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 Interpretation
Regarding the claim term “computer-readable memory storage device” that is recited in claims 11-12, there appears to be a special definition in applicant’s 8/23/24 specification at para. [0098] that states: “The term “computer-readable medium” should be understood to include tangible items and exclude carrier waves and transient signals, i.e., non-transitory.”. (MPEP 2173.05(a) New Terminology; 2173.05(a)(III) lexicographer).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2, 4-7, 10-11, and 13-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Altshuler US20240329202 in view of Altshuler US20240252242.
Regarding independent claims 1, 11, and 17, Altshuler ‘202 discloses, in at least Fig. 1-9, 12, 15A, 22, and 39,
A system and method for a laser console (Altshuler ‘202; at least Fig. 1-9, 12, 15A, 22, and 39; smart laser system 100), comprising:
a processor (Altshuler ‘202; [0107] processor of control system 150; feedback analyzer computing device 650); and
a memory device (Altshuler ‘202; [0359] non-transitory CRM memory with instructions) coupled to the processor, the memory device having instructions stored thereon, which instructions when executed by the processor, cause the system to:
receive a first electrical signal generated by a first light sensor (Altshuler ‘202; Fig. 39; photodiode 646a), the first electrical signal comprising an indication of a power of a light received at the first light sensor, wherein the light received at the first light sensor corresponds to laser light generated by a laser source (Altshuler ‘202; Fig. 39; light source 615) and emitted from a distal end of an optical fiber (Altshuler ‘202; Fig. 39; surgical fiber 645) towards one or more targets (Altshuler ‘202; Fig. 39; target 630);
receive a second electrical signal generated by a second light sensor (Altshuler ‘202; Fig. 39; photodiode 646b), the second electrical signal comprising an indication of a power of a light received at the second light sensor, wherein the light received at the second light sensor corresponds to a laser light reflected from at least one or more targets (Altshuler ‘202; Fig. 39; target 630);
determine, during a time period, a plurality of distances based on the second electrical signal and the first electrical signal, each of the distances corresponding to a distance between the distal end of the optical fiber and at least one of the one or more targets (Altshuler ‘202; Fig. 15A; step 614 “determine a distance to treatment target”; [0278] photodetectors 646a-646i; [0097 “laser system… can determine a distance between a treatment target or target material (e.g. a kidney stone), and act accordingly based on the determined distance”]; [0098] “determining a distance… between tissue and the distal end of the fiber can increase treatment efficiencies (and allow the laser system or the practitioner to act accordingly)”);
A computer-readable memory storage device (Altshuler ‘202; [0359] non-transitory CRM memory with instructions);
a medical laser console (Altshuler ‘202; at least Fig. 1-9, 12, 15A, 22, and 39; smart laser system 100; [0093] laser lithotripsy).
Altshuler ‘202 does not disclose determine a pop-dusting efficiency based on the plurality of distances.
Altshuler ‘242 teaches determine a pop-dusting efficiency based on the plurality of distances (Altshuler ‘242; [0089] “Ablation efficiency and the retropulsion effect are the results of the combination of many factors which include but are not limited to”; [0092] “3. The distance between the fiber end and the stone”; [0093] “The efficiency of ablation decreases with the increase of K because of the increasing distance between the fiber end and the bottom of the laser crater”; [0097 and 0107] compute stone ablation efficiency “Ka”; [0011] control surgical procedures based on ablation efficiency and “the distance between the distal end of the fiber and the stone” which “plays an important role”).
It would have been obvious to one having ordinary skill at the effective filing date of the invention to modify the system as taught by Altshuler ‘202 to include determining the pop-dusting efficiency based on the plurality of distances as taught by Altshuler ‘242 for the purpose of providing important information for performing surgical control procedures (Altshuler ‘242; [0011] control surgical procedures based on ablation efficiency and “the distance between the distal end of the fiber and the stone” which “plays an important role”) to optimize/minimize the duration of the laser lithotripsy procedure for patient care (Altshuler ‘202; [0202] “assist in controlling the laser for purposes of helping the doctor make more informed decisions, increase the efficiency of the stone treatment, shorten the procedure time, and to avoid injuries caused by improper positioning of the fiber tip during laser pulses where the camera's view is limited by stone dust.”).
Regarding claim 2, Modified Altshuler ‘202 teaches the invention substantially the same as described above, and The system of claim 1, wherein the optical fiber (Altshuler ‘202; Fig. 1; [0107] laser source 110 is optically coupled to surgical optical fiber 145; Fig. 39; surgical fiber 645; [0278] the surgical fiber 645 is optically coupled to the light source 615) is coupled to the laser console (Altshuler ‘202; Fig. 39; light source 615).
Regarding claim 4, Modified Altshuler ‘202 teaches the invention substantially the same as described above, and The system of claim 1, wherein the laser console comprises a lasing system comprising: the light sensor; a laser source (Altshuler ‘202; Fig. 39; light source 615) arranged to generate the laser light; and a beam splitter arranged (Altshuler ‘202; beam splitter M1 385a; Fig. 39 with beam divider 685) to direct a portion of the laser light from the laser source to the optical fiber (Altshuler ‘202; Fig. 39; surgical fiber 645) and arranged to direct the laser light reflected from the one or more targets (Altshuler ‘202; Fig. 39; target 630) to the light sensor (Altshuler ‘202; Fig. 39; photodiode 646a).
Regarding claim 5, Modified Altshuler ‘202 teaches the invention substantially the same as described above, and The system of claim 4, wherein the laser console comprises the second light sensor and wherein the beam splitter (Altshuler ‘202; beam splitter M1 385a; Fig. 39 with beam divider 685) is further arranged to direct a portion of the laser light from the laser source to the second light sensor (Altshuler ‘202; Fig. 39; photodiode 646b).
Regarding claim 6, Modified Altshuler ‘202 teaches the invention substantially the same as described above, and The system of claim 4, wherein the laser source comprising either a Holmium-based lasing medium or a Thulium-based lasing medium (Altshuler ‘202; [0275] TFL thulium fiber laser).
Regarding claim 7, Modified Altshuler ‘202 teaches the invention substantially the same as described above, and The system of claim 4, wherein the laser console further comprises an optical head comprising at least a lens (Altshuler ‘202; coupling lens 389) arranged to couple the laser light to the optical fiber (Altshuler ‘202; Fig. 5; [0125] coupling lens 389 optically couples between the light/laser/LED source optical head and the surgical fiber 345).
Regarding claim 10, Modified Altshuler ‘202 teaches the invention substantially the same as described above, and The system of claim 1, wherein the optical fiber is arranged to be inserted through a working channel of a scope (Altshuler ‘202; [0248] medical scope; [0003] endoscope for laser lithotripsy).
Modified Altshuler ‘202 is silent regarding the scope being a ureteroscope.
Modified Altshuler ‘242 teaches the scope being a ureteroscope (Modified Altshuler ‘242; [0003] ureteroscope for laser lithotripsy).
It would have been obvious to one having ordinary skill at the effective filing date of the invention to substitute the scope as taught by Modified Altshuler ‘202 with the ureteroscope as taught by Modified Altshuler ‘242 for the purpose of providing laser lithotripsy treatment for a urinary tract.
Regarding claim 13, Modified Altshuler ‘202 teaches the invention substantially the same as described above, and The computer-readable memory storage device of claim 11, wherein as the plurality of distances decreases, the pop-dusting efficiency increases (Altshuler ‘202; [0159] “stones benefit more from laser light being focused more closely at the stone corresponding to better ablative performance…harder stone types can benefit from a smaller distance (e.g. more focused laser light being directed at a harder stone) as opposed to softer stone”).
Regarding claim 14, Modified Altshuler ‘202 teaches the invention substantially the same as described above, and The computer-readable memory storage device of claim 11, wherein as the plurality of distances increases, the pop-dusting efficiency decreases (Altshuler ‘202; [0159] “stones benefit more from laser light being focused more closely at the stone corresponding to better ablative performance…harder stone types can benefit from a smaller distance (e.g. more focused laser light being directed at a harder stone) as opposed to softer stone”).
Regarding claim 15, Modified Altshuler ‘202 teaches the invention substantially the same as described above, and The computer-readable memory storage device of claim 11, the medical laser console comprising a display (Altshuler ‘202; [0161] “display the determined distance”) and wherein the instructions, when executed by the processor further cause the medical laser console to: generate one or more graphical information elements comprising indications of the pop-dusting efficiency (Altshuler ‘242; [0089] “Ablation efficiency and the retropulsion effect are the results of the combination of many factors which include but are not limited to”; [0092] “3. The distance between the fiber end and the stone”; [0093] “The efficiency of ablation decreases with the increase of K because of the increasing distance between the fiber end and the bottom of the laser crater”; [0097 and 0107] compute stone ablation efficiency “Ka”; [0011] control surgical procedures based on ablation efficiency and “the distance between the distal end of the fiber and the stone” which “plays an important role”); and cause the display to display the graphical information elements as part of a user interface (Altshuler ‘202; [0193] “displaying the results”; [0257] display results so that the laser system or practitioner can “adjust control of the treatment laser accordingly”).
Regarding claim 16, Modified Altshuler ‘202 teaches the invention substantially the same as described above, and The computer-readable memory storage device of claim 15, wherein the one or more graphical information elements comprise a pop-dusting efficiency gauge, which is configured to display the pop-dusting efficiency (Altshuler ‘242; [0089] “Ablation efficiency and the retropulsion effect are the results of the combination of many factors which include but are not limited to”; [0092] “3. The distance between the fiber end and the stone”; [0093] “The efficiency of ablation decreases with the increase of K because of the increasing distance between the fiber end and the bottom of the laser crater”; [0097 and 0107] compute stone ablation efficiency “Ka”; [0011] control surgical procedures based on ablation efficiency and “the distance between the distal end of the fiber and the stone” which “plays an important role”).
Claim(s) 3 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Altshuler US20240329202 in view of Altshuler US20240252242 as applied to claims 1 and 17 above, and further in view of Altman US20220166178.
Regarding claim 3, Modified Altshuler ‘202 teaches the invention substantially the same as described above, and The system of claim 1, the instructions, when executed by the processor, further cause the system to: a memory (Altshuler ‘202; [0359] non-transitory CRM memory with instructions) coupled to the processor (Altshuler ‘202; [0107] processor of control system 150; feedback analyzer computing device 650), and a distance of the target with the first electrical signals and second electrical signals (Altshuler ‘202; Fig. 15A; step 614 “determine a distance to treatment target”; [0278] photodetectors 646a-646i; [0097 “laser system… can determine a distance between a treatment target or target material (e.g. a kidney stone), and act accordingly based on the determined distance”]; [0098] “determining a distance… between tissue and the distal end of the fiber can increase treatment efficiencies (and allow the laser system or the practitioner to act accordingly)”); and determine the distance of the target from the distal end of the optical fiber (Altshuler ‘202; Fig. 15A; step 614 “determine a distance to treatment target”; [0278] photodetectors 646a-646i; [0097 “laser system… can determine a distance between a treatment target or target material (e.g. a kidney stone), and act accordingly based on the determined distance”]; [0098] “determining a distance… between tissue and the distal end of the fiber can increase treatment efficiencies (and allow the laser system or the practitioner to act accordingly)”).
Modified Altshuler ‘202 does not teach a lookup table, wherein the lookup table is stored in a memory coupled to the processor, and wherein the lookup table correlates a distance of the target with the first electrical signals and second electrical signals; and determine the distance of the target from the distal end of the optical fiber based on the reference.
Altman teaches a lookup table, wherein the lookup table correlates a distance of the target; and determine the distance of the target from the distal end of the optical fiber based on the reference (Altman; Fig. 9-10; [0091] distance measurement module 929 uses a lookup table to repeatedly determine the distance “D” based on experimental results so that the controller can dynamically adjust laser treatment parameters based on the distance results).
It would have been obvious to one having ordinary skill at the effective filing date of the invention to modify the system as taught by Modified Altshuler ‘202 to additionally include distance-determination based on a lookup table as taught by Altman for the purpose of providing a redundant/backup means for determining the distance for dynamic laser treatment adjustment/optimization (Altman; Fig. 9-10; [0091] distance measurement module 929 uses a lookup table to repeatedly determine the distance “D” based on experimental results so that the controller can dynamically adjust laser treatment parameters based on the distance results).
Regarding claim 19, Modified Altshuler ‘202 teaches the invention substantially the same as described above in reference to claim 3.
Claim(s) 8 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Altshuler US20240329202 in view of Altshuler US20240252242 as applied to claims 4 and 17 above, and further in view of Khachaturov US20230350021.
Regarding claim 8, Modified Altshuler ‘202 teaches the invention substantially the same as described above, and The system of claim 4, wherein the lasing system further comprises and wherein the instructions, when executed by the processor, further cause the system to: receive by the first light sensor; and determine, at the processor during the time period, the plurality of distances based on the first electrical signal, the second electrical signal (Altshuler ‘242; [0089] “Ablation efficiency and the retropulsion effect are the results of the combination of many factors which include but are not limited to”; [0092] “3. The distance between the fiber end and the stone”; [0093] “The efficiency of ablation decreases with the increase of K because of the increasing distance between the fiber end and the bottom of the laser crater”; [0097 and 0107] compute stone ablation efficiency “Ka”; [0011] control surgical procedures based on ablation efficiency and “the distance between the distal end of the fiber and the stone” which “plays an important role”).
Modified Altshuler ‘202 does not teach a second laser source; receive a third electrical signal generated by the first light sensor, the third electrical signal comprising an indication of a power of a light received at the first light sensor that corresponds to laser light generated by the second laser source and emitted from the distal end of the optical fiber towards the one or more targets; receive a fourth electrical signal generated by the second light sensor, the fourth electrical signal comprising an indication of a power of a light received at the second light sensor that corresponds to laser light reflected from at least one of the one or more targets; and determine, at the processor during the time period, the plurality of distances based on the first electrical signal, the second electrical signal, the third electrical signal and the fourth electrical signal.
Khachaturov teaches a second laser source and using the plurality of laser light sources to determine distance between a fiber end and a target based on the ratio of the measured intensities belonging to different wavelengths (Khachaturov; [0196, 0205, 0223] “estimating the distance between the distal end of the optical fiber and the target comprises: [0197] determining, by the processing unit, a ratio of the measured intensities of the light beams of the reflected light belonging to two different wavelengths of the plurality of wavelengths, wherein the two different wavelengths belong to one of a first polarized laser source (L1) and a second polarized laser source (L2)”; [0056] “for accurately estimating a distance between a fiber end and a target”).
It would have been obvious to one having ordinary skill at the effective filing date of the invention to modify the system and distance determination as taught by Altshuler ‘202 to comprise a second laser source and distance determination based on a plurality of laser sources as taught by Khachaturov for the purpose of “accurately estimating a distance between a fiber end and a target” (Khachaturov; [0056] “for accurately estimating a distance between a fiber end and a target”).
Regarding claim 18, Modified Altshuler ‘202 teaches the invention substantially the same as described above in reference to claim 8.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Altshuler US20240329202 in view of Altshuler US20240252242 as applied to claim 1 above, and further in view of Camarillo US20200297444.
Regarding claim 9, Modified Altshuler ‘202 teaches the invention substantially the same as described above, and The system of claim 1, the instructions, when executed by the processor, further cause the system the first electrical signal and second electrical signals as input.
Modified Altshuler ‘202 does not teach a machine learning (ML) model to generate an inference of the distance of a target from the distal end of the optical fiber, wherein the machine learning model is executed with at least the first electrical signal and second electrical signals as input.
Camarillo teaches using a machine learning module 430 to determine an instrument’s distance to a target for navigational control (Camarillo; [0160] using a machine learning module 430 to determine an instrument’s distance to a target for navigational control).
It would have been obvious to one having ordinary skill at the effective filing date of the invention to modify the system and distance determination as taught by Modified Altshuler ‘202 to include a machine learning (ML) model to generate an inference of the distance of a target as taught by Camarillo for the purpose of providing data for navigational control (Camarillo; [0160] using a machine learning module 430 to determine an instrument’s distance to a target for navigational control).
Allowable Subject Matter
Claim(s) 12 and 20 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Khachaturov US20220160435 teaches a Light Emitting, Transmitting and Detecting (LETD) system.
Bukesov US20210038310 teaches a laser fiber distance measurement between an endoscope distal end and a target.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN MALIKASIM whose telephone number is (313)446-6597. The examiner can normally be reached M-F; 8 am - 5 pm (CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yuqing Xiao can be reached at 571-270-3603. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN MALIKASIM/ Primary Examiner, Art Unit 3645 9/17/26
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