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 .
Status of claims
Claims 1-12 are currently pending.
Response to Arguments
Applicant’s arguments, see pages 2-3 of Applicant’s Remarks, filed 11/17/25, with respect to the rejections of claims 1, 8 and 10 under 35 U.S.C. 101 as being directed to an abstract idea without significantly more have been fully considered and are not persuasive.
Applicant argues that because the claims recite an extracorporeal circulation system with specific elements, such as the circulation circuit, flow rate measurement unit, pressure measurement unit, display unit, and extracorporeal circulation management controller, the claims are directed to a physical system and not a mental process, and that the claim cannot be performed as a mental process. However, as discussed below, the extracorporeal circulation management controller is configured or programmed to receive flow rate and pressure data from the measurement devices, perform calculations with that data, and display that data and calculation results. While this is performed with a physical system, they amount to observations (reading data from the measurement devices) and evaluations (performing calculations with the data from the measurement devices). The courts have held that “a claim to ‘collecting information, analyzing it, and displaying certain results of the collection and analysis’, where the data analysis steps are recited at a high level of generality” could be practically performed in the human mind. Please see MPEP §2106.04(a)(2)(III)(A) with respect to Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016). Furthermore, even if the process is performed on a computer, such as the claimed extracorporeal circulation management controller, if the computer is merely a tool to perform the process, then it is still a mental process. Please see MPEP §2106.04(a)(2)(III)(C)(3). Furthermore, even though the claims recite a physical system, the extracorporeal circulation system, such physical systems may still recite a mental process. Please see MPEP §2106.04(a)(2)(III)(D).
Applicant further argues that the abstract idea alleged by the examiner is integrated into a practical application by improving the functioning of the claimed extracorporeal circulation system. However, as discussed below, as claimed, the measurement data received by the extracorporeal circulation management controller, the data resulting from the calculations, and the displayed data are not used or applied by the extracorporeal circulation system to affect or change the therapy being applied by the extracorporeal circulation system. In the claims as written, the system is merely measuring data, performing calculations with the data, and displaying the measured data and results of the calculations. Therefore, the abstract idea is not integrated into a practical application. Please see MPEP §2106.04(d)(2)(c).
Applicant’s arguments, see pages 3-5 of Applicant’s Remarks, with respect to the rejections of claims 1-2 and 10-11 under 35 U.S.C. 103 as being unpatentable over Molducci in view of Khair, of claim 3 in further view of Burbank, of claims 4-6 and 8 in further view of Müller-Spanka, of claims 7 and 12 in further view of Hersenius, and of claim 9 in further view of Burbank, Müller-Spanka, and Hersenius have been fully considered and are not persuasive.
With respect to independent claims 1, 8, and 10, applicant argues that Khair does not teach the calculation of “a standard pressure … based on the expected flow rate and on standard information which represents a relation between a blood flow rate and a pressure loss” because Khair teaches that real-time measured inputs are used to estimate what the output flow rates or pressure should be, in contrast to the estimated standard pressure recited by claim 1. However, Khair teaches that the model is developed using the expected, non-real time flow rate data and pressure data (¶0036), and therefore the expected data is incorporated into the calculation of the standard pressure using the model.
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, 8, and 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite extracorporeal circulation systems with an extracorporeal circulation management controller or computer configured or programmed to receive flow rate and pressure data from measurement devices, perform calculations with the data, and display the data and calculations, which amounts to mental processes using the controller or computer as a tool. A human could perform these steps without a computer by reading the data from the measurement devices, recording the data using a pen and paper (thereby displaying it), and manually performing calculations with the data. Please see MPEP §2106.04(a)(2)(III). This judicial exception is not integrated into a practical application because the additional elements of the extracorporeal circulation system do not impose meaningful limits on the mental processes performed by the extracorporeal circulation management controller or computer and are therefore merely a field-of-use for the mental processes. In the claims as written, the received data, calculated data, and displayed data are not used or applied by the extracorporeal circulation system, and therefore the abstract ideas are not integrated into a practical application. Please see MPEP §2106.04(d)(2)(c). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed extracorporeal circulation system that the mental process is used with is a conventional system known in the medical arts as demonstrated with respect to the prior art examples below, and therefore the claimed system as written amounts to using a generic computer to run a conventional extracorporeal circulation system. Please see MPEP §2106(I)(A),
Claims 2-7, 9 and 11-12 are rejected due to their dependency.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Molducci et al. (US 2008/0249377 A1) in view of Khair (US 2018/0236152 A1).
Regarding claim 1, Molducci discloses an extracorporeal circulation system (Fig. 1, feat. 1; ¶0033-0038) comprising: a circulation circuit adapted to circulate blood taken out from a patient (Fig. 1, feat. 24; ¶0035) through a plurality of instrument elements (4, 23, 25-28) and return the blood to a patient (25); a flow rate measurement unit measuring an actual flow rate value of the blood flowing inside the circulation circuit (¶0037 and 0058: the blood flow rate in the tubing may be measured either directly or indirectly); a pressure measurement unit measuring an actual pressure value of the blood flowing inside the circulation circuit (Fig. 1, feat. 29; ¶0037); a display unit (Figs. 1-3, feat. 30; ¶0039); and an extracorporeal circulation management controller (18; ¶0034 and 0037-0044) configured to 1) store an expected flow rate of the blood to be provided to the patient (¶0058: the blood flow rate in the tubing is a parameter monitored via the display unit), wherein the expected flow rate is determined for the patient in advance according to an operator input to the extracorporeal circulation management controller (¶0003-0004, 0055-0058, and 0063-0070: parameters such as the blood flow rate in the tubing may be set, before or during treatment, via the display unit), 2) receive the actual flow rate from the flow rate measurement unit (¶0041: the controller receives data from the sensors in the system), 3) display the expected flow rate and the actual flow rate on the display unit (Figs. 2-3 and 5-6; ¶0064-0070: the display unit displays both the set, expected value and the actual, measured value of monitored parameters such the blood flow rate in the tubing).
Molducci does not disclose that the controller is configured to 4) calculate a standard pressure corresponding to at least one of the instrument elements based on the expected flow rate and on standard information which represents a relation between a blood flow rate and a pressure loss occurring in the at least one of the instrument elements or to 5) display the calculated standard pressure and the actual pressure value corresponding to the at least one of the instrument elements on the display unit.
Khair teaches methods for estimating the flow rate and/or pressure (Figs. 3-6 and 12) associated with an instrument in an extracorporeal circulation system (Fig. 1; ¶0025). Khair teaches that a model based on the pressure-flow rate relationship may be used to calculate an expected pressure and/or flow rate for a fluid flowing through that instrument (¶0036-0037) by using one or more pressures and/or flow rates as an input to the model (Figs. 3-6, and 12, feats. 304, 404, 504, 604, and 1204). Khair further teaches that estimating an expected pressure and/or flow rate for a given instrument using a model of the pressure-flow rate relationship allows for the comparison of expected pressures and/or flow rates with measured or actual pressures and/or flow rates and the detection of abnormal flow states or abnormal measurement conditions associated with the instrument due to differences or discrepencies between the expected and actual values (¶0037). Molducci teaches that displaying multiple versions of a given parameter, such as set or expected values for a parameter and the actual, measured values for that parameter, on the same display makes it easy for the user to retrieve and visualize key information about the system (¶0026-0027 and 0063). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Molducci so that the controller is configured to 4) calculate a standard pressure corresponding to at least one of the instrument elements based on the expected flow rate and on standard information which represents a relation between a blood flow rate and a pressure loss occurring in the at least one of the instrument elements and to 5) display the calculated standard pressure and the actual pressure value corresponding to the at least one of the instrument elements on the display unit in order to monitor the system for abnormal flow states due to differences between the expected, standard pressure and the measured pressure as taught by Khair and to make it easy for a user to understand the differences between the expected, standard pressure and the measured pressure as taught by Molducci.
Regarding claim 2, Molducci in view of Khair discloses the system according to claim 1. Khair further teaches that the differences between the estimated or expected values for flow rate and pressure and the actual measured values for flow rate and pressure should be monitored because those differences may indicate abnormal flow states or abnormal measurement conditions in the extracorporeal circulation system (¶0037). As discussed above, Molducci teaches that displaying both multiple versions of a given parameter on the same display makes it easy for the user to retrieve and visualize key information about the system (¶0026-0027 and 0063). Therefore, modifying the system disclosed by Molducci in view of Khair so that the differences between the expected and measured values of flow rate and pressure are displayed on the same display as the measured values would make it easier for a user to monitor those differences and detect abnormal flow states or measurement conditions in the system. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Molducci in view of Khair so that a differential flow rate representing a difference between the expected flow rate and the actual flow rate and a differential pressure representing a difference between the standard pressure and the actual pressure value are further displayed on the display unit in order make it easy for a user to detect abnormal flow states or measurement conditions in the system as suggested by Khair and Molducci.
Regarding claim 10, Molducci discloses a non-transitory computer readable media having a extracorporeal circulation management program (¶0039-0044 and 0079: the controller includes a memory containing programs for running the system), executed by a computer of an extracorporeal circulation management device (Fig. 1, feat. 18; ¶0034 and 0037-0044) that manages an extracorporeal circulation device (Fig. 1, feat. 1; ¶0033-0038) which extracorporeally circulates blood using a circulation circuit (Fig. 1, feats. 4 and 23-28; ¶0035-0038), the extracorporeal circulation management program causing the computer to execute operations comprising: displaying an expected flow rate, which is expected in advance as an expected value of a flow rate of the blood flowing inside of the circulation circuit (Figs. 2-3 and 5-6; ¶0064-0070: the display unit displays both the set, expected value and the actual, measured value of monitored parameters such the blood flow rate in the tubing), on a display unit (Figs. 1-3, feat. 30; ¶0039), wherein the expected flow rate is determined for a particular patient according to an operator input (¶0003-0004, 0055-0058, and 0063-0070: parameters such as the blood flow rate in the tubing may be set, before or during treatment, via the display unit); displaying an actual flow rate (Figs. 2-3 and 5-6; ¶0064-0070: the display unit displays both the set, expected value and the actual, measured value of monitored parameters such the blood flow rate in the tubing), which is measured by a flow rate measurement unit as an actually measured value of the flow rate of the blood flowing inside the circulation circuit (¶0037 and 0058: the blood flow rate in the tubing may be measured either directly or indirectly), on the display unit (30).
Molducci is silent with respect to displaying a standard pressure and an actual pressure as claimed.
As discussed above, Khair teaches methods for estimating the flow rate and/or pressure (Figs. 3-6 and 12) associated with an instrument in an extracorporeal circulation system (Fig. 1; ¶0025). Khair teaches that a model based on the pressure-flow rate relationship, corresponding to the claimed standard information, may be used to calculate an expected or estimated pressure, corresponding to the claimed standard pressure, and/or flow rate for a fluid flowing through that instrument (¶0036-0037) by using one or more pressures and/or flow rates as an input to the model (Figs. 3-6, and 12, feats. 304, 404, 504, 604, and 1204). Khair further teaches that estimating an expected pressure and/or flow rate for a given instrument using a model of the pressure-flow rate relationship allows for the comparison of expected pressures and/or flow rates with measured or actual pressures and/or flow rates and the detection of abnormal flow states or abnormal measurement conditions associated with the instrument due to differences or discrepencies between the expected and actual values (¶0037). Molducci teaches that displaying multiple versions of a given parameter, such as set or expected values for a parameter and the actual, measured values for that parameter, on the same display makes it easy for the user to retrieve and visualize key information about the system (¶0026-0027 and 0063). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the non-transitory computer readable media having a program disclosed by Molducci so that the program has operations comprising displaying a standard pressure calculated based on the expected flow rate by referring to standard information, which represents a relation between the blood flow rate and a pressure loss occurring in a device provided in the circulation circuit and is stored in a storage unit and displaying an actual pressure related to the device, which is calculated based on an actual pressure measured by a pressure measurement unit as an actually measured value of a pressure of the blood flowing inside the circulation circuit and the actual flow rate on the display unit in order to monitor the system for abnormal flow states due to differences between the expected, standard pressure and the measured pressure as taught by Khair and to make it easy for a user to understand the differences between the expected, standard pressure and the measured pressure as taught by Molducci.
Regarding claim 11, Molducci in view of Khair discloses the non-transitory computer readable media of claim 10. As discussed above, Khair further teaches that the differences between the estimated or expected values for flow rate and pressure and the actual measured values for flow rate and pressure should be monitored because those differences may indicate abnormal flow states or abnormal measurement conditions in the extracorporeal circulation system (¶0037). As discussed above, Molducci teaches that displaying both multiple versions of a given parameter on the same display makes it easy for the user to retrieve and visualize key information about the system (¶0026-0027 and 0063). Therefore, modifying the system disclosed by Molducci in view of Khair so that the differences between the expected and measured values of flow rate and pressure are displayed on the same display as the measured values would make it easier for a user to monitor those differences and detect abnormal flow states or measurement conditions in the system. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the non-transitory computer readable media having a program disclosed by Molducci in view of Khair so that the operations further comprise displaying a differential flow rate representing a difference between the expected flow rate and the actual flow rate on the display unit and displaying a differential pressure representing a difference between the standard pressure and the actual pressure value on the display unit in order make it easy for a user to detect abnormal flow states or measurement conditions in the system as suggested by Khair and Molducci.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Molducci et al. (US 2008/0249377 A1) in view of Khair (US 2018/0236152 A1), as applied to claim 2 above, and in further view of Burbank et al. (US 2003/0128125 A1).
Regarding claim 3, Molducci in view of Khair discloses the system of claim 2. Molducci further discloses that the pressure measurement unit includes a plurality of pressure sensors (Fig. 1, feat. 29; ¶0035-0038), each pressure sensor measuring a respective actual pressure value between respective instrument elements (Fig. 1: pressure sensors 29 are positioned to monitor the pressure between instruments 26 and 4, and instruments 4 and 28). As discussed above, Molducci further teaches that displaying multiple versions of a given parameter on the same display makes it easy for the user to retrieve and visualize key information about the system (¶0026-0027 and 0063). As discussed above with respect to claim 1, Khair teaches that a model based on the pressure-flow rate relationship, corresponding to the claimed standard information, for a given instrument may be used to calculate an expected pressure, corresponding to the claimed standard pressure, for a fluid flowing through that instrument (¶0036-0037). As discussed above with respect to claim 2, Khair further teaches that the differences between the expected or estimated values and the actual, measured values for pressure, corresponding to the claimed differential pressure, should be monitored to detect abnormal flow states or abnormal measurement conditions associated with the given instrument (¶0037). Khair, and therefore Molducci in view of Khair, only teaches the use of such a model, and therefore the calculation of the claimed standard pressure and differential pressure, for a single given instrument, and not a plurality of instruments as claimed.
Burbank teaches methods for detecting leaks in extracorporeal blood treatment circuits (Abstract; ¶0001). Burbank teaches that one indication for a disconnection or leak in a given portion of the blood circuit is the pressure drop across that portion of the circuit (¶0015-0018). Therefore, by monitoring the pressure drop across a plurality of portions of the blood circuit, disconnections or leaks in each of the circuit portions in the plurality can be detected. By modifying the system disclosed by Molducci in view of Khair so that the pressure drop across each portion of the extracorporeal circuit, and therefore each instrument in the circuit, is displayed on the display unit of Molducci, along with the expected, standard pressure and differential pressure for each portion of the circuit, a user would be more easily able to detect abnormal flow states or measurement conditions, as taught by Khair, in each portion of the circuit, as taught by Burbank. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Molducci in view of Khair so that a plurality of standard pressures are calculated based on i) the expected flow rate by referring to a plurality of pieces of the standard information each representing a relation between the blood flow rate and the pressure loss occurring in each of the plurality of instrument elements, and ii) the actual pressures related to the plurality of instrument elements calculated based on a plurality of actual pressure values measured by the plurality of pressure sensors and the actual flow rate, wherein a plurality of respective differential pressures are calculated, each representing a difference between a respective one of the plurality of standard pressures and a respective one of the actual pressure values related to a respective one of the plurality of instrument elements wherein the plurality of standard pressure values, the plurality of actual pressure values, and the plurality of differential pressure values are displayed on the display unit in order to make it easy for a user to monitor for abnormal flow states or measurement conditions in each instrument in each part of the extracorporeal circuit.
Claims 4-6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Molducci et al. (US 2008/0249377 A1) in view of Khair (US 2018/0236152 A1), in further view of Burbank et al. (US 2003/0128125 A1), and in further view of Müller-Spanka et al. (US 2011/0208107 A1).
Regarding claim 4, Molducci in view of Khair and in further view of Burbank discloses the system of claim 3. Molducci further discloses that the plurality of instrument elements includes: a blood removing catheter which is partially inserted into the patient and guides the blood taken out from the patient (Fig. 1, feat. 23; ¶0035), a pump which is provided on a downstream side of the blood removing catheter, takes out the blood from the patient through the blood removing catheter and sends the blood to a downstream side of the pump (Fig. 1, feat. 26); a blood treatment unit (Fig. 1, feat. 4); and a blood feeding catheter which is provided on a downstream side of the blood treatment unit and is partially inserted into the patient, and guides the blood that has passed through the blood treatment unit to the patient (Fig. 1, feat. 25). Molducci discloses that the blood treatment unit is a dialysis unit (¶0034-0035), and not an oxygenator as claimed. Therefore, the prior art system of Molducci in view of Khair and in further view of Burbank differs from the claimed system by the substitution of a dialysis unit for the claimed oxygenator.
Müller-Spanka teaches an extracorporeal circulation system (Fig. 1; ¶0010) comprising a circulation circuit for circulating blood taken from a patient through a blood removing catheter (Figs. 5-6, feat. V; ¶0058 and 0073-0075), a pump provided downstream from the blood removing catheter for taking blood from the patient through the blood removing catheter and sending it downstream of the pump (44), an oxygenator downstream of the pump which performs a gas exchange operation for the blood (64), and a blood feeding catheter downstream from the oxygenator and which returns oxygenated blood to the patient (A). The extracorporeal circulation system of Müller-Spanka further includes a flow rate measurement unit (Fig. 5, feat. 84; ¶0058 and 0075), a pressure measurement unit (Figs. 5-6, feats. 74, 75, and 127; ¶0058 and 0079), and a display unit (Fig. 1, feat. 26; ¶0047-0049). Therefore, an extracorporeal circulation system comprising an oxygenator as claimed was known in the art. One of ordinary skill in the art could have substituted the oxygenator of Müller-Spanka for the dialysis unit of Molducci in view of Khair and in further view of Burbank by connecting the oxygenator downstream of the pump in the same way that the dialysis unit is connected downstream of the pump, with the predictable results of the substituted system taking the blood of the patient, treating it, and returning it to the patient because both the oxygenator of Müller-Spanka and the dialysis unit of Molducci are downstream of both the pump and the blood removing catheter and upstream of the blood feeding catheter. Furthermore, the data collection, calculation, and display functions of the controller of Molducci in view of Khair and in further view of Burbank would not be affected by the substitution because these functions all involve flow rate and pressure data taken on the blood circuit portion of the system, which would not be changed by the substitution of the oxygenator for the dialysis unit. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Molducci in view of Khair and in further view of Burbank to substitute an oxygenator which is provided on the downstream side of the pump and performs a gas exchange operation for the blood for the dialysis unit. Please see MPEP §2143(I)(B).
Regarding claim 5, Molducci in view of Khair, in further view of Burbank, and in further view of Müller-Spanka discloses the system of claim 4. Molducci further discloses pressure sensors (Fig. 1, feats. 29; ¶0035-0037) upstream and downstream of the treatment unit (Fig. 1, feat. 4), and therefore a first pressure sensor between the blood removing catheter and the treatment unit and a second pressure sensor between the treatment unit and the blood feeding catheter. Therefore, Molducci in view of Khair, in further view of Burbank, and in further view of Müller-Spanka further discloses that the plurality of pressure sensors includes a first pressure sensor provided in the circulation circuit between the blood removing catheter and the oxygenator and a second pressure sensor provided in the circulation circuit between the oxygenator and the blood feeding catheter. As discussed above, Molducci discloses that the blood flow rate in the tubing may be measured either directly or indirectly (¶0037 and 0058), but is silent with respect to a flow rate sensor provided in the circulation circuit.
As discussed above, Müller-Spanka teaches an extracorporeal circulation system including a blood removing catheter (Fig. 6, feat. V; ¶0058 and 0073-0075), a pump downstream of the blood removing catheter (44), an oxygenator downstream from the pump (64), and a blood feeding catheter downstream from the oxygenator for returning blood to the patient (A). Müller-Spanka further teaches a blood flow rate sensor (84) upstream of the blood feeding catheter (A) which continuously monitors the blood returned to the patient (¶0073-0075). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Molducci in view of Khair, in further view of Burbank, and in further view of Müller-Spanka so that the flow rate measurement unit is a flow rate sensor provided in the circulation circuit upstream of the blood feeding catheter in order to continuously monitor the blood returned to the patient as taught by Müller-Spanka.
Regarding claim 6, Molducci in view of Khair, in further view of Burbank, and in further view of Müller-Spanka discloses the system of claim 5. As discussed above, with respect to claim 5, the extracorporeal circulation system of Molducci in view of Khair, in further view of Burbank, and in further view of Müller-Spanka comprises a flow rate sensor, a blood removing catheter, an oxygenator, and a blood feeding catheter, and first and second pressure sensors positioned to measure the pressure of these circuit instrument elements. As discussed above with respect to claim 1, Khair teaches that a model based on the pressure-flow rate relationship, corresponding to the claimed standard information, for a given instrument may be used to calculate an expected pressure, corresponding to the claimed standard pressure, for a fluid flowing through that instrument (¶0036-0037). As discussed above with respect to claim 2, Khair further teaches that the differences between the expected or estimated values and the actual, measured values for pressure, corresponding to the claimed differential pressure, should be monitored to detect abnormal flow states or abnormal measurement conditions associated with the given instrument (¶0037). As discussed above with respect to claim 3, Burbank teaches that monitoring the pressure drop in each portion of an extracorporeal circulation circuit, which includes the instruments in the circuit, helps to indicate a disconnection or leak in each portion of the circuit. As discussed above, Molducci teaches simultaneously displaying multiple versions of a given parameter on the same display in order to make it easy for a user to retrieve and visualize key information about the extracorporeal circulation system (Figs. 2-3 and 5-6; ¶0026-0027 and 0063-0070). As discussed above with respect to claim 1, Molducci in view of Khair discloses that the parameters may be the flow rate and pressure, and that the versions of the parameters may be the expected or estimated flow rate and pressure and the actual or measured flow rate or pressure. As discussed above with respect to claim 2, Molducci in view of Khair further discloses that that the versions of the parameters may include the differential flow rate and differential pressure. Therefore, Molducci in view of Khair, in further view of Burbank, and in further view of Müller-Spanka further discloses that the display simultaneously displays: the expected flow rate; the actual flow rate acquired by the flow rate sensor; the differential flow rate; a standard pressure related to the blood removing catheter calculated based on the expected flow rate by referring to the standard information related to the blood removing catheter which represents a relation between the blood flow rate and the pressure loss occurring in the blood removing catheter; a standard pressure related to the oxygenator calculated based on the expected flow rate by referring to the standard information related to the oxygenator which represents a relation between the blood flow rate and the pressure loss occurring in the oxygenator; a standard pressure related to the blood feeding catheter calculated based on the expected flow rate by referring to the standard information related to the blood feeding catheter which represents a relation between the blood flow rate and the pressure loss occurring in the blood feeding catheter; an actual pressure related to the blood removing catheter calculated based on an actual pressure measured by the first pressure sensor and the actual flow rate; an actual pressure related to the oxygenator calculated based on the actual pressure measured by the first pressure sensor, an actual pressure measured by the second pressure sensor, and the actual flow rate; an actual pressure related to the blood feeding catheter calculated based on the actual pressure measured by the second pressure sensor and the actual flow rate; a differential pressure related to the blood removing catheter which represents a difference between the standard pressure related to the blood removing catheter and the actual pressure related to the blood removing catheter; a differential pressure related to the oxygenator which represents a difference between the standard pressure related to the oxygenator and the actual pressure related to oxygenator; and a differential pressure related to the blood feeding catheter which represents a difference between the standard pressure related to the blood feeding catheter and the actual pressure related to the blood feeding catheter.
Regarding claim 8, Molducci discloses an extracorporeal circulation system circulating blood of a patient (Fig. 1, feat. 1 ¶0033-0038), comprising: a display unit that displays various types of information (Figs. 1-3, feat. 30; ¶0039); a circulation circuit including: a blood removing catheter which is partially inserted into the patient and guides the blood taken out from the patient (Fig. 1, feat. 23; ¶0035), a pump which is provided on a downstream side of the blood removing catheter, takes out the blood from the patient through the blood removing catheter and sends the blood to a downstream side of the pump (Fig. 1, feat. 26); a blood treatment unit (Fig. 1, feat. 4); and a blood feeding catheter which is provided on a downstream side of the blood treatment unit and is partially inserted into the patient, and guides the blood that has passed through the blood treatment unit to the patient (Fig. 1, feat. 25); a flow rate measurement unit measuring an actual flow rate value of the blood flowing inside the circulation circuit (¶0037 and 0058: the blood flow rate in the tubing may be measured either directly or indirectly); a pressure measurement unit measuring an actual pressure value of the blood flowing inside the circulation circuit (Fig. 1, feat. 29; ¶0037); an extracorporeal circulation management controller (18; ¶0034 and 0037-0044) configured to 1) store an expected flow rate of the blood to be provided to the patient (¶0058: the blood flow rate in the tubing is a parameter monitored via the display unit), wherein the expected flow rate is determined for the patient in advance according to an operator input to the extracorporeal circulation management controller (¶0003-0004, 0055-0058, and 0063-0070: parameters such as the blood flow rate in the tubing may be set, before or during treatment, via the display unit), 2) receive the actual flow rate from the flow rate measurement unit (¶0041: the controller receives data from the sensors in the system), and 6) display the expected flow rate and the actual flow rate on the display unit (Figs. 2-3 and 5-6; ¶0064-0070: the display unit displays both the set, expected value and the actual, measured value of monitored parameters such the blood flow rate in the tubing).
As discussed above with respect to claim 4, Molducci discloses a treatment unit comprising a dialysis unit instead of the claimed oxygenator. Molducci is also silent with respect to calculating a differential flow rate as claimed, calculating standard pressures as claimed, calculating differential pressures as claimed, and displaying the calculated standard pressures, the actual pressure values and the differential pressures on the display unit.
As discussed above, Khair teaches methods for estimating the flow rate and/or pressure (Figs. 3-6 and 12) associated with an instrument in an extracorporeal circulation system (Fig. 1; ¶0025). Khair teaches that a model based on the pressure-flow rate relationship, corresponding to the claimed standard information, may be used to calculate an expected pressure, corresponding to the claimed standard pressure, and/or flow rate for a fluid flowing through that instrument (¶0036-0037) by using one or more pressures and/or flow rates as an input to the model (Figs. 3-6, and 12, feats. 304, 404, 504, 604, and 1204). Khair further teaches that estimating an expected pressure and/or flow rate for a given instrument using a model of the pressure-flow rate relationship allows for the comparison of expected pressures and/or flow rates with measured or actual pressures and/or flow rates and the detection of abnormal flow states or abnormal measurement conditions associated with the instrument due to differences or discrepencies between the expected and actual values, which correspond to the claimed differential flow rate and pressures (¶0037). As discussed above, Molducci teaches that displaying both multiple versions of a given parameter on the same display makes it easy for the user to retrieve and visualize key information about the system (¶0026-0027 and 0063). Modifying the system disclosed by Molducci so that the differences between the expected and measured values of flow rate and pressure are displayed on the same display as the measured values and expected or estimated values for flow rate and pressure would make it easier for a user to monitor those differences and detect abnormal flow states or measurement conditions in the system. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Molducci so that the controller is configured to 3) calculate a differential flow rate representing a difference between the expected flow rate and the actual flow rate, 4) calculate a standard pressure for an instrument in the circuit based on the expected flow rate and on standard information which represents a relation between a blood flow rate and a pressure loss occurring in the instrument, 5) calculate a differential pressure representing a difference between the standard pressure for the instrument and the actual pressure value and 6) displaying the calculated standard pressures, the actual pressure values, and the differential pressure values on the display unit in order make it easy for a user to detect abnormal flow states or measurement conditions in the system as suggested by Khair and Molducci.
As discussed above, Khair, and therefore Molducci in view of Khair, only teaches the use of such a model, and therefore the calculation of the claimed standard pressure and differential pressure, for a single given instrument, and not a plurality of instruments as claimed.
As discussed above, Burbank teaches methods for detecting leaks in extracorporeal blood treatment circuits (Abstract; ¶0001). Burbank teaches that one indication for a disconnection or leak in a given portion of the blood circuit is the pressure drop across that portion of the circuit (¶0015-0018). Therefore, by monitoring the pressure drop across a plurality of portions of the blood circuit, disconnections or leaks in each of the circuit portions in the plurality can be detected. By modifying the system disclosed by Molducci in view of Khair so that the pressure drop across each portion of the extracorporeal circuit, and therefore each instrument in the circuit, is displayed on the display unit of Molducci, along with the expected, standard pressure and differential pressure for each portion of the circuit, a user would be more easily able to detect abnormal flow states or measurement conditions, as taught by Khair, in each portion of the circuit, as taught by Burbank. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Molducci in view of Khair so that the standard pressure is calculated for each of the blood removing catheter, the pump, the treatment unit, and the blood feeding catheter and so that the differential pressure is calculated for each of the blood removing catheter, the pump, the treatment unit, and the blood feeding catheter in order to make it easy for a user to monitor for abnormal flow states or measurement conditions in each instrument in each part of the extracorporeal circuit.
As discussed above, Molducci discloses that the blood treatment unit is a dialysis unit (¶0034-0035), and not an oxygenator as claimed. Therefore, the prior art system of Molducci in view of Khair and in further view of Burbank differs from the claimed system by the substitution of a dialysis unit for the claimed oxygenator.
As discussed above, Müller-Spanka teaches an extracorporeal circulation system (Fig. 1; ¶0010) comprising a circulation circuit for circulating blood taken from a patient through a blood removing catheter (Figs. 5-6, feat. V; ¶0058 and 0073-0075), a pump provided downstream from the blood removing catheter for taking blood from the patient through the blood removing catheter and sending it downstream of the pump (44), an oxygenator downstream of the pump which performs a gas exchange operation for the blood (64), and a blood feeding catheter downstream from the oxygenator and which returns oxygenated blood to the patient (A). The extracorporeal circulation system of Müller-Spanka further includes a flow rate measurement unit (Fig. 5, feat. 84; ¶0058 and 0075), a pressure measurement unit (Figs. 5-6, feats. 74, 75, and 127; ¶0058 and 0079), and a display unit (Fig. 1, feat. 26; ¶0047-0049). Therefore, an extracorporeal circulation system comprising an oxygenator as claimed was known in the art. One of ordinary skill in the art could have substituted the oxygenator of Müller-Spanka for the dialysis unit of Molducci in view of Khair and in further view of Burbank by connecting the oxygenator downstream of the pump in the same way that the dialysis unit is connected downstream of the pump, with the predictable results of the substituted system taking the blood of the patient, treating it, and returning it to the patient because both the oxygenator of Müller-Spanka and the dialysis unit of Molducci are downstream of both the pump and the blood removing catheter and upstream of the blood feeding catheter. Furthermore, the data collection, calculation, and display functions of the controller of Molducci in view of Khair and in further view of Burbank would not be affected by the substitution because these functions all involve flow rate and pressure data taken on the blood circuit portion of the system, which would not be changed by the substitution of the oxygenator for the dialysis unit. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Molducci in view of Khair and in further view of Burbank to substitute an oxygenator which is provided on the downstream side of the pump and performs a gas exchange operation for the blood for the dialysis unit. Please see MPEP §2143(I)(B).
Claims 7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Molducci et al. (US 2008/0249377 A1) in view of Khair (US 2018/0236152 A1), as applied to claims 2 and 11 above, and in further view of Hersenius (WO 2016/096241 A1).
Regarding claim 7, Molducci in view of Khair discloses the system of claim 2, but does not disclose that a notification of a warning is provided when an absolute value of at least one of the differential flow rate and the differential pressure exceeds a predetermined value.
Hersenius teaches methods of monitoring the operational state of a medical apparatus for critical situations (Page 1, line 10 – Page 2, line 31). Hersenius teaches that the medical apparatus should monitor parameters such as flow rate for how close the measured value of the parameter is to the prescribed or expected value of the parameter (Page 11, line 12 – Page 12, line 9). Hersenius teaches that when the measured value of the parameter deviates too much from the expected value of the parameter, a critical state may be present and an alarm should be activated to indicate to a user that a critical state needs attention (Page 12, lines 1-27; Page 18, lines 16-22). In the system of Molducci in view of Khair, the differential flow rate and differential pressure are some of the monitored parameters. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Molducci in view of Khair so that notification of a warning is provided when an absolute value of at least one of the differential flow rate and the differential pressure exceeds a predetermined value in order to alert the user that the system is in a critical state that needs attention as taught by Hersenius.
Regarding claim 12, Molducci in view of Khair discloses the non-transitory computer readable media of claim 11, but does not disclose displaying a notification of a warning on the display unit when an absolute value of at least one of the differential flow rate and the differential pressure exceeds a respective predetermined value.
Hersenius teaches methods of monitoring the operational state of a medical apparatus for critical situations (Page 1, line 10 – Page 2, line 31). Hersenius teaches that the medical apparatus should monitor parameters such as flow rate for how close the measured value of the parameter is to the prescribed or expected value of the parameter (Page 11, line 12 – Page 12, line 9). Hersenius teaches that when the measured value of the parameter deviates too much from the expected value of the parameter, a critical state may be present and an alarm should be activated to indicate to a user that a critical state needs attention (Page 12, lines 1-27; Page 18, lines 16-22). In the system of Molducci in view of Khair, the differential flow rate and differential pressure are some of the monitored parameters. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the non-transitory computer readable media disclosed by Molducci in view of Khair so that the operations further comprise displaying a notification of a warning on the display unit when an absolute value of at least one of the differential flow rate and the differential pressure exceeds a respective predetermined value in order to alert the user that the system is in a critical state that needs attention as taught by Hersenius.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Molducci et al. (US 2008/0249377 A1) in view of Khair (US 2018/0236152 A1), in further view of Burbank et al. (US 2003/0128125 A1), in further view of Müller-Spanka et al. (US 2011/0208107 A1), as applied to claim 8 above, and in further view of Hersenius (WO 2016/096241 A1).
Regarding claim 9, Molducci in view of Khair, in further view of Burbank, and in further view of Müller-Spanka discloses the system of claim 8, but does not disclose that a notification of a warning is provided when an absolute value of at least one of the differential flow rate and the differential pressure exceeds a predetermined value.
Hersenius teaches methods of monitoring the operational state of a medical apparatus for critical situations (Page 1, line 10 – Page 2, line 31). Hersenius teaches that the medical apparatus should monitor parameters such as flow rate for how close the measured value of the parameter is to the prescribed or expected value of the parameter (Page 11, line 12 – Page 12, line 9). Hersenius teaches that when the measured value of the parameter deviates too much from the expected value of the parameter, a critical state may be present and an alarm should be activated to indicate to a user that a critical state needs attention (Page 12, lines 1-27; Page 18, lines 16-22). In the system of Molducci in view of Khair, in further view of Burbank, and in further view of Müller-Spanka, the differential flow rate and differential pressure are some of the monitored parameters. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the system disclosed by Molducci in view of Khair, in further view of Burbank, and in further view of Müller-Spanka so that notification of a warning is provided when an absolute value of at least one of the differential flow rate and the differential pressure exceeds a predetermined value in order to alert the user that the system is in a critical state that needs attention as taught by Hersenius.
Conclusion
THIS ACTION IS MADE FINAL. 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 ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781