DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
Claim 29 is objected to because of the following informalities: in line 3, “having a housing an electrode" should read --having a housing with an electrode--. 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.
Claims 1-16 and 29-32 are 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.
Claims 1 and 29 each recite the limitation “the current” in line 6. There is insufficient antecedent basis for this limitation in the claim. Dependent claims 2-16 and 30-32 are necessarily rejected as depending upon rejected base claims.
Claims 11 and 12 recite the limitations “the first threshold time” and “a second threshold time,” but depend on claim 8, which does not recite the limitation of a first threshold time. The antecedent basis and scope of claims 11 are therefore unclear. For examination purposes, claim 11 will be read as dependent upon claim 10.
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.
Claims 1-8, 13-16, and 29-31 are rejected under 35 U.S.C. 103 as being unpatentable over Pate et al. (US PGPub No. 2021/0267675), hereinafter Pate, in view of Ogata et al. (US PGPub No. 2014/0309632), hereinafter Ogata.
Regarding claims 1 and 29, Pate teaches a system for forming a fistula between two adjacent vessels (Figs. 15A-15B and par. 0071: “the catheters described here may comprise one or more elements for forming a fistula. A fistula-forming element may comprise any element capable of forming a fistula between two vessels”), the system comprising:
a first catheter comprising a housing with an electrode (Figs. 15A-15B: first catheter 1504 with housing and electrode 1506);
a second catheter comprising a backstop (Figs. 15A-15B: second catheter 1500 with backstop 1502);
an energy source for supplying radiofrequency energy to the electrode (par. 0128: “the electrodes described herein may be connected to a radiofrequency current generator (e.g., via the monopolar or bipolar output of the current generator) to energize the electrodes for the various applications described herein”);
and a current sensor for measuring the current flowing to the electrode (par. 0170: “To measure impedance of tissue between the electrodes, low power DC or alternating voltage may be applied to the electrodes. The resulting current and/or phase may be measured to determine impedance”).
Pate does not explicitly teach a waveform detector coupled to the current sensor for determining a phase state of the electrode based on a waveform of the measured current. However, in an analogous art, Ogata teaches a radiofrequency ablation catheter with a waveform detector coupled to a current sensor (Fig. 1: measurement devices 124(1)-124(n); par. 0033: “one of the one or more measurement devices 124(1)-124(n) is an electrical device configured to measure one or more electric characteristics such as current”) for determining a phase state of an electrode based on a waveform of the measured current (Figs. 5-6: electrode phase states 400-404 in voltage and current; par. 0038: “The phase state of tissue ablation may be determined by way of example by voltage and/or current waveforms received from one or more of the measuring devices 124(1)-124(n)”). Ogata teaches that using waveforms to detect phases of tissue response to radiofrequency energy, as disclosed, provides the ability to control energy delivery based on waveform data (par. 0048: “the tissue ablation monitoring device 108 is configured to control energy delivery based on data related to one or more pre-determined waveform patterns. For example, based on the data related to one or more pre-determined waveform patterns, the computer executable instructions can cause the tissue ablation monitoring computing device 108 to apply a voltage level that is configured to substantially minimize the treatment time needed to achieve plasma generation as observed in the plasma phase and thereby minimizing the duration of and the thermal effects during the pre-plasma phase”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Pate by providing a waveform detector coupled to the current sensor for determining a phase state of the electrode based on a waveform of the measured current, as taught by Ogata, in order to provide the ability to control energy delivery based on the waveform data, as taught by Ogata.
Method claim 29 is also rejected over Pate in view of Ogata for the same reasons set forth in the rejection of claim 1, since the claim merely recites simple method steps of using the system recited in claim 1.
Regarding claims 2-3, the combination teaches the system of claim 1 as described previously. Ogata further teaches wherein the waveform detector comprises an oscilloscope (par. 0033: “The one of the one or more measurement devices 124(1)-124(n) may be, by way of example only, an oscilloscope”), wherein the oscilloscope is configured to display the waveform of the measured current (Fig. 2: display interface 122; par. 0044: “the tissue ablation monitoring computing device 108 is configured to produce a visual indication based on the determined phase of the ablation. For example, based on the measured and processed voltage data, if it is determined that the plasma phase has been achieved, an indication may be displayed on the display unit 122”).
Regarding claims 4-7 and 30, the combination teaches the system of claim 1 and the method of claim 29 as described previously. Ogata further teaches wherein the waveform detector is configured to determine a dry-out phase state if the current peak amplitude rises above a first threshold (Fig. 6: line 2 representing current; par. 0043: “during the channel phase 404, the current increases when compared to the current measured during plasma phase 402”), wherein the waveform detector is further configured to determine a plasma phase state if the current peak amplitude is below a second threshold, wherein the second threshold is lower than the first threshold, and wherein the waveform detector is further configured to determine a pre-plasma phase state when the current peak amplitude is between the first and second threshold (Fig. 6: line 2, initial plasma phases 400, 402; par. 0038: “the tissue ablation monitoring computing device 108 optionally determines a phase state of the tissue ablation process based on the received one or more items of data. The phase state of tissue ablation may be determined by way of example by voltage and/or current waveforms received from one or more of the measuring devices 124(1)-124(n);” claim 16: “wherein the pre-plasma phase is indicated by a minimum current measurement for the waveform”). Examiner notes that although Ogata’s disclosure uses the term “pre-plasma phase” to describe the plasma phase 400, the phase encompasses the initial dissociation of molecular bonds in the tissue due to heating and the corresponding drop in current amplitude (par. 0039: “a pre-plasma phase occurs where the surrounding material, such as the tissue or fluid near treatment region by way of example, can be vaporized to form bubbles, and ionization activities can take place in this region that further lead to plasma discharge in step 402”) and is therefore interpreted to read on the plasma phase of the claimed invention.
Regarding claims 8 and 31, the combination teaches the system of claim 4 and the method of claim 30 as described previously. Ogata further teaches wherein the waveform detector is configured to determine a time taken to reach the dry-out phase state (par. 0050: “If in step 212, the tissue ablation monitoring computing device 108 determines that the threshold has been exceeded indicating a phase state change to a channel phase, then the Yes branch is taken to step 214 where the tissue ablation monitoring computing device 108 is configured to terminate energy delivery based on measured values reaching or exceeding the pre-determined threshold, such as current level, voltage level, power level, impedance level, and/or activation time”).
Regarding claim 13, the combination teaches the system of claim 4 as described previously. Ogata further teaches wherein the waveform detector is configured to activate an indicator or alarm when the electrode reaches the dry-out phase state (par. 0044: “the tissue ablation monitoring computing device 108 is configured to produce a visual indication based on the determined phase of the ablation”).
Regarding claims 14-16, the combination teaches the system of claim 4 as described previously. Ogata further teaches further comprising a processor coupled to the energy source and the waveform detector (Figs. 1-2: processor 114 in computing device 108 coupled to energy source 106 and measurement devices 124(1)-(n)), wherein the processor is configured to turn off (that is, reduce the power of) the energy source when it receives a signal from the waveform detector that the electrode has reached the dry-out phase state (par. 0050: “If in step 212, the tissue ablation monitoring computing device 108 determines that the threshold has been exceeded indicating a phase state change to a channel phase, then the Yes branch is taken to step 214 where the tissue ablation monitoring computing device 108 is configured to terminate energy delivery”).
Allowable Subject Matter
Claims 9-10 and 32 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
The closest prior art found regarding the limitations in claims 9-10 and 32 are Matsubara et al. (US PGPub No. 2015/0209526), hereinafter Matsubara, and Reu et al. (US Patent No. 11,844,524), hereinafter Reu. Matsubara teaches identifying calcification at a blood vessel, but teaches the use of spectral analysis to identify atheroma deposits and evaluate the suitability of the vessel for a vascular access site before performing a fistula procedure (par. 0034: “spectral analysis tools are used in conjunction with imaging to further improve visualization of factors that contribute to a vessel's health (such as any sclerosis, atheroma deposits, and/or thrombus morphology (i.e., virtual histology)), and thus its suitability for vascular access formation”) and does not teach using a measured duration and current waveform of an active fistula formation process to detect whether calcium is present in a vessel wall. Reu teaches monitoring the progress of fistula formation using gap distance feedback (Fig. 11), including a timeout feature in order to avoid excessive heating (col 20, lines 50-56: “It should be noted that, after the maximum six pulses specified in the thermal profile of FIG. 10 for thermal cycle C, the cycle times out, even if the gap distance remains greater than 0.1 mm, since the catheter is likely closed and has cut through and fused the vessel tissue walls, and excessive heating is to be avoided”), but does not teach detecting calcification of vessel walls or using the measured duration of time to do so. Examiner has not found any piece of art that discloses, fairly suggests, or makes obvious such a technique for detecting vessel wall calcification during fistula formation or other puncturing procedures.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claims 11-12 would be allowable if the claims are rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action, and if claim 10 is rewritten as laid out previously.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Highsmith et al. (US PGPub No. 2021/0401483) teaches a radiofrequency puncture system and method that measures impedance and compares the duration of providing energy to an electrode with a predetermined duration threshold to evaluate the completeness of a puncture procedure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JOANNE M RODDEN can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.E.L./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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