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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitations “an aspiration pump configured to…pump the aspiration fluid from the eye” and “the pump controller is configured to…reverse the flow direction and set the flow rate of the aspiration pump at which to pump the aspiration fluid into the eye”. Because the first limitation only recites that the aspiration pump is configured to pump aspiration fluid from the eye, it is unclear if/how the aspiration pump can pump the aspiration fluid into the eye per the second limitation. For examination purposes, the Examiner interprets that the aspiration pump is configured to…pump the aspiration fluid from the eye in an aspiration direction and to pump the aspiration fluid back into the eye in a reverse flow direction. The Examiner further interprets that the pump controller is configured to…reverse the flow direction and set the flow rate of the aspiration pump at which to pump the aspiration fluid back into the eye. The Examiner suggests amending the claim accordingly.
Claims 2-10 are rejected by virtue of their dependency on rejected claim 1.
Claim 10 recites “a given actuation rate” in line 4. It is unclear whether this is intended to be the same as the “a given actuation rate” previously introduced in claim 9 or whether these are intended to be different rates. For examination purposes, the Examiner interprets “a given actuation rate” in claim 10 as “the given actuation rate”.
Claim 11 recites the limitations “pumping aspiration fluid from the eye” and “reversing the flow direction and setting the flow rate of the pumping at which to pump the aspiration fluid into the eye”. Per the first limitation, the pumping is required to pump aspiration fluid in a direction from the eye. Because “the pumping” must pump aspiration fluid “from the eye”, it is unclear if/how the pumping (of the aspiration fluid from the eye) can be reversed/set to pump the aspiration fluid into the eye per the second limitation. In other words, if the flow direction changes to pump the aspiration fluid back into the eye, this can no longer be limiting the step of “pumping aspiration fluid from the eye”. For examination purposes, the Examiner interprets that the claim should be interpreted/amended accordingly:
-Page 14, line 5: change “controlling a flow direction and a flow rate of the pumping” to “controlling a flow direction and a flow rate of the aspiration fluid”
-Page 14, lines 8-10: change “reversing the flow direction and setting the flow rate of the pumping at which to pump the aspiration fluid into the eye” to “reversing the flow direction and setting the flow rate to pump the aspiration fluid back into the eye”.
Claims 12-20 are rejected by virtue of their dependency on rejected claim 11.
Claim 20 recites “a given actuation rate” in line 4. It is unclear whether this is intended to be the same as the “a given actuation rate” previously introduced in claim 19 or whether these are intended to be different rates. For examination purposes, the Examiner interprets “a given actuation rate” in claim 20 as “the given actuation rate”.
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 1-7, 9-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over King et al. (US 2018/0296738 A1) in view of Kashani et al. (US 2020/0016334 A1).
Regarding claim 1, King discloses a phacoemulsification system (see Figs. 1-2A, par. [0030] and [0034]), comprising:
a phacoemulsification probe (handpiece 12) having a distal end comprising a needle (probe tip, see par. [0032]), and configured to be inserted into an eye (see Figs. 1-2, par. [0032]);
an irrigation line (irrigation fluid conduit path 47) configured to be connected to the probe (handpiece 12) and to provide irrigation fluid into the eye (see Figs. 1-2A, par. [0031]-[0032] and [0041]);
an aspiration line (aspiration flow network 50) configured to be connected to the probe (handpiece 12) and to convey aspiration fluid from the eye (see Figs. 1-2A, par. [0031]-[0032] and [0042]);
an aspiration pump (pump 54) configured to be connected to the aspiration line (aspiration flow network 50) and to pump the aspiration fluid from the eye (see Figs. 1-2A, par. [0031]-[0032] and [0042]-[0043]);
a pump controller (controller 40) configured to control a flow direction and a flow rate of the aspiration pump (pump 54) (see Figs. 1-2A, par. [0033], [0043], [0062], and [0064]); and
an aspiration rate user input device (foot pedal 44) configured to provide a signal indicative of user actuation of the aspiration rate user input device (foot pedal 44) (see Fig. 1, par. [0048], [0062], and [0064]), wherein:
the pump controller (controller 40) is configured to: receive the signal provided by the aspiration user input device (foot pedal 44); and reverse the flow direction and set the flow rate of the aspiration pump at which to pump the aspiration fluid into the eye (see Fig. 1, par. [0048], [0062], and [0064]).
However, King fails to expressly state the flow rate in the reverse flow direction being set responsively to an actuation rate at which the aspiration rate user input device is actuated.
Kashani teaches an ophthalmic surgical system (see Figs. 1-2, par. [0055]) comprising the flow rate in the reverse flow direction being set responsively to an actuation rate at which the aspiration rate user input device is actuated (see Figs. 1-2, par. [0021], the pressing of the foot pedal 120 is linear and proportional to the change in flow rate such that a change in flow rate would occur more quickly with a faster depression of the foot pedal and vice versa).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the phacoemulsification system of King to include the flow rate in the reverse flow direction being set responsively to an actuation rate at which the aspiration rate user input device is actuated, as taught by Kashani, in order to give the operator more direct control over the flow rate while using the foot pedal (see Kashani par. [0021]).
Regarding claim 2, modified King teaches the system according to claim 1 substantially as claimed. Modified King further teaches wherein: the aspiration rate user input device (King, foot pedal 44) includes a widget (King, foot pedal 44 is a widget) (see King Fig. 1, King par. [0048]); and the actuation rate at which the aspiration rate user input device (King, foot pedal 44) is actuated is a rate of change of position of the widget (King, foot pedal 44) (see King Fig. 1, King par. [0048], [0062], and [0064]; Kashani par. [0021], the pressing of the foot pedal 120 is linear and proportional to the change in flow rate such that a change in flow rate would occur more quickly with a faster depression of the foot pedal and vice versa; see previous modifications in rejection of claim 1 above).
Regarding claim 3, modified King teaches the system according to claim 2 substantially as claimed. Modified King further teaches wherein the widget (King, foot pedal 44) includes a foot pedal (King, foot pedal 44), and the rate of change of position of the widget (King, foot pedal 44) is a rate of change of release of the foot pedal (King, foot pedal 44) (see King Fig. 1, King par. [0048], [0062], and [0064]; Kashani par. [0021], the pressing of the foot pedal 120 is linear and proportional to the change in flow rate such that a change in flow rate would occur more quickly with a faster depression of the foot pedal and vice versa; see previous modifications in rejection of claim 1 above).
Regarding claim 4, modified King teaches the system according to claim 2 substantially as claimed. Modified King further teaches wherein the widget (King, foot pedal 44) includes a foot pedal (King, foot pedal 44), and the rate of change of position of the widget (King, foot pedal 44) is a rate of change of pressing of the foot pedal (King, foot pedal 44) (see King Fig. 1, King par. [0048], [0062], and [0064]; Kashani par. [0021], the pressing of the foot pedal 120 is linear and proportional to the change in flow rate such that a change in flow rate would occur more quickly with a faster depression of the foot pedal and vice versa; see previous modifications in rejection of claim 1 above).
Regarding claim 5, modified King teaches the system according to claim 1 substantially as claimed. Modified King further teaches wherein: the aspiration rate user input device (King, foot pedal 44) includes a widget (King, foot pedal 44 is a widget); and the actuation rate at which the aspiration rate user input device (King, foot pedal 44) is actuated is a rate of change of velocity of the widget (King, foot pedal 44) (see King Fig. 1, King par. [0048], [0062], and [0064]; Kashani par. [0021], the pressing of the foot pedal 120 is linear and proportional to the change in flow rate such that a change in flow rate would occur more quickly with a faster depression of the foot pedal and vice versa; see previous modifications in rejection of claim 1 above).
Regarding claim 6, modified King teaches the system according to claim 5 substantially as claimed. Modified King further teaches wherein the widget (King, foot pedal 44) includes a foot pedal (King, foot pedal 44), and the rate of change of velocity of the widget (King, foot pedal 44) is a rate of change of release of the foot pedal (King, foot pedal 44) (see King Fig. 1, King par. [0048], [0062], and [0064]; Kashani par. [0021], the pressing of the foot pedal 120 is linear and proportional to the change in flow rate such that a change in flow rate would occur more quickly with a faster depression of the foot pedal and vice versa; see previous modifications in rejection of claim 1 above).
Regarding claim 7, modified King teaches the system according to claim 5 substantially as claimed. Modified King further teaches wherein the widget (King, foot pedal 44) includes a foot pedal (King, foot pedal 44), and the rate of change of velocity of the widget (King, foot pedal 44) is a rate of change of pressing of the foot pedal (King, foot pedal 44) (see King Fig. 1, King par. [0048], [0062], and [0064]; Kashani par. [0021], the pressing of the foot pedal 120 is linear and proportional to the change in flow rate such that a change in flow rate would occur more quickly with a faster depression of the foot pedal and vice versa; see previous modifications in rejection of claim 1 above).
Regarding claim 9, modified King teaches the system according to claim 1 substantially as claimed. Modified King further teaches wherein the pump controller (King, controller 40) is configured to set the flow rate in the reverse flow direction responsively to the actuation rate at which the aspiration rate user input device (King, foot pedal 44) is actuated being greater than a given actuation rate (see King Fig. 1, King par. [0048], [0062], and [0064], the flow direction is reversed when foot pedal 44 is released; Kashani par. [0021], the pressing of the foot pedal 120 is linear and proportional to the change in flow rate; see previous modifications in rejection of claim 1 above, a fast release of the foot pedal will reverse the direction of the pump).
Regarding claim 10, modified King teaches the system according to claim 9 substantially as claimed. Modified King further teaches wherein the pump controller (King, controller 40) is configured to reduce the flow rate of the aspiration pump (King, pump 54) at which to pump the aspiration fluid from the eye, without reversing the flow direction responsively to the actuation rate at which the aspiration rate user input device (King, foot pedal 44) is actuated being less than a given actuation rate (see King Fig. 1, King par. [0048], [0062], and [0064], the flow direction is reversed only when foot pedal 44 is released; Kashani par. [0021], the pressing of the foot pedal 120 is linear and proportional to the change in flow rate; see previous modifications in rejection of claim 1 above, a slow and partial release of the foot pedal (i.e. not all the way back to the nominal/zero position) will reduce the flow rate without reversing the direction of the pump).
Regarding claim 11, King discloses a phacoemulsification method (see Figs. 1-2A, par. [0030] and [0034]), comprising:
inserting a phacoemulsification probe (handpiece 12) having a distal end comprising a needle (probe tip, see par. [0032]) into an eye (see Figs. 1-2, par. [0032]);
providing irrigation fluid into the eye via an irrigation line (irrigation fluid conduit path 47) connected to the probe (handpiece 12) (see Figs. 1-2A, par. [0031]-[0032] and [0041]);
pumping aspiration fluid from the eye via an aspiration line (aspiration flow network 50) connected to the probe (handpiece 12) (see Figs. 1-2A, par. [0031]-[0032] and [0042]);
controlling a flow direction and a flow rate of the pumping (see Figs. 1-2A, par. [0033], [0043], [0062], and [0064]);
providing a signal indicative of user actuation of an aspiration rate user input device (foot pedal 44) (see Fig. 1, par. [0048], [0062], and [0064]);
receiving the signal provided by the aspiration user input device (foot pedal 44); and
reversing the flow direction and setting the flow rate of the pumping at which to pump the aspiration fluid into the eye (see Fig. 1, par. [0048], [0062], and [0064]).
However, King fails to expressly state the flow rate in the reverse flow direction being set responsively to an actuation rate at which the aspiration rate user input device is actuated.
Kashani teaches an ophthalmic surgical method (see Figs. 1-2, par. [0055]) comprising the flow rate in the reverse flow direction being set responsively to an actuation rate at which the aspiration rate user input device is actuated (see Figs. 1-2, par. [0021], the pressing of the foot pedal 120 is linear and proportional to the change in flow rate such that a change in flow rate would occur more quickly with a faster depression of the foot pedal and vice versa).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the phacoemulsification method of King to include the flow rate in the reverse flow direction being set responsively to an actuation rate at which the aspiration rate user input device is actuated, as taught by Kashani, in order to give the operator more direct control over the flow rate while using the foot pedal (see Kashani par. [0021]).
Regarding claim 12, modified King teaches the method according to claim 11 substantially as claimed. Modified King further teaches wherein: the aspiration rate user input device (King, foot pedal 44) includes a widget (King, foot pedal 44 is a widget) (see King Fig. 1, King par. [0048]); and the actuation rate at which the aspiration rate user input device (King, foot pedal 44) is actuated is a rate of change of position of the widget (King, foot pedal 44) (see King Fig. 1, King par. [0048], [0062], and [0064]; Kashani par. [0021], the pressing of the foot pedal 120 is linear and proportional to the change in flow rate such that a change in flow rate would occur more quickly with a faster depression of the foot pedal and vice versa; see previous modifications in rejection of claim 11 above).
Regarding claim 13, modified King teaches the method according to claim 12 substantially as claimed. Modified King further teaches wherein the widget (King, foot pedal 44) includes a foot pedal (King, foot pedal 44), and the rate of change of position of the widget (King, foot pedal 44) is a rate of change of release of the foot pedal (King, foot pedal 44) (see King Fig. 1, King par. [0048], [0062], and [0064]; Kashani par. [0021], the pressing of the foot pedal 120 is linear and proportional to the change in flow rate such that a change in flow rate would occur more quickly with a faster depression of the foot pedal and vice versa; see previous modifications in rejection of claim 11 above).
Regarding claim 14, modified King teaches the method according to claim 12 substantially as claimed. Modified King further teaches wherein the widget (King, foot pedal 44) includes a foot pedal (King, foot pedal 44), and the rate of change of position of the widget (King, foot pedal 44) is a rate of change of pressing of the foot pedal (King, foot pedal 44) (see King Fig. 1, King par. [0048], [0062], and [0064]; Kashani par. [0021], the pressing of the foot pedal 120 is linear and proportional to the change in flow rate such that a change in flow rate would occur more quickly with a faster depression of the foot pedal and vice versa; see previous modifications in rejection of claim 11 above).
Regarding claim 15, modified King teaches the method according to claim 11 substantially as claimed. Modified King further teaches wherein: the aspiration rate user input device (King, foot pedal 44) includes a widget (King, foot pedal 44 is a widget); and the actuation rate at which the aspiration rate user input device (King, foot pedal 44) is actuated is a rate of change of velocity of the widget (King, foot pedal 44) (see King Fig. 1, King par. [0048], [0062], and [0064]; Kashani par. [0021], the pressing of the foot pedal 120 is linear and proportional to the change in flow rate such that a change in flow rate would occur more quickly with a faster depression of the foot pedal and vice versa; see previous modifications in rejection of claim 11 above).
Regarding claim 16, modified King teaches the method according to claim 15 substantially as claimed. Modified King further teaches wherein the widget (King, foot pedal 44) includes a foot pedal (King, foot pedal 44), and the rate of change of velocity of the widget (King, foot pedal 44) is a rate of change of release of the foot pedal (King, foot pedal 44) (see King Fig. 1, King par. [0048], [0062], and [0064]; Kashani par. [0021], the pressing of the foot pedal 120 is linear and proportional to the change in flow rate such that a change in flow rate would occur more quickly with a faster depression of the foot pedal and vice versa; see previous modifications in rejection of claim 11 above).
Regarding claim 17, modified King teaches the method according to claim 15 substantially as claimed. Modified King further teaches wherein the widget (King, foot pedal 44) includes a foot pedal (King, foot pedal 44), and the rate of change of velocity of the widget (King, foot pedal 44) is a rate of change of pressing of the foot pedal (King, foot pedal 44) (see King Fig. 1, King par. [0048], [0062], and [0064]; Kashani par. [0021], the pressing of the foot pedal 120 is linear and proportional to the change in flow rate such that a change in flow rate would occur more quickly with a faster depression of the foot pedal and vice versa; see previous modifications in rejection of claim 11 above).
Regarding claim 19, modified King teaches the method according to claim 11 substantially as claimed. Modified King further teaches wherein the setting includes setting the flow rate in the reverse flow direction responsively to the actuation rate at which the aspiration rate user input device (King, foot pedal 44) is actuated being greater than a given actuation rate (see King Fig. 1, King par. [0048], [0062], and [0064], the flow direction is reversed when foot pedal 44 is released; Kashani par. [0021], the pressing of the foot pedal 120 is linear and proportional to the change in flow rate; see previous modifications in rejection of claim 11 above, a fast release of the foot pedal will reverse the direction of the pump).
Regarding claim 20, modified King teaches the method according to claim 19 substantially as claimed. Modified King further teaches reducing the flow rate of the pumping at which to pump the aspiration fluid from the eye, without reversing the flow direction, responsively to the actuation rate at which the aspiration rate user input device (King, foot pedal 44) is actuated being less than a given actuation rate (see King Fig. 1, King par. [0048], [0062], and [0064], the flow direction is reversed only when foot pedal 44 is released; Kashani par. [0021], the pressing of the foot pedal 120 is linear and proportional to the change in flow rate; see previous modifications in rejection of claim 11 above, a slow and partial release of the foot pedal (i.e. not all the way back to the nominal/zero position) will reduce the flow rate without reversing the direction of the pump).
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over King et al. (US 2018/0296738 A1) in view of Kashani et al. (US 2020/0016334 A1), as applied to claims 1 and 11 above, further in view of Zacharias (US 10,398,595 B2).
Regarding claim 8, modified King teaches the system according to claim 1 substantially as claimed. However, modified King fails to expressly state wherein the pump controller includes a proportional integral derivative (PID) controller configured to control the flow rate in the reverse flow direction responsively to control parameters, wherein the pump controller is configured to set the control parameters responsively to the actuation rate at which the aspiration rate user input device is actuated.
Zacharias teaches a phacoemulsification system (see Fig. 1E, col. 4 lines 35-38) wherein the pump controller (actuator controller 132) includes a proportional integral derivative (PID) controller (see Fig. 1E, col. 14 line 62 – col. 15 line 8) configured to control the flow rate in the reverse flow direction responsively to control parameters (see Fig. 1, col. 14 line 62 – col. 15 line 8), wherein the pump controller (actuator controller 132) is configured to set the control parameters responsively to the actuation rate at which the aspiration rate user input device (foot pedal 152) is actuated (see Fig. 1, col. 14 lines 24-37, col. 14 line 62 – col. 15 line 8, col. 21 line 50 – col. 22 line 3).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the phacoemulsification system of modified King to further include wherein the pump controller includes a proportional integral derivative (PID) controller configured to control the flow rate in the reverse flow direction responsively to control parameters, wherein the pump controller is configured to set the control parameters responsively to the actuation rate at which the aspiration rate user input device is actuated, as taught by Zacharias, in order to incorporate a control loop into the pump controller to accurately and rapidly adjust the flow rate (see Zacharias col. 14 line 62 – col. 15 line 8).
Regarding claim 18, modified King teaches the method according to claim 11 substantially as claimed. However, modified King fails to expressly state setting control parameters of a proportional integral derivative (PID) controller to control the flow rate in the reverse flow direction responsively to the actuation rate at which the aspiration rate user input device is actuated.
Zacharias teaches a phacoemulsification method (see Fig. 1E, col. 4 lines 35-38) comprising setting control parameters of a proportional integral derivative (PID) controller (see Fig. 1E, col. 14 line 62 – col. 15 line 8) to control the flow rate in the reverse flow direction responsively to the actuation rate at which the aspiration rate user input device (foot pedal 152) is actuated (see Fig. 1, col. 14 lines 24-37, col. 14 line 62 – col. 15 line 8, col. 21 line 50 – col. 22 line 3).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the phacoemulsification method of modified King to further include setting control parameters of a proportional integral derivative (PID) controller to control the flow rate in the reverse flow direction responsively to the actuation rate at which the aspiration rate user input device is actuated, as taught by Zacharias, in order to incorporate a control loop into the pump controller to accurately and rapidly adjust the flow rate (see Zacharias col. 14 line 62 – col. 15 line 8).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783