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 amendments overcome the objections to the claim. Applicant’s new drawings are accepted and the drawings objection is withdrawn. Applicant’s amendments further merit new grounds for rejection in view of Hoang et al. (U.S. Patent Application Publication No. 2022/0409275).
Applicant's arguments filed 3/11/2026 have been fully considered but they are not persuasive.
With respect to the arguments on p. 11 directed to Talbot, Applicant states that Talbot does not teach “a laser operating parameter” because the user input does not include specific laser parameters, but rather that the controller selects and iterates through multiple base settings of variable laser light source parameters.
This is not found persuasive. From cited ¶[0046] of Talbot:
The one or more instructions received from the input device 34 can indicate a first range (that is, an upper limit and a lower limit) of values of the peak power Ppeak of the laser light. The controller 32 can then determine the value of each of the plurality of base settings of the peak power Ppeak of the laser light that falls within the first range of the values of the peak power Ppeak of the laser light indicated by the one or more instructions. Moreover, the controller 32 can determine the value of the each of the plurality of base settings of the peak power Ppeak to be evenly distributed within the first range of values of the peak power Ppeak.
The examiner considers this cited portion of Talbot to teach a user entering at least a upper and lower limit of values of peak power, for example, which is specifically a laser parameter value entered by a user.
On pp. 11-12, Applicant states that “the interconnectivity of laser operating parameters is also not taught or appreciated by Talbot.”
This is not found persuasive because Applicant does not claim any particular laser operating parameter in claim 1, nor any such interconnectivity to be considered or determined. Furthermore, from the background section of Talbot indicating well-known considerations: ¶[0005] Such a calculus or stone may be more easily fragmented or broken with laser light having a single set of operating parameters (e.g., energy, peak power, pulse width, average power, and frequency). In contrast, a calculus or stone having a heterogeneous composition is more likely to have a variety of mechanical properties. This provides contextual information that the operating parameters discussed throughout Talbot include all of “energy, peak power, pulse width, average power, and frequency,” further clear in ¶[0020] and throughout.
Applicant’s remaining arguments have been fully 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.
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.
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.
Claim(s) 1-2, 6, 8, 10-12, 19-22, 25, and 28-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harrah et al. (U.S. Patent Application Publication No. 2020/0337786) hereinafter referred to as Harrah; in view of Talbot et al. (U.S. Patent Application Publication No. 2021/0045812) hereinafter referred to as Talbot; in view of Hoang et al. (U.S. Patent Application Publication No. 2022/0409275) hereinafter referred to as Hoang.
Regarding claim 1, Harrah teaches a laser system (Abstract, system for lithotripsy), comprising:
a processing laser configured to generate a laser beam (¶[0019] energy delivery electronics, including a laser source);
a beam delivery system configured to direct the laser beam at a target (¶[0023] energy delivery fiber, deliver energy to a desired treatment location);
a user input device configured to receive input from a user (¶[0016] touchscreen, mouse, keyboard allowing user to send commands to processor); and
a controller coupled to the processing laser and the user input device (¶[0043] processor connected to energy delivery electronics, and connector to directly receive parameters from user input device and remotely control energy delivery parameters) and configured to:
receive initial user input data from the user input device (¶[0042] stone density and type can be input ahead of the procedure, and preloaded table of settings can provide initial settings), the initial user input data including at least one of:
one or more properties of the beam delivery system, and
one or more properties of the target (¶[0042] input includes, for example, stone density and type);
determine at least one initial laser operating parameter based on
the initial user input data (¶[0042] stone density and type can be input ahead of the procedure), and
electronically stored information (¶[0042] preloaded table of settings can provide initial settings); and
control the processing laser using the at least one initial laser operating parameter value (¶[0046] activated to deliver energy);
receive one or more adjusted laser operating parameter values from the user input device (¶[0043] the urologist controls the laser energy settings); and
control the processing laser using at least one of the adjusted laser operating parameter value (¶[0043] the delivered laser energy is controlled by the urologist).
Harrah does not specifically teach determining an initial laser operating parameter range, rather teaching broadly preloaded “settings” without explicit recitation of the types or ranges of the settings. Harrah further does not teach the controller further configured to: determine at least one modified laser operating parameter value and corresponding modified laser operation parameter range based on: the one or more adjusted laser operating parameter values, and the electronically stored information wherein the at least one laser operating parameter that is modified is different than the one or more laser operating parameters that is adjusted, and an adjusted laser operating parameter range and the modified laser operating parameter range are determined such that a lower limit value of each range corresponds to a minimum efficacy for the laser operating parameter, and an upper limit value of each range corresponds to a tissue safety limit for the laser operating parameter.
Attention is brought to the Talbot reference, which teaches determining an initial laser operating parameter range (¶[0046]); and
a controller (¶[0025] controller) configured to: determine at least one modified laser operating parameter value and corresponding modified laser operating parameter range based on the one or more adjusted laser operating parameter values, and the electronically stored information (Figs. 2-3, the operating parameter is adjusted, which determines the base settings, resulting in optimized settings after iterations; these are based on user input and stored information, see ¶¶[0051-0053] for adjustments based on user input and ¶[0040], ¶[0083] stored information about optimized settings for different stone mechanical properties); and
wherein the at least one laser operating parameter that is modified is different than the one or more laser operating parameters that is adjusted (Fig. 3, for example, the variable operating parameter is selected/adjusted and the value of the optimized settings are determined/modified).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the laser parameter determination of Harrah to include ranges, as taught by Talbot, because optimized laser parameter ranges, as taught by Talbot, more effectively and efficiently fragment or break kidney stones (Talbot ¶[0057]).
Harrah as modified does not teach the parameter ranges limited to a lower limit corresponding to a minimum efficacy for the laser operating parameter, and an upper limit corresponding to a tissue safety limit for the laser operating parameter.
Attention is drawn to the Hoang reference, which teaches parameter ranges limited to a lower limit (¶[0230]) corresponding to a minimum efficacy for the laser operating parameter (¶[0052], ¶[0295]), and an upper limit (¶[0230]) corresponding to a tissue safety limit for the laser operating parameter (¶[0229], ¶[0231]).
It would have been obvious to one of ordinary skill in the art to modify the laser system of Harrah as modified to include lower and upper power limits applied to updated laser operating parameters, as taught by Hoang, because they are results effective for efficacy and safety, resulting in a patient having shorter time in recovery, less post operation complications and pain and the hospital can have more surgery cases per day (Hoang, ¶[0295]).
Regarding claim 2, Harrah as modified teaches the laser system of claim 1.
Harrah further teaches wherein the controller is configured to display the at least one initial operating parameter value on a display device (Fig. 8, operating parameters are displayed, ¶[0041]).
As noted above, Harrah does not teach an initial laser operating parameter ranges.
Attention is brought to the Talbot reference, which teaches to display the at least one initial laser operating parameter range on a display device (¶¶[0044-0046], ¶[0051]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the laser parameter determination of Harrah to include ranges, as taught by Talbot, because optimized laser parameter ranges, as taught by Talbot, more effectively and efficiently fragment or break kidney stones (Talbot ¶[0057]).
Regarding claim 6, Harrah as modified teaches the laser system of claim 1.
Harrah further teaches wherein the controller is configured to display the lower and upper limit values of each range on a display device (¶¶[0042-0043], Fig. 8, Harrah teaches display of energy delivery parameters, which in combination with Talbot and Mitchell includes upper and lower limit values).
Regarding claim 8, Harrah as modified teaches the laser system of claim 6.
Hoang further teaches wherein the laser operating parameter range is narrower than the system laser operating range (¶¶[0226-0230] for example, each of these is less than 100% duty cycle, and limitations are set for the system which operate within the operation boundaries of the system)
Regarding claim 10, Harrah as modified teaches the laser system of claim 1.
Talbot further teaches wherein the controller is configured to determine the at least one modified laser operating parameter value and corresponding modified laser operating parameter range such that
at least one of an initial laser operating parameter value, and a corresponding initial laser operating parameter range for one of the at least one initial laser operating parameter is held constant (¶[0061], energy E of the laser light is held constant, ¶[0066] average power is held constant).
Regarding claim 11, Harrah as modified teaches the laser system of claim 10.
Talbot further teaches wherein the one of the at least one initial laser operating parameters that is held constant is average power (¶[0066] average power of the laser light is held constant).
Regarding claim 12, Harrah as modified teaches the laser system of claim 11.
Hoang further teaches wherein at least one of a minimum efficacy value and a safety limit value for the average power are held constant (¶¶[0016-0019], examples of maximum power per pulse held constant).
Regarding claim 19, Harrah as modified teaches the laser system of claim 1.
Harrah further teaches wherein the one or more properties of the beam delivery system comprises at least one of:
irrigation flow rate (¶[0020] irrigation activation and flowrate).
Regarding claim 20, Harrah as modified teaches the laser system of claim 1.
Harrah further teaches wherein the one or more properties of the target comprises at least one of:
target size (¶[0049] size of stone).
Regarding claims 21-22, 25, and 28-30, the claims are directed to a method comprising substantially the same subject matter as claims 1-2, 6, 8, and 10-12, and are rejected under substantially the same sections of Harrah, Talbot, and Hoang.
Claim(s) 9 and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harrah, Talbot, and Hoang as applied to claims 1 and 21 above, and further in view of Bharadwaj et al. (U.S. Patent Application Publication No. 2020/0242830) hereinafter referred to as Bharadwaj.
Regarding claims 9 and 27 Harrah as modified teaches the laser system/method of claim 1/21.
Harrah as modified does not teach wherein the controller is further configured to
determine if the one or more adjusted laser operating parameter values received from the user input device exceed the upper limit value of either range, and
in response to the one or more adjusted laser parameter values exceeding the upper limit of either range, perform at least one of:
display a visual alarm on a display device, and
sound an auditory alarm on an auditory device.
Attention is brought to the Bharadwaj reference, which teaches a controller (¶[0060]) further configured to
determine if the one or more adjusted laser operating parameter values received from a user input device exceed an upper limit value of either range (¶[0083] exceed a boundary threshold), and
in response to the one or more adjusted laser parameter values exceeding the upper limit of either range (¶[0083] spot size exceeds limit), perform at least one of:
display a visual alarm on a display device (¶[0083]), and
sound an auditory alarm on an auditory device.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the laser system and method of Harrah as modified to include an alarm for settings exceeding a maximum, as taught by Bharadwaj, because it prevents clinicians from setting parameters outside of achievable ranges.
Claim(s)16-17 and 34-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Harrah, Talbot, and Hoang as applied to claims 11 and 29 above, and further in view of Marcus et al. (S. Marcus and G. M. Carter, "Electrooptically Q-switched CO2 waveguide laser," Appl. Opt. 18, 2824-2826 (1979)Top of Form
).
Regarding claim 16, Harrah as modified teaches the laser system of claim 1.
Harrah further teaches displaying average power on a display device (¶¶[0042-0043], Fig. 8, Harrah teaches display of energy delivery parameters).
Harrah as modified does not teach wherein the controller is further configured to
determine an effective average laser power (EAP) as a laser operating parameter according to the following expression:
EAP=(AP*LOT)/LTT,
where
AP= average power,
LOT= laser on time duration during LTT, and
LTT= laser treatment time.
Attention is drawn to the Marcus reference, which teaches determining an effective average laser power (EAP) as a laser operating parameter according to the following expression:
EAP=(AP*LOT)/LTT p. 2824, col. 2, ¶ 4 dividing observed average power by duty factor is an equivalent calculation as a duty factor is the LOT/LTT derived from the duty cycle of PWM laser control),
where
AP= average power,
LOT= laser on time duration during LTT, and
LTT= laser treatment time.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the laser system of Harrah as modified to include determining effective average laser power, as taught by Marcus, because Marcus teaches that it accurately describes pulsed laser behavior (Marcus, Abstract).
Regarding claim 17, Harrah as modified teaches the laser system of claim 1.
Harrah further teaches displaying average power on a display device (¶¶[0042-0043], Fig. 8, Harrah teaches display of energy delivery parameters including pulses per second and total time).
Marcus further teaches wherein the controller is further configured to
determine an effective duty cycle (EDC) as a laser operating parameter according to the following expression:
EDC=LOT/LTT (p. 2824, col. 2, ¶ 2, 20% duty cycle obtained by this expression based on the values of 5msec LOT and 20msec off, therefore 25msec LTT),
where
LOT= laser on time duration during LTT, and
LTT= laser treatment time.
Regarding claims 34-35, the claims are directed to a method comprising substantially the same subject matter as claims 16-17, and are rejected under substantially the same sections of Harrah, Talbot, Hoang, and Marcus.
Conclusion
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 AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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/AMANDA L STEINBERG/ Examiner, Art Unit 3792
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