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 .
Response to Amendments
This Action is in response to the Office Action dated March 26, 2026.
In view of the amendments, the rejection of the claims under 35 USC 101, as set forth in the Office Action, is withdrawn.
Claims 1, 7-8, 13-14, and 20 are amended.
Claims 1-20 are pending.
Response to Arguments
Applicant's arguments filed 03/26/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claim 6 is objected to because of the following informalities: Claim 2, line 1 refers to the “first boundary of the first range”, but claim 6 from which it depends refers to “the first boundary”. Is the first boundary of the first range, or of the second range? Appropriate correction is required.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5, 7-9, 12, and 14-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication No. 2016/0196020 to Utsugida.
Regarding claim 1, Utsugida discloses a medical device system (e.g., Title and Abstract: display apparatus and method of a medical instrument), comprising: a signal receiver circuit configured to receive physiologic information of a patient (e.g., paragraphs [0069] and [00074]: controller 10 is in communication with physiological sensors recording patient information), including at least one of respiration information, cardiac electrical information, impedance information, cardiac acceleration information, sleep incline information, or a composite physiologic parameter of the patient (e.g., paragraph [0129]: respiration information); an assessment circuit (e.g., paragraph [0016]: range determination unit) configured to: determine, at a first time, one or more initial boundaries of a display of the received physiologic information based on different first and second ranges of physiologic information (e.g., paragraph [0064]: it is necessary for a user/clinician engineer to set in advance ranges of measurements including danger and alarm ranges – that is, initial boundaries are set in advance (a first time)), including to: determine initial first and second boundaries of a first range of the received physiologic information along a first axis (e.g. Fig. 8 alarm 77.8 and alarm 98.0); and determine initial first and second boundaries of a second range of the received physiologic information (e.g., Fig. 8, warning 80.0 and warning 90.0), the second range extending along the first axis and within and not extending beyond the first range (see Fig. 8); and adjust one or more of the initial boundaries based on physiologic information received subsequent to the first time (e.g., paragraphs [0018]: the setting range information is changeable based on the input numerical value information; [0023]-[0024]; [0117]: it is possible to change the display from “45” to “46” …); and an output circuit configured to provide the one or more initial boundaries or the adjusted one or more initial boundaries of the display for presentation to a user, the display comprising the initial first and second boundaries of the first range and the initial first and second boundaries of the second range or the adjusted one or more initial boundaries (see Fig. 6, ST 9; Fig. 8 where an output circuit displays the initial boundaries; paragraphs [0102] and [0113]-[0117]; Fig. 11 the input numerical value in G11).
Referring to claim 14, Utsugida discloses a method (e.g. title), comprising: receiving, using a signal receiver circuit, physiologic information of a patient (e.g., paragraphs [0069] and [00074]: controller 10 is in communication with physiological sensors recording patient information), including at least one of respiration information, cardiac electrical information, impedance information, cardiac acceleration information, sleep incline information, or a composite physiologic parameter of the patient (e.g., paragraph [0129]: respiration information); adjusting, determining, at a first time, using an assessment circuit, one or more determined initial boundaries of a display of the received physiologic information based on different first and second ranges of physiologic information (e.g., paragraph [0064]: it is necessary for a user/clinician engineer to set in advance ranges of measurements including danger/warning and alarm ranges – that is, initial boundaries are set in advance (a first time)), the adjusting determining comprising: determining initial first and second boundaries of a first range of the received physiologic information along a first axis (e.g. Fig. 8 alarm 77.8 and alarm 98.0); and determining initial first and second boundaries of a second range of the received physiologic information, the second range extending along the first axis and within and not extending beyond the first range (e.g., Fig. 8, warning 80.0 and warning 90.0); adjusting one or more of the initial boundaries based on physiologic information received subsequent to the first time (e.g., paragraphs [0018]: the setting range information is changeable based on the input numerical value information; [0023]-[0024]; [0117]: it is possible to change the display from “45” to “46” …); and providing, using an output circuit, the one or more determined initial boundaries or the adjusted one or more initial boundaries of the display for presentation to a user, the display comprising the determined initial first and second boundaries of the first range and the determined initial first and second boundaries of the second range or the adjusted one or more initial boundaries (see Fig. 6, ST 9; Fig. 8 where an output circuit displays the initial boundaries; paragraphs [0102] and [0113]-[0117]; Fig. 11 the input numerical value in G11).
With respect to claims 2 and 15, Utsugida 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 (e.g., paragraph [0083]: bar-shape numerical value display section G12 of Fig. 7 is a selectable target display – thus the first boundary of the warning comprises a target value of the 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., paragraph [0109]: threshold values/boundaries of the setting ranges are determined for the particular patient and particular procedure to be performed).
As to claims 3 and 16, Utsugida 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 (e.g., paragraph [0117]), wherein to update the one or more boundaries comprises to update the target value in a direction towards the clinical target, wherein the assessment circuit is restricted from updating the target value in a direction away from the clinical target value (e.g., paragraphs [0110]-[0113] and [0117]: target value is updated up to maximum/threshold value of “50.0” and is restricted to go above or away from the maximum clinical value).
With respect to claims 4 and 17, Utsugida 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 [0110]-[0113]: target value “50” is determined as a function of the clinical target value and a first extremum value of the received physiological information).
As to claims 5 and 18, Utsugida discloses the medical device system of claim 2 and the method of claim 14, wherein the second boundary of the first range comprises a second extremum value of the received physiologic information occurring over the first range, wherein one of the first and second extremum value is a maximum value and another is a minimum value (e.g. Fig. 8 first range is between alarm 77.8 and alarm 98.0, which correspond to physiologic information that occur over the first range and the alarm values are a minimum and a maximum), 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. 8, second range is between warning 80.0 and warning 90.0, which correspond to physiologic information that occur during the second range and its boundaries are a minimum/low and a maximum/high – see Fig. 5).
With respect to claim 7, Utsugida discloses the medical device system of claim 1, wherein the initial 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. 8 first range is between alarm 77.8 and alarm 98.0, which correspond to physiologic information that occur over the first range and the alarm values are a minimum and a maximum),wherein the initial 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. 8, second range is between warning 80.0 and warning 90.0, which correspond to physiologic information that occur during the second range and its boundaries are a minimum/low and a maximum/high – see Fig. 5).
As to claim 8, Utsugida discloses the medical device system of claim 1, wherein the display comprises the one or more initial boundaries or the adjusted one or more initial boundaries of the first and second ranges and a single representative current value of the received physiologic information (e.g., paragraphs [0080]-[0088]: Fig. 7 shows normal range G12c and warning lower boundary G12b and warning upper boundary G12a and numerical value input G11 being displayed).
With respect to claim 9, Utsugida discloses the medical device of claim 8, wherein the single representative current value of the received physiologic information comprises a most recent daily value of the received physiological information (e.g., Fig. 7, G11)
As to claim 12, Utsugida 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., paragraph [0129]: respiration information).
With respect to claim 20, Utsugida 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. 8 first range is between alarm 77.8 and alarm 98.0, which correspond to physiologic information that occur over the first range and the alarm values are a minimum and a maximum), 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. 8, second range is between warning 80.0 and warning 90.0, which correspond to physiologic information that occur during the second range and its boundaries are a minimum/low and a maximum/high – see Fig. 5).
wherein the display comprises the one or more initial boundaries or the adjusted one or more initial boundaries of the first and second ranges and a single representative current value of the received physiologic information (e.g., paragraphs [0080]-[0088]: Fig. 7 shows normal range G12c, warning lower boundary G12b, warning upper boundary G12a and numerical value input G11 (recent value) being displayed).
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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 6 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Utsugida in view of US Patent Application Publication No. 2015/02577 to Humphrys et al. (hereinafter referred to as “Humphrys”).
Utsugida discloses the medical device system of claim 5 and the method of claim 18, 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 Utsugida 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
Utsugida and US Patent Application Publication No. 2010/0174205 to Wegerif.
With respect to claim 10, Utsugida 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 To and ends at T1 of a second range where a second number of daily
values are displayed from To 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 would have modified the same of Utsugida 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].
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Utsugida in view of US Patent Application Publication No. 2023/0063782 to McSweeney et al. (hereinafter referred to as “McSweeney”).
Utsugida discloses the medical device of claim 12, wherein the physiologic information includes respiration values (e.g., paragraph [0129]) discloses the medical device system of claim 12, wherein the physiologic information daily respiration
values, wherein the display comprises the one or more initial boundaries or the adjusted one or more initial boundaries of the first and second ranges , and a
most recent daily value (e.g., paragraphs [0080]-[0088]: Fig. 7 shows normal range G12c and warning lower boundary G12b and warning upper boundary G12a and numerical value input G11 being displayed), but does not expressly disclose a plurality of daily respiration values and a most recent daily respiration value. However, McSweeney, in a related art: continuous monitoring of a patient, teaches a display providing enhanced visualization of the measured vital signs including respiration rate or blood oxygen saturation percentage (e.g., paragraph [0004] of McSweeney); a chart 1200 that shows respiration rate values (e.g., Fig. 12); that the most recent respiration value can be displayed (e.g., Fig. 15 and corresponding paragraphs). Accordingly, one of ordinary skill in the art would have recognized the benefits of a medical device system for displaying one or more initial boundaries of respiration values and a most recent daily respiration value in view of the teachings of McSweeney that such was a well-known protocol in the respiration monitoring art as taught by Utsugida in view of McSweeney, and because the combination would have yielded a predictable result.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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