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 information disclosure statement (IDS) was submitted on 12/06/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “200” in Fig. 3C. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because [1] reference character “225” has been used to designate both the “adapter member 225” and the “connecting portion 228” in Fig. 3C (i.e., the second recitation of “225” in Fig. 3C, which is on the left side of the figure, should be changed to “228” to reference the connecting portion); and [2] reference character “345” has been used to designate both the step of “exceeds a threshold temperature value 344” and the step of “cause 345 an intervening action” in Fig. 6 (i.e., see Para. [0072]). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because the reference number “177” has been used to designate the “memory 173” box in Fig. 4 instead of designating the “modules” box within the “memory 173” box in Fig. 4 (i.e., see Para. [0051-0052] and [0055]). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: [1] “an area 199” in Para. [0066]; and [2] “a threshold temperature value 344” in Para. [0072]. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 5, 8, and 11-16 are objected to because of the following informalities:
Claim 5, lines 2-3, the limitation “through which the LDF is to be inserted” should be changed to “through which the LDF is configured to be inserted”;
Claim 5, line 6, the limitation “wherein the MR safe temperature probe is to be inserted through” should be changed to “wherein the MR safe temperature probe is configured to be inserted through”;
Claim 8, line 2, the limitation “associated with the calculated temperature data” should be changed to “associated with the calculated temperature” (i.e., remove the word “data” in order to maintain consistent terminology throughout the claims);
Claim 8, line 3, the limitation “compare the calculated temperature data” should be changed to “compare the calculated temperature” (i.e., remove the word “data” in order to maintain consistent terminology throughout the claims);
Claim 11, line 8, the limitation “determine when a temperature delta between the calculated temperature” should be changed to “determine when a temperature delta between the second calculated temperature”;
Claim 12, line 8, the limitation “based on the measured temperature” should be changed to “based on the measured temperature data”;
Claim 13, line 1, the limitation “The non-transitory computer-readable medium of claim 9 wherein” should be changed to “The non-transitory computer-readable medium of claim 9, wherein” (i.e., add a comma in order to maintain consistency throughout the claims);
Claim 14, lines 5-6, the limitation “a location of the temperature sensor” should be changed to “a location of the MR safe temperature sensor”;
Claim 15, line 1, the limitation “wherein the temperature sensor” should be changed to “wherein the MR safe temperature sensor”; and
Claim 16, lines 1-2, the limitation “further comprising positioning the temperature sensor” should be changed to “further comprising positioning the MR safe temperature sensor”.
Appropriate correction is required.
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.
Claim 5 is 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.
Claim 5 recites the limitation “the bone anchor” in lines 4-5. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether this limitation is referring to the “bone anchor fixture” of claim 1, to the “bone anchor body” of claim 5, or to a different component. For examination purposes, the limitation “the bone anchor” of claim 5 is interpreted as corresponding to the “bone anchor fixture” of claim 1. Clarification is required.
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.
Claims 1, 3-5, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Streicher et al. (NPL: “Effects of air susceptibility on proton resonance frequency MR thermometry”, of record, hereinafter Streicher) in view of Dowlatshahi (US 2002/0151778 A1, of record, hereinafter Dowlatshahi), and further in view of Tyc et al. (US 2015/0257830 A1, of record, hereinafter Tyc).
Regarding claim 1, Streicher discloses a system comprising:
a magnetic resonance (MR) safe temperature probe comprising a temperature sensor (see, e.g., Page 42, left-hand column, lines 21-28, “An accurate fibre-optic temperature sensor (Luxtron LumaSense Technologies, Santa Clara, CA, USA) was placed inside the polystyrene box to monitor the air temperature around the phantom, and another fibre-optic temperature sensor was placed in the centre of the agar phantom. At the active point of the fibre-optic thermometer, a MR image voxel was used to compare the fibre-optic temperature with the MR temperature”); and
a processor (see, e.g., Page 42, right-hand column, lines 13-19, “MR magnitude and phase images were acquired continuously throughout the experiments with a standard 2D spoiled gradient echo sequence (… voxel size 2 x 2 x 2 mm3 for the hot air experiment and 3 x 3 x 3 mm3 for the gas composition experiment)”, where the processing is performed by a computer by use of voxels) to:
receive measured temperature data from the MR safe temperature probe (see, e.g., Page 42, left-hand column, lines 21-28, “An accurate fibre-optic temperature sensor (Luxtron LumaSense Technologies, Santa Clara, CA, USA) was placed inside the polystyrene box to monitor the air temperature around the phantom, and another fibre-optic temperature sensor was placed in the centre of the agar phantom. At the active point of the fibre-optic thermometer, a MR image voxel was used to compare the fibre-optic temperature with the MR temperature”);
correlate a pixel in a magnetic resonance image with a location of the temperature sensor (see, e.g., Page 42, left-hand column, lines 26-28, “a MR image voxel was used to compare the fibre-optic temperature with the MR temperature”, where this step inevitably requires the correlation of the voxel with the location of the sensor); and
compare a calculated temperature of the pixel from a temperature model with the measured temperature data from the MR safe temperature probe (see, e.g., Page 42, left-hand column, lines 26-28, “a MR image voxel was used to compare the fibre-optic temperature with the MR temperature”).
Streicher does not specifically disclose [1] a bone anchor fixture configured to maintain a target distance between the MR safe temperature probe and a laser diffusion fiber (LDF); and [2] determining when a difference between the calculated temperature and the measured temperature data exceeds a threshold.
However, in the same field of endeavor of temperature probes, Dowlatshahi discloses a bone anchor fixture (probe holder 12) configured to maintain a target distance (radial distance r3) between the MR safe temperature probe (temperature probe 16) and a laser diffusion fiber (LDF) (laser probe 14) (see, e.g., Figs. 1A, 2A-2B, and 3, and Abstract, which discloses that the system is configured to be inserted into a tumor mass, and Para. [0035], “the present invention preferably includes a laser gun 10 including a probe holder 12 employed during interstitial laser therapy. The probe holder 12 is adapted to receive a laser probe 14 and a temperature probe 16. The laser probe 14 and temperature probe 16 are removably inserted in and extend from the probe holder. The laser probe 14 and the temperature probe 16 are held in fixed position relative to each other by the gun”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Streicher by including [1] a bone anchor fixture configured to maintain a target distance between the MR safe temperature probe and a laser diffusion fiber (LDF), as disclosed by Dowlatshahi. One of ordinary skill in the art would have been motivated to make this modification in order to desirably and correctly position the temperature probe relative to the temperature sensor/laser probe, as recognized by Dowlatshahi (see, e.g., Para. [0032-0036]).
Streicher modified by Dowlatshahi still does not specifically disclose [2] determining when a difference between the calculated temperature and the measured temperature data exceeds a threshold.
However, in the same field of endeavor of MRI compatible laser probes/sensors that provide thermal therapy, Tyc discloses determining when a difference between the calculated temperature and the measured temperature data exceeds a threshold (see, e.g., Para. [0368], “the reference points selected in Stage 1 may be "validated." The reference points are used to compute a temperature difference at every location within the Stage 1 masked region. A temperature threshold can then be applied. Pixels whose temperature difference exceeds the threshold can be removed or masked, indicating to the operator the stability of the temperature mapping in the treatment area prior to treatment”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the system of Streicher modified by Dowlatshahi by including [2] determining when a difference between the calculated temperature and the measured temperature data exceeds a threshold, as disclosed by Tyc. One of ordinary skill in the art would have been motivated to make this modification in order to indicate to the operator the stability of the temperature mapping in the treatment area prior to treatment, as recognized by Tyc (see, e.g., Para. [0368]).
Regarding claim 3, Streicher modified by Dowlatshahi and Tyc discloses the system of claim 1, as set forth above. Streicher does not specifically disclose wherein the target distance is between 5 millimeters and 10 millimeters.
However, in the same field of endeavor of temperature probes, Dowlatshahi discloses wherein the target distance (radial distance r3) is between 5 millimeters and 10 millimeters (see, e.g., Para. [0051], “Each temperature detector is also located at various radial distances from the temperature sensor Tc (i.e., the temperature at the center of the tumor mass) of the laser probe 14, namely, r1, r2, r3, r4 and r5. The radial distance between Tc and T3 (i.e., r3) is known, that is, the axial distance between Tc and T3, preferably 1.0 cm”, and Fig. 3, where the distance between the MR safe temperature probe/sensor and the laser diffusion fiber/probe is represented as r3, which is disclosed to be 1 cm=10 mm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the system of Streicher modified by Dowlatshahi and Tyc by including wherein the target distance is between 5 millimeters and 10 millimeters, as disclosed by Dowlatshahi. One of ordinary skill in the art would have been motivated to make this modification in order to desirably and correctly position the temperature probe relative to the temperature sensor/laser probe, as recognized by Dowlatshahi (see, e.g., Para. [0032-0036]).
Regarding claim 4, Streicher modified by Dowlatshahi and Tyc discloses the system of claim 1, as set forth above. Streicher modified by Dowlatshahi and Tyc does not disclose wherein the target distance is specifically 8 millimeters. However, Dowlatshahi does disclose wherein the target distance (radial distance r3) is 10 millimeters (see, e.g., Para. [0051], “Each temperature detector is also located at various radial distances from the temperature sensor Tc (i.e., the temperature at the center of the tumor mass) of the laser probe 14, namely, r1, r2, r3, r4 and r5. The radial distance between Tc and T3 (i.e., r3) is known, that is, the axial distance between Tc and T3, preferably 1.0 cm”, and Fig. 3, where the distance between the MR safe temperature probe/sensor and the laser diffusion fiber/probe is represented as r3, which is disclosed to be 1 cm=10 mm).
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, through routine experimentation, to have further modified the system of Streicher modified by Dowlatshahi and Tyc by including that the target distance is specifically 8 millimeters (instead of 10 millimeters as disclosed by Dowlatshahi) because, as seen in MPEP § 2144.05, subsection II, under the header “Routine Optimization”, this would be seen as optimizing the spacing between the MR safe temperature probe/sensor and the laser diffusion fiber/probe to achieve the desired functionality, as evidenced by Dowlatshahi (see, e.g., Para. [0055], “When T3 reaches or increases to a temperature, preferably 60.degree. C., which would destroy the tumor mass, that is, the tumor mass destruction temperature, the volume of tumor mass destroyed effectively corresponds to the volume of a spherical region having a radial distance of r3”). It is considered routine optimization because, as evidenced above in Dowlatshahi, a person having ordinary skill in the art would be motivated to do routine experimentation to obtain the end result of providing an optimized spacing between the MR safe temperature probe/sensor and the laser diffusion fiber/probe that is configured to achieve the desired functionality (i.e., being the correct sizing to accurately apply the disclosed therapy to the tumor/tissue). See MPEP § 2144.05, subsection II(A).
Regarding claim 5, Streicher modified by Dowlatshahi and Tyc discloses the system of claim 1, as set forth above. Streicher does not specifically disclose wherein the bone anchor fixture comprises: a bone anchor body comprising a first lumen through which the LDF is to be inserted; and an adapter coupled to the bone anchor body and extending to a side of the bone anchor, the adapter comprising a second lumen that is the target distance away from the first lumen, wherein the MR safe temperature probe is to be inserted through the second lumen.
However, in the same field of endeavor of temperature probes, Dowlatshahi discloses wherein the bone anchor fixture (probe holder 12) comprises: a bone anchor body comprising a first lumen through which the LDF (laser probe 14) is to be inserted; and an adapter coupled to the bone anchor body and extending to a side of the bone anchor, the adapter comprising a second lumen that is the target distance (radial distance r3) away from the first lumen, wherein the MR safe temperature probe (temperature probe 16) is to be inserted through the second lumen (see, e.g., Figs. 1A, 2A-2B, and 3, and Para. [0035], “the present invention preferably includes a laser gun 10 including a probe holder 12 employed during interstitial laser therapy. The probe holder 12 is adapted to receive a laser probe 14 and a temperature probe 16. The laser probe 14 and temperature probe 16 are removably inserted in and extend from the probe holder. The laser probe 14 and the temperature probe 16 are held in fixed position relative to each other by the gun”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the system of Streicher modified by Dowlatshahi and Tyc by including wherein the bone anchor fixture comprises: a bone anchor body comprising a first lumen through which the LDF is to be inserted; and an adapter coupled to the bone anchor body and extending to a side of the bone anchor, the adapter comprising a second lumen that is the target distance away from the first lumen, wherein the MR safe temperature probe is to be inserted through the second lumen, as disclosed by Dowlatshahi. One of ordinary skill in the art would have been motivated to make this modification in order to desirably and correctly position the temperature probe relative to the temperature sensor/laser probe, as recognized by Dowlatshahi (see, e.g., Para. [0032-0036]).
Regarding claim 7, Streicher modified by Dowlatshahi and Tyc discloses the system of claim 1, as set forth above. Streicher modified by Dowlatshahi does not specifically disclose wherein when the threshold is exceeded, the processor causes an intervening action to occur; and wherein to cause the intervening action comprises at least one of generating an alert, transmitting a control signal to a laser ablation system, and updating the temperature model.
However, in the same field of endeavor of MRI compatible laser probes/sensors that provide thermal therapy, Tyc discloses wherein when the threshold is exceeded, the processor causes an intervening action to occur (see, e.g., Para. [0368], “the reference points selected in Stage 1 may be "validated." The reference points are used to compute a temperature difference at every location within the Stage 1 masked region. A temperature threshold can then be applied. Pixels whose temperature difference exceeds the threshold can be removed or masked, indicating to the operator the stability of the temperature mapping in the treatment area prior to treatment”); and
wherein to cause the intervening action comprises at least one of generating an alert, transmitting a control signal to a laser ablation system, and updating the temperature model (see, e.g., Para. [0368], “the reference points selected in Stage 1 may be "validated." The reference points are used to compute a temperature difference at every location within the Stage 1 masked region. A temperature threshold can then be applied. Pixels whose temperature difference exceeds the threshold can be removed or masked, indicating to the operator the stability of the temperature mapping in the treatment area prior to treatment”, where the operator is alerted/indicated to a temperature difference exceeding the threshold that affects the stability of the temperature mapping).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the system of Streicher modified by Dowlatshahi and Tyc by including wherein when the threshold is exceeded, the processor causes an intervening action to occur; and wherein to cause the intervening action comprises at least one of generating an alert, transmitting a control signal to a laser ablation system, and updating the temperature model, as disclosed by Tyc. One of ordinary skill in the art would have been motivated to make this modification in order to indicate to the operator the stability of the temperature mapping in the treatment area prior to treatment, as recognized by Tyc (see, e.g., Para. [0368]).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Streicher (NPL) in view of Dowlatshahi (US 2002/0151778 A1) and Tyc (US 2015/0257830 A1), as applied to claim 1 above, and further in view of Kocaturk et al. (US 2021/0298606 A1, of record, hereinafter Kocaturk).
Regarding claim 2, Streicher modified by Dowlatshahi and Tyc discloses the system of claim 1, as set forth above. Streicher modified by Dowlatshahi and Tyc does not specifically disclose wherein the temperature sensor comprises a gallium arsenide crystal.
However, in the same field of endeavor of temperature sensors used during MRI, Kocaturk discloses wherein the temperature sensor comprises a gallium arsenide crystal (see, e.g., Para. [0063], “Yet in another alternative embodiment, a temperature sensor may be integrated into the acousto-optical based MRI dosimeter device, for example, by attaching the temperature sensor at the end of the optical fiber. In certain exemplary implementations, a reflection spectrum corresponding the localized temperature may be monitored to provide absolute temperature information… Such gallium arsenide (GaAs) crystal-based optical temperature sensors are well known, but they have not previously been integrated with acousto-optical RF sensors”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the system of Streicher modified by Dowlatshahi and Tyc by including wherein the temperature sensor comprises a gallium arsenide crystal, as disclosed by Kocaturk. One of ordinary skill in the art would have been motivated to make this modification in order to provide/determine the desired temperature data, as recognized by Kocaturk (see, e.g., Para. [0063]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Streicher (NPL) in view of Dowlatshahi (US 2002/0151778 A1) and Tyc (US 2015/0257830 A1), as applied to claim 1 above, and further in view of Andrews et al. (US 2015/0265366 A1, of record, hereinafter Andrews).
Regarding claim 6, Streicher modified by Dowlatshahi and Tyc discloses the system of claim 1, as set forth above. Streicher modified by Dowlatshahi and Tyc does not specifically disclose wherein the bone anchor fixture comprises: a bone anchor body with a single lumen; and a guide member disposed within the bone anchor body, wherein the guide member separates the LDF and the MR safe temperature probe within the single lumen by the target distance.
However, in the same field of endeavor of MRI compatible laser probes/sensors that provide thermal therapy, Andrews discloses wherein the bone anchor fixture (low profile skull anchoring device 504) comprises:
a bone anchor body (guide stem 506) with a single lumen (see, e.g., Para. [0086], “Turning to FIG. 5A, the low profile skull anchoring device 504 includes a removable guide stem 506”); and
a guide member (guide sheath 540) disposed within the bone anchor body (506) (see, e.g., Para. [0127], “Turning to FIGS. 5F and 5G, in certain embodiments, rather than inserting instruments directly into the removable guide stem 506 or 520, a guide sheath 540 is inserted into the removable guide stem (e.g., removable guide stem 506). The guide sheath 540 may include, for example, one or more distal openings and one or more proximal openings to introduce at least one neurosurgical instrument to the ROI in the patient's brain”), wherein the guide member (540) separates a first instrument and a second instrument within the single lumen by the target distance (see, e.g., Para. [0132], “one or more guide sleeves (not illustrated) may be secured inside the guide sheath 540, each of the one or more guide sleeves having a different distal end diameter. A divided (e.g., bifurcated) guide sleeve, in certain embodiments, may be used to introduce two or more instruments simultaneously or concurrently, each with a particular instrument diameter”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the system of Streicher modified by Dowlatshahi and Tyc by including wherein the bone anchor fixture comprises: a bone anchor body with a single lumen; and a guide member disposed within the bone anchor body, wherein the guide member separates the LDF and the MR safe temperature probe within the single lumen by the target distance, as disclosed by Andrews. One of ordinary skill in the art would have been motivated to make this modification in order to desirably introduce two or more instruments (each with a desired instrument diameter) simultaneously or concurrently into a single lumen, as recognized by Andrews (see, e.g., Para. [0132]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Streicher (NPL) in view of Dowlatshahi (US 2002/0151778 A1) and Tyc (US 2015/0257830 A1), as applied to claim 1 above, and further in view of Grant et al. (US 2016/0287334 A1, of record, hereinafter Grant).
Regarding claim 8, Streicher modified by Dowlatshahi and Tyc discloses the system of claim 1, as set forth above. Streicher modified by Dowlatshahi and Tyc does not specifically disclose wherein the processor is further configured to record a time stamp associated with the calculated temperature data and the measured temperature data and compare the calculated temperature data and the measured temperature data of the pixel across time.
However, in the same field of endeavor of temperature sensing of tissue (with treatment), Grant discloses wherein the processor is further configured to record a time stamp associated with the calculated temperature data and the measured temperature data and compare the calculated temperature data and the measured temperature data of the pixel across time (see, e.g., Disclosed claim 19, “A method for monitoring brain signal activity using a plurality of interstitial recording instruments, comprising: positioning each recording instrument of the plurality of interstitial recording instruments in a respective predetermined geographic zone within brain tissue of a patient, […] wherein the at least one recording element is within, upon, or proximate the tip region, over a period of time, collecting a series of signal sets from the plurality of interstitial recording instruments, wherein collecting the series of signal sets comprises collecting, by processing circuitry, a respective signal set from each recording instrument of the plurality of interstitial recording instruments; associating, by the processing circuitry, each respective signal set with a) the respective predetermined geographic zone of the corresponding recording instrument of the plurality of interstitial recording instruments, and b) a timestamp; analyzing, by the processing circuitry, the series of signal sets to identify one or more geographic zones exhibiting evidence of an unwellness condition; and responsive to identifying the one or more geographic zones exhibiting the evidence, issuing a response to the evidence, wherein the response comprises at least one of i) alerting an operator, ii) activating suppression of the evidence of the unwellness condition, and iii) activating suppression of nearby signals to continue to record the evidence with reduced noise”, and Para. [0158], “The signals recordings may include discrete signal measurements and/or signal patterns sensed over a period of time. The signals, in some examples, may optionally be filtered, amplified, or otherwise adjusted prior to receipt by the method 580. Further, in some embodiments, the signal recordings may be provided with contemporaneous data such as, in some examples, time stamp data, tissue temperature recording data, probe temperature recording data, therapeutic emission pattern data, and/or biometric data (e.g., heart rate, pulse rate, breathing rate, etc.) of the patient”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the system of Streicher modified by Dowlatshahi and Tyc by including wherein the processor is further configured to record a time stamp associated with the calculated temperature data and the measured temperature data and compare the calculated temperature data and the measured temperature data of the pixel across time, as disclosed by Grant. One of ordinary skill in the art would have been motivated to make this modification in order to desirably record and compare temperature data over a time period, as recognized by Grant (see, e.g., Disclosed claim 19, and Para. [0158]).
Claims 9-11, 14, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Streicher et al. (NPL: “Effects of air susceptibility on proton resonance frequency MR thermometry”, of record, hereinafter Streicher) in view of Tyc et al. (US 2015/0257830 A1, of record, hereinafter Tyc).
Regarding claim 9, Streicher discloses a non-transitory computer-readable medium including instructions that when executed by one or more processors (see, e.g., Page 42, right-hand column, lines 13-19, “MR magnitude and phase images were acquired continuously throughout the experiments with a standard 2D spoiled gradient echo sequence (… voxel size 2 x 2 x 2 mm3 for the hot air experiment and 3 x 3 x 3 mm3 for the gas composition experiment)”, where the processing is performed by a computer by use of voxels) of a temperature control system (see, e.g., Page 42, left-hand column, lines 21-28, “An accurate fibre-optic temperature sensor (Luxtron LumaSense Technologies, Santa Clara, CA, USA) was placed inside the polystyrene box to monitor the air temperature around the phantom, and another fibre-optic temperature sensor was placed in the centre of the agar phantom. At the active point of the fibre-optic thermometer, a MR image voxel was used to compare the fibre-optic temperature with the MR temperature”) cause the temperature control system to:
receive measured temperature data from a magnetic resonance (MR) safe temperature probe comprising a temperature sensor (see, e.g., Page 42, left-hand column, lines 21-28, “An accurate fibre-optic temperature sensor (Luxtron LumaSense Technologies, Santa Clara, CA, USA) was placed inside the polystyrene box to monitor the air temperature around the phantom, and another fibre-optic temperature sensor was placed in the centre of the agar phantom. At the active point of the fibre-optic thermometer, a MR image voxel was used to compare the fibre-optic temperature with the MR temperature”);
correlate a pixel in a magnetic resonance image with a location of the temperature sensor (see, e.g., Page 42, left-hand column, lines 26-28, “a MR image voxel was used to compare the fibre-optic temperature with the MR temperature”, where this step inevitably requires the correlation of the voxel with the location of the sensor); and
compare a calculated temperature of the pixel from a temperature model with the measured temperature data from the MR safe temperature probe (see, e.g., Page 42, left-hand column, lines 26-28, “a MR image voxel was used to compare the fibre-optic temperature with the MR temperature”).
Streicher does not specifically disclose determining when a difference between the calculated temperature and the measured temperature data exceeds a threshold, wherein when the threshold is exceeded, cause an intervening action to occur.
However, in the same field of endeavor of MRI compatible laser probes/sensors that provide thermal therapy, Tyc discloses determining when a difference between the calculated temperature and the measured temperature data exceeds a threshold, wherein when the threshold is exceeded, cause an intervening action to occur (see, e.g., Para. [0368], “the reference points selected in Stage 1 may be "validated." The reference points are used to compute a temperature difference at every location within the Stage 1 masked region. A temperature threshold can then be applied. Pixels whose temperature difference exceeds the threshold can be removed or masked, indicating to the operator the stability of the temperature mapping in the treatment area prior to treatment”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the non-transitory computer-readable medium of Streicher by including determining when a difference between the calculated temperature and the measured temperature data exceeds a threshold, wherein when the threshold is exceeded, cause an intervening action to occur, as disclosed by Tyc. One of ordinary skill in the art would have been motivated to make this modification in order to indicate to the operator the stability of the temperature mapping in the treatment area prior to treatment, as recognized by Tyc (see, e.g., Para. [0368]).
Regarding claim 10, Streicher modified by Tyc discloses the non-transitory computer-readable medium of claim 9, as set forth above. Streicher does not specifically disclose wherein the intervening action comprises generating an alert on a computer interface.
However, in the same field of endeavor of MRI compatible laser probes/sensors that provide thermal therapy, Tyc discloses wherein the intervening action comprises generating an alert on a computer interface (see, e.g., Para. [0368], “the reference points selected in Stage 1 may be "validated." The reference points are used to compute a temperature difference at every location within the Stage 1 masked region. A temperature threshold can then be applied. Pixels whose temperature difference exceeds the threshold can be removed or masked, indicating to the operator the stability of the temperature mapping in the treatment area prior to treatment”, where the operator is alerted/indicated to a temperature difference exceeding the threshold that affects the stability of the temperature mapping).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the non-transitory computer-readable medium of Streicher modified by Tyc by including wherein the intervening action comprises generating an alert on a computer interface, as disclosed by Tyc. One of ordinary skill in the art would have been motivated to make this modification in order to indicate to the operator the stability of the temperature mapping in the treatment area prior to treatment, as recognized by Tyc (see, e.g., Para. [0368]).
Regarding claim 11, Streicher modified by Tyc discloses the non-transitory computer-readable medium of claim 9, as set forth above. Streicher does not specifically disclose wherein the instructions are further to cause the temperature control system to: track a second calculated temperature with a second pixel, wherein the second pixel is at a location removed from the MR safe temperature probe; compare the second calculated temperature of the second pixel from the temperature model with the measured temperature data from the MR safe temperature probe; and determine when a temperature delta between the calculated temperature and the measured temperature data exceeds a second threshold, wherein when the second threshold is exceeded, cause the intervening action to occur.
However, in the same field of endeavor of MRI compatible laser probes/sensors that provide thermal therapy, Tyc discloses wherein the instructions are further to cause the temperature control system to: track a second calculated temperature with a second pixel, wherein the second pixel is at a location removed from the MR safe temperature probe; compare the second calculated temperature of the second pixel from the temperature model with the measured temperature data from the MR safe temperature probe; and determine when a temperature delta between the calculated temperature and the measured temperature data exceeds a second threshold, wherein when the second threshold is exceeded, cause the intervening action to occur (see, e.g., Para. [0367], “With reference to FIG. 101, the first stage of noise masking (Stage 1) may simply analyze the quality of the incoming phase data, applying a threshold to formulate a masked image. During this process, the operator may select reference points in each of a plurality of views. Points that do not fall within the noise mask may be deleted. Once the minimum number of reference points has been selected, the process may then continue to a Stage 2 noise mask to compute a phase drift compensated temperature difference. Stage 1 may be immediately skipped if the reference points already exist prior to MRI data arriving”, and [0368], “In Stage 2, the reference points selected in Stage 1 may be "validated." The reference points are used to compute a temperature difference at every location within the Stage 1 masked region. A temperature threshold can then be applied. Pixels whose temperature difference exceeds the threshold can be removed or masked, indicating to the operator the stability of the temperature mapping in the treatment area prior to treatment”, where the disclosed “every location” would include a location corresponding to the claimed second pixel (i.e. a second pixel at a location removed from the temperature probe)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the non-transitory computer-readable medium of Streicher modified by Tyc by including wherein the instructions are further to cause the temperature control system to: track a second calculated temperature with a second pixel, wherein the second pixel is at a location removed from the MR safe temperature probe; compare the second calculated temperature of the second pixel from the temperature model with the measured temperature data from the MR safe temperature probe; and determine when a temperature delta between the calculated temperature and the measured temperature data exceeds a second threshold, wherein when the second threshold is exceeded, cause the intervening action to occur, as disclosed by Tyc. One of ordinary skill in the art would have been motivated to make this modification in order to indicate to the operator the stability of the temperature mapping in the treatment area prior to treatment, as recognized by Tyc (see, e.g., Para. [0368]).
Regarding claim 14, Streicher discloses a method for temperature control (see, e.g., Page 42, left-hand column, lines 21-28, “An accurate fibre-optic temperature sensor (Luxtron LumaSense Technologies, Santa Clara, CA, USA) was placed inside the polystyrene box to monitor the air temperature around the phantom, and another fibre-optic temperature sensor was placed in the centre of the agar phantom. At the active point of the fibre-optic thermometer, a MR image voxel was used to compare the fibre-optic temperature with the MR temperature”), the method comprising:
receiving measured temperature data from a magnetic resonance (MR) safe temperature sensor (see, e.g., Page 42, left-hand column, lines 21-28, “An accurate fibre-optic temperature sensor (Luxtron LumaSense Technologies, Santa Clara, CA, USA) was placed inside the polystyrene box to monitor the air temperature around the phantom, and another fibre-optic temperature sensor was placed in the centre of the agar phantom. At the active point of the fibre-optic thermometer, a MR image voxel was used to compare the fibre-optic temperature with the MR temperature”);
correlating a pixel in a magnetic resonance image with a location of the temperature sensor (see, e.g., Page 42, left-hand column, lines 26-28, “a MR image voxel was used to compare the fibre-optic temperature with the MR temperature”, where this step inevitably requires the correlation of the voxel with the location of the sensor); and
comparing a calculated temperature of the pixel from a temperature model with the measured temperature data from the MR safe temperature sensor (see, e.g., Page 42, left-hand column, lines 26-28, “a MR image voxel was used to compare the fibre-optic temperature with the MR temperature”).
Streicher does not disclose [1] wherein the method is for temperature control specifically for tumor ablation; and [2] determining when a difference between the calculated temperature and the measured temperature data exceeds a threshold. Streicher only discloses “The main implication of these results for in vivo applications is the need for careful calibration methods” (see, e.g., Page 46, right-hang column, lines 14-15).
However, in the same field of endeavor of MRI compatible laser probes/sensors that provide thermal therapy, Tyc discloses a method for temperature control for tumor ablation (see, e.g., Para. [0098]); and determining when a difference between the calculated temperature and the measured temperature data exceeds a threshold (see, e.g., Para. [0368], “the reference points selected in Stage 1 may be "validated." The reference points are used to compute a temperature difference at every location within the Stage 1 masked region. A temperature threshold can then be applied. Pixels whose temperature difference exceeds the threshold can be removed or masked, indicating to the operator the stability of the temperature mapping in the treatment area prior to treatment”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Streicher by including [1] wherein the method is for temperature control specifically for tumor ablation; and [2] determining when a difference between the calculated temperature and the measured temperature data exceeds a threshold, as disclosed by Tyc. One of ordinary skill in the art would have been motivated to make this modification in order to indicate to the operator the stability of the temperature mapping in the treatment area prior to treatment, as recognized by Tyc (see, e.g., Para. [0368]).
Regarding claim 19, Streicher modified by Tyc discloses the method of claim 14, as set forth above. Streicher does not specifically disclose wherein when the threshold is exceeded, cause an intervening action to occur; and wherein to cause the intervening action comprises at least one of generating an alert, transmitting a control signal to a laser ablation system, and updating the temperature model.
However, in the same field of endeavor of MRI compatible laser probes/sensors that provide thermal therapy, Tyc discloses wherein when the threshold is exceeded, cause an intervening action to occur (see, e.g., Para. [0368], “the reference points selected in Stage 1 may be "validated." The reference points are used to compute a temperature difference at every location within the Stage 1 masked region. A temperature threshold can then be applied. Pixels whose temperature difference exceeds the threshold can be removed or masked, indicating to the operator the stability of the temperature mapping in the treatment area prior to treatment”); and
wherein to cause the intervening action comprises at least one of generating an alert, transmitting a control signal to a laser ablation system, and updating the temperature model (see, e.g., Para. [0368], “the reference points selected in Stage 1 may be "validated." The reference points are used to compute a temperature difference at every location within the Stage 1 masked region. A temperature threshold can then be applied. Pixels whose temperature difference exceeds the threshold can be removed or masked, indicating to the operator the stability of the temperature mapping in the treatment area prior to treatment”, where the operator is alerted/indicated to a temperature difference exceeding the threshold that affects the stability of the temperature mapping).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of Streicher modified by Tyc by including wherein when the threshold is exceeded, cause an intervening action to occur; and wherein to cause the intervening action comprises at least one of generating an alert, transmitting a control signal to a laser ablation system, and updating the temperature model, as disclosed by Tyc. One of ordinary skill in the art would have been motivated to make this modification in order to indicate to the operator the stability of the temperature mapping in the treatment area prior to treatment, as recognized by Tyc (see, e.g., Para. [0368]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Streicher (NPL) in view of Tyc (US 2015/0257830 A1), as applied to claim 9 above, and further in view of Kumar et al. (WO 2014/043201 A1, of record, hereinafter Kumar).
Regarding claim 12, Streicher modified by Tyc discloses the non-transitory computer-readable medium of claim 9, as set forth above. Streicher modified by Tyc does not specifically disclose wherein the intervening action is chosen based on an amount of excess of the calculated temperature over the threshold, wherein for a greater excess the intervening action comprises transmitting a control signal to a laser ablation system to cause the laser ablation system to stop emitting a laser output, and wherein for a smaller excess the intervening action comprises updating the temperature model based on the measured temperature.
However, in the same field of endeavor of image guided temperature control, Kumar discloses wherein the intervening action is chosen based on an amount of excess of the calculated temperature over the threshold, wherein for a greater excess the intervening action comprises transmitting a control signal to a laser ablation system to cause the laser ablation system to stop emitting a laser output, and wherein for a smaller excess the intervening action comprises updating the temperature model based on the measured temperature (see, e.g., Para. [0068], “Figure 4 provides a detailed procedure for performing laser ablation while maintaining control of temperatures experienced by ablation and safety zones. Upon placement of the laser source(s) and the thermal sensors 32, the physician 21 activates the laser source(s) 33 and starts delivery of laser energy 34. The computer 11 starts calculating the temperature based on a combination of ultrasound thermometry, heat equations and the measurements at each thermal sensor. The temperatures can be displayed as a color-coded overlay or isothermal contours 15, 16 such that the temperatures in the ablation and safety zones can be computed and monitored in real-time 35. If the safety zone reaches high temperature threshold T.sub.a†' .sub.ly before ablation is completed 36, the computer automatically sends signal to controller for shutting off the laser 39. The system then waits for temperature to drop below T^, , following which it activates the laser again 34. The process is repeated until the temperature reaches at least T.sub.a'.sup.™.sub.atjon inside the ablation zone 37. After the ablation zone is fully treated such that the tissues in that zone have all reached at least T'™.sub.aljm , the ablation is completed 38”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the non-transitory computer-readable medium of Streicher modified by Tyc by including wherein the intervening action is chosen based on an amount of excess of the calculated temperature over the threshold, wherein for a greater excess the intervening action comprises transmitting a control signal to a laser ablation system to cause the laser ablation system to stop emitting a laser output, and wherein for a smaller excess the intervening action comprises updating the temperature model based on the measured temperature, as disclosed by Kumar. One of ordinary skill in the art would have been motivated to make this modification in order to desirably monitor temperatures in the ablation and safety zones, as recognized by Kumar (see, e.g., Para. [0068]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Streicher (NPL) in view of Tyc (US 2015/0257830 A1), as applied to claim 9 above, and further in view of Grant et al. (US 2016/0287334 A1, of record, hereinafter Grant).
Regarding claim 13, Streicher modified by Tyc discloses the non-transitory computer-readable medium of claim 9, as set forth above. Streicher modified by Tyc does not specifically disclose wherein the instructions are further to cause the temperature control system to: record a time stamp associated with the calculated temperature and the measured temperature data; and compare the calculated temperature and the measured temperature data of the pixel across time.
However, in the same field of endeavor of temperature sensing of tissue (with treatment), Grant discloses wherein the instructions are further to cause the temperature control system to: record a time stamp associated with the calculated temperature and the measured temperature data; and compare the calculated temperature and the measured temperature data of the pixel across time (see, e.g., Disclosed claim 19, “A method for monitoring brain signal activity using a plurality of interstitial recording instruments, comprising: positioning each recording instrument of the plurality of interstitial recording instruments in a respective predetermined geographic zone within brain tissue of a patient, […] wherein the at least one recording element is within, upon, or proximate the tip region, over a period of time, collecting a series of signal sets from the plurality of interstitial recording instruments, wherein collecting the series of signal sets comprises collecting, by processing circuitry, a respective signal set from each recording instrument of the plurality of interstitial recording instruments; associating, by the processing circuitry, each respective signal set with a) the respective predetermined geographic zone of the corresponding recording instrument of the plurality of interstitial recording instruments, and b) a timestamp; analyzing, by the processing circuitry, the series of signal sets to identify one or more geographic zones exhibiting evidence of an unwellness condition; and responsive to identifying the one or more geographic zones exhibiting the evidence, issuing a response to the evidence, wherein the response comprises at least one of i) alerting an operator, ii) activating suppression of the evidence of the unwellness condition, and iii) activating suppression of nearby signals to continue to record the evidence with reduced noise”, and Para. [0158], “The signals recordings may include discrete signal measurements and/or signal patterns sensed over a period of time. The signals, in some examples, may optionally be filtered, amplified, or otherwise adjusted prior to receipt by the method 580. Further, in some embodiments, the signal recordings may be provided with contemporaneous data such as, in some examples, time stamp data, tissue temperature recording data, probe temperature recording data, therapeutic emission pattern data, and/or biometric data (e.g., heart rate, pulse rate, breathing rate, etc.) of the patient”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the non-transitory computer-readable medium of Streicher modified by Tyc by including wherein the instructions are further to cause the temperature control system to: record a time stamp associated with the calculated temperature and the measured temperature data; and compare the calculated temperature and the measured temperature data of the pixel across time, as disclosed by Grant. One of ordinary skill in the art would have been motivated to make this modification in order to desirably record and compare temperature data over a time period, as recognized by Grant (see, e.g., Disclosed claim 19, and Para. [0158]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Streicher (NPL) in view of Tyc (US 2015/0257830 A1), as applied to claim 14 above, and further in view of Natarajan et al. (US 2019/0029756 A1, of record, hereinafter Natarajan).
Regarding claim 15, Streicher modified by Tyc discloses the method of claim 14, as set forth above. Streicher modified by Tyc does not specifically disclose wherein the temperature sensor comprises a fluoroptic sensor whose fluorescence changes in response to temperature.
However, in the same field of endeavor of laser therapy of tissue, Natarajan discloses wherein the temperature sensor comprises a fluoroptic sensor whose fluorescence changes in response to temperature (see, e.g., Para. [0074], “the at least one thermal sensor 230 can be any suitable sensor that can measure temperature in vivo, such as a thermistor or a fluoroptic sensor”, where fluoroptic is shown to be a known temperature/thermal sensor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of Streicher modified by Tyc by including wherein the temperature sensor comprises a fluoroptic sensor whose fluorescence changes in response to temperature, as disclosed by Natarajan. One of ordinary skill in the art would have been motivated to make this modification in order to provide an improved system/method for focal laser therapy of soft tissue and in order to provide means for real-time monitoring of the performance of the laser and treatment progress, as recognized by Natarajan (see, e.g., Para. [0004] and [0074]).
Claims 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Streicher (NPL) in view of Tyc (US 2015/0257830 A1), as applied to claim 14 above, and further in view of Dowlatshahi (US 2002/0151778 A1, of record, hereinafter Dowlatshahi).
Regarding claim 16, Streicher modified by Tyc discloses the method of claim 14, as set forth above. Streicher modified by Tyc does not specifically disclose the method further comprising positioning the temperature sensor and a laser diffusion fiber (LDF) a target distance apart using a bone anchor fixture.
However, in the same field of endeavor of temperature probes, Dowlatshahi discloses the method further comprising positioning the temperature sensor (temperature probe 16) and a laser diffusion fiber (LDF) (laser probe 14) a target distance (radial distance r3) apart using a bone anchor fixture (probe holder 12) (see, e.g., Figs. 1A, 2A-2B, and 3, and Abstract, which discloses that the system is configured to be inserted into a tumor mass, and Para. [0035], “the present invention preferably includes a laser gun 10 including a probe holder 12 employed during interstitial laser therapy. The probe holder 12 is adapted to receive a laser probe 14 and a temperature probe 16. The laser probe 14 and temperature probe 16 are removably inserted in and extend from the probe holder. The laser probe 14 and the temperature probe 16 are held in fixed position relative to each other by the gun”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of Streicher modified by Tyc by including the method further comprising positioning the temperature sensor and a laser diffusion fiber (LDF) a target distance apart using a bone anchor fixture, as disclosed by Dowlatshahi. One of ordinary skill in the art would have been motivated to make this modification in order to desirably and correctly position the temperature probe relative to the temperature sensor/laser probe, as recognized by Dowlatshahi (see, e.g., Para. [0032-0036]).
Regarding claim 17, Streicher modified by Tyc and Dowlatshahi discloses the method of claim 16, as set forth above. Streicher modified by Tyc does not specifically disclose wherein the target distance is between 5 millimeters and 10 millimeters.
However, in the same field of endeavor of temperature probes, Dowlatshahi discloses wherein the target distance (radial distance r3) is between 5 millimeters and 10 millimeters (see, e.g., Para. [0051], “Each temperature detector is also located at various radial distances from the temperature sensor Tc (i.e., the temperature at the center of the tumor mass) of the laser probe 14, namely, r1, r2, r3, r4 and r5. The radial distance between Tc and T3 (i.e., r3) is known, that is, the axial distance between Tc and T3, preferably 1.0 cm”, and Fig. 3, where the distance between the MR safe temperature probe/sensor and the laser diffusion fiber/probe is represented as r3, which is disclosed to be 1 cm=10 mm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the method of Streicher modified by Tyc and Dowlatshahi by including wherein the target distance is between 5 millimeters and 10 millimeters, as disclosed by Dowlatshahi. One of ordinary skill in the art would have been motivated to make this modification in order to desirably and correctly position the temperature probe relative to the temperature sensor/laser probe, as recognized by Dowlatshahi (see, e.g., Para. [0032-0036]).
Regarding claim 18, Streicher modified by Tyc and Dowlatshahi discloses the method of claim 16, as set forth above. Streicher modified by Tyc and Dowlatshahi does not specifically disclose wherein the target distance is 8 millimeters. However, Dowlatshahi does disclose wherein the target distance (radial distance r3) is 10 millimeters (see, e.g., Para. [0051], “Each temperature detector is also located at various radial distances from the temperature sensor Tc (i.e., the temperature at the center of the tumor mass) of the laser probe 14, namely, r1, r2, r3, r4 and r5. The radial distance between Tc and T3 (i.e., r3) is known, that is, the axial distance between Tc and T3, preferably 1.0 cm”, and Fig. 3, where the distance between the MR safe temperature probe/sensor and the laser diffusion fiber/probe is represented as r3, which is disclosed to be 1 cm=10 mm).
However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, through routine experimentation, to have further modified the method of Streicher modified by Tyc and Dowlatshahi by including that the target distance is specifically 8 millimeters (instead of 10 millimeters as disclosed by Dowlatshahi) because, as seen in MPEP § 2144.05, subsection II, under the header “Routine Optimization”, this would be seen as optimizing the spacing between the MR safe temperature probe/sensor and the laser diffusion fiber/probe to achieve the desired functionality, as evidenced by Dowlatshahi (see, e.g., Para. [0055], “When T3 reaches or increases to a temperature, preferably 60.degree. C., which would destroy the tumor mass, that is, the tumor mass destruction temperature, the volume of tumor mass destroyed effectively corresponds to the volume of a spherical region having a radial distance of r3”). It is considered routine optimization because, as evidenced above in Dowlatshahi, a person having ordinary skill in the art would be motivated to do routine experimentation to obtain the end result of providing an optimized spacing between the MR safe temperature probe/sensor and the laser diffusion fiber/probe that is configured to achieve the desired functionality (i.e., being the correct sizing to accurately apply the disclosed therapy to the tumor/tissue). See MPEP § 2144.05, subsection II(A).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,161,406 (hereinafter ‘406). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
Regarding claim 1 of the instant application, claim 1 and/or claim 6 of ‘406 discloses a system (see, e.g., ‘406, claim 1, line 1, and ‘406, claim 6, line 1) comprising:
a magnetic resonance (MR) safe temperature probe comprising a temperature sensor (see, e.g., ‘406, claim 1, lines 2-3, and ‘406, claim 6, lines 2-3);
a bone anchor fixture configured to maintain a target distance between the MR safe temperature probe and a laser diffusion fiber (LDF) (see, e.g., ‘406, claim 1, lines 4-6, and ‘406, claim 6, lines 4-6); and
a processor (see, e.g., ‘406, claim 1, line 12, and ‘406, claim 6, line 12) to:
receive measured temperature data from the MR safe temperature probe (see, e.g., ‘406, claim 1, lines 18-19, and ‘406, claim 6, lines 18-19);
correlate a pixel in a magnetic resonance image with a location of the temperature sensor (see, e.g., ‘406, claim 1, lines 20-21, and ‘406, claim 6, lines 20-21);
compare a calculated temperature of the pixel from a temperature model with the measured temperature data from the MR safe temperature probe (see, e.g., ‘406, claim 1, lines 22-24, and ‘406, claim 6, lines 22-24); and
determine when a difference between the calculated temperature and the measured temperature data exceeds a threshold (see, e.g., ‘406, claim 1, lines 26-28, and ‘406, claim 6, lines 26-28).
Regarding claim 2 of the instant application, claim 1 and/or claim 6 of ‘406 discloses the system of claim 1 of the instant application, as set forth above. Claim 2 of ‘406 further discloses wherein the temperature sensor comprises a gallium arsenide crystal (see, e.g., ‘406, claim 2, lines 1-2).
Regarding claim 3 of the instant application, claim 1 and/or claim 6 of ‘406 discloses the system of claim 1 of the instant application, as set forth above. Claim 3 of ‘406 further discloses wherein the target distance is between 5 millimeters and 10 millimeters (see, e.g., ‘406, claim 3, lines 1-2).
Regarding claim 4 of the instant application, claim 1 and/or claim 6 of ‘406 discloses the system of claim 1 of the instant application, as set forth above. Claim 4 of ‘406 further discloses wherein the target distance is 8 millimeters (see, e.g., ‘406, claim 4, lines 1-2).
Regarding claim 5 of the instant application, claim 1 and/or claim 6 of ‘406 discloses the system of claim 1 of the instant application, as set forth above. Claim 7 of ‘406 further discloses wherein the bone anchor fixture comprises: a bone anchor body comprising a first lumen through which the LDF is to be inserted (see, e.g., ‘406, claim 7, lines 1-5); and an adapter coupled to the bone anchor body and extending to a side of the bone anchor, the adapter comprising a second lumen that is the target distance away from the first lumen, wherein the MR safe temperature probe is to be inserted through the second lumen (see, e.g., ‘406, claim 7, lines 6-11).
Regarding claim 6 of the instant application, claim 1 and/or claim 6 of ‘406 discloses the system of claim 1 of the instant application, as set forth above. Claim 1 of ‘406 further discloses wherein the bone anchor fixture comprises: a bone anchor body with a single lumen; and a guide member disposed within the bone anchor body, wherein the guide member separates the LDF and the MR safe temperature probe within the single lumen by the target distance (see, e.g., ‘406, claim 1, lines 31-36).
Regarding claim 7 of the instant application, claim 1 and/or claim 6 of ‘406 discloses the system of claim 1 of the instant application, as set forth above. Claims 1 and/or 6 of ‘406 further discloses wherein when the threshold is exceeded, the processor causes an intervening action to occur (see, e.g., ‘406, claim 1, lines 28-30, and ‘406, claim 6, lines 28-30), and claim 5 of ‘406 further discloses wherein to cause the intervening action comprises at least one of generating an alert, transmitting a control signal to a laser ablation system, and updating the temperature model (see, e.g., ‘406, claim 5, lines 1-4).
Regarding claim 8 of the instant application, claim 1 and/or claim 6 of ‘406 discloses the system of claim 1 of the instant application, as set forth above. Claim 6 of ‘406 further discloses wherein the processor is further configured to record a time stamp associated with the calculated temperature data and the measured temperature data and compare the calculated temperature data and the measured temperature data of the pixel across time (see, e.g., ‘406, claim 6, lines 31-35).
Regarding claim 9 of the instant application, claim 8 and/or claim 10 and/or claim 11 of ‘406 discloses a non-transitory computer-readable medium including instructions that when executed by one or more processors of a temperature control system cause the temperature control system to (see, e.g., ‘406, claim 8, lines 1-4, and ‘406, claim 10, lines 1-4, and ‘406, claim 11, lines 1-4):
receive measured temperature data from a magnetic resonance (MR) safe temperature probe comprising a temperature sensor (see, e.g., ‘406, claim 8, lines 9-11, and ‘406, claim 10, lines 9-11, and ‘406, claim 11, lines 9-11);
correlate a pixel in a magnetic resonance image with a location of the temperature sensor (see, e.g., ‘406, claim 8, lines 12-13, and ‘406, claim 10, lines 12-13, and ‘406, claim 11, lines 12-13);
compare a calculated temperature of the pixel from a temperature model with the measured temperature data from the MR safe temperature probe (see, e.g., ‘406, claim 8, lines 14-16, and ‘406, claim 10, lines 14-16, and ‘406, claim 11, lines 14-16); and
determine when a difference between the calculated temperature and the measured temperature data exceeds a threshold, wherein when the threshold is exceeded, cause an intervening action to occur (see, e.g., ‘406, claim 8, lines 18-21, and ‘406, claim 10, lines 18-22, and ‘406, claim 11, lines 18-22).
Regarding claim 10 of the instant application, claim 8 and/or claim 10 and/or claim 11 of ‘406 discloses the non-transitory computer-readable medium of claim 9 of the instant application, as set forth above. Claim 9 of ‘406 further discloses wherein the intervening action comprises generating an alert on a computer interface (see, e.g., ‘406, claim 9, lines 1-3).
Regarding claim 11 of the instant application, claim 8 and/or claim 10 and/or claim 11 of ‘406 discloses the non-transitory computer-readable medium of claim 9 of the instant application, as set forth above. Claim 10 of ‘406 further discloses wherein the instructions are further to cause the temperature control system to (see, e.g., ‘406, claim 10, lines 23-24): track a second calculated temperature with a second pixel, wherein the second pixel is at a location removed from the MR safe temperature probe (see, e.g., ‘406, claim 10, lines 25-27); compare the second calculated temperature of the second pixel from the temperature model with the measured temperature data from the MR safe temperature probe (see, e.g., ‘406, claim 10, lines 28-31); and determine when a temperature delta between the calculated temperature and the measured temperature data exceeds a second threshold (see, e.g., ‘406, claim 10, lines 32-34), wherein when the second threshold is exceeded, cause the intervening action to occur (see, e.g., ‘406, claim 10, lines 35-36).
Regarding claim 12 of the instant application, claim 8 and/or claim 10 and/or claim 11 of ‘406 discloses the non-transitory computer-readable medium of claim 9 of the instant application, as set forth above. Claim 8 of ‘406 further discloses wherein the intervening action is chosen based on an amount of excess of the calculated temperature over the threshold (see, e.g., ‘406, claim 8, lines 22-24), wherein for a greater excess the intervening action comprises transmitting a control signal to a laser ablation system to cause the laser ablation system to stop emitting a laser output (see, e.g., ‘406, claim 8, lines 25-28), and wherein for a smaller excess the intervening action comprises updating the temperature model based on the measured temperature (see, e.g., ‘406, claim 8, lines 29-31).
Regarding claim 13 of the instant application, claim 8 and/or claim 10 and/or claim 11 of ‘406 discloses the non-transitory computer-readable medium of claim 9 of the instant application, as set forth above. Claim 11 of ‘406 further discloses wherein the instructions are further to cause the temperature control system to (see, e.g., ‘406, claim 11, lines 22-23): record a time stamp associated with the calculated temperature and the measured temperature data (see, e.g., ‘406, claim 11, lines 24-25); and compare the calculated temperature and the measured temperature data of the pixel across time (see, e.g., ‘406, claim 11, lines 27-28).
Regarding claim 14 of the instant application, claim 12 of ‘406 discloses a method for temperature control for tumor ablation, the method comprising (see, e.g., ‘406, claim 12, lines 1-2):
receiving measured temperature data from a magnetic resonance (MR) safe temperature sensor (see, e.g., ‘406, claim 12, lines 7-8);
correlating a pixel in a magnetic resonance image with a location of the temperature sensor (see, e.g., ‘406, claim 12, lines 9-10);
comparing a calculated temperature of the pixel from a temperature model with the measured temperature data from the MR safe temperature sensor (see, e.g., ‘406, claim 12, lines 11-13); and
determining when a difference between the calculated temperature and the measured temperature data exceeds a threshold (see, e.g., ‘406, claim 12, lines 15-17).
Regarding claim 15 of the instant application, claim 12 of ‘406 discloses the method of claim 14 of the instant application, as set forth above. Claim 12 of ‘406 further discloses wherein the temperature sensor comprises a fluoroptic sensor whose fluorescence changes in response to temperature (see, e.g., ‘406, claim 12, lines 19-21).
Regarding claim 16 of the instant application, claim 12 of ‘406 discloses the method of claim 14 of the instant application, as set forth above. Claim 13 of ‘406 further discloses the method further comprising positioning the temperature sensor and a laser diffusion fiber (LDF) a target distance apart using a bone anchor fixture (see, e.g., ‘406, claim 13, lines 1-4).
Regarding claim 17 of the instant application, claims 12-13 of ‘406 discloses the method of claim 16 of the instant application, as set forth above. Claim 14 of ‘406 further discloses wherein the target distance is between 5 millimeters and 10 millimeters (see, e.g., ‘406, claim 14, lines 1-2).
Regarding claim 18 of the instant application, claims 12-13 of ‘406 discloses the method of claim 16 of the instant application, as set forth above. Claim 15 of ‘406 further discloses wherein the target distance is 8 millimeters (see, e.g., ‘406, claim 15, lines 1-2).
Regarding claim 19 of the instant application, claim 12 of ‘406 discloses the method of claim 14 of the instant application, as set forth above. Claim 12 of ‘406 further discloses wherein when the threshold is exceeded, cause an intervening action to occur (see, e.g., ‘406, claim 12, lines 17-18); and claim 16 of ‘406 further discloses wherein to cause the intervening action comprises at least one of generating an alert, transmitting a control signal to a laser ablation system, and updating the temperature model (see, e.g., ‘406, claim 16, lines 1-4).
Conclusion
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/T.D./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
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