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 .
In a Preliminary Amendment filed on August 23, 2023, claims 1, 5, 9, and 13 were amended and claims 3, 4, 11, 12, and 20 were cancelled.
Claims 1, 2, 5-10, and 13-19 are pending, of which claims 1 and 9 are independent claims.
Priority
Applicant’s claim for the benefit of US provisional application 63/207,339 filed on February 23, 2021 is acknowledged.
Abstract
The Abstract is objected to because of the following informalities: according to MPEP 608.01(b), the form and legal phraseology often used in patent claims, such as “comprising” should be avoided in the abstract of the disclosure. In this instance, the abstract includes legal phraseology such as “A method for controlling a system, comprising…”, which should be avoided.
Appropriate correction is required.
Claim Objections
The following claims are objected to for lack of antecedent support or for redundancies. The Examiner recommends the following changes:
Claim 1, line 8, replace “an operational characteristic” with “the at least one operational characteristic”.
Claim 1, line 9, replace “monitored characteristic” with “the at least one operational characteristic”.
Claim 1, line 9, replace “characteristic” with “at least one operational characteristic”.
Claim 1, line 10, replace “the operational characteristic” with “the at least one operational characteristic”.
Claim 1, line 12, replace “the operational characteristic” with “the at least one operational characteristic”.
Claim 1, line 13, insert “the” before “adapting”.
Claim 1, line 17, insert “of the system” before “are adjusted”.
Claim 6, line 1, insert “the” before “adapting”.
Claim 7, line 1, insert “the” before “adapting”.
Claim 8, line 1, insert “the” before “adapting”.
Claim 9, line 9, replace “an operational characteristic” with “the at least one operational characteristic”.
Claim 9, line 10, replace “monitored characteristic” with “the at least one operational characteristic”.
Claim 9, line 11, replace “characteristic” with “at least one operational characteristic”.
Claim 9, line 10, replace “the operational characteristic” with “the at least one operational characteristic”.
Claim 9, line 13, replace “the operational characteristic” with “the at least one operational characteristic”.
Claim 9, line 14, insert “the” before “adapting”.
Claim 9, line 18, insert “of the system” before “are adjusted”.
Claim 14, line 1, insert “the” before “adapting”.
Claim 15, line 1, insert “the” before “adapting”.
Claim 16, line 1, insert “the” before “adapting”.
Claim 18, line 4, insert “the” before “patient”.
Claim 18, line 5, insert “at least one” before “operational”.
Claim 18, line 6, insert “the” before “system”.
Claim 18, line 6, insert “at least one” before “operational”.
Appropriate correction is respectfully requested.
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.
Claim 19 is rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 19 recites “the patient presentation data includes blood vessel diameter, blood clot length, clot type, blood clot age, and other therapeutically useful information. (Emphasis added) The intended meaning of “useful” is unclear and indefinite because it is a subjective term instead of being objective. See MPEP 2173.05(b)(IV) It is up to a surgeon to determine which type of therapeutically information would be found useful. The intended meaning of “useful” is not defined in the Specification, as the description provided simply repeats the claimed recitations. See Paragraphs [0043] and [0110] of the published Specification.
For purposes of examination, the term “useful” will be disregarded from the claim. The Office respectfully recommends that claim be amended by deleting the term “useful” from the claim.
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.
Claims 1, 5, 9, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nott et al. (US Patent Publication No. 2019/0274717 A1) (“Nott”).
Regarding independent claim 1, Nott teaches:
A method for controlling a system, comprising: Nott: Abstract (“A generator, ultrasonic device, and method for controlling a temperature of an ultrasonic blade are disclosed. A control circuit coupled to a memory determines an actual resonant frequency of an ultrasonic electromechanical system comprising an ultrasonic transducer coupled to an ultrasonic blade by an ultrasonic waveguide.”)
(a) repeatedly monitoring at least one operational characteristic of a system that includes an ultrasonic transducer, Nott: Paragraph [0409] (“As previously described, the generator monitors 133124 the phase angle φ between the voltage Vg(t) and current Ig(t) signals applied to the ultrasonic transducer and based on the phase angle φ, the generator infers 133126 the temperature of the ultrasonic blade using the techniques described herein in connection with FIGS. 19A-21.”) [The phase angle φ between the voltage Vg(t) and current Ig(t) signals reads on “at least one operational characteristic”.]
(i) wherein the ultrasonic transducer is powered by an ultrasonic generator and is configured to drive a device at predetermined levels of vibration amplitude, and Nott: Paragraph [0231] (“FIG. 3 illustrates one form of a surgical system 1000 comprising a generator 1100 and various surgical instruments 1104, 1106, 1108 usable therewith, where the surgical instrument 1104 is an ultrasonic surgical instrument, the surgical instrument 1106 is an RF electrosurgical instrument, and the multifunction surgical instrument 1108 is a combination ultrasonic/RF electrosurgical instrument.”) Nott: Paragraph [0232] (“The generator 1100 is configured to drive multiple surgical instruments 1104, 1106, 1108. The first surgical instrument is an ultrasonic surgical instrument 1104 and comprises a handpiece 1105 (HP), an ultrasonic transducer 1120, a shaft 1126, and an end effector 1122. The end effector 1122 comprises an ultrasonic blade 1128 acoustically coupled to the ultrasonic transducer 1120 and a clamp arm 1140. The handpiece 1105 comprises a trigger 1143 to operate the clamp arm 1140 and a combination of the toggle buttons 1134 a, 1134 b, 1134 c to energize and drive the ultrasonic blade 1128 or other function. The toggle buttons 1134 a, 1134 b, 1134 c can be configured to energize the ultrasonic transducer 1120 with the generator 1100.”) Nott: Paragraph [0300] (“Block 2580 of the processor 1740 may implement an algorithm for modulating the current amplitude of the drive signal in order to control the drive signal current, voltage and power in accordance with user specified setpoints, or in accordance with requirements specified by other processes or algorithms implemented by the generator 1100. Control of these quantities may be realized, for example, by scaling the LUT samples in the LUT 2280 and/or by adjusting the full-scale output voltage of the DAC 1680 (which supplies the input to the power amplifier 1620) via a DAC 1860. Block 2600 (which may be implemented as a PID controller in certain aspects) may receive, as input, current feedback samples (which may be suitably scaled and filtered) from the memory location 2180. The current feedback samples may be compared to a “current demand” Id value dictated by the controlled variable (e.g., current, voltage or power) to determine if the drive signal is supplying the necessary current. In aspects in which drive signal current is the control variable, the current demand Id may be specified directly by a current setpoint 2620A (Isp). For example, an RMS value of the current feedback data (determined as in block 2340) may be compared to user-specified RMS current setpoint lsp to determine the appropriate controller action. If, for example, the current feedback data indicates an RMS value less than the current setpoint Isp, LUT scaling and/or the full-scale output voltage of the DAC 1680 may be adjusted by the block 2600 such that the drive signal current is increased. Conversely, block 2600 may adjust LUT scaling and/or the full-scale output voltage of the DAC 1680 to decrease the drive signal current when the current feedback data indicates an RMS value greater than the current setpoint Isp.”) [The generator driving the ultrasonic transducer, which in turn drives the ultrasonic blade reads on “an ultrasonic generator” and the ultrasonic blade reads on “a device”. The user specified setpoints for the current are predetermined current amplitude levels for the drive signal, where the predetermined current amplitude levels of the drive signal that drives the transducer, which in turn drives the ultrasonic blade, correspond to predetermined amplitudes of the vibrations driven by the transducer reads on “to drive a device at predetermined levels of vibration amplitudes”.]
(ii) wherein the ultrasonic generator includes a controller configured to monitor operational parameters of the system; Nott: Paragraphs [0300] and [0409] [As described above.] [The generator including a processor or a controller to monitor the signals reads on “a controller configured to monitor operational parameters of the system”.]
(b) detecting a change in an operational characteristic based on a comparison of the monitored characteristic against a predetermined threshold for that characteristic; Nott: Paragraph [0401] (“As previously described, the temperature of the ultrasonic blade may be inferred by detecting the impedance of the ultrasonic transducer … or equivalently, detecting the phase angle φ between the voltage Vg(t) and current Ig(t) signals applied to the ultrasonic transducer. The phase angle φ information also may be used to infer the conditions of the ultrasonic blade. As discussed with particularity herein, the phase angle φ changes as a function of the temperature of the ultrasonic blade. Therefore, the phase angle φ information may be employed to control the temperature of the ultrasonic blade. This may be done, for example, by reducing the power delivered to the ultrasonic blade when the ultrasonic blade runs too hot and increasing the power delivered to the ultrasonic blade when the ultrasonic blade runs too cold. FIGS. 27A-27B are graphical representations of temperature feedback control for adjusting ultrasonic power applied to an ultrasonic transducer when a sudden drop in temperature of an ultrasonic blade is detected.”) Nott: Paragraph [0402] (“At time t0, the temperature of the ultrasonic blade drops below the desired minimum temperature 133082 and the frequency-temperature feedback control algorithm detects the drop in temperature and begins to increase or “ramp up” the power as shown by the power ramp 133074 delivered to the ultrasonic blade to start raising the temperature of the ultrasonic blade above the desired minimum temperature 133082.”) [The change of the phase angle (“operational characteristic”) as a function of the temperature of the ultrasonic blade detected below the desired minimum temperature reads on “detecting a change in an operational characteristic based on a comparison of the monitored characteristic against a predetermined threshold for that characteristic”.]
(c) inferring a system-use criteria based on the detected change in the operational characteristic; and Nott: Paragraphs [0401] and [0402] [As described above.] [The inferred temperature reads on “inferring a system-use criteria” based on the change of the phase angle reads on “based on the detected change in the operational characteristic”.]
(d) adapting system control by using the controller to alter the operational characteristic based on the inferred use criteria, Nott: Paragraphs [0401] and [0402] [As described above.] [The processor or controller increasing the power to change the inferred temperature of the ultrasonic blade dropping below the minimum temperature, where the phase angle, which is a function of the temperature, will also be altered based on the inferred use criteria reads on “adapting system control by using the controller to alter the operational characteristic based on the inferred use criteria”.]
wherein adapting system control includes operating the system at a reduced amplitude set point for a predetermined period of time after the system use criteria is inferred; or operating the system at an increased amplitude set point for a predetermined period of time after the system use criteria is inferred, and… Nott: Paragraphs [0401] and [0402] [As described above.] [Increasing the power to change the inferred temperature of the ultrasonic blade dropping below the minimum temperature, where the phase angle, which is a function of the temperature, will also be altered based on the inferred use criteria reads on “operating the system at an increased amplitude set point … after the system use criteria is inferred”. The time period for increasing the power until the inferred temperature reaches or is above the minimum temperature reads on “a predetermined period of time”.]
further comprising a second amplitude modulation scheme wherein operating levels are adjusted based on a second modulation criteria. Nott: Paragraph [0416] (“The processor or control circuit of the generator or instrument or both determines 133148 if the initial temperature of the ultrasonic blade is low. If the initial temperature of the ultrasonic blade is low, the process continues along YES branch and the processor or control circuit of the generator or instrument or both applies 133152 a high power level to the ultrasonic transducer to increase the temperature of the ultrasonic blade and completes 133156 the vessel transection procedure.”) Nott: Paragraph [0423] (“In accordance with the process depicted by the logic flow diagram 133160, the processor or control circuit of the generator or instrument or both monitors 133162 the phase angle φ between the voltage Vg(t) and current Ig(t) signals applied to the ultrasonic transducer. The processor or control circuit of the generator or instrument or both infers 133164 the temperature of the ultrasonic blade based on the phase angle φ between the voltage Vg(t) and current Ig(t) signals applied to the ultrasonic transducer. The processor or control circuit of the generator or instrument or both compares 133166 the inferred temperature of the ultrasonic blade to an ultrasonic blade instability trigger point threshold. The processor or control circuit of the generator or instrument or both determines 133168 whether the ultrasonic blade is approaching instability. If not, the process proceed along the NO branch and monitors 133162 the phase angle φ, infers 133164 the temperature of the ultrasonic blade, and compares 133166 the inferred temperature of the ultrasonic blade to an ultrasonic blade instability trigger point threshold until the ultrasonic blade approaches instability. “) [The temperature increase requirement for the vessel transection procedure reads on “a second modulation criteria”. The high power level to increase the temperature for the vessel transection procedure reads on “operating levels are adjusted based on the second modulation criteria”.]
Regarding claim 5, Nott teaches all the claimed features of claim 1, from which claim 5 depends. Nott further teaches:
The method of claim 1, wherein the second modulation criteria include continuously increasing the amplitude set point as an operator operates the system. Nott: Paragraphs [0416] and [04723] [As described in claim 1.] Nott: Paragraph [0397] (“In one aspect, a CTM algorithm according to the present disclosure detects the “tissue sealed” state and activates a notification. Similar to the end of cut detection, tissue seals between approximately 105° C. and approximately 200° C. The change in frequency from an initial frequency required to indicate that a temperature of the ultrasonic blade has reached 200° C., which indicates a seal only state, can be calculated at the onset of activation of the ultrasonic transducer…the surgeon could continue activation of the ultrasonic transducer to achieve a tissue cut state.”)
Regarding independent claim 9, Nott teaches:
A method for controlling a system, comprising: Nott: Abstract (“A generator, ultrasonic device, and method for controlling a temperature of an ultrasonic blade are disclosed. A control circuit coupled to a memory determines an actual resonant frequency of an ultrasonic electromechanical system comprising an ultrasonic transducer coupled to an ultrasonic blade by an ultrasonic waveguide.”)
(a) repeatedly monitoring at least one operational characteristic of an ultrasonic therapeutic system that includes an ultrasonic transducer, Nott: Paragraph [0409] (“As previously described, the generator monitors 133124 the phase angle φ between the voltage Vg(t) and current Ig(t) signals applied to the ultrasonic transducer and based on the phase angle φ, the generator infers 133126 the temperature of the ultrasonic blade using the techniques described herein in connection with FIGS. 19A-21.”) [The phase angle φ between the voltage Vg(t) and current Ig(t) signals reads on “at least one operational characteristic”.]
(i) wherein the ultrasonic transducer is powered by an ultrasonic generator and is configured to drive an end-effector at one or more predetermined levels of vibration amplitude, and Nott: Paragraph [0231] (“FIG. 3 illustrates one form of a surgical system 1000 comprising a generator 1100 and various surgical instruments 1104, 1106, 1108 usable therewith, where the surgical instrument 1104 is an ultrasonic surgical instrument, the surgical instrument 1106 is an RF electrosurgical instrument, and the multifunction surgical instrument 1108 is a combination ultrasonic/RF electrosurgical instrument.”) Nott: Paragraph [0232] (“The generator 1100 is configured to drive multiple surgical instruments 1104, 1106, 1108. The first surgical instrument is an ultrasonic surgical instrument 1104 and comprises a handpiece 1105 (HP), an ultrasonic transducer 1120, a shaft 1126, and an end effector 1122. The end effector 1122 comprises an ultrasonic blade 1128 acoustically coupled to the ultrasonic transducer 1120 and a clamp arm 1140. The handpiece 1105 comprises a trigger 1143 to operate the clamp arm 1140 and a combination of the toggle buttons 1134 a, 1134 b, 1134 c to energize and drive the ultrasonic blade 1128 or other function. The toggle buttons 1134 a, 1134 b, 1134 c can be configured to energize the ultrasonic transducer 1120 with the generator 1100.”) Nott: Paragraph [0300] (“Block 2580 of the processor 1740 may implement an algorithm for modulating the current amplitude of the drive signal in order to control the drive signal current, voltage and power in accordance with user specified setpoints, or in accordance with requirements specified by other processes or algorithms implemented by the generator 1100. Control of these quantities may be realized, for example, by scaling the LUT samples in the LUT 2280 and/or by adjusting the full-scale output voltage of the DAC 1680 (which supplies the input to the power amplifier 1620) via a DAC 1860. Block 2600 (which may be implemented as a PID controller in certain aspects) may receive, as input, current feedback samples (which may be suitably scaled and filtered) from the memory location 2180. The current feedback samples may be compared to a “current demand” Id value dictated by the controlled variable (e.g., current, voltage or power) to determine if the drive signal is supplying the necessary current. In aspects in which drive signal current is the control variable, the current demand Id may be specified directly by a current setpoint 2620A (Isp). For example, an RMS value of the current feedback data (determined as in block 2340) may be compared to user-specified RMS current setpoint lsp to determine the appropriate controller action. If, for example, the current feedback data indicates an RMS value less than the current setpoint Isp, LUT scaling and/or the full-scale output voltage of the DAC 1680 may be adjusted by the block 2600 such that the drive signal current is increased. Conversely, block 2600 may adjust LUT scaling and/or the full-scale output voltage of the DAC 1680 to decrease the drive signal current when the current feedback data indicates an RMS value greater than the current setpoint Isp.”) [The generator driving the ultrasonic transducer, which in turn drives the ultrasonic blade, reads on “an ultrasonic generator” and the ultrasonic blade reads on “an end-effector”. The user specified setpoints for the current are predetermined current amplitude levels for the drive signal, where the predetermined current amplitude levels of the drive signal that drives the transducer, which in turn drives the ultrasonic blade, correspond to predetermined amplitudes of the vibrations driven by the transducer reads on “to drive an end-effector at predetermined levels of vibration amplitudes”.]
(ii) wherein the ultrasonic generator includes a controller configured to monitor operational parameters of the therapeutic system; Nott: Paragraphs [0300] and [0409] [As described above.] [The generator including a processor or a controller to monitor the signals reads on “a controller configured to monitor operational parameters of the therapeutic system”.]
(b) detecting a change in an operational characteristic based on a comparison of the monitored characteristic against a predetermined threshold for that characteristic; Nott: Paragraph [0401] (“As previously described, the temperature of the ultrasonic blade may be inferred by detecting the impedance of the ultrasonic transducer … or equivalently, detecting the phase angle φ between the voltage Vg(t) and current Ig(t) signals applied to the ultrasonic transducer. The phase angle φ information also may be used to infer the conditions of the ultrasonic blade. As discussed with particularity herein, the phase angle φ changes as a function of the temperature of the ultrasonic blade. Therefore, the phase angle φ information may be employed to control the temperature of the ultrasonic blade. This may be done, for example, by reducing the power delivered to the ultrasonic blade when the ultrasonic blade runs too hot and increasing the power delivered to the ultrasonic blade when the ultrasonic blade runs too cold. FIGS. 27A-27B are graphical representations of temperature feedback control for adjusting ultrasonic power applied to an ultrasonic transducer when a sudden drop in temperature of an ultrasonic blade is detected.”) Nott: Paragraph [0402] (“At time t0, the temperature of the ultrasonic blade drops below the desired minimum temperature 133082 and the frequency-temperature feedback control algorithm detects the drop in temperature and begins to increase or “ramp up” the power as shown by the power ramp 133074 delivered to the ultrasonic blade to start raising the temperature of the ultrasonic blade above the desired minimum temperature 133082.”) [The change of the phase angle (“operational characteristic”) as a function of the temperature of the ultrasonic blade detected below the desired minimum temperature reads on “detecting a change in an operational characteristic based on a comparison of the monitored characteristic against a predetermined threshold for that characteristic”.]
(c) inferring a system-use criteria based on the detected change in the operational characteristic; and Nott: Paragraphs [0401] and [0402] [As described above.] [The inferred temperature reads on “inferring a system-use criteria” based on the change of the phase angle reads on “based on the detected change in the operational characteristic”.]
(d) adapting system control by using the controller to alter the operational characteristic based on the inferred use criteria, Nott: Paragraphs [0401] and [0402] [As described above.] [The processor or controller increasing the power to change the inferred temperature of the ultrasonic blade dropping below the minimum temperature, where the phase angle, which is a function of the temperature, will also be altered based on the inferred use criteria reads on “adapting system control by using the controller to alter the operational characteristic based on the inferred use criteria”.]
wherein adapting system control includes operating the system at a reduced amplitude set point for a predetermined period of time after the system use criteria is inferred; or operating the system at an increased amplitude set point for a predetermined period of time after the system use criteria is inferred, and Nott: Paragraphs [0401] and [0402] [As described above.] [Increasing the power to change the inferred temperature of the ultrasonic blade dropping below the minimum temperature, where the phase angle, which is a function of the temperature, will also be altered based on the inferred use criteria reads on “operating the system at an increased amplitude set point … after the system use criteria is inferred”. The time period for increasing the power until the inferred temperature reaches or is above the minimum temperature reads on “a predetermined period of time”.]
further comprising a second amplitude modulation scheme wherein operating levels are adjusted based on a second modulation criteria. Nott: Paragraph [0416] (“The processor or control circuit of the generator or instrument or both determines 133148 if the initial temperature of the ultrasonic blade is low. If the initial temperature of the ultrasonic blade is low, the process continues along YES branch and the processor or control circuit of the generator or instrument or both applies 133152 a high power level to the ultrasonic transducer to increase the temperature of the ultrasonic blade and completes 133156 the vessel transection procedure.”) Nott: Paragraph [0423] (“In accordance with the process depicted by the logic flow diagram 133160, the processor or control circuit of the generator or instrument or both monitors 133162 the phase angle φ between the voltage Vg(t) and current Ig(t) signals applied to the ultrasonic transducer. The processor or control circuit of the generator or instrument or both infers 133164 the temperature of the ultrasonic blade based on the phase angle φ between the voltage Vg(t) and current Ig(t) signals applied to the ultrasonic transducer. The processor or control circuit of the generator or instrument or both compares 133166 the inferred temperature of the ultrasonic blade to an ultrasonic blade instability trigger point threshold. The processor or control circuit of the generator or instrument or both determines 133168 whether the ultrasonic blade is approaching instability. If not, the process proceed along the NO branch and monitors 133162 the phase angle φ, infers 133164 the temperature of the ultrasonic blade, and compares 133166 the inferred temperature of the ultrasonic blade to an ultrasonic blade instability trigger point threshold until the ultrasonic blade approaches instability. “) [The temperature increase requirement for the vessel transection procedure reads on “a second modulation criteria”. The high power level to increase the temperature for the vessel transection procedure reads on “operating levels are adjusted based on the second modulation criteria”.]
Regarding claim 13, Nott teaches all the claimed features of claim 9, from which claim 13 depends. Nott further teaches:
The method of claim 9, wherein the second modulation criteria include continuously increasing the amplitude set point as an operator operates the therapeutic system. Nott: Paragraphs [0416] and [04723] [As described in claim 1.] Nott: Paragraph [0397] (“In one aspect, a CTM algorithm according to the present disclosure detects the “tissue sealed” state and activates a notification. Similar to the end of cut detection, tissue seals between approximately 105° C. and approximately 200° C. The change in frequency from an initial frequency required to indicate that a temperature of the ultrasonic blade has reached 200° C., which indicates a seal only state, can be calculated at the onset of activation of the ultrasonic transducer…the surgeon could continue activation of the ultrasonic transducer to achieve a tissue cut state.”)
It is noted that any citations to specific, pages, columns, lines, or figures in the prior art references and any interpretation of the reference should not be considered to be limiting in any way. A reference is relevant for all it contains and may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. See MPEP 2123.
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.
Claims 2, 7, 8, 10, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Nott, in view of Barthe et al. (US Patent Publication No. 2016/0361573 A1) (“Barthe”).
Regarding claim 2, Nott teaches all the claimed features of claim 1, from which claim 2 depends. Nott further teaches:
The method of claim 1, wherein the at least one operational characteristic includes resonant impedance,…, Nott: Paragraph [0251] (“Stated another way, at resonance the inductive impedance is equal to the capacitive impedance.”) transducer drive frequency, Nott: Paragraph [0251] (“The generator electronics can easily monitor the phase difference between the voltage Vg(t) and current Ig(t) signals and can continuously adjust the drive frequency until the phase difference is once again zero. At this point, the new drive frequency is equal to the new resonant frequency of the electromechanical ultrasonic system.”) voltage and current being delivered to the transducer, and combinations thereof. Nott: Paragraph [0401] [As described in claim 1.] Nott: Paragraph [0409] (“As previously described, the generator monitors 133124 the phase angle φ between the voltage Vg(t) and current Ig(t) signals applied to the ultrasonic transducer…” which reads on “voltage and current being delivered to the transducer”.)
Nott does not expressly teach “total operational use time of the device”. However, Barthe describes ultrasound imaging of the region of interest for localization of the treatment area, delivering ultrasound energy at a depth and pattern to achieve the desired therapeutic effects, and/or monitoring the treatment area to assess the results and/or provide feedback. Barthe teaches:
…a total operational use time of the device… Paragraph [0029] (“After localization, delivery of ultrasound energy 220 at a depth, distribution, timing, and energy level to achieve the desired therapeutic effect of thermal ablation to treat an epidermis layer 212, superficial dermis layer 214, mid-dermis layer 216, and/or deep dermis layer 218 can be provided. Before, during, and after therapy, i.e., before, during, and after the delivery of ultrasound energy 220, exemplary method and system 200 can suitably monitor the treatment area and surrounding structures to plan and assess the results and/or provide feedback to control system 202 and/or a system user.”)
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having the teachings of Nott and Barthe before them, to include a total operational use time of the device because the references are in the same field of endeavor as the claimed invention.
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do this modification because it would provide an alternative operation characteristic to control probe and system functionality. Barthe Paragraphs [0009] and [0029].
Regarding claim 7, Nott and Barthe teach all the claimed features of claim 2, from which claim 7 depends. Nott further teaches:
The method of claim 2, wherein adapting system control includes temporarily changing the transducer drive frequency based on conditions encountered during use of the device. Nott: Paragraph [0378] (“In one aspect, the initial proof of concept assumed a static, linear relationship between the natural frequency of the electromechanical ultrasonic system and the temperature of the ultrasonic blade. By reducing the power as a function of the natural frequency of the electromechanical ultrasonic system (i.e., regulating temperature with feedback control), the temperature of the ultrasonic blade tip could be controlled directly. In this example, the temperature of the distal tip of the ultrasonic blade can be controlled to not exceed the melting point of the Teflon pad.”) [The ongoing change of the frequency to accommodate feedback control of the temperature reads on “temporarily changing the transducer drive frequency based on conditions…”.]
Regarding claim 8, Nott and Barthe teach all the claimed features of claim 2, from which claim 8 depends. Nott further teaches:
The method of claim 2, wherein adapting system control includes changing the voltage and current being delivered to the transducer based on conditions encountered during use of the device. Nott: Paragraph [0300] (“The current feedback samples may be compared to a “current demand” Id value dictated by the controlled variable (e.g., current, voltage or power) to determine if the drive signal is supplying the necessary current. In aspects in which drive signal current is the control variable, the current demand Id may be specified directly by a current setpoint 2620A (Isp). For example, an RMS value of the current feedback data (determined as in block 2340) may be compared to user-specified RMS current setpoint Isp to determine the appropriate controller action. If, for example, the current feedback data indicates an RMS value less than the current setpoint Isp, LUT scaling and/or the full-scale output voltage of the DAC 1680 may be adjusted by the block 2600 such that the drive signal current is increased. Conversely, block 2600 may adjust LUT scaling and/or the full-scale output voltage of the DAC 1680 to decrease the drive signal current when the current feedback data indicates an RMS value greater than the current setpoint Isp.”) Nott: Paragraph [0420] (“Some ultrasonic blades exhibit displacement instability or modal instability in the presence of increasing temperature. This known relationship may be employed to interpret when an ultrasonic blade is approaching instability and then adjusting the power level driving the ultrasonic transducer (e.g., by adjusting the driving voltage V.sub.g(t) or current I.sub.g(t) signals, or both, applied to the ultrasonic transducer) to modulate the temperature of the ultrasonic blade to prevent instability of the ultrasonic blade.”) [The adjustment of the voltage and current based on the determination an RMS value greater than the current setpoint and/or instability of the ultrasonic blade reads on “on conditions encountered during use of the device”.]
Regarding claim 10, Nott teaches all the claimed features of claim 9, from which claim 10 depends. Nott further teaches:
The method of claim 9, wherein the at least one operational characteristic includes resonant impedance,…, Nott: Paragraph [0251] (“Stated another way, at resonance the inductive impedance is equal to the capacitive impedance.”) transducer drive frequency, Nott: Paragraph [0251] (“The generator electronics can easily monitor the phase difference between the voltage Vg(t) and current Ig(t) signals and can continuously adjust the drive frequency until the phase difference is once again zero. At this point, the new drive frequency is equal to the new resonant frequency of the electromechanical ultrasonic system.”) voltage and current being delivered to the transducer, and combinations thereof. Nott: Paragraph [0401] [As described in claim 1.] Nott: Paragraph [0409] (“As previously described, the generator monitors 133124 the phase angle φ between the voltage Vg(t) and current Ig(t) signals applied to the ultrasonic transducer…” which reads on “voltage and current being delivered to the transducer”.)
Nott does not expressly teach “total operational use time of the device”. However, Barthe describes ultrasound imaging of the region of interest for localization of the treatment area, delivering ultrasound energy at a depth and pattern to achieve the desired therapeutic effects, and/or monitoring the treatment area to assess the results and/or provide feedback. Barthe teaches:
…a total operational use time of the device… Paragraph [0029] (“After localization, delivery of ultrasound energy 220 at a depth, distribution, timing, and energy level to achieve the desired therapeutic effect of thermal ablation to treat an epidermis layer 212, superficial dermis layer 214, mid-dermis layer 216, and/or deep dermis layer 218 can be provided. Before, during, and after therapy, i.e., before, during, and after the delivery of ultrasound energy 220, exemplary method and system 200 can suitably monitor the treatment area and surrounding structures to plan and assess the results and/or provide feedback to control system 202 and/or a system user.”)
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having the teachings of Nott and Barthe before them, to include a total operational use time of the device because the references are in the same field of endeavor as the claimed invention.
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do this modification because it would provide an alternative operation characteristic to control probe and system functionality. Barthe Paragraphs [0009] and [0029].
Regarding claim 15, Nott and Barthe teach all the claimed features of claim 10, from which claim 15 depends. Nott further teaches:
The method of claim 10, wherein adapting system control includes temporarily changing the transducer drive frequency based on conditions encountered during use of the end-effector. Nott: Paragraph [0378] (“In one aspect, the initial proof of concept assumed a static, linear relationship between the natural frequency of the electromechanical ultrasonic system and the temperature of the ultrasonic blade. By reducing the power as a function of the natural frequency of the electromechanical ultrasonic system (i.e., regulating temperature with feedback control), the temperature of the ultrasonic blade tip could be controlled directly. In this example, the temperature of the distal tip of the ultrasonic blade can be controlled to not exceed the melting point of the Teflon pad.”) [The ongoing change of the frequency to accommodate feedback control of the temperature reads on “temporarily changing the transducer drive frequency based on conditions…”.]
Regarding claim 16, Nott and Barthe teach all the claimed features of claim 10, from which claim 16 depends. Nott further teaches:
The method of claim 10, wherein adapting system control includes changing the voltage and current being delivered to the transducer based on conditions encountered during use of the end-effector. Nott: Paragraph [0300] (“The current feedback samples may be compared to a “current demand” Id value dictated by the controlled variable (e.g., current, voltage or power) to determine if the drive signal is supplying the necessary current. In aspects in which drive signal current is the control variable, the current demand Id may be specified directly by a current setpoint 2620A (Isp). For example, an RMS value of the current feedback data (determined as in block 2340) may be compared to user-specified RMS current setpoint Isp to determine the appropriate controller action. If, for example, the current feedback data indicates an RMS value less than the current setpoint Isp, LUT scaling and/or the full-scale output voltage of the DAC 1680 may be adjusted by the block 2600 such that the drive signal current is increased. Conversely, block 2600 may adjust LUT scaling and/or the full-scale output voltage of the DAC 1680 to decrease the drive signal current when the current feedback data indicates an RMS value greater than the current setpoint Isp.”) Nott: Paragraph [0420] (“Some ultrasonic blades exhibit displacement instability or modal instability in the presence of increasing temperature. This known relationship may be employed to interpret when an ultrasonic blade is approaching instability and then adjusting the power level driving the ultrasonic transducer (e.g., by adjusting the driving voltage V.sub.g(t) or current I.sub.g(t) signals, or both, applied to the ultrasonic transducer) to modulate the temperature of the ultrasonic blade to prevent instability of the ultrasonic blade.”) [The adjustment of the voltage and current based on the determination an RMS value greater than the current setpoint and/or instability of the ultrasonic blade reads on “on conditions encountered during use of the device”.]
Claims 6 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Nott, in view of Barthe, and further in view of Thompson (US Patent No. 7,335,169 B2) (“Thompson”).
Regarding claim 6, Nott and Barthe teach all the claimed features of claim 2, from which claim 6 depends. Nott and Barthe do not expressly teach the features of claim 6. However, Thompson describes delivering ultrasound energy to an ultrasound transducer having an impedance subject to variations. Thompson teaches:
The method of claim 2, wherein adapting system control includes limiting the total operational use time of the device such that operation of the system ceases prior to expiration of the device. Thompson: Claim 1 (“A method comprising (i) selecting a prescribed maximum treatment time having a start of treatment time and an end of treatment time for percutaneously applying ultrasound energy into a thoracic cavity, (ii) placing an ultrasound transducer on a skin surface overlaying the thoracic cavity… (b) setting the tuned frequency as the set transducer output frequency over the maximum treatment time, (c) delivering ultrasound energy percutaneously through the ultrasound transducer at only the set transducer output frequency at an increasing output power condition that transitions, according to a ramping function based upon preprogrammed rules at a rate of between about 0.01 W/s to about 10 W/s, from a condition at or near the first output power condition toward a second output power condition that is greater than the first output power condition, (d) until the end of the treatment time, continue delivering ultrasound energy to the ultrasound transducer at only the set output frequency and at the second output power condition; (e) maintaining the second output power condition essentially constant, despite variations in the impedance, based upon preprogrammed rules, and (f) disabling operation of the ultrasound transducer at the end of treatment time.”)
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having the teachings of Nott, Barthe, and Thompson before them, for the adapting system control to include temporarily changing the transducer drive frequency based on conditions encountered during use of the device because the references are in the same field of endeavor as the claimed invention.
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do this modification because it would provide deliver ultrasound energy to the ultrasound transducer at a set output frequency and at an output power level that remains essentially constant, despite variations in the impedance, based upon preprogrammed rules. Thompson Column 1, lines 63-67.
Regarding claim 14, Nott and Barthe teach all the claimed features of claim 10, from which claim 14 depends. Nott and Barthe do not expressly teach the features of claim 14. However, Thompson describes delivering ultrasound energy to an ultrasound transducer having an impedance subject to variations. Thompson teaches:
The method of claim 10, wherein adapting system control includes limiting the total operational use time of the end-effector such that operation of the system ceases prior to expiration of the end-effector. Thompson: Claim 1 (“A method comprising (i) selecting a prescribed maximum treatment time having a start of treatment time and an end of treatment time for percutaneously applying ultrasound energy into a thoracic cavity, (ii) placing an ultrasound transducer on a skin surface overlaying the thoracic cavity… (b) setting the tuned frequency as the set transducer output frequency over the maximum treatment time, (c) delivering ultrasound energy percutaneously through the ultrasound transducer at only the set transducer output frequency at an increasing output power condition that transitions, according to a ramping function based upon preprogrammed rules at a rate of between about 0.01 W/s to about 10 W/s, from a condition at or near the first output power condition toward a second output power condition that is greater than the first output power condition, (d) until the end of the treatment time, continue delivering ultrasound energy to the ultrasound transducer at only the set output frequency and at the second output power condition; (e) maintaining the second output power condition essentially constant, despite variations in the impedance, based upon preprogrammed rules, and (f) disabling operation of the ultrasound transducer at the end of treatment time.”)
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having the teachings of Nott, Barthe, and Thompson before them, for the adapting system control to include temporarily changing the transducer drive frequency based on conditions encountered during use of the device because the references are in the same field of endeavor as the claimed invention.
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do this modification because it would provide deliver ultrasound energy to the ultrasound transducer at a set output frequency and at an output power level that remains essentially constant, despite variations in the impedance, based upon preprogrammed rules. Thompson Column 1, lines 63-67.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Nott in view of Nita et al. (US Patent Publication No. 2019/0216487 A1) (“Nita”).
Regarding claim 17, Nott teaches all the claimed features of claim 9, from which claim 17 depends. Nott does not expressly teach the features of claim 17. However, Nita describes a steerable ultrasound catheter. Nita teaches:
The method of claim 9, wherein the inferred system use criteria includes use of the end-effector in tortuous vasculature. Nita: Paragraph [0048] (“Typically, it is advantageous to have guidewire 132 exit approximately the center of distal head 131, to facilitate tracking of catheter device 130 along guidewire 132. It may also be advantageous, however, to offset guidewire tube 134 within catheter body 136, so that guidewire tube 134 and ultrasound transmission member 138 may fit within a catheter body having a smaller inner diameter. Smaller diameter catheters, of course, are more easily advanced through tortuous vasculature.”)
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having the teachings of Nott and Nita before them, for the inferred system use criteria to include use of the end-effector in tortuous vasculature because the references are in the same field of endeavor as the claimed invention.
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do this modification because it would facilitate tracking of catheter device along guidewire and allow for passage of a guidewire without interfering with, and perhaps even enhancing, disruption of vascular occlusions. Nita Paragraphs [0007] and [0048].
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Nott in view of Thompson.
Regarding claim 18, Nott teaches all the claimed features of claim 9, from which claim 18 depends. Nott further teaches:
The method of claim 9, wherein the generator is configured to … adapting system control by using the controller to alter the operational characteristic based on the inferred use criteria. Nott: Paragraph [0340] (“…controlling the amount of power delivered to tissue as the impedance of the tissue changes and controlling the power delivery to maintain a constant rate of tissue impedance increase. Some of these algorithms are used to determine the phase difference between the generator drive signal current and voltage signals. At resonance, the phase difference between the current and voltage signals is zero. The phase changes as the ultrasonic system goes off-resonance. Various algorithms may be employed to detect the phase difference and adjust the drive frequency until the ultrasonic system returns to resonance, i.e., the phase difference between the current and voltage signals goes to zero. The phase information also may be used to infer the conditions of the ultrasonic blade. As discussed with particularity below, the phase changes as a function of the temperature of the ultrasonic blade. Therefore, the phase information may be employed to control the temperature of the ultrasonic blade. This may be done, for example, by reducing the power delivered to the ultrasonic blade when the ultrasonic blade runs too hot and increasing the power delivered to the ultrasonic blade when the ultrasonic blade runs too cold.”)
Nott does not expressly teach wherein the generator is configured to allow a user to input information into the ultrasonic therapeutic system, wherein the inputted information includes patient presentation data, and that the generator adjusts the predetermined thresholds, operational ranges, and other predetermined operational settings based on patient presentation data during the steps of inferring a system use criteria based on the detected change in the operational characteristic. However, Thompson describes delivering ultrasound energy to an ultrasound transducer having an impedance subject to variations. Thompson teaches:
wherein the generator is configured to allow a user to input information into the ultrasonic therapeutic system, wherein the inputted information includes patient presentation data, and Thompson: Column 4, lines 30-39 (“The machine 16 also preferably includes an operator interface 28. Using the interface 28, the operator inputs information to the controller 26 to affect the operating mode of the module 24. Through the interface 28, the controller 26 also outputs status information for viewing by the operator. The interface 28 can provide a visual readout, printer output, or an electronic copy of selected information regarding the treatment. The interface 28 is shown as being carried on the chassis 22, but it could be located external of the chassis 22 as well.”) Thompson: Column 8, lines 56-57 (“… the morphology of the patient (e.g., size, weight, girth) …”, which reads on “patient presentation data”.)
wherein the generator adjusts the predetermined thresholds, operational ranges, and other predetermined operational settings based on patient presentation data during the steps of inferring a system use criteria based on the detected change in the operational characteristic; and… Thompson: Column 8, lines 12-60 (“Depending upon the treatment parameters and outcome desired, the controller 26 can operate a given transducer 40 at a fundamental frequency below about 50 kHz, or in a fundamental frequency range between about 50 kHz and about 1 MHz, or at fundamental frequencies above 1 MHz… A given transducer 40 can be operated at a frequency within a certain range of frequencies suitable to the transducer 40. The optimal frequency for a given treatment is dependent on a number of factors, e.g., the magnitude of the fill volume of the bladder chamber 50; the characteristics of the acoustic coupling between the acoustic contact area (i.e., bladder 48) and the patient's skin; the morphology of the patient (e.g., size, weight, girth) which affect the transmission of ultrasound energy through the skin and within the body; the acoustic load impedance seen by the transducer 40.”) [The range of frequencies read on “operational ranges”, the optimal frequency reads on “predetermined thresholds”, the characteristics of the acoustic coupling reads on “other predetermine operational settings”, the morphology of the patient reads on “patient presentation data”.]
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having the teachings of Nott and Thompson before them, for the generator is configured to allow a user to input information into the ultrasonic therapeutic system, wherein the inputted information includes patient presentation data, and that the generator adjusts the predetermined thresholds, operational ranges, and other predetermined operational settings based on patient presentation data during the steps of inferring a system use criteria based on the detected change in the operational characteristic because the references are in the same field of endeavor as the claimed invention.
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do this modification because it would provide deliver ultrasound energy to the ultrasound transducer at a set output frequency and at an output power level that remains essentially constant, despite variations in the impedance, based upon preprogrammed rules and to consider parameters that would affect transmission of ultrasound energy through a patient’s skin. Thompson Column 1, lines 63-67, and Column 8, lines 12-60.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Nott, in view of Thompson, and further in view of Vale et al. (US Patent Publication No. 2021/0275197 A1) (“Vale”).
Regarding claim 19, Nott and Thompson teaches all the claimed features of claim 18, from which claim 19 depends. Nott and Thompson do not expressly teach the features of claim 19. However, Vale describes a method and apparatus to manage acute ischemic events. Vale teaches:
The method of claim 18, wherein the patient presentation data includes blood vessel diameter, blood clot length, clot type, blood clot age, and other therapeutically useful patient data. Vale: Paragraph [0008] (“The reason for poor revascularization results using current devices and approaches is multifaceted. Challenges such as the type of clot, length of the clot, vascular architecture, and patient comorbidities can play key roles. Complex vessel tortuosity in some patients, particularly in the aged can further exacerbate the difficulty of addressing these challenging occlusions. Tortuosity can make it more difficult not just to access but also to dislodge the clot, possibly due to the line of force applied to the clot by the device and the potential for vessel movement and deformation.”) Vale: Paragraph [0009] (“Regarding variation in types of clots, clots can range broadly in their composition, distribution of components (heterogeneity) and mechanical properties. The variation is due to multiple factors, including but not limited to origin of the clot, clot location, age of the clot, cellular content, non-cellular content, red blood cells, platelets, and white blood cells.”) Vale: Paragraph [0363] (“Smaller size guidewires having an approximately 0.010″ outer diameter and microcatheters having an inner diameter lumen of approximately 0.016″ are sometimes used, particularly in smaller or more distal vessels.”) [The cellular content, non-cellular content, red blood cells, platelets, and white blood cells read on “other therapeutically…patient data”.]
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, having the teachings of Nott, Thompson, and Vale before them, for the patient presentation data includes blood vessel diameter, blood clot length, clot type, blood clot age, and other therapeutically useful patient data because the references are in the same field of endeavor as the claimed invention.
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do this modification because it would provide a practical way to determine the best treatment for the patient because of the time involved with sampling and analysis based on clot and vessel data. Vale Paragraph [0009]-[0011].
It is noted that any citations to specific, pages, columns, lines, or figures in the prior art references and any interpretation of the reference should not be considered to be limiting in any way. A reference is relevant for all it contains and may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. See MPEP 2123.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Publication No. 2018/0070915 A1 to Miyachi describes in Paragraph [0052] “…an ultrasonic diagnostic device including: an ultrasonic probe that transmits ultrasound to a body under test and that receives ultrasonic echo reflected off the body under test to output a reception signal; image data generation means that generates, based on the reception signal output from the ultrasonic probe, image data representing an ultrasonic image on a blood vessel of the body under test; IMT measurement means that measures, based on the image data generated by the image data generation means, an IMT (intima media thickness) of the blood vessel; elastic index measurement means that determines, based on the image data generated by the image data generation means, a value representing an elastic index of the blood vessel; and display means that displays a two-dimensional coordinate system in which the IMT is represented on a first coordinate axis and the value representing the elastic index of the blood vessel is represented on a second coordinate axis.” Miyachi also describes in Paragraph [0136] “The age of a blood vessel is determined by employing an average index value for an age group from the results obtained by performing measurements on a large number of persons to be tested.”
US Publication No. 2022/0034985 A1 to Maier et al. describes an approach to estimate noise, Rician signal bias and true signal in magnitude signal data obtained with magnetic resonance imaging. The method uses multiple measurements at different scan parameter settings, also referred to as weightings, and an iterative algorithm to estimate noise, expected signal and associated Rician signal bias. Measurements at all measured weighting levels contribute to the ultimate estimation of the bias-free signal decay function. Therefore, of the so processed magnetic resonance image data, weighted signals can be computed at arbitrary weighting levels and with considerably better signal-to-noise ratio than the originally obtained data at corresponding weightings. Bias-free weighted image data at desired weighting levels, maps of the decay function fit parameters, or maps of a combination of such decay function parameters can be used for rapid and highly sensitive tissue characterization.
US Patent Publication No. 2014/0288465 A1 to Akagane describes that in order to keep an amplitude or a vibration velocity of the ultrasound vibration in the treatment portion of the handpiece at a predetermined value according to the handpiece, a predetermined drive current value to be outputted to the ultrasound transducer, the predetermined drive current value corresponding to the predetermined value, is determined. A variable current setting section is configured to variably set the drive current so that the drive current produced by the drive current output section based on the parameter stored in the first information storage section and the drive frequency detected by the drive frequency output section has the predetermined drive current value, in order to keep the amplitude or the vibration velocity of the ultrasound vibration in the treatment portion provided at a distal end portion of the probe in the handpiece connected to the power supply apparatus at the predetermined value.
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/ALICIA M. CHOI/Primary Patent Examiner, Art Unit 2117
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