DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 5/28/2026 has been entered.
Response to Arguments
First, Applicant argues that Turner does not teach preventing execution of a user-interface command. Specifically, Applicant writes: “Turner does not disclose blocking or preventing execution of a command that exceeds a threshold. This distinction is dispositive: adjusting output in response to a measured feedback signal is fundamentally different from preventing execution of a user-interface command that would cause a threshold to be exceeded, as required by the amended claims.” See Remarks at 8-9.
Second, Applicant argues that “Turner's thresholds are based on internal system measurements rather than externally stored device information. Thus, the cited combination fails to disclose or suggest the claimed device-aware safety architecture in which thresholds are generated from device-supplied data and used to constrain user-commanded operation.” See Remarks at 9.
Third, Applicant argues that “[t]he references address different problems in different technical domains - Anderson concerns laser-fluid interactions, while Turner concerns electrosurgical generator control - and neither recognizes the problem solved by the present invention, namely preventing user-commanded operation beyond device-specific limits.” See Remarks at 9.
Applicants’ arguments have been fully considered but they are not persuasive.
Turner teaches that a generator which powers a surgical instrument may utilize persistent memory to store operational data for control of instruments. See, e.g., [0130]. Note that feedback control and real-time tuning of operational instrument parameters are merely possible embodiments. See, e.g., [0126]. Turner also teaches that the generator may comprise of input devices, such as suitable user interfaces displayed on a touchscreen. See, e.g., [0149].
It is important to appreciate that these teachings above apply generally to all sorts of surgical instruments, not just ultrasound and electrosurgical devices. Indeed, Turner’s teaching concerning error-checks of user inputs also apply to all sorts of surgical instruments, including laser devices.
For example, Turner teaches that “[a]lthough the processor 190 may primarily support UI functionality, it may also coordinate with the processor 174 to implement hazard mitigation in certain embodiments. For example, the processor 190 may be programmed to monitor various aspects of user input and/or other inputs (e.g., touch screen inputs, footswitch 120 inputs, temperature sensor inputs) and may disable the drive output of the generator 102 when an erroneous condition is detected.” See [0162].
The person of ordinary skill in the art of laser-based surgical devices would find that Turner’s teachings of using graphical user interfaces, persistent memory, and error-checks of user input are reasonable pertinent to the problem of avoiding erroneous conditions by disabling the drive output of the generator in order to implement hazard mitigation.
Note that all claims are drawn to the same invention claimed in the application prior to the entry of the submission under 37 CFR 1.114 and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al. (US 5632739 A, 1997-05-27) (hereinafter “Anderson”) in view of Turner et al. (US 20120265196 A1, 2012-10-18) (hereinafter “Turner”)
Regarding claims 1-20, Anderson teaches a method of controlling a laser delivery console, comprising: receiving at a controller for a laser delivery console electronically (27) stored information from a medical device; wherein various operating parameters may be adjusted (Fig. 4 and associated text). [A1]
Note that Anderson also teaches causing, by the controller, a laser source to generate an initiation pulse (50) at a first time (Tl) and a treatment pulse (52) at a second time (T2), wherein the second time (T2) follows the first time (Tl) by a predetermined time delay (54) (t); wherein a tip of the medical is configured to be inserted into a liquid medium (12), and wherein an absorbed energy in the liquid medium located between the tip and a target tissue creates a bubble in a short delay after the first time (Tl). See, e.g., 6:45-64 (“Referring now to FIG. 4, the time-dependent properties of the optical fields, i.e., the duration of and spacing between the first 46 and second 48 optical pulses, can be adjusted so as to maximize the amount of energy delivered to the tissue of interest. For example, the durations of the first 46 and second 48 optical pulses (indicated in the figure by arrows 50 and 52, respectively) can be adjusted so as to increase the amount of heat deposited in the liquid region, or in the tissue. In particular, the duration (i.e., power) of the first pulse 46 can be adjusted to vary the size, rate of expansion, and lifetime before collapse of the vapor bubble generated in the fluid region. Alternatively, the energy of the pulse can be adjusted to vary these properties. Preferably, for light at 2.1 microns, the time duration of the first pulse 46 is between about 1000 and 500 microseconds, and the pulse energy is between about 0.5 and 10 Joules/pulse. Typically, the collective size of the vapor bubbles produced with radiation of this magnitude is between about 0.5 and 6.0 mm.sup.3, and the lifetime before collapse is about 100-400 microseconds.”); 7:19-34 (“In addition, because the vapor bubble size is time dependent, the time duration (indicated in the figure by the arrow 54) between the first 46 and second 48 optical pulses will determine the amount of fluid present in the pathway along which the second optical pulse 48 must propagate. Thus, this temporal separation partially determines the amount of radiation delivered to the tissue, and is dependent on the expansion rate of the bubble and the distance between the tissue illuminator and the target tissue. Preferably, the time duration separating the two pulses is chosen so that the second pulse 48 is emitted from the distal tip of the second fiber when the bubble size, and the corresponding amount of displaced fluid, is at a maximum. Typically, this separation is between about 50 and 600 microseconds, and is most preferably about 150 microseconds.”). [A2]
However, Anderson does not expressly teach a plurality of operating parameter threshold values.
Turner teaches operating parameter threshold values. See, e.g., [0306] (disclosing power curves and impedance thresholds). [T1] Turner also teaches feedback control. See, e.g., [0126]-[0129]. [T2]
As discussed above, Turner teaches that a generator which powers a surgical instrument may utilize persistent memory to store operational data for control of instruments. See, e.g., [0130]. Note that feedback control and real-time tuning of operational instrument parameters are merely possible embodiments. See, e.g., [0126]. Turner also teaches that the generator may comprise of input devices, such as suitable user interfaces displayed on a touchscreen. See, e.g., [0149]. [T3]
It is important to appreciate that these teachings above apply generally to all sorts of surgical instruments, not just ultrasound and electrosurgical devices. Indeed, Turner’s teaching concerning error-checks of user inputs also apply to all sorts of surgical instruments, including laser devices. For example, Turner teaches that “[a]lthough the processor 190 may primarily support UI functionality, it may also coordinate with the processor 174 to implement hazard mitigation in certain embodiments. For example, the processor 190 may be programmed to monitor various aspects of user input and/or other inputs (e.g., touch screen inputs, footswitch 120 inputs, temperature sensor inputs) and may disable the drive output of the generator 102 when an erroneous condition is detected.” See [0162]. [T4]
The person of ordinary skill in the art of laser-based surgical devices would find that Turner’s teachings of using graphical user interfaces, persistent memory, and error-checks of user input are reasonable pertinent to the problem of avoiding erroneous conditions by disabling the drive output of the generator in order to implement hazard mitigation.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of Turner with the invention taught by Anderson such that the invention further comprises: receiving at a controller for a laser delivery console electronically stored information from a medical device; converting, using at least one processor of the controller, the electronically stored information to a plurality of operating parameter threshold values, wherein the plurality of operating parameter threshold values includes maximum frequency values and maximum energy values for laser energy supplied by the laser delivery console to the medical device;
causing, by the controller, a laser source to generate an initiation a first pulse at a first time (Tl) and a second pulse at a second time (T2), wherein the second time (T2) follows the first time (Tl) by a predetermined time delay (t), wherein the first pulse and the second pulse have respective energy values and frequency values selected via a user interface; and preventing, in response to a command received via the user interface adjusting or setting the energy values or frequency values of laser energy of the initiation the first pulse and/or the second pulse supplied to the medical device, the delivery of laser energy with a frequency or energy value that exceeds one or more of the threshold values (e.g., [A1]-[A2], [T1]-[T4]) (as recited in claim 1);
wherein the first pulse is characterized by a first energy (Ei), and the second pulse is characterized by a second energy (Et), and wherein the second pulse is fired during a period the bubble is collapsing values (e.g., [A1]-[A2], [T1]-[T4]) (as recited in claim 2); wherein a tip of the medical device is configured to be inserted into a liquid medium, and wherein an absorbed energy in the liquid medium located between the tip and a target tissue creates a bubble in a short delay after the first time (Tl), wherein the bubble expands and reaches its nearly maximum size at around the second time (T2) (e.g., [A1]-[A2], [T1]-[T4]) (as recited in claim 3); wherein firing the second pulse during the period the bubble is collapsing reduces retropulsion of the target tissue (as recited in claim 4); a medical laser system for treating a target tissue with a laser beam comprising: a laser source; and a controller, the controller configured to: receive, from an optical fiber coupled to the medical laser system, electronically stored information; convert the electronically stored information to a plurality of operating parameter threshold values, wherein the plurality of operating parameter threshold values includes maximum frequency values and maximum energy values for laser energy supplied by the medical laser system to the optical fiber; fire, by the laser source, a first pulse at a first time (T1) and a second pulse at a second time (T2), wherein the second time (T2) follows the first time (T1) by a predetermined time delay (t); wherein the first pulse and the second pulse have respective energy values and frequency values selected via a user interface; and prevent, in response to a command received via the user interface, adjustment or setting of the energy values or frequency values of laser energy of the first pulse and the second pulse with a frequency value and energy value that exceeds one or more of the threshold values (e.g., [A1]-[A2], [T1]-[T4]) (as recited in claim 5); comprising the optical fiber, wherein the optical fiber comprises a fiber tip for guiding the laser beam to the target tissue, the target tissue being immersed in a liquid medium formed primarily of water, and wherein an absorbed energy in the liquid medium located between the fiber tip and the target tissue creates a bubble in a short delay after the first time (T1) (e.g., [A1]-[A2], [T1]-[T4]) (as recited in claim 6); wherein the first pulse is characterized by a first energy (Ei), and the second pulse is characterized by a second energy (Et), and wherein the second pulse (20) is fired during a period the bubble is collapsing (e.g., [A1]-[A2], [T1]-[T4]) (as recited in claim 7); wherein the bubble expands and reaches its nearly maximum size at around the second time (T2) (e.g., [A1]-[A2], [T1]-[T4]) (as recited in claim 8); wherein firing the second pulse during the period the bubble is collapsing reduces retropulsion of the target tissue (e.g., [A1]-[A2], [T1]-[T4]) (as recited in claim 9); wherein firing the second pulse during the period the bubble is collapsing improves target ablation (e.g., [A1]-[A2], [T1]-[T4]) (as recited in claim 10); wherein the bubble reduces a liquid layer thickness between the fiber tip and the target tissue which the beam passes through, thus decreasing the beam's total absorption in water (e.g., [A1]-[A2], [T1]-[T4]) (as recited in claim 11); wherein the second time (T2) at which the treatment pulse is fired is dependent upon at least one of: a total pulse energy, a pulse repetition rate, a fiber type, a fiber tip-to-target distance (e.g., [A1]-[A2], [T1]-[T4]) (as recited in claim 12); further comprising a closed loop control system that controls the energy level of each initiation pulse to be within a specified predefined range of energies (e.g., [A1]-[A2], [T1]-[T4]) (as recited in claim 13); wherein the system is configured to measure the pulse energy, to compare the measured pulse energy to the predefined range of energies, and to provide feedback in a closed feedback loop to a pumping energy source, in order to compensate for incorrectly-energized pulses and to assure that the level of each first pulse is within the predefined range of energies (e.g., [A1]-[A2], [T1]-[T4]) (as recited in claim 14); wherein the target tissue is a stone (e.g., [A1]-[A2], [T1]-[T4]) (as recited in claim 15); wherein the laser system comprises a Holmium laser source or a Thulium laser source (e.g., [A1]-[A2], [T1]-[T4]) (as recited in claim 16); one or more non-transitory machine-readable medium, comprising instructions that when executed by a processor of a laser delivery console, cause the laser delivery console to: receive electronically stored information from a medical device; convert the electronically stored information to a plurality of operating parameter threshold values, wherein the plurality of operating parameter threshold values includes maximum frequency values and maximum energy values for laser energy supplied by the laser delivery console to the medical device; cause a laser source of the laser delivery console to generate a firstpulse at a first time (T1) and a second pulse at a second time (T2), wherein the second time (T2) follows the first time (T1) by a predetermined time delay (t); wherein the first pulse and the second pulse have respective energy values and frequency values selected via a user interface; and preventing, in response to a command received via the user interface adjusting the energy values or frequency values of laser energy of the first pulse and the second pulse with a frequency value and energy value that exceeds one or more of the threshold values (e.g., [A1]-[A2], [T1]-[T4]) (as recited in claim 17); wherein the first pulse is characterized by a first energy (Ei), and the second pulse is characterized by a second energy (Et), and wherein the second pulse (20) is fired during a period the bubble is collapsing (e.g., [A1]-[A2], [T1]-[T4]) (as recited in claim 18); wherein a tip of the medical device is configured to be inserted into a liquid medium, and wherein an absorbed energy in the liquid medium located between the tip and a target tissue creates a bubble in a short delay after the first time (Tl), wherein the bubble expands and reaches its nearly maximum size at around the second time (T2) (e.g., [A1]-[A2], [T1]-[T4]) (as recited in claim 19); wherein firing the second pulse during the period the bubble is collapsing reduces retropulsion of the target tissue (e.g., [A1]-[A2], [T1]-[T4]) (as recited in claim 20) in order to improve the safety, efficiency, and efficacy of the invention.
Conclusion
All claims are drawn to the same invention claimed in the application prior to the entry of the submission under 37 CFR 1.114 and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 extension fee 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 SCOTT T LUAN whose telephone number is (571)270-1860. The examiner can normally be reached on 9am-5pm, M-F (generally).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, William Thomson, can be reached on 571-272-3718. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Scott Luan
/SCOTT LUAN/Primary Examiner, Art Unit 3792
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