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(s) (IDS) submitted on 1/26/26; 4/6/26; 5/13/26; 7/22/26 has/have been acknowledged and is/are being considered by the Examiner.
Response to Arguments
Applicant’s arguments, see Remarks, filed 1/26/26, with respect to the rejection(s) of claim(s) 1-22 under 35 USC 102 and 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Drown et al. (U.S. Pub. 2021/0338328 in view of “Drown”).
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5-10 and 12-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 has been amended to state that each optical fiber catheter is connected to a corresponding laser device, and said N laser devices are configured to emit lasers of multiple wavelengths including 980nm and 1064nm. However, the specification states that each laser device emits a single wavelength and that a catheter that includes multiple wavelengths includes multiple devices (e.g. ¶¶21-22). Therefore, it is unclear how a single laser device emits multiple wavelengths. Therefore, the claim fails to comply with the written description requirement.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 5-10, 13, 15, 18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tyc et al. (US 2015/0087963) (hereinafter Tyc) in view of Drown et al. (U.S. Pub. 2021/0338328 in view of “Drown”).
Regarding claim 1, Tyc discloses a multi-wavelength laser system for thermal ablation in neurosurgery (Abstract; Fig. 1), comprising:
a magnetic resonance guidance unit including a magnetic resonance imaging (MRI) device (MRI system) and an MRI control center (MRI control room with control workstation) configured to perform processing including at least one of: data acquisition, data processing, image reconstruction, image display, or image storage (para. 365: “an MRI control workstation extrapolates the drift pattern to all of the areas in the image in order to compensate subsequently received images. As a result, the phase drift can be accounted for (as a constant) and removed so that any fluctuation that an operator observes is actually related to temperature, and not extraneous factors”, describing data acquisition, processing, image reconstruction, and display);
a laser ablation unit connected to the magnetic resonance guidance unit (Fig. 2, laser delivery probe inserted into patient), the laser ablation unit including a control host (control workstation) configured to complete, according to digital image information of a patient, at least one of: profiling, 3D modeling, or generating a surgical plan of the patient, the control host further configured to fuse the digital image information through an MRI temperature imaging technique to generate a real-time temperature image, and display the real-time temperature image on a human-computer interaction module (para. 15-16; para. 101: “The workstation includes a user interface, e.g., a graphical user interface (GUI), for procedure planning, interactive monitoring of procedures, and interfaces to the MRI and hardware subsystems. The probe driver allows for precise positioning, stabilization and manipulation of a probe”; para. 126: “The system can be utilized for planning and monitoring thermal therapies under MRI visualization, and can provide MRI-based trajectory planning assistance for the stereotactic placement of an MRI compatible (conditional) probe. It also provides real-time thermographic analysis of selected MRI images”), wherein the laser ablation unit further includes a laser module connected to the control host and provided with N laser devices, wherein N is a positive integer greater than 1 (para. 126 suggests multiple lasers of same or different wavelength); the control host is configured to synchronously or asynchronously regulating laser operation parameters of some or all of the N laser devices according to the surgical plan and the real-time temperature image (para. 19: “The workstation may be configured to process a sequence of the energy control signals to: effect a symmetrical treatment to the tissue with the probe; and effect an asymmetrical treatment to the tissue with the probe after the symmetrical treatment”); and
an optical fiber catheter unit connected to the laser ablation unit and having M optical fiber catheters for ablation, wherein M is a positive integer greater than 0 (Fig. 57 depicts example of probe 400 with optical fiber 406).
Tyc discloses the multi-wavelength system including using 1064nm lasers and other frequencies but fails to explicitly state that the second frequency is 980nm. However Drown discloses a similar multi-wavelength ablation device that utilizes two lasers with 1064nm and 980nm frequencies as set forth in Paragraphs 13 and 19-20 to provide control over the size of the lesion. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Tyc, with 980nm and 1064nm lasers as taught by Drown, since such a modification would provide the predictable results of having two separate frequency lasers for allowing the users to customize the lesion in the patient, enabling them to achieve both large and small lesions.
Regarding claim 5, meeting the limitations of claim 1 above, Tyc discloses each laser device is configured to emit lasers of at least one wavelength; the N laser devices all emit lasers of the same wavelength; and/or one part of the N laser devices emit lasers of a first wavelength, and the other part of the N laser devices emits lasers of a second wavelength different from the first wavelength (para. 126).
Regarding claim 6, meeting the limitations of claim 1 above, Tyc discloses when N is equal to 2, the laser module includes a first laser device and a second laser device (para. 126 suggests multiple laser devices); the control host is configured to synchronously or asynchronously regulate laser operation parameters of the first laser device and the second laser device according to the surgical plan and the real-time temperature image (para. 19); and the optical fiber catheter unit includes a first optical fiber catheter connected to the first laser device and a second optical fiber catheter connected to the second laser device (para. 126 suggests multiple lasers and thus multiple optical fibers).
Regarding claim 7, meeting the limitations of claim 1 above, Tyc discloses at least one of the first optical fiber catheter or the second optical fiber catheter is provided with a temperature measuring optical fiber configured to detect real-time temperatures of the optical fiber catheter unit (Fig. 57, thermocouple 404 with attached optical fiber which is unlabeled); the temperature measuring optical fiber is connected to an optical fiber temperature measuring module in the laser ablation unit (thermocouple 404); and the optical fiber temperature measuring module is connected to a temperature correction module in the control host for temperature correction (para. 238: “The thermocouple 404 detects a temperature in the expansion chamber 416. A workstation can control an amount of cooling gas (either or both of a flow and pressure of the gas) or cooling fluid inputted into the expansion chamber 416 via the cooling tube 402 to control a temperature of the tissue via conduction through the capsule 408”).
Regarding claims 8-9, meeting the limitations of claim 1 above, Tyc discloses the temperature correction module is configured to complete processing including at least: taking a real-time temperature value of the tissue acquired by the optical fiber temperature measuring module in real time as a reference temperature measurement value of the magnetic resonance guidance unit , and feeding back a corrected temperature image to the control host; the corrected temperature image is generated by the magnetic resonance guidance unit based on the reference temperature measurement value; and the corrected temperature image fed back to the control host is used to replace the real-time temperature image; wherein the control host is configured to perform real-time regulation on the laser module according to the corrected temperature image (para. 382-384 describe steps of comparing actual tissue temperature image to baseline temperature and then applying correction for noise masking; Abstract: “By tracking a probe position within tissue through feedback, multiple data slices provided around the probe position can be processed to monitor treatment and view thermal data. The operator selects treatment area reference points with the assistance of noise masking”).
Regarding claim 10, meeting the limitations of claims 1 and 6 above, Drown discloses the first laser device generates lasers of a first wavelength, and the second laser device generates lasers of a second wavelength; the first wavelength is 980nm and the second wavelength is 1064nm (e.g. paras. 13 and 19-20).
Regarding claim 13, meeting the limitations of claim 1 above, Tyc discloses the laser module is further configured with a cooling module connected to the control host and the optical fiber catheter unit (Fig. 57, cooling tube 402); and the control host is configured to control operation of the cooling module such that the cooling module cools the optical fiber and a surrounding tissue of the optical fiber catheter unit by driving and controlling flow of a cooling medium (para. 238).
Regarding claim 15, meeting the limitations of claim 1 above, Tyc discloses the laser ablation unit includes the control host (see rejection of claim 1 above), the human-computer interaction module (Fig. 8 depicts computer set up with keyboard and mouse), the laser module, the cooling module (Fig. 57, probe 400 includes optical fiber 406, cooling tube 402), a power module (Fig. 8, power switch, emergency stop), the optical fiber temperature measuring module (Fig. 57, thermocouple 404), and an effect measuring module (Abstract discloses tracking probe position within tissue through feedback, processing data from probe to monitor treatment and view thermal data).
Regarding claim 18, meeting the limitations of claim 1 above, Tyc discloses the effect evaluation module is configured to make real-time intraoperative estimates of a tissue ablation condition using an Arrhenius model or a CEM43 model (para. 383: “the thermal damage or "dose" may be computed using an Arrhenius-type relationship between time and tissue temperature. This allows the operator to view temperature maps of the brain tissue illustrating predictive damage that the software has calculated based on the sequencing of MRI data while providing the required treatment”); and the control host is configured to generate in real time, according to ablation progress fed back by the effect evaluation module, a regulation instruction including a coolant flow rate (para. 238: “When heating a tissue, to control an amount of therapy or heat applied to the tissue, cooling is provided via the cooling tube 402, which outputs a cooling gas or fluid to the expansion chamber 416. The thermocouple 404 detects a temperature in the expansion chamber 416. A workstation can control an amount of cooling gas (either or both of a flow and pressure of the gas) or cooling fluid inputted into the expansion chamber 416 via the cooling tube 402 to control a temperature of the tissue via conduction through the capsule 408”).
Regarding claim 20, meeting the limitations of claim 1 above, Drown discloses the claimed invention including MRI temperature monitoring, first and second laser adjustments, cooling adjustments and multiple monitors but does not disclose expressly which adjustments are on which touchscreen monitor (e.g. ¶¶8, 48, 68-69 and 105; one or more interfaces (touchscreens) to display and control the parameters). It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the system as taught by Tyc in view of Drown with the three separate touchscreens, because Applicant has not disclosed that three touchscreens provides an advantage, is used for a particular purpose, or solve a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with multiple touchscreens as taught by Tyc in view of Drown, because it provides multiple interfaces for viewing and controlling the system and since it appears to be an arbitrary design consideration which fails to patentably distinguish over Tyc in view of Drown.
Therefore, it would have been an obvious matter of design choice to modify Tyc in view of Drown to obtain the invention as specified in the claim(s).
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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Tyc in view of Drown and further in view of Bean et al. (US 2011/0040358) (hereinafter Bean).
Regarding claim 12, Tyc in view of Drown does not disclose the laser operation parameters include at least one of: a laser output power, laser light emitting time, or a laser light emitting mode.
Bean, however, teaches a laser for medical treatment (Abstract) wherein in cauterization, and many other procedures, the ability to control the rate of coagulation or other treatment by adjusting either the distance of the laser from the target, or the input power to the laser, is very helpful for avoiding unwanted side effects such as charring, and transmission of energy deeper into tissue than is desired (para. 68).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Tyc in view of Drown such that the laser operation parameters include a laser output power. Making this modification would be useful for avoiding unwanted side effects such as charring, and transmission of energy deeper into tissue than is desired, as taught by Bean.
Claims 14 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Tyc in view of Drown and further in view of Liu et al. (CN 108836477) (hereinafter Liu).
Regarding claim 14, Tyc in view of Drown discloses the optical fiber catheter unit has the first optical fiber catheter and the second optical fiber catheter of the same structure (para. 126 suggests multiple lasers and thus multiple optical fibers), and wherein the first optical fiber catheter includes an optical fiber (Fig. 57 depicts exemplary probe with optical fiber 406); a proximal end of the optical fiber is a beveled end (Fig. 57 depicts beveled end at 412).
Tyc does not disclose the first optical fiber catheter including a cooling inner tube and a cooling outer tube.
Liu, however, teaches an MRI guided laser therapy device (Abstract) wherein a minimally invasive surgical fiber assembly comprises a cooling outer sleeve tube 4 and a cooling inner sleeve tube 3 (Fig. 6). The cooling substance from inlet/water outlet 10 flows into the cooling sleeve outer tube 4 gap of the cooling sleeve pipe 3 and back through the fiber optic probe 2, through the gap 2 between the tube and the optical fiber probe cooling sleeve from outlet/inlet 11 out to take away heat of the optical probe 2 (pg. 9, under “minimally invasive surgical fiber assembly”, para. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Tyc in view of Drown to include the first optical fiber catheter including a cooling inner tube and a cooling outer tube. Making this modification would be useful for taking heat away from the optical probe, as taught by Liu.
Regarding claim 22, Tyc in view of Drown discloses software configured to perform a function including surgical plan generation, wherein the surgical plan contains information corresponding to each of the N laser devices, wherein the information includes: an insertion path planning for an optical fiber catheter of the M optical fiber catheters (para. 126: “The system can be utilized for planning and monitoring thermal therapies under MRI visualization, and can provide MRI-based trajectory planning assistance for the stereotactic placement of an MRI compatible (conditional) probe”) .
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Tyc in view of Drown and further in view of Mekanik et al. (US 5638244) (hereinafter Mekanik).
Regarding claim 16, Tyc in view of Drown does not disclose the power module has at least one uninterruptible power supply (UPS) device and at least one power distribution control board; an electric energy input end of the laser ablation unit is connected to a power line; and the power line has one end connected to a commercial power end and the other end connected to the electric energy input end of the UPS device.
Mekanik, however, teaches apparatus for generating uninterruptible AC signals (Abstract). Referring now to FIG. 2, the construction and operation of the power supply 22 will be described in further detail. The power supply 22 basically comprises a line disconnect switch 120, a motor/generator module 122, a source select switch array 124, a bypass module 126, an uninterruptible power supply (UPS) module 128, an output select switch 120, a power distribution unit (PDU) 132 comprising first through eighth power distribution switch boards 134-148, and a monitor/control portion 150. The source select switch array 124 comprises first through fourth switches 152-158 and first and second transfer switches 160 and 162. The monitor/control portion 150 comprises a generator interface 164, a switch interface 166, a UPS interface 168, a bypass interface 170, a PDU interface 172, and a power supply interface 174. The line inlet 100 and the gas inlet 102 are also both shown in FIG. 1 (Col. 5-6, under “II. Basic Operation of Power Supply”, ll. 59-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Tyc in view of Drown to include the power module has at least one uninterruptible power supply (UPS) device and at least one power distribution control board; an electric energy input end of the laser ablation unit is connected to a power line; and the power line has one end connected to a commercial power end and the other end connected to the electric energy input end of the UPS device. Making this modification would be useful such that disruptions in communications due to power failures are substantially reduced, as taught by Mekanik (Col. 1, ll. 10-13).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Tyc in view of Drown and further in view of Gregg, II et al. (US 9,597,160) (hereinafter Gregg).
Regarding claim 17, Tyc in view of Drown discloses the human-computer interaction module includes an emergency stop switch (Fig. 8, E-Stop), a foot pedal controller (para. 350 discloses a foot pedal used to activate one or more probes), a physical button (Fig. 8, power switch), and an indicator light (para. 112: “The workstation can include an emergency stop (E-Stop) switch, which includes a red light to indicate that it is on (i.e., the presence of the red light indicates the system and/or the MRI system has been stopped via the emergency stop switch)”).
Tyc in view of Drown does not disclose a relay to connect an emergency stop switch and key switch along with a second power signal for the cooling module.
Gregg, however, teaches a laser system that includes a relay connected to a first channel connected to the stop switch and key switch along with a second signal connected to the cooling module as taught in Figure 3A, Column 8, lines 55-65 and Column 9, lines 21-33 to provide a two-step fail-safe for providing or cutting power, and are connected to power supply.
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Tyc in view of Drown to include the relay with a stop switch and key switch and second signal to the cooling module. Making this modification would be useful for providing a two-step fail-safe for providing or cutting power to each module, as taught by Gregg.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Tyc in view of Drown and further in view of VanGilder et al. (US 2013/0044111) (hereinafter VanGilder).
Regarding claim 19, Tyc in view of Drown discloses the human-computer interaction module includes an emergency stop switch (Fig. 8, E-Stop), a foot pedal controller (para. 350 discloses a foot pedal used to activate one or more probes), a physical button (Fig. 8, power switch), and an indicator light (para. 112: “The workstation can include an emergency stop (E-Stop) switch, which includes a red light to indicate that it is on (i.e., the presence of the red light indicates the system and/or the MRI system has been stopped via the emergency stop switch)”).
Tyc in view of Drown does not disclose a first, second, third touch screen.
VanGilder, however, teaches a dynamic central monitoring station having multiple touch screens for displaying numerical and graphical representation of vital statistics of one or more patients. The multiple touch screens are configurable to simultaneously display real time and historic patient data corresponding to a plurality of patients. One screen serves as a dedicated display screen for the review of individual patient data while the remaining screens continue to display vital statistics for all of the monitored patients (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Tyc in view of Drown to include a first, second, third touch screen. Making this modification would be useful for providing multiple touch screens for displaying data of one or more patients, as taught by VanGilder.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Tyc in view of Drown and further in view of Mordaunt et al. (US 9610124) (hereinafter Mordaunt).
Regarding claim 21, Tyc in view of Drown does not disclose the control host is configured to monitor safe operation parameters of the laser module, the optical fiber temperature measuring module, and the cooling module in real time; and when an operation parameter exceeds a safe operation threshold value, the control host control the laser module to stop emitting light.
Mordaunt, however, teaches a medical laser (Abstract) including a safety monitor circuit and a first and second current sensor providing input to said safety monitor circuit, and wherein said second current sensor provides input to disable current flow through said laser power supply if the current exceeds a threshold current (Claim 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of this invention to modify Tyc in view of Drown such that the control host is configured to monitor safe operation parameters of the laser module, the optical fiber temperature measuring module, and the cooling module in real time; and when an operation parameter exceeds a safe operation threshold value, the control host control the laser module to stop emitting light. Making this modification would be useful for ensuring safety by disabling the laser if the current exceeds a threshold current, as suggest by Mordaunt.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Moran et al. (U.S. Pat. 6,086,363) – discloses a dual wavelength laser system at 980nm and 1064nm.
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 REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at (571) 270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REX R HOLMES/Primary Examiner, Art Unit 3796
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