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 .
Response to Amendment
The amendment filed April 09, 2026 has been entered. Claims 64-79 remain pending in the application. Claims 1-63 were previously cancelled. Applicant’s amendments to the claims have overcome the rejections under 35 USC 112 and objections previously set forth in the Non-Final Office Action mailed January 09, 2026.
Claim Objections
Claim 71 is objected to because there appears to be a typo regarding “…when a change the irrigation source occurs.” in line 4 as opposed to “…when a change of the irrigation source occurs.” Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 72-79 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 72, the limitations “the surgical console comprises a pump” in line 5 and “a pump transferring the irrigation fluid” in line 16-17 renders the claim indefinite. It is unclear if “a pump” in the surgical console is the same pump as the “pump transferring the irrigation fluid” or if the system comprises two separate pumps. For examination purposes, the “pump transferring the irrigation fluid” in line 16-17 has been interpreted to be the same structure as “a pump” in line 5.
Claims 73-79 are rejected for being dependent upon claim 72.
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 64-79 are rejected under 35 U.S.C. 103 as being unpatentable over Eddo et al. (US 20160367735) in view of Cull et al. (US 20100145302) in further view of Duchon et al. (US 20040092885).
Regarding claim 64, Eddo discloses a surgical method (“method for providing pressurized infusion of liquids and, more particularly, providing a stable and pressurized flow of fluid to the eye during surgery.” [Abstract]) comprising:
irrigating, via a handpiece (handpiece 12) during a surgery, an eye (eye E) with an irrigation fluid from an irrigation source (irrigation source 46; “an irrigation flow through handpiece 12 (or a separate probe structure) may also be provided,” [0027]; “A tertiary peristaltic pump and an additional fluid reservoir may be provided to pressurize a balanced salt solution (BSS) bag.” [0016]; “Irrigation from pressure infusion tank 507 is provided via phacoemulsification irrigation line 511, and I/A and vitrectomy irrigation line 512 as shown in FIG. 4.” [0039]);
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 (“irrigation and aspiration are employed by the surgeon using the device to remove unwanted tissue and maintain pressure within the eye” [0008]; “The system software…would allow a surgeon to select a desired inter-ocular pressure and would then control the pumps and valves to achieve and maintain the selected pressure.” [0016]; “the handpiece 12 may be configured as an I/A 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 12 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 12 (or a separate probe structure) may also be provided, with both the aspiration and irrigations flows being controlled by console 14.” [0027]);
providing a processor (“Controller 40 may include an embedded microcontroller and/or many of the components of a personal computer, such as a processor, a data bus, a memory, input and/or output devices (including a touch screen user interface 42), and the like.” [0029]) in a surgical console (console 14 having controller 40 and console interface 600), a pump (peristaltic pump 501A) transferring the irrigation fluid to an infusion tank (pressurized infusion tank 507) in the surgical console (Figures 4-5; “the system would make use of tertiary peristaltic roller from 501 to push fluid from the fluid source into tank 507.” [0041]); and
providing a graphical user interface (GUI) (touch screen user interface 42) of the surgical console (Figure 1).
Eddo fails to explicitly disclose determining in real-time, via the processor in the surgical console, the IOP and via tracking a starting and ending encoder count of a pump transferring the irrigation fluid to an infusion tank in the surgical console the volume of irrigation fluid used from the irrigation source during the surgery; and displaying, on the graphical user interface (GUI) of the surgical console, the determined IOP and at least one of the volume of irrigation fluid used or a remaining fluid volume of the irrigation source.
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 Eddo 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 Cull 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 (Cull [0003], [0028]).
Modified Eddo fails to explicitly disclose determining in real-time, via the processor in the surgical console, via tracking a starting and ending encoder count of a pump transferring the irrigation fluid to an infusion tank in the surgical console the volume of irrigation fluid used from the irrigation source during the surgery; and displaying, on the graphical user interface (GUI) of the surgical console, at least one of the volume of irrigation fluid used or a remaining fluid volume of the irrigation source.
Duchon teaches a surgical method (“a fluid management and component detection system used during a surgical procedure.” [0001]) comprising determining in real-time, via a processor in a surgical console (injector system 10), via tracking a starting and ending encoder count of a pump (syringe plunger 20 of injector subassembly 16 and associated motor: “the syringe plunger 20 is connected to and driven by a motor” [0049]) transferring fluid to an infusion tank (syringe body 18) in the surgical console, a volume of fluid used from a fluid source (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, which may be used with optional information input by the operator for the bottle size/volume of the injection fluid, allows the system 10 to continuously and accurately calculate the volume of fluid remaining in the bottle 22.” [0093]); and displaying, on a graphical user interface (GUI) (user-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]).
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 Eddo to include determining in real-time, via the processor in the surgical console, via tracking a starting and ending encoder count of a pump transferring the irrigation fluid to an infusion tank in the surgical console, the volume of irrigation fluid used from the irrigation source during the surgery based on the teachings of Duchon to allow the system to accurately monitor the amount of BSS remaining the in the container in order avoid running out of BSS during a procedure without requiring premature replacement of the BSS container and causing unnecessary waste (Duchon [0091]) and to modify the surgical method of Eddo to include displaying, on the graphical user interface (GUI) of the surgical console, at least one of the volume of irrigation fluid used or a remaining fluid volume of the irrigation source based on the teachings of Duchon to accurately and effectively control the timing of when the BSS container needs to be replaced (Duchon [0095]).
Regarding claim 65, modified Eddo discloses the method of claim 64, wherein the irrigation fluid comprises a balanced salt solution (BSS) and wherein the irrigation source comprises a BSS container (“an additional fluid reservoir may be provided to pressurize a balanced salt solution (BSS) bag.” [0016]; “An initial fluid intake line (from a balanced salt solution (BSS) source) may be provided to line 501,” [0037]).
Regarding claim 66, modified Eddo discloses the method of claim 65, wherein the BSS container comprises a bag (“a balanced salt solution (BSS) bag.” [0016]) or a bottle.
Regarding claim 67, modified Eddo discloses the method of claim 64.
Modified Eddo fails to explicitly disclose the irrigation source has a starting fluid volume, 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.
Duchon teaches a surgical method comprising an fluid source (bottle 22) that has a starting fluid volume (“information input by the operator for the bottle size/volume of the injection fluid” [0093]), and wherein the method further comprises: displaying on the GUI (user-interface subassembly 14), the remaining fluid volume of the fluid source based on the determined volume of fluid used and the starting fluid volume (“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, which may be used with optional information input by the operator for the bottle size/volume of the injection fluid, allows the system 10 to continuously and accurately calculate the volume of fluid remaining in the bottle 22.” [0093]; “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]).
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 method of Eddo to include that the irrigation source has a starting fluid volume, 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 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 68, modified Eddo discloses the method of claim 64.
Modified Eddo fails to explicitly disclose wherein the remaining fluid volume of the irrigation source is periodically displayed on the GUI.
Duchon teaches a surgical method (“a fluid management and component detection system used during a surgical procedure.” [0001]) comprising determining a remaining fluid volume of a fluid source (reservoir/bottle 22), wherein the remaining fluid volume of the fluid source is periodically displayed on the GUI (“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, which may be used with optional information input by the operator for the bottle size/volume of the injection fluid, allows the system 10 to continuously and accurately calculate the volume of fluid remaining in the bottle 22.” [0093]; “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]).
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 method of Eddo to include the remaining fluid volume of the irrigation source is periodically displayed on the GUI 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 69, modified Eddo discloses the method of claim 67, further comprising a memory of the surgical console (“Controller 40 may include…a memory” [0029]).
Modified Eddo fails to explicitly disclose the remaining fluid volume of the irrigation source is stored in the memory.
Duchon teaches a surgical method (“a fluid management and component detection system used during a surgical procedure.” [0001]) comprising determining a remaining fluid volume of a fluid source (reservoir/bottle 22), wherein the remaining fluid volume of the fluid source is stored in a memory (“the memory system of the user-interface subassembly 14.” [0084]) of the surgical console (“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, which may be used with optional information input by the operator for the bottle size/volume of the injection fluid, allows the system 10 to continuously and accurately calculate the volume of fluid remaining in the bottle 22.” [0093]; “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 remaining volume is at least temporarily stored when it is displayed).
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 method of Eddo to include the remaining fluid volume of the irrigation source is stored in the memory 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 70, modified Eddo discloses the method of claim 67.
Modified Eddo 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 Eddo 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 Eddo discloses the method of claim 67.
Modified Eddo fails to explicitly discloses wherein the volume of irrigation fluid used from the irrigation source during the surgery is reset when a fluidics pack is removed from the console and wherein the remaining fluid volume of the irrigation source is reset when a change the irrigation source occurs.
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 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 remaining fluid volume of the fluid source is reset when a change the fluid source occurs (“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 Eddo to include the volume of irrigation fluid used from the irrigation source during the surgery is reset when a fluidics pack is removed from the console and the remaining fluid volume of the irrigation source is reset when a change the irrigation source occurs 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 72, Eddo discloses a system (system 10) for performing surgery on an eye (eye E) of a patient (“Apparatus, system and method for providing pressurized infusion of liquids and, more particularly, providing a stable and pressurized flow of fluid to the eye during surgery.” [Abstract]), the system comprising:
a separately provided irrigation source (irrigation source 46; Figures 2 and 3);
a surgical console (console 14 having controller 40 and console interface 600 and cassette 16) in fluid communication with the irrigation source (Figures 1-5), wherein the surgical console comprises a pump (peristaltic pump 501A), a processor and a graphical user interface (GUI) (“Controller 40 may include…a processor…input and/or output devices (including a touch screen user interface 42), and the like.” [0029]); and
a handpiece (handpiece 12) in fluid communication with the surgical console (“handpiece 12 coupled to a console 14 by a cassette 16 mounted on the console. Handpiece 12 generally includes a handle for manually manipulating and supporting an insertable probe tip. The probe tip has a distal end which is insertable into the eye, with one or more lumens in the probe tip allowing irrigation fluid to flow from the console 14 and/or cassette 16 into the eye. Aspiration fluid may also be withdrawn through a lumen of the probe tip” [0026]), wherein the handpiece comprises an irrigation port (connected to irrigation source 46/ phacoemulsification irrigation line 511, for example; Figure 2) and an aspiration port (connected aspiration flow path 52/phacoemulsification aspiration line 505, for example; Figure 2);
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 (“an irrigation flow through handpiece 12 (or a separate probe structure) may also be provided,” [0027]; “A tertiary peristaltic pump and an additional fluid reservoir may be provided to pressurize a balanced salt solution (BSS) bag.” [0016]; “Irrigation from pressure infusion tank 507 is provided via phacoemulsification irrigation line 511, and I/A and vitrectomy irrigation line 512 as shown in FIG. 4.” [0039]);
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 (“irrigation and aspiration are employed by the surgeon using the device to remove unwanted tissue and maintain pressure within the eye” [0008]; “The system software…would allow a surgeon to select a desired inter-ocular pressure and would then control the pumps and valves to achieve and maintain the selected pressure.” [0016]; “the handpiece 12 may be configured as an I/A 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 12 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 12 (or a separate probe structure) may also be provided, with both the aspiration and irrigations flows being controlled by console 14.” [0027]); and
a pump (peristaltic pump 501A) transferring the irrigation fluid to an infusion tank (pressurized infusion tank 507) in the surgical console (Figures 4-5; “the system would make use of tertiary peristaltic roller from 501 to push fluid from the fluid source into tank 507.” [0041]).
Eddo fails to explicitly disclose the processor of the surgical console is configured to determine, in real-time, the IOP and, via tracking a starting and ending encoder count of a pump transferring the irrigation fluid to an infusion tank in the surgical consoler, a volume of irrigation fluid used from the irrigation source during the surgery; and wherein the GUI is configured to display the determined IOP and at least one of the volume of irrigation fluid used or a remaining fluid volume of the irrigation source.
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 Eddo 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 Cull 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 (Cull [0003], [0028]).
Modified Eddo fails to explicitly disclose the processor is configured to determine, in real-time via tracking a starting and ending encoder count of a pump transferring the irrigation fluid to an infusion tank in the surgical consoler, a volume of irrigation fluid used from the irrigation source during the surgery; and wherein the GUI is configured to display at least one of the volume of irrigation fluid used or a remaining fluid volume of 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, in real-time, via tracking a starting and ending encoder count of a pump (syringe plunger 20 of injector subassembly 16 and associated motor: “the syringe plunger 20 is connected to and driven by a motor” [0049]) transferring fluid to an infusion tank (syringe body 18) in the surgical console, 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]).
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 Eddo to include the processor is configured to determine, in real-time via tracking a starting and ending encoder count of a pump transferring the irrigation fluid to an infusion tank in the surgical consoler, a volume of irrigation fluid used from the irrigation source during the surgery based on the teachings of Duchon to allow the system to accurately monitor the amount of BSS remaining the in the container in order avoid running out of BSS during a procedure without requiring premature replacement of the BSS container and causing unnecessary waste (Duchon [0091]) and to modify the system of Eddo to include the GUI is configured to display at least one of the volume of irrigation fluid used or a remaining fluid volume of the irrigation source based on the teachings of Duchon to accurately and effectively control the timing of when the BSS container needs to be replaced (Duchon [0095]).
Regarding claim 73, modified Eddo discloses the system of claim 72, wherein the irrigation fluid comprises a balanced salt solution (BSS) and wherein the irrigation source comprises a BSS container (“an additional fluid reservoir may be provided to pressurize a balanced salt solution (BSS) bag.” [0016]; “An initial fluid intake line (from a balanced salt solution (BSS) source) may be provided to line 501,” [0037]).
Regarding claim 74, modified Eddo discloses the system of claim 73, wherein the BSS container comprises a bag (“a balanced salt solution (BSS) bag.” [0016]) or a bottle.
Regarding claim 75, modified Eddo discloses the system of claim 72.
Modified Eddo fails to explicitly disclose the irrigation source has a starting fluid volume, 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.
Duchon teaches a system for performing surgery (“a fluid management and component detection system used during a surgical procedure.” [0001]) comprising a fluid source (bottle 22) that has a starting fluid volume (“information input by the operator for the bottle size/volume of the injection fluid” [0093]), and a processor of a surgical console is configured to determine the remaining fluid volume of the fluid source based on a determined volume of fluid used and the starting fluid volume (“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, which may be used with optional information input by the operator for the bottle size/volume of the injection fluid, allows the system 10 to continuously and accurately calculate the volume of fluid remaining in the bottle 22.” [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 Eddo to include the irrigation source has a starting fluid volume, 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 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 76, modified Eddo discloses the system of claim 72.
Modified Eddo fails to explicitly disclose wherein the remaining fluid volume of the irrigation source is periodically displayed on the GUI.
Duchon teaches a system for performing surgery (“a fluid management and component detection system used during a surgical procedure.” [0001]) comprising determining a remaining fluid volume of a fluid source (reservoir/bottle 22), wherein the remaining fluid volume of the fluid source is periodically displayed on the GUI (“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, which may be used with optional information input by the operator for the bottle size/volume of the injection fluid, allows the system 10 to continuously and accurately calculate the volume of fluid remaining in the bottle 22.” [0093]; “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]).
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 Eddo to include the remaining fluid volume of the irrigation source is periodically displayed on the GUI 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 77, modified Eddo discloses the system of claim 75, further comprising a memory of the surgical console (“Controller 40 may include…a memory” [0029]).
Modified Eddo fails to explicitly disclose the remaining fluid volume of the irrigation source is stored in the memory.
Duchon teaches a system for performing surgery (“a fluid management and component detection system used during a surgical procedure.” [0001]) comprising determining a remaining fluid volume of a fluid source (reservoir/bottle 22), wherein the remaining fluid volume of the fluid source is stored in a memory (“the memory system of the user-interface subassembly 14.” [0084]) of the surgical console (“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, which may be used with optional information input by the operator for the bottle size/volume of the injection fluid, allows the system 10 to continuously and accurately calculate the volume of fluid remaining in the bottle 22.” [0093]; “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 remaining volume is at least temporarily stored when it is displayed).
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 Eddo to include the remaining fluid volume of the irrigation source is stored in the memory 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 78, modified Eddo discloses the system of claim 75.
Modified Eddo 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 Eddo 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 Eddo discloses the system of claim 75.
Modified Eddo fails to explicitly disclose the volume of irrigation fluid used from the irrigation source during the surgery is 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 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 Eddo to include the volume of irrigation fluid used from the irrigation source during the surgery is 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 64-79 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.
Regarding the argument that “Cull does not appear to disclose determining (and/or displaying) IOP in real-time during a surgery” (Remarks Page 7), the examiner respectfully disagrees. As detailed in the rejection above, Cull discloses a surgical method/system determining in real-time the IOP (see at least: “From the resistance to irrigation flow Ωi identified in a look-up table and the infusion pressure at the bottle Pib, the intraocular pressure Peye of the eye is determined as outlined in equation 1 above” [0028], steps 310-340 Figure 2), displaying the IOP on a GUI (“The intraocular pressure Peye may be displayed on a Graphical User Interface” [0028]), and additionally controlling inflow and outflow of fluid from the eye to maintain IOP (see at least: “Once the Intraocular pressure Peye is determined, the infusion pressure Pib, vacuum Pv, or flow Q can be adjusted to maintain a constant desired intraocular pressure Peye.” [0028]; Step 350 Figure 2). Cull additionally discloses another embodiment to determine, display, and maintain IOP in Figure 3 and detailed in paragraphs [0040-0041]. It is therefore maintained it would have been obvious to modify the surgical method of Eddo to include determining in real-time the IOP; and displaying, on the GUI, the determined IOP based on the teachings of Cull 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 (Cull [0003], [0028]).
In response to applicant's argument that Duchon et al. (US 20040092885) is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, the field of the inventor’s endeavor appears to be “medical apparatuses and methods that provide pressurized infusion of liquids for ophthalmic surgery, and more particularly, to medical apparatuses and methods that require determinable, stable or controlled intraoperative intraocular pressure (IOP) within the anterior chamber of the eye” (Specification [002]). Particular problems with which the inventor is concerned include providing a means for determining static intraoperative pressure (IOP) of a patient’s eye, dynamic IOP, and total IOP (Specification [011]) and also determining the amount of a fluid remaining in a source container during a procedure (Specification [018]). Duchon is reasonably pertinent to the particular problem with which the inventor is concerned of accurately tracking the amount of fluid remaining in a source container (“to avoid the possibility of running out of fluid during a procedure, thereby requiring the procedure to be repeated, an operator will prematurely replace the bottle 22. This practice creates added hospital or health care facility expense due to the high cost of wasted contrast media or other injection fluids. This particular problem is addressed by the following fluid sensing and fluid tracking features which accurately monitor and efficiently manage fluid use.” [0091], the fluid tracking features described in [0091-0093]). Because the disclosure of Duchon is reasonably pertinent to a particular problem with which the inventor is concerned, it is maintained that Duchon is sufficiently analogous to the invention and one having ordinary skill in the art would have found it obvious to consider its teachings.
Regarding the argument that Duchon fails to disclose determining a volume of irrigation fluid used via tracking a starting and ending encoder count of a pump transferring irrigation fluid to an infusion tank in the surgical console as required by the independent claims (Remarks Page 8), the examiner respectfully disagrees. As detailed above, Duchon discloses a surgical method and system ([0001]) comprising determining in real-time, via a processor in a surgical console (10), via tracking a starting and ending encoder count of a pump (20; [0049]) transferring fluid to an infusion tank (18) in the surgical console, a volume of fluid used from a fluid source (22) during the surgery ([0093]); and displaying, on a GUI (14), at least one of the volume of fluid used or a remaining fluid volume of the fluid source ([0095]). It would have been obvious to one having ordinary skill in the art to modify the surgical method of Eddo to include determining in real-time, via tracking a starting and ending encoder count of a pump transferring the irrigation fluid to an infusion tank in the surgical console the volume of irrigation fluid used from the irrigation source during the surgery based on the teachings of Duchon to allow the system to accurately monitor the amount of BSS remaining the in the container in order avoid running out of BSS during a procedure without requiring premature replacement of the BSS container and causing unnecessary waste (Duchon [0091]) and to modify the surgical method of Eddo to include displaying on the GUI at least one of the volume of irrigation fluid used or a remaining fluid volume of the irrigation source based on the teachings of Duchon to accurately and effectively control the timing of when the BSS container needs to be replaced (Duchon [0095]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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/LEAH J SWANSON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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