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 .
Claim Status: Claims 1-28 are pending; Claims 14-28 have been withdrawn from consideration as directed to non-elected invention.
Response to Arguments
Applicant's arguments filed August 13, 2025 have been fully considered but they are not persuasive.
Re Claim 1, Applicant made an argument that the Office Action failed to identify any motivation within the cited references to replace the first laser of Brinkmann with the laser of Bragagna. Applicant further stated that incorporating the first laser of Bragagna into the system of Brinkmann is not a simple substitution of similar components based on applicant’s disclosure about different design requirement when using thulium laser vs holmium laser.
This argument has been considered but is not persuasive.
The primary reference, Brinkmann, discloses Holmium laser for lithotripsy procedure (para. [015]) with first wavelength (para. [152], Ho:YAG ablation laser source 501 (Auriga XL by SiarMedTec operating at a wavelength of 2100nm).
Brinkmann is silent regarding the laser producing continuous wave of light with the first wavelength.
Bragagna was relied on to teach the first activation mode of the laser producing a continuous wave of laser light with the first wavelength for the purpose of lithotripsy (para. [0205]-[0210], a laser device used to treat pathogenic clumps in the body (gallstones, arterial calcifications, kidney stones, bladders stones etc) with a Holmium-doped crystalline laser rod (para. [0175], [0178], [0179], a wavelength in particular between 1675 nm and 2100 nm, whereby the gain medium 2 comprises a Holmium-doped and/or a Thulium doped crystalline laser rod for generating laser light in a range between 1.67 and 2.1 μm. GaSb laser diodes emitting at between 1600 to 2050 nm, and can be delivered in either a CW (continuous wave) or a QCW (quasi-continuous wave) mode of operation).
Therefore, Bragagna teaches using continuous wave of light with the first wavelength using same or equivalent laser technology for the purpose of lithotripsy, which provides a motivation as to why continuous wave of light can be used for lithotripsy as another mode of operation.
Election/Restrictions
Applicant’s election without traverse of Inventive Group I directed to claims 1-13 in the reply filed on January 21, 2025 is acknowledged.
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.
Claims 1-5, 7, and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Brinkmann et al. (WO2016201092A1) in view of Bragagna et al. (US 2012/0165801) and Tedford (US 2016/0067086A1).
Re Claim 1, Brinkmann discloses a laser lithotripsy system comprising:
a first laser that, upon activation, produces laser light with a first wavelength, wherein the first laser includes a second activation mode, when the first laser is in the second activation mode the first laser produces uniformly spaced, intermittent pulses of laser light with the first wavelength (fig. 5, fig. 6, para. [152], Ho:YAG ablation laser source 501 (Auriga XL by SiarMedTec operating at a wavelength of 2100nm at a repetition rate of < 30Hz and a power of 50 W, pulse duration was between 100 µs and 800 µs); para. [032] and [033] discloses other wavelengths for “a first wavelength”);
a second laser that, upon activation, produces laser light with a second wavelength, which is shorter than the first wavelength (fig. 5, 6, para. [153], a 532nm-diode laser module 401);
a first optically powered element positioned to receive both the laser light from the first laser and the laser light from the second laser, wherein the optically powered surface transmits at least 90% of the laser light received from the first laser and reflects a part of the laser light received from the second laser such that the transmitted laser light from the first laser and the reflected laser light from the second laser are superimposed (fig. 5, 6, para. [153], dichroic mirror 606, the first one 606 transmitting at a wavelength of 532 nm (T>95% 532 nm and 2100 nm, R>90% between 560 nm and 850 nm);
a waveguide positioned to receive the coincidental laser light from the first and second lasers and guide the superimposed laser light to a target (fig. 5, 6, para. [153], probe fiber 402);
an optical detector positioned to receive light emitted by the target and measure one or more characteristics of the received light emitted by the target (fig. 5, para. [152], spectrometer 404, fig. 6, para. [153], photodiode 604);
a controller communicatively coupled to both the optical detector and the first laser such that the controller allows activation of the first laser to produce the laser light with the first wavelength only when the one or more measured characteristics are within a predetermined range of values (para. [77], [99], ablation laser configured to deliver ablation energy to a treatment site, a probe laser configured to deliver excitation radiation to the treatment site, a phase-sensitive receiver device configured to receive photoluminescence radiation emitted from the treatment site in response to being illuminated by the excitation radiation and a controller configured to detect a human stone in the treatment site based on the received photoluminescence radiation, para. [114] The optional controller 104 can be configured to process the output detection signal to determine one or more parameters based on the received photoluminescence radiation. Moreover, the medical device 101 can be configured to generate an output signal indicative of a type of bodily substance of the treatment site based on the one or more parameters, may be configured to generate a signal that prevents emission of the ablation energy 110 based on the received photoluminescence radiation, or may be configured to generate a signal that causes ablation energy 110 to be emitted from ablation device 101, based on the received photoluminescence radiation, para. [135], Such parameters may allow the user to adjust the photoluminescence signal detection sensitivity or associated processing (e.g., adjust thresholds) used to determine a type of bodily substance onto which the excitation signal is applied, para. [180] In one example, the method includes determining that an intensity of the received photoluminescence radiation exceeds a predetermined threshold. If an intensity of the received radiation exceeds the predetermined threshold, it can be determined that the treatment site includes a human stone (e.g., a kidney stone or a bile stone). If the intensity of the received radiation does not exceed the predetermined threshold, it can be determined that the treatment site does not include a human stone, para. [014]).
Brinkmann is silent regarding the first laser including a first activation mode when the first laser is in the first activation mode the first laser produces a continuous wave of laser light with the first wavelength and the controller allowing activation of the first laser to produce the continuous wave of laser light with the first wavelength.
Bragagna discloses a laser lithotripsy system and teaches a laser device that has various operating modes including continuous wave, quasi continuous wave (pulsed), and gain switched with a wavelength in mid-infrared range of between 1700 nm to 3200 nm (para. [0205]-[0210], a laser device used to treat pathogenic clumps in the body (gallstones, arterial calcifications, kidney stones, bladders stones etc; para. [0238], para. [0010], a laser device suitable to be used in the medical field, in particular with a wavelength in the mid-infrared (MIR) range of between 1700 nm to 3200 nm, and/or in particular suitable for treating, cutting or ablating biological tissue; para. [0179], a wavelength in particular between 1675 nm and 2100 nm, whereby the gain medium 2 comprises a Holmium-doped and/or a Thulium doped crystalline laser rod for generating laser light in a range between 1.67 and 2.1 μm. GaSb laser diodes emitting at between 1600 to 2050 nm, and can be delivered in either a CW (continuous wave) or a QCW (quasi-continuous wave) mode of operation).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Brinkmann, by adding to the first laser a first activation mode when the first laser is in the first activation mode the first laser produces a continuous wave of laser light with the first wavelength and configuring the controller to allow activation of the first laser to produce the continuous wave of laser light with the first wavelength only when the one or more measured characteristics are within a predetermined range of values, as taught by Bragagna, for the purpose of ablating pathogenic clumps in the body (para. [0205]-[0210], [0179]).
Brinkmann and Bragagna are silent regarding the optically powered surface reflecting at least 90% of the laser light received from the second laser.
However, Tedford discloses light therapy system and teaches an optically powered element with optically powered surface transmitting at least 90% of the laser light received from the first laser and reflecting at least 90% of the laser light received from the second laser such that the transmitted laser light from the first laser and the reflected laser light from the second laser are superimposed (para. [0069], light directing components 424 a, 424 b are reflective filters. Light directing component 424 a is selected to pass light in light beam 430 a having a first wavelength generated by first light source 422 a and to reflect light in light beam 430 b having a second wavelength generated by second light source 422 b. Light directing component 424 b is selected to pass light in light beam 430 a having a first wavelength and light in light beam 430 b having a second wavelength generated by second light source 422 b. Light directing component 424 b reflects light in light beam 430 c having a third wavelength generated by second light source 422 c. The light directing component 424 b directs the desired wavelengths of light to lens 426.) and a logic circuit to increase or decrease the power output of the device to adjust desired dosage (para. [0100], [0101], [0102]).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Brinkmann as modified by Bragagna, by adding an optically powered element with optically powered surface transmitting at least 90% of the laser light received from the first laser and reflecting at least 90% of the laser light received from the second laser such that the transmitted laser light from the first laser and the reflected laser light from the second laser are superimposed and adding a logic circuit to adjust the light output of the second laser and the first laser, as taught by Tedford, because such a modification is the result of simple substitution of one known element for another producing a predictable result. More specifically, Brinkmann’s dichroitic mirror 606 and Tedford’s light directing component 424a and logic circuit to adjust laser power perform the same general and predictable function, the predictable function being combining beams with desired power levels from each beam. Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself - that is in the substitution of Brinkmann’s dichroitic mirror 606 by replacing it with Tedford’s light directing component 424a and logic circuit to adjust laser power. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
Re Claim 2, Brinkmann discloses that the controller is communicatively coupled to both the optical detector and the first laser such that the controller prevents activation of the first laser when the one or more measured characteristics are outside of the predetermined range of values (para. [77], [99], ablation laser configured to deliver ablation energy to a treatment site, a probe laser configured to deliver excitation radiation to the treatment site, a phase-sensitive receiver device configured to receive photoluminescence radiation emitted from the treatment site in response to being illuminated by the excitation radiation and a controller configured to detect a human stone in the treatment site based on the received photoluminescence radiation, para. [114] The optional controller 104 can be configured to process the output detection signal to determine one or more parameters based on the received photoluminescence radiation. Moreover, the medical device 101 can be configured to generate an output signal indicative of a type of bodily substance of the treatment site based on the one or more parameters, may be configured to generate a signal that prevents emission of the ablation energy 110 based on the received photoluminescence radiation, or may be configured to generate a signal that causes ablation energy 110 to be emitted from ablation device 101, based on the received photoluminescence radiation, para. [135], Such parameters may allow the user to adjust the photoluminescence signal detection sensitivity or associated processing (e.g., adjust thresholds) used to determine a type of bodily substance onto which the excitation signal is applied, para. [180] In one example, the method includes determining that an intensity of the received photoluminescence radiation exceeds a predetermined threshold. If an intensity of the received radiation exceeds the predetermined threshold, it can be determined that the treatment site includes a human stone (e.g., a kidney stone or a bile stone). If the intensity of the received radiation does not exceed the predetermined threshold, it can be determined that the treatment site does not include a human stone, para. [014]).
Re Claim 3, Brinkmann discloses that the first laser produces light with a wavelength of less than 2100 nm (para. [033], the laser delivers ablation energy at a pulse length between 100 and 10 ms μβ, a wavelength between 1600 nm and 2500 nm and a pulse energy between 50 mJ and 6 J).
Re Claim 4, Brinkmann discloses that the first laser produces light with a wavelength of less than 2050 nm (para. [033], the laser delivers ablation energy at a pulse length between 100 and 10 ms μβ, a wavelength between 1600 nm and 2500 nm and a pulse energy between 50 mJ and 6 J).
Re Claim 5, Brinkmann discloses that the first laser produces light with a wavelength of less than 2000 nm (para. [033], the laser delivers ablation energy at a pulse length between 100 and 10 ms μβ, a wavelength between 1600 nm and 2500 nm and a pulse energy between 50 mJ and 6 J).
Re Claim 7, Brinkmann discloses a housing enclosing the first laser, the second laser, the optical detector, and the controller (para. [134], a single unit 301 (e.g., in a single housing); fig. 6, para. [152], Ho:YAG ablation laser source 501, para. [153], 532nm-diode laser module 401, a photodiode 604, a pulse generator 603; para. [042], [099], a controller for processing the detection signal and/or controlling one or more of the probe device and the radiation-receiving device).
Re Claims 9 and 10, Brinkmann as modified by Bragagna and Tedford discloses the claimed invention substantially as set forth in claim 1.
Brinkmann further discloses a second optically powered surface positioned to receive the light emitted by the target, wherein the second optically powered surface reflects at least 90% of the light emitted by the target and received by the second optically powered surface (fig. 5, 6, para. [153], dichroic mirror 606, the first one 606 transmitting at a wavelength of 532 nm (T>95% 532 nm and 2100 nm, R>90% between 560 nm and 850 nm), wherein the light emitted by the target has a third wavelength, which is shorter than the first wavelength and longer than the second wavelength (para. [181], [182], In the example of FIG. 11a, it can be seen that the photoluminescence response of kidney stones can be particularly high in particular wavelength ranges. fig. 11a and 11b; para. [185], The characteristics of the received radiation can be determined as one or more parameters of the received radiation. The detection of a human stone in the sampled treatment site can include evaluating the one or more parameters. For instance, a parameter can be an intensity of a received radiation in a predetermined wavelength range (e.g., an intensity at 590 nm); para. [153], second wavelength is 532 nm, para. [033], first wavelength is between 1600 nm and 2500 nm).
Therefore, it would have been obvious to one of ordinary skill in the art, to modify Brinkmann as modified by Bragagna and Tedford, by adding a second optically powered surface positioned to receive the light emitted by the target, wherein the second optically powered surface reflects at least 90% of the light emitted by the target and received by the second optically powered surface, wherein the light emitted by the target has a third wavelength, which is shorter than the first wavelength and longer than the second wavelength, as taught by Brinkmann, for the purpose of reflecting light emitted by the target to the optical detector (para. [153]).
Re Claim 11, Brinkmann discloses that the light emitted by the target has a wavelength between 550 nm and 900 nm (para. [181], [182], In the example of FIG. 11a, it can be seen that the photoluminescence response of kidney stones can be particularly high in particular wavelength ranges. fig. 11a and 11b; para. [185], The characteristics of the received radiation can be determined as one or more parameters of the received radiation. The detection of a human stone in the sampled treatment site can include evaluating the one or more parameters. For instance, a parameter can be an intensity of a received radiation in a predetermined wavelength range (e.g., an intensity at 590 nm)).
Re Claim 12, Brinkmann discloses that the second laser is a green excitation laser (para. [153], 532nm-diode laser module 401; para. [167], a green continuous wave laser at mean power below 1 mW).
Re Claim 13, Brinkmann discloses that the second wavelength is between 520 nm and 532 nm (para. [153], 532nm-diode laser module 401).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Brinkmann et al. (WO 2016/201092A1), as modified by Bragagna et al. (US 2012/0165801) and Tedford (US 2016/0067086A1), and further in view of Vogler (US 2008/0259970 A1).
Re Claim 6, Brinkmann as modified by Bragagna and Tedford discloses the claimed invention substantially as set forth in claim 1.
Brinkmann is silent regarding the first laser is a thulium-based laser.
However, Vogler discloses a lithotripsy laser system and teaches a thulium-based laser configured to generate wavelength in a range around 2 µm. (para. [0018] Examples for doped active fiber 2 include Thallium doped fibers (Tm-doped fibers) and fibers having different dopings enabling generation of laser radiation having a wavelength in a range around 2.0 µm (or 1.5 µm to 3.0 µm). The wavelength can be, e.g., in the range of 1.92 µm to 1.96 µm, such as 1.94 µm; para. [0019] As can be derived from FIG. 1, such a radiation wavelength improves precisely localized treatments and the confinement of radiation energy within an area of interest because the water absorption coefficient at a wavelength of 2.0 µm is even higher than the water absorption coefficient effective in prior approaches; para. [0031], Fiber laser 1 can be operated to generate pulsed laser radiation and/or continuous laser radiation (continues wave emission, cw emission). Pulsed emission of fiber laser 1 can be software controlled to generate, for example, laser pulses having a duration in the range of 0.5 ms to 20 ms, e.g. of about 1 ms. Operating fiber laser 1 in a pulsed mode is suitable for applications such as lithotripsy of kidney stones or stones in the gall bladder, endoscopic microsurgery or treatments concerning BPH).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Brinkmann as modified by Bragagna and Tedford, by configuring the first laser to be a thulium-based laser, because such a modification is the result of simple substitution of one known element for another producing a predictable result.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Brinkmann et al. (WO 2016/201092A1), as modified by Bragagna et al. (US 2012/0165801) and Tedford (US 2016/0067086A1), and further in view of Moll (US 2008/0058836 A1).
Re Claim 8, Brinkmann as modified by Bragagna and Tedford discloses the claimed invention substantially as set forth in claims 1 and 7.
Brinkmann is silent regarding the housing is mounted on one or more wheels.
However, Moll discloses robotic surgical system with an electronics rack 114 being supported by a cart or configured with wheels (para. [0140], [0218], the electronics rack (114) may be support by a cart or configured with wheels for easy movability within the operating room or catheter lab, one advantage of which is location of the operator control station (102) which may be moved away from the operation table (104) and radiation sources, thereby substantially decrease or eliminate the potential for exposure to radiation or reduce the radiation dosage to the operator).
Therefore, it would have been obvious to one of ordinary skill in the art, at the time of filing, to modify Brinkmann as modified by Bragagna and Tedford, by configuring the housing to be mounted on one or more wheels, as taught by Moll, for the purpose of easy movability within the operating room or catheter lab (para. [0218]).
Conclusion
THIS ACTION IS MADE FINAL. 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 VYNN V HUH whose telephone number is (571)272-4684. The examiner can normally be reached Monday to Friday from 9 am to 5 pm.
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/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
/V.V.H./
Vynn Huh, December 20, 2025
Examiner, Art Unit 3792