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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/17/2026 has been entered.
Response to Arguments
Applicant's arguments filed 08/27/2025 have been fully considered but they are not persuasive.
Applicant’s argument, that Daniel’s system does not teach the concurrent photothermal ablation and interstitial photodynamic therapy, is unpersuasive. If the PDT is done “during” the ablative therapy, it is concurrent. Further, the claims do not require concurrent ablation and PDT, just that the controller maintains the temperature at a level where both could occur, which Daniel does. Applicant’s further argument that Daniel does not teach a temperature feedback system to maintain the temperature in a range effective for the ablation and PDT is unpersuasive for the same reasons, and as Daniel does teach the temperature feedback in Para. 0181.
For these reasons, the rejections are maintained. Prior art is also applied to Claims 8-16 that have been newly added.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 10, and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S Patent Publication 20040059328 awarded to Daniel et al, hereinafter Daniel.
Regarding Claim 1, Daniel teaches a method for treating a tissue (abstract), comprising: administering a photosensitizer to the tissue (Para. 0178, “The apparatus of an embodiment can be configured to deliver a phototherapeutic agent, or photodynamic agent, to the target tissue site”); providing one or more optical fibers placed in the tissue and applying a treatment light to the tissue by way of the one or more optical fibers (Para. 0178, “Examples of optical energy delivery devices 420 include but are not limited to optical fibers, light pipes, wave-guides and the like”), the treatment light having a fluence rate (Examiner notes all light has a fluence); measuring a temperature of the tissue during application of the treatment light with a temperature sensor (Para. 0181) and modifying the fluence rate of the treatment light based on the temperature of the tissue to maintain a temperature of the tissue within a range effective for concurrent photothermal ablation and interstitial photodynamic therapy (Para. 0179, “In various embodiments, photodynamic therapy can be conducted prior, concurrently or after thermal ablative therapy”, Para. 0181, “Feedback control system 436 receives temperature or impedance data from sensors 440 and the amount of electromagnetic energy received by energy delivery devices 442 and 444 is modified from an initial setting of ablation energy output, ablation time, temperature, and current density (the "Four Parameters")”).
Regarding Claim 2, Daniel teaches the method of Claim 1, wherein the fluence rate is modified to be lower if the temperature of the tissue is higher than a predetermined threshold (Para. 0181, “Feedback control system 436 can automatically change any of the Four Parameters. Feedback control system 436 can detect impedance or temperature and change any of the Four Parameters”).
Regarding Claims 3-5, Daniel teaches the method of Claim 1, wherein the fluence rate is modified to maintain a tissue temperature between 50-65 degrees Celsius or 60-90 degrees Celsius (Para. 0198 teaches selecting a temperature to ablate the tissue at, such as at 50 degrees Celsius, while Para. 0121 teaches that 60 and 65 degrees Celsius can be threshold temperatures chosen to ablate or necrose tumor tissue).
Regarding Claim 10, Daniel teaches the method of Claim 1, wherein measuring the temperature of the tissue comprises measuring temperature at a plurality of locations throughout a volume of the tissue (Para. 0184).
Regarding Claim 15, Daniel teaches the method of Claim 1, further comprising providing a second optical fiber placed in the tissue and configured to deliver a second treatment light dose to the tissue (Para. 0182 states that ablation source can be an optical fiber source instead of an RF source).
Regarding Claim 16, Daniel teaches the method of Claim 15, wherein the fluence rate of the second treatment light dose is modified based on a temperature at a second location of the tissue (Para. 0193 teaches that multiple sensors provide temperature feedback, Para. 0184 teaches adjusting the fluence based on the temperature data received).
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
i. Determining the scope and contents of the prior art.
Ii. Ascertaining the differences between the prior art and the claims at issue.
iii. Resolving the level of ordinary skill in the pertinent art.
iv. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6-9 and 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over U.S Patent Publication 20040059328 awarded to Daniel et al, hereinafter Daniel, in view of U.S. Patent Publication 20170128132 awarded to Yu, hereinafter Yu.
Regarding Claims 6-9 and 13, Daniel teaches the method of Claim 1. Daniel does not teach providing one or more dosimetry fibers placed in the tissue and configured to measure light dose and wherein the one or more optical fibers and/or the one or more dosimetry fibers are disposed within one or more light-transmitting catheters placed in the tissue, wherein each optical fiber or dosimetry fiber is disposed in a lumen of the one or more light-transmitting catheters.
However, in the art of optical fiber treatments, Yu teaches wherein the one or more optical fibers and/or the one or more dosimetry fibers are disposed within one or more light-transmitting catheters (LTCs) placed in the tissue (Para. 0044, “At least a portion of treatment fiber 12, dosimetry fiber 14, two diffuse reflectance spectroscopy fibers 16A, 16B, and temperature sensor fiber 20 may be housed in a protective cable 22, which may also be referred to as protective coating 22, fiber optic jacket 22, or elongated sleeve 22, which extends into a distal end covering 24A, 24B. Protective cable 22 may be utilized to protect the fibers from damage, such as mechanical scratch or chemical or biological corrosion. In one or more embodiments, protective cable 22 may be made from polyvinyl chloride (PVC), polyethylene (PE), polyurethane (PUR), polybutylene terephthalate (PBT), polyamide (PA), and low smoke free of halogen (LSFH) materials”), wherein the optical and dosimetery fibers are contained within a lumen of the LTC (see Fig. 2, showing the fibers within the central lumen of protective cable 22) and provide their data to a spectrometer (Para. 0084).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Daniel by Yu, i.e. by using a dosimetry fiber/spectrometer to detect the treatment parameters, for the predictable purpose of simply substituting one method of detection for another. It would also be obvious to contain the optical fiber and dosimetry fiber of Daniel in a protective catheter as taught above in Yu, for the predictable purpose of improving the device of Daniel in the same way as the similar device of Yu.
Regarding Claim 11, Daniel teaches the method of Claim 10. Daniel does not teach wherein the temperature sensor is a magnetic resonance thermometer, but does teach monitoring treatment progress using MRI (Para. 0195).
However, in the art of light therapy of tissues (abstract), Yu teaches the usage of magnetic resonance thermometry to monitor treatment (Para. 0012, discussing magnetic resonance thermometry in conjunction with magnetic resonance imaging as a non-invasive option for monitoring temperature at the speed and accuracy needed for tissue ablation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Daniel by Yu, i.e. by monitoring the system of Daniel using MRT as in Yu, for the predictable purpose of simply substituting one known method of temperature measurement for another to improve the similar devices in the same way taught above.
Regarding Claim 12, Daniel modified by Yu makes obvious the method of Claim 10. Daniel does not teach wherein sensing the temperature comprises a plurality of temperature sensitive catheters.
However, Yu teaches the usage of temperature sensitive catheters (Para. 0044, “At least a portion of treatment fiber 12, dosimetry fiber 14, two diffuse reflectance spectroscopy fibers 16A, 16B, and temperature sensor fiber 20 may be housed in a protective cable 22, which may also be referred to as protective coating 22, fiber optic jacket 22, or elongated sleeve 22, which extends into a distal end covering 24A, 24B. Protective cable 22 may be utilized to protect the fibers from damage, such as mechanical scratch or chemical or biological corrosion. In one or more embodiments, protective cable 22 may be made from polyvinyl chloride (PVC), polyethylene (PE), polyurethane (PUR), polybutylene terephthalate (PBT), polyamide (PA), and low smoke free of halogen (LSFH) materials”). Examiner notes that protective cable 22 can be made of a variety of temperature-sensitive materials capable of deforming under an increase in temperature or stiffening under a decrease in temperature. Figure 4 shows a plurality of probes 10 used to treat one treatment area, meeting the instant claim limitation of “plurality of temperature sensitive catheters”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Daniels by Yu, i.e. by using the temperature sensitive catheters of Yu to protect the fibers of Daniels, for the predictable purpose of increasing the protection of the optical fibers in Daniels.
Regarding Claim 14, Daniel modified by Yu makes obvious the method of Claim 13. Daniel further teaches wherein a desired total light dose is delivered to the tissue while the fluence rate of the treatment light is modified based on the temperature of the tissue (Para. 0181, “ablation energy output”).
Conclusion
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/JLM/
Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792