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 .
Response to Amendment
This Office action is in response to the applicant’s communication filed 11/07/2025.
Status of the claims:
Claims 1 – 9 and 11 – 23 are pending in the application.
Claims 1, 3, 5, 7, 9, and 23 are amended.
Claims 12 – 22 are withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “wherein the microcontroller is configured to deactivate the ultrasound transducer when the electrical impedance falls below a predefined impedance value and at least one of: a sensed pressure or a sensed vacuum level or a sensed flow rate crosses a respective predefined threshold.”, however, this is not grammatically correct, therefore the Examiner suggests the line be amended to read “wherein the microcontroller is configured to deactivate the ultrasound transducer when the electrical impedance falls below a predefined impedance value and when at least one of: a sensed pressure or a sensed vacuum level or a sensed flow rate crosses a respective predefined threshold.”;
Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 – 7, 11, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Banko (US 2019/0133822 A1) (previously cited) and in view of Giordano et al (EP 3260065 B1) (reference PDF version attached) and Boukhny et al (US 2013/0211435 A1) (previously cited).
Regarding claims 1 and 11, Banko discloses a phacoemulsification probe (phacoemulsification system 10) (abstract, paragraph [0034], and Fig. 2) comprising:
a needle (work tip 15) configured for insertion into an eye of a patient (Examiner’s note: a needle is defined as slender pointed object; as shown in Figs. 6 and 7 the working tip is a slender pointed object. Furthermore, the device is a phacoemulsification device which is inserted into the eye, and the work tip is what is inserted into the eye);
an ultrasound transducer (transducer 219) configured to vibrate the needle (work tip 15) (paragraph [0039]);
a sensing element (sensor 24) configured to output an indication (vacuum pressure) (paragraphs [0038 – 0039]) indicative of physical contact between the needle and a lens of the eye (Examiner’s note: the change in vacuum pressure from the un-occluded state to an occluded state is an indication that the needle contacts a lens); and
a controller (controller 30), which is configured to receive the indication (pressure level), and to activate and deactivate the ultrasound transducer according to the indication when at least one of: a sensed pressure or a sensed vacuum level or a sensed flow rate crosses a respective predefined threshold. (Examiner’s note: as stated in paragraph [0047] when the pressure reaches a preset value, the controller will start or turn off the vibrations) [claim 11] wherein the controller is configured to deactivate the ultrasound transducer by cutting power to the ultrasound transducer (Examiner’s note: as stated in paragraph [0039] the ultrasonic signal drives (i.e., powers) the transducer which causes the vibration at the work tip. As stated in paragraph [0047] the controller turns off the vibration to the work tip, which has to be done by cutting the signal that drives (i.e., powers) the transducer. Therefore, Banko is configured as claimed) .
However, Banko is silent regarding (i) wherein the controller is a microcontroller and (ii) wherein the microcontroller is further configured to sense physical contact between the needle and the lens of the eye based on receiving an electrical impedance of the ultrasound transducer, and wherein the microcontroller is configured to deactivate the ultrasound transducer when the electrical impedance falls below a predefined impedance value.
As to (i), Boukhny teaches, in the same field of endeavor, a phacoemulsification probe (control system 100 and ultrasonic hand piece 112) (paragraphs [0003 – 0004], [0046], and [0051]) comprising a needle (cutting tip 113), an ultrasonic transducer (piezoelectric crystals) (paragraph [0089]), a sensing element (irrigation pressure sensor 122) configured to output data to a microcontroller (paragraphs [0051 – 0052] and [0071). Furthermore, the microcontroller is configured to adjust the power of the ultrasonic transducer based on monitored irrigation flute flow rate (paragraph [0071] and Fig. 7). Additionally, Boukhny recites, in paragraph [0051], wherein the CPU can be either a microcontroller or a computer (i.e., a non-microcontroller).
It should be understood that Banko and Boukhny are known references in the art that teach an ophthalmic device comprising a sensor element that sends feedback to a controller, wherein the controller uses the feedback to adjust the parameters of the system (abstract, paragraphs [0034], [0039], and [0047] – Banko ; paragraphs [0003 – 0004], [0046], [0051], [0071], and Fig. 7 – Boukhny); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted the controller of Banko with the microcontroller of Boukhny (Examiner’s note: it should be understood that the substituted microprocessor functions in the same way as the controller of Banko), and the results of the substitution would have been predictable and resulted in the modified system being able to function as intended to properly alter the parameters of the phacoemulsification device based on the sensor feedback. The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143.
As to (ii), Giordano teaches an ultrasonic surgical system comprising a blade 79 (which equates to the needle of Banko) which vibrates in response to a drive signal 416 sent to a transducer (transducer 50) and a controller configured to sense physical contact between the blade 79 and tissue based on receiving an electrical impedance of the ultrasound transducer (paragraphs [0032], [0033], [0034], [0036 – 0043], [0046]) (Examiner’s note: as stated in paragraphs [0032 – 0043] and [0046] the processor senses the change in the impedance which indicates contact and transection with the tissue layer), and wherein the microcontroller is configured to deactivate the ultrasound transducer when the electrical impedance falls below a predefined impedance value (Examiner’s note: as stated in paragraph [0057] the processor 400 can cut off the drive signal (i.e., deactivate the ultrasonic transducer) when the impedance reaches a predetermined value (which includes being below a predefined value)). Giordano further teaches, in paragraph [0008], the desire to have some form of feedback to indicate the tissue has been cut in order to have the user stop the ultrasonic transducer in order to reduce the heat, and possible damage, applied to the surrounding tissue; and in paragraph [0071], that the operational modes [of the system] include, without limitation, disconnecting or shutting down the output power of the generator 30, 500; the operational modes of the ultrasonic instrument in response to the change in tissue state [measured by the change in impedance] can be selected, for example, to minimize heating effects of the end effector 81 [which includes blade 79], to prevent or minimize possible damage to the surgical instrument 100 and/or surrounding tissue. This is advantageous because heat is generated exponentially when the transducer 50 is activated with nothing between the jaws of the end effector 81, 810 as is the case when a change in tissue state occurs (which equates to the needle of Banko not being in contact with the lens tissue of the eye).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the system and (micro)controller of Banko in view of Boukhny, based on the teachings of Giordano, to incorporate a tissue impedance sensor and for the (micro)controller to be configured to sense tissue contact and to be able to deactivate the ultrasound transducer when the electrical impedance falls below a predefined impedance value for the purpose of reducing the amount of heat that is generated by the needle in order to reduce the amount of damage to the system and to any surrounding tissue (paragraphs [0008] and [0071] – Giordano).
Regarding claims 2 and 4, as discussed above, the combination of Banko, Giordano, and Boukhny teaches the device of claim 1. Additionally, Banko discloses wherein the sensing element is an aspiration pressure sensor / [claim 4] vacuum sensor (sensor 24) coupled with an aspiration channel (aspiration line 22) comprised in the probe (paragraph [0038] and Fig. 2), and wherein the indication is indicative of a pressure / [claim 4] vacuum level in the aspiration channel (Examiner’s note: the vacuum pressure sensor measures the pressure in the aspiration channel, the pressure is a vacuum pressure as aspiration is induced by negative pressure (i.e., a vacuum), therefore the pressure measurement is indicative of the pressure / vacuum pressure in the aspiration channel).
Regarding claims 3 and 5, as discussed above, the combination of Banko, Giordano, and Boukhny teaches the device of claim 1. Additionally, Banko discloses wherein the microcontroller is configured to [claim 3] activate the ultrasound transducer when the pressure in the aspiration channel is below a predefined threshold, and to deactivate the ultrasound transducer when the pressure is above the predefined threshold and/or [claim 5] activate the ultrasound transducer when the vacuum in the aspiration channel is above a predefined threshold, and to deactivate the ultrasound transducer when the vacuum level is below the predefined threshold (Examiner’s note: as stated paragraph [0047] the controller can turn on / off the ultrasonic vibration based on the change in the vacuum pressure relative to the preset threshold level; therefore, the controller is configured to operate as claimed).
Regarding claim 6, as discussed above, the combination of Banko, Giordano, and Boukhny teaches the device of claim 1. Additionally, Banko discloses wherein the sensing element is an aspiration flow rate sensor (sensor 24) coupled with an aspiration channel (aspiration line 22) comprised in the probe (paragraph [0038] and Fig. 2), and wherein the indication is indicative of a flow rate in the aspiration channel (Examiner’s note: the sensor 24 measures the pressure and/or the change in the pressure in the aspiration line, and the pressure is an indication of the flow rate. And as discussed in paragraph [0044 – 0046] the flow rate is altered based on the vacuum level, which provides evidence that the vacuum level is used as an indication of the flow rate).
Regarding claim 7, as discussed above, the combination of Banko, Giordano, and Boukhny teaches the device of claim 1. Additionally, Banko discloses wherein the microcontroller is configured to activate the ultrasound transducer when the flow rate in the aspiration channel is below a predefined threshold, and to deactivate the ultrasound transducer when the flow rate is above the predefined threshold (Examiner’s note: the sensor 24 measures the pressure and/or the change in the pressure in the aspiration line, and the pressure is an indication of the flow rate. And as discussed in paragraph [0044 – 0046] the flow rate is altered based on the vacuum level, as stated in paragraph [0016] the control system can determine the flow rate of aspiration [within the tube], and as stated in paragraph [0047] the controller is programed to turn on and off based on the pressure level / pressure level change. Therefore, it can be said that the controller (modified to be a microcontroller) is configured / capable of operating as claimed).
Regarding claim 23, as discussed above, the combination of Banko, Giordano, and Boukhny teaches the device of claim 1. Additionally, the combination further encompasses wherein the microcontroller is further configured monitor piezoelectric element impedance by briefly operating the ultrasound transducer for tens of milliseconds to verify whether the needle is in or out of the eye of the patient (Examiner’s note: as discussed in the rejection of claim 1, the (micro)controller of Banko in view of Boukhny is modified with Giordano to monitor electrical impedance of the transducer and the change in impedance of the tissue and to be configured to turn on/off the transducer in response to any pre-selected impedance value. Moreover, the above limitation is an intended use limitation, which requires only that the microcontroller be capable of operating as claimed (i.e., run for the time required and verify the needle is in or out of the eye); because the microcontroller operates the transducer and is modified to monitor the impedance, which determines if the needle is in contact with the lens tissue, the microcontroller is capable of running the transducer for tens of milliseconds and verify, based on the impedance value data, if the needle is in or out of the eye. Therefore, the microcontroller of the modified device is configured as claimed).
Claims 8 – 9 are rejected under 35 U.S.C. 103 as being unpatentable over Banko (US 2019/0133822 A1) and in view of Giordano et al (EP 3260065 B1) (reference PDF version attached) and Boukhny et al (US 2013/0211435 A1), as applied to claim 1 above, and further in view of Urich et al (US 2015/0045806 A1).
Regarding claims 8 – 9, as discussed above, the combination of Banko, Giordano, and Boukhny teaches the device of claim 1. Additionally, Banko discloses an irrigation channel (irrigation line 16) comprised in the probe (paragraph [0036] and Fig. 2).
However, the combination is silent regarding (i) [claim 8] wherein the sensing element is an irrigation pressure sensor coupled with the irrigation channel, wherein the indication is indicative of a pressure in the irrigation channel and (ii) [claim 9] wherein the microcontroller is configured to activate the ultrasound transducer when the pressure in the irrigation channel is above a predefined threshold, and deactivate the ultrasound transducer when the pressure is below the predefined threshold.
As to the above, Urich teaches, in the same field of endeavor, a phacoemulsification probe (phaco handpiece 114) comprising a needle (needle 106), an ultrasonic transducer (piezoelectric transducer 116) (abstract, paragraphs [0017 – 0021], and Fig. 3A), and a sensing element (sensor – not shown – discussed in paragraph [0045]) placed in an irrigation channel (irrigation pathway 118) configured to output an indication indicative of physical contact between the needle and a lens to a controller (Examiner’s note: as stated in paragraph [0045] the irrigation pathway has an irrigation flow sensor used to measure / sense the flow rate within the irrigation pathway, and a presence of particulates either occluding or partially occluding the aspiration path way, the flow rate changes / diminishes, which means that the flow sensor output is indicating that there is physical contact between the needle / system and the tissue / lens of the eye. Additionally, the circuit 313 (i.e., the controller) uses the output data from the sensor to alter the amount of power delivered to the ultrasonic transducer for the purpose of reducing the heat at the cornea).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the sensing element of Banko in view of Giordano and Boukhny to incorporate the irrigation flow sensor as a means of feedback to a controller / microcontroller, such that the (micro)controller can alter (i.e., turn on/off) the power of the ultrasonic transducer in response to the change in irrigation flow for the purpose of reducing the heating of the cornea (paragraph [0043] – Urich).
Additionally, based on the above it should be understood that Banko and Urich are known references in the art that teach an ophthalmic device comprising a sensor element that sends feedback to a controller, wherein the controller uses the feedback to adjust the parameters of the system (abstract, paragraphs [0034], [0039], and [0047] – Banko ; paragraphs [0017 – 0020], [0045], and Fig. 3 – Urich); and the Examiner contends that it would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have substituted one sensor / means of feedback of Banko for another (i.e., substituting the aspiration flow sensor for the irrigation flow sensor) and the results of the substitution would have been predictable and resulted in the modified system being able to function as intended to properly to be able alter the parameters of the phacoemulsification device based on sensor feedback (i.e., to allow the controller to know when to turn on/off the transducer based on the feedback data). The examiner notes the rejection above is based on KSR int’l Co. V. Teleflex inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), rational B, outlined in MPEP 2143. Furthermore, it should be understood that because the microcontroller of Banko in view of Giordano and Boukhny is modified to receive data from the above sensors, and because the microcontroller of Banko in view of Giordano and Boukhny is configured to activate / deactivate the transducer in response to the received data, the combination makes obvious wherein the microcontroller is configured to activate / deactivate in the manner recited in claim 9 (i.e., configured to activate / deactivate at the desired data points); additionally, it should be understood that the microcontroller of Banko in view of Giordano and Boukhny functions in the same way as previously discussed, except using the irrigation flow data to turn on/off the ultrasonic transducer of Banko.
Response to Arguments
Applicant’s arguments, filed 11/07/2025, with respect to the rejection of claims 1 – 9, 11, and 23 under Banko, Boukhny, and Giordano have been considered but are not persuasive. More specifically:
With regards to Applicant’s argument that “The Office Action alleges that Giordano discloses this feature of claim 1. Giordano is directed to a surgical cutting instrument that senses change when transection of a tissue or vessel occurs based on a change in transducer impedance. {[0046]. Giordano does not disclose or suggest sensing physical contact between a needle and a lens of the eye based on receiving an electrical impedance of the ultrasound transducer. Giordano is concerned with sensing changes tissue and not contact between an instrument and the tissue. “Accordingly, the impedance Z of the transducer 50 can be monitored to detect the transection of the inner muscle tissue layer of the vessel from the adventitia layer and can also be monitored to detect when the vessel has been transected and sealed.” (Giordano, J[0046]).”, the Examiner notes that sensing changes in tissue is also sensing the contact between the instrument and the tissue, when the sensor starts providing feedback to the user regarding the impedance value, the user is made aware of contact between the instrument and the tissue. Additionally, paragraphs [0033 – 0043] of Giordano recite wherein the system output is changed based on the electrical impedance of the transducer in accordance with the programmed values (i.e., predefined values), and the electrical impedance value is measured based on the changes between the voltage, current, power, and frequency changes made to the system induced by a load (i.e., tissue contact) being placed on the system.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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/Andrew Restaino/Primary Examiner, Art Unit 3771