DETAILED ACTION
Notices to Applicant
This communication is a non-final rejection. Claims 1-20, as filed 11/30/2203, are currently pending and have been considered below.
Priority is generally acknowledged as shown on the filing receipt with the earliest priority date being 11/30/2022. The Examiner notes that the specification’s cross-reference paragraph cites “U.S. Provisional Application No. 22210675.9.” This appears to be a typographical mistake since the foreign application on the filing receipt is from the EPO. Appropriate correction is required.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Claim Objections
Claims 1, 6, and 13 are objected to because of the following informalities. Claim 1 recites “a processor configured to…causing” which the Examiner suggests should read “cause”. Claim 6 recites “wherein the parameters is plotted against time” which the examiner suggests should read “parameter”. Claim 13 lacks a conjunction in the list. The Examiner interprets claim 13 as required an EMR or an electronic medical device.
Appropriate correction is required.
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 6, 7, 19, and 20 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 pre-AIA the applicant regards as the invention. Claim 6 recites “such as…and/or”, so it is unclear which items are part of the claim. MPEP 2173.05(d). Claim 19 recite “the display through the display device” but these terms lack antecedent basis.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter 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.
Step 1
The claim(s) recite(s) subject matter within a statutory category as a process, machine, and/or article of manufacture which recite:
1. A visualization device for showing a patient status, the visualization device comprising:
a communication interface configured to receive physiological parameters indicative of a patient status, a display interface configured to enable a display to show a visualization of the patient status, a processor system configured to obtain a medical intervention that has been applied to the patient at a first point in time, (additional element – merely applying the abstract idea with a computer; insignificant extra-solution activity, namely, data gathering and outputting a result)
compute an effect that the medical intervention is expected to have on the patient at a second point in time, (abstract idea – mental process)
generate a visualization representing the physiological parameter at the first and/or second time point, and the expected effect at the second time point, (abstract idea – mental process because a clinician can record patient values and an expected medication effect with pen and paper)
causing the generated visualization to be displayed on the display through the display interface (additional element – merely applying the abstract idea with a computer; insignificant extra-solution activity, namely, data gathering and outputting a result).
Claim 1 is presented as an exemplary claim but the same analysis applies to the other claims 2-20.
Step 2A Prong One
The broadest reasonable interpretation of these steps includes mental processes because the italicized portions are analogous to steps a clinician could perform mentally or with pen and paper. For example, but for the generic computer language, computing the effect of a medical intervention is analogous to a clinician making notes on a paper flowsheet such as noting a time of medication administration and estimating from experience or reference materials an effect, and writing the measured vitals and expected effects side by side.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims. For example, claims 2-4 specify the time points evaluated. Claims 5-7 and 18 specify the form and content of what is charted by the clinician. Claims 8-12 name the data values under analysis, and claims 15-17 refine how the computation is made.
Step 2A Prong Two
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements:
amount to mere instructions to apply an exception. For example, the processor system recitation amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea. For example, receiving physiological parameters through the communication interface amounts to mere data and causing the visualization to be displayed amounts to mere data output, see MPEP 2106.05(g))
generally link the abstract idea to a particular technological environment or field of use such as patient monitoring, see MPEP 2106.05(h))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. For example, claims 13 and 14 recite additional limitations which amount to invoking computers as a tool to perform the abstract idea. Claim recites additional limitations which add insignificant extra-solution activity to the abstract idea which amounts to mere data gathering. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields such as receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i), performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii), electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii), and/or storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 5, 6, 9, 13, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang (US20170004258A1).
Regarding claim 1, Wang discloses: A visualization device for showing a patient status (“a patient monitoring system 10 integrating the display of vital sign data and relevant medical intervention data,” [0024]), the visualization device comprising:
--a communication interface configured to receive physiological parameters indicative of a patient status (“The vital sign data is received 12 over time from one or more vital sign data sources 14, typically in real-time,” [0025]; “the patient monitor 72 typically receives the medical intervention data from a remote, patient data repository 76 over a communications network 78 using a network interface 80,” [0041]),
--a display interface configured to enable a display to show a visualization of the patient status (“The received vital sign data is displayed 20 on a display 22 of the patient monitoring system 10 using a display device 24,” [0027])
--a processor system configured to obtain a medical intervention that has been applied to the patient at a first point in time (“software, which is executed by one or more processors 68 of the patient monitoring system 10,” [0039]; “as an icon 40 on the graph 30 at the time along the time axis of the graph 30 that corresponds to the medical intervention. The corresponding time of an administered medical intervention is the time the medical intervention was administered,” [0031]),
--compute an effect that the medical intervention is expected to have on the patient at a second point in time (“Expected vital sign changes due to a medical intervention are predicted quantitatively by a prediction model,” [0023]; “the medical intervention effect prediction model 48 is embodied by a software module, a hardware module, or a hybrid software and hardware module,” [0040]),
--generate a visualization representing the physiological parameter at the first and/or second time point, and the expected effect at the second time point (“predictions spanning the one or more temporal ranges of displayed vital sign measurements effected by administered medical interventions, such as a prediction at the time of each displayed vital sign measurement effected by an administered medical intervention,” [0033]),
--causing the generated visualization to be displayed on the display through the display interface (“The received predictions are displayed 112 on the graph over time temporally synchronized with the vital sign measurements,” [0046).
Regarding claim 2, Wang discloses: wherein the physiological parameters are shown in real time (“receiving 102 measurements of a vital sign for a patient over time, typically in real time. For example, a new measurement can be received every second,” [0044]).
Regarding claim 3, Wang discloses wherein the second time point corresponds to the moment when the generated visualization is displayed (“A prediction is typically received for each time point of the vital sign measurements,” [0046]; “receiving 102 measurements of a vital sign for a patient over time, typically in real time,” [0044]; FIG. 6).
Regarding claim 5, Wang discloses: wherein the visualized expected effect comprises a visualization of magnitude and/or trend of the effect (“when the predictions of received medical intervention effect prediction data are single, predicted values, the predictions can be plotted as a function of time on the graph 30 to illustrate the trend of the predictions,” [0035]).
Regarding claim 6, Wang discloses: wherein the visualization representing the physiological parameter comprises one or more of: a trend view of the physiological parameter or a derived parameter against time, wherein the parameters is plotted against time, a scatter view of the physiological parameters or a derived parameter, wherein at least two physiological or derived parameters are plotted against each other, a graphical model of at least part of the patient indicating one or more physiological parameters, such as a cardiopulmonary (CP) model or visual representation of the patient, and/or a medical image (“the measurements of the vital sign are displayed as a function of time on a graph 30 illustrating the trend of the vital sign over time,” [0028]).
Regarding claim 9, Wang discloses: wherein the physiological parameters comprise
one or more vital signs, including one or more of: heart rate (HR), electrocardiography (ECG), respiration rate (RR), core body temperature (CBT), oxygen saturation (SpO2) or blood pressure (BP), and/or
one or more hemodynamic parameters, including one or more of: cardiac output (CO), stroke volume (SV), stroke volume variation (SVV), ejection fraction (EF), cardiac index (CI), systemic vascular resistance (SVR), pulmonary vascular resistance (PVR), pulmonary artery pressure (PAP), or extravascular lung water index (ELWI), one or more of blood parameters, and/or urine output (“vital sign data source 14 is a source of measurements for a vital sign of a patient. Examples of vital signs include systolic blood pressure (SBP), heart rate (HR), oxygen saturation (SpO2), mean arterial pressure (MAP), and so on. Examples of vital sign data sources 14 include a patient data repository, a patient monitor, a vital sign sensor (e.g., a SpO2 sensor or an ECG sensor), a user input device (e.g., for clinician input), and so on,” [0025]).
Regarding claim 13, Wang discloses: wherein the interventions are obtained from: an electronic medical record (EMR), an electronic medical device (“the patient monitor 72 typically receives the medical intervention data from a remote, patient data repository 76 over a communications network 78 using a network interface 80. The remote patient data repository 76 typically includes EMRs and other patient medical data. The components 24, 36, 48, 68, 70, 74, 80 of the patient monitor 10 are suitably interconnected locally by one or more data buses 82,” [0041]; [0026]).
Claims 19 and 20 are substantially similar to claim 1 and are rejected with the same reasoning. The Examiner further notes that Wang discloses a memory and processor in [0039] and [0049].
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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 4, 8, 10, 14, 16 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US20170004258A1) in view of Westenskow (US20030156143A1).
Regarding claim 4, Wang discloses a display mode showing only the most recent measurement of the vital reading in the same window as the graph with the predictions (“According to the second display mode, only the most recent measurement of the vital sign is displayed,” [0028]; “supposing the vital sign window 26 initially displays only the most recent measurement, selecting a region within the vital sign window 26 replaces the most recent measurement with a graph 30 illustrating the trend of the vital sign over time,” [0029]).
Wang does not expressly disclose but Westenskow teaches: wherein the generated visualization represents a snapshot of the physiological parameter at the second time point (“H-state is a 3-D snapshot of the system's health at one point of time,” [0104]; “Functional relationships can be added to this view to predict how treatment can be expected to bring the variables back to normal,” [0141]).
It would have been obvious to a POSITA before the effective filing date to expand Wang’s display of measurements and predicted effects to include the “one point of time” display of Westenskow because this would allow clinicians to improve a patient’s treatment by estimating “how the drug should be expected to affect the patient” (Westenskow [0024]).
Regarding claim 8, Wang does not expressly disclose but Westenskow teaches: wherein the intervention comprises administration of a medically active composition, the effect comprising a computed plasma concentration in the patient (“past, present and future plasma or effect site concentrations of a drug administered, displayed according to a frame of reference,” claim 17; “Based on the drug input, the software programmed pharmacokinetic 4102 and pharmacodynamic models 4103 for remifentanil, propofol and rocuronium, for example, predict the effect site concentrations and the drug effects in real time,” [0161]).
The motivation to combine is the same as in claim 4.
Regarding claim 10, Wang does not expressly disclose but Westenskow teaches: wherein the blood parameter is one or more of: a blood gas parameter or a blood value (“CO2 concentrations and oxygen saturation of the arterial blood 2001 versus time are also shown,” [0140]).
The motivation to combine is the same as in claim 4.
Regarding claim 14, Wang does not expressly disclose but Westenskow teaches: wherein the electronic medical device is an infusion pump or a ventilator (“Bar coded syringes 4104 and monitored infusion pumps 4105 constitute the hardware the tracks the drugs administered by the physician,” [0161]).
The motivation to combine is the same as in claim 4.
Regarding claim 16, Wang discloses: obtaining multiple medical interventions and predicting their combined effects (“the medical intervention effect prediction model 48 can be employed to predict the combined effect of multiple medical interventions on the vital sign,” [0034]).
Wang does not expressly disclose but Westenskow teaches: the effects of which overlap in time (“Colored bands 4014 indicate the effects of individual drugs. The gray bars 4015 indicate the synergism of the drugs in combination,” [0160]; “mathematical models have been implemented to incorporate drug-drug synergism 4115 between propofol (sedative-hypnotic) and opiods (analgesics). The drug synergism is shown as a gray bar 4115 representing the additional effect due to the drug interactions,” [0163]).
The motivation to combine is the same as in claim 4.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Wang (US20170004258A1) in view of Sandy (US20060058660A1).
Regarding claim 7, Wang does not expressly disclose but Sandy teaches: wherein the medical image is an ultrasound image or ultrasound frame(s) (“the integrated system may include a single display that shows a user-selected combination of selected ultrasound images and selected hemodynamic monitoring parameters,” [0010]; “the combined display 30 includes an ultrasound image viewing section 31 that includes the ultrasound image 32 and the plurality of thumb nail images 34,” [0032]).
It would have been obvious to a POSITA before the effective filing date to expand Wang’s display of measurements and predicted effects to include the ultrasound images of Sandy because combining the display improves usability for clinicians by not requiring clinicians to “constantly shift their attention between the two separate displays in order to acquire the information needed to either perform a procedure or analyze the current situation,” (Sandy [0031]).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Wang (US20170004258A1) in view of Westenskow (US20030156143A1) and Cardarelli (US20110179361A1).
Regarding claim 11, Wang does not expressly disclose but Cardarelli teaches: discloses: wherein the blood gas parameter is one or more of: blood pH or blood COOH (“These labels are self evident except BE=base excess (mmol/L), pH (no unit), PCO2=partial pressure of Carbon-dioxide in blood (millimeters of Mercury, mm Hg), PO2=partial pressure of oxygen in blood (mm Hg), HCO3=bicarbonate (mmol/L), SaO2(%),” [0094]).
It would have been obvious to a POSITA before the effective filing date to expand Wang and Westenskow’s display of measurements and predicted effects to include the particular patient data types of Cardarelli because this would provide pertinent information to providers and thus improve patient outcomes.
Additionally, each element is taught by either Wang, Westenskow, and Cardarelli. The data types of Cardarelli does not affect the normal functioning of the elements of the claim which are taught by Wang and Westenskow. Because the elements do not affect the normal functioning of each other, the results of their combination would have been predictable. Therefore, before the effective filing date of the claimed invention, it would have been obvious to combine the teachings of Cardarelli with the teachings of Wang and Westenskow since the result is merely a combination of old elements, and, since the elements do not affect the normal functioning of each other, the results of the combination would have been predictable.
Regarding claim 12, Wang does not expressly disclose but Cardarelli teaches: wherein the blood value is one or more of: blood Hb, blood Ht, or blood Hct (“The diagram 455 lists the values (in order left/top/bottom/right, respectively) of: white blood cell count (thousands/L), hemoglobin (g/dL), hematocrit (%), platelet (thousands/mcL),” [0092]).
The motivation to combine is the same as in claim 11.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Wang (US20170004258A1) in view of Dellimore (WO2022152661A1).
Regarding claim 15, Wang does not expressly disclose but Dellimore teaches: wherein the first time point is estimated from a measured effect of the intervention (“Another characteristic event may be considered to occur, based on an indication from the subject, at the instant that an effect of the substance in the subject’s body is first detected,” page 5; “tdiff (i.e. the time delay of concentration changes (e.g. characteristic events) in sweat compared to equivalent changes in blood) may be approximated,” page 5).
It would have been obvious to a POSITA before the effective filing date to expand Wang’s display of measurements and predicted effects to include the time point estimates of Dellimore because this would improve patient care by encouraging the correct dose to be administered at the correct time (Dellimore page 2).
Additionally, each element is taught by either Wang or Dellimore. The estimates of Dellimore do not affect the normal functioning of the elements of the claim which are taught by Wang. Because the elements do not affect the normal functioning of each other, the results of their combination would have been predictable. Therefore, before the effective filing date of the claimed invention, it would have been obvious to combine the teachings of Dellimore with the teachings of Wang since the result is merely a combination of old elements, and, since the elements do not affect the normal functioning of each other, the results of the combination would have been predictable.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Wang (US20170004258A1) in view of Aya (Aya HD, Ster IC, Fletcher N, Grounds RM, Rhodes A, Cecconi M. Pharmacodynamic Analysis of a Fluid Challenge. Crit Care Med. 2016 May;44(5):880-91).
Regarding claim 17, Wang does not expressly disclose but Aya teaches: wherein the medical intervention is a fluid challenge, the computed effect indicating a time from maximum effect of the fluid challenge on the patient (“The predicted maximal effect on cardiac output was observed at 1.2 minutes (95% credible interval, –0.6 to 2.8 min) in responders…A fluid challenge is a test in which a small bolus of IV fluid is given over a short period of time to assess hemodynamic response,” page 880).
It would have been obvious to a POSITA before the effective filing date to expand Wang’s display of measurements and predicted effects to include the fluid challenge data because this would improve patient care by providing pertinent information to providers (Aya Abstract: “The maximal change in cardiac output should be assessed 1 minute after the end of the fluid infusion.”)
Additionally, each element is taught by either Wang or Aya. The fluid data of Aya do not affect the normal functioning of the elements of the claim which are taught by Wang. Because the elements do not affect the normal functioning of each other, the results of their combination would have been predictable. Therefore, before the effective filing date of the claimed invention, it would have been obvious to combine the teachings of Aya with the teachings of Wang since the result is merely a combination of old elements, and, since the elements do not affect the normal functioning of each other, the results of the combination would have been predictable.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Wang (US20170004258A1) in view of Navratil (US20160029995A1).
Regarding claim 18, Wang does not expressly disclose but Navratil teaches: wherein the generated visualization comprises a plot of stroke volume vs a diastolic pressure (“Another example of data displays are Frank-Starling charts (APVinsp . . . x axes, SVC vti . . . y axes), as depicted in the exemplary screenshot 400 of a display in FIG. 16. The user may be provided with the option to show data as per minute or per beat on the Frank-Starling charts. The user may utilize the Frank-Starling charts to help determine hemodynamic parameters and status of the mammalian patient,” [0122]; “ome exemplary options include, but are not limited to, (SVCvti/min and SVCvti/beat); (VR and VR/beat), (CO and SV), and/or (CI and SI). The same options may be available for setup of the Frank-Starling charts previously described in conjunction with FIG. 16,” [0130]; [0122]).
It would have been obvious to a POSITA before the effective filing date to expand Wang’s display of measurements and predicted effects to include the hemodynamic parameters of Navratil because this would improve patient care by providing pertinent information to providers that would “help determine hemodynamic parameters and status,” ([0130]).
Additionally, each element is taught by either Wang or Navratil. The hemodynamic parameters of Navratil do not affect the normal functioning of the elements of the claim which are taught by Wang. Because the elements do not affect the normal functioning of each other, the results of their combination would have been predictable. Therefore, before the effective filing date of the claimed invention, it would have been obvious to combine the teachings of Navratil with the teachings of Wang since the result is merely a combination of old elements, and, since the elements do not affect the normal functioning of each other, the results of the combination would have been predictable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BLANCHETTE whose telephone number is (571)272-2299. The examiner can normally be reached on Monday - Thursday 7:30AM - 6:00PM, EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant, can be reached on (571) 270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA B BLANCHETTE/Primary Examiner, Art Unit 3624
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