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 .
Election/Restrictions
Applicant’s election without traverse of Group II species d (claims 11-12, 15-17, and 18-23) in the reply filed on 06/29/2026 is acknowledged. However, due to the Talbot reference that teaches claims 13-14 and is therefore not a search burden. Therefore, claims 11-23 are pending and under examination.
Claims 1-2, 4-10, and 26-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/29/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/12/2024 and 08/02/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 12-23 are objected to because of the following informalities: the phrase “A fiber-optic medical treatment apparatus according to claim X” should be amended to recite “The fiber-optic medical treatment apparatus according to claim X”. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: the phrase “to one or more of: a user command, an operational parameter of at least the first treatment laser radiation an operational parameter of at least the first treatment laser radiation, or a sensor signal obtained by a sensor module”. Appropriate correction is required.
Claim 20 is objected to because of the following informalities: the phrase “doubled-clad” should be amended to recite “double-clad”, similar to that of claim 20 line 2. Appropriate correction is required.
Claim 11-13, 15, 18, 20, and 22 are objected to because of the following informalities: the phrase “the apparatus” should be amended to recite “the fiber-optic medical treatment apparatus”. Appropriate correction is required.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15-16 and 19-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 15 recites the limitation "said pilot light" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 15 line 2 recites the phrase “visible pilot light”.
Regarding claim 15, it is unclear if the “visible pilot light” of line 5 is the same or different than the “visible pilot light” of line 2.
Regarding claim 16, it is unclear if the “visible pilot light” of line 2 is the same or different than the “visible pilot light” of line 2 of claim 15. Examiner suggests clarifying to recite that the visible pilot light is multicolored, and that the extra phrase after the comma be removed.
Claim 19 recites the limitation "the medical treatment device" in line 2 and 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the optical fiber" in line 2. There is insufficient antecedent basis for this limitation in the claim. Claim 11 recites “at least one optical fiber”.
Claim 21 recites the limitation "said at least one cladding" in line 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 22 recites the limitation "the tissue" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 23, it is unclear if the “target spot” of line 2 is the same or different than the “target spot” of claim 22 line 3.
Claim 23 recites the limitation "the tissue" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 23, it is unclear what is “configured to illuminate a target spot”.
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.
Claim(s) 11-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Talbot et al. (US 20210038062)(IDS)(Hereinafter Talbot) in view of Millett (US 20140180119 A1)(Hereinafter Millett).
Regarding claim 11, Talbot teaches A fiber-optic medical treatment apparatus for treatment of a urinary tract of a subject (Abstract “A multifiber assembly and methods of using the same in an endoscopic procedure for transmitting illumination light to, and a response signal reflected from, a target is disclosed.” [0062] “exemplary laser treatment system including a laser feedback control system 100 according to illustrative examples of the present disclosure. Example applications of the laser feedback control system 100 include integration into laser systems for many applications, such as industrial and/or medical applications for treatment of soft (e.g., non-calcified) or hard (e.g., calcified) tissue, or calculi structures such as kidney or pancreobiliary or gallbladder stones.”), the apparatus comprising: a first treatment laser source and a fiber-optic device including at least one optical fiber ([0064] “The first laser system 102 may also include a first optical fiber 108 operatively coupled with the first laser source 106.”); wherein the fiber-optic device has a proximal end and a distal end ([0054] “An exemplary device comprises a proximal end, and distal end, and a transition section between the proximal and distal ends. The proximal end includes a first connector to be connected to a light source and a second connector configured to be connected to a spectrometer. The distal end include a shaft including at least two first optical fibers to transmit light and at least one second optical fiber to transmit a spectroscopic signal.”), wherein the first treatment laser source is configured to output first treatment laser radiation for treatment of a medical condition of the urinary tract and to optically couple the first treatment laser radiation into the fiber-optic device ([0065] “the first laser source 106 may be configured to provide a first output 110. The first output 110 may extend over a first wavelength range…In such examples, the first output 110 may advantageously provide effective ablation and/or carbonation of the target tissue 122 since the first output 110 is over a wavelength range that corresponds to the absorption spectrum of the tissue.” [0166] “Another application of the Laser System is with regard to efficient laser lithotripsy process to fragment a kidney or bladder stone in a patient. The application relates to a process using multi wavelength lasers energy having a wavelength with less absorption by the target to heat a target first and then a stronger absorption wavelength to fragment the target, such as a kidney stone for example.”), wherein the apparatus is configured, responsive to a user command to emit the first treatment laser radiation, to emit a burst of the first treatment laser radiation from the distal end towards tissue of the urinary tract to be treated ([0143] “FIG. 18 is a schematic diagram of a semi-automated Laser System where the System requires user approval, such as via a user interface including an input 1850 and a display 1860. In an example, the laser settings may be adjusted within a set range, which in an example maybe predetermined by the user at the start of the procedure.” [0130] “sequenced pulses includes bursts of pulses which combine to deliver the selected pulse energy.” [0166] “Another application of the Laser System is with regard to efficient laser lithotripsy process to fragment a kidney or bladder stone in a patient. The application relates to a process using multi wavelength lasers energy having a wavelength with less absorption by the target to heat a target first and then a stronger absorption wavelength to fragment the target, such as a kidney stone for example.”).
However, Talbot does not teach the distal end of the fiber-optic device being configured to be advanced through a working channel of a cystoscope into the urinary tract of the subject. Millett, in the same field of endeavor, teaches an ablation and imaging system to provide treatment (Abstract), and further teaches the distal end being configured to be advanced through a working channel of a cystoscope into the urinary tract of the subject ([0038] “the imaging catheter 504 includes a tool lumen [working channel] 506 and is configured to receive a tool catheter or tool element 516. Through the tool lumen 506, a tool catheter or tool element 516 (e.g. delivery catheter, atherectomy device, ablation device) can be introduced into a vessel to perform an intraluminal procedure.” [0113] “an ablation tool is used to remove an unwanted or damaged vein by delivering energy (RF energy, laser energy [which requires a fiber optic], etc)”) to ablate the target tissue of choice ([0012]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Talbot, with the distal end being configured to be advanced through a working channel of a cystoscope into the urinary tract of the subject of Millett, because such a modification would allow to ablate the target tissue of choice.
However, Talbot does not teach the wherein the burst has a burst duration of between 1 ms and 1 s. Allowing for burst duration between 1 ms and 1 s that is selectable (user-controlled time period of Tolbert [0180]) to that time range would allow for the treatment of the target kidney ([0181]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to a have a burst duration of between 1 ms and 1 s, for the purpose of treatment of the target kidney ([0181]), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 12, Talbot teaches wherein the apparatus is configured to emit the burst of the first treatment laser radiation at an output power between 10 W and 200 W ([0130] “a 2 W average power setting with a pulse energy of 1 J occurs at a frequency of 2 Hz if there is only one pulse.”).
However, Talbot does not teach the output power between 10 W and 200 W. Allowing for the output power between 10 W and 200 W that is selectable (user input of laser settings of Tolbert [0142]) to that time range would allow for the treatment of the target kidney ([0181]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to a have the output power between 10 W and 200 W, for the purpose of treatment of the target kidney ([0181]), since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 13, Talbot teaches wherein the apparatus further comprises a second treatment laser source configured to output second treatment laser radiation for treatment of said medical condition of the urinary tract and to optically couple the second treatment laser radiation into the fiber-optic device, wherein the second laser radiation has wavelength different from a wavelength of the first treatment laser radiation ([0068] “the laser treatment system of the present disclosure may optionally include a second laser system 104. The second laser system 104, as mentioned previously, includes a second laser source 116 for providing a second output 120, and associated components, such as power supply, display, cooling systems and the like… In some examples, the second laser system 104 may include a second optical fiber 118 (separate from the first optical fiber 108) operatively coupled to the second laser source 116 for transmitting the second output 120.” [0069] “the second output 120 may extend over a second wavelength range, distinct from the first wavelength range… Further, in another example, the second output 120 may ablate carbonized tissue that has been previously ablated.”).
Regarding claim 14, Talbot teaches wherein the second treatment laser radiation has a wavelength between 1000 nm and 2000 nm ([0071] “or In.sub.xGa.sub.1-xAs with the second output 120 in the second wavelength range of between about 904 nanometer and about 1065 nanometer.”).
Regarding claim 15, Talbot teaches wherein the apparatus further comprises a pilot light source configured to output visible pilot light and to optically couple the pilot light into the fiber-optic device, wherein the apparatus is configured to emit a pilot beam of said pilot light from the distal end towards tissue of the urinary tract to be treated so as to illuminate a target spot on the tissue to be treated by visible pilot light ([0111] “The endoscope 1110 can include, or otherwise be coupled to via an endoscope port 1114, at least one endoscopic illumination source 1130 [pilot light source]. The at least one endoscopic illumination source 1130 may be controllably provide different amounts of illumination. The optical fiber 1120A, when inserted through the working channel 1112, can be coupled to a non-endoscopic illumination source 1140 [pilot light source] such as via the endoscope port 1114. The non-endoscopic illumination source 1140 can emit a diagnostic beam 1142 through the optical fiber 1120A and proximate a distal end 1116 of the endoscope 1110. The optical fiber 1120A can direct the diagnostic beam 1142 at a target 1001. In an example, the non-endoscopic illumination source 1140 can be a laser source configured to emanating the diagnostic beam including a laser beam. In various examples, white light lamps, led light source, or fluoroscopy light sources” [0113] “low-illumination mode, reflection from the target of the diagnostic beam incident on the target can be enhanced, which can help improve target identification.”).
Regarding claim 16, Talbot teaches wherein visible pilot light is multicolored, visible pilot light (0117] “In an example, the electromagnetic radiation can include one or more ultraviolet wavelengths between 10 nm to 400 nm. In another example, as illustrated in FIG. 12, the reflectance spectra used to identify of different types of targets can be recoded from the spectrometer in a wavelength range 200-1100 nm. Illustrated therein are reflectance spectra of kidney stone compositions, including ammonium magnesium (AM MAG) phosphate hydrate, calcium (CA) oxalate monohydrate, calcium (CA) oxalate hydrate, calcium (CA) phosphate, and uric acid. … FIG. 13A illustrates a portion of the reflectance spectra shown in FIG. 12 in the 200-400 nm wavelength range, including ammonium magnesium phosphate hydrate spectra 1310, calcium oxalate monohydrate spectra 1320, calcium oxalate hydrate spectra 1330, calcium phosphate spectra 1340, and uric acid spectra 1350. This UV wavelength range is one area where the differences may be identified in the spectra of the stone images. FIG. 13B illustrates reflectance spectra of various kidney stone compositions in the 400-700 nm wavelength range, including cystine spectra 1360, uric acid spectra 1370, and calcium oxalate monohydrate spectra 1380.”).
Regarding claim 17, Talbot teaches wherein the multicolored, visible pilot light includes at least two detectable color components that are at least 40 nm apart ([0117] “In an example, the electromagnetic radiation can include one or more ultraviolet wavelengths between 10 nm to 400 nm. In another example, as illustrated in FIG. 12, the reflectance spectra used to identify of different types of targets can be recoded from the spectrometer in a wavelength range 200-1100 nm. Illustrated therein are reflectance spectra of kidney stone compositions, including ammonium magnesium (AM MAG) phosphate hydrate, calcium (CA) oxalate monohydrate, calcium (CA) oxalate hydrate, calcium (CA) phosphate, and uric acid. … FIG. 13A illustrates a portion of the reflectance spectra shown in FIG. 12 in the 200-400 nm wavelength range, including ammonium magnesium phosphate hydrate spectra 1310, calcium oxalate monohydrate spectra 1320, calcium oxalate hydrate spectra 1330, calcium phosphate spectra 1340, and uric acid spectra 1350. This UV wavelength range is one area where the differences may be identified in the spectra of the stone images. FIG. 13B illustrates reflectance spectra of various kidney stone compositions in the 400-700 nm wavelength range, including cystine spectra 1360, uric acid spectra 1370, and calcium oxalate monohydrate spectra 1380.”).
Regarding claim 18, Talbot teaches wherein the apparatus is configured to control a visible attribute of the visible pilot light responsive to one or more of: a user command, an operational parameter of at least the first treatment laser radiation and a sensor signal obtained by a sensor module ([0105] “the endoscopic camera 916, such as a CCD or CMOS camera [sensor module], may collect the signal reflected from target structure 122, produce an imaging signal 1050 of the target structure, and deliver the imaging signal to the feedback-controlled laser treatment system 1010.” [0112] “The controller 1150 may controllably operate the at least one endoscopic illumination source 1130 in different operating modes [control visible attribute], including for example, a first mode having a first amount of illumination and the second mode having a second amount of illumination lower than the first amount. In an example, the endoscope includes an imaging system 1160 that can take an image [sensor signal from sensor module] of the target 1001, and the controller 1150 can generate a control signal to the endoscope to change the illumination mode (e.g., from the first mode to the second mode) in response to a change in brightness or intensity of an image of the target.”).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Talbot et al. (US 20210038062)(IDS)(Hereinafter Talbot) in view of Millett (US 20140180119 A1)(Hereinafter Millett) and Rajagopalan et al. (US 20130345670)(IDS)(Hereinafter Rajagopalan).
Regarding claim 19, Talbot in view of Millett teach the device of claim 11. However, Talbot in view of Millett do not teach medical treatment device and the fiber-optic device, wherein the medical treatment device comprises at least the first treatment laser source, and wherein the fiber-optic device is a disposable fiber-optic device configured to be detachably and optically coupled to the medical treatment device. Rajagopalan, in the same field of endeavor, teaches the treatment of tissue and the imaging of the tissue (Abstract), and further teaches comprising a medical treatment device and the fiber-optic device, wherein the medical treatment device comprises at least the first treatment laser source, and wherein the fiber-optic device is a disposable fiber-optic device configured to be detachably and optically coupled to the medical treatment device ([0222] “Each of the components of system 300 may be removably attached to another component, particularly controller 360, energy delivery unit 330, motion transfer element 335, ground pad 332 and endoscope [medical treatment device] 350 and elongate device 301.”) for ease of replacement of components ([0263]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Talbot in view of Millett, with the medical treatment device and the fiber-optic device, wherein the medical treatment device comprises at least the first treatment laser source, and wherein the fiber-optic device is a disposable fiber-optic device configured to be detachably and optically coupled to the medical treatment device of Rajagopalan, because such a modification would allow for ease of replacement of components.
Claim(s) 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Talbot et al. (US 20210038062)(IDS)(Hereinafter Talbot) in view of Millett (US 20140180119 A1)(Hereinafter Millett), Rajagopalan et al. (US 20130345670)(IDS)(Hereinafter Rajagopalan), and Seifert et al. (US 20220110525)(Hereinafter Seifert).
Regarding claim 20, Talbot in view of Millett teach the device of claim 11. However, Talbot in view of Millett and Rajagopalan do not teach optical fiber is an at least double-clad optical fiber and wherein the apparatus is configured to output the first treatment laser radiation via a cladding of the at least doubled-clad optical fiber. Seifert, in the same field of endeavor, teaches a first and second light source (Abstract) for treating a sample ([0021]), and further teaches wherein the optical fiber is an at least double-clad optical fiber and wherein the apparatus is configured to output the first treatment laser radiation via a cladding of the at least doubled-clad optical fiber ([0047] “A probe may comprise any one or combination of one or more single mode fibers and one or more multi-mode fibers. For example, a probe may comprise one or more multi-clad fibers, such as a double clad fiber.” [0079] “A probe may include one or more waveguides for transmitting light from one or more light sources to a sample. One or more waveguides may be one or more optical fibers, such as one or more single mode fibers and/or one or more multi-mode fibers. In some embodiments, a probe comprises a multi-clad fiber (e.g., a double clad fiber) wherein light from one light source is provided through a core of the fiber and light from a second light source is provided through a cladding of the fiber.”) to rapidly scan a patient ([0003]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Talbot in view of Millett and Rajagopalan, with the optical fiber is an at least double-clad optical fiber and wherein the apparatus is configured to output the first treatment laser radiation via a cladding of the at least doubled-clad optical fiber of Siefert, because such a modification would allow to rapidly scan a patient.
Regarding claim 21, Talbot in view of Millett teach the device of claim 11. However, Talbot in view of Millett and Rajagopalan do not teach optical side combiner configured to couple the first treatment radiation into said at least one cladding of the at least double-clad optical fiber. Seifert, in the same field of endeavor, teaches a first and second light source (Abstract) for treating a sample ([0021]), and further teaches comprising an optical side combiner configured to couple the first treatment radiation into said at least one cladding of the at least double-clad optical fiber (Fig. 1C and [0084] “The first waveguide 110a and the second waveguide 110b are connected to a rotary junction 112. The first waveguide 110a and the second waveguide 110b may be coupled (e.g., spliced) into a common waveguide (e.g., a multi-clad fiber) before rotary junction 112 (not shown).”) to rapidly scan a patient ([0003]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Talbot in view of Millett and Rajagopalan, with the optical side combiner configured to couple the first treatment radiation into said at least one cladding of the at least double-clad optical fiber of Siefert, because such a modification would allow to rapidly scan a patient.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Talbot et al. (US 20210038062)(IDS)(Hereinafter Talbot) in view of Millett (US 20140180119 A1)(Hereinafter Millett), and Davenport et al. (US 6554824)(Hereinafter Davenport).
Regarding claim 22, Talbot in view of Millett teach the device of claim 11. However, Talbot in view of Millett do not teach apparatus is configured to emit the first treatment laser radiation from the distal end as a divergent first treatment beam configured to illuminate a target spot on the tissue to be treated. Davenport, in the same field of endeavor, teaches the ablation of tissue using laser pulses (Abstract), and further teaches wherein the apparatus is configured to emit the first treatment laser radiation from the distal end as a divergent first treatment beam configured to illuminate a target spot on the tissue to be treated (Col. 8 lines 59-62 “as a result of the low M.sub.2 some embodiments of this invention are capable producing laser light that upon exiting a flat end of a fiber having a diameter of 600 .mu.m has a divergence of 15.3.degree.”) to increase the efficiency in ablation rate (Col. 7 lines 5-10). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Talbot in view of Millett, with the apparatus is configured to emit the first treatment laser radiation from the distal end as a divergent first treatment beam configured to illuminate a target spot on the tissue to be treated of Davenport, because such a modification would allow to increase the efficiency in ablation rate.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Talbot et al. (US 20210038062)(IDS)(Hereinafter Talbot) in view of Millett (US 20140180119 A1)(Hereinafter Millett), Davenport et al. (US 6554824)(Hereinafter Davenport), and Zhang et al. (US 20160081749)(Hereinafter Zhang).
Regarding claim 23, Talbot in view of Millett teach the device of claim 11. However, Talbot in view of Millett do not teach configured to illuminate a target spot of spot diameter between 1 mm and 10 mm. Davenport, in the same field of endeavor, teaches the ablation of tissue using laser pulses (Abstract), and further teaches configured to…when the distal end is displaced from the tissue to be treated by between 1 mm and 10 mm (Col. 8 lines 59-62 “as a result of the low M.sub.2 some embodiments of this invention are capable producing laser light that upon exiting a flat end of a fiber having a diameter of 600 .mu.m has a divergence of 15.3.degree.”) to increase the efficiency in ablation rate (Col. 7 lines 5-10). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Talbot in view of Millett, with the apparatus is configured to emit the first treatment laser radiation from the distal end as a divergent first treatment beam configured to illuminate a target spot on the tissue to be treated of Davenport, because such a modification would allow to increase the efficiency in ablation rate.
However, Talbot in view of Millett do not teach the distal end is displaced from the tissue to be treated by between 1 mm and 10 mm. Zhang, in the same field of endeavor, teaches the ablation of tissue using laser pulses from a medical laser (Abstract), and further teaches when the distal end is displaced from the tissue to be treated by between 1 mm and 10 mm ([0025] “the spacing 122 between the surface 116 of the optical fiber 112 and the targeted object (e.g., calculus 124) provided by the fiber tip 114 can allow for efficient ablation of the targeted object while protecting the optical fiber 122. In some embodiments, the distance 122 is approximately 0.1-4 mm. In some embodiments, the distance 122 is 0.1 mm-1 mm.”) to allow for efficient ablation ([0025]). It would have been obvious to one skilled in the art, prior to the effective filing date of the invention, to modify the device of Talbot in view of Millett and Davenport, with the distal end is displaced from the tissue to be treated by between 1 mm and 10 mm of Zhang, because such a modification would allow to allow for efficient ablation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
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