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 .
Priority
Claims 1-20 are deemed to have an effective filing date of February 20, 2023.
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.
Claims 1-13 recited a system, and therefore is a product, and claims 14-20 recite a method for using the medical device system. Therefore, the claims fall within the statutory categories.
Step 2A, Prong 1:
Claims 1 and 14 recite a signal receiver circuit to receive physiological information of a patient (extra-solution activity); an assessment circuit that “adjusts” by determining first and second boundaries of a first range of received information, and determining first and second boundaries of a second range of received physiological information; and an output circuit that provides the determined first and second boundaries and the second determined physiological information on a display (extra-solution activity).
The limitations, as drafted, describe a process that, under its broadest reasonable interpretation, includes performance of limitations in the mind except for the recitation of pre- and post- extra-solution activities. The Examiner notes that the assessment circuit is configured to adjust, but the recited determining steps of the circuit in the claims do not adjust the boundaries. Paragraphs [0124] and [0125] of the originally-filed specification indicate that the claimed invention is directed to a collection of circuits controlled by a computer. That is, other than reciting a signal receiver circuit, an assessment circuit, and an output circuit, nothing in the claims preclude the steps from practically being performed in the human mind. MPEP 2106.04(a)(2)(III) states that the courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pend and paper” to be an abstract idea. For example, aside from the recitation of the pre- and post- extra-solution activities, the claims encompass a user determining or thinking what the boundaries should be.
Step 2A, Prong 2:
The claims recite a “signal receiver circuit” and an “output circuit”. The signal receiver circuit is mere data gathering which the courts have held amounts to insignificant extra-solution activity (MPEP 2106.05(g)). Similarly, the courts have held that providing the determined data on a display to be mere instructions to implement an abstract idea as the claim limitations cover presenting the determined abstract idea with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result (see MPEP 2106.05(f)). The courts have held that these extra-solution activities do not integrate a judicial exception into a practical application or provide significantly more.
In addition, the output circuit and display are recited at a high level of generality, i.e., as a generic processor, performing a generic computer function of processing data. This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional limitation does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B:
As discussed with respect to Step 2A, Prong 2, the additional elements in the claims do not amount to significantly more than the judicial exception. The same analysis applies here in 2B, i.e. insignificant extra-solution activity and mere instructions to apply an exception on a generic computer cannot integrate a judicial exception into a practical application at 2A or provide an inventive concept in Step 2B.
Even when viewed in combination, the additional elements do no more than automate the mental process (e.g., the mental computation of identifying/determining first and second boundaries of physiological information) using an implied generic computer as a tool.
Claims 2-13 and 15-20 further limit the abstract idea of claims 1 and 14 with no additional elements. Accordingly, the claims, taken as a whole, do not integrate the recited judicial exception into a practical application. Thus, the above-identified claim are directed to the judicial exception.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 7-9, and 12-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2023/0063782 to McSweeney et al. (EFD: at least 08/17/2022; hereinafter referred to as “McSweeney”).
Regarding claim 1, McSweeney discloses a medical device system (e.g., title: continuous patient monitor), comprising: a signal receiver circuit configured to receive physiologic information of a patient (e.g., Abstract: device for monitoring a physiological value of a patient receives physiological data values during a time window; paragraph [0007]: device receives physiological data values from a physiological sensor); an assessment circuit configured to adjust one or more determined boundaries of a display of the received physiologic information based on different first and second ranges of physiologic information (e.g., paragraphs [0136]: upper and lower alarm limits 1506, 1508 can be adjusted to an acceptable range based on the expected effect; [0137]: a modified/adjusted range for heart values is defined/determined by upper and lower limits 1506, 1508 and those boundaries can be adjusted as shown in Fig. 15; and [0144]: upper and lower limits 1502, 1504 of the normal range of heart values can self-adjust when the application operates in crisis mode; and upper and lower limits 1506, 1508 of the modified range of the heart rate can self-adjust (automatic using an assessment circuit)), including to: determine first and second boundaries of a first range of the received physiologic information (e.g., [0131]: upper and lower limits 1506, 1508 show an expected/determined increase of the physiological vital signs over a time window (first range); or [0132]: upper and lower limits 1502, 1504 of a determined normal range are based on personalized baselines of the patient); and determine first and second boundaries of a second range of the received physiologic information (e.g., paragraph [0133]: display chart 1500 displays an event that starts at time T0 and ends at T1 of a second range), the second range within the first range (e.g., Fig. 15: the time range is within the time window of the first range); and an output circuit configured to provide the one or more determined boundaries of the display for presentation to a user, the display comprising the determined first and second boundaries of the first range and the determined first and second boundaries of the second range (e.g., paragraphs [0131]-[0140] and Fig. 15).
Referring to claim 14, McSweeney discloses a method (e.g., paragraph [0006]: method of continuous physiological monitoring), comprising: receiving, using a signal receiver circuit, physiologic information of a patient (e.g., Abstract: device for monitoring a physiological value of a patient receives physiological data values during a time window; paragraph [0007]: device receives physiological data values from a physiological sensor); adjusting, using an assessment circuit, one or more determined boundaries of a display of the received physiologic information based on different first and second ranges of physiologic information (e.g., paragraphs [0136]: upper and lower alarm limits 1506, 1508 can be adjusted to an acceptable range based on the expected effect; [0137]: a modified/adjusted range for heart values is defined/determined by upper and lower limits 1506, 1508 and those boundaries can be adjusted as shown in Fig. 15; and [0144]: upper and lower limits 1502, 1504 of the normal range of heart values can self-adjust when the application operates in crisis mode; and upper and lower limits 1506, 1508 of the modified range of the heart rate can self-adjust (automatic using an assessment circuit)), the adjusting comprising: determining first and second boundaries of a first range of the received physiologic information (e.g., [0131]: upper and lower limits 1506, 1508 show an expected/determined increase of the physiological vital signs over a time window (first range); or [0132]: upper and lower limits 1502, 1504 of a determined normal range are based on personalized baselines of the patient); and determining first and second boundaries of a second range of the received physiologic information (e.g., paragraph [0133]: display chart 1500 displays an event that starts at time T0 and ends at T1 of a second range), the second range within the first range (e.g., Fig. 15: the time range is within the time window of the first range); and providing, using an output circuit, the one or more determined boundaries of the display for presentation to a user, the display comprising the determined first and second boundaries of the first range and the determined first and second boundaries of the second range (e.g., paragraphs [0131]-[0140] and Fig. 15).
With respect to claims 2 and 15, McSweeney discloses the medical device system of claim 1 and the method of claim 14, wherein the first boundary of the first range comprises a target value of the received physiologic information, wherein the assessment circuit is configured to determine the target value as a function of a clinical target value and the received physiologic information (e.g., paragraphs [0063]: target value is a physiological measurement within the normal range; [0139]: upper and lower limits 1506, 1508 show an expected/determined increase of the physiological vital signs over a time window (first range); or [0132]: upper and lower limits 1502, 1504 of a determined normal range are based on personalized baselines of the patient; and [0144]: upper and lower limits 1502, 1504 of the normal range of heart values can self-adjust when the application operates in crisis mode; and upper and lower limits 1506, 1508 of the modified range of the heart rate can self-adjust [to a new normal level based on a clinical target value and received physiologic information of the patient).
As to claims 3 and 16, McSweeney discloses the medical device system of claim 2 and the method of claim 15, wherein the assessment circuit is configured to update the one or more boundaries at a regular interval using additionally received physiologic information, wherein to update the one or more boundaries comprises to update the target value in a direction towards the clinical target (e.g., paragraph [0139]: upper and lower limits 1506, 1508 of the modified range show expected increases in heart rate values – updates the boundaries in an upward direction based on clinical expectation), wherein the assessment circuit is restricted from updating the target value in a direction away from the clinical target (e.g., paragraph [0074]: when the measured blood pressure (or other physiological value) is not improving and is away from the target value (normal value), an alarm is triggered, which would restrict updating away from the normal value).
With respect to claims 4 and 17, McSweeney discloses the medical device system of claim 2 and the method of claim 15, wherein the assessment circuit is configured to determine the target value as a function of the clinical target value and a first extremum value of the received physiologic information occurring over the first range (e.g., paragraphs [0063]: target value is a physiological measurement within the normal range; and [0142]-[0143]: heart rate values are considered abnormal when they exceed the upper limit 1502/1506 – thus as shown in Fig. 15, the target values at the first extremum value are considered abnormal as indicated by the bolded dots on the display between 14:00 and 18:00(when 1502 is exceeded) or by the bolded dots of the extremum on the display between 18:00 and 20:00).
As to claims 5 and 18, McSweeney discloses the medical device system of claim 2 and the method of claim 18, wherein the second boundary of the first range comprises a second extremum value of the received physiologic information occurring over the first range (e.g., Fig. 15, the second boundary 1504 or 1508 of the first range (time window) comprises a second extremum value of the received physiological information (the lowest values of HR line), wherein one of the first and second extremum value is a maximum value and another is a minimum value (e.g., Fig. 15, peaks above limit 1502 or 1506 have a maximum value and the lowest troughs of the HR line include the minimum value), wherein the first and second boundaries of the second range comprise respective minimum and maximum values of the received physiologic information occurring over the second range (e.g., Fig. 15, time T0 is the minimum value and time T1 is the maximum value).
With respect to claim 7, McSweeney discloses the medical device system of claim 1, wherein the first and second boundaries of the first range comprise respective minimum and maximum values of the received physiologic information occurring over the first range (e.g., Fig. 15, peaks above limit 1502 or 1506 have a maximum value and the lowest troughs of the HR line include the minimum value), wherein the first and second boundaries of the second range comprise respective minimum and maximum values of the received physiologic information occurring over the second range (e.g., Fig. 15, time T0 is the minimum value and time T1 is the maximum value).
As to claim 8, McSweeney discloses the medical device system of claim 1, wherein the display comprises the determined first and second boundaries of the first range, the determined first and second boundaries of the second range, and a single representative current value of the received physiologic information (e.g., Fig. 15, determined first and second boundaries of the first range: 1502/1506 and 1504/1508; determined first and second boundaries of the second range: T0 and T1; and paragraphs [0004]: monitor device provides enhanced visualization of the measure vital signs including heart rate and electrocardiogram; and [0113]: chart 1200 (Fig. 12) shows respiration rate values, but can also be heart rate values; and Fig. 15 and corresponding paragraphs where the most recent heart rate value displayed can be the single current representative value).
With respect to claim 9, McSweeney discloses the medical device system of claim 8, wherein the single representative current value of the received physiologic information comprises a most recent daily value of the received physiologic information (e.g., paragraphs [0004]: monitor device provides enhanced visualization of the measure vital signs including heart rate and electrocardiogram; and [0113]: chart 1200 (Fig. 12) shows respiration rate values, but can also be heart rate values; and Fig. 15 and corresponding paragraphs where the most recent heart rate value displayed can be the single current representative value).
As to claim 12, McSweeney discloses the medical device system of claim 1, wherein the physiologic information includes at least one of respiration information of the patient, cardiac electrical information of the patient, impedance information of the patient, cardiac acceleration information of the patient, or sleep incline information of the patient (e.g., paragraphs [0004]: various vital signs can be monitored according to the present disclosure including heart rate, blood pressure, blood oxygen saturation percentage, respiration rate, electrocardiogram, and end tidal Carbon dioxide; [0131]: visualization application displays heart rate values (cardiac electrical information) of a patient, but can also display other types of physiological data values blood oxygen saturation and end tidal carbon dioxide (respiration information of the patient).
With respect to claim 13, McSweeney discloses the medical device system of claim 12, wherein the physiologic information includes a plurality of daily respiration values, wherein the display comprises the determined first and second boundaries of the first range, the determined first and second boundaries of the second range, and a most recent daily respiration value (e.g., paragraphs [0004]: as above and monitor device provides enhanced visualization of the measure vital signs including respiration rate or the blood oxygen saturation percentage and [0113]: chart 1200 (Fig. 12) shows respiration rate values; and Fig. 15 and corresponding paragraphs where the most recent respiration value displayed can be the respiration rate or the blood oxygen saturation percentage that was recently monitored in the continuous monitoring of the patient).
As to claim 20, McSweeney discloses the method of claim 14, wherein determining the first and second boundaries of the first range comprise determining respective minimum and maximum values of the received physiologic information occurring over the first range (e.g., Fig. 15, peaks above limit 1502 or 1506 have a maximum value and the lowest troughs of the HR line include the minimum value), wherein determining the first and second boundaries of the second range comprise determining respective minimum and maximum values of the received physiologic information occurring over the second range (e.g., Fig. 15, time T0 is the minimum value and time T1 is the maximum value), wherein the display comprises the determined first and second boundaries of the first range, the determined first and second boundaries of the second range, and a single representative current value of the received physiologic information (e.g., Fig. 15, determined first and second boundaries of the first range: 1502/1506 and 1504/1508; determined first and second boundaries of the second range: T0 and T1; and paragraphs [0004]: monitor device provides enhanced visualization of the measure vital signs including heart rate and electrocardiogram; and [0113]: chart 1200 (Fig. 12) shows respiration rate values, but can also be heart rate values; and Fig. 15 and corresponding paragraphs where the most recent heart rate value displayed can be the single current representative value).
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over McSweeney in view of US 2015/0257716 to Humphrys et al. (hereinafter referred to as “Humphrys”).
McSweeney discloses the medical device system of claim 5, but does not expressly disclose that the output is configured to provide the first boundary as an arrow indicating a desired direction and the target value of the received physiologic information in contrast to the second range of the received physiologic information. However, Humphrys, in a related art: compact technique for visualization of physiological clinical and bedside data, teaches that an arrow can be added to the display monitor to provide more information about the status of a patient’s vital sign measurement where an upward arrow indicates that the patient’s vital sign is higher than the normal range while a downward arrow indicates the patient vital sign is lower than the normal range (e.g., paragraph [0030] of Humphrys). Accordingly, one of ordinary skill in the art would have recognized the benefits of using an arrow to indicate an upper boundary of normal or a lower boundary of normal in view of the teachings of Humphrys. Consequently, one of ordinary skill in the art would have modified the medical device system of McSweeney to provide the first boundary as an arrow indicating a desired direction and the target value of the received physiologic information in contrast to the second range of the received physiologic information (treatment event) in view of the teachings of Humphrys that such an arrow was a well-known protocol in the medical display art for physiological signals, and because the combination would have yielded a predictable result (one could quickly tell if the physiological signal was trending in the correct direction after treatment).
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over McSweeney and US Patent Application Publication No. 2010/0174205 to Wegerif.
With respect to claim 10, McSweeney discloses the medical device system of claim 8, wherein the first range comprises a first number of daily values (e.g., paragraph [0131]: visualization application 128 displays the heart rate values having a first number of daily values from 12:00 to 20:00), wherein the second range comprises a second number of daily values (e.g., paragraph [0133]: display chart 1500 displays an event that starts at time T0 and ends at T1 of a second range where a second number of daily values are displayed from T0 to T1), wherein the first number of daily values is greater than the second number of daily values (e.g., Fig. 15), but does not expressly disclose that the second number of daily values being more than two days and less than three weeks. However, Wegerif, in a related art: measurement of heart rate variability, teaches that it was known in the medical monitoring art to display significant day to day changes, as well as long term trends where a first time may be 3 months of daily values and a second time period may be a week for a second group of daily values (e.g., paragraph [0068] of Wegerif). Accordingly, one of ordinary skill in the art would have recognized the benefits of monitoring changes in heart rate for a short period and a longer period and display the same so a user can easily visualize the day-to-day changes as well as longer trends as taught by Wegerif, and because the combination would have yielded a predictable result.
As to claim 11, McSweeney in view of Wegerif discloses the medical device system of claim 10, wherein the received physiologic information comprises daily values of the received physiologic information (e.g., paragraph [0131]: visualization application 128 displays the heart rate values having a first number of daily values from 12:00 to 20:00), wherein the single representative current value of the received physiologic information comprises a most recent daily value of the received physiologic information (e.g., paragraphs [0004]: monitor device provides enhanced visualization of the measure vital signs including heart rate and electrocardiogram; and [0113]: chart 1200 (Fig. 12) shows respiration rate values, but can also be heart rate values; and Fig. 15 and corresponding paragraphs where the most recent heart rate value displayed can be the single current representative value), but does not expressly disclose that the first range comprises a previous six months of daily values with respect to the most recent daily value and that the second range comprises a previous two weeks of daily values with respect to the most recent daily value. However, Wegerif, in a related art: measurement of heart rate variability, teaches that it was known in the medical monitoring art to display significant day to day changes, as well as long term trends where a first time may be 3 months of daily values and a second time period may be a week for a second group of daily values (e.g., paragraph [0068] of Wegerif). Accordingly, one of ordinary skill in the art would have recognized the benefits of monitoring changes in heart rate for a short period and a longer period and display the same so a user can easily visualize the day-to-day changes as well as longer trends as taught by Wegerif, and because the combination would have yielded a predictable result. With respect to the time periods of six months for the first range and two weeks for the second range, those time periods would have been obvious to one having ordinary skill in the art at the time the invention was made, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application Publication No. 2022/0071507 to Stolen et al. is directed to remote monitoring of vital signs of a patient where the data that is displayed illustrate short-term (3-day) and long-term (up to three preceding months) averages or daily values of physiologic information.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at 571 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CATHERINE M VOORHEES/ Primary Examiner, Art Unit 3792