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 February 23, 2026 has been entered. Claims 1-2, 4-19, 22-31, 34-38, 48-53, and 64 remain pending in the application. Claims 3, 20-21, 32-33, 39-47, and 54-63 have been cancelled.
Claim Objections
Claim 31 is objected to because there is a lack of antecedent basis for “the size of the incision” in lines 1-2. 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 1-2, 4, 7-8, 14, 16-17, 19, 22-26, 28-29, and 64 are rejected under 35 U.S.C. 103 as being unpatentable over Gerg et al. (US 2012/0041362) in view of Gordon (US 2014/0114237) and in further view of Wilson et al. (US 2014/0163455).
Regarding claim 1, Gerg discloses a system (system 2000) for detecting intraocular pressure events during phacoemulsification surgery, the system comprising:
a surgical console (control unit 2102, shown outlined in dotted line in Figure 8) including at least one computing processor (microprocessor computer 2110) capable of accessing at least one computing memory (“a computer-based algorithm” [0034]) associated with the at least one computing processor (“The control unit 2102 further includes a microprocessor computer 2110 which is operably connected to and controls the various other elements of the system…in accordance with algorithms described in the Claus application referenced above. A pressure differential .DELTA.P sensor 2120 provides an input to the computer 2110 representing the pressure differential between the first and second vacuum sensors 2250/2260.” [0039]);
a surgical handpiece (handpiece 2104) having a distal end and a proximal end (Figure 8), the proximal end being communicatively connected to at least one irrigation line (from irrigation source 2128) and at least one aspiration line (aspiration line 1110 in Figure 6, unlabeled in Figure 8);
a first sensor (first vacuum sensor 2250, 1300 in Figure 6) in communication with the at least one aspiration line (Figures 6 and 8) and located between the distal end of the surgical handpiece (at port 1120) and a second sensor (Figure 6 and 8) for providing a first measurement value (Pport-side); and
a second sensor (second vacuum sensor 2260, 1350 in Figure 6) in communication with the at least one aspiration line and located within the surgical console (Figures 6 and 8, sensor 2260 within dotted line denoting control unit/surgical console 2102) for providing a second measurement value (Ppump-side);
wherein at least one characteristic of an irrigation fluid in the at least one irrigation line or an aspiration fluid in the at least one aspiration line is changed in accordance with a difference between the first measurement value and the second measurement value (“By utilizing the first and second vacuum sensors 1300/1350, a ΔP (Pport-side-Ppump-side) pressure differential can be measured and utilized in a computer-based algorithm…to detect the onset, presence, breakage, or elimination of an occlusion. If the flow restrictor 1200 is a variable flow restrictor, then the vacuum-based aspiration system 1000 can provide both computer-based detection of occlusion and precise control of the volumetric flow rate while still maintaining the vacuum-based pump's 1140 full range of operation” [0034]; “an improved system and method for controlling the rate of fluid flow and vacuum based on the detection of occlusion within a fluid circuit” [0008], control of rate of fluid flow vacuum discussed in [0028]), wherein the difference is based in part on constants L and r, where L = a length of the at least one aspiration line between the first sensor and the second sensor and r = an inner radius of the at least one aspiration line along the length L (“As one of ordinary skill in the art would appreciate, during aspiration, by increasing the effective resistance in a localized segment of the aspiration line 1110, the flow restrictor 1200 will produce a differential volumetric flow rate between the port 1120 side of the line and the pump 1140 side of the line. This accordingly, will cause a vacuum or pressure differential, .DELTA.P, between the port 1120 side of the line 1110 and the pump 1140 side of the line.” [0034]; “the variable flow restrictor 150 is configured to deform a specific, localized, deformable segment 115 of the aspiration line 110. By distorting the cross-sectional area of the segment 115 into a smaller total area or by significantly distorting the width vs. height ratio of the segment 115, the instantaneous effective resistance can be increased, which inversely lowers both the current actual volumetric flow rate and also the theoretical maximum volumetric flow rate potential of the fluid.” [0028]; wherein the disclosed ΔP is partially based on the constant radius of the aspiration line 1110 outside of flow restrictor 1200 and/or the constant radius when the flow restrictor 1200 is in a fully open position and the aspiration line 1110 is unrestricted and the constant length of the line between the sensors 1300/1350 shown in Figure 6. Noted that the limitation “an inner radius of the at least one aspiration line along the length L” does not require that the inner radius is constant and unable to adjusted along the entirety of the length L. Additionally, if the flow restrictor 1200 is in a fully open position and the aspiration line 1110 is unrestricted and having a constant radius over the entirety of its length, the ΔP is still based in part on the constant inner radius as claimed);
wherein the difference represents a change in intraoperative pressure due to aspiration fluid outflow changes along the at least one aspiration line, and a corresponding difference in pressure detected by the first sensor and the second sensor (“By utilizing the first and second vacuum sensors 1300/1350, a ΔP (Pport-side-Ppump-side) pressure differential can be measured and utilized in a computer-based algorithm…to detect the onset, presence, breakage, or elimination of an occlusion. If the flow restrictor 1200 is a variable flow restrictor, then the vacuum-based aspiration system 1000 can provide both computer-based detection of occlusion and precise control of the volumetric flow rate while still maintaining the vacuum-based pump's 1140 full range of operation” [0034] wherein “the onset, presence, breakage, or elimination of an occlusion” changes the intraoperative pressure of the system, specifically along the aspiration line and between the sensors); and
wherein a pressure of the aspiration line is changed in proportion to the difference between the first measurement value and the second measurement value (“By utilizing the first and second vacuum sensors 1300/1350, a ΔP (Pport-side-Ppump-side) pressure differential can be measured and utilized in a computer-based algorithm…to detect the onset, presence, breakage, or elimination of an occlusion. If the flow restrictor 1200 is a variable flow restrictor, then the vacuum-based aspiration system 1000 can provide both computer-based detection of occlusion and precise control of the volumetric flow rate while still maintaining the vacuum-based pump's 1140 full range of operation” [0034]; “The most common approach to preventing or minimizing the post-occlusion surge is to quickly adjust the vacuum-level or rate of fluid flow in the aspiration line 45 and/or the ultrasonic power of the handpiece 10 upon detection of an occlusion.” [0007], wherein based on ΔP, an occlusion or the elimination of an occlusion is detected, and the flow/pressure through the aspiration line is changed in proportion to ΔP), where the difference between the first measurement value and the second measurement value is ΔP ([0034]).
Gerg fails to explicitly teach the first sensor is located on the surgical handpiece or adjacent to the proximal end of the surgical handpiece; and wherein a pressure of the at least one irrigation line is changed in proportion to the difference between the first and second measurement value according to Irrigation Pressure(t)=Irrigation Pressure(t-1) +/- ΔP, where Irrigation Pressure(t-1) is a target intraocular pressure.
Gordon teaches a system for detecting intraocular pressure events during phacoemulsification surgery (Figure 1), the system comprising using an aspiration pressure sensor for detecting a change in pressure ΔP (“Upon occlusion break, the aspiration pressure sensor 1160 detects a drop in pressure in aspiration line 1155” [0047]; “the aspiration pressure sensor 1160 may also detect the presence of an occlusion” [0049]), wherein a pressure of the at least one irrigation line is changed in proportion to a change in pressure ΔP (“The controller may use a reading from the aspiration pressure sensor to determine if an occlusion is present or if an occlusion break occurs. In such a case, the controller may control the pressurized irrigation fluid source to accommodate for changes in fluid flow that result from the occlusion or the occlusion break.” [0016]) according to Irrigation Pressure(t)=Irrigation Pressure(t-1) +/- ΔP, where Irrigation Pressure(t-1) is a target intraocular pressure (“Upon occlusion break, the aspiration pressure sensor 1160 detects a drop in pressure in aspiration line 1155…Signals from the irrigation pressure sensor 1130 and/or the aspiration pressure sensor 1160 may be used by the controller 1230 to control the irrigation source 1105” [0047]; “when an occlusion occurs, irrigation pressure may increase as the fluid aspirated from the eye decreases. An increase in irrigation fluid pressure detected by irrigation pressure sensor 1130 can be used to control pressurized irrigation fluid source 1105 to regulate the pressure in eye 1145--that is to keep the pressure in eye 1145 within an acceptable range. In such a case, the aspiration pressure sensor 1160 may also detect the presence of an occlusion and a reading from it may be used by controller 1230 to control pressurized irrigation source 1105” [0049]; “a surgeon selects a desired IOP. The pressurized irrigation fluid source 1105 is then controlled to maintain the desired IOP…When an occlusion is present (as detected by the irrigation pressure sensor 1130 or the aspiration pressure sensor 1160), IOP can be maintained by this control scheme. On occlusion break (as detected by the irrigation pressure sensor 1130 or the aspiration pressure sensor 1160), the pressurized irrigation fluid source 1105 can be controlled to maintain a relatively constant IOP.” [0068], See further detailed in [0072-0073]. A change in pressure ΔP, such as a pressure drop or increase, is determined by the aspiration and/or irrigation pressure sensor (see [0016] and [0047-0049]), and the irrigation pressure is changed based on the detected change in pressure and the target/desired IOP).
Before the effective filing date of the claimed invention, it would have been obvious to modify the system of Gerg to include that a pressure of the at least one irrigation line is changed in proportion to the difference between the first measurement value and the second measurement value ΔP (as disclosed by Gerg) according to Irrigation Pressure(t)=Irrigation Pressure(t-1) +/- ΔP, where Irrigation Pressure(t-1) is a target intraocular pressure based on the teachings of Gordon to maintain consistent intraocular pressure throughout surgery, particularly by counteracting post-occlusion surge (Gordon [0048]).
Modified Gerg fails to explicitly teach the first sensor is located on the surgical handpiece or adjacent to the proximal end of the surgical handpiece.
Wilson teaches a system (Figure 1) for detecting occlusion or post occlusion surge ([0039]), the system comprising a surgical console (console 100), a surgical handpiece (hand piece 112), and a first sensor (sensor 392) in communication with an aspiration line (aspiration path 375; “a sensor 392 associated with the aspiration system 365. In some exemplary embodiments, the sensor 392 may be located along the aspiration path 375” [0026]) and located on the surgical handpiece or adjacent to the proximal end of the surgical handpiece (Figure 3; [0039]) for providing a first measurement value (“the sensor 392 can accurately read the pressure conditions in the aspiration conduit 370 very close to the surgical site” [0039]).
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 first sensor of Gerg to be located on the surgical handpiece or adjacent the proximal end of the surgical handpiece based on the teachings of Wilson to provide accurate readings of the aspiration very close to the surgical site, which would allow for more accurate measurement of the pressure on the port side of the aspiration line in order to provide early detection of occlusion breaks and therefor allow for early response to prevent occlusion surges (Wilson [0039]).
Regarding claim 2, modified Gerg teaches the system of claim 1, wherein the difference between the first measurement value and the second measurement value is caused by an occlusion at the distal end of the surgical handpiece (“a ΔP (Pport-side-Ppump-side) pressure differential can be measured and utilized in a computer-based algorithm…to detect the onset, presence, breakage, or elimination of an occlusion.” [0034]).
Regarding claim 4, modified Gerg teaches the system of claim 1.
Modified Gerg fails to explicitly teach at least one characteristic of the irrigation fluid is increased by raising an irrigation source communicatively connected to the at least one irrigation line.
Gordon teaches a phacoemulsification system, wherein at least one characteristic of the irrigation fluid is increased by raising an irrigation source communicatively connected to the at least one irrigation line (“raising the IV pole results in a corresponding increase in head pressure and increase in fluid pressure at the eye, resulting in a corresponding increase in irrigation flow rate” [0006]).
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 Gerg to include that a characteristic of the irrigation fluid is increased by raising an irrigation source based on the teachings of Gordon to maintain consistent fluid pressure in the eye during surgery (Gordon [0006]).
Regarding claim 7, modified Gerg teaches the system of claim 1.
Modified Gerg fails to explicitly teach wherein at least one characteristic of the irrigation fluid is decreased by lowering an irrigation source communicatively connected to the at least one irrigation line.
Gordon teaches a phacoemulsification system, wherein at least one characteristic of the irrigation fluid is decreased by lowering an irrigation source communicatively connected to the at least one irrigation line (“lowering the IV pole results in a corresponding decrease in pressure at the eye and corresponding irrigation flow rate to the eye” [0006]).
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 Gerg to include that a characteristic of the irrigation fluid is decreased by lowering an irrigation source based on the teachings of Gordon to maintain consistent fluid pressure in the eye during surgery (Gordon [0006]).
Regarding claim 8, modified Gerg teaches the system of claim 1.
Modified Gerg fails to explicitly teach at least one characteristic of the irrigation fluid is increased to maintain a predetermined intraocular pressure.
Gordon teaches a phacoemulsification system (Figure 1), wherein at least one characteristic of the irrigation fluid is increased to maintain a predetermined intraocular pressure (“When an occlusion breaks and a surge occurs, pressurized irrigation fluid source 1105 increases the pressure of the irrigation fluid in response. Increasing the irrigation pressure of pressurized irrigation fluid source 1105 meets the added fluid demand caused by occlusion break. In this manner, the pressure and resulting operating space in eye 1145 can be maintained at a relatively constant value which may be selected by the surgeon.” [0048]).
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 Gerg to include increasing a characteristic of the irrigation fluid based on the teachings of Gordon to maintain consistent pressure within the eye throughout surgery (Gordon [0048]).
Regarding claim 14, modified Gerg teaches the system of claim 1, wherein the at least one characteristic of the irrigation fluid or the aspiration fluid is selected form the group consisting of pressure, flow rate, and vacuum (“during aspiration, by increasing the effective resistance in a localized segment of the aspiration line 1110, the flow restrictor 1200 will produce a differential volumetric flow rate between the port 1120 side of the line and the pump 1140 side of the line. This accordingly, will cause a vacuum or pressure differential, ΔP, between the port 1120 side of the line 1110 and the pump 1140 side of the line” [0034]).
Regarding claim 16, modified Gerg teaches the system of claim 1, the system having a vent (vent 2122).
Modified Gerg fails to explicitly teach wherein at least one characteristic of the aspiration fluid is changed by venting.
Gordon teaches a phacoemulsification system, wherein at least one characteristic of the aspiration fluid is changed by venting (“to reduce this surge, such as by venting the aspiration line or otherwise limiting the buildup of negative pressure in the aspiration system” [0010]).
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 Gerg to include that a characteristic of the aspiration fluid is changed by venting based on the teachings of Gordon to limit post-occlusion surges and prevent collapse of the eye (Gordon [0009-0010]).
Regarding claims 17 and 19, modified Gerg teaches the system of claim 1.
Modified Gerg fails to explicitly teach a third sensor communicatively connected to the at least one irrigation line or at least one aspiration line for providing a third measurement value, as required by claim 17, and wherein the third sensor is located proximate the surgical console as required by claim 19.
Gordon teaches a phacoemulsification system (Figure 1), comprising a surgical console (outlined in dotted line in Figure 1), a surgical handpiece (hand piece 1150) connected to an irrigation line (irrigation line 1140) and aspiration line (aspiration line 1155), a first sensor (aspiration pressure sensor 1160) associated with the aspiration line for providing a first measurement value (“The aspiration pressure sensor 1160 is associated with the aspiration line 1155 and performs the function of measuring the waste fluid pressure in the aspiration line 1155.” [0038]), and a third sensor (irrigation pressure sensor 1130) communicatively connected to the at least one irrigation line (irrigation line 1140) for providing a third measurement value (“An irrigation pressure sensor 1130 measures the pressure of the irrigation fluid in irrigation line 1140” [0030]), the third sensor is located proximate the surgical console (Figure 1, wherein the surgical console is represented by the dotted line and sensor 1130 is within the dotted line).
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 Gerg to include a third sensor proximate the surgical console for providing a third measurement value based on the teachings of Gordon to provide the system a means of estimating flow rate of the irrigation fluid in order to maintain a constant IOP during surgery (Gordon [0051]).
Regarding claim 22, modified Gerg teaches the system of claim 17.
Modified Gerg fails to explicitly teach one of a flow rate or a pressure of the irrigation fluid in the at least one irrigation line is changed in accordance with a calculated intraocular pressure.
Gordon teaches a phacoemulsification system, wherein a flow rate or a pressure of the irrigation fluid in the at least one irrigation line is changed in accordance with a calculated intraocular pressure (“The irrigation pressure sensor 1130 is used to provide an estimate of IOP…Since irrigation fluid flow (estimated flow through the system as modified by the compensation factor) is related to IOP, the controller 1230 directs the operation of pressurized irrigation fluid source 1105 to maintain a flow rate consistent with the desired IOP.” [0071]).
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 Gerg to include a flow rate or a pressure of the irrigation fluid in the at least one irrigation line is changed in accordance with a calculated intraocular pressure based on the teachings of Gordon to maintain a consistent IOP throughout surgery (Gordon [0071]).
Regarding claim 23, modified Gerg teaches the system of claim 17.
Modified Gerg fails to explicitly teach one of a pressure or a vacuum of the aspiration line is changed in accordance with a calculated intraocular pressure.
Wilson teaches a phacoemulsification system (Figure 1), wherein one of a pressure or a vacuum of the aspiration line is changed in accordance with a calculated intraocular pressure (Figure 4; “If the IOP is outside the desired range, then the system adjusts the pump valve setting to alter the flow at a step 435, thereby directly influencing the IOP. The pump valve adjustment may be done to either increase the flow or to decrease the flow based on the measurement taken.” [0043]; “aspiration and irrigation flows can be adjusted using the pump 360 and the aspiration valve 390” [0041]).
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 Gerg to include wherein one of a pressure or a vacuum of the aspiration line is changed in accordance with a calculated intraocular pressure based on the teachings of Wilson to reduce the effects of a post-occlusion surge (Wilson [0041]).
Regarding claim 24, modified Gerg teaches the system of claim 17.
Modified Gerg fails to explicitly teach one of a flow rate or a pressure of the irrigation fluid in the at least one irrigation line is changed in accordance with a targeted intraocular pressure.
Gordon teaches a phacoemulsification system, wherein a flow rate or a pressure of the irrigation fluid in the at least one irrigation line is changed in accordance with a targeted intraocular pressure (“Since irrigation fluid flow (estimated flow through the system as modified by the compensation factor) is related to IOP, the controller 1230 directs the operation of pressurized irrigation fluid source 1105 to maintain a flow rate consistent with the desired IOP.” [0071]).
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 Gerg to include a flow rate or a pressure of the irrigation fluid in the at least one irrigation line is changed in accordance with a targeted intraocular pressure based on the teachings of Gordon to maintain a consistent IOP throughout surgery (Gordon [0071]).
Regarding claim 25, modified Gerg teaches the system of claim 17.
Modified Gerg fails to explicitly teach one of a pressure or a vacuum of the aspiration line is changed in accordance with a targeted intraocular pressure.
Wilson teaches a phacoemulsification system (Figure 1), wherein one of a pressure or a vacuum of the aspiration line is changed in accordance with a targeted intraocular pressure (Referring to FIG. 4, at a step 420, the surgeon sets a target IOP on the console” [0042]; “If the IOP is outside the desired range, then the system adjusts the pump valve setting to alter the flow at a step 435, thereby directly influencing the IOP. The pump valve adjustment may be done to either increase the flow or to decrease the flow based on the measurement taken.” [0043]; “aspiration and irrigation flows can be adjusted using the pump 360 and the aspiration valve 390” [0041]).
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 Gerg to include wherein one of a pressure or a vacuum of the aspiration line is changed in accordance with a targeted intraocular pressure based on the teachings of Wilson to reduce the effects of a post-occlusion surge (Wilson [0041]).
Regarding claim 26, modified Gerg teaches the system of claim 1.
Modified Gerg fails to explicitly teach a desired intraoperative pressure is predetermined.
Gordon teaches a phacoemulsification system, wherein a desired intraoperative pressure is predetermined (“a surgeon selects a desired IOP” [0068]).
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 Gerg to include that a desired intraoperative pressure is predetermined based on the teachings of Gordon to ensure that the pressure within the eye is maintained at a safe pressure throughout surgery (Gordon [0068]).
Regarding claim 28, modified Gerg teaches the system of claim 1, wherein the first sensor and the second sensor are selected from the group consisting of a flow sensor and a vacuum sensor (first vacuum sensor 2250/1300 and second vacuum sensor 2260/1350).
Regarding claim 29, modified Gerg teaches the system of claim 17.
Modified Gerg fails to explicitly teach the third sensor is selected from the group consisting of a flow sensor and a vacuum sensor.
Gordon teaches a phacoemulsification system comprising a third sensor (irrigation pressure sensor 1130) that is a flow sensor (“the irrigation pressure sensor 1130 may be…a flow sensor” [0036]).
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 Gerg to include a third sensor that is a flow sensor based on the teachings of Gordon to directly measure flow rate in order to more accurately control the IOP during surgery (Gordon [0036]).
Regarding claim 64, modified Gerg teaches the system of claim 1, wherein the aspiration line (aspiration line 1110 in Figure 6, unlabeled in Figure 8) only includes the first sensor (first vacuum sensor 2250, 1300 in Figure 6) and the second sensor (second vacuum sensor 2260, 1350 in Figure 6; wherein there additionally is a variable flow restrictor 1200/2270 associated with the aspiration line. However, the variable flow restrictor is located outside of the aspiration line, as shown in Figures 5a and 5b, and is therefore not included within the aspiration line).
Claims 5, 6, 15, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Gerg et al. (US 2012/0041362) in view of Gordon (US 2014/0114237) and in further view of Wilson et al. (US 2014/0163455) as applied in claim 1 above, and further in view of Claus et al. (US 2006/0224107).
Regarding claim 5, modified Gerg teaches the system of claim 1, wherein at least on characteristic of fluid in the system is changed in response the difference between the first measurement value and the second measurement value ([0034]).
Modified Gerg fails to explicitly teach at least one characteristic of the irrigation fluid is decreased in response the difference between the first measurement value and the second measurement value.
Modified Claus teaches a system (phacoemulsification system 600) for detecting intraocular pressure events, the system comprising a surgical console (controller 602), a surgical handpiece (handpiece 604) connected to at least one irrigation line and at least one aspiration line ([0062]; Figure 7), wherein at least one characteristic of the irrigation fluid (control system parameter 420) is decreased in response to the difference between the first measurement value and the second measurement value (“the controlled system parameter 420 is the pressure of a pressurized infusion system…the controlled system parameter 420 is the expansion or contraction of an expandable bladder or control volume that is used to increase and/or decrease the capacity of an irrigation line to supply fluid flow into the eye (for example after an occlusion has broken and the aspiration flow suddenly increases).” [0059]; wherein sudden aspiration flow increase would result in a pressure differential in the aspiration line).
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 Gerg to include that at least one characteristic of the irrigation fluid is decreased in response the difference between the first measurement value and the second measurement value based on the teachings of Claus to allow the surgeon to safely and effectively utilize the full range of aspiration rates, vacuum pressure and flow rates while still avoiding unsafe fluidic surges during occlusion events (Claus [0063]).
Regarding claim 6, modified Gerg teaches the system of claim 5, wherein the difference between the first measurement value and the second measurement value decreases (“if an occlusion in the port 1120 occurs, the volumetric flow rate on the port 1120 side of the line will be reduced, which will in turn reduce the pressure, Pport-side, on the port 1120 side of the line, while the vacuum, or pressure, Ppump-side, on the pump 1140 side of the line remains substantially tied to the vacuum-level of the pump” [0034]; “The pressure differential between the two sensors can provide an indication of the onset, presence, and/or elimination of an occlusion.” [0010] wherein the pressure differential decreases upon elimination of an occlusion).
Regarding claim 15, modified Gerg teaches the system of claim 1.
Modified Gerg fails to explicitly teach the at least one characteristic of the irrigation fluid is changed in accordance with being communicatively connected to at least one pressurized infusion tank.
Claus teaches a system (phacoemulsification system 600) comprising a surgical handpiece (handpiece 604) connected to at least one irrigation line and at least one aspiration line ([0062]; Figure 7), wherein at least one characteristic of the irrigation fluid (control system parameter 420) is changed in accordance with being communicatively connected to at least one pressurized infusion tank (“the controlled system parameter 420 is the pressure of a pressurized infusion system…the controlled system parameter 420 is the expansion or contraction of an expandable bladder or control volume that is used to increase and/or decrease the capacity of an irrigation line to supply fluid flow into the eye (for example after an occlusion has broken and the aspiration flow suddenly increases).” [0059]).
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 Gerg to include that the at least one characteristic of the irrigation fluid is changed in accordance with being communicatively connected to at least one pressurized infusion tank based on the teachings of Claus to allow the surgeon to safely and effectively utilize the full range of aspiration rates, vacuum pressure and flow rates while still avoiding unsafe fluidic surges during occlusion events (Claus [0063]).
Regarding claim 27, modified Gerg teaches the system of claim 1.
Modified Gerg fails to explicitly teach the at least one characteristic of the irrigation fluid is increased or decreased based on aspiration flow rate or aspiration pressure.
Modified Claus teaches a system (phacoemulsification system 600) comprising a surgical handpiece (handpiece 604) connected to at least one irrigation line and at least one aspiration line ([0062]; Figure 7), wherein at least one characteristic of the irrigation fluid (control system parameter 420) is increased or decreased based on aspiration flow rate or aspiration pressure (“the controlled system parameter 420 is the pressure of a pressurized infusion system…the controlled system parameter 420 is the expansion or contraction of an expandable bladder or control volume that is used to increase and/or decrease the capacity of an irrigation line to supply fluid flow into the eye (for example after an occlusion has broken and the aspiration flow suddenly increases).” [0059]).
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 Gerg to include that the at least one characteristic of the irrigation fluid is changed is increased or decreased based on aspiration flow rate or aspiration pressure based on the teachings of Claus to allow the surgeon to safely and effectively utilize the full range of aspiration rates, vacuum pressure and flow rates while still avoiding unsafe fluidic surges during occlusion events (Claus [0063]).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Gerg et al. (US 2012/0041362) in view of Gordon (US 2014/0114237) and in further view of Wilson et al. (US 2014/0163455) as applied in claim 1 above, and further in view of Injev (US 2011/0295191).
Regarding claims 9 and 10, modified Gerg teaches the system of claim 1, further comprising a graphical user interface (monitor 2132) as required by claim 9.
Modified Gerg fails to explicitly teach the graphical user interface for receiving and displaying an alert associated with a change in irrigation pressure as required by claim 9, wherein the alert comprises an audible component as required by claim 10.
Injev teaches a phacoemulsification system (emulsification surgical machine 100) comprising a graphical user interface (display screen 104 and “input device” [0026]) for receiving and displaying an alert associated with a change in irrigation pressure, the alert comprising an audible component (“When the measured infusion pressure passes the threshold, the controller 103 generates a fault signal… the controller 103 activates a visual alert to notify the health care provider that the measured infusion pressure is outside the acceptable range. These visual alerts may include a message displayed on the panel display 104… include an audible signal generated to alert the health care provider to the unacceptable infusion pressure” [0050]).
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 graphical user interface of Gerg to be for receiving and displaying an audible alert associated with a change in irrigation pressure based on the teachings of Injev to inform the user that the irrigation pressure is too high and therefore reduce risk to the patient’s eye by ensuring that IOP is consistent throughout surgery (Injev [0050]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Gerg et al. (US 2012/0041362) in view of Gordon (US 2014/0114237) and in further view of Wilson et al. (US 2014/0163455) as applied in claim 1 above, and further in view of Polaschegg et al. (USPN 6533747).
Regarding claim 11, modified Gerg teaches the system of claim 1.
Modified Gerg fails to explicitly teach wherein an alert is provided when at least one of the first measurement value or second measurement value is at or near atmospheric pressure.
Polaschegg teaches a fluid infusion and aspiration system (Figure 1A) comprising a sensor (sensor 109) providing a first measurement value (“pressure signal from the sensor 109” [Col 8, line 9]), wherein an alert is provided (“In response to this condition, the microprocessor stops the pump and alarms the user.” [Col 8, line 24]) when the measurement value is at or near atmospheric pressure (“The same pressure signal from the sensor 109 is used to detect the disconnect of the withdrawal bloodline 104 from the needle 102. This condition is detected by the abrupt decrease of the withdrawal pressure generated by the pump. The resistance of the 18 Gage needle…at a flow rate corresponding to a 60 mmHg, pressure drop is on the order of the 100 mmHg. The resistance of 2 meters of blood tubing…at the same flow rate is on the order of 20 mmHg.” [Col 8, line 9]; “All pressure measurements in the fluid extraction system are referenced to atmospheric” [Col 7, line 61]).
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 Gerg to include an alert is provided when at least one of the first measurement value or second measurement value is at or near atmospheric pressure based on the teachings of Polaschegg to alert the operator when either the infusion or aspiration line is disconnected (Polaschegg [Col 8, line 9]).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Gerg et al. (US 2012/0041362) in view of Gordon (US 2014/0114237) and in further view of Wilson et al. (US 2014/0163455) as applied in claim 1 above, and further in view of Calderin et al. (USPN 9482563)
Regarding claim 12, modified Gerg teaches the system of claim 1.
Modified Gerg fails to explicitly teach wherein one of the first measurement value and the second measurement value are stored.
Calderin teaches a fluid delivery system (Figure 1) comprising a first sensor (pressure transducer 10) and a second sensor (pressure transducer 12), wherein a first measurement value and a second measurement value are stored (“the controller performs at least the following functions: it selectively receives and stores pressure data from each of the two pressure transducers, storing it preferably along with the time at which the data was generated or received” [Col 4, line 50]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the system of Gerg to include that one of the first measurement value and the second measurement value are stored based on the teachings of Calderin to provide a means to calculate the total volume of fluid delivered during a phacoemulsification surgery (Calderin [Col 1, line 55]).
Regarding claim 13, modified Gerg teaches the system of claim 1.
Modified Gerg fails to explicitly teach wherein a first measurement value stored prior to surgery is compared to a first measurement value stored during surgery as required by claim 13.
Calderin teaches a fluid delivery system (Figure 1) comprising a first sensor (pressure transducer 10) and a second sensor (pressure transducer 12), wherein a first measurement value stored prior to surgery is compared to a first measurement value stored during surgery (“the controller performs at least the following functions: it selectively receives and stores pressure data from each of the two pressure transducers, storing it preferably along with the time at which the data was generated or received” [Col 4, line 50]; Figures 5 and 6 wherein before surgery is at time 400 and during is at time 600).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the system of Gerg to include that a first measurement value stored prior to surgery is compared to a first measurement value stored during surgery based on the teachings of Calderin to provide a means to calculate the total volume of fluid delivered during a phacoemulsification surgery (Calderin [Col 1, line 55]).
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Gerg et al. (US 2012/0041362) in view of Gordon (US 2014/0114237) and in further view of Wilson et al. (US 2014/0163455) as applied in claim 1 above, and further in view of Bui (US 2002/0019607).
Regarding claims 17-19, modified Gerg teaches the system of claim 1.
Modified Gerg fails to explicitly teach a third sensor communicatively connected to the at least one irrigation line or at least one aspiration line for providing a third measurement value as required by claim 17, wherein at least one characteristic of the irrigation fluid in the at least one irrigation line is changed in accordance with a difference between the first measurement value and the third measurement value as required by claim 18, and the third sensor is located proximate the surgical console as required by claim 19.
Bui teaches a system (system 10) for detecting intraocular pressure events during phacoemulsification surgery ([0023]), the system comprising: a surgical console (Figure 1, irrigation system 14 and aspiration system 16); a surgical handpiece (handpiece 20) communicatively connected to an irrigation line (irrigation line 30) and an aspiration line (aspiration line 22); a first sensor (pressure sensor 27) in communication with the at least one aspiration line for providing a first measurement value (“pressure sensor 27 that senses the pressure of the aspiration line 22.” [0011]); and a third sensor (accumulator pressure sensor 34) communicatively connected to the at least one irrigation line (“an accumulator pressure sensor 34 coupled to the irrigation line 30” [0013]) for providing a third measurement value ([0014-0015]) proximate the surgical console (Figure 1, wherein sensor 34 is within the irrigation system 14/surgical console); wherein at least one characteristic of irrigation fluid in the at least one irrigation line is changed in accordance with a difference between the first measurement value and the third measurement value (“The threshold resistance value(s) can be normalized with the actual resistance of the system by either calculating the system resistance…The system resistance can be calculated by allowing irrigation fluid to flow through the irrigation line, test chamber and aspiration line, and then determining the resistance by dividing the sensed differential pressure by the measured flowrate. The flowrate can be determined from the speed of the pump 28. The differential pressure can be determined from the pressures sensed by sensors 27 and 34.” [0025], wherein the system resistance includes characteristics of the irrigation fluid in the irrigation line).
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 Gerg to include a third sensor proximate the surgical console communicatively connected to the irrigation line for providing a third measurement value, wherein at least one characteristic of the irrigation fluid in the at least one irrigation line is changed in accordance with a difference between the first measurement value and the third measurement value based on the teachings of Bui to accurately determine the fluidic resistance within the entire system in order to determine the presence of an occlusion in a manner that allows for control and adjustment of both the upstream irrigation fluid and the downstream aspiration fluid in order to clear the occlusion (Bui [0006, 0023-0026]).
Claims 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Gerg et al. (US 2012/0041362) in view of Gordon (US 2014/0114237) in further view of Wilson et al. (US 2014/0163455) in further view of Artsyukhovich et al. (US 2015/0057524).
Regarding claim 30, Gerg discloses a system (system 2000) for phacoemulsification surgery, the system comprising:
a surgical console (control unit 2102, shown outlined in dotted line in Figure 8) including at least one computing processor (microprocessor computer 2110) capable of accessing at least one computing memory (“a computer-based algorithm” [0034]) associated with the at least one computing processor (“The control unit 2102 further includes a microprocessor computer 2110 which is operably connected to and controls the various other elements of the system…in accordance with algorithms described in the Claus application referenced above. A pressure differential .DELTA.P sensor 2120 provides an input to the computer 2110 representing the pressure differential between the first and second vacuum sensors 2250/2260.” [0039]);
a surgical handpiece (handpiece 2104) having a distal end and a proximal end (Figure 8), the proximal end being communicatively connected to at least one irrigation line (from irrigation source 2128) and at least one aspiration line (aspiration line 1110 in Figure 6, unlabeled in Figure 8);
a first sensor (first vacuum sensor 2250, 1300 in Figure 6) in communication with the at least one aspiration line (Figures 6 and 8) and located between the distal end of the surgical handpiece (at port 1120) and a second sensor (Figure 6 and 8) for providing a first real-time measurement value (Pport-side); and
a second sensor (second vacuum sensor 2260, 1350 in Figure 6) in communication with the at least one aspiration line and located within the surgical console (Figures 6 and 8, sensor 2260 within dotted line denoting control unit/surgical console 2102) for providing a second real-time measurement value (Ppump-side);
wherein at least one characteristic of the phacoemulsification surgery is changed in accordance with a difference between the first real-time measurement value and the second real-time measurement value (“By utilizing the first and second vacuum sensors 1300/1350, a ΔP (Pport-side-Ppump-side) pressure differential can be measured and utilized in a computer-based algorithm…to detect the onset, presence, breakage, or elimination of an occlusion. If the flow restrictor 1200 is a variable flow restrictor, then the vacuum-based aspiration system 1000 can provide both computer-based detection of occlusion and precise control of the volumetric flow rate while still maintaining the vacuum-based pump's 1140 full range of operation” [0034]; “an improved system and method for controlling the rate of fluid flow and vacuum based on the detection of occlusion within a fluid circuit” [0008], control of rate of fluid flow vacuum discussed in [0028], wherein ΔP is the difference between the first real-time measurement value and the second real-time measurement value, and ΔP is directly proportion to the flow rate through the aspiration line), wherein the difference is based in part on, constants L and r, where L = a length of the at least one aspiration line between the first sensor and the second sensor and r = an inner radius of the at least one aspiration line along the length L (“As one of ordinary skill in the art would appreciate, during aspiration, by increasing the effective resistance in a localized segment of the aspiration line 1110, the flow restrictor 1200 will produce a differential volumetric flow rate between the port 1120 side of the line and the pump 1140 side of the line. This accordingly, will cause a vacuum or pressure differential, .DELTA.P, between the port 1120 side of the line 1110 and the pump 1140 side of the line.” [0034]; “the variable flow restrictor 150 is configured to deform a specific, localized, deformable segment 115 of the aspiration line 110. By distorting the cross-sectional area of the segment 115 into a smaller total area or by significantly distorting the width vs. height ratio of the segment 115, the instantaneous effective resistance can be increased, which inversely lowers both the current actual volumetric flow rate and also the theoretical maximum volumetric flow rate potential of the fluid.” [0028]; wherein the disclosed ΔP is partially based on the constant radius of the aspiration line 1110 outside of flow restrictor 1200 and/or the constant radius when the flow restrictor 1200 is in a fully open position and the aspiration line 1110 is unrestricted and the constant length of the line between the sensors 1300/1350 shown in Figure 6. Noted that the limitation “an inner radius of the at least one aspiration line along the length L” does not require that the inner radius is constant and unable to adjusted along the entirety of the length L. Additionally, if the flow restrictor 1200 is in a fully open position and the aspiration line 1110 is unrestricted and having a constant radius over the entirety of its length, the ΔP is still based in part on the constant inner radius as claimed).
Gerg fails to explicitly teach the system is for calibrating patient eye level and wound leakage during phacoemulsification surgery, the first sensor located on the surgical handpiece or adjacent to the proximal end of the surgical handpiece, wherein at least one characteristic of a wound leakage calibration is changed in according with a difference between the first real-time measurement value and the second real-time measurement value; wherein a target intraocular pressure is maintained in accordance with the changed at least one characteristic of the wound leakage calibration by adjusting aspiration pressure or adjusting both aspiration pressure and irrigation pressure; and wherein the system calculates a total intraocular pressure at distinct time points before and during the phacoemulsification surgery.
Gordon discloses a system for calibrating patient eye level and wound leakage during phacoemulsification surgery (“FIG. 1 is a diagram of the components in the fluid path of a phacoemulsification system including a pressurized irrigation source according to the principles of the present invention” [0029]; “This calculation of incision leakage may then be used to more accurately determine the compensation factor. In one embodiment of the of the present invention, the compensation factor is determined dynamically based in part on the calculated incision leakage.” [0076]), the system comprising: a surgical console (dotted outline shown Figure 1); a surgical handpiece (hand piece 1150) having a proximal end (Figure 1) communicatively connected to at least one irrigation line (irrigation line 1140) and at least one aspiration line (aspiration line 1155); a second sensor (aspiration pressure sensor 1160) in communication with the at least one aspiration line and located within the surgical console (Figure 1 showing sensor 1160 is located within dotted outline denoting the surgical console) for providing a second real-time measurement value (“The sensor 1160, like the sensor 1130, may be any suitable type of sensor, such as a flow sensor that detects actual fluid flow.” [0038]);
wherein at least one characteristic of a wound leakage calibration (compensation factor determined by calculated incision leakage [0076]) is changed in accordance with the second real-time measurement value, which is related to the aspiration flow rate (“Using the calculated values for irrigation flow and aspiration flow, one can find incision leakage as the difference between irrigation flow and aspiration flow. This calculation of incision leakage may then be used to more accurately determine the compensation factor. In one embodiment of the present invention, the compensation factor is determined dynamically based in part on the calculated incision leakage” [0076]); wherein a target intraocular pressure is maintained in accordance with the changed at least one characteristic of wound leakage calibration by adjusting the irrigation pressure (“The pressurized irrigation fluid source 1105 is then controlled to maintain the desired IOP.” [0068]; “control of the pressurized irrigation fluid source 1105 can be based on irrigation pressure and flow through the system as modified by the compensation factor…Flow through the system as modified by the compensation factor can be used to compensate for incision leakage and sleeve compression and maintain a relatively constant IOP. Collectively, these parameters can be used to maintain a relatively constant IOP during the procedure.” [0066]), wherein the system calculates a total intraocular pressure at distinct time points during the phacoemulsification surgery (“the method may also comprise one or more of the following:…calculating an intraocular pressure of an eye based on the reading from the irrigation pressure sensor; calculating an intraocular pressure of an eye based on the estimated flow value modified by the compensation factor” [0021]).
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 Gerg to be for calibrating patient eye level and wound leakage during phacoemulsification surgery, wherein at least one characteristic of a wound leakage calibration is changed in according with a difference between the first real-time measurement value and the second real-time measurement value (ΔP, as disclosed by Gerg), wherein a target intraocular pressure is maintained in accordance with the changed at least one characteristic of the wound leakage calibration by adjusting irrigation pressure; and wherein the system calculates a total intraocular pressure at distinct time points during the phacoemulsification surgery based on the teachings of Gordon to dynamically maintain a relatively constant intraocular pressure throughout a phacoemulsification surgery by compensating for incision leakage (Gordon [0066], [0076]).
Modified Gerg fails to explicitly teach the first sensor located on the surgical handpiece or adjacent to the proximal end of the surgical handpiece, wherein a target intraocular pressure is maintained in accordance with the changed at least one characteristic of the wound leakage calibration by adjusting aspiration pressure; and wherein the system calculates a total intraocular pressure at distinct time points before the phacoemulsification surgery.
Wilson teaches a phacoemulsification system (Figure 1), the system comprising a surgical console (console 100), a surgical handpiece (hand piece 112), and a first sensor (sensor 392) in communication with an aspiration line (aspiration path 375; “a sensor 392 associated with the aspiration system 365. In some exemplary embodiments, the sensor 392 may be located along the aspiration path 375” [0026]) and located on the surgical handpiece or adjacent to the proximal end of the surgical handpiece (Figure 3; [0039]) for providing a first measurement value (“the sensor 392 can accurately read the pressure conditions in the aspiration conduit 370 very close to the surgical site” [0039]); and wherein the target intraocular pressure is maintained by adjusting aspiration pressure (Referring to FIG. 4, at a step 420, the surgeon sets a target IOP on the console” [0042]; “If the IOP is outside the desired range, then the system adjusts the pump valve setting to alter the flow at a step 435, thereby directly influencing the IOP. The pump valve adjustment may be done to either increase the flow or to decrease the flow based on the measurement taken.” [0043]; “aspiration and irrigation flows can be adjusted using the pump 360 and the aspiration valve 390” [0041]).
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 Gerg to include that the first sensor is located on the surgical handpiece or adjacent the proximal end of the surgical handpiece based on the teachings of Wilson to provide accurate readings of the aspiration very close to the surgical site, which would allow for more accurate measurement of the pressure on the port side of the aspiration line in order to provide early detection of occlusion breaks and therefor allow for early response to prevent occlusion surges (Wilson [0039]) and to modify the system of Gerg in view of Gordon to include that the target intraocular pressure is maintained in accordance with the changed characteristic of wound leakage calibration at least by adjusting aspiration pressure based on the teachings of Wilson to reduce the effects of a post-occlusion surge (Wilson [0041]).
Modified Gerg fails to explicitly teach wherein the system calculates a total intraocular pressure at distinct time points before the phacoemulsification surgery.
Artsyukhovich teaches a system for calibration during phacoemulsification surgery (Figure 8, detailed in paragraphs [0045-0051]; see Figure 8, step 306 regarding phacoemulsification: “With the instruments in the eye, at a step 306, the surgeon begins emulsifying the lens or the cataracts to prepare the eye for an implantable intraocular lens.” [0046]), the system comprising calculating a total intraocular pressure at distinct time points before (“Prior to surgery, the surgeon may measure the patient's IOP in order to determine a normal or natural pressure or IOP for the patient.” [0045]) and during phacoemulsification surgery (“At a step 308, the surgeon may pause the surgical procure to take intraoperative biometry and/or refractive measurements in the eye…at a step 310, the control unit or other controller may convert the measured pressure to IOP in order to provide a more accurate indication of the state of the eye at a particular time.” [0047]).
Before the effective filing date of the claimed invention, it would have been obvious to further modify the system of Gerg to include that the system calculates a total intraocular pressure at distinct time points before and during the phacoemulsification surgery based on the teachings of Artsyukhovich to determine a baseline normal intraocular pressure for the patient and ensure that the replacement lens will fit properly after surgery (Artsyukhovich [0045-0051]).
Regarding claim 31, modified Gerg teaches the system of claim 30.
Modified Gerg fails to explicitly teach wherein wound leakage is determined by the size of the incision made during the surgery.
Gordon teaches a system (Figure 1) for calibrating patient eye level and wound leakage during phacoemulsification surgery (“FIG. 1 is a diagram of the components in the fluid path of a phacoemulsification system including a pressurized irrigation source according to the principles of the present invention” [0029]; “This calculation of incision leakage may then be used to more accurately determine the compensation factor. In one embodiment of the of the present invention, the compensation factor is determined dynamically based in part on the calculated incision leakage.” [0076]), wherein wound leakage is determined by the size of the incision made during the surgery (“Surgeons also prefer different sizes of needles and sleeves as well as different incision sizes. These surgeon specific factors also impact incision leakage and sleeve compression.” [0059]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the system of Gerg to include that wound leakage is determined by the size of the incision made during the surgery based on the teachings of Gordon to dynamically maintain a relatively constant intraocular pressure throughout a phacoemulsification surgery by compensating differences in surgical techniques (Gordon [0059], [0066]).
Claims 34-38 are rejected under 35 U.S.C. 103 as being unpatentable over Gerg et al. (US 2012/0041362) in view Wilson et al. (US 2014/0163455) in further view of Claus et al. (US 2006/0224107) and in further view of Gordon (US 2014/0114237).
Regarding claim 34, Gerg discloses a system (system 2000) for detecting occlusion or post occlusion surge, the system comprising:
a surgical console (control unit 2102) including at least one computing processor (microprocessor computer 2110) capable of accessing at least one computing memory (“a computer-based algorithm” [0034]) associated with the at least one computing processor (“The control unit 2102 further includes a microprocessor computer 2110 which is operably connected to and controls the various other elements of the system…in accordance with algorithms described in the Claus application referenced above. A pressure differential .DELTA.P sensor 2120 provides an input to the computer 2110 representing the pressure differential between the first and second vacuum sensors 2250/2260.” [0039]);
a surgical handpiece (handpiece 2104) having a distal end and a proximal end (Figure 8), the proximal end being communicatively connected to at least one irrigation line (from irrigation source 2128) and at least one aspiration line (aspiration line 1110 in Figure 6, unlabeled in Figure 8);
a first sensor (first vacuum sensor 2250, 1300 in Figure 6) in communication with the at least one aspiration line (Figures 6 and 8) located between the distal end of the surgical handpiece (at port 1120) and a second sensor (Figure 6 and 8) for providing a first measurement value (Pport-side); and
a second sensor (second vacuum sensor 2260, 1350 in Figure 6) in communication with the at least one aspiration line and located within the surgical console (Figures 6 and 8, sensor 2260 within dotted line denoting control unit/surgical console 2102) for providing a second measurement value (Ppump-side);
wherein at least one characteristic of an irrigation fluid and/or an aspiration fluid in the at least one irrigation line and/or at least one aspiration line is changed in accordance with a difference between the first measurement value of the first sensor and the second measurement value of the second sensor (“By utilizing the first and second vacuum sensors 1300/1350, a ΔP (Pport-side-Ppump-side) pressure differential can be measured and utilized in a computer-based algorithm…to detect the onset, presence, breakage, or elimination of an occlusion. If the flow restrictor 1200 is a variable flow restrictor, then the vacuum-based aspiration system 1000 can provide both computer-based detection of occlusion and precise control of the volumetric flow rate while still maintaining the vacuum-based pump's 1140 full range of operation” [0034]; “an improved system and method for controlling the rate of fluid flow and vacuum based on the detection of occlusion within a fluid circuit” [0008], control of rate of fluid flow vacuum discussed in [0028]), wherein the difference is based, at least in part on constants L and r, wherein L = a length of the at least one aspiration line between the first and second sensors and r = an inner radius of the at least one aspiration line along the length L (“As one of ordinary skill in the art would appreciate, during aspiration, by increasing the effective resistance in a localized segment of the aspiration line 1110, the flow restrictor 1200 will produce a differential volumetric flow rate between the port 1120 side of the line and the pump 1140 side of the line. This accordingly, will cause a vacuum or pressure differential, .DELTA.P, between the port 1120 side of the line 1110 and the pump 1140 side of the line.” [0034]; “the variable flow restrictor 150 is configured to deform a specific, localized, deformable segment 115 of the aspiration line 110. By distorting the cross-sectional area of the segment 115 into a smaller total area or by significantly distorting the width vs. height ratio of the segment 115, the instantaneous effective resistance can be increased, which inversely lowers both the current actual volumetric flow rate and also the theoretical maximum volumetric flow rate potential of the fluid.” [0028]; wherein the disclosed ΔP is partially based on the constant radius of the aspiration line 1110 outside of flow restrictor 1200 and/or the constant radius when the flow restrictor 1200 is in a fully open position and the aspiration line 1110 is unrestricted and the constant length of the line between the sensors 1300/1350 shown in Figure 6. Noted that the limitation “an inner radius of the at least one aspiration line along the length L” does not require that the inner radius is constant and unable to adjusted along the entirety of the length L. Additionally, if the flow restrictor 1200 is in a fully open position and the aspiration line 1110 is unrestricted and having a constant radius over the entirety of its length, the ΔP is still based in part on the constant inner radius as claimed);
wherein the difference represents a change in intraoperative pressure due to aspiration fluid outflow changes along the at least one aspiration line, and a corresponding difference in pressure ΔP detected by the first sensor and the second sensor (“By utilizing the first and second vacuum sensors 1300/1350, a ΔP (Pport-side-Ppump-side) pressure differential can be measured and utilized in a computer-based algorithm…to detect the onset, presence, breakage, or elimination of an occlusion. If the flow restrictor 1200 is a variable flow restrictor, then the vacuum-based aspiration system 1000 can provide both computer-based detection of occlusion and precise control of the volumetric flow rate while still maintaining the vacuum-based pump's 1140 full range of operation” [0034] wherein “the onset, presence, breakage, or elimination of an occlusion” changes the intraoperative pressure of the system, specifically along the aspiration line and between the sensors); and
wherein a pressure of the aspiration line is changed in proportion to the difference between the first measurement value and the second measurement value (“By utilizing the first and second vacuum sensors 1300/1350, a ΔP (Pport-side-Ppump-side) pressure differential can be measured and utilized in a computer-based algorithm…to detect the onset, presence, breakage, or elimination of an occlusion. If the flow restrictor 1200 is a variable flow restrictor, then the vacuum-based aspiration system 1000 can provide both computer-based detection of occlusion and precise control of the volumetric flow rate while still maintaining the vacuum-based pump's 1140 full range of operation” [0034]; “The most common approach to preventing or minimizing the post-occlusion surge is to quickly adjust the vacuum-level or rate of fluid flow in the aspiration line 45 and/or the ultrasonic power of the handpiece 10 upon detection of an occlusion.” [0007], wherein based on ΔP an occlusion or the elimination of an occlusion is detected, and the flow/pressure through the aspiration line is changed in proportion to ΔP), where the difference between the first measurement value and the second measurement value is ΔP ([0034]).
Gerg fails to explicitly teach the first sensor is located on the surgical handpiece or adjacent to the proximal end of the surgical handpiece, and wherein at least one characteristic of an aspiration fluid in the at least one aspiration line is changed in accordance with the difference compared to a predetermined occlusion value or predetermined range of occlusion values; wherein a pressure of the at least one irrigation line is changed in proportion to the difference between the first and second measurement value according to Irrigation Pressure(t)=Irrigation Pressure(t-1) +/- ΔP, where Irrigation Pressure(t-1) is a target intraocular pressure.
Wilson teaches a system (Figure 1) for detecting occlusion or post occlusion surge ([0039]), the system comprising a surgical console (console 100), a surgical handpiece (hand piece 112), and a first sensor (sensor 392) in communication with an aspiration line (aspiration path 375; “a sensor 392 associated with the aspiration system 365. In some exemplary embodiments, the sensor 392 may be located along the aspiration path 375” [0026]) and located on the surgical handpiece or adjacent to the proximal end of the surgical handpiece (Figure 3; [0039]) for providing a first measurement value (“the sensor 392 can accurately read the pressure conditions in the aspiration conduit 370 very close to the surgical site” [0039]).
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 first sensor of Gerg to be located on the surgical handpiece or adjacent the proximal end of the surgical handpiece based on the teachings of Wilson to provide accurate readings of the aspiration very close to the surgical site, which would allow for more accurate measurement of the pressure on the port side of the aspiration line in order to provide early detection of occlusion breaks and therefor allow for early response to prevent occlusion surges (Wilson [0039]).
Modified Gerg fails to explicitly teach wherein at least one characteristic of an aspiration fluid in the at least one aspiration line is changed in accordance with the difference compared to a predetermined occlusion value or predetermined range of occlusion values; wherein a pressure of the at least one irrigation line is changed in proportion to the difference between the first and second measurement value according to Irrigation Pressure(t)=Irrigation Pressure(t-1) +/- ΔP, where Irrigation Pressure(t-1) is a target intraocular pressure.
Claus teaches a system (phacoemulsification system 600) for detecting occlusion, the system comprising a surgical console (controller 602), a surgical handpiece (handpiece 604) connected to at least one irrigation line and at least one aspiration line (“The irrigation fluid is configured to supply an irrigation fluid source to the eye 608. The aspiration source is configured to apply a vacuum to the handpiece 604 in order to aspirate the irrigation fluid from the eye 608 through the handpiece 604.” [0062]; Figure 7), wherein at least one characteristic of an aspiration fluid (vacuum pressure 420’) in the at least one aspiration line is changed in accordance with a measurement value (occlusion indicating parameter 422) compared to a predetermined occlusion value (“controlled system parameter 420 (in this case the vacuum pressure 420' shown in the upper graph of FIG. 5) of a phacoemulsification system is controlled based, at least in part, on the value of an occlusion indicating parameter 422 (in this case the flow rate 422' shown in lower graph of FIG. 5, for example an irrigation flow or an aspiration flow).” [0052]; “the occlusion threshold value is set at a percentage (i.e. <100%) of the Max Vac level, such as, for example, in a range between about 20% to about 95%” [0037]).
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 Gerg to include wherein at least one characteristic of an aspiration fluid in the at least one aspiration line is changed in accordance with the difference compared to a predetermined occlusion value based on the teachings of Claus to allow the surgeon to safely and effectively utilize the full range of aspiration rates, vacuum pressure and flow rates while still avoiding unsafe fluidic surges during occlusion events (Claus [0063]).
Modified Gerg fails to explicitly teach wherein a pressure of the at least one irrigation line is changed in proportion to the difference between the first and second measurement value according to Irrigation Pressure(t)=Irrigation Pressure(t-1) +/- ΔP, where Irrigation Pressure(t-1) is a target intraocular pressure.
Gordon teaches a system for detecting occlusion or post occlusion surge (Figure 1), the system comprising using an aspiration pressure sensor for detecting a change in pressure ΔP (“Upon occlusion break, the aspiration pressure sensor 1160 detects a drop in pressure in aspiration line 1155” [0047]; “the aspiration pressure sensor 1160 may also detect the presence of an occlusion” [0049]), wherein a pressure of the at least one irrigation line is changed in proportion to a change in pressure ΔP (“The controller may use a reading from the aspiration pressure sensor to determine if an occlusion is present or if an occlusion break occurs. In such a case, the controller may control the pressurized irrigation fluid source to accommodate for changes in fluid flow that result from the occlusion or the occlusion break.” [0016]) according to Irrigation Pressure(t)=Irrigation Pressure(t-1) +/- ΔP, where Irrigation Pressure(t-1) is a target intraocular pressure (“Upon occlusion break, the aspiration pressure sensor 1160 detects a drop in pressure in aspiration line 1155…Signals from the irrigation pressure sensor 1130 and/or the aspiration pressure sensor 1160 may be used by the controller 1230 to control the irrigation source 1105” [0047]; “when an occlusion occurs, irrigation pressure may increase as the fluid aspirated from the eye decreases. An increase in irrigation fluid pressure detected by irrigation pressure sensor 1130 can be used to control pressurized irrigation fluid source 1105 to regulate the pressure in eye 1145--that is to keep the pressure in eye 1145 within an acceptable range. In such a case, the aspiration pressure sensor 1160 may also detect the presence of an occlusion and a reading from it may be used by controller 1230 to control pressurized irrigation source 1105” [0049]; “a surgeon selects a desired IOP. The pressurized irrigation fluid source 1105 is then controlled to maintain the desired IOP…When an occlusion is present (as detected by the irrigation pressure sensor 1130 or the aspiration pressure sensor 1160), IOP can be maintained by this control scheme. On occlusion break (as detected by the irrigation pressure sensor 1130 or the aspiration pressure sensor 1160), the pressurized irrigation fluid source 1105 can be controlled to maintain a relatively constant IOP.” [0068], See further detailed in [0072-0073]. A change in pressure ΔP, such as a pressure drop or increase, is determined by the aspiration and/or irrigation pressure sensor (see [0016] and [0047-0049]), and the irrigation pressure is changed based on the detected change in pressure and the target/desired IOP).
Before the effective filing date of the claimed invention, it would have been obvious to further modify the system of Gerg to include that a pressure of the at least one irrigation line is changed in proportion to the difference between the first measurement value and the second measurement value ΔP (as disclosed by Gerg) according to Irrigation Pressure(t)=Irrigation Pressure(t-1) +/- ΔP, where Irrigation Pressure(t-1) is a target intraocular pressure based on the teachings of Gordon to maintain consistent intraocular pressure throughout surgery, particularly by counteracting post-occlusion surge (Gordon [0048]).
Regarding claim 35, modified Gerg teaches the system of claim 34.
Modified Gerg fails to explicitly teach wherein the predetermined occlusion value is greater than 90% of a maximum set vacuum.
Claus teaches a system (phacoemulsification system 600) for detecting occlusion, the system comprising a surgical console (controller 602), a surgical handpiece (handpiece 604) connected to at least one irrigation line and at least one aspiration line (“The irrigation fluid is configured to supply an irrigation fluid source to the eye 608. The aspiration source is configured to apply a vacuum to the handpiece 604 in order to aspirate the irrigation fluid from the eye 608 through the handpiece 604.” [0062]; Figure 7), wherein at least one characteristic of an aspiration fluid (vacuum pressure 420’) in the at least one aspiration line is changed in accordance with a measurement value (occlusion indicating parameter 422) compared to a predetermined occlusion value that is greater than 90% of a maximum set vacuum (“controlled system parameter 420 (in this case the vacuum pressure 420' shown in the upper graph of FIG. 5) of a phacoemulsification system is controlled based, at least in part, on the value of an occlusion indicating parameter 422 (in this case the flow rate 422' shown in lower graph of FIG. 5, for example an irrigation flow or an aspiration flow).” [0052]; “the occlusion threshold value is set at a percentage (i.e. <100%) of the Max Vac level, such as, for example, in a range between about 20% to about 95%” [0037]).
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 Gerg to include wherein at least one characteristic of an aspiration fluid in the at least one aspiration line is changed in accordance with the difference compared to a predetermined occlusion value greater than 90% of a maximum set vacuum based on the teachings of Claus to allow the surgeon to safely and effectively utilize the full range of aspiration rates, vacuum pressure and flow rates while still avoiding unsafe fluidic surges during occlusion events (Claus [0063]).
Regarding claim 36, modified Gerg teaches the system of claim 34, wherein the at least one characteristic is selected from the group consisting of pressure, flow rate, and vacuum (“during aspiration, by increasing the effective resistance in a localized segment of the aspiration line 1110, the flow restrictor 1200 will produce a differential volumetric flow rate between the port 1120 side of the line and the pump 1140 side of the line. This accordingly, will cause a vacuum or pressure differential, ΔP, between the port 1120 side of the line 1110 and the pump 1140 side of the line…If the flow restrictor 1200 is a variable flow restrictor, then the vacuum-based aspiration system 1000 can provide both computer-based detection of occlusion and precise control of the volumetric flow rate while still maintaining the vacuum-based pump's 1140 full range of operation.” [0034]).
Regarding claim 37, modified Gerg teaches the system of claim 34.
Modified Gerg fails to explicitly teach wherein the at least one characteristic of the irrigation fluid is changed in accordance with being communicatively connected to at least one pressurized infusion tank.
Claus teaches a system (phacoemulsification system 600) for detecting occlusion, the system comprising a surgical console (controller 602), a surgical handpiece (handpiece 604) connected to at least one irrigation line and at least one aspiration line (“The irrigation fluid is configured to supply an irrigation fluid source to the eye 608. The aspiration source is configured to apply a vacuum to the handpiece 604 in order to aspirate the irrigation fluid from the eye 608 through the handpiece 604.” [0062]; Figure 7), wherein at least one characteristic of the irrigation fluid (control system parameter 420) is changed in accordance with being communicatively connected to at least one pressurized infusion tank (“the controlled system parameter 420 is the pressure of a pressurized infusion system…the controlled system parameter 420 is the expansion or contraction of an expandable bladder or control volume that is used to increase and/or decrease the capacity of an irrigation line to supply fluid flow into the eye (for example after an occlusion has broken and the aspiration flow suddenly increases).” [0059]).
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 Gerg to include wherein at least one characteristic of the irrigation fluid is changed in accordance with being communicatively connected to at least one pressurized infusion tank based on the teachings of Claus to allow the surgeon to safely and effectively utilize the full range of aspiration rates, vacuum pressure and flow rates while still avoiding unsafe fluidic surges during occlusion events (Claus [0063]).
Regarding claim 38, modified Gerg teaches the system of claim 34, the system having a vent (vent 2122).
Modified Gerg fails to explicitly teach wherein at least one characteristic of the aspiration fluid is changed by venting.
Gordon teaches a phacoemulsification system, wherein at least one characteristic of the aspiration fluid is changed by venting (“to reduce this surge, such as by venting the aspiration line or otherwise limiting the buildup of negative pressure in the aspiration system” [0010]).
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 Gerg to include that a characteristic of the aspiration fluid is changed by venting based on the teachings of Gordon to limit post-occlusion surges and prevent collapse of the eye (Gordon [0009-0010]).
Claims 48-51 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Gerg et al. (US 2012/0041362) in view of Claus et al. (US 2006/0224107) in further view of Gordon (US 2014/0114237).
Regarding claim 48, Gerg discloses a system (system 2000) for detecting a fluid line abnormality, the system comprising:
a surgical console (control unit 2102) including at least one computing processor (microprocessor computer 2110) capable of accessing at least one computing memory (“a computer-based algorithm” [0034]) associated with the at least one computing processor (“The control unit 2102 further includes a microprocessor computer 2110 which is operably connected to and controls the various other elements of the system…in accordance with algorithms described in the Claus application referenced above. A pressure differential .DELTA.P sensor 2120 provides an input to the computer 2110 representing the pressure differential between the first and second vacuum sensors 2250/2260.” [0039]);
a surgical handpiece (handpiece 2104) having a distal end and a proximal end (Figure 8), the proximal end being communicatively connected to at least one fluid line (aspiration line 1110 in Figure 6, unlabeled in Figure 8);
a first sensor (first vacuum sensor 2250, 1300 in Figure 6) in communication with the at least one fluid line and located proximate to the surgical handpiece (Figures 6 and 8) for providing a first measurement value (Pport-side); and
a second sensor (second vacuum sensor 2260, 1350 in Figure 6) in communication with the at least one fluid line and located proximate the surgical console (Figures 6 and 8, sensor 2260 within dotted line denoting control unit/surgical console 2102) for providing a second measurement value (Ppump-side);
wherein the line abnormality is detected based on a difference between the first measurement value and the second measurement value (“By utilizing the first and second vacuum sensors 1300/1350, a ΔP (Pport-side-Ppump-side) pressure differential can be measured and utilized in a computer-based algorithm…to detect the onset, presence, breakage, or elimination of an occlusion. If the flow restrictor 1200 is a variable flow restrictor, then the vacuum-based aspiration system 1000 can provide both computer-based detection of occlusion and precise control of the volumetric flow rate while still maintaining the vacuum-based pump's 1140 full range of operation” [0034]), wherein the difference is based, at least in part on constants L and r, wherein L = a length of the at least one fluid line between the first sensor and the second sensor and r = an inner radius of the at least one fluid line along the length L (“As one of ordinary skill in the art would appreciate, during aspiration, by increasing the effective resistance in a localized segment of the aspiration line 1110, the flow restrictor 1200 will produce a differential volumetric flow rate between the port 1120 side of the line and the pump 1140 side of the line. This accordingly, will cause a vacuum or pressure differential, .DELTA.P, between the port 1120 side of the line 1110 and the pump 1140 side of the line.” [0034]; “the variable flow restrictor 150 is configured to deform a specific, localized, deformable segment 115 of the aspiration line 110. By distorting the cross-sectional area of the segment 115 into a smaller total area or by significantly distorting the width vs. height ratio of the segment 115, the instantaneous effective resistance can be increased, which inversely lowers both the current actual volumetric flow rate and also the theoretical maximum volumetric flow rate potential of the fluid.” [0028]; wherein the disclosed ΔP is partially based on the constant radius of the aspiration line 1110 outside of flow restrictor 1200 and/or the constant radius when the flow restrictor 1200 is in a fully open position and the aspiration line 1110 is unrestricted and the constant length of the line between the sensors 1300/1350 shown in Figure 6. Noted that the limitation “an inner radius of the at least one aspiration line along the length L” does not require that the inner radius is constant and unable to adjusted along the entirety of the length L. Additionally, if the flow restrictor 1200 is in a fully open position and the aspiration line 1110 is unrestricted and having a constant radius over the entirety of its length, the ΔP is still based in part on the constant inner radius as claimed);
wherein the detected abnormality causes a change of at least one characteristic of a fluid in the at least one fluid line (“if an occlusion in the port 1120 occurs, the volumetric flow rate on the port 1120 side of the line will be reduced, which will in turn reduce the pressure, Pport-side, on the port 1120 side of the line, while the vacuum, or pressure, Ppump-side, on the pump 1140 side of the line remains substantially tied to the vacuum-level of the pump” [0034]);
wherein the difference represents a change in intraoperative pressure along the at least one fluid line between the first sensor and the second sensor (“By utilizing the first and second vacuum sensors 1300/1350, a ΔP (Pport-side-Ppump-side) pressure differential can be measured and utilized in a computer-based algorithm…to detect the onset, presence, breakage, or elimination of an occlusion. If the flow restrictor 1200 is a variable flow restrictor, then the vacuum-based aspiration system 1000 can provide both computer-based detection of occlusion and precise control of the volumetric flow rate while still maintaining the vacuum-based pump's 1140 full range of operation” [0034] wherein “the onset, presence, breakage, or elimination of an occlusion” changes the intraoperative pressure of the system, specifically along the aspiration line and between the sensors); and
wherein a pressure of the aspiration line is changed in proportion to the difference between the first measurement value and the second measurement value (“By utilizing the first and second vacuum sensors 1300/1350, a ΔP (Pport-side-Ppump-side) pressure differential can be measured and utilized in a computer-based algorithm…to detect the onset, presence, breakage, or elimination of an occlusion. If the flow restrictor 1200 is a variable flow restrictor, then the vacuum-based aspiration system 1000 can provide both computer-based detection of occlusion and precise control of the volumetric flow rate while still maintaining the vacuum-based pump's 1140 full range of operation” [0034]; “The most common approach to preventing or minimizing the post-occlusion surge is to quickly adjust the vacuum-level or rate of fluid flow in the aspiration line 45 and/or the ultrasonic power of the handpiece 10 upon detection of an occlusion.” [0007], wherein based on ΔP an occlusion or the elimination of an occlusion is detected, and the flow/pressure through the aspiration line is changed in proportion to ΔP), where the difference between the first measurement value and the second measurement value is ΔP ([0034]).
Gerg fails to explicitly teach wherein the line abnormality is detected based on a difference compared to a predetermined threshold; and wherein a pressure of at least one irrigation line is changed in proportion to the difference between the first and second measurement value according to Irrigation Pressure(t)=Irrigation Pressure(t-1) +/- ΔP, where Irrigation Pressure(t-1) is a target intraocular pressure.
Claus teaches a system (phacoemulsification system 600) for detecting a fluid line abnormality, the system comprising a surgical console (controller 602), a surgical handpiece (handpiece 604) connected to at least one fluid line (“The aspiration source is configured to apply a vacuum to the handpiece 604 in order to aspirate the irrigation fluid from the eye 608 through the handpiece 604.” [0062]; Figure 7), wherein the line abnormality is detected based on a measurement value compared to a predetermined threshold (“aspirating handpiece becomes occluded, i.e. partially or fully blocked, flow rate will decrease. An occlusion flow rate threshold value may be pre-set in the system or entered into the system. The occlusion flow rate threshold value is the value at which the flow rate is recognized by the system and/or user as indicating that an occlusion has occurred” [0039]; “the occlusion indicating parameter 422 may be selected to indicate a complete (100%)…occlusion of a fluid line, such as an aspiration line.” [0053]).
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 Gerg to include wherein the line abnormality is detected based on the difference when compared to a predetermined threshold based on the teachings of Claus to allow the surgeon to safely and effectively utilize the full range of aspiration rates, vacuum pressure and flow rates while still avoiding unsafe fluidic surges during occlusion events (Claus [0063]).
Modified Gerg fails to explicitly teach a pressure of at least one irrigation line is changed in proportion to the difference between the first and second measurement value according to Irrigation Pressure(t)=Irrigation Pressure(t-1) +/- ΔP, where Irrigation Pressure(t-1) is a target intraocular pressure.
Gordon teaches a system for detecting a fluid line abnormality (Figure 1), the system comprising using an aspiration pressure sensor for detecting a change in pressure ΔP (“Upon occlusion break, the aspiration pressure sensor 1160 detects a drop in pressure in aspiration line 1155” [0047]; “the aspiration pressure sensor 1160 may also detect the presence of an occlusion” [0049]), wherein a pressure of the at least one irrigation line is changed in proportion to a change in pressure ΔP (“The controller may use a reading from the aspiration pressure sensor to determine if an occlusion is present or if an occlusion break occurs. In such a case, the controller may control the pressurized irrigation fluid source to accommodate for changes in fluid flow that result from the occlusion or the occlusion break.” [0016]) according to Irrigation Pressure(t)=Irrigation Pressure(t-1) +/- ΔP, where Irrigation Pressure(t-1) is a target intraocular pressure (“Upon occlusion break, the aspiration pressure sensor 1160 detects a drop in pressure in aspiration line 1155…Signals from the irrigation pressure sensor 1130 and/or the aspiration pressure sensor 1160 may be used by the controller 1230 to control the irrigation source 1105” [0047]; “when an occlusion occurs, irrigation pressure may increase as the fluid aspirated from the eye decreases. An increase in irrigation fluid pressure detected by irrigation pressure sensor 1130 can be used to control pressurized irrigation fluid source 1105 to regulate the pressure in eye 1145--that is to keep the pressure in eye 1145 within an acceptable range. In such a case, the aspiration pressure sensor 1160 may also detect the presence of an occlusion and a reading from it may be used by controller 1230 to control pressurized irrigation source 1105” [0049]; “a surgeon selects a desired IOP. The pressurized irrigation fluid source 1105 is then controlled to maintain the desired IOP…When an occlusion is present (as detected by the irrigation pressure sensor 1130 or the aspiration pressure sensor 1160), IOP can be maintained by this control scheme. On occlusion break (as detected by the irrigation pressure sensor 1130 or the aspiration pressure sensor 1160), the pressurized irrigation fluid source 1105 can be controlled to maintain a relatively constant IOP.” [0068], See further detailed in [0072-0073]. A change in pressure ΔP, such as a pressure drop or increase, is determined by the aspiration and/or irrigation pressure sensor (see [0016] and [0047-0049]), and the irrigation pressure is changed based on the detected change in pressure and the target/desired IOP).
Before the effective filing date of the claimed invention, it would have been obvious to modify the system of Gerg to include that a pressure of the at least one irrigation line is changed in proportion to the difference between the first measurement value and the second measurement value ΔP (as disclosed by Gerg) according to Irrigation Pressure(t)=Irrigation Pressure(t-1) +/- ΔP, where Irrigation Pressure(t-1) is a target intraocular pressure based on the teachings of Gordon to maintain consistent intraocular pressure throughout surgery, particularly by counteracting post-occlusion surge (Gordon [0048]).
Regarding claim 49, modified Gerg teaches the system of claim 48, wherein the at least one fluid line is one selected from the group consisting of an irrigation line and an aspiration line (aspiration line 1110 in Figure 6, unlabeled in Figure 8).
Regarding claim 50, modified Gerg teaches the system of claim 48.
Modified Gerg fails to explicitly teach wherein the predetermined threshold is zero.
Claus teaches a system (phacoemulsification system 600) for detecting a fluid line abnormality, the system comprising a surgical console (controller 602), a surgical handpiece (handpiece 604) connected to at least one fluid line (“The aspiration source is configured to apply a vacuum to the handpiece 604 in order to aspirate the irrigation fluid from the eye 608 through the handpiece 604.” [0062]; Figure 7), wherein the line abnormality is detected based on a measurement value compared to a predetermined threshold that is zero (“aspirating handpiece becomes occluded, i.e. partially or fully blocked, flow rate will decrease. An occlusion flow rate threshold value may be pre-set in the system or entered into the system. The occlusion flow rate threshold value is the value at which the flow rate is recognized by the system and/or user as indicating that an occlusion has occurred” [0039]; “the occlusion indicating parameter 422 may be selected to indicate a complete (100%)…occlusion of a fluid line, such as an aspiration line.” [0053], wherein a complete 100% occlusion in indicated by a flow rate of zero [0019]).
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 Gerg to include wherein the line abnormality is detected based on the difference when compared to a predetermined threshold that is zero based on the teachings of Claus to allow the surgeon to safely and effectively utilize the full range of aspiration rates, vacuum pressure and flow rates while still avoiding unsafe fluidic surges during occlusion events (Claus [0063]).
Regarding claim 51, modified Gerg teaches the system of claim 48, wherein the detected abnormality is indicative of an occlusion (“a ΔP (Pport-side-Ppump-side) pressure differential can be measured and utilized in a computer-based algorithm…to detect the onset, presence, breakage, or elimination of an occlusion.” [0034]).
Regarding claim 53, modified Gerg teaches the system of claim 48, wherein the at least one characteristic is selected from the group consisting of pressure, flow rate, and vacuum (“during aspiration, by increasing the effective resistance in a localized segment of the aspiration line 1110, the flow restrictor 1200 will produce a differential volumetric flow rate between the port 1120 side of the line and the pump 1140 side of the line. This accordingly, will cause a vacuum or pressure differential, ΔP, between the port 1120 side of the line 1110 and the pump 1140 side of the line…If the flow restrictor 1200 is a variable flow restrictor, then the vacuum-based aspiration system 1000 can provide both computer-based detection of occlusion and precise control of the volumetric flow rate while still maintaining the vacuum-based pump's 1140 full range of operation.” [0034]).
Claim 52 is rejected under 35 U.S.C. 103 as being unpatentable over Gerg et al. (US 2012/0041362) in view of Claus et al. (US 2006/0224107) in further view of Gordon (US 2014/0114237) as applied in claim 48 above, and further in view of Zhang (US 2014/0171869).
Regarding claim 52, modified Gerg teaches the system of claim 48.
Modified Gerg fails to explicitly teach the detected abnormality is indicative of a break or disconnection in the fluid line.
Zhang teaches a system (stored operating program 36 of pump 10) for detecting a fluid line abnormality (Figure 7), wherein the line abnormality is detected based on a measurement value compared to a predetermined threshold, and the detected abnormality is indicative of a break or disconnection in the fluid line (“flow information obtained from the flow sensor elements 18 and 18' may be provided to the controller 32… to shut down operation of the pump in cases where an obstruction or misconnection may be detected…A flow rate that is too high may indicate that the IV line has been disconnected from the patient” [0054]).
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 detected abnormality to be indicative of a break or disconnection in the fluid line based on the teachings of Zhang to prevent excess fluid removal during surgery by automatically shutting down operation of the surgical console upon detection of a disconnection (Zhang [0054]).
Response to Arguments
Applicant's arguments filed 02/06/26 and 02/23/26 have been fully considered but they are not persuasive.
Regarding the argument that Gerg does not disclose “a difference is based in part on constants L and r, where L= a length of the at least one aspiration line between the first sensor and second sensor and r= an inner radius of the at least one aspiration line along the length L” as required by independent claims 1, 30, 34, and 48 (02/23/26 Remarks, page 13-14), the examiner respectfully disagrees. As detailed above in the rejections of each of claims 1, 30, 34 and 48, Gerg discloses at least one characteristic of an irrigation fluid in the at least one irrigation line or an aspiration fluid in the at least one aspiration line is changed in accordance with a difference between the first measurement value and the second measurement value ([0034]; [0008], [0028]), wherein the difference is based in part on constants L and r, where L = a length of the at least one aspiration line between the first sensor and the second sensor and r = an inner radius of the at least one aspiration line along the length L ([0034]; [0028]). The disclosed ΔP is partially based on the constant radius of the aspiration line 1110 outside of flow restrictor 1200 and/or the constant radius when the flow restrictor 1200 is in a fully open position and the aspiration line 1110 is unrestricted and the constant length of the line between the sensors 1300/1350 shown in Figure 6. The limitation “an inner radius of the at least one aspiration line along the length L” does not require that the inner radius is constant and unable to adjusted along an entirety of the length L. The radius along at least part of the length L is constant. Additionally, if the flow restrictor 1200 is in a fully open position and the aspiration line 1110 is unrestricted and having a constant radius over the entirety of its length, the ΔP is based in part on the constant inner radius as claimed.
Regarding the arguments directed to the “Applicant’s arguments noting the incompatible teachings of Gerg and Calderin” with respect to the rejections of claims 34-38, 48-51, and 53 (02/06/26 Remarks, page 13 referencing the Remarks filed 07/17/25), that the rejections of claims 34-38, 48-51, and 53 in the present rejection and in the previous Non-Final Rejection mailed 11/06/25 did not rely on the combination of Gerg et al. (US 2012/0041362) and Calderin et al. (USPN 9482563). As detailed above, Claims 34-38 are rejected under 35 U.S.C. 103 as being unpatentable over Gerg et al. (US 2012/0041362), Wilson et al. (US 2014/0163455), Claus et al. (US 2006/0224107), and Gordon (US 2014/0114237) and Claims 48-51 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Gerg, Claus, and Gordon. In the present rejection and the previous Non-Final Rejection mailed 11/06/25, Calderin was relied upon in the rejections of claims 12-13 for a teachings of storing first and second measurement values for the purpose of providing a means to calculate the total volume of fluid delivered during a phacoemulsification surgery (Calderin [Col 1, line 55]). No arguments were presented for these specific rejections in the Remarks filed 07/17/25.
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.
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/LEAH J SWANSON/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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