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 .
Claims 1-18, 22-24 and 26 are hereby under examination.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-18, 22-24 and 26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 1-18, 22-24 and 26 are directed to a device, which describes one of the four statutory categories of patentable subject matter, i.e., a machine.
Step 2A of the subject matter eligibility test (see MPEP 2106.04)
Prong one: Claims 1-18, 22-24 and 26 recite abstract idea, as follows:
Claim 1: “…acquire venous pressure and cardiac output that are calculated based on physiological information of a subject, wherein the venous pressure is an index that reflects right atrial pressure measured in a right atrium and an amount of blood returning to the heart and right atrial preload; analyze hemodynamic parameters of the subject based on the venous pressure and the cardiac output, wherein the hemodynamic parameters includes congestion of the subject and circulatory failure of the subject; compare the venous pressure with a predetermined venous pressure threshold and the cardiac output with a predetermined cardiac output threshold; classify the subject into one of a plurality of groups based on the hemodynamic parameters; and prompt administration of one of a plurality of predetermined treatments based on a classification of the subject into the one of the plurality of groups, wherein the plurality of groups comprises: a first group indicating congestion without circulatory failure, a second group indicating circulatory failure without congestion, or a third group indicating both congestion and circulatory failure.”
Claim 10: “…calculate venous pressure non-invasively based on a signal acquired by a sensor that is in contact with or close to a body surface of a subject; acquire cardiac output non-invasively calculated based on a heart rate of the subject and pulse wave transit time obtained based on a pulse wave, wherein the venous pressure is an index that reflects right atrial pressure measured in a right atrium and an amount of blood returning to the heart and right atrial preload; compare the venous pressure with a predetermined venous pressure threshold and the cardiac output with a predetermined cardiac output threshold; classify the subject into one of a plurality of groups based on the hemodynamic parameters; prompt administration of one of a plurality of predetermined treatments based on a classification of the subject into the one of the plurality of groups; and display the venous pressure and the cardiac output on a coordinate plane with venous pressure and cardiac output as coordinate axes wherein the plurality of groups comprises: a first group indicating congestion without circulatory failure, a second group indicating circulatory failure without congestion, or a third group indicating both congestion and circulatory failure.”
Claim 23: “…acquire venous pressure and cardiac output that are calculated based on physiological information of a subject; analyze hemodynamic parameters of the subject based on the venous pressure and the cardiac output compare the venous pressure with a predetermined venous pressure threshold and the cardiac output with a predetermined cardiac output threshold, classify the subject into one of a plurality of groups based on the hemodynamic parameters; and prompt administration of one of a plurality of predetermined treatments based on a classification of the subject into the one of the plurality of groups, wherein the plurality of groups comprises: a first group indicating congestion without circulatory failure, a second group indicating circulatory failure without congestion, or a third group indicating both congestion and circulatory failure.”
Claim 24: “calculate venous pressure based on a signal acquired by a sensor that is in contact with or close to a body surface of a subject; acquire cardiac output non-invasively calculated based on a heart rate of the subject and pulse wave transit time obtained based on a pulse wave; compare the venous pressure with a predetermined threshold and the cardiac output with a predetermined threshold; classify the subject into one of a plurality of groups based on the hemodynamic parameters; prompt administration of one of a plurality of predetermined treatments based on a classification of the subject into the one of the plurality of groups; and display the venous pressure and the cardiac output on a coordinate plane with venous pressure and cardiac output as coordinate axes wherein the plurality of groups comprises: a first group indicating congestion without circulatory failure, a second group indicating circulatory failure without congestion, or a third group indicating both congestion and circulatory failure.”
Based on the broadest reasonable interpretation, acquiring venous pressure and cardiac output, calculating venous pressure and cardiac output non-invasively, analyzing hemodynamic parameters of the subject based on the venous pressure and the cardiac output, comparing the venous pressure and cardiac output to a predetermined threshold, classifying the subject into one of a plurality of groups, and prompting administration of one of a plurality of predetermined treatments based on a classification, and displaying the venous pressure and the cardiac output that are acquired on a coordinate plane with venous pressure and cardiac output as coordinate axes can be done mentally with the aid of a pen and paper. A person can acquire venous pressure and cardiac output on a piece of paper either in data table or graph format. Then the person can calculate the venous pressure and cardiac output by looking at the data presented on the piece of paper, and analyze the hemodynamic parameters by observing the numerical trend of venous pressure and cardiac output. The person can compare the venous pressure and cardiac output mathematically and classify by categorizing the comparison. The person can prompt administration of one of a plurality of predetermined treatments based on a classification by looking at the classification on a piece of paper, and verbally saying the instructions of administration. Finally, the person can display the venous pressure and cardiac output on a coordinate plane by drawing the coordinate plane on a piece of paper and plotting the data points for venous pressure and cardiac output, and generate a prompt by writing down the treatment instructions on a piece of paper.
Prong two: Claims 1-18, 22-24 and 26 do not include additional elements that integrate the abstract into a practical application.
The additional elements are as follows:
a display (claims 9 and 10)
A non-transitory computer readable medium (claims 23 and 24)
a sensor (claim 24)
a processor (claims 1, 10 and 23-24)
Reciting a computer or computer components (non-transitory computer readable medium and processor) simply amounts to reciting a general processor to perform general functions of a computer as above to perform the mental processes of acquiring venous pressure and cardiac output, calculating venous pressure and cardiac output non-invasively, analyzing hemodynamic parameters of the subject based on the venous pressure and the cardiac output, comparing the venous pressure and cardiac output to a predetermined threshold, classifying the subject into one of a plurality of groups, and generate a prompt regarding one of a plurality of predetermined treatment based on a classification of the subject, and displaying the venous pressure and the cardiac output that are acquired on a coordinate plane with venous pressure and cardiac output as coordinate axes are mere instructions to apply the judicial exception to general technology. Such elements do not integrate the exception into a practical application since they are merely instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.04(d) and MPEP 2106.05(f).
Reciting a notification unit, output unit, and display do not integrate the exception into a practical application since it is merely insignificant extra-solution activity to the judicial exception, e.g., simply outputting the results of the algorithm in a high-level implementation.
Reciting a sensor do not integrate the exception into a practical application since it is merely insignificant extra-solution activity to the judicial exception, e.g., mere data gathering at a higher level of generality.
Therefore, claims 1-18, 22-24 and 26 are ineligible at step 2A, prong two.
Step 2B of the subject matter eligibility test (see MPEP 2106.05)
Reciting a computer or computer components (non-transitory computer readable medium and processor) simply amounts to reciting a general processor to perform general functions of a computer as above to perform the mental processes of acquiring venous pressure and cardiac output, calculating venous pressure and cardiac output non-invasively, analyzing hemodynamic parameters of the subject based on the venous pressure and the cardiac output, comparing the venous pressure and cardiac output to a predetermined threshold, classifying the subject into one of a plurality of groups, and generate a prompt regarding one of a plurality of predetermined treatment based on a classification of the subject, and displaying the venous pressure and the cardiac output that are acquired on a coordinate plane with venous pressure and cardiac output as coordinate axes are mere instructions to apply the judicial exception to general technology.
Such elements do not qualify as significantly more because this limitation is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (see Electric Power Group, 830 F.3d 1350 (Fed. Cir. 2016); Alice Corp. v. CLS Bank Int’l, 110 USPQ2d 1976 (2014); SAP Am. v. InvestPic, 890 F.3d 1016 (Fed. Circ. 2018)).
Reciting a display do not integrate the exception into a practical application since it is merely insignificant extra-solution activity to the judicial exception, e.g., simply outputting the results of the algorithm in a high-level implementation.
U.S. Patent Application Publication No. US 20100094112 A1 (previously cited) discloses that a display is conventional: [0336], “Touch screen displays are well known.”
Reciting a sensor do not integrate the exception into a practical application since it is merely insignificant extra-solution activity to the judicial exception, e.g., mere data gathering at a higher level of generality.
U.S. Patent Application Publication No. US 20220233085 A1 (previously cited) discloses that sensors are conventional: [0004], “a conventional wearable blood pressure measuring device”
In view of the above, the additional elements individually do not integrate the exception into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Therefore, claims 1-18, 22-24 and 26 are ineligible at step 2B.
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
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.
Claims 1-4, 8-15, 22-24 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over US20090221923A1 (Uemura et. al), previously cited and hereto referred as Uemura, and in view of US20220142495A1 (De Marco et. al), previously cited and hereto referred as De Marco, and in view of US20190298180A1 (Sakai et. al), cited by Applicant and hereto referred to as Sakai, and in view of US20110098540A1 (Tanishima et. al), previously cited and hereto referred as Tanishima.
As to claims 1 and 23, Uemura teaches a processor to acquire venous pressure and cardiac output based on physiological information of a subject (Uemura, [0067], “The hemodynamics numeric data (AP value and CO value, as well as Pra and Pla values) input by input means (2) are respectively obtained using a conventional measurement device.”; [0029], “a Swan-Gianz catheter for measuring CO, Pla, and Pra”), wherein the venous pressure is an index that reflects right atrial pressure measured in a right atrium and an amount of blood returning to the heart and right atrial preload (Uemura, [0062], “right atrial pressure (Pra)”);
analyze hemodynamic parameters of the subject based on the venous pressure and the cardiac output, wherein the hemodynamic parameters includes congestion of the subject and circulatory failure of the subject (Uemura, [0063], "(e.g., reduction in CO (peripheral circulatory failure), elevation in Pla (pulmonary congestion)"; [0110], "FIG. 4 shows venous return surface (c) of a normal subject and venous return surface (d) of a congestive patient where the effective circulating blood volume is increased."; [0100], "FIG. 3 shows CO curve (a) of a normal heart and CO curve (b) of a failing heart.").
compare the venous pressure with a predetermined threshold and the cardiac output with a predetermined threshold (Uemura, [0110], "FIG. 4 shows venous return surface (c) of a normal subject and venous return surface (d) of a congestive patient where the effective circulating blood volume is increased."; [0100], "FIG. 3 shows CO curve (a) of a normal heart and CO curve (b) of a failing heart.");
classify the subject into one of a plurality of groups based on the hemodynamic parameters (Uemura, [0120], “According to this comparison result, first comparison means (41) sends the dosing means (first dosing means (51)) described below a signal indicating that the calculated pumping ability value of the left heart is larger than (signal “large”), equal to (signal “equal”), or smaller than (signal “small”) the target pumping ability value of the left heart.”; [0174], “or the target pumping ability value of the right heart”); and
prompt administration of one of a plurality of predetermined treatments based on a classification of the subject into the one of the plurality of groups (Uemura, [0132], “The drug administration according to the signal of the comparison results from first comparison means (41) allows first dosing means (51) to start drug administration when abnormal pumping ability is detected.”).
However, Uemura does not necessarily teach that venous pressure and cardiac output are calculated based on physiological information of a subject. De Marco and Sakai teaches a similar art of analyzing hemodynamic parameter (De Marco, [0008], “The analysis of the retrieved light modulations is known to be relevant to identify cardiovascular information from the user such a as heart rate, heart rate variability, blood constituents, blood pressure and other cardiovascular parameters.”; Sakai, abstract, “measuring the heart rate”). De Marco teaches venous pressure is calculated based on physiological information of a subject (De Marco, [0075], “The PPG sensor 100 can be used for determining…venous pressure”) and Sakai teaches cardiac output is calculated based on physiological information of a subject (Sakai, [0004], “the cardiac output which is calculated by using the heart rate and pulse wave transit time”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Uemura in view of De Marco and Sakai to include venous pressure and cardiac output are calculated based on physiological information of a subject because Uemura already teaches acquiring venous pressure and cardiac output by conventional methods (Uemura, [0067], “The hemodynamics numeric data (AP value and CO value, as well as Pra and Pla values) input by input means (2) are respectively obtained using a conventional measurement device… though not limited to these”), and De Marco and Sakai supplies a predictable method of acquiring venous pressure and cardiac output.
Additionally, Uemura does not necessarily teach that the plurality of groups comprises: a first group indicating congestion without circulatory failure, a second group indicating circulatory failure without congestion, or a third group indicating both congestion and circulatory failure. Tanishima teaches a relevant art of cardiac assessment. Tanishima teaches classification into plurality groups comprising a first group indicating congestion without circulatory failure, a second group indicating circulatory failure without congestion, or a third group indicating both congestion and circulatory failure (Tanishima, Fig. 7). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Uemura-De Marco-Sakai in view of Tanishima because Uemura-De Marco-Sakai already teaches classifications into a plurality of groups (Uemura, Figs. 3-5), and Tanishima further suggests interpretation of the classifications, i.e. circulatory failure without congestion, congestion without circulatory failure, or both congestion and circulatory failure.
As to claim 2, Uemura-De Marco-Sakai-Tanishima teaches the processor to analyze at least one of congestion of the subject and circulatory failure of the subject based on the venous pressure and the cardiac output (Uemura, [0063], "Cardiac disease treatment system (1) is used to determine the functional cause of abnormality in the cardiovascular system based on a hemodynamic abnormality (e.g., reduction in CO (peripheral circulatory failure), elevation in Pla (pulmonary congestion)"; Figs. 3-5).
As to claim 3, Uemura-De Marco-Sakai-Tanishima teaches the processor to estimate a degree of congestion of the subject to be estimated based on the venous pressure (Uemura, [0110], "FIG. 4 shows venous return surface (c) of a normal subject and venous return surface (d) of a congestive patient where the effective circulating blood volume is increased" ) and a degree of circulatory failure of the subject to be estimated based on the cardiac output (Uemura, [0100], "FIG. 3 shows CO curve (a) of a normal heart and CO curve (b) of a failing heart.").
As to claim 4, Uemura-De Marco-Sakai-Tanishima teaches processor to set a threshold value for venous pressure and cardiac output (Uemura, [0110], "FIG. 4 shows venous return surface (c) of a normal subject and venous return surface (d) of a congestive patient where the effective circulating blood volume is increased."; [0100], "FIG. 3 shows CO curve (a) of a normal heart and CO curve (b) of a failing heart."; the examiner notes, the predetermined venous pressure threshold and the predetermined cardiac output threshold is interpreted as the limit in Fig. 3 and Fig. 4 where the heart function is determined to be abnormal);
determine a classification corresponding to the degree of congestion of the subject and the degree of circulatory failure of the subject based on a classification group related to congestion and circulatory failure (Uemura, [0120], " the calculated pumping ability value of the left heart is larger than (signal “large”), equal to (signal “equal”), or smaller than (signal “small”) the target pumping ability value of the left heart."),
the classification group being classified based on the threshold value of venous pressure and the threshold value of cardiac output (Ueumra, Equation 4, the target CO value and target Pra determines the target pumping ability value, which the classification is based on.).
As to claim 8, Uemura-De Marco-Sakai-Tanishima teaches processor to output an analysis result of hemodynamic parameters of the subject analyzed (Uemura, [0028], “a display means (6) continuously displaying each of the calculated values”).
As to claim 9, Uemura-De Marco-Sakai-Tanishima teaches display configured to display the analysis result, and wherein the display is configured to display an analysis result of hemodynamic parameters of the subject on a coordinate plane with venous pressure and cardiac output as coordinate axes (Uemura, Figs. 3-5).
As to claims 10, 12 and 24, Uemura-De Marco-Sakai-Tanishima teaches processor to calculate venous pressure based on a signal acquired by a sensor that is in contact with or close to a body surface of a subject (De Marco, [0075], “The PPG sensor 100 can be used for determining…venous pressure”);
acquire cardiac output non-invasively calculated based on a heart rate of the subject and pulse wave transit time obtained based on a pulse wave (Sakai, [0004], “the cardiac output which is calculated by using the heart rate and pulse wave transit time”);
compare the venous pressure with a predetermined threshold and the cardiac output with a predetermined threshold;
compare the venous pressure with a predetermined threshold and the cardiac output with a predetermined threshold (Uemura, [0110], "FIG. 4 shows venous return surface (c) of a normal subject and venous return surface (d) of a congestive patient where the effective circulating blood volume is increased."; [0100], "FIG. 3 shows CO curve (a) of a normal heart and CO curve (b) of a failing heart.");
classify the subject into one of a plurality of groups based on the hemodynamic parameters (Uemura, [0120], “According to this comparison result, first comparison means (41) sends the dosing means (first dosing means (51)) described below a signal indicating that the calculated pumping ability value of the left heart is larger than (signal “large”), equal to (signal “equal”), or smaller than (signal “small”) the target pumping ability value of the left heart.”; [0174], “or the target pumping ability value of the right heart”); and
generate a prompt regarding one of a plurality of predetermined treatment based on a classification of the subject into the one of the plurality of groups (Uemura, [0132], “The drug administration according to the signal of the comparison results from first comparison means (41) allows first dosing means (51) to start drug administration when abnormal pumping ability is detected.”)
display the venous pressure and the cardiac output on a coordinate plane with venous pressure and cardiac output as coordinate axes (Uemura, Figs. 3-5).
As to claim 11, Uemura-De Marco-Sakai-Tanishima teaches to non-invasively calculate the venous pressure based on a pulse wave acquired from the subject and applied pressure applied to the subject (De Marco, [0075], “The PPG sensor 100 can be used for determining…venous pressure”; the examiner notes, a PPG sensor is in contact with surface of skin, which applies pressure and measures pulse waves).
As to claim 13, Uemura-De Marco-Sakai-Tanishima teaches set a threshold value for dividing the coordinate plane into a plurality of regions for venous pressure and cardiac output, wherein the display is configured to display a degree of congestion and peripheral circulatory failure in each region divided by the threshold value on the coordinate plane (Uemura, Figs.3-4, the thresholds are set by the grids, and each region shows a degree of congestion).
As to claim 14, Uemura-De Marco-Sakai-Tanishima teaches respectively set a threshold value of venous pressure and a threshold value of cardiac output for venous pressure and cardiac output so as to divide the coordinate plane into four regions (Uemura, Figs.3-4, the thresholds are set by the grids, and each region shows a degree of congestion), and
wherein the display (Uemura, [0028], “display means (6)”) is configured to display, in a region where venous pressure on the coordinate plane is larger than the threshold value of venous pressure, that a possibility of congestion is present (Uemura, [0110], "FIG. 4 shows venous return surface (c) of a normal subject and venous return surface (d) of a congestive patient where the effective circulating blood volume is increased"), and
display, in a region where cardiac output on the coordinate plane is smaller than the threshold value of cardiac output, that a possibility of peripheral circulatory failure is present (Uemura, [0100], "FIG. 3 shows CO curve (a) of a normal heart and CO curve (b) of a failing heart.").
As to claim 15, Uemura-De Marco-Sakai-Tanishima teaches the processor to acquire venous pressure and cardiac output of the subject at different times, and wherein the display is configured to display a history of venous pressure and cardiac output at the different times by plotting a marker at each position of the coordinate plane corresponding to the venous pressure and the cardiac output (Uemura, Figs. 3-4, the markers are the plots of the curve that represents venous pressure and cardiac output. Also see Fig. 7).
As to claim 22, Uemura-De Marco-Sakai-Tanishima teaches display is configured to display, when acquired venous pressure decreases or increases beyond a threshold value or when acquired cardiac output decreases or increases beyond a threshold value during the different times due to treatment performed by a medical worker for the subject, information related to the treatment performed by the medical worker and a time at which the treatment is performed (Uemura, Figs. 7-8).
As to claim 26, Uemura-De Marco-Sakai-Tanishima teaches the program is further configured to cause the at least one processor to: prompt administration of one of a plurality of predetermined treatments selected from: a vasodilator and a diuretic when the analyzed hemodynamic parameters indicate congestion without circulatory failure, fluid infusion and blood transfusion when the analyzed hemodynamic parameters indicate circulatory failure without congestion, or a vasodilator, a diuretic, and cateracolamine when the analyzed hemodynamic parameters indicate both congestion and circulatory failure (Uemura, [0145], “the signal indicates abnormal vascular resistance, third dosing means (53) starts drug administration to reduce vascular resistance”).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Uemura-De Marco-Sakai-Tanishima as applied to claim 1 above, and further in view of US 20140073900 A1 (Wood et. al), previously cited and hereto referred as Wood.
Claim 1 is taught as above.
As to claim 5, Uemura-De Marco-Sakai-Tanishima teaches processor to the predetermined venous pressure threshold and the predetermined cardiac output threshold (Uemura, [0110], "FIG. 4 shows venous return surface (c) of a normal subject and venous return surface (d) of a congestive patient where the effective circulating blood volume is increased."; [0100], "FIG. 3 shows CO curve (a) of a normal heart and CO curve (b) of a failing heart."; the examiner notes, the predetermined venous pressure threshold and the predetermined cardiac output threshold is interpreted as the limit in Fig. 3 and Fig. 4 where the heart function is determined to be abnormal), but does not teach the processor to adjust the predetermined venous pressure threshold and the predetermined cardiac output threshold based on at least one of an attribute of the subject including sex and age and a state of a disease of the subject.
Wood teaches a solution to a relevant problem of attributing characteristics of the subject to cardiac parameters (Wood, [0001], “non-invasively measure cardiac output”). Wood teaches a threshold value of cardiac output based on at least one of an attribute of the subject including sex and age (Wood, [0037], “Additionally, the processor-based device (e.g., monitor 12 and/or multi-parameter monitor) may compare the determined cardiac output to a threshold… a user may input parameters related to the patient 22, such as age, gender, and/or weight, to the processor-based device. The processor-based device may be configured to apply the parameters to various algorithms to determine the threshold or threshold range specific for the patient 22”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Uemura-De Marco-Sakai-Tanishima in view of Wood to include the predetermined venous pressure threshold and the predetermined cardiac output threshold adjusted based on sex and age because doing so would more accurately assess the condition of the subject.
Claims 6 and 16 rejected under 35 U.S.C. 103 as being unpatentable over Uemura-De Marco-Sakai-Tanishima as applied to claims 1 and 15 above, and further in view of US20190029635A1 (Oura et. al), previously cited and hereto referred as Oura.
Claims 1 and 15 are taught as above.
As to claims 6 and 16, Uemura-De Marco-Sakai-Tanishima teaches processor to set the predetermined venous pressure threshold and the predetermined cardiac output threshold (Uemura, [0110], "FIG. 4 shows venous return surface (c) of a normal subject and venous return surface (d) of a congestive patient where the effective circulating blood volume is increased."; [0100], "FIG. 3 shows CO curve (a) of a normal heart and CO curve (b) of a failing heart."; the examiner notes, the predetermined venous pressure threshold and the predetermined cardiac output threshold is interpreted as the limit in Fig. 3 and Fig. 4 where the heart function is determined to be abnormal);
acquire venous pressure and cardiac output of the subject at different times (Uemura, [0068], “(1) according to the present invention continuously obtains these measurement values and uses them for a continuous diagnosis of a patient.”). However, Uemura-De Marco-Sakai-Tanishima does not teach processor to issue an alarm when at least one of conditions (a) to (d) is satisfied during the different times.
Oura teaches a relevant art of monitoring cardiac output (Oura, [0023], “The first calculating section 13 measures various numerical data (the blood pressure, the body temperature, the oxygen concentration, the carbon dioxide concentration, the cardiac output, and the like) related to the vital sign signals”). Oura teaches processor to issue an alarm when at least one of conditions (a) to (d) is satisfied during the different times (Oura, [0023] “The first calculating section 13 measures various numerical data (the blood pressure, the body temperature, the oxygen concentration, the carbon dioxide concentration, the cardiac output, and the like) related to the vital sign signals received from the measurement sensors 21, 22. Moreover, the first calculating section 13 produces lists and graphs of the measurement values based on the measured numerical data. The first calculating section 13 determines whether each of the measurement values indicates an abnormal value (a value which exceeds a preset threshold) or not, and, if it is determined that the measurement value indicates an abnormal value, produces an alarm display or the like.”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Uemura-De Marco-Sakai-Tanishima in view of Oura to include issuing an alarm when at least one of conditions (a) to (d) is satisfied because doing so would result in allowing for accurate targeted treatment, which Uemura recognizes the need of (Uemura, [0089], “user to obtain a desired patient condition.”)
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Uemura-De Marco-Sakai-Tanishima as applied to claims 1 and 15 above, and further in view of US20160317070A1 (Sivaramanet. al), previously cited and hereto referred as Sivaraman.
Claims 1 and 15 are taught as above
As to claims 7 and 17, Uemura-De Marco-Sakai-Tanishima teaches the processor to set the predetermined venous pressure threshold and the predetermined cardiac output threshold (Uemura, [0110], "FIG. 4 shows venous return surface (c) of a normal subject and venous return surface (d) of a congestive patient where the effective circulating blood volume is increased."; [0100], "FIG. 3 shows CO curve (a) of a normal heart and CO curve (b) of a failing heart."; the examiner notes, the predetermined venous pressure threshold and the predetermined cardiac output threshold is interpreted as the limit in Fig. 3 and Fig. 4 where the heart function is determined to be abnormal);
and acquire physiological information of the subject, wherein venous pressure and cardiac output of the subject are acquired at different times (Uemura, [0068], “(1) according to the present invention continuously obtains these measurement values and uses them for a continuous diagnosis of a patient.”), and
when at least one of conditions (a) to (d) is satisfied during the different times (Uemura, Fig. 7).
However, Uemura-De Marco-Sakai-Tanishima does not teach to increase a frequency of acquiring physiological information of the subject when at least one of conditions (a) to (d) is satisfied during the different times. Sivaramanet teaches a relevant art of hemodynamic parameter analysis (Sivaramanet, abstract, “non-invasive blood glucose monitoring”). Sivaramanet teaches increase a frequency of acquiring physiological information of the subject when a threshold has been exceeded (Sivaramanet, [0022], “Additionally, processor 104 and/or an application stored in information handling system 126 may be configured to automatically initiate a blood glucose test at pre-programmed time intervals, increase the frequency of the pre-programmed time intervals in response to one of the multiple blood glucose levels exceeding the upper blood glucose threshold level or being below the lower blood glucose threshold level”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Uemura-De Marco-Sakai-Tanishima in view Sivaramanet to include increasing the frequency of acquiring physiological information so that the safety of the subject can be monitored more accurately as suggested by Sivaramanet (Sivaramanet, [0022], “being outside the pre-defined safe blood glucose rate of change”).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Uemura-De Marco-Sakai-Tanishima as applied to claim 14 above, and further in view of US20120253209A1 (Ukawa et. al), previously cited and hereto referred as Ukawa.
Claim 14 is taught as above.
As to claim 18, Uemura-De Marco-Sakai-Tanishima teaches a first display screen (Uemura, [0028], “display means (6)”) configured to display physiological information of the subject and/or a measurement value measured based on the physiological information (Uemura, Fig. 7)
and a second screen configured to display an analysis result of hemodynamic parameters of the subject (Uemura, Fig. 3 also Fig. 8), and
display, when the first screen is displayed, that a possibility of congestion is present on the first screen in a case in which venous pressure acquired exceeds the predetermined venous pressure threshold (Uemura, [0110], "FIG. 4 shows venous return surface (c) of a normal subject and venous return surface (d) of a congestive patient where the effective circulating blood volume is increased"), and that a possibility of peripheral circulatory failure is present on the first screen in a case in which cardiac output acquired exceeds the predetermined cardiac output threshold (Uemura, [0100], "FIG. 3 shows CO curve (a) of a normal heart and CO curve (b) of a failing heart.").
Uemura does not explicitly state that the first screen and the second screen dis configured to switch. Ukawa teaches a relevant art of hemodynamic parameter analysis (Ukawa, abstract). Ukawa teaches a display is configured to switch between the first screen and the second screen (Ukawa, [0037], “Alternatively, the displaying section 14 may be a touch panel which receives an external signal for switching the display.”) and displaying possibility of abnormality in the first screen (Ukawa, [0037], “Alternatively, the displaying section 14 may be a touch panel which receives an external signal for switching the display.”).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Uemura-De Marco-Sakai-Tanishima in view of Ukawa to include switching screen displays and displaying the possibility of abnormality in the first screen because Uemura-De Marco-Sakai-Tanishima already teaches a first screen and a second screen, amd switching the screen display would allow a user to view both the physiological information and analysis result of hemodynamic parameters.
Response to Arguments
Applicant's arguments filed 10/06/2025 have been fully considered but they are not persuasive.
Applicant amends the claims to overcome the 112(a) and 112(b) rejection. The 112(a) and 112(b) rejections are withdrawn.
As to the 101 rejections, Applicant alleges “PWTT represents pulse wave transit time measured with millisecond precision. These physiological calculations cannot practically be performed in the human mind” on pg. 21. The examiner disagrees. A claim to "collecting information, analyzing it, and displaying certain results of the collection and analysis" could be practically performed in the human mind because if the pulse pressure data is presented on a paper, it is readable by a person and the person can observe the venous pressure. See MPEP 2106.04(a)(2)(III)(A).
Applicant also alleges “Considering the claim as a whole, the elements work together to provide automated hemodynamic assessment and treatment guidance” on pg. 21. However, assessment and treatment guidance are part of the abstract idea. An inventive concept "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself.” See MPEP 2106.05(I).
Applicant also alleges “The claimed apparatus achieves this by non-invasively calculating parameters and automatically classifying patients into treatment groups” on pg. 21. However, However, an improvement in the abstract idea itself (e.g. calculating parameters and classifying patients) is not an improvement in technology. See MPEP 2103.05(a)(II).
Applicant also alleges, “This represents a particular way to achieve non-invasive hemodynamic assessment, not an abstract idea of classification” on pg. 23. However, the recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it". Comparing or classifying or prompting are merely claiming the idea of a solution or outcome. See MPEP 2106.05(f).
Applicant also alleges, “the claimed invention transforms physiological signals into actionable medical classifications through automated analysis that cannot be performed mentally”. However, the examiner disagrees. Acquiring data, analyzing data, comparing data, classifying the data, and prompting an outcome can be all performed mentally, as explained in the 101 rejection above. For data, mere "manipulation of basic mathematical constructs [i.e.,] the paradigmatic ‘abstract idea,’" has not been deemed a transformation. See MPEP 2106.05(c).
For the reasons above, the 101 rejection is maintained.
As to the 103 rejections, upon further search and consideration, claims 1, 10 and 23 are rejected in view of Uemura-De Marco-Sakai, and in view of Tanishima, necessitated by the amendment.
Conclusion
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/ELINA SOHYUN JANG/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791