DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see “Applicant Arguments/Remarks”, filed 11/18/2025, with respect to the objections to the claims, rejections under U.S.C. 112(b), and interpretations under U.S.C. 112(f) have been fully considered and are persuasive. The objections to the claims, rejections under U.S.C. 112(b), and interpretations under U.S.C. 112(f) have been withdrawn.
Applicant’s arguments, see “Applicant Arguments/Remarks”, filed 11/18/2025, with respect to rejections under U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Pringle, Kircher, and Altshuler, which is necessitated by applicant’s amendments.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1, 5-13, 16-17, 19-20, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20190267221 awarded to Pringle et al, hereinafter Pringle, in view of U.S. Patent Publication 20150018807awarded to Kircher et al, hereinafter Kircher, in view of U.S. Patent Publication 20080262577 awarded to Altshuler et al, hereinafter Altshuler.
Regarding Claims 1 and 17, Pringle teaches a laser device comprising: an ablation laser source configured to generate an ablating laser beam (laser 532, Para. 0261, “In one embodiment, there is provided an endoscope adapted for combined mass spectrometric (“MS”) and optical spectroscopic analysis of a target proximate the distal end of an endoscope, wherein the target has been ablated using a laser”) for ablating a human or animal hard tissue as a surgical intervention and generate a plume (Para. 0248, “The user may, for example, select one or more tissue types that should be monitored for (e.g. bone, skeletal muscle tissue, skin tissue, cancerous or non-cancerous tissue) in order to reduce the computational burden of the analysis”), and a plume analyzing arrangement (combined mass spectrometer 531 and LIBS system of Fig. 5, Para. 0204) and a laser spectroscope (Fig. 5, Para. 0204 states that the configuration of Fig. 5 uses both a mass spec and LIBS system, the Examiner is assuming this LIBS system is unidentified component 529, as it visually matches the spectrometer of Fig. 3) configured to receive light of the analyzing laser beam reflected by the debris to identify and/or quantify at least one substance in the debris of the plume, and a processing unit configured to evaluate measurement data of the at least one substance in the debris of the plume generated by the ablating laser beam ablating the human or animal hard tissue for real-time analysis (Para. 0249) of the at least one substance to identify tissue boundaries (Para. 0234, “The optical signals which are transmitted and recorded may be analysed to determine one or more characteristics of the target material. For example, a determination may be made of the elements, molecules or compounds present in the target material and/or their relative abundances. In particular, the apparatus allows the boundaries of a region of interest of the target to be precisely determined”), wherein the at least one substance comprises a biomarker of the ablated human or animal hard tissue (Para. 0234). Pringle does not teach wherein the laser operates at a wavelength of 2940 nanometers, or wherein the plume analyzing arrangement comprises a separate analyzing laser source configured to source configured to provide an analyzing a laser to debris of the plume, wherein the analyzing laser beam is adapted to induce reflection or emission from the debris of the plume, a beam mixing structure configured to redirect the ablating laser beam of the ablation laser source and/or the analyzing laser beam of the analyzing laser source such that an optical axis of the ablating laser beam is parallel to an optical axis of the analyzing laser beam.
However, in the art of laser spectroscope systems, Kircher teaches a laser system that uses both an ablation laser (CO2 laser 2751) in a system with a spectrograph (Raman analyzer 2705) that uses a separate analysis laser from the ablation laser (Raman laser 2704), wherein the analyzing laser beam is adapted to induce reflection or emission from the debris of the plume (Para. 0035), wherein the ablating laser and the analysis laser are combined in a beam path to the target structure (Fig. 27), for the purposes determining the presence of dangerous tissue (Para. 0037) such as bone cancer (Para. 0289).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pringle by Kircher, i.e. by the Raman system of Kircher in the system of Pringle, for the predictable purpose of better targeting of dangerous tissues as taught above in Kircher.
Further, in the art of laser therapy, Altshuler teaches a laser ablation wavelength of 2940 nm for hard tissue (Para. 0004).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Pringle by Altshuler, i.e. by operating the ablation laser of Pringle at 2940 nm, as one of ordinary skill in the art would be capable of selecting the wavelength necessary for the tissue sample being treated, and Altshuler teaches that this wavelength/tissue combination is known in the art.
Regarding Claim 5, Pringle modified by Kircher and Altshuler makes obvious the laser device of Claim 1. Pringle further teaches wherein the laser spectroscope is a laser induced breakdown spectroscope (Para. 0036).
Regarding Claim 6 and 19, Pringle modified by Kircher and Altshuler makes obvious the laser device of Claim 1. Pringle further teaches wherein the plume analyzing arrangement comprises a mass spectrometer or an aspirating ion-mobility spectrometer (Para. 0014).
Regarding Claims 7 and 20, Pringle modified by Kircher and Altshuler makes obvious the laser device of Claim 6. Pringle further teaches wherein the plume analyzing arrangement comprises a debris gathering unit arranged to collect debris of the plume generated by the ablating laser beam when ablating the human or animal hard tissue when the debris gathering unit is connected to the mass spectrometer or the aspirating ion-mobility spectrometer (collection tubing 534, Para. 0263).
Regarding Claim 8, Pringle modified by Kircher and Altshuler makes obvious the laser device of Claim 7. Pringle further teaches wherein the debris gathering unit of the plume analyzing arrangement comprising an aspirating mouthpiece (Para. 0100).
Regarding Claim 9, Pringle modified by Kircher and Altshuler makes obvious the laser device of Claim 7. Pringle further teaches wherein the debris gathering unit of the plume analyzing arrangement comprises a pump unit configured to forward the debris to the mass spectrometer (Para. 0240).
Regarding Claim 10, Pringle modified by Kircher and Altshuler makes obvious the laser device of Claim 7. Pringle further teaches wherein the debris gathering unit of the plume analyzing arrangement comprises an electrical field generator to collect the debris of the plume (Electrical field generators are implicit to mass spectrometers, see https://www.bronkhorst.com/en-us/blog-en/mass-spectrometry-and-mass-flow-control-a-closer-ion-them/).
Regarding Claim 11, Pringle modified by Kircher and Altshuler makes obvious the laser device of Claim 1. Pringle further teaches wherein the processing unit is configured to evaluate the measurement data of the at least one substance in the debris of the plume generated by the abating laser beam ablating the human or animal hard tissue by applying a statistical or prediction model (Para. 0236).
Regarding Claim 12, Pringle modified by Kircher and Altshuler makes obvious the laser device of Claim 1. Pringle further teaches wherein the system further comprises a camera configured to capture an image of the human or animal hard tissue (Para. 0259).
Regarding Claim 13, Pringle modified by Kircher and Altshuler makes obvious the laser device of Claim 1. Pringle further teaches wherein the plume analyzing arrangement is configured to three-dimensionally localize an origin of the plume (Para. 0044).
Regarding Claims 16 and 23, Pringle modified by Kircher and Altshuler makes obvious the laser device of Claim 1. Pringle further teaches wherein the ablation laser source is three dimensionally movable relative to the human or animal hard tissue (Para. 0260).
Regarding Claim 22, Pringle modified by Kircher and Altshuler makes obvious the laser device of Claim 1. Pringle further teaches wherein the human or animal hard tissue is a bone tissue (Para. 0248).
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20190267221 awarded to Pringle et al, hereinafter Pringle, in view of U.S. Patent Publication 20150018807awarded to Kircher et al, hereinafter Kircher, in view of U.S. Patent Publication 20080262577 awarded to Altshuler et al, hereinafter Altshuler, further in view of U.S. Patent Publication 20180042583 awarded to Pringle et al, hereinafter Jones (for clarity to distinguish between the 2019 Pringle reference).
Regarding Claims 14 and 15, Pringle in view of Kircher and Altshuler makes obvious the laser device of Claim 1. Pringle does not teach wherein the plume analyzing arrangement is configured to augment the image captured by the camera with information derived from the substance in the debris of the plume, further comprising a processing unit configured to identify a movement of the human or animal hard tissue relative to the laser source on the capture image and to correct a position of the laser source in accordance with the identified movement of the human or animal hard tissue.
However, in the art of laser therapy, Jones teaches a system wherein a camera captured image is augmented by information derived from the substance in the debris of the plume (Para. 0386) and wherein the device further comprises a processing unit configured to identify a movement of the human or animal hard tissue relative to the laser source on the captured image and to correct a position of the laser source in accordance with the identified movement of the human or animal hard tissue (Para. 0301).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Pringle in view of Kircher and Altshuler by Jones, i.e. by using the augmented image system and repositioning system of Jones in the device of Pringle in view of Kircher and Altshuler, for the predictable purpose of improving the accuracy of similar laser surgical device in the same way.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jess Mullins whose telephone number is (571)-272-8977. The examiner can normally be reached between the hours of 9:00 a.m. to 5:00 p.m. PST M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung, can be reached at (571)-272-8506. The fax number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/JLM/
Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792