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 .
Information Disclosure Statement
The work of several of the inventors of the instant application in the field of appear to be relevant to the prosecution of the instant application. Application is encouraged to submit an appropriate IDS detailing any relevant documents
Response to Amendment
The amendment of 03/30/2026 has been entered and fully considered by the examiner. Claims 19 and 21 are amended. Claims 1-18 are canceled. Claims 19-32 are currently pending in the application with claim 19 being independent.
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.
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.
Claim 19 is rejected under 35 U.S.C. 103 as being obvious over Cao et al. (U.S. Publication No. 2024/0285341) hereinafter “Cao” in view of Torchia et al. (U.S. Publication No. 2014/0288542) hereinafter “Torchia”.
Regarding claim 19, Cao discloses a medical treatment apparatus [see abstract of Cao], comprising:
a magnetic resonance imaging (MRI) device, [MRI device 101; see [0059] of Cao] configured for imaging of a specific region comprising a target object and generating a magnetic resonance image; [see [0059] of Cao]
a laser interstitial thermal therapy (LITT) device, [see [0054]; a multi-wavelength LITT device which sued for ablation therapy] comprising: an LITT probe, the LITT probe being positioned close to the target object based on the magnetic resonance image, and configured to treat the target object by emitting laser; and [see [0060] of Cao] and
a temperature measurement element, [temperature measuring optical fiber (TMOF) 8] configured to measure a temperature of a position at an edge of the target object, [see [0086]-[0087] and FIG. 2 of Cao] the position being farthest from the LITT probe. [see [0107] of Cao disclosing production of a temperature image around the focal area of the LITT device. The temperature image would include a measure of temperature at all positions around the target region including the position being farthest from the LITT probe]
a processing module, configured to determine a target output dose value of the LITT device based at least partially on the temperature of the position at the edge of the target object.
a processing module, configured to determine a target output dose value of the LITT device based at least partially on the temperature of the position at the edge of the target object.
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the apparatus of Cao further such that it includes a processing module, configured to determine a target output dose value of the LITT device based at least partially on the temperature of the position at the edge of the target object.
Cao does not disclose a processing module, configured to determine a target output dose value of the LITT device based at least partially on the temperature of the position at the edge of the target object.
Torchia, directed toward laser therapy with temperature monitoring in real-time [see abstract of Torchia] further discloses a processing module, configured to determine a target output dose value of the LITT device based at least partially on the temperature of the position at the edge of the target object. [see [0149] and claim 19 of Torchia disclosing that the temperature in the boundary zone 90 is monitored and used to determine the heating dose of the laser device]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the apparatus of Cao further such that it includes a processing module, configured to determine a target output dose value of the LITT device based at least partially on the temperature of the position at the edge of the target object according to the teachings of Torchia in order to avoid temperature overshoot which results in damaging the tissue. [see [0149] of Torchia]
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Cao et al. (U.S. Publication No. 2024/0285341) hereinafter “Cao” in view of in view of Torchia et al. (U.S. Publication No. 2014/0288542) hereinafter “Torchia” as applied to claim 19 above and further in view of Manns et al. (“In situ temperature measurements with thermocouple probes during laser interstitial thermotherapy (LITT), Lasers in surgery and Medicine 23:94-103 (1998)) hereinafter “Manns”.,
Regarding claim 20, Cao as modified by Torchia discloses all the limitations of claim 19 [see rejection of claim 19]
Cao as modified by Torchia does not expressly disclose that the temperature measurement element comprises an LITT photon thermometric probe.
Manns further discloses that the temperature measurement element comprises an LITT photon thermometric probe. [see page 95, right column, section under “materials and methods” disclosing using a fiber-optic LITT probe]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the apparatus of Cao as modified by Torchia further such that the temperature measurement element comprises an LITT photon thermometric probe according to the teachings of Manns in order to ensure consistent light emission of the probe [see page 96, left column, first 5 lines]
Claims 21-27 are rejected under 35 U.S.C. 103 as being unpatentable over Cao et al. (U.S. Publication No. 2024/0285341) hereinafter “Cao” in view of in view of Torchia et al. (U.S. Publication No. 2014/0288542) hereinafter “Torchia” as applied to claim 19 above and further in view of Capote et al. (U.S. Publication No. 2021/0386478) hereinafter “Capote”.
Regarding claim 21, Cao as modified by Torchia discloses all the limitations of claim 19 above [see rejection of claim 19]
Cao as modified by Torchia does not expressly disclose a processing module, configured to: determine a target output dose value of the LITT device based on a difference between the temperature measured by the temperature measurement element the and a preset temperature range when the temperature measured by the temperature measurement element exceeds the preset temperature range so that temperature measured by the temperature measurement element returns back to the preset temperature range.
Capote, directed towards dose adjustment of a LITT probe [see abstract of Capote] further disclose a processing module [processors 174], configured to: determine a target output dose value of the LITT device based on a difference between the temperature measured by the temperature measurement element the and a preset temperature range[see [0055]-[0056] of Capote] when the temperature measured by the temperature measurement element exceeds the preset temperature range so that temperature measured by the temperature measurement element returns back to the preset temperature range [see [0059]-[0060] of Capote; if the temperature threshold is passed, the laser is turned off (i.e. dose is zero) to bring the temperature down]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the apparatus of Cao as modified by Torchia further such that it includes a processing module, configured to: determine a target output dose value of the LITT device based on a difference between the temperature measured by the temperature measurement element the and a preset temperature range when the temperature measured by the temperature measurement element exceeds the preset temperature range so that temperature measured by the temperature measurement element returns back to the preset temperature range according to the teachings of Capote in order to relate and control the temperature of the tissue during the LITT treatment [see [0002] of Capote]
Regarding claim 22, Cao as modified by Torchia and Capote discloses all the limitations of claim 21 above [see rejection of claim 21]
Capote further discloses a laser power attenuator, configured to adjust a current output dose value of the LITT device to the target output dose value. [see [0059]-[0060] of Capote; if the temperature threshold is passed, the laser is turned off (i.e. dose is zero) to bring the temperature down]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the apparatus of Cao as modified by Torchia further such that it includes a laser power attenuator, configured to adjust a current output dose value of the LITT device to the target output dose value according to the teachings of Capote in order to relate and control the temperature of the tissue during the LITT treatment [see [0002] of Capote]
Regarding claim 23, Cao as modified by Torchia and Capote discloses all the limitations of claim 22 above [see rejection of claim 22]
Capote further discloses that the laser power attenuator adjusts current output dose value dynamically so that the temperature measured by the temperature measurement element is within the preset temperature range. [see [0059]-[0060] of Capote; if the temperature threshold is passed, the laser is turned off (i.e. dose is zero) to bring the temperature down]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the apparatus of Cao and Torchia further such that the laser power attenuator adjusts current output dose value dynamically so that the temperature measured by the temperature measurement element is within the preset temperature range according to the teachings of Capote in order to relate and control the temperature of the tissue during the LITT treatment [see [0002] of Capote]
Regarding claim 24, Cao as modified by Torchia and Capote discloses all the limitations of claim 21 above [see rejection of claim 21]
Cao as modified by Torchia and Capote discloses a preset temperature set by the user [see [0059]-[0060] of Capote]
Cao as modified by Capote does not specify the set temperature range is 46±1°C.
However, it would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the temperature setting of Cao as modified by Capote and make the preset temperature be at 46±1 degrees since it has been held that once the general conditions of a claim are disclosed in the prior art, discovering optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 25, Cao as modified by Torchia discloses all the limitations of claim 19 above [see rejection of claim 19]
Cao as modified by Torchia does not expressly disclose that the LITT probe comprises an LITT lateral ablation probe and an LITT circumferential ablation probe.
Capote further discloses that the LITT probe comprises an LITT lateral ablation probe and an LITT circumferential ablation probe. [see [0027] disclosing that the handle 112 may include a single laterally extending arm, rectangular or circular shaped laterally extending arms]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the apparatus of Cao as modified by Torchia further such that the LITT probe comprises an LITT lateral ablation probe and an LITT circumferential ablation probe according to the teachings of Capote in order to better anchor to the body during treatment [see [0027] of Capote]
Regarding claim 26, Cao as modified by Torchia and Capote discloses all the limitations of claim 25 above [see rejection of claim 25]
Capote further discloses that the LITT circumferential ablation probe is set at an equivalent center of the target object, the temperature measurement element is set at a position on the edge of the target object and farthest from the LITT circumferential ablation probe, and a distance between the LITT circumferential ablation probe and the temperature measurement element is equal to or close to an equivalent radius of the target object. [see [0032] disclosing a radial distance L1 between the tip of the probe and the temperature sensor]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the apparatus of Cao as modified by Torchia and Capote further such that the LITT circumferential ablation probe is set at an equivalent center of the target object, the temperature measurement element is set at a position on the edge of the target object and farthest from the LITT circumferential ablation probe, and a distance between the LITT circumferential ablation probe and the temperature measurement element is equal to or close to an equivalent radius of the target object according to the teachings of Capote in order to radially separate the laser probe from the temperature probe providing accurate temperature reading [see [0027] and [0032] of Capote disclosing distance of between 5mm-10mm]
Cao as modified by Capote does not specify that the distance is equal to the radius of the target object.
However, it would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the temperature setting of Cao as modified by Capote and make the preset temperature be at 46±1 degrees since it has been held that once the general conditions of a claim are disclosed in the prior art, discovering optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 27, Cao as modified by Torchia and Capote discloses all the limitations of claim 25 above [see rejection of claim 25]
Capote further discloses that the LITT lateral ablation probe is set at a lateral side on an edge of the target object, the temperature measurement element is set at an opposite side of the LITT lateral ablation probe on the edge of the target object and farthest from the LITT lateral ablation probe, and a distance between the LITT lateral ablation probe and the temperature measurement element is equal to or close to an equivalent diameter of the target object. [see [0032] disclosing a radial distance L1 between the tip of the probe and the temperature sensor]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the apparatus of Cao as modified by Torchia and Capote further such that the LITT lateral ablation probe is set at a lateral side on an edge of the target object, the temperature measurement element is set at an opposite side of the LITT lateral ablation probe on the edge of the target object and farthest from the LITT lateral ablation probe, and a distance between the LITT lateral ablation probe and the temperature measurement element is equal to or close to an equivalent diameter of the target object according to the teachings of Capote in order to radially separate the laser probe from the temperature probe providing accurate temperature reading [see [0027] and [0032] of Capote]
Cao as modified by Torchia and Capote does not specify that the distance is equal to the diameter of the target object.
However, it would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the temperature setting of Cao as modified by Capote and make the preset temperature be at 46±1 degrees since it has been held that once the general conditions of a claim are disclosed in the prior art, discovering optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 28-30 are rejected under 35 U.S.C. 103 as being unpatentable over Cao et al. (U.S. Publication No. 2024/0285341) hereinafter “Cao” in view of in view of Torchia et al. (U.S. Publication No. 2014/0288542) hereinafter “Torchia” as applied to claim 19 above and further in view of Andrews et al. (U.S. Publication No. 2015/0265353) hereinafter “Andrews”.
Regarding claim 28, Cao as modified by Torchia discloses all the limitations of claim 19 above [see rejection of claim 19]
Cao as modified by Torchia does not expressly disclose a first driving device, wherein the first driving device is coupled to the LITT probe and controls a translational motion and a rotational motion of the LITT probe; and a second driving device, wherein the second driving device is coupled to the temperature measurement element and controls a translational motion of the temperature measurement element.
Andrews disclose a first driving device, wherein the first driving device [probe driver 208; see [0055] and [0058] and FIG. 2] is coupled to the LITT probe and controls a translational motion and a rotational motion of the LITT probe; [see [0059] of Andrews] and a second driving device, wherein the second driving device is coupled to the temperature measurement element and controls a translational motion of the temperature measurement element. [see [0057]-[0059] of Andrews]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the apparatus of Cao as modified by Torchia further such that it would include a first driving device, wherein the first driving device is coupled to the LITT probe and controls a translational motion and a rotational motion of the LITT probe; and a second driving device, wherein the second driving device is coupled to the temperature measurement element and controls a translational motion of the temperature measurement element according to the teachings of Andrews in order to bring the LITT device in proper location for treatment [see [0059] of Andrews]
Regarding claim 29, Cao as modified by Torchia and Andrews discloses all the limitations of claim 28 above [see rejection of claim 28]
Andrews further discloses that the first driving device comprises: a first translation cable and a first rotation cable, and a first translation control mechanism and a first rotation control mechanism, wherein the first translation cable and the first rotation cable are connected to the first translation control mechanism and the first rotation control mechanism, [see [0059] of Andrews] respectively, the first translation control mechanism and the first rotation control mechanism are connected to the LITT probe, and the translational motion and the rotational motion of the LITT probe are controlled via the first translation cable and the first rotation cable, respectively. [see [0057]-[0059] of Andrews]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the apparatus of Cao as modified by Torchia and Andrews further such that the first driving device comprises: a first translation cable and a first rotation cable, and a first translation control mechanism and a first rotation control mechanism, wherein the first translation cable and the first rotation cable are connected to the first translation control mechanism and the first rotation control mechanism, respectively, the first translation control mechanism and the first rotation control mechanism are connected to the LITT probe, and the translational motion and the rotational motion of the LITT probe are controlled via the first translation cable and the first rotation cable, respectively according to the teachings of Andrews in order to bring the LITT device in proper location for treatment [see [0059] of Andrews]
Regarding claim 30, Cao as modified by Torchia and Andrews discloses all the limitations of claim 29 above [see rejection of claim 29]
Andrews further discloses that the second driving device comprises: a second translation cable, and a second translation control mechanism, wherein the second translation cable is connected to the second translation control mechanism, the second translation control mechanism is connected to temperature measurement element, and the translational motion of the temperature measurement element is controlled via the second translation cable. [see [0057]-[0059] of Andrews]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the apparatus of Cao as modified by Torchia and Andrews further such that the second driving device comprises: a second translation cable, and a second translation control mechanism, wherein the second translation cable is connected to the second translation control mechanism, the second translation control mechanism is connected to temperature measurement element, and the translational motion of the temperature measurement element is controlled via the second translation cable according to the teachings of Andrews in order to bring the LITT device in proper location for treatment [see [0059] of Andrews]
Claims 31, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Cao et al. (U.S. Publication No. 2024/0285341) hereinafter “Cao” in view of in view of Torchia et al. (U.S. Publication No. 2014/0288542) hereinafter “Torchia” as applied to claim 19 above and further in view of Yang et al (““Optical coherence and doppler tomography for monitoring tissue changes induced by laser thermal therapy”, Rev. of Sci. Instruments, Vol 74, No. 1, 2003) hereinafter “Yang”.
Regarding claim 31, Cao as modified by Torchia discloses all the limitations of claim 19 [see rejection of claim 19]
Cao as modified by Torchia does not expressly disclose that the medical treatment apparatus further comprises: an optical coherence tomography (OCT) device, configured for imaging of the target object, and generate an OCT image.
Yang, directed towards monitoring tissue changes during LITT procedure [see abstract of Yang] further discloses that the medical treatment apparatus further comprises: an optical coherence tomography (OCT) device, configured for imaging of the target object, and generate an OCT image. [see FIG. 1 and page 437, left column, section under “apparatus” disclosing an OCT device to monitor the target]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the apparatus of Cao as modified by Torchia further such that the medical treatment apparatus further comprises: an optical coherence tomography (OCT) device, configured for imaging of the target object, and generate an OCT image according to the teachings of Yang in order to monitor the microstructural and microvascular changes induced by laser thermal therapy [see page 437, left column, section under “Introduction”]
Regarding claim 32, Cao as modified by Torchia and Yang discloses all the limitations of claim 31 [see rejection of claim 31]
Yang further disclose that the OCT device comprises an OCT probe, the OCT probe emitting light signals to the target object for imaging of the target object in a treatment process. [see FIG. 1 and page 437, left column, section under “apparatus” continued in the right column disclosing an OCT probe emitting light and detecting images of the target during the treatment process.]
It would have been obvious to a person of ordinary skill level at the time of the filing of the invention to modify the apparatus of Cao as modified by Torchia and Yang further such that the OCT device comprises an OCT probe, the OCT probe emitting light signals to the target object for imaging of the target object in a treatment process according to the teachings of Yang in order to monitor the microstructural and microvascular changes induced by laser thermal therapy [see page 437, left column, section under “Introduction”]
Response to Arguments
Applicant’s arguments with respect to claim(s) 03/30/2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 MARJAN - SABOKTAKIN whose telephone number is (303)297-4278. The examiner can normally be reached M-F 9 am-5pm CT.
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/MARJAN SABOKTAKIN/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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