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 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 1-18 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.
In claim 1, it is set forth a method of …treating tissue; however no step performed any treatment. Furthermore, the claim set forth “characterizing” the tissue; it is unclear what encompasses characterizing tissue.\
In claim 19, it is unclear as to how smoke can comprise near-infrared signals;
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-7, 9, 12, 13, 16, 18, 19, 22-26, 28, 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Advanced osteotomy Tools, WO 2018/115415.
Regarding Claim 1, Advanced Osteotomy Tools discloses a method of characterizing and treating tissue (laser device and tissue characterizing method...A laser device (100) has an ablation laser source (401) adapted to provide an ablating laser beam (402; 402i) for ablating a target tissue (120); Title; see also Abstract), the method comprising:
measuring a spectrum of smoke generated from tissue to be characterized; wherein the spectrum comprises near infrared signals ((A typical LIBS system can comprise of a Nd:YAG solid-state laser and a spectrometer with a wide spectral range and a high sensitivity, fast response rate, time gated detector. With a wavelength of 1064 nm [near-infrared] and pulse duration around of 1O ns it can generate a power density exceeding 1 GW-cm2 at the focal point. This can be coupled to a computer to process and interpret the acquired data; Para. [0043]).
and characterizing the tissue based on the measured spectrum of the smoke (The laser device 100 comprises an ablation laser source 401 adapted to provide an ablating laser beam 402 for ablating a bone 120 as target tissue...The laser device 100 further comprises a plume analyzing arrangement 250 with a mass spectrometer 300, a debris gathering unit 350, a microphone 310 and a laser spectroscope
200. The plume analyzing arrangement 250 is embodied to identify and to quantify substances [characterizing] in the debris of a plume 110 [smoke] generated by the composite laser beam 400 ablating the bone 120...A specific portion of the analyzing laser beam 404 contained in the composite laser beam 400 is reflected by the debris of the plume 11O . This reflected light 450 travels more or less in an opposite direction than the composite laser beam 400 away from the bone 120. Thereby, ii hits the dichromatic mirror 4 10 which redirects the reflected light 450 towards the laser spectroscope 200. There, substances of the debris of the plume 110 are identified and/or at least the spectra are recorded.; Fig. 1; Paras. (0083)-(0085]).
Regarding Claim 2, Advanced Osteotomy Tools discloses the method of claim 1, further comprising heating the tissue to be characterized to generate the smoke (The laser device 100 comprises an ablation laser source 401 adapted to provide an ablating laser beam 402 for ablating a bone 120 as target tissue; Fig. 1; Pciri:I. [0083)).
Regarding Claim 3, Advanced Osteotomy Tools discloses the method of claim 2, wherein the smoke is generated by applying one or more of light or heat to the tissue (The laser device 100 comprises an ablation laser source 401 adapted to provide an ablating laser beam 402 for ablating a bone 120 as target tissue; Fig. 1; Para. [0083]).
Regarding Claim 4, Advanced Osteotomy Tools discloses the method of claim 3, wherein the one or more of the light or heat is applied by an ablation device (The laser device 100 comprises an ablation laser source 401 adapted to provide an ablating laser beam 402 for ablating a bone 120 as target tissue; Fig. 1; Para. [0083]).
Regarding Claim 5, Advanced Osteotomy Tools discloses the method of claim 1, further comprising ablating the tissue (The laser device 100 comprises an ablation laser source 401 adapted to provide an ablating laser beam 402 for ablating a bone 120 as target tissue; Fig. 1; Para. [0083]).
Regarding Claim 6, Advanced Osteotomy Tools discloses the method of claim 5, wherein ablating the tissue generates the smoke (The plume analyzing arrangement 250 is embodied to identify and to quantify substances in the debris of a plume 11O generated by the composite laser beam 400 ablating the bone 120 along a predefined osteotomic line 130 after being focused by a beam focusing optics 420; Fig. 1; Para. [0084]).
Regarding Claim 7, Advanced Osteotomy Tools discloses the method of claim 5, wherein the tissue is ablated in situ (The laser device according to the invention allows accurately analysing the tissue during a medical and particularly surgical intervention in a comparably fast and accurate manner and, advantageously, within the time of the surgical intervention or in runtime. The proposed device, when being used for in-vivo cancer diagnosis; Para. [0015]).
Regarding Claim 9, Advanced Osteotomy Tools discloses the method of claim 1, further comprising capturing the smoke generated (the debris of the plume 110 generated by the composite laser beam 400 is collected or sucked by an aspirating mouthpiece 351 of the debris gathering unit 350 and forwarded to the mass spectrometer 300 by means of a pump; Fig. 1; Para. (0086])..
Regarding Claim 12, Advanced Osteotomy Tools discloses the method of claim 1, wherein the tissue is characterized as cancerous or non-cancerous (the plume analyzing arrangement preferably is adapted to augment the image captured by the camera with information derived from the substance in the debris of the plume. Like this, the information about the substance can be associated to the image of the target tissue. For example, the type of the substance or the substance itself can be three-dimensionally displayed in the image. In particular, such display can be performed more or less runtime such that a practitioner continuously knows what kind of tissue is ablated by the laser beam. This, e.g. allows for precisely knowing when a cancer tissue is ablated and when the end of the cancerous tissue is reached; Para. (00681).
Regarding Claim 13, Advanced Osteotomy Tools discloses the method of claim 12, further comprising ablating the tissue and continuing ablating the tissue until the tissue is characterized as non-cancerous (the plume analyzing arrangement preferably is adapted to augment the image captured by the camera with information derived from the substance in the debris of the plume. Like this, the information about the substance can be associated to the image of the target tissue. For example, the type of the substance or the substance itself can be three-dimensionally displayed in the image. In particular, such display can be performed more or less runtime such that a practitioner continuously knows what kind of tissue is ablated by the laser beam. This, e.g. allows for precisely knowing when a cancer tissue is ablated and when the end of the cancerous tissue is reached; Para. (00681).
Regarding Claim 16, Advanced Osteotomy Tools discloses the method of claim 1, wherein the measured spectrum is a near-infrared spectrum (A typical LIBS system can comprise of a Nd:YAG solid-state laser and a spectrometer with a wide spectral range and a high sensitivity, fast response rate, time gated detector. With a wavelength of 1064 nm [near-infrared] and pulse duration around of 10 ns it can generate a power density exceeding 1 GW-cm2 at the focal point. This can be coupled to a computer to process and interpret the acquired data; Para. (00431).
Regarding Claim 18, Advanced Osteotomy Tools discloses the method of claim 16, wherein the measured spectrum comprises a wavelength below 1,300 nm (A typical LIBS system can comprise of a Nd:YAG solid-state laser and a spectrometer with a wide spectral range and a high sensitivity, fast response rate, time gated detector. With a wavelength of 1064 nm [near-infrared] and pulse duration around of 1O ns it can generate a power density exceeding 1 GW-cm2 at the focal point This can be coupled to a computer to process and interpret the acquired data; Para. (00431).
Regarding Claim 19, Advanced Osteotomy Tools discloses a device for (laser device and tissue characterizing method...A laser device (100) has an ablation laser source (401) adapted to provide an ablating laser beam (402; 402i) for ablating a target tissue (120); Title; see also Abstract), the device comprising:
an energy source to heat tissue and generate smoke therefrom; a spectrometer to measure a spectrum of the smoke generated from the tissue wherein the smoke comprises nir signals (The laser device 100 comprises an ablation laser source 401 adapted to provide an ablating laser beam 402 for ablating a bone 120 as target tissue...The laser device 100 further comprises a plume analyzing arrangement 250 with a mass spectrometer 300, a debris gathering unit 350, a microphone 310 and a laser spectroscope 200. The plume analyzing arrangement 250 is embodied to identify and to quantify substances [characterizing] in the debris of a plume 110 [smoke] generated by the composite laser beam 400 ablating the bone 120...A specific portion of the analyzing laser beam 404 contained in the composite laser beam 400 is reflected by the debris of the plume 110. This reflected light 450 travels more or less in an opposite direction than the composite laser beam 400 away from the bone 120. Thereby, it hits the dichromatic mirror 4 10 which redirects the reflected light 450 towards the laser spectroscope 200. There, substances of the debris of the plume 110 are identified and/or at least the spectra are recorded.; Fig. 1; Paras. (0083)-(0085]). (A typical LIBS system can comprise of a Nd:YAG solid-state laser and a spectrometer with a wide spectral range and a high sensitivity, fast response rate, time gated detector. With a wavelength of 1064 nm [near-infrared] and pulse duration around of 1O ns it can generate a power density exceeding 1 GW-cm2 at the focal point. This can be coupled to a computer to process and interpret the acquired data; Para. [0043]).
Regarding Claim 22, Advanced Osteotomy Tools discloses the device of claim 19, wherein the energy source is configured to ablate tissue (The laser device 100 comprises an ablation laser source 401 adapted to provide an ablating laser beam 402 for ablating a bone 120 as target tissue; Fig. 1; Para. (00831).
Regarding Claim 23, Advanced Osteotomy Tools discloses the device of claim 19, wherein the spectrometer comprises a nearinfrared spectrometer (A typical LIBS system can comprise of a Nd:YAG solid-state laser and a spectrometer with a wide spectral range and a high sensitivity, fast response rate, lime gated detector. With a wavelength of 1064 nm [near-infrared] and pulse duration around of 10 ns it can generate a power density exceeding 1 GW-cm2 at the focal point. This can be coupled to a computer to process and interpret the acquired data; Para. (00431).
Regarding Claim 24, Advanced Osteotomy Tools discloses the device of claim 19, wherein the energy source comprises one or more of a tissue cauterizer or laser (The laser device 100 comprises an ablation laser source 401 adapted to provide an ablating laser beam 402 for ablating a bone 120 as target tissue; Fig. 1; Para. (00831).
Regarding Claim 25, Advanced Osteotomy Tools discloses the device of claim 19, further comprising a processor coupled to the spectrometer, the processor being configured to characterize the tissue based on the measured spectrum of the smoke (The plume analyzing arrangement 250 is embodied to identify and to quantify substances in the debris of a plume 110 generated by the composite laser beam 400 ablating the bone 120 along a predefined osteotomic line 130 after being focused by a beam focusing optics 420.; Fig. 1; Para. (00841).
Regarding Claim 26, Advanced Osteotomy Tools discloses the device of claim 25, wherein the processor is configured to characterize the tissue as cancerous or non-cancerous (the plume analyzing arrangement preferably is adapted to augment the image captured by the camera with information derived from the substance in the debris of the plume. Like this, the information about the substance can be associated to the image of the target tissue. For example, the type of the substance or the substance itself can be three-dimensionally displayed in the image. In particular, such display can be performer! more or less runtime such that a practitioner continuously knows what kind of tissue is ablated by the laser beam. This, e.g. allows for precisely knowing when a cancer tissue is ablated and when the end of the cancerous tissue is reached; Para. (00681).
Regarding Claim 28, Advanced Osteotomy Tools discloses the device of claim 19, wherein the measured spectrum is a near-infrared spectrum (A typical LIBS system can comprise of a Nd:YAG solid-state laser and a spectrometer with a wide spectral range and a high sensitivity, fast response rate, time gated detector. With a wavelength of 1064 nr)1 [near-infrared] and pulse duration around of 10 ns it can generate a power density exceeding 1 GW-cm2 at the focal point. This can be coupled to a computer to process and interpret the acquired 'data; Para. [0043]).
Regarding Claim 30, Advanced Osteotomy Tools discloses the device of claim 28, wherein the measured spectrum comprises a wavelength below 1,300 nm (A typical LIBS system can comprise of a Nd:YAG solid-state laser and a spectrometer with a wide spectral range and a high sensitivity, fast response rate, time gated detector. With a wavelength of 1064 nm [near-infrared] and pulse duration around of 1O ns it can generate a power density exceeding 1 GW-cm2 at the focal point. This can be coupled to a computer to process and interpret the acquired data; Para. [0043]).
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) 8, 14, 15, 17, 27, 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over AOT above, in view of Sloan-Kettering US 2016/0000329.
Regarding Claim 8, Advanced Osteotomy Tools discloses the method of claim 5, , however fails to explicitly disclose further comprising excising the tissue from a patient, and wherein the ablated tissue comprises the excised tissue.
Sloan-Kettering Institute For Cancer Research teaches an apparatus and methods...that permit real time, accurate detection of residual tumor in the operating room (Abstract) comprising: excising tissue from a patient, and ablated tissue comprises the excised tissue (Both in vitro [excised tissue] and in vivo proof-of-concept data demonstrate the R-MRs' ability to outline multiple different tumor types; Paras. (0091), (0104); As shown in FIG. 26, system 2600 of the disclosure includes a hand-held instrument/housing 2601 having a terminal end 2612. The instrument 2601 may include optics for directing an excitation light onto a target sample 2630 (e.g., cells, or tissue)....Such signal follows cable 2620 to signal analyzer 2603. In this exemplary system, signal analyzer 2603 is a Raman analyzer. Upon determination that an appropriate signal is detected, signal analyzer 2603 relays a positive signal to ablation controller 2604. Ablation controller 2604 is operably linked to instrument 2601 via cable 2605, which terminates in an ablation device near terminal end 2612 of instrument 2601. Upon receiving a positive signal from ablation controller 2604, the ablation device ablates cells and/or tissue at or near target 2630; Fig. 26; Paras. (0185)-(01861).
It would have been obvious to one of ordinary skill in the art at the time of the invention lo modify Advanced Osleotomy Tools with the teaching of Sloan-Kettering Institute For Cancer Research by excising tissue for ablation for the purpose of enhancing the safety of the process by reducing the chances of inadvertently ablating in vivo tissue.
Regarding Claim 14, Advanced Osleotomy Tools discloses the method of claim 1, however fails to explicitly disclose wherein the tissue comprises skin.
Sloan-Kettering Institute For Cancer Research teaches an apparatus and methods...that permit real time, accurate detection of residual tumor in the operating room (Abstract) comprising:
measuring a spectrum of a sample generated from tissue to be characterized;
and characterizing the tissue based on the measured spectrum of the sample (As shown in FIG. 26, system 2600 of the disclosure includes a hand-held instrument housing 2601 having a terminal end 2612. The instrument 2601 may include optics for directing an excitation light onto a target sample 2630 (e.g., cells, or tissue)....Such signal follows cable 2620 to signal analyzer 2603. In this
exemplary system, signal analyzer 2603 is a Raman analyzer. Upon determination that an appropriate signal is detected, signal analyzer 2603 relays a positive signal to ablation controller 2604. Ablation controller 2604 is operably linked to instrument 2601 via cable 2605, 'which terminates in an ablation device near terminal end 2612 of instrument 2601. Upon receiving a positive signal from ablation controller 2604, the ablation device ablates cells and/or tissue at or near target 2630; Fig. 26; Paras. [018.5]-[01861);
wherein the tissue comprises skin (A surgeon using the disclosed system can destroy or remove cancerous (or otherwise abnormal) tissue quickly and with high precision in a semiautomated fashion...The system may be used, for example, during open surgical procedures,
in-office (non-Surgical) procedures, invasive procedures, non-invasive or minimally invasive procedures, endoscopic procedures, robotically-assisted procedures, or in external applications such as skin cancer removal; Para. [0027)).
II would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Advanced Osteotomy Tools to include wherein the tissue comprises skin as taught by Sloan-Kettering Institute For Cancer Research. The motivation being to destroy or remove cancerous (or otherwise abnormal) tissue quickly and with high precision in a semiautomated fashion (Sloan-Kettering Institute For Cancer Research; Para. [0027)).
Regarding Claim 15, modified Advanced Osteotomy Tools discloses the method of claim 14, wherein the tissue is characterized as comprising cancerous cells or normal cells (the plume analyzing arrangement preferably is adapted to augment the image captured by the camera with information derived from the substance in the debris of the plume. Like this, the information about the substance can be associated to the image of the target tissue. For example, the type of the substance or the substance itself can be three-dimensionally displayed in the image. In particular, such display can be performed more or less runtime such that a practitioner continuously knows what kind of tissue is ablated by the laser beam. This, e.g. allows for precisely knowing when a cancer tissue is ablated and when the end of the cancerous tissue is reached; Para. [00681).
Advanced Osteotomy Tools fails to explicitly disclose wherein the tissue is characterized as comprising basal cell carcinoma (BCC) cells, squamous cell carcinoma (SCC) cells, or normal cells.
Sloan-Kettering Institute For Cancer Research teaches an apparatus and methods...that permit real time, accurate detection of residual tumor in the operating room (Abstract) wherein the tissue is characterized as comprising basal cell carcinoma (BCC) cells (The apparatus and methods described herein can further be used to identify hyperplastic tissue...Hyperplastic disorders include, but are not limited to...basal cell hyperplasia; Para. [02091), squamous cell carcinoma (SCC) cells (More particular examples of such cancers are noted below and include squamous cell cancer (e.g., epithelial squamous cell cancer); Para. [0208)), or normal cells (the method further comprises scanning the Subject prior to implementation of the instrument to confirm the absence of nanoparticles from healthy (e.g., normal, e.g., non-cancerous) tissue; Para. [00351).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Advanced Osteotomy Tools to include wherein the tissue is characterized as comprising basal cell carcinoma (BCC) cells, squamous cell carcinoma (SCC) cells, or normal cells. as taught by Miller. The motivation being to accurately detect and visually identify residual tumor during a real-time surgical procedure (Sloan-Kettering Institute For Cancer Research; Para. [00051). .
Regarding Claim 17, Advanced Osteotomy Tools discloses the method of claim 16, however fails to explicitly disclose wherein the measured spectrum is within a wavelength range of 1,300 nm to 1,600 nm.
Sloan-Kettering Institute For Cancer Research teaches an apparatus and methods...that permit real time, accurate detection of residual tumor in the operating room (Abstract) wherein the measured spectrum is within a wave[ength range of 1,300 nm to 1,600 nm (the excitation light has a wavelength of about 500 nm to about 10um. In some embodiments, the excitation light has a wavelength of about 785 run. In 1,;t:!rli:lin embodiments, the excitation light is near-infrared light; Para. [00311).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Advanced Osteotomy Tools to include wherein the measured spectrum is within a wavelength range of 1,300 nm to 1,600 nm as taught by Sloan-Kettering Institute For Cancer Research. The motivation being to allow deeper measurement penetration (Sloan-Kettering Institute For Cancer Research; Para. [00311).
Regarding Claim 27, Advanced Osteotomy Tools discloses the device of claim 26, wherein the tissue comprises skin, and wherein the processor is configured to characterize the tissue as comprising cancerous cells, or normal cells (the plume analyzing arrangement preferably is adapted to augment the image captured by the camera with information derived from the substance in the debris of the plume. Like this, the information about the substance can be associated to the image of the target tissue. For example, the type of the substance or the substance itself can be three-dimensionally displayed in the image. In particular, such display can be performed more or less runtime such that a practitioner continuously knows what kind of tissue is ablated by the laser beam. This, e.g. allows for precisely knowing when a cancer tissue is ablated and when the end of the cancerous tissue is reached; Para. [00681).
I Advanced Osteotomy Tools fails to explicitly disclose wherein the tissue is characterized as comprising basal cell carcinoma (BCC) cells, 'squamous cell carcinoma (SCC) cells, or normal cells.
Sloan-Kettering Institute For Cancer Research teaches an apparatus and methods...that permit real time, accurate detection of residual tumor in the operating room (Abstract) wherein the tissue is characterized as comprising basal cell carcinoma (BCC) cells (The apparatus and methods described herein can further be used to identify hyperplastic tissue...Hyperplastic disorders include, but are not limited to...basal cell hyperplasia; Para. [02091), squamous cell carcinoma (SCC) cells (More particular examples of such cancers are noted below and include squamous cell cancer (e.g., epithelial squamous cell cancer); Para. [0208]), or normal cells (the method further comprises 'scanning the Subject prior to implementation of the instrument to confirm the absence of nanoparticles from healthy (e.g., normal, e.g., non-cancerous) tissue; Para. [00351).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the device of Advanced Osteotomy Tools to include wherein the tissue is characterized as comprising basal cell carcinoma (BCC) cells, squamous cell carcinoma (SCC) cells, or normal cells. as taught by Miller. The motivation being to accurately detect and visually identify residual tumor during a real-time surgical procedure (Sloan-Kettering Institute For Cancer Research; Para. [0005]).
Regarding Claim 29, Advanced Osteotomy Tools discloses the device of claim 28, however fails to explicitly disclose wherein the measured spectrum is within a wavelength range of 1,300 nm to 1,600 nm.
Sloan-Kettering Institute For Cancer Research teaches an apparatus and methods...that permit real time, accurate detection of residual tumor in the operating room (Abstract) wherein the measured spectrum is within a wavelength range of 1,300 nm to 1,600 nm (the excitation light has a wavelength of about 500 nm to about 1Oum. In some embodiments, the excitation light has a wavelength of about 785 nm. In certain embodiments, the excitation light is near-infrared light; Para. [0031]).
II would have been obvious to one of ordinary skill in the art at the time of the invention to modify the device of Advanced Osteotomy Tools to include wherein the measured spectrum is within a wavelength range of 1,300 nm to 1,600 nm as taught by Sloan-Kettering Institute For Cancer Research. The motivation being to allow deeper measurement penetration (Sloan-Kettering Institute For Cancer Research; Para. [00311).
Claim(s) 10, 11, 20, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over AOT above, in view of Kittrell US 2002/0045811.
Regarding Claim 10, Advanced ·osteotomy Tools discloses the method of claim 9, wherein the smoke is captured in a debris gathering unit (the debris of the plume 11O generated by the composite laser beam 400 is collected or sucked by an aspirating mouthpiece 351 of the debris gathering unit 350; Fig. 1; Para. (0086]).
Advanced Osteotomy Tools fails to explicitly disclose the debris gathering unit is a cuvette. Kittrell teaches a laser ablation process (Title) comprising:
measuring a spectrum generated from tissue to be characterized;
and characterizing the tissue based on the measured spectrum (The laser catheter 1O permits delivery of high power laser radiation from the coupler 46 at the proximal end through the optical fibers 20a-c' and through the optical shield 12 to the tissue to be treated. The laser catheter 10 may also be employed to deliver spectral diagnostic radiation, either from a laser or a conventional light source. The scattered or fluorescent light returning from the tissue passes through the optical shield 12 and re-enters the distal ends of the optical fibers 20a-c', and exits the proximal ends of the optical fibers 40a-c' in the coupler 46, where it may be analyzed; Fig. 1; Para. (0068]);
wherein the sample is captured in a cuvette (Whole arterial wall samples were placed in quartz cuvettes, immersed in saline solution. The lumen side of each sample was secured flush against a face of the cuvette, thus providing a well defined surface from which to observe fluorescence. Sample cuvettes were placed in a Perkin Elmer spectrofluorimeter of standard type; Para. (0135]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Advanced Osteotomy Tools to include wherein the sample is captured in a cuvette as taught by Kittrell. The motivation being to isolate histological sections (Kittrell; Para. [0136]).
Regarding Claim 11, modified Advanced Osteotomy Tools discloses the method of claim 10, wherein the spectrum of smoke is measured at the debris gathering unit (A specific portion of the analyzing laser beam 404 contained in the composite laser beam 400 is reflected by the debris of the plume 11O . This reflected light 450 travels more or less in an opposite direction than the composite laser beam 400 away from the bone 120. Thereby, it hits the dichromatic mirror 410 which redirects the reflected light 450 towards the laser spectroscope 200. There, substances of the debris of the plume 110 are identified and/or at least the spectra are recorded. Simultaneously, the debris of the plume 110 generated by the composite laser beam 400 is collected or sucked by an aspirating mouthpiece 351 of the debris gathering unit 360; Fig. 1; Porac. (0086) (0086]).
Advanced Osteotomy. Tools fails to explicitly disclose the debris gathering unit is a cuvette.
Kittrell teaches a laser ablation process (Title) wherein the sample is captured in a cuvette (Whole arterial wall samples were placed in quartz cuvettes, immersed in saline solution. The lumen side of each sample was secured flush against a face of the cuvette, thus providing a well defined surface from which to observe fluorescence. Sample cuvettes were placed in a Perkin Elmer spectrofluorimeter of standard type; Para. (0135]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Advanced Osteotomy Tools to include wherein the sample is captured in a cuvette as taught by Kittrell. The motivation being to isolate histological sections (Kittrell; Para. (0136)).
Regarding Claim 20, Advanced Osteotomy Tools discloses the device of claim 19, further comprising a debris gathering unit to capture the smoke generated from the tissue (the debris of the plume 110 generated by the composite laser beam 400 is collected or sucked by an aspirating mouthpiece 351 of the debris gathering unit 350; Fig. 1; Para. (0086)).
Advanced Osteotomy Tools fails to explicitly disclose the debris gathering unit is a cuvette.
Kittrell teaches a laser ablation process (Title) wherein the sample is captured in a cuvette (Whole arterial wall samples were placed in quartz cuvettes, immersed in saline solution. The lumen side of each sample was secured flush against a face of the cuvette, thus providing a well defined surface from which to observe fluorescence. Sample cuvettes were placed in a Perkin Elmer spectrofluorimeter.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Advanced Osteotomy Tools to include wherein. the sample is captured in a cuvette as taught by Kittrell. The motivation being to isolate histological sections (Kittrell; Para. (0136)).
Regarding Claim 21, modified Advanced Osteotomy Tools discloses the device of claim 20, further comprising a negative pressure source to direct the smoke generated from the tissue to the debris gathering unit (the debris of the plume 11O generated by the composite laser beam 400 is collected or sucked by an aspirating mouthpiece 351 of the debris gathering unit 350 and forwarded to the mass spectrometer 300 by means of a pump [negative pressure source); Fig. 1; Para. (0086)).
Advanced Osteotomy Tools fails to explicitly disclose the debris gathering unit is a cuvette.
Kittrell teaches a laser ablation process (Title) wherein the sample is captured in a cuvette (Whole arterial wall samples were placed in quartz cuvettes, immersed in saline solution. The lumen side of each sample was secured flush against a face of the cuvette, thus providing a well defined surface from which to observe fluorescence. Sample cuvettes were placed in a Perkin Elmer spectrofluorimeter of standard type; Para. (0135)).
It would have been obvious to one of ordinary skill in the art at the lime of the invention to modify the method of Advanced Osteotomy Tools to include wherein the sample is captured in a cuvette as taught by Kittrell. The motivation being to isolate histological sections (Kittrell; Para. (0136)).
Response to Arguments
It should be noted that the amendments are sufficient to overcome the outstanding 112(b) rejections toward claims 19-30.
It should be noted that claim 1 still sets forth that a treating of tissue; but the claim body fails to set forth any kind of treatment.
Applicant's arguments filed 06/20/2026 have been fully considered but they are not persuasive. It should be noted that the arguments toward the near infrared signals, the primary rference discloses (A typical LIBS system can comprise of a Nd:YAG solid-state laser and a spectrometer with a wide spectral range and a high sensitivity, fast response rate, time gated detector. With a wavelength of 1064 nm [near-infrared] and pulse duration around of 1O ns it can generate a power density exceeding 1 GW-cm2 at the focal point. This can be coupled to a computer to process and interpret the acquired data; Para. [0043]).
And toward the characterization of tissue, the primary reference discloses (The plume analyzing arrangement 250 is embodied to identify and to quantify substances [characterizing] in the debris of a plume 110 [smoke] generated by the composite laser beam 400 ablating the bone 120...A specific portion of the analyzing laser beam 404 contained in the composite laser beam 400 is reflected by the debris of the plume 11O . This reflected light 450 travels more or less in an opposite direction than the composite laser beam 400 away from the bone 120. Thereby, ii hits the dichromatic mirror 4 10 which redirects the reflected light 450 towards the laser spectroscope 200. There, substances of the debris of the plume 110 are identified and/or at least the spectra are recorded.; Fig. 1; Paras. (0083)-(0085]).
The rejections have been respectfully maintained.
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 JOSEPH M SANTOS RODRIGUEZ whose telephone number is (571)270-7782. The examiner can normally be reached Monday-Friday 8:30am to 5:30pm.
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/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797