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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on November 17, 2025 has been entered.
Claims 64-79 remain pending in the application. Claims 1-63 have been canceled.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 71 and 79 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 71 and 79, the limitation “the volume of irrigation fluid used from the irrigation source during the surgery is automatically reset when a fluidics pack is removed from the console and wherein the determined remaining fluid volume of the irrigation source is changed upon changing the irrigation source” in lines 1-4 of each claims is a recitation of new matter. The disclosure as originally filed does not provide support for automatic resetting of either the volume of irrigation fluid used or the determined remaining fluid volume. Paragraph [0022] discloses “the amount of fluid remaining stored in the console is reset when a change of the container occurs”; and paragraph [0121] discloses “The BSS usage may be reset when the fluid pack 855 is ejected from the system.”. However, there is not disclosure of the resetting being automatic as required by claims 71 and 79.
Claim Objections
Claim 71 is objected to because there is a lack of antecedent basis for “the determined remaining fluid volume of the irrigation source” in line 3. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 64-69 and 72-77 are rejected under 35 U.S.C. 103 as being unpatentable over Mallough et al. (US 20160220751) in view of Cull et al. (US 20100145302).
Regarding claim 64, Mallough discloses a surgical method (“a processor-based method is disclosed for operating a surgical system…The method may comprise the steps of determining in the processor a volume of fluid in the irrigation source, receiving in the processor sensed measurements regarding a rate of fluid flow over time from the irrigation source, and processing the rate of fluid flow relative to the determined volume and produce a first signal for the display to indicate a remaining capacity of the volume of fluid.” [0011]) comprising:
irrigating, via a handpiece (handpiece 110) during a surgery, an eye (eye 114) with an irrigation fluid from an irrigation source (fluid bottle 112; “the system may operate flow selector valve 202 to connect handpiece 110 with BSS fluid bottle 112, reservoir 204 or with pump 203 based on signals received from console 115 resulting from the surgeon's input to user interface 130.” [0029]; “handpiece 110 may be configured as an irrigation/aspiration (l/A) and/or vitrectomy handpiece…So as to balance the volume of material removed by the aspiration flow, an irrigation flow through handpiece 110 (or a separate probe structure) may also be provided, with both the aspiration and irrigation flows being controlled by console 115.” [0024]);
aspirating, with the handpiece, the irrigation fluid from the eye, along with any lens material, wherein an inflow and an outflow of the irrigation fluid are controlled to substantially maintain an intraocular pressure (IOP) within the eye (“handpiece 110 may be configured as an irrigation/aspiration (l/A) and/or vitrectomy handpiece. Also, the ultrasonic transmitter may be replaced by other means for emulsifying a lens, such as a high energy laser beam. The ultrasound energy from handpiece 110 helps to fragment the tissue of the lens, which can then be drawn into a port of the tip by aspiration flow. So as to balance the volume of material removed by the aspiration flow, an irrigation flow through handpiece 110 (or a separate probe structure) may also be provided, with both the aspiration and irrigation flows being controlled by console 1 15.” [0024]; “Fluid balance may be determined from the pressure gradient and is considered "balanced" when adequate pressure is available to keep up with the outflow. This balance maintains a stable anterior chamber by keeping the pressure in the anterior chamber fairly constant.” [0058]);
determining in real-time, via a processor (“Console 115 may include controller 125, which may include…a processor” [0026]; processor 503) in a surgical console (console 115), a volume of irrigation fluid used from the irrigation source during the surgery (“a plurality of techniques for detecting the use and/or depletion of an irrigation source. As will be discussed in greater detail below, one exemplary technique comprises the utilization of time and flow processing, where depletion is measured based on an initial volume and an approximate use of irrigation fluid over time. Another exemplary technique comprises the use of optical or resistive flow detection, where irrigation fluid depletion is calculated through optical and/or resistive sensors. In another exemplary technique, gravimetric detection may be utilized, where depletion is measured based on an initial volume and the weight of the irrigation fluid source or waste over time. In a still further exemplary technique, pressure detection may be utilized to measure depletion based on pressure exerted by the irrigation fluid upon a pressure sensor.” [0043], see detailed in [0054-0056], [0064], [0066]); and
displaying, on a graphical user interface (GUI) (touch screen display 159) of the surgical console, at least one of the volume of irrigation fluid used or a remaining fluid volume of the irrigation source (Figure 3A-3B; “irrigation fluid status and advanced warnings may be provided as illustrated in FIGs. 3A and 3B. For example, if one or more flow sensors detect a heavier flow of irrigation fluid being used during a procedure, the processor in the system may calculate a remaining use time and display 300 the time (e.g., "24 minutes of remaining irrigation fluid supply") so that personnel can quickly determine if adjustments to the procedure may be necessary. If the irrigation fluid in use is reduced in response to the notification, the system processor may automatically update 301 the time accordingly (e.g., "27 minutes of remaining irrigation fluid supply")” [0056]).
Mallough fails to explicitly disclose determining in real-time, via the processor in the surgical console, the IOP; and displaying, on the graphical user interface (GUI) of the surgical console, the determined IOP.
Cull teaches a surgical method (Figure 2) comprising irrigating and aspirating via a handpiece (ophthalmic device 120), wherein an inflow and an outflow of irrigation fluid are controlled to substantially maintain an intraocular pressure (IOP) within the eye (“It is accordingly possible to monitor the flow rate Q of fluid aspirated from the eye, and to control the infusion pressure at the bottle p.sub.ib and/or vacuum pressure p.sub.v, to maintain a constant intraocular pressure by adjusting the infusion pressure p.sub.ib of the irrigation fluid in the bottle 130 (by adjusting the bottle height or by adjusting the bottle pressure). From the above data, intraocular pressure can be estimated and used as a surgical parameter.” [0025]); determining in real time, via a controller in a surgical console, the IOP (“At step 310, the surgeon or user enters into the controller 200 a configuration for the device…The pressure P.sub.ib of the irrigation fluid in the irrigation bottle 130 is then set…The system then monitors fluid flow rate using a positive displacement pump, a flow sensor, electromagnetic flow technology, or other similar flow sensing or estimating technology. From the resistance to irrigation flow .OMEGA..sub.i identified in a look-up table and the infusion pressure at the bottle P.sub.ib, the intraocular pressure P.sub.eye of the eye is determined as outlined in equation 1 above” [0028], see steps 310-340 of Figure 2 and see detailed in [0019-0027]); and displaying, on the graphical user interface (GUI) of the surgical console, the determined IOP (“The intraocular pressure P.sub.eye may be displayed on a Graphical User Interface (not shown).” [0028]).
Before the effective filing date of the claimed invention, it would have been obvious to modify the surgical method of Mallough to include determining in real-time, via the processor in the surgical console, the IOP; and displaying, on the GUI, the determined IOP based on the teachings of Mallough to allow for constant monitoring of the IOP and to maintain a constant target IOP throughout the surgical method to avoid trauma to the eye (Mallough [0003], [0028]).
Regarding claim 65, modified Mallough discloses the method of claim 64, wherein the irrigation fluid comprises a balanced salt solution (BSS) (“A typical irrigation solution may comprise a balanced salt solution” [0044]) and wherein the irrigation source comprises a BSS container (“balanced saline solution (BSS) fluid bottle 112” [0029]).
Regarding claim 66, modified Mallough discloses the method of claim 65, wherein the BSS container comprises a bag or a bottle (“balanced saline solution (BSS) fluid bottle 112” [0029]).
Regarding claim 67, modified Mallough discloses the method of claim 64, wherein the irrigation source has a starting fluid volume (“initial volume” [0043]), and wherein the method further comprises: displaying on the GUI, the remaining fluid volume of the irrigation source based on the determined volume of irrigation fluid used and the starting fluid volume (“one exemplary technique comprises the utilization of time and flow processing, where depletion is measured based on an initial volume and an approximate use of irrigation fluid over time. Another exemplary technique comprises the use of optical or resistive flow detection, where irrigation fluid depletion is calculated through optical and/or resistive sensors. In another exemplary technique, gravimetric detection may be utilized, where depletion is measured based on an initial volume and the weight of the irrigation fluid source or waste over time. In a still further exemplary technique, pressure detection may be utilized to measure depletion based on pressure exerted by the irrigation fluid upon a pressure sensor.” [0043], see detailed in [0054-0056], [0064], [0066]; “irrigation fluid status and advanced warnings may be provided as illustrated in FIGs. 3A and 3B. For example, if one or more flow sensors detect a heavier flow of irrigation fluid being used during a procedure, the processor in the system may calculate a remaining use time and display 300 the time (e.g., "24 minutes of remaining irrigation fluid supply") so that personnel can quickly determine if adjustments to the procedure may be necessary. If the irrigation fluid in use is reduced in response to the notification, the system processor may automatically update 301 the time accordingly (e.g., "27 minutes of remaining irrigation fluid supply" [0056]).
Regarding claim 68, Mallough discloses the method of claim 64, wherein the remaining fluid volume of the irrigation source is periodically displayed on the GUI (Figure 3A-3B; “irrigation fluid status and advanced warnings may be provided as illustrated in FIGs. 3A and 3B. For example, if one or more flow sensors detect a heavier flow of irrigation fluid being used during a procedure, the processor in the system may calculate a remaining use time and display 300 the time (e.g., "24 minutes of remaining irrigation fluid supply") so that personnel can quickly determine if adjustments to the procedure may be necessary. If the irrigation fluid in use is reduced in response to the notification, the system processor may automatically update 301 the time accordingly (e.g., "27 minutes of remaining irrigation fluid supply")” [0056]).
Regarding claim 69, modified Mallough discloses the method of claim 67, wherein the remaining fluid volume of the irrigation source is stored in a memory (controller 125) of the surgical console (“Console 115 may include controller 125, which may include…a memory…Along with programming code, controller 125 may include stored data for implementing the methods described herein, and may generate and/or store data that records parameters corresponding to the treatment of one or more patients.” [0026]; “if one or more flow sensors detect a heavier flow of irrigation fluid being used during a procedure, the processor in the system may calculate a remaining use time and display 300 the time” [0056], wherein the remaining volume is at least temporarily stored when it is displayed).
Regarding claim 72, Mallough discloses a system (surgical cassette system 200) for performing surgery on an eye of a patient, the system comprising:
a separately provided irrigation source (BSS fluid bottle 112; Figure 2A, see also irrigation source 151 provided separately Figure 1B);
a surgical console (surgical console 115) in fluid communication with the irrigation source (Figure 1B and 2A), wherein the surgical console comprises a pump (“Cassette 250 may be configured to interface with reusable components of console 115, including, but not limited to, peristaltic pump rollers, a Venturi or other vacuum source, a controller 125” [0025]), a processor and a graphical user interface (GUI) (“Console 115 may include controller 125, which may include…a processor…input and/or output devices (including a user interface 130 (e.g. touch screen, graphical user interface (GUI), etc.), and the like” [0026]); and
a handpiece (handpiece 110) in fluid communication with the surgical console (“a system 10 for treating an eye E of a patient P generally includes an eye treatment probe handpiece 110 coupled with a console 115 by a cassette 250.” [0023]), wherein the handpiece comprises an irrigation port (at fluid pathway 113; Figure 2A) and an aspiration port (at fluid pathway 220; Figure 2A);
wherein the system is configured to enable a user to irrigate the eye during the surgery through the irrigation port of the handpiece, with an irrigation fluid from the irrigation source at an irrigation flow rate (“the system may operate flow selector valve 202 to connect handpiece 110 with BSS fluid bottle 112, reservoir 204 or with pump 203 based on signals received from console 115 resulting from the surgeon's input to user interface 130.” [0029]; “handpiece 110 may be configured as an irrigation/aspiration (l/A) and/or vitrectomy handpiece…So as to balance the volume of material removed by the aspiration flow, an irrigation flow through handpiece 110 (or a separate probe structure) may also be provided, with both the aspiration and irrigation flows being controlled by console 115.” [0024]; “An estimation of flow rate from irrigation source 151 may be calculated using the various factors discussed above (e.g., IV pole height, pump speed, valving, pressure)” [0054]);
wherein the system is configured to simultaneously aspirate the irrigation fluid, along with any lens material, through the aspiration port, at an aspiration flow rate, wherein the irrigation flow rate and the aspiration flow rate are controlled to substantially maintain an intraocular pressure (IOP) within the eye (“handpiece 110 may be configured as an irrigation/aspiration (l/A) and/or vitrectomy handpiece. Also, the ultrasonic transmitter may be replaced by other means for emulsifying a lens, such as a high energy laser beam. The ultrasound energy from handpiece 110 helps to fragment the tissue of the lens, which can then be drawn into a port of the tip by aspiration flow. So as to balance the volume of material removed by the aspiration flow, an irrigation flow through handpiece 110 (or a separate probe structure) may also be provided, with both the aspiration and irrigation flows being controlled by console 1 15.” [0024]; “Fluid balance may be determined from the pressure gradient and is considered "balanced" when adequate pressure is available to keep up with the outflow. This balance maintains a stable anterior chamber by keeping the pressure in the anterior chamber fairly constant.” [0058]);
wherein the processor of the surgical console is configured to determine, in real-time, a volume of irrigation fluid used from the irrigation source during the surgery (“a plurality of techniques for detecting the use and/or depletion of an irrigation source. As will be discussed in greater detail below, one exemplary technique comprises the utilization of time and flow processing, where depletion is measured based on an initial volume and an approximate use of irrigation fluid over time. Another exemplary technique comprises the use of optical or resistive flow detection, where irrigation fluid depletion is calculated through optical and/or resistive sensors. In another exemplary technique, gravimetric detection may be utilized, where depletion is measured based on an initial volume and the weight of the irrigation fluid source or waste over time. In a still further exemplary technique, pressure detection may be utilized to measure depletion based on pressure exerted by the irrigation fluid upon a pressure sensor.” [0043], see detailed in [0054-0056], [0064], [0066]); and
wherein the GUI (display 159) is configured to display at least one of the volume of irrigation fluid used or a remaining fluid volume of the irrigation source (Figure 3A-3B; “irrigation fluid status and advanced warnings may be provided as illustrated in FIGs. 3A and 3B. For example, if one or more flow sensors detect a heavier flow of irrigation fluid being used during a procedure, the processor in the system may calculate a remaining use time and display 300 the time (e.g., "24 minutes of remaining irrigation fluid supply") so that personnel can quickly determine if adjustments to the procedure may be necessary. If the irrigation fluid in use is reduced in response to the notification, the system processor may automatically update 301 the time accordingly (e.g., "27 minutes of remaining irrigation fluid supply")” [0056]).
Mallough fails to explicitly disclose the processor of the surgical console is configured to determine, in real-time, the IOP; and wherein the GUI is configured to display the determined IOP.
Cull teaches a system for performing surgery on an eye of a patient (Figure 2; “the present invention provides improved apparatus and methods of performing vitrectomy surgery” [0049]) comprising irrigating and aspirating via a handpiece (ophthalmic device 120), wherein an irrigation flow rate and an aspiration flow rate are controlled to substantially maintain an intraocular pressure (IOP) within the eye (“It is accordingly possible to monitor the flow rate Q of fluid aspirated from the eye, and to control the infusion pressure at the bottle p.sub.ib and/or vacuum pressure p.sub.v, to maintain a constant intraocular pressure by adjusting the infusion pressure p.sub.ib of the irrigation fluid in the bottle 130 (by adjusting the bottle height or by adjusting the bottle pressure). From the above data, intraocular pressure can be estimated and used as a surgical parameter.” [0025]); wherein a controller is configured to determine, in real time, the IOP (“At step 310, the surgeon or user enters into the controller 200 a configuration for the device…The pressure P.sub.ib of the irrigation fluid in the irrigation bottle 130 is then set…The system then monitors fluid flow rate using a positive displacement pump, a flow sensor, electromagnetic flow technology, or other similar flow sensing or estimating technology. From the resistance to irrigation flow .OMEGA..sub.i identified in a look-up table and the infusion pressure at the bottle P.sub.ib, the intraocular pressure P.sub.eye of the eye is determined as outlined in equation 1 above” [0028], see steps 310-340 of Figure 2 and see detailed in [0019-0027]); and wherein a GUI is configured to display the determined IOP (“The intraocular pressure P.sub.eye may be displayed on a Graphical User Interface (not shown).” [0028]).
Before the effective filing date of the claimed invention, it would have been obvious to modify the surgical method of Mallough to include the processor of the surgical console is configured to determine, in real-time, the IOP; and wherein the GUI is configured to display the determined IOP based on the teachings of Mallough to allow for constant monitoring of the IOP and to maintain a constant target IOP throughout the surgical method to avoid trauma to the eye (Mallough [0003], [0028]).
Regarding claim 73, modified Mallough discloses the system of claim 72, wherein the irrigation fluid comprises a balanced salt solution (BSS) (“A typical irrigation solution may comprise a balanced salt solution” [0044]) and wherein the irrigation source comprises a BSS container (“balanced saline solution (BSS) fluid bottle 112” [0029]).
Regarding claim 74, modified Mallough discloses the system of claim 73, wherein the BSS container comprises a bag or a bottle (“balanced saline solution (BSS) fluid bottle 112” [0029]).
Regarding claim 75, modified Mallough discloses the system of claim 72, wherein the irrigation source has a starting fluid volume (“initial volume” [0043]), and wherein the processor is further configured to determine the remaining fluid volume of the irrigation source based on the determined volume of irrigation fluid used and the starting fluid volume (“one exemplary technique comprises the utilization of time and flow processing, where depletion is measured based on an initial volume and an approximate use of irrigation fluid over time. Another exemplary technique comprises the use of optical or resistive flow detection, where irrigation fluid depletion is calculated through optical and/or resistive sensors. In another exemplary technique, gravimetric detection may be utilized, where depletion is measured based on an initial volume and the weight of the irrigation fluid source or waste over time. In a still further exemplary technique, pressure detection may be utilized to measure depletion based on pressure exerted by the irrigation fluid upon a pressure sensor.” [0043], see detailed in [0054-0056], [0064], [0066]).
Regarding claim 76, modified Mallough discloses the system of claim 72, wherein the remaining fluid volume of the irrigation source is periodically displayed on the GUI (Figure 3A-3B; “irrigation fluid status and advanced warnings may be provided as illustrated in FIGs. 3A and 3B. For example, if one or more flow sensors detect a heavier flow of irrigation fluid being used during a procedure, the processor in the system may calculate a remaining use time and display 300 the time (e.g., "24 minutes of remaining irrigation fluid supply") so that personnel can quickly determine if adjustments to the procedure may be necessary. If the irrigation fluid in use is reduced in response to the notification, the system processor may automatically update 301 the time accordingly (e.g., "27 minutes of remaining irrigation fluid supply")” [0056]).
Regarding claim 77, modified Mallough discloses the system of claim 75, wherein the remaining fluid volume of the irrigation source is stored in a memory (controller 125) of the surgical console (“Console 115 may include controller 125, which may include…a memory…Along with programming code, controller 125 may include stored data for implementing the methods described herein, and may generate and/or store data that records parameters corresponding to the treatment of one or more patients.” [0026]; “if one or more flow sensors detect a heavier flow of irrigation fluid being used during a procedure, the processor in the system may calculate a remaining use time and display 300 the time” [0056], wherein the remaining volume is at least temporarily stored when it is displayed).
Claims 70-71 and 78-79 are rejected under 35 U.S.C. 103 as being unpatentable over Mallough et al. (US 20160220751) in view of Cull et al. (US 20100145302) as applied to claims 67 and 75 above, and further in view of Duchon et al. (US 20040092885).
Regarding claim 70, modified Mallough discloses the method of claim 67.
Modified Mallough fails to explicitly disclose the starting fluid volume is input by a user via the GUI of the surgical console.
Duchon teaches a surgical method (“a fluid management and component detection system used during a surgical procedure.” [0001]), the method comprising determining in real-time a volume of fluid used from a fluid source (reservoir/bottle 22) during the surgery (“an encoder or sensors 74 located on a motor in combination with a gear assembly 76 attached to a potentiometer track the volume of fluid used on the system 10 via the number of turns of the motor. This data…allows the system 10 to continuously and accurately calculate the volume of fluid remaining in the bottle 22. Alternatively, the system 10 can be completely automated whereby even the bottle size/volume is detected using bar-codes and bar-code readers, sensors or similar devices, and the information is then automatically processed by the system 10.” [0093]); and displaying, on a GUI of the surgical console (interface subassembly 14), at least one of the volume of fluid used or a remaining fluid volume of the fluid source (“The sensors continuously track the fluid level in the reservoir 22 and send this information to the user-interface subassembly 14. The information is them processed by the system 10 and communicated to the operator via the system display.” [0095]), wherein the fluid source has a starting fluid volume that is input by a user via the GUI of the surgical console (“information input by the operator for the bottle size/volume of the injection fluid” [0093]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the surgical method of Mallough to include the starting fluid volume is input by a user via the GUI of the surgical console based on the teachings of Duchon to allow for accurate monitoring of the amount of irrigation fluid remaining in the irrigation source in order avoid both depletion of irrigation fluid during a procedure and premature replacement of the irrigation source which would cause unnecessary waste (Duchon [0091]).
Regarding claim 71, modified Mallough discloses the method of claim 67.
Modified Mallough fails to explicitly discloses wherein the volume of irrigation fluid used from the irrigation source during the surgery is automatically reset when a fluidics pack is removed from the console and wherein the determined remaining fluid volume of the irrigation source is changed upon changing the irrigation source.
Duchon teaches a surgical method (“a fluid management and component detection system used during a surgical procedure.” [0001]), the method comprising determining both the volume of fluid used from a fluid source (bottle 22) during the surgery and the remaining fluid volume of the fluid source (“an encoder or sensors 74 located on a motor in combination with a gear assembly 76 attached to a potentiometer track the volume of fluid used on the system 10 via the number of turns of the motor. This data…allows the system 10 to continuously and accurately calculate the volume of fluid remaining in the bottle 22. Alternatively, the system 10 can be completely automated whereby even the bottle size/volume is detected using bar-codes and bar-code readers, sensors or similar devices, and the information is then automatically processed by the system 10.” [0093]; “sensors or similar devices are positioned at various levels along the supply reservoir 22. The sensors continuously track the fluid level in the reservoir 22 and send this information to the user-interface subassembly 14.” [0095]); the method further comprising wherein the volume of fluid used from the fluid source during the surgery is automatically reset when a fluidics pack (single use components 46) is removed from the console (“Upon completion of the procedure, the system operator terminates the case, for example, by pressing the "End Case" key or button. As such, the system 10 tracks and/or counts this as one use of the syringe 18. After the fifth use (or maximum number of uses) of the syringe 18, the system 10 notifies the operator that the syringe 18 has been used it maximum number of uses. At this point, the operator may either replace the syringe 18 with a new, sterile syringe” [0070]; “During normal operation and upon completion of a procedure, the system 10 is shut-down by a system operator using the appropriate shut-down sequence of steps, including completion of an "End Case" action. Following this procedure, a subsequent powering-up of the system 10 only allows a user to re-start the system 10 and requires new disposable components to be installed on the system.” [0080]; “the input parameters and the case totals for the injection fluids and the last injection values are lost and re-set to zero.” [0082]); and wherein the determined remaining fluid volume of the fluid source is changed upon changing the fluid source (“When the bottle 22 is empty, the user of the device simply discards the empty bottle 22 and attaches a full bottle 22 of contrast media onto the contrast container spike 48.” [0092], wherein when a new bottle 22 is attached, the sensors, such as those disclosed in paragraph [0095], would track and send data about the new bottle to the subassembly 14).
Before the effective filing date of the claimed invention, it would have been obvious to modify the method of Mallough to include the volume of irrigation fluid used from the irrigation source during the surgery is automatically reset when a fluidics pack is removed from the console and the determined remaining fluid volume of the irrigation source is changed upon changing the irrigation source based on the teachings of Duchon to allow for accurate monitoring of the amount of irrigation fluid remaining in the irrigation source in order avoid both depletion of irrigation fluid during a procedure and premature replacement of the irrigation source which would cause unnecessary waste (Duchon [0091], [0095]).
Regarding claim 78, modified Mallough discloses the system of claim 75.
Modified Mallough fails to explicitly disclose the starting fluid volume is input by a user via the GUI of the surgical console.
Duchon teaches a system for performing surgery (“a fluid management and component detection system used during a surgical procedure.” [0001]), the system configured to determine, in real-time, a volume of fluid used from a fluid source (reservoir/bottle 22) during the surgery (“an encoder or sensors 74 located on a motor in combination with a gear assembly 76 attached to a potentiometer track the volume of fluid used on the system 10 via the number of turns of the motor. This data…allows the system 10 to continuously and accurately calculate the volume of fluid remaining in the bottle 22. Alternatively, the system 10 can be completely automated whereby even the bottle size/volume is detected using bar-codes and bar-code readers, sensors or similar devices, and the information is then automatically processed by the system 10.” [0093]); and a GUI (interface subassembly 14) is configured to display at least one of the volume of fluid used or a remaining fluid volume of the fluid source (“The sensors continuously track the fluid level in the reservoir 22 and send this information to the user-interface subassembly 14. The information is them processed by the system 10 and communicated to the operator via the system display.” [0095]), wherein the fluid source has a starting fluid volume that is input by a user via the GUI (“information input by the operator for the bottle size/volume of the injection fluid” [0093]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the system of Mallough to include the starting fluid volume is input by a user via the GUI of the surgical console based on the teachings of Duchon to allow for accurate monitoring of the amount of irrigation fluid remaining in the irrigation source in order avoid both depletion of irrigation fluid during a procedure and premature replacement of the irrigation source which would cause unnecessary waste (Duchon [0091]).
Regarding claim 79, modified Mallough discloses the system of claim 75.
Modified Mallough fails to explicitly disclose the volume of irrigation fluid used from the irrigation source during the surgery is automatically reset when a fluidics pack is removed from the surgical console and wherein the determined remaining fluid volume of the irrigation source is reset upon changing the irrigation source.
Duchon teaches a system for performing surgery (“a fluid management and component detection system used during a surgical procedure.” [0001]), the system configured to determine both a volume of fluid used from a fluid source (reservoir/bottle 22) during the surgery and remaining fluid volume of the fluid source (“an encoder or sensors 74 located on a motor in combination with a gear assembly 76 attached to a potentiometer track the volume of fluid used on the system 10 via the number of turns of the motor. This data…allows the system 10 to continuously and accurately calculate the volume of fluid remaining in the bottle 22. Alternatively, the system 10 can be completely automated whereby even the bottle size/volume is detected using bar-codes and bar-code readers, sensors or similar devices, and the information is then automatically processed by the system 10.” [0093]; “sensors or similar devices are positioned at various levels along the supply reservoir 22. The sensors continuously track the fluid level in the reservoir 22 and send this information to the user-interface subassembly 14.” [0095]); wherein the volume of fluid used from the fluid source during the surgery is automatically reset when a fluidics pack (single use components 46) is removed from the console (“Upon completion of the procedure, the system operator terminates the case, for example, by pressing the "End Case" key or button. As such, the system 10 tracks and/or counts this as one use of the syringe 18. After the fifth use (or maximum number of uses) of the syringe 18, the system 10 notifies the operator that the syringe 18 has been used it maximum number of uses. At this point, the operator may either replace the syringe 18 with a new, sterile syringe” [0070]; “During normal operation and upon completion of a procedure, the system 10 is shut-down by a system operator using the appropriate shut-down sequence of steps, including completion of an "End Case" action. Following this procedure, a subsequent powering-up of the system 10 only allows a user to re-start the system 10 and requires new disposable components to be installed on the system.” [0080]; “the input parameters and the case totals for the injection fluids and the last injection values are lost and re-set to zero.” [0082]); and wherein the determined remaining fluid volume of the fluid source is reset upon changing the fluid source (“When the bottle 22 is empty, the user of the device simply discards the empty bottle 22 and attaches a full bottle 22 of contrast media onto the contrast container spike 48.” [0092], wherein when a new bottle 22 is attached, the sensors, such as those disclosed in paragraph [0095], would track and send data about the new bottle to the subassembly 14).
Before the effective filing date of the claimed invention, it would have been obvious to modify the system of Mallough to include the volume of irrigation fluid used from the irrigation source during the surgery is automatically reset when a fluidics pack is removed from the console and the determined remaining fluid volume of the irrigation source is changed upon changing the irrigation source based on the teachings of Duchon to allow for accurate monitoring of the amount of irrigation fluid remaining in the irrigation source in order avoid both depletion of irrigation fluid during a procedure and premature replacement of the irrigation source which would cause unnecessary waste (Duchon [0091], [0095]).
Response to Arguments
Applicant’s arguments with respect to claims 67-79 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEAH J SWANSON/Examiner, Art Unit 3783 /CHELSEA E STINSON/Supervisory Patent Examiner, Art Unit 3783