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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/29/2025, 03/20/2026, and 08/10/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 9, 10, 11, 12, 17, 18, 19, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 4, 6, 7, 11, 12, 14, and 15 of U.S. Patent No. 12,246,122.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following:
Present Application No. 19/039,888
U.S. Patent No. 12,246,122
1. A heart-lung machine system comprising: an arterial pump comprising a centrifugal pump; a reservoir level detector system comprising a level sensor configured to detect a level of fluid in a reservoir; and a central computer system configured to: query the centrifugal pump to determine whether the centrifugal pump is active or inactive; in response to determining that the centrifugal pump is inactive, automatically activate the centrifugal pump by adjusting the centrifugal pump to a pre-configured rotational speed setting; query the reservoir level detector system to determine whether the reservoir level detector system is active or inactive; in response to determining that the reservoir level detector system is inactive, automatically activate the reservoir level detector system; and in response to a fluid level detected by the reservoir level detector system, automatically adjust a rotational speed of the centrifugal pump from the pre-configured rotational speed setting.
8. The heart-lung machine system of claim 1, wherein the central computer system is configured to: in response to automatic activation of the reservoir level detector system, automatically prevent alarms related to a detection of a lack of fluid by the reservoir level detector system from being generated; and after automatic prevention of the alarms related to the detection of the lack of fluid by the reservoir level detector system, discontinue the automatic prevention of the alarms in response to a first detection of fluid by the reservoir level detector system.
1. A heart-lung machine system comprising: an arterial pump; a reservoir level detector system comprising two reservoir level detectors and by which a level of fluid in a reservoir is maintainable between the two reservoir level detectors; a user interface; and a central computer system configured to: query the reservoir level detector system to determine whether the reservoir level detector system is active or inactive; in response to determining that the reservoir level detector system is inactive, automatically activate the reservoir level detector system; in response to the automatic activation of the reservoir level detector system: (i) automatically generate an indication for display on the user interface that the reservoir level detector system is active, and (ii) automatically prevent alarms related to detection of a lack of fluid by the reservoir level detector system from being generated; and after the automatic prevention of the alarms related to the detection of the lack of fluid by the reservoir level detector system, discontinue the automatic prevention of the alarms in response to a first detection of fluid by the reservoir level detector system.
3. The heart-lung machine system of claim 1, wherein the central computer system is configured to stop adjusting the centrifugal pump to the pre-configured rotational speed setting in response to a manual input to the heart-lung machine system that effects the pre-configured rotational speed setting of the centrifugal pump.
6. The heart-lung machine system of claim 5, wherein the central computer system is configured to stop adjusting the centrifugal pump to the pre-configured RPM setting in response to a manual input to the heart-lung machine system that effects the pre-configured RPM setting of the centrifugal pump.
9. The heart-lung machine system of claim 1, comprising an air detector, and wherein the central computer system is further configured to: query the air detector to determine whether the air detector is active or inactive; and in response to determining that the air detector is inactive, automatically activate the air detector.
2. The heart-lung machine system of claim 1, further comprising an air detector, and wherein the central computer system is further configured to: query the air detector to determine whether the air detector is active or inactive; and in response to determining that the air detector is inactive, automatically activate the air detector.
10. The heart-lung machine system of claim 1, comprising a fast clamp, and wherein the central computer system is further configured to: query the fast clamp to determine whether the fast clamp is active or inactive; and in response to determining that the fast clamp is inactive, automatically activate the fast clamp by closing the fast clamp.
3. The heart-lung machine system of claim 1, further comprising a fast clamp, and wherein the central computer system is further configured to: query the fast clamp to determine whether the fast clamp is active or inactive; and in response to determining that the fast clamp is inactive, automatically activate the fast clamp by closing the fast clamp.
11. The heart-lung machine system of claim 1, comprising a venous occluder, and wherein the central computer system is further configured to: query the venous occluder to determine whether the venous occluder is active or inactive; and in response to determining that the venous occluder is inactive, automatically activate the venous occluder by adjusting the venous occluder to a pre-configured occlusion setting.
4. The heart-lung machine system of claim 1, further comprising a venous occluder, and wherein the central computer system is further configured to: query the venous occluder to determine whether the venous occluder is active or inactive; and in response to determining that the venous occluder is inactive, automatically activate the venous occluder by adjusting the venous occluder to a pre-configured occlusion setting.
12. A method of operating a heart-lung machine system, the method comprising: querying, by a central computer system of the heart-lung machine system, a centrifugal pump of an arterial pump system of the heart-lung machine system to determine whether the centrifugal pump is active or inactive; in response to determining that the centrifugal pump is inactive, automatically activating the centrifugal pump by the central computer system; and in response to a fluid level detected by a reservoir level detector system of the heart-lung machine system, automatically adjusting, by the central computer system, a rotational speed of the centrifugal pump.
17. The method of claim 16, comprising: in response to automatically activating the reservoir level detector system, automatically preventing, by the central computer system of the heart-lung machine system, alarms related to detection of a lack of fluid by the reservoir level detector system from being generated; and discontinuing, by the central computer system of the heart-lung machine system, automatic prevention of the alarms in response to a first detection of fluid by the reservoir level detector system after the automatic prevention of the alarms.
7. A method of operating a heart-lung machine system, the method comprising: querying, by a central computer system of the heart-lung machine system, a reservoir level detector system of the heart-lung machine system to determine whether the reservoir level detector system is active or inactive, wherein the reservoir level detector system comprises two reservoir level detectors; in response to determining that the reservoir level detector system is inactive, automatically activating, by the central computer system of the heart-lung machine system, the reservoir level detector system; in response to the automatic activation of the reservoir level detector system, automatically preventing, by the central computer system of the heart-lung machine system, alarms related to detection of a lack of fluid by the reservoir level detector system from being generated; and discontinuing, by the central computer system of the heart-lung machine system, the automatic prevention of the alarms in response to a first detection of fluid by the reservoir level detector system after the automatic prevention of the alarms.
18. The method of claim 12, comprising: querying, by the central computer system, an air detector of the heart-lung machine system to determine whether the air detector is active or inactive; and in response to determining that the air detector is inactive, automatically activating, by the central computer system, the air detector.
11. The method of claim 7, further comprising: querying, by the central computer system, an air detector of the heart-lung machine system to determine whether the air detector is active or inactive; and in response to determining that the air detector is inactive, automatically activating, by the central computer system, the air detector.
19. The method of claim 12, comprising: querying, by the central computer system, a fast clamp of the heart-lung machine system to determine whether the fast clamp is active or inactive; and in response to determining that the fast clamp is inactive, automatically activating, by the central computer system, the fast clamp.
12. The method of claim 7, further comprising: querying, by the central computer system, a fast clamp of the heart-lung machine system to determine whether the fast clamp is active or inactive; and in response to determining that the fast clamp is inactive, automatically activating, by the central computer system, the fast clamp.
20. The method of claim 12, comprising: querying, by the central computer system, a venous occluder of the heart-lung machine system to determine whether the venous occluder is active or inactive; and in response to determining that the venous occluder is inactive, automatically activating, by the central computer system, the venous occluder by adjusting the venous occluder to a pre-configured occlusion setting.
14. The method of claim 7, further comprising: querying, by the central computer system, a venous occluder of the heart-lung machine system to determine whether the venous occluder is active or inactive; and in response to determining that the venous occluder is inactive, automatically activating, by the central computer system, the venous occluder.
15. The method of claim 14, wherein activating the venous occluder comprises adjusting the venous occluder to a pre-configured occlusion setting.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the applic ation 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.
Claims 1-6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Schubert et al. WO 2021052553 A1 (hereinafter Schubert), as cited in the IDS, in view of Chahal et al. US 2020/0169275 A1 (hereinafter Chahal), Fontanazzi et al. US 2014/0074008 A1 (hereinafter Fontanazzi), and Zonatti et al. US 2014/0074008 A1 (hereinafter Zonatti).
Regarding claim 1, Schubert discloses a heart-lung machine system 100 (Fig. 1A-1B – heart lung machine 100) comprising:
an arterial pump 310 (Fig. 3 – system pump 310) comprising a centrifugal pump (Par. 27 – “a centrifugal pump”);
a reservoir level detector system 304 (Fig. 3) comprising a level sensor 304 (Fig. 3 – level sensor 304) configured to detect a level of fluid in a reservoir (Par. 48 – “the level sensor detects air in the reservoir”; thus capable of detecting fluid level); and
a central computer system 312 (Fig. 3 – control assembly 312 and Par. 40) configured to:
query the centrifugal pump 310 (Fig. 3) to determine whether the centrifugal pump is active or inactive (Par. 48 – “if a pump is active and, also, if the pump is not active”);
adjusting the centrifugal pump to a pre-configured rotational speed setting (Par. 27 – “select a display mode corresponding to a particular HLM component (e.g., a centrifugal pump, a roller pump, etc.), to select a particular display module (e.g., a pre-configured set of data fields in a particular arrangement), and/or the like”, thus indicating selecting a pre-configured value for the pump);
query the reservoir level detector system 304 (Fig. 5 – step 502: provide safety check UI) to determine whether the reservoir level detector system is active or inactive (Abstract, Fig. 4, and Par. 45 – control assembly 312 providing a safety check on the sensors, which indicates checking the operational state of the reservoir level detector 304);
However, Schubert does not disclose in response to determining that the centrifugal pump is inactive, automatically activate the centrifugal pump; in response to determining that the reservoir level detector system is inactive, automatically activate the reservoir level detector system; and in response to a fluid level detected by the reservoir level detector system, automatically adjust a rotational speed of the centrifugal pump from the pre-configured rotational speed setting.
Chahal, considered to be analogous to the claimed invention as both teach sensors/actuators being controlled by a central control unit used in biomedical setting (Par. 5), teaches that it is known in the art that in response to determining that the sensor/transducer is inactive (Par. 48 – sensors/transducer that is queried by the controller), a central computer system configured to automatically activate the sensor/transducer (Par. 48 – sensor/transducer is activated directly from the signal received by the controller).
Fontanazzi, in same field of endeavor of extracorporeal blood treatment (Abstract), teaches adjusting the pump 21 (Fig. 1) to a pre-configured rotational speed setting (Par. 336 – a blood pump 21 “operatively connected to the control unit” and “the value of the blood pump is imposed at the start of treatment”).
Zanotti, in the same field of endeavor of blood reservoir with level sensor (Title), teaches in response to a fluid level detected by the reservoir level detector system (Par. 44 – “the blood level sensor 58 may be an ultrasonic sensor in which ultrasound is used to detect the blood level within the blood reservoir 56”), automatically adjust a rotational speed of the centrifugal pump (Par. 25 – “one or more of the pump modules 16 may be centrifugal pumps”, and Par. 58 – “the calculated blood volume is communicated to the HLM 54 so that it may adjust an operating parameter of the HLM 54. In various exemplary embodiments, the HLM 54 may alter a pump speed to either increase or decrease blood flow into or out of the blood reservoir 56. It may be important, for example, to prevent the blood level in the reservoir 56 from moving below a certain minimum level or volume. Accordingly, in various embodiments, the HLM will compare the blood level or volume to this minimum level and adjust pump speed appropriately”) from the pre-configured rotational speed setting (Par. 59 – “auto-loading of pump segments”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the central computer system of Schubert to include the automatic component activation step from the central computer system as taught by Chahal, in order to automate an integrity check which increases the safety for the patient in the event that an operator forgets to turn on and check the reservoir level detector. It is also well-known in the art that sensors, such as reservoir level detectors, are commonly controlled by a central computer system and constantly monitor to ensure a machine is working as intended. Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the device of Schubert automatic, since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192 (CCPA 1958); In re Rundell, 9 USPQ 220 (CCPA 1931). See MPEP 2144.04 III. Therefore, the limitation of “in response to determining that the centrifugal pump is inactive, automatically activate the centrifugal pump” and “in response to determining that the reservoir level detector is inactive, a central computer system configured to automatically activate the reservoir level detector” is met via Schubert in view of Chahal. The querying and activation/actuation of the pump and sensors by the central computer system as taught by Chahal is hereby incorporated in its entirety to the heart-lung machine system of Schubert. Once the combination is made as discussed, the central computer of Schubert will perform the claimed steps of querying and automatically activating the pump and the reservoir level detector.
It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controlled centrifugal pump of the combination to be programmed at a pre-configured rotational speed as taught by Fontanazzi, in order to improve the efficiency of operators. By automatically having the speed pre-set, the heart-lung machine allows operators to proceed with other preparational steps, such as connecting the patient’s vessel, and quickly reaches the state of ready-to-use. It reduces the number of tasks operators require to perform and also adds another safety layer in the event that operators overestimate the initial rotational speed that potentially leads to rapid blood drawing.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to further adjust in response to the detected fluid level as taught by Zanotti, in order to prevent the blood level in the reservoir form moving below a certain minimum level or volume (Par. 58 of Zanotti).
Regarding claim 2, Schubert in view of Chahal in view of Fontanazzi in view of Zanotti discloses the invention of claim 1. The combination further discloses wherein the central computer system is configured to:
in response to a first fluid level detected by the reservoir level detector system 304 (Fig. 3 of Schubert), automatically increase the rotational speed of the arterial pump 310 (Fig. 3 of Schubert) from the pre-configured rotational speed setting (Par. 58 of Zanotti – “the calculated blood volume is communicated to the HLM 54 so that it may adjust an operating parameter of the HLM 54. In various exemplary embodiments, the HLM 54 may alter a pump speed to either increase… flow into… the blood reservoir 56”); and
in response to a second fluid level detected by the reservoir level detector system 304 (Fig. 3 of Schubert), automatically decrease the rotational speed of the arterial pump 310 (Fig. 3of Schubert) from the pre-configured rotational speed setting (Par. 58 of Zanotti – “the calculated blood volume is communicated to the HLM 54 so that it may adjust an operating parameter of the HLM 54. In various exemplary embodiments, the HLM 54 may alter a pump speed to either… decrease… flow… out of the blood reservoir 56”).
Examiner notes that once the modification is made as discussed in claim 1, the pump speed adjustment of Zanotti is incorporated into the device of the combination. Thus, the limitation is met.
Regarding claim 3, Schubert in view of Chahal in view of Fontanazzi in view of Zanotti discloses the invention of claim 1. However, the combination does not currently disclose wherein the central computer system is configured to stop adjusting the centrifugal pump to the pre-configured rotational speed setting in response to a manual input to the heart-lung machine system that effects the pre-configured rotational speed setting of the centrifugal pump.
Fontanazzi, in same field of endeavor of extracorporeal blood treatment (Abstract), teaches that that the central computer system is configured to stop adjusting the pump to the pre-configured rotational speed setting (Par. 339 – manually interrupt the setting sequence) in response to a manual input (Par. 345 – an imposed manual process, user interface shows message to “invite the user to start the sequence… from the setting of the new blood flow rate”) to the heart-lung machine system that effects pre-configured rotational speed setting of the pump (Par. 345).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controlled centrifugal pump of the combination to further allow the centrifugal pump to perform under the setting defined by operators as taught by Fontanazzi, as configuring varying blood flow rates in a heart-lung machine is well-known in the art. It allows operators the ability to select a pump speed that is more suitable for each patient’s need, resulting in a more customized and effective extracorporeal procedure. Applying a known technique of adjusting the pump speed, which yields predictable results of a system performing under the new input value by a user, would also yield such predictable result in the claimed invention.
Regarding claim 4, Schubert in view of Chahal in view of Fontanazzi in view of Zanotti discloses the invention of claim 3. The combination further discloses comprising a user interface 152 (Fig. 1A-1B of Schubert – display device 152), wherein the central computer system 312 (Fig. 3 of Schubert) is configured to:
store a pre-defined setting for adjusting the rotational speed of the centrifugal pump 310 (Fig. 3 of Schubert, and Par. 27 of Schubert – “…a display mode corresponding to a particular HLM component (e.g., a centrifugal pump, a roller pump, etc.), to select a particular display module (e.g., a pre-configured set of data fields in a particular arrangement)”, which indicates a stored pre-configured setting); and
generate a selectable option on the user interface 152 (Fig. 3 of Schubert, and Par. 27 of Schubert – “the control display device 156 may include selectable representations presented onscreen that can be used to configure the display such as, for example, by enabling a user to select a display mode corresponding to a particular HLM component (e.g., a centrifugal pump, a roller pump, etc.), to select a particular display module (e.g., a pre-configured set of data fields in a particular arrangement), and/or the like”);
wherein the manual input to the heart-lung machine system comprises activating the selectable option on the user interface 152 (Fig. 3 of Schubert, and Par. 27-28 of Schubert – “the peripheral display device 152 and/or the control display device 156 may include an input mechanism configured to enable user interaction with one or more features displayed on the display device 152”).
Regarding claim 5, Schubert in view of Chahal in view of Fontanazzi in view of Zanotti discloses the invention of claim 1. The combination further discloses comprising a user interface 152 (Fig. 1A-1B of Schubert) communicatively coupled to the central computer system 312 (Fig. 3 of Schubert, and Par. 45 of Schubert – “The control assembly 312 may include, for example, a control display device”), wherein the user interface 152 (Fig. 1A-1B of Schubert) is configured to display in real-time one or more values of a parameter of the heart-lung machine system 100 (Fig. 1A-1B of Schubert, and Par. 25 of Schubert – “the peripheral display device 152 may be operably connected to the peripheral processing unit and configured to present a set of parameter data received from the peripheral processing unit… the peripheral display device 152 may be configured to obtain and record all of the operative HLM parameter values and/or patient parameters provided by any number of additional monitoring devices”).
Regarding claim 6, Schubert in view of Chahal in view of Fontanazzi in view of Zanotti discloses the invention of claim 5. The combination further discloses wherein the central computer system 312 (Fig. 3 of Schubert) is configured to:
in response to receiving the one or more values of the parameter, generate a graphical trend analysis of the parameter of the heart-lung machine system 100 (Fig. 3 of Schubert, and Par. 30 of Schubert – “The peripheral processing unit associated with the peripheral display device may be configured to allow user interaction therewith, generate reports based on the obtained data, generate printable documents corresponding to a medical procedure, interact with a printer to cause the printer to print such reports, and/or the like. In embodiments, the peripheral processing unit may be configured to generate… graphs (e.g., trend charts, curves, etc.) and/or other visual representations of any number of various aspects of data received from HLM components and/or external devices”); and
display the graphical trend analysis on the user interface 152 (Fig. 1A-1B of Schubert, and Par. 30 of Schubert – “the peripheral processing unit may be configured to generate, and cause the peripheral display device to present, graphs (e.g., trend charts, curves, etc.) and/or other visual representations of any number of various aspects of data received from HLM components and/or external devices”).
Regarding claim 9, Schubert in view of Chahal in view of Fontanazzi in view of Zanotti discloses the invention of claim 5. The combination further discloses comprising an air detector 302 (Fig. 3 of Schubert – bubble sensor 302), and wherein the central computer system 312 (Fig. 3 of Schubert) is further configured to:
query (Fig. 5, step 502 of Schubert) the air detector 302 to determine whether the air detector is active or inactive (Abstract, Fig. 4, and Par. 45 of Schubert – control assembly 312 providing a safety check on the sensors, which indicates checking the operational state of the air detector 302); and
in response to determining that the air detector 302 (Fig. 3 of Schubert) is inactive, automatically activate the air detector 302 (Fig. 3 of Schubert, and Par. 48 of Chahal).
Examiner notes that once the combination is made as discussed in claim 1, all sensors, including the air detector, will be activated by the central computer system after being queried by the central computer system as taught by Chahal. Thus, the limitation of “in response to determining that the air detector is inactive, automatically activate the air detector” is met.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Schubert in view of Chahal in view of Fontanazzi in view of Zanotti as applied to claim 6 above, and further in view of Barrett et al. US 2010/0113891 A1 (hereinafter Barrett).
Regarding claim 7, Schubert in view of Chahal in view of Fontanazzi in view of Zanotti discloses the invention of claim 6. The combination further discloses wherein the user interface 152 (Fig. 1A-1B of Schubert) is configured to concurrently display a trend analysis and the graphical trend analysis of the one or more parameters of the heart-lung machine system 100 (Fig. 1A-1B of Schubert, and Par. 27 of Schubert – “all of the information configured to be presented on the control display device 156 may be presented simultaneously - that is, without having tabs for accessing screens showing additional information, without requiring menus for accessing screens showing additional information during a procedure, and/or the like”).
However, the combination does not disclose a projected trend analysis.
Barrett, in the same field of endeavor of patient data acquisition and management (Title), teaches a projected trend analysis (Fig. 11, and Par. 68 – “Turning now to the Patient Graph screen in FIG. 11, the Patient Graph screen 135 includes a graph 142 which displays a trend of the patient's (patient ID #1006) hemoglobin levels, both measured (open circles) and predicted (open squares)…”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of the combination to further include displaying projected trends, as taught by Barrett, in order to predict future treatment for each patient and such data can be used to recommend therapeutic care, such as medication dosing (Par. 1 of Barrett).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Schubert in view of Chahal in view of Fontanazzi in view of Zanotti as applied to claim 1 above, and further in view of Gagel US 2019/0255241 A1 (previously cited, hereinafter Gagel).
Regarding claim 10, Schubert in view of Chahal in view of Fontanazzi in view of Zanotti discloses the invention of claim 1. However, the combination does not disclose comprising a fast clamp, and wherein the central computer system is further configured to: query the fast clamp to determine whether the fast clamp is active or inactive; and in response to determining that the fast clamp is inactive, automatically activate the fast clamp by closing the fast clamp.
Examiner notes that the central computer system of Schubert “may be configured to facilitate control of a pump, a motorized clamp, a motorized occluder…” (Par. 20 and Par. 24 – actuator control unit, or ACU, is communicative with the processing unit).
Gagel, in the same field of endeavor of blood purification therapy (Par. 2), teaches comprising a fast clamp 29 (Fig. 1 – arterial clamp 29), and wherein the central computer system 30 (Fig. 1) is further configured to:
query the fast clamp 29 (Fig. 1 and Par. 51) to determine whether the fast clamp 29 is active or inactive (Par. 51 – “the control unit… querying a status” and “…querying whether this [clamp] is already closed”); and
in response to determining that the fast clamp 29 is inactive, automatically activate the fast clamp 29 by closing the fast clamp 29 (Par. 51 – “the control unit… control a clamp so as to close said clamp, possibly after querying whether this is already closed”).
Examiner notes that in Par. 48, Gagel states that the central computer system 30 is connected to the individual actuators and sensors of the apparatus, hence the fast clamp 29 is interpreted to be in communication with the central computer system 30.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the heart-lung machine of the combination to further include a motorized fast clamp at the arterial blood line as taught by Gagel, as it is known in the art that stopping extracorporeal blood from returning to a patient is critical should there be any abnormality and malfunction, such as air embolism or unresponsive components, present in a heart-lung machine. Furthermore, one of ordinary skill in the art would have been motivated to automate closing of the clamp via the central computer system because it greatly enhances efficiency for operators, as opposed to manually closing the valve which might be overlooked by the operators. Adding this function would also improve the safety for patients by delivering prompt actions.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Schubert in view of Chahal in view of Fontanazzi in view of Zanotti as applied to claim 1 above, and further in view of Gagel and Ellingboe et al. US 2002/0085952 A1, as cited in the IDS (hereinafter Ellingboe).
Regarding claim 11, Schubert in view of Chahal in view of Fontanazzi in view of Zanotti discloses the invention of claim 1. However, the combination does not disclose comprising a venous occluder, and wherein the central computer system is further configured to: query the venous occluder to determine whether the venous occluder is active or inactive; and in response to determining that the venous occluder is inactive, automatically activate the venous occluder by adjusting the venous occluder to a pre-configured occlusion setting.
While a venous occluder is not explicitly disclosed in Schubert and Chahal, Examiner notes that the central computer system of Schubert “may be configured to facilitate control of a pump, a motorized clamp, a motorized occluder…” (Par. 20 and Par. 24 – actuator control unit, or ACU, is communicative with the processing unit).
Gagel, in the same field of endeavor of blood purification therapy (Par. 2), teaches comprising a venous occlude 11 (Fig. 1 – a venous clamp 11), and wherein the central computer system 30 (Fig. 1) is further configured to:
query the venous occluder 11 to determine whether the venous occluder 11 is active or inactive (Par. 51 – “the control unit… querying a status” and “…querying whether this [clamp] is already closed”); and
in response to determining that the venous occluder 11 is inactive, automatically activate the venous occluder 11 (Par. 51 – “the control unit… control a clamp so as to close said clamp, possibly after querying whether this is already closed”). Examiner also notes that in Par. 48, Gagel states that the central computer system 30 is connected to the individual actuators and sensors of the apparatus, hence the venous occluder 11 is interpreted to be in communication with the central computer system 30.
Ellingboe, in the same field of endeavor of extracorporeal blood perfusion system (Abstract), teaches adjusting the venous occluder 46 (Fig. 3A) to a pre-configured occlusion setting (Fig. 25 – the central computer system 10 controls a venous occluder 46, and Par. 20 – the venous occluder 46 is set to predetermined degree of occlusion).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of the combination to further include a motorized venous occluder at the venous blood line as taught by Gagel, as stopping extracorporeal blood from circulating into/out of a patient is critical should there be any emergency situation, such as air embolism, present in a heart-lung machine (Par. 43 of Gagel). Furthermore, one of ordinary skill in the art would have been motivated to automate closing of a clamp via a central computer system because it greatly enhances efficiency for operators, as opposed to manually closing the clamp which might be overlooked by the operators. Adding this function would also improve the safety for patients by delivering prompt actions.
It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the venous occluder of the combination to be closed to a desired predetermined occlusion setting as taught by Ellingboe, as it is known in the art that a venous occluder maintains a desired level/volume of blood in the reservoir (Par. 437 of Ellingboe). Setting a predetermined value for the venous occluder to clamp the venous blood line will control the blood flow rate as well as the blood volume present in the reservoir. Therefore, it “increases patient safety as the venous occluder prevents emptying of the reservoir in case of temporary user inattention” (Par. 438 of Ellingboe).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Schubert in view of Chahal in view of Zanotti.
Regarding claim 12, Schubert discloses a method (Par. 5) of operating a heart-lung machine system 100 (Fig. 1A – 1B), the method comprising:
querying (Fig. 5 – step 502: provide safety check UI), by a central computer system 312 (Fig. 3) of the heart-lung machine system 100 (Fig. 1A – 1B), a centrifugal pump of an arterial pump system 310 (Fig. 3 and Par. 40) of the heart-lung machine system 100 (Fig. 1A – 1B) to determine whether the centrifugal pump is active or inactive (Abstract, Fig. 4, and Par. 45 – control assembly 312 providing a safety check on the sensors, which indicates checking the operational state of the reservoir level detector 304);
a reservoir level detector system 304 (Fig. 3) of the heart-lung machine system 100 (Fig. 1A-1B).
However, Schubert does not disclose in response to determining that the centrifugal pump is inactive, automatically activating the centrifugal pump by the central computer system; and in response to a fluid level detected by a reservoir level detector system of the heart-lung machine system, automatically adjusting, by the central computer system, a rotational speed of the centrifugal pump.
Chahal, considered to be analogous to the claimed invention as both teach sensors/actuators being controlled by a central control unit used in biomedical setting (Par. 5), teaches that it is known in the art that in response to determining that the sensor/transducer is inactive (Par. 48 – sensors/transducer that is queried by the controller), a central computer system configured to automatically activate the sensor/transducer (Par. 48 – sensor/transducer is activated directly from the signal received by the controller).
Zanotti, in the same field of endeavor of blood reservoir with level sensor (Title), teaches in response to a fluid level detected by the reservoir level detector system (Par. 44 – “the blood level sensor 58 may be an ultrasonic sensor in which ultrasound is used to detect the blood level within the blood reservoir 56”), automatically adjusting, by the central computer system 60 (Fig. 5 – controller 60), a rotational speed of the centrifugal pump (Par. 25 – “one or more of the pump modules 16 may be centrifugal pumps”, and Par. 58 – “the calculated blood volume is communicated to the HLM 54 so that it may adjust an operating parameter of the HLM 54. In various exemplary embodiments, the HLM 54 may alter a pump speed to either increase or decrease blood flow into or out of the blood reservoir 56. It may be important, for example, to prevent the blood level in the reservoir 56 from moving below a certain minimum level or volume. Accordingly, in various embodiments, the HLM will compare the blood level or volume to this minimum level and adjust pump speed appropriately”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the central computer system of Schubert to include the automatic component activation step from the central computer system as taught by Chahal, in order to automate an integrity check which increases the safety for the patient in the event that an operator forgets to turn on and check the components. Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to make the method of Schubert automatic, since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192 (CCPA 1958); In re Rundell, 9 USPQ 220 (CCPA 1931). See MPEP 2144.04 III. Therefore, the limitation of “in response to determining that the centrifugal pump is inactive, automatically activating the centrifugal pump” is met via Schubert in view of Chahal. The querying and activation/actuation of the pump by the central computer system as taught by Chahal is hereby incorporated in its entirety to the heart-lung machine system of Schubert. Once the combination is made as discussed, the central computer of Schubert will perform the claimed steps of querying and automatically activating the pump.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the combination to further adjust in response to the detected fluid level as taught by Zanotti, in order to prevent the blood level in the reservoir form moving below a certain minimum level or volume (Par. 58 of Zanotti).
Regarding claim 16, Schubert in view of Chahal in view of Zanotti in view of Fontanazzi discloses the invention of claim 13. The combination further discloses comprising:
querying, by the central computer system 312 (Fig. 3 of Schubert), the reservoir level detector system 304 (Fig. 3 of Schubert) of the heart-lung machine system 100 (Fig. 1A of Schubert, and Fig. 5 – step 502: provide safety check UI) to determine whether the reservoir level detector system 304 is active or inactive (Abstract of Schubert, Fig. 4 of Schubert, and Par. 45 of Schubert – control assembly 312 providing a safety check on the sensors, which indicates checking the operational state of the reservoir level detector 304), wherein the reservoir level detector system 304 (Fig. 3 of Schubert) comprises a reservoir level detector 304 (Fig. 3 of Schubert); and
in response to determining that the reservoir level detector system is inactive, automatically activating (Par. 48 of Chahal), by the central computer system 312 (Fig. 3 of Schubert) of the heart-lung machine system 100 (Fig. 1A of Schubert, modified by Par. 48 of Chahal), the reservoir level detector system 304 (Fig. 3 of Schubert).
Examiner notes that once the modification is made as discussed in claim 12, the automated activation of sensors of Chahal will be incorporated into the method of Schubert.
Regarding claim 18, Schubert in view of Chahal in view of Zanotti in view of Fontanazzi discloses the invention of claim 13. The combination further discloses comprising: querying (Fig. 5, step 502 of Schubert), by the central computer system 312 (Fig. 3 of Schubert), an air detector 302 (Fig. 3 of Schubert – bubble sensor 302) of the heart-lung machine system 100 (Fig. 1A of Schubert) to determine whether the air detector 302 is active or inactive (Abstract, of Schubert Fig. 4 of Schubert, and Par. 45 of Schubert – control assembly 312 providing a safety check on the sensors, which indicates checking the operational state of the air detector 302); and
in response to determining that the air detector 302 (Fig. 3 of Schubert) is inactive, automatically activating, by the central computer system 312 (Fig. 3 of Schubert), the air detector 302 (Fig. 3 of Schubert, and Par. 48 of Chahal).
Examiner notes that once the combination is made as discussed in claim 12, all sensors, including the air detector, will be activated by the central computer system after being queried by the central computer system as taught by Chahal.
Claims 13, 14, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Schubert in view of Chahal in view of Zanotti as applied to claim 12 above, and further in view of Fontanazzi.
Regarding claim 13, Schubert in view of Chahal in view of Zanotti discloses the invention of claim 12. The combination further discloses wherein automatically activating (Par. 48 of Chahal) comprises automatically adjusting, by the central computer system 312 (Fig. 3 of Schubert), the centrifugal pump 310 (Fig. 3 of Schubert).
However, the combination does not disclose adjusting to a pre-configured rotational speed setting.
Fontanazzi, in same field of endeavor of extracorporeal blood treatment (Abstract), teaches adjusting the pump 21 (Fig. 1) to a pre-configured rotational speed setting (Par. 336 – a blood pump 21 “operatively connected to the control unit” and “the value of the blood pump is imposed at the start of treatment”).
It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controlled centrifugal pump of the combination to be programmed at a pre-configured rotational speed as taught by Fontanazzi, in order to improve the efficiency of operators. By automatically having the speed pre-set, the heart-lung machine allows operators to proceed with other preparational steps, such as connecting the patient’s vessel, and quickly reaches the state of ready-to-use. It reduces the number of tasks operators require to perform and also adds another safety layer in the event that operators overestimate the initial rotational speed that potentially leads to rapid blood drawing.
Regarding claim 14, Schubert in view of Chahal in view of Zanotti in view of Fontanazzi discloses the invention of claim 13. However, the combination does not currently disclose comprising stopping, by the central computer system, adjusting the centrifugal pump to the pre-configured rotational speed setting in response to a manual input to the heart-lung machine system that effects the pre-configured rotational speed setting of the pump (Par. 345).
Fontanazzi, in the same field of endeavor of extracorporeal blood treatment (Abstract), teaches comprising stopping, by the central computer system, adjusting the centrifugal pump to the pre-configured rotational speed setting (Par. 339 – manually interrupt the setting sequence) in response to a manual input to the heart-lung machine system (Par. 345 – an imposed manual process, user interface shows message to “invite the user to start the sequence… from the setting of the new blood flow rate”) that effects the pre-configured rotational speed setting of the centrifugal pump (Par. 345).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the controlled centrifugal pump of the combination to further allow the centrifugal pump to perform under the setting defined by operators as taught by Fontanazzi, as configuring varying blood flow rates in a heart-lung machine is well-known in the art. It allows operators the ability to select a pump speed that is more suitable for each patient’s need, resulting in a more customized and effective extracorporeal procedure. Applying a known technique of adjusting the pump speed, which yields predictable results of a system performing under the new input value by a user, would also yield such predictable result in the claimed invention.
Regarding claim 15, Schubert in view of Chahal in view of Zanotti in view of Fontanazzi discloses the invention of claim 13. The combination further discloses comprising in response to a first fluid level detected by the reservoir level detector system 304 (Fig. 3 of Schubert), automatically increasing or decreasing, by the central computer system 312 (Fig. 3 of Schubert), the rotational speed of the centrifugal pump from the pre-configured rotational speed setting (Par. 58 of Zanotti – “the calculated blood volume is communicated to the HLM 54 so that it may adjust an operating parameter of the HLM 54. In various exemplary embodiments, the HLM 54 may alter a pump speed to either increase or decrease blood flow into or out of the blood reservoir 56. It may be important, for example, to prevent the blood level in the reservoir 56 from moving below a certain minimum level or volume. Accordingly, in various embodiments, the HLM will compare the blood level or volume to this minimum level and adjust pump speed appropriately.”).
Examiner notes that once the modification is made as discussed in claim 12, the pump speed adjustment of Zanotti is incorporated into the device of the combination. Thus, the limitation is met.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Schubert in view of Chahal in view of Zanotti as applied to claim 12 above, and further in view of Gagel.
Regarding claim 19, Schubert in view of Chahal in view of Zanotti discloses the invention of claim 12. However, the combination does not currently disclose comprising: querying, by the central computer system, a fast clamp of the heart-lung machine system to determine whether the fast clamp is active or inactive; and in response to determining that the fast clamp is inactive, automatically activating, by the central computer system, the fast clamp.
Examiner notes that the central computer system of Schubert “may be configured to facilitate control of a pump, a motorized clamp, a motorized occluder…” (Par. 20 and Par. 24 – actuator control unit, or ACU, is communicative with the processing unit).
Gagel, in the same field of endeavor of blood purification therapy (Par. 2), teaches comprising querying, by the central computer system 30 (Fig. 1), a fast clamp 29 (Fig. 1 – arterial clamp 29) of the system (Fig. 1) to determine whether the fast clamp is active or inactive (Par. 51 – “the control unit… querying a status” and “…querying whether this [clamp] is already closed”); and
in response to determining that the fast clamp 29 is inactive, automatically activating, by the central computer system 30 (Fig. 1), the fast clamp (Par. 51 – “the control unit… control a clamp so as to close said clamp, possibly after querying whether this is already closed”).
Examiner notes that in Par. 48, Gagel states that the central computer system 30 is connected to the individual actuators and sensors of the apparatus, hence the fast clamp 29 is interpreted to be in communication with the central computer system 30.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the combination to further include a motorized fast clamp at the arterial blood line as taught by Gagel, as it is known in the art that stopping extracorporeal blood from returning to a patient is critical should there be any abnormality and malfunction, such as air embolism or unresponsive components, present in a heart-lung machine. Furthermore, one of ordinary skill in the art would have been motivated to automate closing of the clamp via the central computer system because it greatly enhances efficiency for operators, as opposed to manually closing the valve which might be overlooked by the operators. Adding this function would also improve the safety for patients by delivering prompt actions.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Schubert in view of Chahal in view of Zanotti as applied to claim 12 above, and further in view of Gagel and Ellingboe.
Regarding claim 20, Schubert in view of Chahal in view of Zanotti discloses the invention of claim 12. However, the combination does not disclose comprising: querying, by the central computer system, a venous occluder of the heart-lung machine system to determine whether the venous occluder is active or inactive; and in response to determining that the venous occluder is inactive, automatically activating, by the central computer system, the venous occluder by adjusting the venous occluder to a pre-configured occlusion setting.
While a venous occluder is not explicitly disclosed in Schubert and Chahal, Examiner notes that the central computer system of Schubert “may be configured to facilitate control of a pump, a motorized clamp, a motorized occluder…” (Par. 20 and Par. 24 – actuator control unit, or ACU, is communicative with the processing unit).
Gagel, in the same field of endeavor of blood purification therapy (Par. 2), teaches comprising: querying, by the central computer system 30 (Fig. 1), a venous occluder 11 (Fig. 1 – a venous clamp 11) of the system (Fig. 1) to determine whether the venous occluder 11 is active or inactive (Par. 51 – “the control unit… querying a status” and “…querying whether this [clamp] is already closed”); and
in response to determining that the venous occluder 11 is inactive, automatically activating, by the central computer system 30 (Fig. 1), the venous occluder (Par. 51 – “the control unit… control a clamp so as to close said clamp, possibly after querying whether this is already closed”).
Examiner also notes that in Par. 48, Gagel states that the central computer system 30 is connected to the individual actuators and sensors of the apparatus, hence the venous occluder 11 is interpreted to be in communication with the central computer system 30.
Ellingboe, in the same field of endeavor of extracorporeal blood perfusion system (Abstract), teaches adjusting the venous occluder 46 (Fig. 3A) to a pre-configured occlusion setting (Fig. 25 – the central computer system 10 controls a venous occluder 46, and Par. 20 – the venous occluder 46 is set to predetermined degree of occlusion).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of the combination to further include a motorized venous occluder at the venous blood line as taught by Gagel, as stopping extracorporeal blood from circulating into/out of a patient is critical should there be any emergency situation, such as air embolism, present in a heart-lung machine (Par. 43 of Gagel). Furthermore, one of ordinary skill in the art would have been motivated to automate closing of a clamp via a central computer system because it greatly enhances efficiency for operators, as opposed to manually closing the clamp which might be overlooked by the operators. Adding this function would also improve the safety for patients by delivering prompt actions.
It also would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the venous occluder of the combination to be closed to a desired predetermined occlusion setting as taught by Ellingboe, as it is known in the art that a venous occluder maintains a desired level/volume of blood in the reservoir (Par. 437 of Ellingboe). Setting a predetermined value for the venous occluder to clamp the venous blood line will control the blood flow rate as well as the blood volume present in the reservoir. Therefore, it “increases patient safety as the venous occluder prevents emptying of the reservoir in case of temporary user inattention” (Par. 438 of Ellingboe).
Allowable Subject Matter
Claims 8 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 8, no art on record, alone, or in combination could be found to teach: after automatic prevention of the alarms related to the detection of the lack of fluid by the reservoir level detector system, discontinue the automatic prevention of the alarms in response to a first detection of fluid by the reservoir level detector system, in combination with the remaining claimed features.
The closest prior arts of record are Schubert, Chahal, Schael US 4,231,366 (hereinafter Schael), Golarits et al. US 2017/0296736 A1 (hereinafter Golarits), and Krans et al. US 2022/0044546 A1 (as cited in the IDS, hereinafter Krans).
Please refer to the Notice of Allowance mailed on 11/08/2024 of Parent application No. 17/314,856 for a detailed analysis of allowable subject matter.
Regarding claim 17, no art on record, alone, or in combination could be found to teach: discontinuing, by the central computer system of the heart-lung machine system, automatic prevention of the alarms in response to a first detection of fluid by the reservoir level detector system after the automatic prevention of the alarms, in combination with the remaining claimed features.
The closest prior arts of record are Schubert, Chahal, Schael, Golarits, and Krans.
Please refer to the Notice of Allowance mailed on 11/08/2024 of Parent application No. 17/314,856 for a detailed analysis of allowable subject matter.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
O’Mahony et al. US 2005/0230313 A1 teaches receiving input command from an operator who selects a desired blood flow using a user interface.
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/QUYNH DAO LE/Examiner, Art Unit 3781
/KAI H WENG/Primary Examiner, Art Unit 3781
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