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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-10 in the reply filed on 10/25/25 is acknowledged.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected product, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/25/25.
Claim Objections
Claim 2 is objected to because of the following informalities: the claim reads “in case of at least one of the sensors of the at least one of the sensor arrays malfunctioning”, seems to be a typographical error, it appears the claim should read: “in case of at least one of the sensors of the at least one of the sensor arrays is malfunctioning”.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sorensen (EP 2919850).
Regarding claim 1, Sorensen teaches a phacoemulsification system, comprising:
a phacoemulsification probe (112) having a distal end configured for insertion into an eye of a patient, the probe comprising:
an irrigation channel (315, 320) connecting with the irrigation channel of the handpiece 112) for irrigating the eye with irrigation fluid;
an aspiration channel (325/355) connecting with the aspiration channel of the handpiece 112) for evacuating material from the eye; and
at least one sensor array (365/330) fluidly coupled to at least one of the irrigation channel and the aspiration channel,
the at least one sensor array comprising multiple sensors (365/330) configured to measure a parameter indicative of fluid pressure in the irrigation channel or the aspiration channel (sensor 365 indicates the pressure in the irrigation channel and 330 indicates the pressure in the aspiration channel);
a processor (360), which is configured to regulate at least one of irrigation flow and aspiration flow using the measured parameter (Refer to paragraphs 0030, and 0039. “At the step 430, the controller 360 operates the vacuum relief valve 350 to open, or at least partially open, in order to reduce or relieve the vacuum pressure in the aspiration conduit 325. Upon opening or the at least partial opening of the vacuum relief valve 350, the vacuum pressure within the aspiration conduit 325 draws a fluid from the vent reservoir into the bypass conduit 345. This movement of the fluid from the vent reservoir into the bypass conduit 345 alleviates or reduces the amount of vacuum pressure within the aspiration conduit 325. As described above, in some embodiments, opening of the vacuum relief valve 350 maintains the vacuum pressure or increases the rate of decrease of the vacuum pressure”).
Claim(s) 1, 3, and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wilson et al (US 2014/0163455) hereinafter Wilson.
Regarding claim 1, Wilson teaches a phacoemulsification system, comprising:
a phacoemulsification probe (112) having a distal end configured for insertion into an eye of a patient, the probe comprising:
an irrigation channel (345) connecting with the irrigation channel of the handpiece 112) for irrigating the eye with irrigation fluid;
an aspiration channel (375) connecting with the aspiration channel of the handpiece 112) for evacuating material from the eye; and
at least one sensor array (342/392) fluidly coupled to at least one of the irrigation channel and the aspiration channel,
the at least one sensor array comprising multiple sensors (342/392) configured to measure a parameter indicative of fluid pressure in the irrigation channel or the aspiration channel (Paragraph [0027]: “the irrigation system 335 includes an optional irrigation sensor 342 that may be used to detect fluid characteristics of the irrigation fluid in the irrigation conduit 340” Paragraph [0026]: “the sensor 392 may be located along the aspiration path 375 or located near the distal end 310 and in fluid communication with the surgical site. In some embodiments, the sensor 392 may be located within the surgical site and in communication with a controller forming a part of the fluidics subsystem 110, as described below. In some embodiments, the sensor 392 detects a pressure at the surgical site or a pressure associated with the surgical site”.
a processor (405), which is configured to regulate at least one of irrigation flow and aspiration flow using the measured parameter (Refer to paragraphs [0031-0032]”).
Regarding claim 3, Wilson teaches the sensor array is coupled with the irrigation channel (by means of sensor 342), and wherein the sensors are configured to measure a pressure of the irrigation fluid (by means of sensor 342).
Regarding claim 5, Wilson teaches the sensor array is coupled with the aspiration channel (by means of 392), and wherein the sensors are configured to measure a vacuum level in the aspiration channel (by means of 392).
Claim(s) 1, 3, and 5 is/are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Yalamanchili (US 2014/0257172) hereinafter Yalamanchili.
Regarding claim 1, Yalamanchili teaches a phacoemulsification system, comprising:
a phacoemulsification probe (112) having a distal end configured for insertion into an eye of a patient, the probe comprising:
an irrigation channel (300) connecting with the irrigation channel of the handpiece 112) for irrigating the eye with irrigation fluid;
an aspiration channel (305) connecting with the aspiration channel of the handpiece 112) for evacuating material from the eye; and
at least one sensor array (312/365/330) fluidly coupled to at least one of the irrigation channel and the aspiration channel,
the at least one sensor array comprising multiple sensors (312/365/330) configured to measure a parameter indicative of fluid pressure in the irrigation channel or the aspiration channel (Refer to paragraphs [0028, 0030,0034-0035]).
a processor (360), which is configured to regulate at least one of irrigation flow and aspiration flow using the measured parameter (Refer to paragraphs [0047]”).
Regarding claim 3, Yalamanchili teaches the sensor array is coupled with the irrigation channel (by means of sensor 312 and 365), and wherein the sensors are configured to measure a pressure of the irrigation fluid (refer to paragraphs 28 and 35).
Regarding claim 5, Yalamanchili teaches the sensor array is coupled with the aspiration channel (by means of 330), and wherein the sensors are configured to measure a vacuum level in the aspiration channel (by means of 330).
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of Chiabaru et al. (US 20090128160 A1) hereinafter Chiabaru.
Regarding claim 2, Wilson fails to explicitly teach the processor is configured to alert a user in case of at least one of the sensors of the at least one of the sensor arrays malfunctioning. Chiaburu teaches a processor that can detect faults in sensors medical devices (Refer to paragraphs [0010 and 0011] “if output circuit 24 determines that fault signal 28 indicates a fault condition, output circuit 24 may prevent activation of a downstream system, discard or ignore digital transducer output signal 26, and the like”).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to include a fault detection processor in the phacoemulsification system of Wilson as taught by Chiaburu, to detect faults in the sensors of Wilson to avoid damage of the eye while performing the procedure due to inaccurate sensor readings.
Claim(s) 4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of Corl et al (US 20150173629).
Regarding claim 4, Wilson fails to explicitly teach (dep. onclaim 3), wherein the sensor array is fitted into an indentation made in an inner wall of the irrigation channel.
Corl teaches a pressure sensor (300) fitted into an indentation of an inner wall of a channel 225, see Figures 5-6.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to place the sensor array into an indentation of an inner wall of the irrigation channel of the handpiece of modified Wilson as taught by Corl, since doing so would allow accurately sensing of the pressure within the channel without interrupting the flow of fluid within the channel while the device is in operation.
Regarding claim 6, Wilson fails to explicitly teach the sensor array is fitted into an indentation made in an inner wall of the aspiration channel.
Corl teaches a pressure sensor (300) fitted into an indentation of an inner wall of a channel 225, see Figures 5-6. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to place the sensor array into an indentation of an inner wall of the aspiration channel of the handpiece of modified Wilson as taught by Corl, since doing so would allow accurately sensing of the pressure within the channel without interrupting the flow of fluid within the channel while the device is in operation.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wilson in view of Stanton et al. (US 20110066122) hereinafter Stanton.
Regarding claim 8, Wilson teaches the at least one sensor array is comprised in a handpiece of the phacoemulsification probe (112, Figures 1 and 3) but fails to explicitly teach the handpiece is suitable for undergoing sterilization.
Stanton teaches the use of a sterilizable handpiece (Refer to paragraphs 0028 and 0032).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use a sterilizable handpiece as the handpiece of Wilson as taught by Stanton, since doing so would allow reusability or the successful acceptable sterilization of the probe for protection against infection.
Allowable Subject Matter
Claims 7, 9-10 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.
Conclusion
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EDELMIRA BOSQUES
Supervisory Patent Examiner
Art Unit 3762
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3762