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 Objections
Claims 8, 17 and 20-21 are objected to because of the following informalities:
-Claim 8, Line 5: “inflow” should be corrected to “outflow”.
-Claim 17, Line 3: “fourth buffer” should be corrected to “fourth set buffer”.
-Claim 20, Line 2: “the inflow” should be corrected to “an inflow”.
-Claim 21, Line 2: “the outflow” should be corrected to “an outflow”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 11 and 19-22 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by US 2021/0085158 A1 to Ikuma et al. (hereinafter “Ikuma”).
Regarding claim 1, Ikuma discloses a system (fig. 1, 23) for detecting abnormalities in a medical device (endoscope) during a medical procedure in a patient (calculus removal), the system comprising:
an inflow tubing 31 defining an inflow lumen, the inflow lumen configured to provide a fluid (saline) from a fluid source 27 to a site of the medical procedure (see paragraph [0101]); an inflow sensor 34 (flow meter) in communication with the inflow lumen to sense an inflow parameter (flow rate) of the inflow lumen, the inflow sensor configured to generate an inflow signal indicative of the inflow parameter of the inflow tubing (see paragraph [0101]);
an outflow tubing 32 defining an outflow lumen, the outflow lumen configured to extract debris from the site of the medical procedure (see paragraph [0102]);
an outflow sensor 35 in communication with the outflow lumen to sense an
outflow parameter (flow rate) of the outflow lumen, the outflow sensor configured to generate an outflow signal indicative of the outflow parameter of the outflow lumen (see paragraph [0102]);
a memory including instructions (see paragraphs [0091], [0262]-[0264]); and
controller componentry (processing circuitry: see paragraphs [0091], [0262]-[0264]) that, when in operation, is configured by instructions to:
receive the inflow signal (saline flow rate) and the outflow signal (saline and debris flow rate); and
identify an abnormality in either the inflow tubing or the outflow tubing based on comparing the inflow signal or the outflow signal, respectively, to an inflow criterion and an outflow criterion (see pre-determined thresholds of the flow rate in outflow tubing 32: see paragraph [0262]: "the control unit may determine whether or not the flow rate in the conduit 32 has the threshold TH or less based on a detection signal from the flowmeter 35” and implicitly also in inflow tubing 31 in paragraph [0265]: “By doing so, it is possible to provide the pressure gauge 36 in a conduit 31 instead of the conduit 32 and it is also possible to detect a pressure in a subject correctly even when the suction tube 14 or the conduit 32 is clogged with crushed calculus fragments” wherein “A flowmeter 34 is provided at the conduit 31. The flow meter 34 is connected to the control unit 21 by a signal line, detects a flow rate of the physiological saline solution flowing in the conduit 31, and outputs a detection value to the control unit 21” (see paragraph [0101])).
Regarding claim 2, Ikuma discloses an inflow pump 22 in communication with the inflow tubing 13 to control a fluid flow rate of the fluid through the inflow lumen; and an outflow pump 23 in communication with the outflow tubing 14 to control a debris flow rate of the debris through the outflow lumen (see Figure 1).
Regarding claim 3, Ikuma discloses that the inflow signal (saline flow rate at flow meter 34: paragraph [0101]) and the outflow signal (saline and debris flow rate at flow meter 35: paragraph [0102]) are indicative of an inflow fluid flow rate and an outflow debris flow rate, respectively.
Regarding claim 19, Ikuma discloses that the processing circuitry is configured to:
transmit a controlling signal based on the abnormality measured in either the inflow tubing or the outflow tubing (see paragraphs [0262]-[0263], [0265]).
Regarding claims 20-21, Ikuma discloses that the controlling signal alters a voltage supplied to the inflow pump 22 or the outflow pump 23 to change an inflow pumping rate of the inflow pump or an outflow pumping rate of the outflow pump (see paragraph [0265]: “the control unit can control a water feeding pump 22 or a suction pump 23 based on a detection signal” which implicitly altering voltage supplied to pump to change pumping rate).
Regarding claim 22, Ikuma discloses a debris trap (the partition member 41 in the outflow tubing 14 in Figures 17-18) and the controlling signal opens the debris trap to clear the debris from the debris trap (see Figure 1; paragraphs [0213]-[0216]: the ultrasound transducer 37B in the outlet flow tubing 14 to prevent clogging of the outlet flow tubing 14).
Claims 1-2 and 23-26 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by US 2002/0019607 A1 (Bui).
Regarding claim1, Bui discloses a system (fig. 1) suitable for detecting abnormalities (see paragraph [0018]: pressure deviation from desired pressure) in a medical device during a medical procedure in a patient (eye surgery), the system comprising:
an inflow tubing 30 defining an inflow lumen (irrigation line), the inflow lumen configured to provide a fluid from a fluid source 32 to a site of the medical procedure;
an inflow sensor 34, 44 in communication with the inflow lumen to sense an inflow parameter (pressure, [0013]-[0016]) of the inflow lumen, the inflow sensor configured to generate an inflow signal indicative of the inflow parameter of the inflow tubing;
an outflow tubing 22 defining an outflow lumen (aspiration line 22: see paragraph [0011]), the outflow lumen configured to extract debris from the site of the medical procedure (see paragraph [0010]: "The aspiration system 16 removes the irrigation fluid and any detached tissue from the surgical site");
an outflow sensor 27 in communication with the outflow lumen to sense an outflow parameter (pressure) of the outflow lumen (see paragraph [0011]: “a pressure sensor that senses the pressure of the aspiration line 22”), the outflow sensor configured to generate an outflow signal indicative of the outflow parameter of the outflow lumen;
a memory including instructions (see paragraph [0013]); and
controller componentry that, when in operation, is configured by the instructions (see paragraph [0013]: "The controller 36 may include a microprocessor, memory, etc. that can receive input signals, process the signals in accordance with a software routine(s) and provide output signals.") to:
receive the inflow signal and the outflow signal (see paragraphs [0013], [0018], [0025]: “The differential pressure can be determined from the pressures sensed by sensors 27 and 34”); and
identify an abnormality (see paragraph [0018]: "the actual pressure deviates from the desired pressure") in either the inflow tubing or the outflow tubing based on comparing the inflow signal or the outflow signal to an inflow criterion and an outflow criterion, respectively (pre-determined thresholds: see paragraph [0018]: "desired range of pressures"; paragraph [0025]: “The differential pressure can be determined from the pressures sensed by sensors 27 and 34” to determine the resistance by dividing the sensed differential pressure by the measured flow rate).
Regarding claim 2, Bui discloses an inflow pump 28 in communication with the inflow tubing 30 to control a fluid flow rate of the fluid through the inflow lumen; and an outflow pump 24 in communication with the outflow tubing 22 to control a debris flow rate of the debris through the outflow lumen (see paragraphs [0011]-[0012]).
Regarding claim 23, Bui discloses a method for detecting abnormalities (see paragraph [0018]) in a medical device (fig. 1) during a medical procedure in a patient (eye surgery), the method comprising:
receiving, from an inflow sensor 34, 44, an inflow signal indicative of one or more inflow parameters (pressure: see paragraphs [0013]-[0016]) of a fluid within an inflow lumen;
receiving, from an outflow sensor 27, an outflow signal indicative of one or more outflow parameters (pressure) of debris within an outflow lumen (see paragraph [0010]: "The aspiration system 16 removes the irrigation fluid and any detached tissue from the surgical site");
identifying an abnormality (see paragraph [0018]: "the actual pressure deviates from the desired pressure") in the inflow lumen by comparing the inflow signal to an inflow criterion (pre-determined threshold and an outflow pre-determined threshold, respectively (see paragraphs [0013], [0018]); and
generating an inflow error based on the abnormality (see paragraph [0023]: "dividing the differential pressure across the system by the flowrate", the differential pressure being based on the actual, deviating pressure i.e. the abnormality) in the inflow lumen (see paragraphs [0020]-[0023], in particular [0023]: "If the actual resistance is greater than the threshold the controller 36 may activate a visual and/or audio indicator 54 to warn the surgeon that an occlusion may exist in the system.");
identifying an abnormality (see paragraph [0018]: "the actual pressure deviates from the desired pressure") implicitly in the outflow lumen by comparing the outflow signal to an outflow pre-determined threshold and an outflow pre-determined threshold, respectively (see paragraphs [0013], [0018]; and
generating an outflow error based on the abnormality (see paragraph [0023]: "dividing the differential pressure across the system by the flowrate", the differential pressure being based on the actual, deviating pressure i.e. the abnormality) implicitly in the outflow lumen (see paragraphs [0020]-[0023], in particular [0023]: "If the actual resistance is greater than the threshold the controller 36 may activate a visual and/or audio indicator 54 to warn the surgeon that an occlusion may exist in the system.").
Regarding claim 24, Bui discloses transmitting, via a display unit, the inflow error or the outflow error to a clinician performing the medical procedure (see paragraph [0023]: “If the actual resistance is greater than the threshold the controller 36 may activate a visual and/or audio indicator 54 to warn the surgeon that an occlusion may exist in the system”).
Regarding claim 25, Bui discloses generating a controlling signal to alter one or more components of the medical device to mitigate the abnormality causing the inflow error or the outflow error (see paragraph [0018]: "If the actual pressure is outside the desired range the controller 36 can vary the pump speed, accordingly.").
Regarding claim 26, Bui discloses a system for detecting abnormalities (see paragraph [0018]) in a medical device (fig. 1) during a medical procedure in a patient (eye surgery), the system comprising:
An inflow tubing 30 defining an inflow lumen, the inflow lumen configured to provide a fluid from a fluid source 32 to a site of the medical procedure (see paragraph [0012]);
an inflow sensor 34, 44 in communication with the inflow lumen to sense an inflow parameter of the inflow lumen, the inflow sensor configured to generate an inflow signal indicative of the inflow parameter (pressure: see paragraphs [0013]-[0016]) of the inflow tubing; and
controller componentry 36 that, when in operation, is configured to:
receive the inflow signal;
identify an abnormality in the inflow tubing based on comparing the inflow signal to an inflow criterion (see paragraph [0018]: "the actual pressure deviates from the desired pressure" = identifying an abnormality in the inflow lumen by comparing the inflow signal to an inflow criterion (pre-determined threshold and an outflow pre-determined threshold, respectively (see paragraphs [0013], [0018]); and
generating an inflow error based on the abnormality in the inflow tubing (see paragraph [0023]: "dividing the differential pressure across the system by the flowrate", the differential pressure being based on the actual, deviating pressure i.e. the abnormality in the inflow lumen; paragraphs [0020]-[0023], in particular [0023]: "If the actual resistance is greater than the threshold the controller 36 may activate a visual and/or audio indicator 54 to warn the surgeon that an occlusion may exist in the system.").
Allowable Subject Matter
Claims 4-10 and 12-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to claims 1-3, 11 and 19-26 have been considered but are moot because newly claimed recitation of “controller componentry that, when in operation, is configured by instructions to: receive the inflow signal and the outflow signal…comparing the inflow signal or the outflow signal to an inflow criterion and an outflow criterion respectively” in claim 1 and new apparatus claim 26 are taught in Ikuma. Amended claims 23-26 are taught in Bui.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN KIM whose telephone number is (571)272-1142. The examiner can normally be reached Maxi Flex.
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/John Kim/Primary Examiner, Art Unit 1777
JK
7/15/26
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