DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on October 24, 2025 has been entered.
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
The objection of claim 20 is withdrawn based on the Applicant’s amendment.
Claim Rejections - 35 USC § 102
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 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.
Claims 1-8, 10-13, 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boukhny et al. (US 2011/0015563 A1—previously cited).
Regarding claim 1, Boukhny discloses a smart auto phaco phacoemulsification system (paras. [0045]-[0110]), comprising: a surgical console 114 (para. [0046]) having at least one computing processor 116 capable of accessing at least one computing memory (para. [0049]-[0052]) associated with the at least one computing processor (para. [0049]-[0052]), wherein the surgical console is configured to receive one or more configuration variables (para. [0049]-[0052] ); and a surgical instrument 112 comprising a surgical tip 113, wherein the processor is configured to: track time duration during which a maximum targeted ultrasound power is applied during a phacoemulsification surgical procedure, initiate a reset of ultrasound power in response to the time duration reaching a threshold value, and cause the surgical instrument to release or dispense the at least one or more particles from the at least one surgical tip in accordance with the one or more configuration variables (i.e., para. [0069] discloses the temperature of the eye (i.e., threshold value) is determined by performing calculations at specific time intervals, para. [0070] discloses that the amount of power is reduced based on decreasing the duty cycle of the ultrasound signal if the estimated temperature exceeds the threshold value; see also (para. [0076]-[0084] such that power may be pulsed or reset, therefore, the amount of time that the power is “on” is tracked and can be pulsed or shut “off” for a period of time depending on the temperature reaching or exceeding a threshold value, as such the surgical instrument would release the particles of tissue from the distal end that were being treated during the burst (see paras. [0084]-[0086]) and additionally discloses aspiration vacuum and irrigation pressure (paras. [0050]-[0060]); note: see also paras. [0088]-[0089] which discloses not only duration of both cutting intervals and sense intervals, but also that during the interval a maximum amount of power (i.e., all of the power by the surgeon’s request as disclosed by para. [0089]), and the next cutting interval have no power)).
Regarding claim 2, Boukhny discloses the system of claim 1. Boukhny also discloses wherein the one or more configuration variables include one or more of: auto phaco on/off (para. [0077]), max power (para. [0077]), max VAC (para. [0050]), threshold (para. [0068]), and total active time (para. [0069], [0073], [0077]-[0080]).
Regarding claim 3, Boukhny discloses the system of claim 2. Boukhny also discloses the one or more configuration variables are entered into the system by a user (para. [0072]).
Regarding claim 4, Boukhny discloses the system of claim 2. Boukhny also discloses the one or more configuration variables are based on historical data gathered over time with respect to a specific surgeon (para. [0051]).
Regarding claim 5, Boukhny discloses the system of claim 2. Boukhny also discloses the one or more configuration variables are based at least in part on user-entered variables and historical (para. [0049]-[0051]).
Regarding claim 6, Boukhny discloses the system of claim 2. Boukhny also discloses additional variables are determined in response to the one or more configuration variables being related, sharing same functionalities, or depending on each other (para. [0049]-[0052]).
Regarding claim 7, Boukhny discloses the system of claim 6. Boukhny also discloses the additional variables are extracted and calculated from the inputted one or more configuration variables (i.e., see para. [0049]-[0052], [0073]-[0077]).
Regarding claim 8, Boukhny discloses the system of claim 6. Boukhny also discloses the at least one computer processor is configured to cause an ultrasound power reset based at least in part on an ultrasound power condition meeting at least one of the additional variables (paras. [0072]-[0080]).
Regarding claim 10, Scheller discloses an auto phaco system (paras. [0045]-[0110]) including a surgical console 114 (para. [0046]) and a surgical instrument 112, the system having at least one processor 116 coupled to a memory (para. [0049]), the processor being configured to: receive one or more data inputs as initial data settings (variables; para. [0049]-[0052]); extract one or more further data inputs from the received one or more data inputs (paras. [0061], [0068]-[0070]), track time duration during which a maximum targeted ultrasound power is applied during a phacoemulsification surgical procedure, initiate a reset of ultrasound power in response to the time duration reaching a threshold value, and cause the surgical instrument to release or dispense the at least one or more particles from the at least one surgical tip in accordance with the one or more configuration variables (i.e., para. [0069] discloses the temperature of the eye (i.e., threshold value) is determined by performing calculations at specific time intervals, para. [0070] discloses that the amount of power is reduced based on decreasing the duty cycle of the ultrasound signal if the estimated temperature exceeds the threshold value; see also (para. [0076]-[0084] such that power may be pulsed or reset, therefore, the amount of time that the power is “on” is tracked and can be pulsed or shut “off” for a period of time depending on the temperature reaching or exceeding a threshold value, as such the surgical instrument would release the particles of tissue from the distal end that were being treated during the burst (see paras. [0084]-[0086]) and additionally discloses aspiration vacuum and irrigation pressure (paras. [0050]-[0060])).
Regarding claim 11, Boukhny discloses the system of claim 10. Boukhny also discloses the received one or more data inputs are received from a user interface (para. [0072]).
Regarding claim 12, Boukhny discloses the system of claim 10. Boukhny also discloses the received one or more data inputs are based on historical data (para. [0051]).
Regarding claim 13, Boukhny discloses the system of claim 10. Boukhny also discloses the received one or more data inputs are received from a user interface and based on historical data (para. [0049]-[0051]).
Regarding claim 20, Boukhny discloses the system of claim 1. Boukhny further discloses a fluid line 130, 132, 134 operatively coupled to the surgical instrument (para. [0049]); and a sensor 122 operatively coupled to the fluid line (para. [0049]), wherein the sensor is configured measure a pressure in the fluid line (para. [0049]), wherein the at least one computing processor is configured to detect an occlusion at the at least one surgical tip based on a pressure measurement (para. [0050]-[0053]), and wherein the at least one computer processor is further configured to cause an ultrasound power reset and to active the venting system based on detection of the occlusion for a period of time (para. [0067]-[0080]).
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 9 is rejected under 35 U.S.C. 103 as being unpatentable over Boukhny in view of Kuebler (US 2011/0092896 A1—previously cited).
Regarding claim 9, Boukhny discloses the system of claim 6. Boukhny doesn’t directly disclose discloses the system is configured to automatically release or discharge the one or more particles from the at least one surgical tip based on ultrasound power reaching a value of at least one of the additional variables.
In the same field of endevaor, namely surgical systems, Kuebler discloses (paras. [0022]-[0032] a similar device including a handpiece 4 of a phaco-emulsification system that includes vibrating tip 5, an irrigation line 3, an irrigation valve 40, and a venting valve 17. Kuebler also discloses the venting system is configured to automatically release or discharge the one or more particles from the at least one surgical tip based on ultrasound power reaching a value of at least one of the additional variables (para. [0029]-[0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Boukhny to automatically release or discharge the one or more particles from the at least one surgical tip based on ultrasound power reaching a value of at least one of the additional variables for purposes of forcing the particle causing an occlusion away from the needle tip such that the occlusion is no longer present in the system (para. [0029]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Boukhny.
Regarding claim 16, Boukhny discloses the system of claim 10. Boukhny doesn’t expressly disclose the threshold value is 3 seconds as required by the claim.
Instead, Boukhny discloses recording over a period of time, temperature calculations (para. [0069]), and that the temperature needs to be optimized such that it doesn’t reach a temperature threshold to cause tissue damage. As such, the device has “on” and “off” times to reduce the temperature of the tip. Therefore, the time that the power is on (and off) is disclosed to be a result effective variable in that changing the time would change the temperature of the tip during the treatment (para. [0080]). Additionally, the Applicant’s disclosure does not teach any criticality or importance to the value being 3 seconds (para. [0037]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Boukhny by having the time to 3 seconds (i.e., to keep the device cool) as a matter of routine optimization since a person of ordinary skill in the art would have a reasonable expectation of success and since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant's arguments filed October 24, 2025 have been fully considered but they are not persuasive.
Specifically, Applicant argues that Boukhny fails to disclose:
Track time duration during which a maximum targeted ultrasound power is applied during a phacoemulsification surgical procedure and initiate a reset of ultrasound power in response to the time duration reaching a threshold value. Examiner disagrees. In addition to the explanation in claim 1, Examiner further clarifies and cites paras. [0088]-[0089] of Boukhny and specifically that these paragraphs disclose:
Track time duration (i.e., the duration of the cutting interval and sense intervals as disclosed in para. [0088] which are approximately the same) during which a maximum targeted ultrasound power is applied during a phacoemulsification surgical procedure (i.e., approximately all of the power requested by the surgeon as disclosed by para. [0089]) and initiate a reset of ultrasound power (i.e., none of the power as disclosed in para. [0089]) in response to the time duration reaching a threshold value (i.e., during which the first cutting interval was completed at the maximum power and the subsequent cutting interval has no power).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHAEL LYNN GEIGER whose telephone number is (571)272-6196. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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/RACHAEL L GEIGER/ Examiner, Art Unit 3771
/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771