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 § 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.
Claim(s) 1-2, 5-6, and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Milutinovic et al. (US Patent Pub. 20110313343 hereinafter “Milutinovic”) in view of Gao (US Patent 8465467).
Regarding Claim 1, Milutinovic teaches (Figs 1and 3) a phacoemulsification system (100), comprising:
a pump (110, see [0028] 110 is the fluidics subsystem which includes 112 and see [0029] teaching flow control system 300 is a part of 110), comprising:
a first chamber (306) having a first defined volume and configured to flow a first fluid at a first flow rate, between a first reservoir (302) and an eye (Fig 3) of a patient; and
a second chamber (308) having a second defined volume and configured to flow a second fluid at a second flow rate, between a second reservoir (304) and the eye (Fig 3); and
a processor (320), configured to control the pump to:
set a first flow rate of the first fluid in the first defined volume (see [0039]), so as to obtain a predefined intra-ocular pressure (IOP) in the eye (See [0009] teaching that the invention is designed to maintain a stable IOP);
a second flow rate of the second fluid that maintains the predefined IOP constant (See [0009] teaching that the invention is designed to maintain a stable IOP); and set the calculated second flow rate to the second fluid (see [0039-0040] teaching how the controller 320 sets the aspiration flow rate).
Milutinovic does not specify based on the first and second defined volumes and on the first flow rate, calculate a second flow rate of the second fluid.
Gao teaches (col 3 lines 8-36) an irrigation and aspiration system, where the first flow rate (irrigation rate) is measured by a sensor (26) and the control circuity estimates the aspiration flow rate based on irrigation and aspiration flow (the volumes of irrigation and aspiration fluid).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Milutinovic such that it calculates a second flow rate of the second fluid based on the first and second volumes and on the first flow rate as taught by Gao. One of ordinary skill in the art would have been motivated to do so in order to allow for the system to control and adjust the flow rate based on detected events such as possible leakage, obstructions or occlusions (Gao Col 3 lines 31-36).
Regarding Claim 2, the combination of Milutinovic and Gao teaches the phacoemulsification system according to claim 1, wherein the first defined volume is different from the second defined volume (see Milutinovic [0032] teaching that the irrigation fluid is a greater volume than the aspiration fluid, as such the ‘defined volume’ is different), and wherein the processor is configured to calculate the second flow rate to compensate for the difference between the first and second volumes (see Gao Col 3 lines 8-36 teaching how the aspiration flow rate is estimated based on the irrigation flow rate that is sensed by sensor 26 and the irrigation and aspiration flows/volumes).
Regarding Claim 5, the combination of Milutinovic and Gao teaches the phacoemulsification system according to claim 1, wherein the first fluid comprises an irrigation fluid, which is applied to the eye at the first flow rate, and the second fluid comprises an aspiration fluid, which is aspired from the eye at the second flow rate (see [0039-0040] teaching both irrigation and aspiration lines, and how the processor/controller controls the flow rates).
Regarding Claim 6, the combination of Milutinovic and Gao teaches the phacoemulsification system according to claim 1, wherein the first fluid comprises an aspiration fluid, which is aspired from the eye at the first flow rate, and the second fluid comprises an irrigation fluid, which is applied to the eye at the second flow rate (see [0039-0040] teaching both irrigation and aspiration lines, and how the processor/controller controls the flow rates).
Regarding Claim 9, the combination of Milutinovic and Gao teaches all elements of claim 1 as described above. The combination further teaches the phacoemulsification system further comprising one or more sensors (Gao irrigation flow rate sensor 26, fluid level sensor 20, aspiration pressure transducer 16), which are configured to sense at least one of: (i) the first flow rate (Gao irrigation flow rate sensor 26; Col 3 lines 15-16), (ii) the second flow rate, (iii) a first pressure of the first fluid (Gao irrigation pressure sensor 26; Col 3 lines 15-16), and (iv) a second pressure of the second fluid (Gao aspiration pressure transducer 16; Col 3 lines 20-21).
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Milutinovic (US Patent Pub. 20110313343) in view of Gao (US Patent 8465467) as applied to claim 2 above, and further in view of Hickey et al. (US Patent Pub. 20170224888 hereinafter “Hickey”).
Regarding Claim 3, the combination of Milutinovic and Gao teaches all elements of claim 2 as described above. Milutinovic does not specify the phacoemulsification system wherein in a calibration step, the processor is configured to produce, for a given set of conditions, a dataset comprising: (i) a value of the first flow rate, and (ii) a value of the second flow rate based on a calculated ratio between the value of the first flow rate and the second flow rate.
Hickey teaches a phacoemulsification system including a calibration step [0036-0037] that includes providing a dataset that includes a predetermined flow rate R and respective calculated pressures (see Fig 7) in order to calibrate or set a new tip for the system.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Milutinovic such that the processor is configured to produce, for a given set of conditions, a dataset as taught by Hickey. One of ordinary skill in the art would have been motivated to do so in order to ensure that the device is calibrated for proper performance settings based on the characteristics of the device (Hickey [0023]).
Regarding Claim 4, the combination of Milutinovic, Gao and Hickey teaches the phacoemulsification system according to claim 3, wherein the given set of conditions comprises: (i) the first and second defined volumes (See Milutinovic [0032] teaches volumes of the first and second fluid, and [0039-0040] teaches how the flow rates are calculated), and (ii) operational conditions of the phacoemulsification system (See Hickey [0036-0037] teaching that the calibration calculations are based on characteristics of the tips of the device and resulting pressure sensed from the predetermined flow rate).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable Milutinovic (US Patent Pub. 20110313343) in view of Gao (US Patent 8465467) as applied to claim 1 above, and further in view of Archambeau et al. (US Patent Pub. 20080139674 hereinafter “Archambeau”).
Regarding Claims 7 and 8, the combination of Milutinovic and Gao teaches all elements of claim 1 as described above. Milutinovic does not specify the phacoemulsification system wherein the pump comprises first and second progressive cavity pumps (PCPs) integrated together; wherein the first PCP comprises the first chamber and a first electric motor, which is configured to flow the first fluid, and the second PCP comprises the second chamber and a second electric motor, which is configured to flow the second fluid.
Archambeau teaches [0215] a known/suitable pump includes progressive cavity pumps.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the pump of Milutinovic with first and second progressive cavity pumps (PCPs) integrated together; wherein the first PCP comprises the first chamber and a first electric motor, which is configured to flow the first fluid, and the second PCP comprises the second chamber and a second electric motor, which is configured to flow the second fluid as taught by Archambeau. One of ordinary skill in the art would have been motivated to do so as it would bring similar expected results of providing the system with capabilities of irrigation (Archambeau [0076]), and therefore would be a simple substitution of known equivalents (see MPEP 2144.06).
Response to Arguments
Applicant's arguments filed 2/3/2026 have been fully considered but they are not persuasive.
As to the remarks on Pgs. 8-10, the applicant argues that neither Milutinovic nor Gao teach specific values for a ‘defined volume’ for the first chamber and second chamber, and as such the combination of Milutinovic and Gao would not teach the calculation of a second flow rate that maintains the predefined IOP constant. The examiner does not find this to be persuasive. While Milutinovic does not define a specific value for the ‘defined volume’ the ‘volume’ of the first chamber and second chamber is ‘defined’ by the dimensions of the pathways of 306 and 308. The size (diameter and length) would ‘define’ the volume of the pathway/chamber. Therefore Milutinovic does teach a first chamber and second chamber with ‘defined volumes’. Furthermore, [0039] teaches how the controller maintains/adjusts pressure accordingly in each chamber (through data collected by the sensors in each chamber, the valves and the calculations that could be done as taught by the modification done in view of Gao described above.) For these reasons the rejection is maintained.
The 112 rejections of 11/3/2025 have been withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Stubkjaer et al. (US 20080154095) teaches Fig 3, a pump system (10) comprising two pumps (30, 40) for irrigation and aspiration. Stubkjaer also teaches [0040] that pressure and flow rate are controlled by flow control system.
Claus (WO 2010054225) teaches [0082-0085] a controller modifying aspiration rate to match irrigation rate or vice versa.
Dumas et al. (US 20190070343) teaches [0047] autocalibration of pump to determine the proper pressure/rate.
Balkenbush et al. (US 20190365567) teaches [0122] a system where the irrigation flow rate can be monitored and the aspiration flow rate is estimated based on the irrigation flow rate.
Keh et al. (US Patent Pub. 20190099546) teaches a system with an irrigation and aspiration pump and a processor that maintains IOP.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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