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 I (claims 29-47) in the reply filed on 10/8/2025 is acknowledged. Claims 48-61 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Priority
As discussed below, in relation to the 112a written description rejections, the current specification fails to disclose “a computing device configured to simultaneously analyze the optical data”, therefore the effective filing date of the current application is 8/6/2021 (the filing of the PCT).
Additionally or Alternatively, if it is somehow determined that the instant specification provides inherent/implicit support for such simultaneous analysis (which the examiner does not concede), the provisional application 63/062118 does not provide sufficient support for the claimed “at least two photodetectors… each photodetector configured to receive the portion of light in a different selected wavelength band” and/or “a computing device configured to simultaneously analyze the optical data from each photodetector relative to characteristic criteria, and based on a comparison of the optical data to the characteristic criteria, determine whether the treatment target is a target material or a non- target material”. Therefore, the earliest possible effective filing date for the current application is 5/6/2021.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 29-47 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
First, it is noted that the current claims are not original claims, as they were filed on 4/17/2023 which is after the original filing date of 2/2/2023. The limitation “a computing device configured to simultaneously analyze the optical data from each photodetector relative to characteristic criteria, and based on a comparison of the optical data to the characteristic criteria, determine whether the treatment target is a target material or a non- target material” is not sufficiently supported in the specification. The only mention of “simultaneously” in the specification is this single sentence “Simultaneously, the computing device synchronizes the calibration pulse with the three (or more) original baseline (reference) pulsed probe source signals into memory: at the moment right before the pulse (moment A), during the pulse (moment B) and right after the pulse (moment C), as shown in FIG. 23”, which has nothing to do with the analysis from different photodetectors. Therefore, this new claim language is not supported by the originally filed specification.
Claim Rejections - 35 USC § 102 or 35 USC § 103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
Claims 29-47 are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as anticipated by US 2021/0044079 to Bukesov et al.* or, in the alternative, under 35 U.S.C. 103 as obvious over Bukesov in view of US 2008/0226029 to Weir (both of these reference have been previously provided by the examiner on the 892 mailed 8/14/2025).
*As described above, the examiner considers the effective filing date of the current application to be 8/6/2021, which would make Bukesov a 102(a)(1) reference, i.e. printed before. However, if it is determined that the effective filing date of the current application is 5/6/2021 (or even 8/6/2020), then Bukesov qualifies as a 102(a)(2) reference, i.e. filed before. Both situations are covered by the current rejection.
[Claim 29] Bukesov discloses a surgical laser system (best seen in Figs. 1, 5 and 9-11) comprising
a surgical fiber (150, Fig. 5) configured to receive light reflected by a treatment target and surrounding area in a treatment area (feedback signals 130; at least Pars 0003 and 0076-80);
at least two photodetectors (spectrometers 142 and/or image sensor 144; Fig. 5), each photodetector configured to receive a portion of the light reflected from the treatment area in a selected wavelength band, and to generate optical data corresponding to the portion of the reflected light detected by the photodetector, each photodetector configured to receive the portion of light in a different selected wavelength band (at least Pars 0077-79, 0110-111 and 0120-122; Figs. 12-16. Specifically, Par 0078 states “The feedback analyzer 140 may include optionally, an imaging sensor 144 (e.g., CCD or CMOS camera sensitive in ultraviolet (UV), visible (VIS) or infrared (IR) wavelengths) in an example. In some examples, the spectroscopic sensor 142 may include more than a single type of spectrometer or imaging camera listed herein to enhance sensing and detection of various features (e.g., carbonized and non-carbonized tissue, vasculature, and the like)”. Additionally or alternatively, each photodetector is inherently capable of receiving any portion of light in any desired/selected wavelength band. If applicant disagrees; see alternative 103 rejection in view of Weir below); and
a computing device (laser controller 160) configured to simultaneously analyze the optical data from each photodetector relative to characteristic criteria, and based on a comparison of the optical data to the characteristic criteria, determine whether the treatment target is a target material or a non-target material a surgical fiber, at least two photodetectors and a computing device configured to simultaneously analyze the optical data from each photodetector relative to characteristic criteria, and based on a comparison of the optical data to the characteristic criteria, determine whether the treatment target is a target material or a non-target material (At least Pars 0058 and 0082-84. In particular, Par 0083 states “The laser controller 160 may determine one or more properties of the target tissue 122 based on the feedback signal(s), as will be described further herein. For instance, the laser controller 160 may compare the amplitude of the feedback signals to present minimum and maximum amplitudes, and determine a property (e.g., carbonized, coagulated, etc.) of the tissue” and Par 0058 states “For example, in laser lithotripsy that applies laser to break apart or dust calculi, automatic and in vivo recognition of calculi of a particular type (e.g., chemical composition of a kidney or pancreobiliary or gallbladder stone) and distinguishing it from surrounding tissue would allow a physician to adjust a laser setting (e.g., power, exposure time, or firing angle) to more effectively ablate the target stone, while at the same time avoiding irradiating non-treatment tissue neighboring the target stone.”).
Regarding the simultaneous analysis, Bukesov discloses real-time analysis/processing of the optical signals for both the imaging sensor (Par 0104) and the spectroscopy (Par 0131), therefore it stands to reason that if both of these are done in real-time they are analyzed/processed simultaneously. If applicant disagrees, then it would be obvious to simultaneous analyze each of the optical signals from the multiple spectrometers and/or multiple image sensors, so that all of the information is made available to the operator in real-time or as close to real-time as possible. Furthermore, there are only two known options for analyzing multiple optical signals/data, i.e. simultaneously or consecutively, the examiner takes the position that either option would be obvious to try, with simultaneous being the most logical choice in order to provide real-time and fast results.
Regarding the limitation “each photodetector configured to receive the portion of light in a different selected wavelength band”, as discussed above the examiner takes the position that Bukesov explicitly teaches these claimed photodetectors, but if applicant disagrees, such photodetectors are obvious. Specifically, in the same field of endeavor, Weir discloses the concept of using separate photodetectors for each detected wavelength (37, Fig. 4; at least Par 0022-28, in particular Par 0028). Therefore, it would have been obvious to modify the multiple photodetectors taught by Bukesov to be specifically configured to analyze/detect a separate/different wavelength, as taught by Weir, as this is a known configuration of a similar laser endoscopic treatment device in order to detect multiple wavelengths reflected from tissue.
[Claims 30-37] Best seen in Fig. 10B, Bukesov discloses a light source (treatment laser 1020 and/or broad spectrum illumination light source 1030) that is associated with a scope (endoscope 910) and a fiber (912) that both sends the light to tissue and receives reflected light from tissue (Par 0109). Additionally or alternatively, the light source (914 within endoscope 910) is also interpreted as the claimed light source (Par 0103). Light source (130) can be a lamp or LED (at least Par 0111 and Table 2). As made clear in Pars 0106-107, 0111 and Table 2, these light sources emit wavelengths that fall completely within or overlap with applicant’s claimed wavelengths; see MPEP 2131.03 and MPEP 2144.05 which states “in the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. Furthermore, Bukesov discloses “multiple narrow emitting” LEDs or laser diodes with a wavelength range in the UV, visible, infrared and fluorescent (Table 2). Therefore, it would have been obvious to choose/try/select any wavelength from 200-2500 nm as the desired center wavelength. The bandwidth of the disclosed laser sources (Par 0107) fall within applicant’s claimed range.
[Claims 38, 39 and 41] Bukesov discloses distinguishing between soft tissue and hard tissue/stone, as well as the specific type of stone/calculus (at least Pars 0058-63, 0077 and 0120-122; Figs. 12-16). Bukesov additionally teaches determining the distance between the distal end of the laser fiber and the target structure (Par 0112)
[Claim 40] At the very least the camera and image processing that provides visualization of the target structure (Pars 0103-104) is inherently capable of determining or identifying a surgical component. Specifically, if a surgical component was in the field of view of the camera/visualization system, such a surgical component would be inherently determined/identified in the image. If applicant disagrees, see alternative 103 rejection below.
[Claims 42 and 43] Bukesov discloses using the determination of tissue as feedback to adjust the laser parameters (at least Pars 0060-63 and 0133). Par 0133 states “Based on the spectroscopic system feedback, the signal analyzer detects target material composition, and suggests a laser operating mode (also referred to as a laser setup), such as operating parameters for at least one laser module, to achieve effective tissue treatments for the identified tissue composition. Examples of the operating parameters may include at least one laser wavelength, pulsed or continuous wave (CW) emission mode, peak pulse power, pulse energy, pulse rate, pulse shapes, and the simultaneous or sequenced emission of pulses from at least one laser module.”
[Claim 44] Bukesov discloses a laser source for lithotripsy (at least 0169). Bukesov is silent regarding a filter positioned upstream of the filters. However, Weir discloses filters in front of the photodetectors (Pars 0028 and 0057). Therefore, it would be obvious to one of ordinary skill in the art to modify the photodetectors taught by Bukesov to includes filters in front of each photodetector to protect them from any damage, as taught by Weir (Par 0057) and/or as a known mechanism to separate/select the desired wavelengths for the photodetector (Par 0028)
[Claim 45] Bukesov discloses a pulsed laser source (At least Par 0133), as well a computer device that performs real-time analysis (Pars 0131). The examiner contends that real-time analysis inherently/necessarily includes analysis between the pulses, as real-time would necessarily include before, during and after laser pulses; it is noted that before and after is the same as in between pulses. This is the same configuration disclosed by applicant “computing device controlled laser system can therefore be used to receive and analyze response signals corresponding to the probing source in real time before, during, and after laser pulses for purposes of distinguishing between contact with stone vs. soft tissue” (Par 0206 of applicant’s specification).
[Claim 46] Bukesov discloses that the optical data corresponds to at least an intensity value of the light (at least Pars 0083, 0087, 0104, 0134-135; Figs. 12 and 24-25). Additionally or alternatively, a photodetector by definition/inherently measures the intensity of light.
[Claim 47] Bukesov discloses a comparison between the amplitude, i.e. intensity value, of the reflected light signal and a preset minimum and maximum amplitude, i.e. reference intensity value (Par 0083; see also Pars 0087, 0091, 0094, 0133 and 0135-143). Comparing two values is necessarily a ratio.
Claim 40 is are rejected under 35 U.S.C. 103 as being unpatentable over Bukesov and Weir as applied to claim 29 above, and further in view of US 2019/0282299 to Fan.
Bukesov and Weir are discussed above, but fail to explicitly teach a computing device that determines that the non-target tissue is a surgical component. However, in the same field of endeavor, Weir discloses a device for laser lithotripsy including a detection system which is “used to determine if a portion of the basket, such as arm 36, is in the path 70 of the laser pulse; located in front of the stone 72. As indicated by block 74, if the basket is not detected, the system may allow the high energy pulse to be delivered as indicated by block 76. However, if the basket is detected, the system may prevent the high energy pulse from being delivered. Thus, the low energy check pulse may be used to determine if it is safe to fire the high energy laser pulse” (Par 0040; see also Figs. 1, 2 and 7-10). Therefore, it would have been obvious to one of ordinary skill in the art to modify the lithotripsy device taught by Bukesov and Weir to include the specific detection and control system taught by Fan in order to prevent the laser from firing at a non-target, specifically a surgical component.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The concept of using a photodetector (or multiple photodetectors) to identify target vs non-target tissue is known in the art:
US 2019/0356469 to Efremkin (Par 0091)
US 2019/0167349 to Shamay (Par 0098)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796