DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement(s) filed on the record are in compliance with the content requirements of 37 CFR 1.97 and 37 CFR 1.98 and have been considered.
Election/Restrictions
Claims 7-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/01/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6 and 13-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites a pump controller that registers a flow rate of irrigation fluid, alters the registered flow rate to a preset adjusted flow rate, and subsequently returns the irrigation pump to the registered flow rate. Independent claim 13 recites corresponding method steps of registering and altering said flow rate. Dependent claims 2-5 and 14-17 incorporate these flow-rate limitations.
However, the specification does not provide sufficient detail regarding registering an irrigation flow rate, and then adjusting the irrigation flow rate, and then returning to the registered irrigation flow rate, in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention.
It is noted that the specification discloses registering an intraocular pressure (IOP) pset (see Fig. 3, block 150) before the aspiration pump sensor is activated (block 154), then altering the irrigation setpoint to a new pressure pnewset and starting a timer to determine when the time or pressure thresholds are exceeded (block 162). If the conditions in block 162 are met, then the irrigation controller is returned to its default setpoint pset. However, pset is neither an irrigation flow rate, nor is it provided responsively to the provided first signal (rather, pset is a pressure value and is provided before the first signal, as indicated in block 150 of Fig. 3).
Further, while the specification discloses that altering the desired pressure may also alter the irrigation flow rate (see para [0053]), the specification is silent to the detailed configuration/steps involving a registered controlled flow rate. IOP is not the same as irrigation fluid flow rate.
Claim 13 is rejected for similar reasons, and claims 2-6 and 14-17 depend from claims 1 and 13, respectively.
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 5, 6 and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 5 and 17, it is not known what is meant by "accelerating a speed of response of the pump" since it is not known what specifically the pump is "responding" to in this context.
Regarding claim 6, the limitation "the feedback control loop" lacks antecedent basis.
Claim Rejections - 35 USC § 103
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 1-6 and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kanda et al (U.S. Pat. 6,780,166 B2, hereinafter "Kanda"), in view of Conley et al (U.S. Pat. 5,242,404 A, hereinafter "Conley").
Regarding claim 1, Kanda discloses a pumping system for a phacoemulsification system, comprising:
a phacoemulsification probe 5 (see Fig. 4) having a distal end comprising a needle 5a (see Fig. 4) configured to be inserted into an eye "E";
an irrigation tube 3 (see Fig. 4) configured to be connected to the probe and to provide irrigation fluid into the eye;
an irrigation pump 27 (see Fig. 4) configured to be connected to the irrigation tube and to pump the irrigation fluid into the eye;
an aspiration tube 6 (see Fig. 4) configured to be connected to the probe and to convey aspiration fluid from the eye;
an aspiration pump 7 (see Fig. 4) configured to be connected to the aspiration tube and to pump the aspiration fluid from the eye;
a pressure sensor 15 configured to provide a second signal indicative of IOP (pressure sensor 15 indicates changes to IOP by measuring pressure in the aspiration line of the handpiece),
a pump controller configured to:
receive the second signal provided by the pressure sensor (see col. 3, lines 47-50; the pressure sensor 15 constantly detects the vacuum pressure within the aspiration tube 6, and sends the result of detection to the control unit 10);
register a flow rate of the irrigation fluid (first set irrigation rate in a normal state; see col. 8, lines 8-10); and
control the irrigation pump to alter the registered flow rate of the irrigation fluid to a preset adjusted flow rate (see col. 8, lines 10-18; setting the irrigation rate at a second set irrigation rate higher than the first irrigation rate) until a predefined threshold, dependent on at least one of a time of operation of the irrigation pump at the preset adjusted flow rate and the second signal, is crossed, and on crossing of the threshold, control the irrigation pump to pump the irrigation fluid at the registered flow rate (see col. 10, lines 19-25; the irrigation rate is returned from the second set irrigation rate to the first set irrigation rate when the pressure sensor detects that the vacuum pressure falls below a predetermined value).
It is noted that Kanda does not appear to disclose an aspiration pump sensor configured to provide a first signal indicative of activation of the aspiration pump, the pump controller being configured to receive the first signal provided by the aspiration pump sensor, and registering the first irrigation flow rate responsively to the provided first signal.
Conley discloses an aspiration control system for a microsurgical procedure in a patient's eye, comprising an aspiration pump sensor 36 (see Fig. 1) that is configured to provide a first signal indicating activation of an aspiration pump (see col. 5, lines 47-51; the signal measures vacuum level and thus indicates inherently that the pump has been activated), a pump controller being configured to receive the first signal provided by the aspiration pump sensor (see col. 5, lines 49-51; the signal is sent to a system controller 26), and then controls the operation of a vacuum pump motor to ensure that the desired vacuum level in the aspiration pump is achieved (see col. 5, lines 59-62).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the device of Kanda, in order to provide an aspiration pump sensor configured to provide a first signal indicative of activation of the aspiration pump, and the pump controller being configured to receive the first signal provided by the aspiration pump sensor, as taught in Conley, in order to ensure that the desired input of the vacuum control matches the actual aspiration provided to the pump, with a reasonable expectation of success. Further, the combination of Kanda and Conley suggests the obviousness of registering the first irrigation flow rate responsively to the provided first signal, since the first signal would control the aspiration pump itself—thus permitting the pressure sensor to detect the vacuum pressure in order to set the first irrigation rate.
Regarding claim 2, Kanda discloses that the preset adjusted flow rate comprises an increase by a preset fraction of the registered flow rate (the two registered rates are inherently divisible in order to arrive at the fractional increase).
Regarding claim 3, Kanda discloses that the preset fraction is a function of a value of the IOP recorded when the first signal is received by the pump controller (pressure sensor 15 indicates changes to IOP by measuring pressure in the aspiration line of the handpiece, and the controller uses this value to arrive at the first registered flow rate; therefore, the fraction is inherently a function of the value of IOP recorded by the controller).
Regarding claim 4, Kanda does not disclose that the pump controller is configured to use the first signal provided by the pump sensor to maintain the IOP at a target IOP, and wherein the preset fraction is a function of the target IOP.
Conley discloses that its aspiration pump sensor 36 measures vacuum level (see col. 5, lines 47-51) for the purpose of assisting in the maintenance of IOP at a target IOP (see col. 8, lines 4-24).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the device of Kanda, so that the pump controller is configured to use the first signal provided by the pump sensor to maintain the IOP at a target IOP, in order to reduce vacuum surges due to occlusions, with a reasonable expectation of success.
Regarding claim 5, Kanda discloses that controlling the irrigation pump comprises accelerating a speed of response of the pump (understood to mean the speed of the pump, which accelerates in order to provide irrigation flow at the second higher irrigation rate).
Regarding claim 6, Kanda discloses that the pump controller is configured to receive input from an anti-vacuum surge (AVS) device (input unit 11; see Fig. 4) configured to block aspiration flow to a distal end of the phacoemulsification handpiece (see col. 3, lines 55-58). The limitation "temporarily boost the preset IOP provided to the feedback control loop based on the input received from the AVS device" has been interpreted to mean "temporarily boost the IOP provided by a feedback control loop based on the input received from the AVS device"; Kanda discloses the control unit 10 receives input from the input unit 11 and the control unit can also boost IOP by controlling the irrigation pressure, as disclosed in col. 3, lines 48-55).
Regarding claim 13, Kanda discloses a method for operating a pumping system for a phacoemulsification system, comprising:
providing a phacoemulsification probe 5 (see Fig. 4) having a distal end comprising a needle 5a (see Fig. 4) configured to be inserted into an eye "E";
connecting an irrigation tube 3 (see Fig. 4) to the probe and to provide irrigation fluid into the eye;
connecting an irrigation pump 27 (see Fig. 4) to the irrigation tube and to pump the irrigation fluid into the eye;
connecting an aspiration tube 6 (see Fig. 4) to the probe and to convey aspiration fluid from the eye;
connecting an aspiration pump 7 (see Fig. 4) to the aspiration tube and to pump the aspiration fluid from the eye;
configuring a pressure sensor 15 to provide a second signal indicative of IOP (pressure sensor 15 indicates changes to IOP by measuring pressure in the aspiration line of the handpiece),
receiving a second signal provided by the pressure sensor (see col. 3, lines 47-50; the pressure sensor 15 constantly detects the vacuum pressure within the aspiration tube 6, and sends the result of detection to the control unit 10);
registering a flow rate of the irrigation fluid (first set irrigation rate in a normal state; see col. 8, lines 8-10); and
controlling the irrigation pump to alter the registered flow rate of the irrigation fluid to a preset adjusted flow rate (see col. 8, lines 10-18; setting the irrigation rate at a second set irrigation rate higher than the first irrigation rate) until a predefined threshold, dependent on at least one of a time of operation of the irrigation pump at the preset adjusted flow rate and the second signal, is crossed, and on crossing of the threshold, control the irrigation pump to pump the irrigation fluid at the registered flow rate (see col. 10, lines 19-25; the irrigation rate is returned from the second set irrigation rate to the first set irrigation rate when the pressure sensor detects that the vacuum pressure falls below a predetermined value).
It is noted that Kanda does not appear to disclose configuring an aspiration pump sensor to provide a first signal indicative of activation of the aspiration pump, and receiving the first signal, and responsively to the first signal, registering the first irrigation flow rate.
Conley discloses an aspiration control system for a microsurgical procedure in a patient's eye, comprising an aspiration pump sensor 36 (see Fig. 1) that is configured to provide a first signal indicating activation of an aspiration pump (see col. 5, lines 47-51; the signal measures vacuum level and thus indicates inherently that the pump has been activated), a pump controller being configured to receive the first signal provided by the aspiration pump sensor (see col. 5, lines 49-51; the signal is sent to a system controller 26), and then controls the operation of a vacuum pump motor to ensure that the desired vacuum level in the aspiration pump is achieved (see col. 5, lines 59-62).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the method of Kanda, thus configuring an aspiration pump sensor to provide a first signal indicative of activation of the aspiration pump, and receiving the first signal, and responsively to the first signal, registering the first irrigation flow rate, as taught in Conley, in order to ensure that the desired input of the vacuum control matches the actual aspiration provided to the pump, with a reasonable expectation of success. Further, the combination of Kanda and Conley suggests the obviousness of registering the first irrigation flow rate responsively to the provided first signal, since the first signal would control the aspiration pump itself—thus permitting the pressure sensor to detect the vacuum pressure in order to set the first irrigation rate.
Regarding claim 14, Kanda discloses that the preset adjusted flow rate comprises an increase by a preset fraction of the registered flow rate (the two registered rates are inherently divisible in order to arrive at the fractional increase).
Regarding claim 15, Kanda discloses that the preset fraction is a function of a value of the IOP recorded when the first signal is received by the pump controller (pressure sensor 15 indicates changes to IOP by measuring pressure in the aspiration line of the handpiece, and the controller uses this value to arrive at the first registered flow rate; therefore, the fraction is inherently a function of the value of IOP recorded by the controller).
Regarding claim 16, Kanda does not disclose using the first signal provided by the pump sensor to maintain the IOP at a target IOP, and wherein the preset fraction is a function of the target IOP.
Conley discloses that its aspiration pump sensor 36 measures vacuum level (see col. 5, lines 47-51) for the purpose of assisting in the maintenance of IOP at a target IOP (see col. 8, lines 4-24).
Accordingly, a skilled artisan would have found it obvious at the time of the invention to modify the device of Kanda, so that the pump controller uses the first signal provided by the pump sensor to maintain the IOP at a target IOP, in order to reduce vacuum surges due to occlusions, with a reasonable expectation of success.
Regarding claim 17, Kanda discloses that controlling the irrigation pump comprises accelerating a speed of response of the pump (understood to mean the speed of the pump, which accelerates in order to provide irrigation flow at the second higher irrigation rate).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Notice of References Cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT J MEDWAY whose telephone number is (571)270-3656. The examiner can normally be reached Monday through Friday, 8:30 AM to 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at (571) 270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783 06/04/2026
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