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 1-20 are pending and examined on the merits.
Response to Arguments
Applicant's arguments filed 10/31/2025 have been fully considered but they are not persuasive. Regarding Applicant’s argument that Gelfand fails to teach or suggest saving in a data management system (DMS), or a system log, of the HLM, successful and unsuccessful safety check results (see page 11 of Remarks filed 10/31/2025), Examiner respectfully disagrees. Specifically, as described on pages 7-8 of the Non-Final Rejection mailed 08/20/2025, Gelfand teaches a monitoring CPU that provides a safety check and determines whether a safety alarm should be issued (see para. [0067]). Therefore, while Gelfand does not explicitly teach that the safety check results are stored in the monitoring CPU, one of ordinary skill in the art would have reasonably recognized that since the CPU determines whether a safety alarm should be issued, the data has to be at least temporarily stored in order to be compared to allowable preset levels so that the monitoring CPU can determine whether a safety alarm should be issued (see para. [0067]). Therefore, one of ordinary skill in the art would have reasonably recognized that an unsuccessful safety check result will cause a safety alarm to be issued while a successful safety check result would not cause such safety alarm to be issued, however, both successful and unsuccessful safety check results have be compared to the safety and alarm levels stored on the CPU’s memory, and therefore, both successful and unsuccessful safety check results are at least temporarily stored in order to be compared by the CPU (pages 7-8 of the Non-Final Rejection mailed 08/20/2025).
Carpenter (U.S. Pre Grant Pub. No. 2005/0063860 A1), Gilbert (U.S. Pre Grant Pub. No. 2016/0346452 A1), Ebler (U.S. Pre Grant Pub. No. 2017/0102846 A1), and Gelfand (U.S. Pre Grant Pub. No. 2002/0085951 A1) are reintroduced as primary and secondary references in the present rejection for disclosing and rendering obvious the limitations presented in the claims.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Carpenter (U.S. Pre Grant Pub. No. 2005/0063860 A1), in view of Gilbert (U.S. Pre Grant Pub. No. 2016/0346452 A1), further in view of Ebler (U.S. Pre Grant Pub. No. 2017/0102846 A1), and further in view of Gelfand (U.S. Pre Grant Pub. No. 2002/0085951 A1).
Regarding claim 1, Carpenter teaches: A heart lung machine (HLM) (see at least para. [0055]), comprising:
a pump (see at least para. [0055]);
a plurality of sensors (see at least para. [0106]),
a control assembly (see AAR controller 400 at least in Fig. 14 and para. [0138-0139]), the control assembly comprising a control display device (see LCD screen 430 in para. [0139] and Fig. 14) and a processing unit (see at least para. [0131]), the processing unit configured to facilitate a semi-automatic safety check by:
providing an HLM system safety check user interface (Ul) on a display device (see for example Figs. 18-57), the HLM system safety check Ul comprising a representation of each of the plurality of sensors (see for example Figs. 23 and 45);
activating a first sensor of the plurality of sensors (para. [0166] teaches that depressing the F2 key in the LCD screen display initiates detection of the absence of fluid);
presenting, via the Ul, an indication of the activation of the first sensor (see for example Figs. 23 and 45 and para. [0166]);
determining an alarm state of the first sensor (at least implicit because para. [0166] discloses that the result is presented and indicated on the LCD screen display);
presenting a representation of the alarm state of the first sensor on the control display device (para. [0166] teaches that detection of the absence of fluid and the successful detection of air is indicated in the LCD screen display; see also Fig. 23);
presenting a safety check result of the first sensor via the Ul (para. [0166] teaches that the result of the alarm state of the first sensor is indicated in the LCD screen display; see also Fig. 23);
activating a second sensor of the plurality of sensors (see air sensor in para. [0176]);
presenting, via the Ul, an indication of the activation of the second sensor (see para. [0176] and Fig. 45);
determining an alarm state of the second sensor (at least implicit because para. [0176] discloses that the result is presented and indicated on the LCD screen display);
presenting a representation of the alarm state of the second sensor on the control display device (see at least para. [0176] and Fig. 45);
presenting, via the Ul, a safety check result of the second sensor (para. [0176] teaches that the result of the alarm state of the second sensor is displayed on the LCD screen; Fig. 45 shows the safety check result).
However, Carpenter fails to explicitly teach a control area network (CAN), that the pump, the plurality of sensors, and/or the control assembly communicatively coupled to the CAN, or saving in a data management system (DMS) or system log of the HLM the safety check result corresponding to the first and/or second sensor, as required by the claim.
Gilbert teaches an analogous extracorporeal circuit for providing cardiac and respiratory support to individuals (see at least para. [0033]) comprising a computing device 1200 that includes a network interface 1212 configured to interface via one or more network devices 1222 including a controller area network (CAN) (see para. [0134]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Carpenter to incorporate the teachings of Gilbert by including a control area network (CAN) at least because choosing between this type of communication technology or any other is well known in the art, as evidenced by its disclosure in Gilbert (see para. [0134]). Additionally, one of ordinary skill in the art would have reasonably recognized that since the device of Carpenter is integrated (see at least Abstract), the pump and sensors will necessarily need to be communicatively coupled to the CAN in order for the device to function as intended.
However, neither Carpenter nor Gilbert explicitly teach saving in a data management system (DMS) or system log of the HLM the safety check result corresponding to the first and/or second sensor, as required by the claim.
Ebler teaches an analogous user interface for heart-lung machines (see Abstract) comprising saving in a data management system (DMS) or system log of the HLM the safety check result corresponding to the sensor (para. [0273] teaches data logging of alarm messages to be displayed on the menu interface 802).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Carpenter in view of Gilbert to incorporate the teachings of Ebler by saving in a data management system (DMS) or system log of the HLM the safety check result corresponding to the first and/or second sensor at least in order for the alarm messages to be saved and displayed, as taught by Ebler (see para. [0273]).
However, none of Carpenter, Gilbert, nor Ebler explicitly teach the saving of successful and unsuccessful safety check results corresponding to the first and second sensors, as required by the claim.
Gelfand teaches an analogous system and method for extracorporeal treatment of blood comprising a monitoring CPU that provides a safety check and determines whether a safety alarm should be issued (see para. [0067]). One of ordinary skill in the art would have reasonably recognized that the monitoring CPU has to at least temporarily store the safety check results in order to compare them to normal operating conditions, which are stored on the CPU (see para. [0067]). Additionally, one of ordinary skill in the art would have reasonably recognized that an unsuccessful safety check result will cause a safety alarm to be issued while a successful safety check result would not cause such safety alarm to be issued, however, both successful and unsuccessful safety check results have be compared to the safety and alarm levels stored on the CPU’s memory, and therefore, both successful and unsuccessful safety check results are at least temporarily stored in order to be compared by the CPU.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Carpenter in view of Gilbert and further in view of Ebler to incorporate the teachings of Gelfand by saving successful and unsuccessful safety check results corresponding to the first and second sensors at least in order to determine whether a safety alarm should be issued and whether to stop or reset the pump, as taught by Gelfand (see para. [0067]).
Regarding claim 2, Carpenter, in view of Gilbert, further in view of Ebler, and further in view of Gelfand teaches the invention as discussed above in claim 1. Additionally, the combined device of Carpenter, Gilbert, and Ebler teaches: wherein the processing unit is further configured to facilitate the semi-automatic safety check by:
receiving a reaction message from the system pump, the reaction message indicating that the system pump acknowledged an alarm state of the first sensor (para. [0012] of Carpenter teaches that when an alarm state of the first sensor is detected, the purging vacuum, which may be produced by a pump 40, is activated; since the overall device of Carpenter is described as being integrated, when the pump is activated after detection of an alarm state of the first sensor, a signal will necessarily be relayed from the pump to the device);
accessing a first alarm message, via the CAN, wherein the first alarm message is generated by the first sensor and indicates the alarm state of the first sensor (para. [0166] of Carpenter teaches an indication on the LCD screen display that indicates the detection of the absence of fluid and the successful detection of air); and
determining the alarm state of the first sensor based on the first alarm message (at least implicit because para. [0166] of Carpenter discloses that the result is presented and indicated on the LCD screen display).
Regarding claim 3, Carpenter, in view of Gilbert, further in view of Ebler, and further in view of Gelfand teaches the invention as discussed above in claim 2. Additionally, Carpenter teaches: wherein the pump is configured to:
receive the first alarm message (para. [0012] of Carpenter, for example, teaches that a sensor signal is processed by circuitry that applies vacuum to the purge line 42; therefore, the pump receives the first alarm message); and
provide, in response to receiving the first alarm message, a reaction message to the processing unit (para. [0012], for example, teaches that vacuum is discontinued in response to a sensor signal); and
perform, in response to receiving the first alarm message, an alarm system reaction, wherein the alarm system reaction comprises ceasing pump operation if the pump is running before receiving the alarm message (para. [0192] teaches that the speed of the blood pump may be automatically lowered if air is detected; therefore, Carpenter teaches the ceasing of pump operation in response to receiving the first alarm message).
Regarding claim 4, Carpenter, in view of Gilbert, further in view of Ebler, and further in view of Gelfand teaches the invention as discussed above in claim 1. Additionally, Carpenter teaches: wherein the processing unit is further configured to:
determine that the alarm system reaction performed by the pump in response to receiving the first alarm message from the first sensor has been executed as intended, thereby identifying a successful safety check result corresponding to the first sensor (as taught in para. [0151], with reference to Figs. 50-56, error messages are displayed on the LCD screen when an alarm state of the first sensor is detected which alert a perfusionist to take appropriate corrective action);
present, via the Ul, the successful safety check result (para. [0166] teaches that the result of the alarm state of the first sensor is indicated in the LCD screen display; see also Fig. 23); and
enable the HLM to perform a perfusion task (at least inherent; see also at least para. [0056]).
Regarding claim 5, Carpenter, in view of Gilbert, further in view of Ebler, and further in view of Gelfand teaches the invention as discussed above in claim 1. Additionally, Carpenter teaches: wherein the processing unit further is configured to:
determine that the alarm system reaction performed by the pump in response to receiving the first alarm message from the first sensor has not been executed as intended, thereby identifying an unsuccessful safety check result corresponding to the first sensor (as taught in para. [0151], with reference to Figs. 50-56, error messages are displayed on the LCD screen when an alarm state of the first sensor is detected which alert a perfusionist to take appropriate corrective action);
present, via the Ul, the unsuccessful safety check result (see for example para. [0168]);
present, via, the UI, a selectable option to a proceed with a perfusion task (para. [0168] teaches that upon successful completion of the sensor tests, the integrated extracorporeal blood circuit 100 is prepared for priming);
receive a user input comprising a confirmation from the user to proceed with the perfusion task despite the fact that the safety check had an unsuccessful result (para. [0168] teaches that is “AIR” or “FLUID” is inappropriately displayed, the AAR controller 400 is replaced and the process is restarted; therefore, a user input is required to proceed with the perfusion task); and
enable the HLM to perform the perfusion task (at least inherent; see also at least para. [0056]).
Regarding claim 6, Carpenter, in view of Gilbert, further in view of Ebler, and further in view of Gelfand teaches the invention as discussed above in claim 5. Additionally, Ebler teaches: wherein the processing unit is further configured to save, in the DMS, or a system log of the HLM, an indication of the receipt of the confirmation to proceed with the perfusion task (para. [0273] teaches data logging of alarm messages to be displayed on the menu interface 802).
Regarding claim 7, Carpenter, in view of Gilbert, further in view of Ebler, and further in view of Gelfand teaches the invention as discussed above in claim 6. Additionally, Ebler teaches: wherein the processing unit is further configured to save, in the DMS, or a system log of the HLM, an indication of the enabling of the perfusion task (para. [0098], for example, teaches that untabbed display page 115 displays sensor data and information pertinent to the operation of the cardio-pulmonary bypass machine 1, which is an indication of the enabling of the perfusion task).
Regarding claim 8, Carpenter, in view of Gilbert, further in view of Ebler, and further in view of Gelfand teaches the invention as discussed above in claim 1. Additionally, Carpenter teaches wherein the first sensor comprises a level sensor, a bubble sensor, or a pressure sensor (para. [0083] teaches an air detector to prevent bubbles from entering the heart).
Regarding claim 9, Carpenter, in view of Gilbert, further in view of Ebler, and further in view of Gelfand teaches the invention as discussed above in claim 1. Additionally, Carpenter teaches wherein the processing unit is configured to provide the Ul in response to receiving a user selection of a machine profile (para. [0148] teaches that various modes of the device can be initiated by depressing keys on the device that correspond to Standby and Automatic modes).
Regarding claim 10, Carpenter, in view of Gilbert, further in view of Ebler, and further in view of Gelfand teaches the invention as discussed above in claim 1. Additionally, Carpenter teaches wherein the processing unit is configured to:
receive a user input comprising an indication of a user interaction with a first switch displayed on the Ul (para. [0148] teaches that function keys F1, F2, and F3 can be depressed in response to a message displayed on the LCD screen); and
activate the first sensor in response to receiving the indication of the user interaction with the first switch (para. [0166] teaches that depression of the F2 key initiates detection of the absence of fluid and the successful detection of air).
Regarding claim 11, Carpenter teaches: A method of operating a heart lung machine (HLM) (see at least para. [0022]), the HLM comprising a pump (see at least para. [0055]), a plurality of sensors (see at least para. [0106]), and a control assembly (see AAR controller 400 at least in Fig. 14 and para. [0138-0139]), the control assembly comprising a control display device (see LCD screen 430 in para. [0139] and Fig. 14) and a processing unit (see at least para. [0131]), the method comprising:
providing an HLM system safety check user interface (Ul) on a display device (see for example Figs. 18-57), the HLM system safety check Ul comprising a representation of each of the plurality of sensors (see for example Figs. 23 and 45);
activating a first sensor of the plurality of sensors (para. [0166] teaches that depressing the F2 key in the LCD screen display initiates detection of the absence of fluid);
presenting, via the Ul, an indication of the activation of the first sensor (see for example Figs. 23 and 45 and para. [0166]);
determining an alarm state of the first sensor (para. [0012] teaches that when an alarm state of the first sensor is detected, the purging vacuum, which may be produced by a pump 40, is activated; since the overall device of Carpenter is described as being integrated, when the pump is activated after detection of an alarm state of the first sensor, a signal will necessarily be relayed from the pump to the device);
presenting a representation of the alarm state of the first sensor on the control display device (para. [0166] teaches that detection of the absence of fluid and the successful detection of air is indicated in the LCD screen display; see also Fig. 23);
presenting, via the Ul, a result of the safety check of the first sensor (para. [0166] teaches that the result of the alarm state of the first sensor is indicated in the LCD screen display; see also Fig. 23);
activating a second sensor of the plurality of sensors (see air sensor in para. [0176]);
presenting, via the Ul, an indication of the activation of the second sensor (see para. [0176] and Fig. 45);
determining an alarm state of the second sensor (at least implicit because para. [0176] discloses that the result is presented and indicated on the LCD screen display);
presenting a representation of the alarm state of the second sensor on the control display device (see at least para. [0176] and Fig. 45);
presenting, via the Ul, a result of the safety check of the second sensor (para. [0176] teaches that the result of the alarm state of the second sensor is displayed on the LCD screen; Fig. 45 shows the safety check result).
However, Carpenter fails to explicitly teach a control area network (CAN), that the pump, the plurality of sensors, and/or the control assembly communicatively coupled to the CAN, or saving in a data management system (DMS) or system log of the HLM the safety check result corresponding to the first and/or second sensor, as required by the claim.
Gilbert teaches an analogous extracorporeal circuit for providing cardiac and respiratory support to individuals (see at least para. [0033]) comprising a computing device 1200 that includes a network interface 1212 configured to interface via one or more network devices 1222 including a controller area network (CAN) (see para. [0134]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Carpenter to incorporate the teachings of Gilbert by including a control area network (CAN) at least because choosing between this type of communication technology or any other is well known in the art, as evidenced by its disclosure in Gilbert (see para. [0134]). Additionally, one of ordinary skill in the art would have reasonably recognized that since the device of Carpenter is integrated (see at least Abstract), the pump and sensors will necessarily need to be communicatively coupled to the CAN in order for the device to function as intended. In addition, since Carpenter in view of Gilbert uses a controller area network, the first and second alarm messages will necessarily be accessed via the CAN, as required by the claim.
However, neither Carpenter nor Gilbert explicitly teach saving in a data management system (DMS) or system log of the HLM the safety check result corresponding to the first and/or second sensor, as required by the claim.
Ebler teaches an analogous user interface for heart-lung machines (see Abstract) comprising saving in a data management system (DMS) or system log of the HLM the safety check result corresponding to the sensor (para. [0273] teaches data logging of alarm messages to be displayed on the menu interface 802).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Carpenter in view of Gilbert to incorporate the teachings of Ebler by saving in a data management system (DMS) or system log of the HLM the safety check result corresponding to the first and/or second sensor at least in order for the alarm messages to be saved and displayed, as taught by Ebler (see para. [0273]).
However, none of Carpenter, Gilbert, nor Ebler explicitly teach the saving of successful and unsuccessful safety check results corresponding to the first and second sensors, as required by the claim.
Gelfand teaches a monitoring CPU that provides a safety check and determines whether a safety alarm should be issued (see para. [0067]). One of ordinary skill in the art would have reasonably recognized that the monitoring CPU has to at least temporarily store the safety check results in order to compare them to normal operating conditions, which are stored on the CPU (see para. [0067]). Additionally, one of ordinary skill in the art would have reasonably recognized that an unsuccessful safety check result will cause a safety alarm to be issued while a successful safety check result would not cause such safety alarm to be issued, however, both successful and unsuccessful safety check results have be compared to the safety and alarm levels stored on the CPU’s memory, and therefore, both successful and unsuccessful safety check results are at least temporarily stored in order to be compared by the CPU.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed method to have modified the device of Carpenter in view of Gilbert and further in view of Ebler to incorporate the teachings of Gelfand by saving successful and unsuccessful safety check results corresponding to the first and second sensors at least in order to determine whether a safety alarm should be issued and whether to stop or reset the pump, as taught by Gelfand (see para. [0067]).
Regarding claim 12, Carpenter, in view of Gilbert, further in view of Ebler, and further in view of Gelfand teaches the method as discussed above in claim 11. Additionally, Carpenter teaches further comprising:
receiving a reaction message from the system pump, the reaction message indicating that the system pump acknowledged an alarm state of the first sensor (para. [0012] teaches that when an alarm state of the first sensor is detected, the purging vacuum, which may be produced by a pump 40, is activated; since the overall device of Carpenter is described as being integrated, when the pump is activated after detection of an alarm state of the first sensor, a signal will necessarily be relayed from the pump to the device);
accessing a first alarm message, via the CAN, wherein the first alarm message is generated by the first sensor and indicates the alarm state of the first sensor (para. [0166] teaches an indication on the LCD screen display that indicates the detection of the absence of fluid and the successful detection of air); and
determining that the system pump reaction to the alarm state of the first sensor based on the first alarm message was executed as intended, thereby identifying and presenting, via the UI, a successful safety check result (as taught in para. [0151], with reference to Figs. 50-56, error messages are displayed on the LCD screen when an alarm state of the first sensor is detected which alert a perfusionist to take appropriate corrective action).
Regarding claim 13, Carpenter, in view of Gilbert, further in view of Ebler, and further in view of Gelfand teaches the method as discussed above in claim 11. Additionally, Carpenter teaches further comprising:
determining that the system pump did not acknowledge an alarm state as intended, thereby identifying and presenting, via the Ul, an unsuccessful safety check result (as taught in para. [0151], with reference to Figs. 50-56, error messages are displayed on the LCD screen when an alarm state of the first sensor is detected which alert a perfusionist to take appropriate corrective action);
presenting, via, the UI, a selectable option to a proceed with a perfusion task (para. [0168] teaches that upon successful completion of the sensor tests, the integrated extracorporeal blood circuit 100 is prepared for priming);
receiving a user input comprising a confirmation from the user to proceed with the perfusion task despite the fact that the safety check was not successfully performed (para. [0168] teaches that is “AIR” or “FLUID” is inappropriately displayed, the AAR controller 400 is replaced and the process is restarted; therefore, a user input is required to proceed with the perfusion task);
enabling the HILM to perform the perfusion task (at least inherent; see also at least para. [0056]); and
Additionally, Ebler teaches saving, in the DMS, or a system log, an indication of the receipt of the confirmation to proceed with the perfusion task (para. [0273] teaches data logging of alarm messages to be displayed on the menu interface 802).
Regarding claim 14, Carpenter, in view of Gilbert, further in view of Ebler, and further in view of Gelfand teaches the method as discussed above in claim 11. Additionally, Carpenter teaches wherein the first sensor comprises a level sensor, a bubble sensor, or a pressure sensor (para. [0083] teaches an air detector to prevent bubbles from entering the heart).
Regarding claim 15, Carpenter, in view of Gilbert, further in view of Ebler, and further in view of Gelfand teaches the method as discussed above in claim 11. Additionally, Carpenter teaches:
receiving a user input comprising an indication of a user interaction with a first switch displayed on the Ul (para. [0148] teaches that the function keys F1, F2, and F3 can be depressed in response to a message displayed on the LCD screen); and
activating the first sensor in response to receiving the indication of the user interaction with the first switch (para. [0166] teaches that upon depression of the F2 key, detection of the absence of fluid and the successful detection of air is initiated).
Regarding claim 16, Carpenter teaches: A heart lung machine (HLM) (see at least para. [0055]), comprising:
a pump (see at least para. [0055]);
a plurality of sensors (see at least para. [0106]),
a control assembly (see AAR controller 400 at least in Fig. 14 and para. [0138-0139]), the control assembly comprising a control display device (see LCD screen 430 in para. [0139] and Fig. 14) and a processing unit (see at least para. [0131]), the processing unit configured to facilitate a semi-automatic safety check by:
providing an HLM system safety check user interface (Ul) on a display device (see for example Figs. 18-57), the HLM system safety check Ul comprising a representation of each of the plurality of sensors (see for example Figs. 23 and 45);
activating a first sensor of the plurality of sensors (para. [0166] teaches that depressing the F2 key in the LCD screen display initiates detection of the absence of fluid);
presenting, via the Ul, an indication of the activation of the first sensor (see for example Figs. 23 and 45 and para. [0166]);
receiving a first reaction message from the system pump, the first reaction message indicating that the system pump acknowledged an alarm state of the first sensor (para. [0012] teaches that when an alarm state of the first sensor is detected, the purging vacuum, which may be produced by a pump 40, is activated; since the overall device of Carpenter is described as being integrated, when the pump is activated after detection of an alarm state of the first sensor, a signal will necessarily be relayed from the pump to the device);
accessing a first alarm message, wherein the first alarm message is generated by the first sensor and indicates the alarm state of the first sensor (para. [0166] teaches an indication on the LCD screen display that indicates the detection of the absence of fluid and the successful detection of air);
determining, based on the first alarm message, an alarm state of the first sensor (at least implicit because para. [0166] discloses that the result is presented and indicated on the LCD screen display);
presenting a representation of the alarm state of the first sensor on the control display device (para. [0166] teaches that detection of the absence of fluid and the successful detection of air is indicated in the LCD screen display; see also Fig. 23);
determining, based on the first reaction message from the system pump acknowledging the first alarm message from the first sensor, the correct execution, or not, of the intended system reaction, thereby identifying the safety check result corresponding to the first sensor (as taught in para. [0151], with reference to Figs. 50-56, error messages are displayed on the LCD screen when an alarm state of the first sensor is detected which alert a perfusionist to take appropriate corrective action);
presenting, via the Ul, the safety check result corresponding to the first sensor (para. [0166] teaches that the result of the alarm state of the first sensor is indicated in the LCD screen display; see also Fig. 23);
activating a second sensor of the plurality of sensors (see air sensor in para. [0176]);
presenting, via the Ul, an indication of the activation of the second sensor (see para. [0176] and Fig. 45);
receiving a second reaction message from the system pump, the second reaction message indicating that the system pump acknowledged an alarm state of the second sensor (para. [0131] teaches that when an alarm state of the second sensor is detected, i.e., when air is detected in the VARD, vacuum is applied; therefore, a second reaction message is received from the system pump that acknowledges the alarm state of the second sensor; see also Fig. 45);
accessing a second alarm message, wherein the second alarm message is generated by the second sensor and indicates the alarm state of the second sensor (para. [0176] teaches that a response to the true air signal or the test air signal can be indicative of failure and that the result is displayed on the LCD screen; see also Fig. 45);
determining, based on the second alarm message, an alarm state of the second sensor (at least implicit because para. [0176] discloses that the result is presented and indicated on the LCD screen display);
presenting a representation of the alarm state of the second sensor on the control display device (see at least para. [0176] and Fig. 45);
determining, based on the second reaction message from the system pump acknowledging the second alarm message from the second sensor, the correct execution, or not, of the intended system reaction, thereby identifying the safety check result corresponding to the second sensor (para. [0176] teaches that the second alarm message from the second sensor corresponds to a display requesting the checking of VARD sensors, upon replacement of the VARD cable, if the error message is repeated, it is an indication that the AAR controller needs replacement; therefore, the device identifies the safety check result corresponding to the second sensor);
presenting, via the Ul, the safety check result corresponding to the second sensor (para. [0176] teaches that the result of the alarm state of the second sensor is displayed on the LCD screen; Fig. 45 shows the safety check result).
However, Carpenter fails to explicitly teach a control area network (CAN), that the pump, the plurality of sensors, and/or the control assembly communicatively coupled to the CAN, accessing the first/second alarm message via the CAN, or saving in a data management system (DMS) or system log of the HLM the safety check result corresponding to the first and/or second sensor, as required by the claim.
Gilbert teaches an analogous extracorporeal circuit for providing cardiac and respiratory support to individuals (see at least para. [0033]) comprising a computing device 1200 that includes a network interface 1212 configured to interface via one or more network devices 1222 including a controller area network (CAN) (see para. [0134]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Carpenter to incorporate the teachings of Gilbert by including a control area network (CAN) at least because choosing between this type of communication technology or any other is well known in the art, as evidenced by its disclosure in Gilbert (see para. [0134]). Additionally, one of ordinary skill in the art would have reasonably recognized that since the device of Carpenter is integrated (see at least Abstract), the pump and sensors will necessarily need to be communicatively coupled to the CAN in order for the device to function as intended. In addition, since Carpenter in view of Gilbert uses a controller area network, the first and second alarm messages will necessarily be accessed via the CAN, as required by the claim.
However, neither Carpenter nor Gilbert explicitly teach saving in a data management system (DMS) or system log of the HLM the safety check result corresponding to the first and/or second sensor, as required by the claim.
Ebler teaches an analogous user interface for heart-lung machines (see Abstract) comprising saving in a data management system (DMS) or system log of the HLM the safety check result corresponding to the sensor (para. [0273] teaches data logging of alarm messages to be displayed on the menu interface 802).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Carpenter in view of Gilbert to incorporate the teachings of Ebler by saving in a data management system (DMS) or system log of the HLM the safety check result corresponding to the first and/or second sensor at least in order for the alarm messages to be saved and displayed, as taught by Ebler (see para. [0273]).
However, none of Carpenter, Gilbert, nor Ebler explicitly teach the saving of successful and unsuccessful safety check results corresponding to the first and second sensors, as required by the claim.
Gelfand teaches a monitoring CPU that provides a safety check and determines whether a safety alarm should be issued (see para. [0067]). One of ordinary skill in the art would have reasonably recognized that the monitoring CPU has to at least temporarily store the safety check results in order to compare them to normal operating conditions, which are stored on the CPU (see para. [0067]). Additionally, one of ordinary skill in the art would have reasonably recognized that an unsuccessful safety check result will cause a safety alarm to be issued while a successful safety check result would not cause such safety alarm to be issued, however, both successful and unsuccessful safety check results have be compared to the safety and alarm levels stored on the CPU’s memory, and therefore, both successful and unsuccessful safety check results are at least temporarily stored in order to be compared by the CPU.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed method to have modified the device of Carpenter in view of Gilbert and further in view of Ebler to incorporate the teachings of Gelfand by saving successful and unsuccessful safety check results corresponding to the first and second sensors at least in order to determine whether a safety alarm should be issued and whether to stop or reset the pump, as taught by Gelfand (see para. [0067]).
Regarding claim 17, Carpenter, in view of Gilbert, further in view of Ebler, and further in view of Gelfand teaches the invention as discussed above in claim 16. Additionally, Carpenter teaches wherein, if the pump is running before receiving the first alarm message, the pump is configured to perform, in response to receiving the first alarm message, an intended alarm system reaction, which comprises ceasing pump operation (para. [0192] teaches that the speed of the blood pump may be automatically lowered if air is detected; therefore, Carpenter teaches the ceasing of pump operation in response to receiving the first alarm message).
Regarding claim 18, Carpenter, in view of Gilbert, further in view of Ebler, and further in view of Gelfand teaches the invention as discussed above in claim 16. Additionally, Carpenter teaches wherein the processing unit further is configured to:
determine that the safety check has not been performed successfully if the alarm system reaction was not executed as intended (as taught in para. [0151], with reference to Figs. 50-56, error messages are displayed on the LCD screen when an alarm state of the first sensor is detected which alert a perfusionist to take appropriate corrective action);
present, via, the UI, the safety check result with a selectable option to proceed with a perfusion task (para. [0168] teaches that upon successful completion of the sensor tests, the integrated extracorporeal blood circuit 100 is prepared for priming);
receive a user input comprising a confirmation from the user to proceed with the perfusion task despite the fact that the safety check was not successfully performed (para. [0168] teaches that is “AIR” or “FLUID” is inappropriately displayed, the AAR controller 400 is replaced and the process is restarted; therefore, a user input is required to proceed with the perfusion task);
enable the HLM to perform the perfusion task (at least inherent; see also at least para. [0056]).
Additionally, Ebler teaches saving, in the DMS, or in the system log, an indication of the receipt of the confirmation to proceed with the perfusion task (para. [0273] teaches data logging of alarm messages to be displayed on the menu interface 802).
Regarding claim 19, Carpenter, in view of Gilbert, further in view of Ebler, and further in view of Gelfand teaches the invention as discussed above in claim 16. Additionally, Carpenter teaches wherein the first sensor comprises a level sensor, a bubble sensor, or a pressure sensor (para. [0083] teaches an air detector to prevent bubbles from entering the heart).
Regarding claim 20, Carpenter, in view of Gilbert, further in view of Ebler, and further in view of Gelfand teaches the invention as discussed above in claim 16. Additionally, Carpenter teaches wherein the processing unit is configured to:
receive a user input comprising an indication of a user interaction with a first switch displayed on the Ul (para. [0148] teaches that function keys F1, F2, and F3 can be depressed in response to a message displayed on the LCD screen); and
activate the first sensor in response to receiving the indication of the user interaction with the first switch (para. [0166] teaches that depression of the F2 key initiates detection of the absence of fluid and the successful detection of air).
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.
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/JIHAD DAKKAK/ Examiner, Art Unit 3781
/JESSICA ARBLE/ Primary Examiner, Art Unit 3781