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) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Injev (US 2011/0295191) in view of Banko (US 2019/0133822).
Regarding claim 1, Injev discloses a phacoemulsification apparatus, comprising: a phacoemulsification probe 118 having a distal end comprising a combination of a needle (¶32) and a sleeve (¶58), the combination being configured for insertion into an eye of a patient, and being configured for fluid transfer between the eye and the combination (¶22); the needle being ultrasonic (¶32, ¶60); a first sensor configured to output a first indication indicative of physical contact between the needle and a lens of the eye (pressure sensor ¶29); a second indication indicative of a parameter associated with the fluid transferred by the combination (a parameter/indication being a fluid flow - ¶10) ; and a microcontroller, which is configured to receive the first and the second indication (¶22), to calculate a threshold for the first indication in response to the second indication (¶22), and to activate and deactivate the device in response to the first indication crossing the threshold (¶37).
While Injev substantially discloses the invention as claimed, it does not disclose an ultrasound actuator configured to vibrate the needle (only that the needle is ultrasonic - ¶32, 60), a second sensor configured to output the second indication, nor activating and deactivating the ultrasound actuator in response to the first indication crossing the threshold.
Injev discloses “Although described as a pressure sensor, the irrigation sensor 204 may be another type of sensor, such as a flow sensor that detects actual fluid flow and may include additional sensors for monitoring additional parameters” (¶29). A lot of Injev’s specification describes the threshold as a pressure threshold, meaning one of ordinary skill in the art reading would consider a pressure sensor as first in line for “additional sensors” to a flow sensor. Further, Injev discloses the pressure threshold as tied to the flow rate (¶22, which uses “various commanded aspiration flow rates”). One of ordinary skill in the art would appreciate that in determining a pressure threshold (and controlling the device based on said threshold) using the actual flow rate detected by the flow sensor described in ¶29 would better reflect the realities of the device, as opposed to a “commanded aspiration flow rate” which may not be the actual flow rate in certain cases (such as a blockage or if the pump is mis-calibrated).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Injev such that it includes a second sensor configured to output the second indication as suggested by Injev itself such that the pressure threshold is calculated based on the actual operation of the device, as opposed to the expected operation.
Banko discloses a phacoemulsification device which has an ultrasound actuator 19 configured to vibrate the needle (¶16) and activating and deactivating the ultrasound actuator in response to the first indication crossing the threshold (¶47).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Injev such that it includes an ultrasound actuator configured to vibrate the needle and activating and deactivating the ultrasound actuator in response to the first indication crossing the threshold as taught by Banko to prevent the apparatus from accidently causing harm when cutting is not occurring and assisting in clearing a blockage when aspirating but a blockage occurs.
Regarding claim 2, wherein the fluid transferred comprises aspiration fluid transferred from the eye to the combination (¶30).
Regarding claims 3-6, while Injev substantially discloses the invention as claimed, it does not disclose wherein the first sensor comprises a pressure sensor, located in a proximal section of the phacoemulsification probe, and wherein the first indication comprises a signal indicative of an aspiration fluid pressure, wherein the parameter comprises an aspiration fluid flow rate, the threshold comprises a function of the aspiration fluid flow rate and an internal diameter of the needle, nor wherein the second sensor comprises a flow rate sensor.
Injev discloses all of this with respect to the infusion/irrigation (see claims 7-10 below), in order for improved system response to unexpected pressure drops (¶9) as it is desired to maintain a consistent fluid pressure in the eye (¶7). As such it is seen as obvious to apply the teaching to the aspiration line as well, to try and maintain as consistent a pressure in the eye as possible.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Injev such that the first sensor comprises a pressure sensor, located in a proximal section of the phacoemulsification probe, and wherein the first indication comprises a signal indicative of an aspiration fluid pressure, wherein the parameter comprises an aspiration fluid flow rate, the threshold comprises a function of the aspiration fluid flow rate and an internal diameter of the needle, nor wherein the second sensor comprises a flow rate sensor as taught by Injev itself to assist in maintaining as consistent a pressure in the eye as possible.
Regarding claim 7, wherein the fluid transferred comprises irrigation fluid transferred to the eye from the combination (¶28).
Regarding claim 8, wherein the first sensor comprises a pressure sensor (¶29), located in a proximal section 115 of the phacoemulsification probe (fig 2), and wherein the first indication comprises a signal indicative of an irrigation fluid pressure (¶29).
Regarding claim 9, wherein the parameter comprises an irrigation fluid flow rate (see claim 1 and “actual flow rate” detected by a flow rate sensor in ¶29).
Regarding claim 10, wherein the threshold comprises a function of the irrigation fluid flow rate and a difference in an inner diameter of the sleeve and an outer diameter of the needle (¶22 – takes into account one or more system operating parameters that affect the infusion pressure, including tip type and infusion sleeve size, which are known to determine the difference in an inner diameter of the sleeve and an outer diameter of the needle as they determine cross-sectional area of the flow path).
Regarding claim 11, Injev discloses a method for controlling a phacoemulsification system, comprising: providing a phacoemulsification system having a probe 118 having a distal end comprising a combination of a needle (¶32) and a sleeve (¶58), a first sensor (¶29) and, wherein the combination is configured for insertion into an eye of a patient, and configured for fluid transfer between the eye and the combination (¶22), the needle is configured to vibrate (¶32, ¶60), wherein the first sensor is configured to output a first indication indicative of physical contact between the needle and a lens of the eye (pressure - ¶29), and configured to output a second indication indicative of a parameter associated with the fluid transferred by the combination (fluid flow, ¶10, ¶29); transferring fluid by the combination (¶22); receiving the first and the second indication (¶22, ¶31); calculating a threshold for the first indication in response to the second indication (¶10, ¶22); and activating and deactivating the apparatus in response to the first indication crossing the threshold (¶31).
While Injev substantially discloses the invention as claimed, it does not an ultrasound actuator is configured to vibrate the needle, a second sensor configured to output the second indication, nor activating and deactivating the ultrasound actuator in response to the first indication crossing the threshold.
Injev discloses “Although described as a pressure sensor, the irrigation sensor 204 may be another type of sensor, such as a flow sensor that detects actual fluid flow and may include additional sensors for monitoring additional parameters” (¶29). A lot of Injev’s specification describes the threshold as a pressure threshold, meaning one of ordinary skill in the art reading would consider a pressure sensor as first in line for “additional sensors” to a flow sensor. Further, Injev discloses the pressure threshold as tied to the flow rate (¶22, which uses “various commanded aspiration flow rates”). One of ordinary skill in the art would appreciate that in determining a pressure threshold (and controlling the device based on said threshold) using the actual flow rate detected by the flow sensor described in ¶29 would better reflect the realities of the device, as opposed to a “commanded aspiration flow rate” which may not be the actual flow rate in certain cases (such as a blockage or if the pump is mis-calibrated).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Injev such that it includes a second sensor configured to output the second indication as suggested by Injev itself such that the pressure threshold is calculated based on the actual operation of the device, as opposed to the expected operation.
Banko discloses a phacoemulsification device which has an ultrasound actuator 19 configured to vibrate the needle (¶16) and activating and deactivating the ultrasound actuator in response to the first indication crossing the threshold (¶47).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Injev such that it includes an ultrasound actuator configured to vibrate the needle and activating and deactivating the ultrasound actuator in response to the first indication crossing the threshold as taught by Banko to prevent the apparatus from accidently causing harm when cutting is not occurring and assisting in clearing a blockage when aspirating but a blockage occurs.
Regarding claim 12, the fluid transferred comprises aspiration fluid transferred from the eye to the combination (¶31).
Regarding claims 13-16, while Injev substantially discloses the invention as claimed, it does not disclose wherein the first sensor comprises a pressure sensor, located in a proximal section of the phacoemulsification probe, and wherein the first indication comprises a signal indicative of an aspiration fluid pressure, wherein the parameter comprises an aspiration fluid flow rate, the threshold comprises a function of the aspiration fluid flow rate and an internal diameter of the needle, nor the second sensor comprises a flow rate sensor.
Injev discloses all of this with respect to the infusion/irrigation (see claims 17-20 below), in order for improved system response to unexpected pressure drops (¶9) as it is desired to maintain a consistent fluid pressure in the eye (¶7). As such it is seen as obvious to apply the teaching to the aspiration line as well, to try and maintain as consistent a pressure in the eye as possible.
It would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Injev such that the fluid transferred comprises aspiration fluid transferred from the eye to the combination, wherein the first sensor comprises a pressure sensor, located in a proximal section of the phacoemulsification probe, and wherein the first indication comprises a signal indicative of an aspiration fluid pressure, wherein the parameter comprises an aspiration fluid flow rate, the threshold comprises a function of the aspiration fluid flow rate and an internal diameter of the needle, nor the second sensor comprises a flow rate sensor as suggested by Injev itself to maintain as consistent an eye pressure as possible.
Regarding claim 17, wherein the fluid transferred comprises irrigation fluid transferred to the eye from the combination (¶28).
Regarding claim 18, wherein the first sensor comprises a pressure sensor (¶29), located in a proximal section 115 of the phacoemulsification probe (fig 2), and wherein the first indication comprises a signal indicative of an irrigation fluid pressure (¶29).
Regarding claim 19, wherein the parameter comprises an irrigation fluid flow rate (see claim 11 and “actual flow rate” detected by a flow rate sensor in ¶29).
Regarding claim 20, wherein the threshold comprises a function of the irrigation fluid flow rate and a difference in the inner diameter of the sleeve and the outer diameter of the needle (¶22 – takes into account one or more system operating parameters that affect the infusion pressure, including tip type and infusion sleeve size, which are known to determine the difference in an inner diameter of the sleeve and an outer diameter of the needle as they determine cross-sectional area of the flow path).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY JAMES OSINSKI whose telephone number is (571)270-3640. The examiner can normally be reached Monday to Thursday 9AM to 5PM.
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/BRADLEY J OSINSKI/Primary Examiner, Art Unit 3783