DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 1/29/2026 with respect to claim 1 have been fully considered but they are not persuasive.
Regarding claim 1, Applicant contends that none of either Masters (US 2024/0299050 A1)(previously of record) or Elder (US 2011/0301861 A1) disclose or suggest the amended limitations of “in response to determining that the first slope of the resonance frequency blade is a decreasing trend and exceeds the first threshold value, calculate a second slope of the resonance frequency of the blade over a second period of time, and determining whether the second slope of the resonance frequency is a decreasing trend and exceeds a second threshold value”. The Examiner respectfully disagrees as Masters discusses in Para. [0106]-[0107] wherein the frequency slope of the blade is continuously monitored at various time intervals and compared to a maximum threshold value. Even if the measured frequency slope over a current period of time were to exceed the threshold value, the controller would take corrective action and would still proceed to measure successive frequency slopes. In regards to the mention of “detecting a decreasing trend”, the Examiner notes that this is understood to be a negative slope value in response to a decrease in frequency output. Masters discloses wherein the frequency applied to the blade may fluctuate based on contact with body tissue or tortuous anatomy (Para. [0106]-[0107]) and the slope is therefore reasonably capable of being negative. This is understood to be a conditional step that the controller of Masters is fully capable of performing based on the conditions of operation and contact with bodily tissue within the anatomy. For Example, should the frequency slope exceed the threshold value, the controller is configured to take corrective action to reduce the applied frequency, which would result in a “negative slope” that exceeds the threshold value for a period of time. Thereafter, the controller would continue to measure the frequency slope for future time periods and compare these values to the threshold value(s).
Applicant’s arguments with respect to claim(s) 1 regarding the limitations of “wherein the second threshold value is larger than the first threshold value” have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, none of either Masters or Elder are relied upon to disclose the amended limitations of the two different threshold values relative to one-another.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 8-11, 21, 26-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Masters (US 2024/0299050 A1)(previously of record) in view of Elder (US 2011/0301861 A1) (previously of record), further in view of Messerly (US 2016/0120563 A1).
Regarding claim 1, Masters discloses:
A treatment device for treating a target tissue (see Figs. 5-11) comprising:
a drive source (transducer 160, see Para. [0056]);
an instrument having a blade (see Para. [0054] mentioning wherein the distal end of the instrument may comprise a blade to improve the delivery of energy and provide a desired tissue effect) connected to the drive source (see Para. [0052]) and configured to apply mechanical vibrations to the target tissue (see Para. [0030], [0036], [0054] and [0062]);
a control unit (controller 202, see Para. [0011] and [0044]) configured to:
calculate a first slope of a resonance frequency of the blade (see Para. [0106]-[0107]; rate of change of the drive frequency over time constitutes a slope) over a first period of time (time period over which the drive frequency is measured for the first time);
determine whether the first slope of the resonance frequency is a decreasing trend (see Para. [0106]-[0107] mentioning wherein the rate of change in resonance frequency may be measured over time; should the rate of change be decreasing (e.g., via interaction with body tissue as mentioned to be possible in Para. [0107]), the controller would “detect” this decreasing trend (i.e., detected in the form of a negative slope value) since it is the variable being measured over time) and exceeds a first threshold value (see Para. [0106]-[0107]; rate of change is compared to a threshold value; should the threshold value be exceeded, the system may take corrective action by lowering the frequency applied to the previous slope value);
responsive to determining that the first slope of the resonance frequency is a decreasing trend and exceeds the first threshold value, calculate a second slope of the resonance frequency of the blade over a second period of time (see Para. [0106]-[0107]; after each instance of recording frequency over time, the controller takes another measurement to determine a second slope in frequency due to continuous operation; should the previous rate of change have exceeded the threshold value (e.g., via interaction with body tissue or tortuous anatomy) and comprised a decreasing trend (e.g., by interaction with the anatomy or lack thereof) the system would thereafter take a second measurement of the resonance frequency over a second period of time due to continuous operation; this limitations is understood to be a conditional step based on the interaction of the ultrasonic tool with the anatomy and the device of Masters is capable of performing this step should the same conditions be met due Masters’ the disclosure providing mention of continuous tracking of the frequency of the blade over periods of time and comparing this “slope” value to a threshold value to determine if corrective action is needed; Masters provides mention in Para. [0106]-[0107] that the frequency of the blade fluctuates via interaction with body tissue and is therefore understood to be reasonably capable of having a “negative slope” which would then be compared to the threshold value);
determine whether the second slope of the resonance frequency is a decreasing trend and exceeds a second threshold value (see Para. [0106]-[0107] mentioning wherein the rate of change in resonance frequency may be measured over time; should the second measurement of the rate of change be decreasing (e.g., via interaction with body tissue as mentioned to be possible in Para. [0107]), the controller would “detect” this decreasing trend (i.e., detected in the form of a negative slope value) since it is the variable being measured over time);
additionally detect a change in ultrasonic impedance (see Para. [108] mentioning wherein the controller may be configured to measure drive impedance of the transducer; see also Para. [0111] and [0113] mentioning wherein the characteristics of various embodiments may be combined); and
responsive to determining that the second slope of the resonance frequency exceeds the second threshold value and detecting the change in ultrasonic impedance, the reduce or stop a supply of electrical energy to the drive source (see Para. [0106]-[0107] mentioning wherein should the measured rate of change in frequency exceed a threshold value, corrective action is taken by reducing the frequency applied to the blade by the transducer; this is understood to occur simultaneously with the measurement of drive impedance mentioned in Para. [0108] since measurement of these parameters is tracked continuously).
However, Masters does not expressly disclose:
wherein the second period of time is less than the first period of time; and
wherein the first threshold is less than the second threshold.
In the relevant field of endeavor, namely control systems for monitoring output frequency and other electrical signals within a single device, Elder teaches wherein a frequency within a system may be measured across multiple time intervals that that differ from one-another in duration. Specifically, Elder teaches wherein after a first frequency measurement is taken across a first time interval (T1), a second frequency measurement is taken across a second time interval (T2) that may be from about 5% to 30% less/shorter than the preceding first time interval (see Para. [0101]) to ensure that the magnitude of the sampled frequency output does not deviate from a theoretical continuous output signal based on the first time interval (i.e., that an output frequency is following a trendline) (see Para. [0101]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the controller of Masters to, after measuring the rate of change in frequency across a first time period, to have the second time period for measurement of the rate of change in frequency be over a time period be shorter/less than the preceding first time period as taught and suggested by Elder to, in this case, ensure that the magnitude of the sampled frequency does not deviate from a predicted, continuous output signal based on the first time period measurement (see Elder Para. [0101]).
In the same field of endeavor, namely ultrasonic cutting devices comprising a controller unit configured to track and measure output blade frequency, Messerly teaches:
An ultrasonic cutting instrument (instrument 100, see Fig. 1) comprising:
a drive source (ultrasonic transducer 50, see Para. [0163]);
a controller unit (generator(s) 30, 500 and/or 1002, see Para. [0423]-[0425]) configured to:
calculate a first slope of a resonance frequency of the blade over a first period of time (see Para. [0322]-[0325], [0360] and [0425]);
determine whether the first slope of the resonance frequency exceeds a first threshold value (see Para. [0425] mentioning wherein the generator/system is configured to compare a measured frequency slope to a past frequency slope offset from the current slope by a window offset time; this past frequency slope is understood to constitute a “first threshold”) to determine if a loading event is taking place (i.e., is the blade in contact with tissue compared to the previous measured time window) (see Para. [0425]);
calculate a second slope of the resonance frequency of the blade over a second period of time (see Para. [0425] mentioning wherein the system is configured to measure the frequency slope on a rolling basis over sequential time windows);
determine whether the second slope of the resonance frequency exceeds a second threshold value (see Para. [0425] mentioning wherein the currently-measured frequency slope is compared to a pre-determined “maximum” frequency threshold value);
wherein the first threshold is lower than the second threshold (in the event a loading action is beginning to take place, the previously-measured frequency slope would be lower than the currently-measured frequency slope and less than the maximum frequency threshold value).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the controller of Masters to track and measure the frequency slope of the blade on a “rolling window” basis in which each currently-recorded frequency slope is compared to a previously-measured frequency slope, wherein the previously-measured frequency slope is defined as the “first threshold”, as taught and suggested by Messerly to, in this case, determine whether a loading event is beginning to take place in which the blade is coming into contact with tissue (see Messerly Para. [0425]). This would aid in allowing a user to more effectively track the condition or contact state of the distal instrument before the maximum threshold value is exceeded. This new “first threshold value” would be lower than the maximum second threshold value since the system is configured to prevent the frequency from exceeding the maximum threshold value per Masters Para. [0107]).
Regarding claim 8, the combination of Masters, Elder and Messerly disclose the invention of claim 1, Masters further discloses wherein the first and/or second threshold value is proportional to the resonance frequency at a specified time (see Para. [0107] mentioning wherein should the operational frequency exceed a predetermined threshold, the frequency will be reduced to the last known value within the limits of the predetermined threshold which is seen to be proportional to the threshold value; therefore, the threshold value is always seen to be proportional to the current frequency at a specific time since the two values are checked against one-another to determine what manipulation is needed to alter the frequency based on comparing the current frequency to the threshold value to determine the proportionality).
Regarding claim 9, the combination of Masters, Elder and Messerly disclose the invention of claim 1, Masters further discloses wherein the first and/or second threshold value is a product of the resonance frequency at a start of a predetermined time period and a coefficient (for the purposes of examination, the term “coefficient” is broadly defined to be, as defined by the Merriam-Webster dictionary, “a number that serves as a measure of some property or characteristic”. Given this definition, the threshold value for the time period between initially starting up to when the frequency increases up to the predetermined threshold value can be represented by an initial frequency of “1” which may be multiplied by a number (i.e., coefficient) equal to the maximum frequency that may be applied. As the current claim language does not define any particular point in time or numerical value for the claimed “coefficient”, the coefficient is defined to be a maximum amount of frequency that may safely be supplied without causing damage until reaching the maximum predetermined value).
Regarding claim 10, the combination of Masters, Elder and Messerly disclose the invention of claim 1, Masters further discloses wherein the first and/or second threshold value is equal to an average resonance frequency over a predetermined time period (see Para. [0106]-[0107] mentioning wherein should the rate of change of the detected frequency be at or beyond the threshold value (i.e., the rate of change is equal to the predetermined value), the controller reduces the frequency supplied. This is taken to mean that at a certain time period, the average frequency can be equal to the threshold value since the frequency changes during use and/or navigation of the device within the vasculature and is entirely capable of having the slope of the frequency equal the threshold value. This limitation is understood to be situational as the frequency constantly changes and would not constantly be equal to the threshold value in at least the initial startup, or the ending of an operation).
Regarding claim 11, the combination of Masters, Elder and Messerly disclose the invention of claim 1, Masters further discloses wherein the first and/or second threshold value is equal to an integral of the resonance frequency over a predetermined time period (an integral is the measure of a quantity change over time; when the frequency change of energy supplied by the transducer is equal to the pre-set threshold, the pre-set threshold value will be equal to an integral of the resonance frequency over a given time period).
Regarding claim 21, the combination of Masters, Elder and Messerly disclose the invention of claim 1, Masters further discloses wherein the drive source comprises a transducer (transducer 160) configured to convert electrical energy to mechanical vibrations (see Para. [0039]).
Regarding claim 26, the combination of Masters, Elder and Messerly disclose the invention of claim 1, Masters further discloses wherein the first threshold value is proportional to the resonance frequency measured at a start of the first time period (see Para. [0106]-[0107] mentioning wherein each frequency measurement is compared to the first threshold value; for measurement during the first time period, the measured frequency would therefore be proportional to the threshold value since the two values are compared against one-another to check proportionality to determine if any manipulation to the output frequency is needed (i.e., if the measured frequency value exceeds or is below the threshold value)).
Regarding claim 27, the combination of Masters, Elder and Messerly disclose the invention of claim 1, Masters, as modified by Messerly, further discloses wherein the control unit is further configured to update the first threshold at regular intervals corresponding to a during of the first period of time (as the “first threshold”, as modified by Messerly, is defined to be the previously-measured frequency slope within the current rolling window, the “first threshold” is continuously updated over each “first period of time”, setting the last measured frequency slope as the new “first threshold” to be compared to the current frequency slope)
Regarding claim 28, the combination of Masters, Elder and Messerly disclose the invention of claim 1, Masters further discloses wherein the control unit, responsive to determining that the first slope of the resonance frequency exceeds the first threshold value, is further configured to: determine whether an elapsed time from the second time period exceeds a predetermined time (see Para. [0109] mentioning wherein operation time of the transducer may be continuously monitored and compared to a first threshold value over a predetermined time period; Para. [0111] mentions wherein the functionality components of the disclosed device are combinable with one-another; therefore, time intervals are measured and compared to the previous first threshold values along with subsequent measurements of frequency); and responsive to determining that the second slope of the resonance frequency exceeds the threshold value and the elapsed time from the second time period exceeds the predetermined time, reduce or stop the supply of electrical energy to the drive source (see Para. [0106]-[0107] and [0109] mentioning wherein, should either the frequency or operation time exceed the pre-determined second threshold value, the controller may reduce the frequency applied to the distal end effector to the previously-measured magnitude).
Regarding claim 29, the combination of Masters, Elder and Messerly disclose the invention of claim 28, Masters further discloses wherein the control unit is configured to: responsive to determining that the elapsed time does not exceed the predetermined time, calculate a third slope of the resonance frequency of the blade over a third period of time (see Para. [0109] mentioning that if the time threshold is not met or exceeded, the device continues operation in which the frequency would only change should the frequency threshold be exceeded).
Regarding claim 30, the combination of Masters, Elder and Messerly disclose the invention of claim 1, Masters further discloses wherein the second slope of the resonance frequency of the blade is steeper than the first slope of the resonance frequency of the blade (see Para. [0106]-[0107] mentioning wherein upon contact of the blade with tissue, the frequency will begin to increase beyond the pre-determined second threshold value. This would result in the “second slope” having a steeper rate of change than the first slope due to contacting tissue. As the various slopes are merely measured frequency values, rather than set values, this limitation is being treated as conditional and the device of Masters is configured to have a second frequency slope be steeper than a first frequency slope in condition the blade comes into contact with tissue).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 9237921 B2 to Messerly, US 2012/0078139 A1 to Aldridge, US 9039695 B2 to Giordano and US 12167866 B2 to Timm all disclose ultrasonic surgical devices configured to detect and measure a electrical parameter and compare it to a threshold value.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./ Examiner, Art Unit 3771
/DARWIN P EREZO/ Supervisory Patent Examiner, Art Unit 3771
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