified (Tscholl abstract, table 1, fig. 1)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the systems and methods as taught by Hong to provide and select a modified version of a set of graphical elements as taught by Tscholl with the motivation to improve perception of vital sign information by presenting patient status as an animated patient avatar that contains different sets of graphical elements for different vital signs modified over time (Tscholl abstract, fig. 1, table 1).
As per claim 2, Hong and Tscholl teach all the limitations of claim 1 and further teach wherein the visual attribute which is modified is a rendering style of the set of graphical elements, for example a line drawing style or line drawing colour, an area filling style or area filling colour, or a transparency (Tscholl Table 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the systems and methods as taught by Hong to use visual attribute which is modified is a rendering style of the set of graphical elements as taught by Tscholl with the motivation to improve perception of vital sign information by presenting patient status as an animated patient avatar that contains different sets of graphical elements for different vital signs modified over time (Tscholl abstract, fig. 1, table 1).
As per claim 9, Hong and Tscholl teach all the limitations of claim 1 and further teach comprising providing the modified version of the set of graphical elements simultaneously with set of graphical elements to simultaneously convey the current state of the physiological parameter and the future state of physiological parameter (Tscholl fig. 1, table 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the systems and methods as taught by Hong to provide the modified version of the set of graphical elements simultaneously with set of graphical elements to simultaneously convey the current state of the physiological parameter and the future state of physiological parameter as taught by Tscholl with the motivation to improve perception of vital sign information by presenting patient status as an animated patient avatar that contains different sets of graphical elements for different vital signs modified over time (Tscholl abstract, fig. 1, table 1).
As per claim 10, Hong and Tscholl teach all the limitations of claim 1 and further teach omitting a numerical visualization of one or more of: the predicted value of the physiological parameter, the future state of the physiological parameter, and the future time instance (Hong par. 173, here displaying less than all of the numerical visualizations may be interpreted as an omission).
As per claim 11, Hong and Tscholl teach all the limitations of claim 1 and further teach the different sets of graphical elements are selected to be visually distinguishable from each other; and/or the modified version of each set of graphical elements is selected to be visually distinguishable from each respective set of graphical elements (Tscholl fig. 1, table 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the systems and methods as taught by Hong to different sets of graphical elements are selected to be visually distinguishable from each other as taught by Tscholl with the motivation to improve perception of vital sign information by presenting patient status as an animated patient avatar that contains different sets of graphical elements for different vital signs modified over time (Tscholl abstract, fig. 1, table 1).
As per claim 12, Hong and Tscholl teach all the limitations of claim 11 and further teach wherein the physiological parameter is one of: temperature, heart rate, pulse rate, ST-segment deviation, invasive arterial blood pressure, central venous pressure, respiratory rate, tidal volume, end-tidal CO2 concentration, train of four ratio, bispectral index, oxygen saturation, and non- invasive arterial blood pressure (Tscholl fig. 1, table 1).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the systems and methods as taught by Hong to use various physiological parameters as taught by Tscholl with the motivation to improve perception of vital sign information by presenting patient status as an animated patient avatar that contains different sets of graphical elements for different vital signs modified over time (Tscholl abstract, fig. 1, table 1).
As per claim 13-15, see claim rejections above.
Claims 3-8 are rejected under 35 U.S.C. 103 as being unpatentable over Hong (IDS Reference) in view of Tscholl (IDS Reference) in further view of Sullivan (IDS Reference).
As per claim 3, Hong and Tscholl teach all the limitations of claim 1, but do not teach the following limitations met by Sullivan, determining a confidence of the prediction of the value of the physiological parameter; providing the modified version of the set of graphical elements only if the confidence exceeds a confidence threshold (Sullivan par. 290).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the systems and methods as taught by Hong and Tscholl to use various physiological parameters as taught by Sullivan with the motivation to improve systems for detecting early warning signs of elevated risk of sudden cardiac death that would enable proactive decisions such as the application of advanced medical intervention (Sullivan par. 3-4).
As per claim 4, Hong, Tscholl, and Sullivan teach all the limitations of claim 3 and further teach wherein the confidence of the prediction is determined based on an average of sensitivity and specificity of the prediction technique (Sullivan par. 371).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the systems and methods as taught by Hong and Tscholl to make predictions based on an average of sensitivity and specificity of the prediction technique as taught by Sullivan with the motivation to improve systems for detecting early warning signs of elevated risk of sudden cardiac death that would enable proactive decisions such as the application of advanced medical intervention (Sullivan par. 3-4).
As per claim 5, Hong and Tscholl teach all the limitations of claim 1, but do not teach the following limitations met by Sullivan, determining if the predicted value of the physiological parameter crosses a physiological threshold associated with the physiological parameter; and providing the modified version of the set of graphical elements only if the predicted value of the physiological parameter has crossed the physiological threshold (Sullivan par. 298).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the systems and methods as taught by Hong and Tscholl to determine if the predicted value of the physiological parameter crosses a physiological threshold associated with the physiological parameter as taught by Sullivan with the motivation to improve systems for detecting early warning signs of elevated risk of sudden cardiac death that would enable proactive decisions such as the application of advanced medical intervention (Sullivan par. 3-4).
As per claim 6, Hong, Tscholl, and Sullivan teach all the limitations of claim 5 and further teach determining a degree of criticality of the predicted value of the physiological parameter having crossed the physiological threshold; and conveying the degree of criticality by selecting at least one of: a further visual attribute, a display time, and a display frequency, of the modified version of the set of graphical elements based on the degree of criticality (Sullivan par. 298).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the systems and methods as taught by Hong and Tscholl to determine a degree of criticality as taught by Sullivan with the motivation to improve systems for detecting early warning signs of elevated risk of sudden cardiac death that would enable proactive decisions such as the application of advanced medical intervention (Sullivan par. 3-4).
As per claim 7, Hong, Tscholl, and Sullivan teach all the limitations of claim 6 and further teach determining the degree of criticality based on at least one of: a confidence of the prediction of the value of the physiological parameter; a time difference with respect to the future time instance of the prediction; and a difference between the predicted value of the physiological parameter and the physiological threshold (Sullivan par. 298).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the systems and methods as taught by Hong and Tscholl to determine a degree of criticality as taught by Sullivan with the motivation to improve systems for detecting early warning signs of elevated risk of sudden cardiac death that would enable proactive decisions such as the application of advanced medical intervention (Sullivan par. 3-4).
As per claim 8, Hong, Tscholl, and Sullivan all the limitations of claim 6 and further teach wherein the further visual attribute is a transparency or a flashing display of the modified version of the set of graphical elements (Sullivan par. 298).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the systems and methods as taught by Hong and Tscholl to use a visual attribute that is a transparency or a flashing display as taught by Sullivan with the motivation to improve systems for detecting early warning signs of elevated risk of sudden cardiac death that would enable proactive decisions such as the application of advanced medical intervention (Sullivan par. 3-4).
Conclusion
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/JAY M. PATEL/Primary Examiner, Art Unit 3686