DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6 October 2025 has been entered.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 3 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kabal (US 5743268) in view of Parolari et al (Cardiopulmonary bypass and oxygen consumption: oxygen delivery and hemodynamics, The Annals of Thoracic Surgery, 1999), Olsen (US 2005/0118059), Merz (US 5810759), and Eggers (US 5928155).
Regarding claim 1, Kabal teaches a method of continuously monitoring a patient’s parameters in real-time during a surgical operation including cardiopulmonary bypass using a heart-lung machine having a controller (column 2, lines 12-18; column 3 line 66 to column 4 line 4), the method comprising
continuously detecting flow rates during the surgical operation (column 13, line 10);
continuously detecting red blood cell values of the patient during the surgical operation (column 13, lines 10-11);
obtaining an arterial oxygen saturation value of the patient during the surgical operation (column 13, lines 11-16);
determining a body surface area of the patient (column 11, lines 34-49);
calculating in real-time during the surgical operation, with the controller, indexed oxygen delivery values based on the continuously sensed and input values (column 13, lines 1-20);
providing an indexed oxygen delivery threshold value which defines an “alarm zone” outside the threshold value (column 1, lines 34-40; column 6, lines 4-9; figures 1, 5) and continuously comparing the calculated indexed oxygen delivery values with the threshold value during the surgical operation (column 1, lines 34-40; figure 1); and
continually displaying in real-time on a display a graph of the calculated indexed oxygen delivery values calculated by the controller (figures 1, 5; column 17, lines 45-51), wherein the graph includes a visual representation of the “alarm zone” (figure 1).
Kabal does not explicitly recite the flow rate being a pump flow rate from a pump of the heart-lung machine or the red blood cell values being a hematocrit, where the hematocrit is continuously detected from a hematocrit value reading device inserted inside an arterial or venous line of the heart-lung machine during the operation.
Parolari teaches a method of monitoring a patient’s parameters during a surgical operation including cardiopulmonary bypass using a heart-lung machine having a controller, the method comprising:
continuously detecting a pump flow rate value from a pump of the heart-lung machine during the surgical operation, detecting a hematocrit value of the patient during the surgical operation, obtaining an arterial oxygen saturation value of the patient during the surgical operation, and calculating, with the controller, an indexed oxygen delivery value based on the arterial oxygen saturation value of the patient, the hematocrit value of the patient, and the continuous measure of the pump flow rate value (per p. 1320, body surface areas for each subject are obtained; DO2 throughout the paper is given the units of mL*min-1*m-2; see also the formulas in the right column of p. 1321 and table 7; p. 1321 the pump flow rate is constant; variables used for calculating indexed DO2 are discussed in “Blood Sampling and Data Collection”, p. 1320); and continually displaying in real-time on a display the calculated indexed oxygen delivery value calculated by the controller (p. 1322, first full paragraph; as the indexed oxygen delivery value is displayed as soon as it is calculated, it is thus shown in real-time). Olsen teaches continuously detecting hematocrit values of a patient during a surgical bypass operation from a hematocrit value reading device inserted inside a venous line of a heart-lung machine during a bypass operation (paragraph [0044]). It would have been obvious to one of ordinary skill in the rt at the time the invention was made to have followed Kabal using the pump flow rate as the flow rate used for finding the indexed DO2 during bypass, as taught by Parolari, because during bypass the heart is stopped and the only source of a flow rate is inherently the pump, whose flow rate Parolari teaches can be used to find indexed DO2, and using continuously measured hematocrit values obtained from a hematocrit device in the venous line for the hematocrit input, as taught by Olsen, in order to allow continuous measurement with no delay in readings.
Kabal, as modified, does not call for triggering an alarm in real-time if the controller determines that the calculated indexed oxygen delivery has breached the threshold and enters the “alarm zone”; Merz teaches a monitoring system for cardiopulmonary bypass which is configured to compare monitored and calculated parameters to thresholds and trigger an alarm if the parameter breaches the threshold (column 10, lines 11-29). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have followed Kabal, as modified, and configured the processor to trigger an alarm if it determines that the calculated indexed oxygen value has breached a threshold, as taught by Merz, in order to allow intervention to prevent adverse conditions.
Kabal, as modified, does not explicitly teach the displayed graph showing the values as a function of time. Eggers teaches a method of monitoring a patient’s cardiopulmonary parameters in real-time (column 5, lines 44-60), and continually displaying in real-time on a display graphs of the monitored parameters and parameters calculated from the monitored parameters as a function of time (column 32, lines 11-35), where the graphs may include visual representations of boundary zones for the parameters (column 34, lines 14-22). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have followed Kabal, as modified, and displayed the graph as a function of time, as taught by Eggers, in order to allow easy observation of trends in the data.
Regarding claim 3, Kabal further discloses both high and low thresholds (figure 1); as modified by Merz this would include the alarm being triggered when the calculated indexed oxygen delivery value falls below the threshold value.
Claims 4, 10, and 11 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kabal, as modified by Parolari, Olsen, Merz, and Eggers above, and further in view of Ellingboe (US 2002/0085952).
Regarding claim 4, Kabal, as modified, does not explicitly call for displaying all of the obtained data in real-time, including the pump flow rate values and hematocrit values, and the alarm. Ellingboe teaches physiological monitoring during cardiopulmonary bypass (paragraph [0001]) which includes real-time display of associated data including pump flow rates and hematocrit (paragraphs [0029], [0031]) and, when conditions warrant an alarm, also showing the alarm on the display (paragraphs [0183], [[0223]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have followed Kabal and further included using the display to display the data and alarm already present in the system, as taught by Ellingboe, in order to allow monitoring of the patient’s condition.
Regarding claim 10, Kabal, as modified, does not further disclose continuously measuring and displaying the patient's body temperature. Ellingboe teaches physiological monitoring during cardiopulmonary bypass (paragraph [0001]) which includes continuously measuring and displaying the patient’s body temperature (paragraphs [0242], [0247], [0255], [0359]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have followed Kabal, as modified above, and further included continuously measuring and displaying the patient’s body temperature, as taught by Ellingboe, in order to provide additional information on the patient’s condition.
Regarding claim 11, Parolari further teaches calculating an indexed oxygen delivery threshold value from a measured body temperature (p. 1322, left paragraph, DO2crit). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have followed Kabal, as modified above, using the measured temperature of Ellingboe in the calculations of Parolari’s indexed oxygen delivery threshold value, in order to make the comparison and alarming using the threshold value more accurate.
Claims 5-8 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kabal, as modified and applied above, and further in view of Ali (US 2002/0035315).
Regarding claims 5, 6, and 8, Kabal, as modified, does not disclose calculating the duration the threshold is breached; Ali teaches a monitoring system which is configured to compare a value to a threshold and to calculate in real-time the consecutive amount of time the threshold has been breached in a given window (paragraph [0097]-[0099]), and triggering the alarm when the accumulated amount of time is greater than a time threshold and not triggering the alarm when the amount is less than the time threshold (paragraphs [0100]-[0102]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have made the system of Kabal, as modified, and included calculating the duration of time the threshold is breached and triggering the alarm only when the amount exceeds a time threshold, as taught by Ali, in order to provide a measure of the patient’s stability while avoiding nuisance alarms for minor data excursions.
Regarding claim 7, Ali does not teach the time threshold being 5 minutes; however, it would have been a mere matter of design choice for one of ordinary skill in the art at the time the invention was made to have set the threshold to 5 minutes, since Applicant has not disclosed use of this particular duration as providing a particular advantage, solving a stated problem, or serving a different purpose than that of the time threshold of Ali, as modifying Kabal. Moreover, it appears that any given time threshold, would perform equally well to prevent nuisance triggering of the alarm for minor data excursions. As such, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have followed Kabal, as modified by Ali, with the time threshold set to 5 minutes, because such a modification would have been considered a mere design consideration that fails to patentably distinguish over Kabal as modified by Parolari, Olsen, Merz, and Ali.
Claim 12 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kabal, as modified by Parolari, Olsen, Merz, and Eggers above, and further in view of Oppenheimer (US 5331958).
Regarding claim 12, Kabal, as modified above, does not disclose calculating, in real-time during the surgical operation, with the controller, a hemoglobin value based on the continuous measure of the hematocrit value. Oppenheimer teaches calculating, in real-time during a surgical operation (column 3, lines 21-31), a hemoglobin value based on a continuous measure of a hematocrit value (column 19, lines 39-42). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have followed Kabal, as modified above, and further found a hemoglobin value based on the continuous measure of the hematocrit value, as taught by Oppenheimer, as these measures are known in the art to be related and useful for similar observations.
Claim 17 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kabal, as modified by Parolari, Olsen, Merz, and Eggers above, and further in view of Lachmann (US 5752509).
Kabal, as modified above, does not further disclose evaluating exhaled carbon dioxide and calculating “indexed” carbon dioxide production. Lachmann teaches a method of monitoring a patient’s parameters during a cardiac operation with cardiopulmonary bypass and a heart-lung machine (abstract; figure 1) which includes continuously detecting exhaled carbon dioxide at the heart-lung machine (column 7, lines 3-12), providing a preset gas flow value (column 7, lines 33-42), and calculating “indexed” carbon dioxide production based on the preset gas flow value and measured exhaled carbon dioxide (column 7, lines 43-53). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have followed Kabal, as modified, and further included determination of “indexed” carbon dioxide production from a preset gas flow value and measured exhaled carbon dioxide, as taught by Lachmann, in order to provide additional information of the patient’s condition.
Claim 18 and 19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kabal in view of Parolari, Olsen, Merz, Eggers, and Ellingboe.
Regarding claim 18, Kabal teaches a method of continuously monitoring a patient’s parameters in real-time during a surgical operation including cardiopulmonary bypass using a heart-lung machine having a controller (column 2, lines 12-18; column 3 line 66 to column 4 line 4), the method comprising
continuously detecting flow rates during the surgical operation (column 13, line 10);
continuously detecting red blood cell values of the patient during the surgical operation (column 13, lines 10-11);
obtaining an arterial oxygen saturation value of the patient during the surgical operation (column 13, lines 11-16);
determining a body surface area of the patient (column 11, lines 34-49);
calculating in real-time during the surgical operation, with the controller, indexed oxygen delivery values based on the continuously sensed and input values (column 13, lines 1-20);
providing an indexed oxygen delivery threshold value which defines an “alarm zone” below the threshold value (column 1, lines 34-40; column 6, lines 4-9; figures 1, 5) and continuously comparing the calculated indexed oxygen delivery values with the threshold value during the surgical operation (column 1, lines 34-40; figure 1); and
continually displaying in real-time on a display the calculated indexed oxygen delivery values calculated by the controller and the threshold value (figures 1, 5; column 17, lines 45-51).
Kabal does not explicitly recite the flow rate being a pump flow rate from a pump of the heart-lung machine or the red blood cell values being continuously detected using a hematocrit value reading device inserted inside an arterial or venous line of the heart-lung machine during the surgical operation; Parolari teaches a method of monitoring a patient’s parameters during a surgical operation including cardiopulmonary bypass using a heart-lung machine having a controller, the method comprising:
continuously detecting a pump flow rate value from a pump of the heart-lung machine during the surgical operation, detecting a hematocrit value of the patient during the surgical operation, obtaining an arterial oxygen saturation value of the patient during the surgical operation, and calculating, with the controller, an indexed oxygen delivery value based on the arterial oxygen saturation value of the patient, the hematocrit value of the patient, and the continuous measure of the pump flow rate value (per p. 1320, body surface areas for each subject are obtained; DO2 throughout the paper is given the units of mL*min-1*m-2; see also the formulas in the right column of p. 1321 and table 7; p. 1321 the pump flow rate is constant; variables used for calculating indexed DO2 are discussed in “Blood Sampling and Data Collection”, p. 1320); and continually displaying in real-time on a display the calculated indexed oxygen delivery value calculated by the controller (p. 1322, first full paragraph; as the indexed oxygen delivery value is displayed as soon as it is calculated, it is thus shown in real-time). Olsen teaches continuously detecting hematocrit values of a patient during a surgical bypass operation from a hematocrit value reading device inserted inside a venous line of a heart-lung machine during a bypass operation (paragraph [0044]). It would have been obvious to one of ordinary skill in the rt at the time the invention was made to have followed Kabal using the pump flow rate as the flow rate used for finding the indexed DO2 during bypass, as taught by Parolari, because during bypass the heart is stopped and the only source of a flow rate is inherently the pump, whose flow rate Parolari teaches can be used to find indexed DO2, and using continuously measured hematocrit values obtained from a hematocrit device in the venous line for the hematocrit input, as taught by Olsen, in order to allow continuous measurement with no delay in readings.
Kabal, as modified, does not call for triggering an alarm in real-time if the controller determines that the calculated indexed oxygen delivery has breached the threshold and enters the “alarm zone”; Merz teaches a monitoring system for cardiopulmonary bypass which is configured to compare monitored and calculated parameters to thresholds and trigger an alarm if the parameter breaches the threshold (column 10, lines 11-29). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have followed Kabal, as modified, and configured the processor to trigger an alarm if it determines that the calculated indexed oxygen value has breached the threshold, as taught by Merz, in order to allow intervention to prevent adverse conditions.
Kabal, as modified, does not explicitly teach the display also showing a graph of the values as a function of time with a visual representation of the “alarm zone”. Eggers teaches a method of monitoring a patient’s cardiopulmonary parameters in real-time (column 5, lines 44-60), and continually displaying in real-time on a display graphs of the monitored parameters and parameters calculated from the monitored parameters as a function of time (column 32, lines 11-35), where the graphs may include visual representations of boundary zones for the parameters (column 34, lines 14-22). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have followed Kabal, as modified, and displayed the graphed value and alarm zone as a function of time, as taught by Eggers, in order to allow easy observation of trends in the data.
Kabal, as modified, does not further disclose continuously measuring and displaying the patient's body temperature and calculating the indexed oxygen delivery threshold value from the continuously measured patient’s body temperature. Ellingboe teaches physiological monitoring during cardiopulmonary bypass (paragraph [0001]) which includes continuously measuring and displaying the patient’s body temperature (paragraphs [0242], [0247], [0255], [0359]). Parolari further teaches calculating an indexed oxygen delivery threshold value from a measured body temperature (p. 1322, left paragraph, DO2crit). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have followed Kabal, as modified above, using the measured temperature of Ellingboe in the calculations of Parolari’s indexed oxygen delivery threshold value, in order to make the comparison and alarming using the threshold value more accurate.
Regarding claim 19, Kabal, as modified, does not explicitly call for displaying all of the obtained data in real-time, including the pump flow rate values and hematocrit values, and the alarm. Ellingboe further teaches physiological monitoring during cardiopulmonary bypass (paragraph [0001]) which includes real-time display of associated data including pump flow rates and hematocrit (paragraphs [0029], [0031]) and, when conditions warrant an alarm, also showing the alarm on the display (paragraphs [0183], [[0223]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have followed Kabal and further included using the display to display the data and alarm already present in the system, as taught by Ellingboe, in order to allow monitoring of the patient’s condition.
Claim 20 is are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kabal, as modified by Parolari, Olsen, Merz, Eggers, and Ellingboe above, and further in view of Ali (US 2002/0035315).
Kabal, as modified, does not disclose calculating the duration the threshold is breached and triggering an alarm when that time is above a particular threshold; Ali teaches a monitoring system which is configured to compare a value to a threshold and to calculate in real-time the consecutive amount of time the threshold has been breached (paragraph [0097]-[0099]), and triggering the alarm when the accumulated amount of time is greater than a time threshold and not triggering the alarm when the amount is less than the time threshold (paragraphs [0100]-[0102]). It would have been obvious to one of ordinary skill in the art at the time the invention was made to have made the system of Kabal, as modified, and included calculating the duration of time the threshold is breached and triggering the alarm only when the amount exceeds a time threshold, as taught by Ali, in order to provide a measure of the patient’s stability while avoiding nuisance alarms for minor data excursions.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-3 and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9 and 10 of U.S. Patent No. 10039490 in view of Olsen. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 of the instant invention and claim 9 of ‘490 are both directed to a method of continuously monitoring a patient's parameters in real-time during a surgical operation including cardiopulmonary bypass using a heart-lung machine having a controller, the method comprising continuously detecting pump flow rate values from a pump of the heart-lung machine during the surgical operation; continuously detecting hematocrit values of the patient during the surgical operation; obtaining arterial oxygen saturation values of the patient during the surgical operation; determining a body surface area of the patient; calculating in real-time during the surgical operation, with the controller, indexed oxygen delivery values based on the arterial oxygen saturation value of the patient, the continuous hematocrit values of the patient, the continuous measure of the pump flow rate values, and the body surface area of the patient; and continually displaying in real-time on a display the calculated indexed oxygen delivery values calculated by the controller as a function of time. Claim 10 of ‘490 is directed to further setting an indexed oxygen delivery threshold value; continuously comparing the calculated indexed oxygen delivery value with the threshold value during the surgical operation; and triggering an alarm in real-time if the calculated indexed oxygen delivery value breaches the threshold value.
Claims 9 and 10 of ‘490 do not call for the source of the continuously detected hematocrit values being from a hematocrit value reading device inserted inside an arterial or venous line of the heart-lung machine during the surgical operation. Olsen teaches continuously detecting hematocrit values of a patient during a surgical bypass operation from a hematocrit value reading device inserted inside a venous line of a heart-lung machine during a bypass operation (paragraph [0044]). It would have been obvious to one of ordinary skill in the rt at the time the invention was made to have set forth the method of claim 9 and 10 of ‘490 using continuously measured hematocrit values obtained from a hematocrit device in the venous line during the surgical operation, as taught by Olsen, as claim 9 and 10 do not specify a source of the values and using a device in the venous line would allow continuous measurements without additional equipment in other locations.
Regarding claim 3, claim 10 of ‘490 also recites that the alarm is triggered when the calculated indexed oxygen delivery value falls below the threshold value.
Response to Arguments
Applicant's arguments filed 15 September 2025 have been fully considered but they are not persuasive.
Applicant argues only that Kabal does not disclose providing an indexed oxygen delivery threshold value and defining an alarm zone outside the threshold value, because Kabal’s showing of an indexed oxygen delivery threshold value and alarm zone outside that threshold in figure 1 is “without any numbers or units so this clearly cannot be used to determine a threshold value or alarm zone”. The Examiner notes that the claimed threshold value and alarm zone are not defined as being shown with numbers or units; in order to function Kabal’s display of parameters is inherently based on the numerical values of each parameter even if those numbers are not explicitly shown, where a bar extending further corresponds to a higher value. Similarly, Kabal clearly shows a line between normal values and high values – that is, it provides a threshold between these values, with that threshold defining the high “alarm zone”. The invention as claimed does not call for providing the threshold value in a numerical format or the alarm zone requiring the display of numbers or units; Kabal’s showing of each parameter in its own bar graph is a display which includes a threshold value between zones that delineates an “alarm zone” and which provides an easily interpreted showing of a relative value of each parameter and whether that parameter is in an alarm zone.
The remainder of Applicant’s arguments are directed only to how the modifying references do not remedy this supposed deficiency in Kabal or do not operate without Kabal providing this teaching; as the limitation is clearly taught in Kabal, these remarks are moot.
Regarding the Double Patenting rejections, Applicant merely asserts that the claims differ without showing any differences that might support this allegation; the rejections stand.
Conclusion
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/KAREN E TOTH/ Examiner, Art Unit 3791