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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/14/25 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-11, 13-19 and 21 and 22 have been considered but are moot because the new ground of rejection as discussed below.
Sinha et al. US 5375595 discloses an apparatus for measuring or monitoring ophthalmic tissue, comprising an apparatus 10 for applying ultrasonic energy to the eye 14 (column 4, line 67-column 5, line 4), monitoring the pressure of the eye (pressure measuring apparatus, column 4, line 68-column 5, line 4), and at least one reference sensor configured to sense an ultrasonic characteristic that is output (column 5, lines 4-8; sensor probe 16 for observing vibrations and transmitting amplitude information to a system 20), the ultrasonic energy characteristics such as the duty cycle, repetition rate, pulse bursts being adjustable (column 2, lines 54-60).
Pugh et al. US 2018/0275429 teaches a sensor system for ophthalmic devices, the systems may comprise a sensor 102, the sensor may comprise a variety of sensors including vibration sensor, a microphone, or an ultrasonic sensor component to detect a characteristic of the eye (paragraphs 0054) and to provide an output based upon the sensed vibration (paragraph 0054).
Claim Objections
Claim 1 is objected to because of the following informalities: “a memory comprising for storing software” should be changed to “a memory for storing software”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 and 13-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites in line 4, “at least one reference sensor configured to sense an ultrasound characteristic”. Claim 1 recites in lines 15-16, “controlling…a characteristic of ultrasound energy”. This language is unclear as to whether it is the same or different ultrasound characteristic as being sensed by the measurement sensor and reference sensor.
Claim 2 recites “the sensor output” in line 3. This language is unclear as claim 1 discloses both measurement sensor output and reference sensor output.
Claim 2 recites “a characteristic value of ultrasound energy”. This language is unclear as to whether it is the same or different ultrasound energy as disclosed in claim 1.
Claim 3 recites “the received sensor output” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites “the sensor output” in line 2. This language is unclear as claim 1 discloses both measurement sensor output and reference sensor output.
Claim 5 recites “the sensor output” in line 2. This language is unclear as claim 1 discloses both measurement sensor output and reference sensor output.
Claim 6 recites “the sensor output” in line 2. This language is unclear as claim 1 discloses both measurement sensor output and reference sensor output.
Claim 8 recites “a value of a characteristic of ultrasound energy”. This language is unclear as to whether it is the same or different characteristic or ultrasound energy as disclosed in claim 1.
Claim 9 recites “a characteristic of the ultrasound energy” ln line 2. This language is unclear as to whether it is the same or different characteristic of the ultrasound energy as disclosed in claim 1.
Claim 10 recites “the sensor output” in line 2. This language is unclear as claim 1 discloses both measurement sensor output and reference sensor output.
Claim 11 recites “the sensor output” in line 2. This language is unclear as claim 1 discloses both measurement sensor output and reference sensor output.
Claim 13 recites “the detecting” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites “at least one sensor” in line 4. This language is unclear as to whether it is the same or an additional at least one sensor than the at least one sensor as disclosed in claim 1.
Claim 14 recites “a processor” in line 8. This language is unclear as to whether it is the same or different processor than disclosed in claim 1.
Claim 14 recites “a memory comprising for storing software executable by the processor” in line 9. This language is unclear as to whether it is the same or different memory than disclosed in claim 1.
Claim 16 recites “the sensor output” in line 3. This language is unclear as claim 1 discloses both measurement sensor output and reference sensor output.
Claim 16 recites “the output information” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 18 recites “an alert criterion” in line 2. This language is unclear as to whether it is the same or different an alert criterion disclosed in claim 14.
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, 3, 5-11 and 13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kadziauskas et al. US 6083193 in view of Sinha et al. US 5375595.
Regarding claims 1 and 14, Kadziauskas et al. teaches an intraoperative ophthalmic tissue monitoring system and method, comprising: at least one measurement sensor output relating to the sensed physical quantity of the measurement sensor (column 2, lines 44-52; output means provide an indication of the eye temperature, sensors 50 and 52 measure and sense the temperature of the eye, even if a calculation is required), an ultrasound characteristic that is output by the tip of a phacoemulsification device (column 2, lines 53-61, column 3, lines 47-50; monitoring power provided to the handpiece and monitoring power removed from the eye, with subsequent regulation of the power to the phacoemulsification handpiece, determining cumulative phaco power), a processor 22 (figure 1, column 3, lines 5-14, column 3 line 64-column 4, line 3), and a memory comprising for storing software executable by the processor (column 4, lines 8-13; system memory for heat factor determination and system response for operation and programmable power deployed, figure 2) for enabling the following: at least one measurement sensor output relating to the sensed physical quantity based on the at least one measurement sensor (column 2, lines 44-52; output means provide a measurement of the eye temperature, sensors 50 and 52) providing an output relating to the sensed ultrasound characteristic (column 2, lines 53-61, monitoring power provided to the handpiece and monitoring power removed from the eye, with subsequent regulation of the power to the phacoemulsification handpiece, monitoring requires an output of the power), controlling, based on the measurement sensor output and the reference output, a characteristic of energy for performing phacoemulsification of a lens of the eye to prevent applying excess ultrasound energy (column 1, lines 13-21; column 1, line 59-column 2, line 6, column 3, lines 5-14; column 3, lines 27-32; column 4, lines 18-37; amount of power delivered to the lens by the handpiece is monitored and controlled based upon the temperature of the eye) to prevent applying excess ultrasound energy (column 1, line 59-column 2, line 6; column 2, lines 44-56; output means may provide an alarm at a selected eye temperature level by continuous monitoring to prevent thermal damage to regulate flow and power to the ultrasonic handpiece). Examiner notes in order to adjust the power, the power must be known by some means of calculating from a sensor or output signal, the power provided to the handpiece being known (column 3, lines 38-43), determining, based on the sensor output, whether an alert to criterion is met for outputting an alert to prevent damage of the ophthalmic tissue due to the application of the ultrasound energy to the lens (column 1, line 59-column 2, line 6; column 2, lines 44-56; output means may provide an alarm at a selected eye temperature level by continuous monitoring to prevent thermal damage to regulate flow and power to the ultrasonic handpiece).
Kadziauskas et al. disclose monitoring power provided to the handpiece and monitoring power removed from the eye, with subsequent regulation of the power to the phacoemulsification handpiece (column 2, lines 53-61), the microprocessor computer 22 accordingly is capable of determining cumulative phaco power delivered over a period of time (column 3, lines 47-50). In addition, the system is also capable of monitoring the cumulative ultrasonic energy deployed into the eye 16 in a given increment of time by utilizing a microprocessor 22 to either calculate energy directly from the power level utilized by the surgeon via foot pedal control, not shown, or by monitoring equivalent phaco time (column 4, lines 24-30), but fails to explicitly disclose at least one reference sensor configured to sense an ultrasound characteristic that is output by the tip of a the device.
Sinha et al. discloses an apparatus for measuring or monitoring ophthalmic tissue, comprising an apparatus 10 for applying ultrasonic energy to the eye 14 (column 4, line 67-column 5, line 4), monitoring the pressure of the eye (pressure measuring apparatus, column 4, line 68-column 5, line 4), and at least one reference sensor configured to sense an ultrasonic characteristic that is output (column 5, lines 4-8; sensor probe 16 for observing vibrations and transmitting amplitude information to a system 20), the ultrasonic energy characteristics such as the duty cycle, repetition rate, pulse bursts being adjustable (column 2, lines 54-60).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Kadziauskas et al., with at least one reference sensor configured to sense an ultrasound characteristic that is output by the tip of the phacoemulsification device, controlling based upon the pressure of the eye, a characteristic of the ultrasonic characteristic, as taught by Sinha et al. as known in the art to provide a sensor for sensing a characteristic of the ultrasonic energy and a measurement sensor as necessary to adjust a characteristic of the ultrasound and maintain the required pressure temperature within the eye.
Regarding claim 3, Kadziauskas et al. in combination discloses performing the controlling automatically based on the received sensor output by providing control feedback to a phacoemulsification device (column 3, line 64-column 4 line 3; column 4 , lines 18-37; monitoring and system response may be provided by pre-programmed or preoperative manner, which may be considered automatically, or alternatively controlled or adjusted by the surgeon).
Regarding claim 5, Kadziauskas et al. in combination discloses wherein the processing comprises determining whether the sensor output meets one or more criteria for a displaying an alert (column 2, lines 43-52, alarm may be either visual or audible).
Regarding claims 6-8, Kadziauskas et al. in combination discloses wherein the processor is configured for determining whether the sensor output meets one or more criteria for modulating a value of a characteristic of ultrasound energy to be applied to the lens and prevention of damaging ophthalmic tissue (column 1, line 59-column 2, line 6; column 2, lines 44-56; output means may provide an alarm at a selected eye temperature level by continuous monitoring to prevent thermal damage to regulate flow and power to the ultrasonic handpiece).
Regarding claim 9, Kadziauskas et al. in combination discloses wherein a characteristic of the ultrasound energy includes one of the following: duration for applying the ultrasound energy, power, a frequency, a phase, a phase difference, an amplitude, or any combination of the aforesaid (column 2, lines 53-61; regulating power to an ultrasonic phacoemulsification handpiece).
Regarding claim 10, Kadziauskas et al. in combination discloses wherein the sensor output relates to one of the following of the ophthalmic tissue: temperature, pressure, shear force, strain, vibrations, or any combination of the aforesaid (column 2, lines 44-52; output means provide an indication of the eye temperature).
Regarding claim 11, Kadziauskas et al. in combination discloses a control apparatus for an ultrasonic phacoemulsification device, comprising a sensor employs one of the following modalities: fiber-optical sensing; thermal sensing; conductivity measurement sensing; MEMS-based vibration and/or sound sensing; remote sensing, tissue-engaging sensor, or any combination of the aforesaid (column 2, lines 44-52; output responsive to the computer may provide an indication of eye temperature to continuously monitor eye temperature to prevent damage; column 3, lines 33-42, any suitable temperature, or thermal sensors, may be connected to the computer processor 22).
Regarding claim 13, Kadziauskas et al. in combination discloses wherein the controlling and the detecting of the ultrasound transducer is performed in real-time or in near real-time to prevent damage of ophthalmic tissue (column 1, lines 4-12, column 1, lines 59-column 2, line 6; controlling power delivered during ocular surgery, to prevent damage which otherwise may occur within seconds).
Regarding claim 15, Kadziauskas et al. in combination discloses wherein the ophthalmic tissue of an eye is the mammalian’s cornea of the same eye (column 1, lines 13-21, phacoemulsification of lenses includes making a corneal incision).
Regarding claim 16, Kadziauskas et al. discloses outputting information related to the sensor output for facilitating, based on the output information, the controlling of a characteristic value of ultrasound energy by the user (column 1, line 59-column 2, line 6; column 3, line 65-column 4, line 3; amount of power delivered to the lens by the handpiece is monitored and controlled based upon the temperature of the eye and programmed by a user).
Regarding claim 17, Kadziauskas et al. in discloses wherein a position of the measurement sensor relative to the ophthalmic tissue is independent of a position of a phacoemulsification device employed for applying the ultrasound energy (figure 1, sensors 50 and 52 are separate from the handpiece and connected via lines, and may therefore be positioned independently even if operatively coupled to the handpiece). Further, Sinha et al. discloses the sensor probe being separate from the ultrasonic device (figure 1).
Claim(s) 2 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kadziauskas et al. US 6083193 in view of Sinha et al. US 5375595, and further in view of Zhang et al. US 2020/0107957.
Regarding claims 2 and 4, Kadziauskas et al. in combination discloses an output of information related to the sensor for controlling a characteristic value of ultrasound energy by a medical professional (column 1, line 59-column 2, line 6; column 2, lines 44-56; output means may provide an alarm at a selected eye temperature level by continuous monitoring to prevent thermal damage to regulate flow and power to the ultrasonic handpiece), but fails to explicitly disclose further comprising displaying information related to the sensor output.
Zhang et al. teaches displaying information related to the sensor output (display or screen 66, paragraph 0023) for facilitating the controlling of a characteristic value of ultrasound energy by a medical professional (paragraph 0023, 0024; display to permit a user to interact with and control the system components, displaying various measurements, criteria or settings which may be selected or altered), wherein the sensor output is processed for performing the displaying to the medical professional and/or for performing the controlling of the characteristic of the ultrasound energy to be applied to the lens (paragraph 0024, 0028, screen displays outputs of the system such as type of procedure, parameters such as vacuum, flow rate and power, the screen allows a user to alter or select settings, such as vacuum level, ultrasonic power type or duration).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Kadziauskas et al. with a display, as taught by Zhang et al. to permit a display for a user to interact with and control the system components, displaying various measurements, criteria or settings which may be selected or altered.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kadziauskas et al. US 6083193 in view of Sinha et al. US 5375595, and further in view of Injev US 2011/0295191.
Regarding claim 18, Kadziauskas et al. discloses an alert criterion (column 1, line 59-column 2, line 6; column 2, lines 44-56; output means may provide an alarm at a selected eye temperature level by continuous monitoring to prevent thermal damage to regulate flow and power to the ultrasonic handpiece), but fails to disclose a user control input configured to be provided by the user is overridden by a system control input which is output to prevent inadvertently inflicting damage to ophthalmic tissue.
Injev teaches wherein, when an alert criterion is met, a user control input provided by the user is overridden by a system control input which is output to prevent inadvertently inflicting damage to ophthalmic tissue (paragraph 0050, 0051, controller activates an alert and may initiate additional mitigation sequences to halt ultrasonic needle generation, or other actions, while also providing an alert to the health care provider and restore the integrity before continuing).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify Kadziauskas et al. by a user control input being overridden by a system control input, as taught by Injev, to activate an alert and may initiate additional mitigation sequences to halt ultrasonic needle generation, or other actions, while also providing an alert to the health care provider and restore the integrity before continuing.
Claim(s) 19, 21 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kadziauskas et al. US 6083193 in view of Pugh et al. US 2018/0275429.
Kadziauskas et al. discloses an intraoperative ophthalmic tissue monitoring system and method, comprising: sensing with at least one sensor configured to sense a physical quantity of an ophthalmic tissue of an eye (column 2, lines 37-43; column 3, lines 43; temperature sensors), providing, responsive to sensing the physical quantity, a sensor output relating to the sensed physical quantity (column 2, lines 44-52; output means provide an indication of the eye temperature), controlling by a processor 22 (figure 1, column 3, lines 5-14, column 3 line 64-column 4, line 3) and a memory, based on the sensor outputs, (column 4, lines 8-13; system memory for heat factor determination and system response for operation and programmable power deployed, figure 2) a characteristic of ultrasound energy for performing phacoemulsification of a lens of the eye (column 1, lines 13-21; column 1, line 59-column 2, line 6, column 3, lines 5-14; column 3, lines 27-32; column 4, lines 18-37; amount of power delivered to the lens by the handpiece is monitored and controlled based upon the temperature of the eye) to prevent the application of ultrasound energy (column 1, line 59-column 2, line 6; column 2, lines 44-56; output means may provide an alarm at a selected eye temperature level by continuous monitoring to prevent thermal damage to regulate flow and power to the ultrasonic handpiece), but fails to disclose wherein the at least one sensor is a microphone sensor configured to derive a physical quantity relating to the at least one ophthalmic tissue characteristic.
Pugh et al. teaches a sensor system for ophthalmic devices, the systems may comprise a sensor 102, the sensor may comprise a variety of sensors including vibration sensor and/or a microphone to detect a characteristic of the eye (paragraphs 0051, 0054) and to provide an output based upon the sensed vibration (paragraph 0054).
Therefore, it would have been obvious to one having ordinary skill in the art to modify Kadziauskas et al. with a microphone sensor, as taught by Pugh et al., as known in the art to provide a variety of sensors, such as a microphone sensor, for providing information on a characteristic of the eye.
Regarding claims 21 and 22, Kadziauskas et al. in combination discloses wherein the sensor is physically decoupled from the position of the phacoemulsification device (figure 1, sensors 50, 52 are independent of the position handpiece, as sensors 50 and 52 are separate from the handpiece and connected via lines, and may therefore be positioned independently from a position of the handpiece adjacent the tissue, even if operatively coupled), wherein the sensor is configured to be physically disengaged from the ophthalmic tissue (figure 1, sensors 50, 52 are independent position of the eye as they are removable from being positioned around the eye).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Berlin US 2002/0013572 discloses an intraoperative ophthalmic tissue monitoring system, comprising: at least one measurement sensor configured to sense a physical quantity of an ophthalmic tissue of an eye (paragraph 0014, pressure sensor to sense interior pressure, paragraph 0016, sensor for sensing the temperature in the eye); a processor (paragraph 0061), providing a measurement sensor output relating to the sensed physical quantity based on the at least one measurement sensor (paragraph 0016, output goes to servo feedback mechanism), controlling, based on the output, a characteristic of light energy for performing ablation of the eye to prevent applying excess energy (paragraph 0054, 0055, if temperature reaches a predetermined level characteristic of the light energy may be adjusted based on the sensor output, temperature is monitored at the target site and parameters may be adjusted, such as adjusting the duration between pulses).
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/CHRISTINA C LAUER/ Examiner, Art Unit 3771