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 .
Priority
Acknowledgment is made of applicant’s claim for priority. The current application claims benefit of provisional application 63/497,451, filed on April, 21st, 2023. Examiner acknowledges the applicant’s claim for priority.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 25th, 2024 is being considered by the examiner.
Status of Claims
In the response dated June 24th, 2026, Applicant amended and canceled no claims. Claims 1-9 are pending.
Response to Arguments
In response to the argument put forward in the amendment, Examiner will address them in the order they were presented.
Regarding page 2 and 3, Applicant’s arguments have been considered but are unpersuasive. Applicant argues that Brown at [0019], merely teaches monitoring optical feedback and “‘does not mention or suggest any sort of usage limit’, particularly of the sleeve or catheter rather than the fiber”. Examiner finds this argument unpersuasive. Under broadest reasonable interpretation, the step of “setting, based on an objective criterion, a usage limit for replacement or re-positioning of the sleeve or catheter” comprises a threshold of a parameter that indicates the use of the device. Brown expressly teaches “the control unit includes an input from an optical feedback fiber optic cable which transmits optical feedback signals... The optical feedback signal is separated into a first wavelength spectrum corresponding to the aiming beam, the attenuation of which indicates build-up of contaminants such as charring on the fiber tip and/or inadequate flushing” [0019]. Attenuation is a parameter measured which indicates a threshold.
Applicant also argues that Brown monitors the fiber rather than the sleeve or catheter. First, the instant claims do not require monitoring the sleeve or catheter. The claimed monitoring encompasses any information which aids the repositioning the catheter or sleeve, not specifically monitoring the degradation of the catheter or sleeve. Brown’s attenuation channel is not limited to the condition of the fiber. Brown states that attenuation of the aiming beam “indicates build-up of contaminants such as charring on the fiber tip and/or inadequate flushing,”, see [0019]. Flushing is performed through the catheter through which the fiber is delivered. Therefore, the monitored attenuation is indicative of the catheter, not solely the fiber. Furthermore, the rejection does not rely upon Brown alone for replacing the sleeve or catheter after the usage limit has been exceeded. Applicant argues that Navarro “contains no suggestion of any sort of usage limit for the catheter”. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references, see MPEP 2145.
Regarding page 4, Applicant’s arguments have been considered but are unpersuasive. Applicant argues that the detection of overheating or burning as taught by Brown means that the replacement of the fiber is overdue, such that Brown is at best overreactive. Brown’s feedback us not limited to after-the-fact detection of heating. Rather, the first wavelength monitors attenuation of the aiming beam, indicative of the progressive contaminant build-up and inadequate flushing before overheating or burning occurs.
Additionally, the discovery of a mechanism or benefit of steps taught or suggested by prior art does not render the steps patentable (MPEP 2145). Applicant’s arguments rely on language solely recited in preamble recitations in claim 1. When reading the preamble in the context of the entire claim, the recitation of the intended results of preventing coagulation or sloughing is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. The preamble furthermore includes alternative limitations, not requiring specifically monitoring degradation of the catheter or sleeve. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Finally, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding page 5, Applicant’s arguments have been considered but are unpersuasive. Regarding claims 2 and 3, Applicant argues that neither an accumulated energy delivered through the sleeve or catheter nor a treatment time divided by an energy output of the laser is used to set, or monitored by, the feedback system of Brown. This argument is not persuasive. Brown teaches that an indicator may include “the laser power setting, for example in watts” and “a display showing the results of a calculation of the laser energy used. A calculation of the laser energy used constitutes an accumulated energy delivered through the sleeve or catheter, the laser output being transmitted through the delivery fiber positioned within the catheter/ introducer. A power setting in watts is a quantity in units of energy per unit of time, and Navarro further teaches setting and modifying the power and burst duration of the laser according to clinical observations and obtained results.
Regarding page 5, Applicant’s arguments regarding claims 4-6, 8, and 9 rely on their dependence from claim 1 and are not persuasive for the reasons set forth above.
Regarding page 6, Applicant’s arguments have been considered but are unpersuasive. Applicant argues that Graham contains no disclosure or suggestion of a usage limit, replacing or re-positioning the cannula when the usage limit has been exceeded. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references, see MPEP 2145. Graham is relied solely upon for the catheter to contain a plurality of openings and for repositioning the sleeve between the respective openings. This argument attacks Graham individually for which features upon which Graham is not relied and therefore is unpersuasive.
Claim Objections
Claim 3 is objected to because of the following informalities: Claim 3 recites "time divided by energy" which reads as “time per energy” rather than standard power measurements of "energy per time". Examiner interprets this to be energy per time i.e., power. Appropriate correction is required.
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 1-6 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. (US20090062782) in view of Navarro at al. (Pat. 6398777).
Regarding claim 1, Brown teaches a method of preventing coagulation or sloughing of a tissue caused by firing of a laser beam through a worn sleeve or catheter ([0018] “catheter/introducer” and [0032] “the laser output is transmitted to a delivery fiber”), or by debris accumulation on the sleeve or catheter, comprising the steps of: ([0017] “detect effects of overheating and/or burning of tissues, bodily fluids, or the apparatus itself”) setting, based on an objective criterion, a usage limit for replacement or re-positioning of the sleeve or catheter; ([0019] the control unit includes an input from an optical feedback fiber optic cable which transmits optical feedback signals... The optical feedback signal is separated into a first wavelength spectrum corresponding to the aiming beam, the attenuation of which indicates build-up of contaminants such as charring on the fiber tip and/or inadequate flushing, and a second wavelength spectrum including infrared wavelengths that directly detect overheating or burning.” Where the inputting [comprising setting] the signals [i.e., objective criterion] indicate built up contaminants and overheating [i.e. a usage limit]) monitoring the objective criterion ([0031] “an external feedback control unit… includes an optical fiber cable input, through which are transmitted optical feedback signals indicative of charring or overheating.) during one or more surgical procedures in which the laser beam is fired through the sleeve or catheter; ([0010] “feedback arrangements to control the laser or fiber position. It can be used in connection with a method for treating varicose veins”)
Brown’s application cites Navarro as one of many patents that are indicative of the state of the art for tissue vaporization. Like Brown, Navarro also utilizes catheter-based tissue ablation systems. Brown teaches equipment temperature and positioning is important to the patient, as “charring and/or other effects of overheating or thermal runaway can directly cause negative effects on the patient”, see Brown [0014].
Regarding claim 1, Brown does not explicitly teach, as taught by Navarro, and replacing or re-positioning the sleeve or catheter after the usage limit has been exceeded. ([9] “monopolar electrocautery, and a bipolar radio frequency-based energy source delivered by a disposable catheter (VNUS).” Where the disposable catheter must be replaced after the usage limit is exceeded)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brown with the teachings of Navarro, with a reasonable expectation of success, by explicitly replacing the catheter or sleeve after reaching a usage limit. “carbonization to the sides of the fiber tip mak[es] it weak with the possibility of falling off into the vein… preventing negative effects resulting from burn back, the invention provides improved control of fiber position”, see Brown [0014-0015]. This would have reduced the risk of equipment melting and causing damage when large amounts of tissue are ablated.
Regarding claim 2, Brown-Navarro as a combination teach all of the limitations of claim 1. Brown also teaches wherein the objective criterion is an accumulated energy delivered through the sleeve or catheter during the one or more surgical procedures. ([0039] “FIGS. 10 and 11 show respective fiber tip arrangements … shown FIGS. 10 and 11 is a thermocouple for temperature feedback” where temperature fluctuations comprise an accumulated energy delivery through a sleeve during a surgical procedure.)
Regarding claim 3, Brown-Navarro as a combination teach all of the limitations of claim 2. Navarro also teaches wherein the step of setting the usage limit is a treatment time divided by an energy output of the laser, in units of energy per unit of time, and wherein the step of monitoring the objective criteria comprises a step of monitoring accumulated usage time of the laser. ([10] “The power and burst duration can be modified according to initial clinical observations and obtained results at the discretion of the provider. The range of power is set forth above.”) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brown with the teachings of Navarro, with a reasonable expectation of success, by explicitly modifying the power and burst duration of a laser ablation as the user obtains results to provide a more controlled ablation setting and reduce the risk of tissue melting. “carbonization to the sides of the fiber tip mak[es] it weak with the possibility of falling off into the vein… preventing negative effects resulting from burn back, the invention provides improved control of fiber position”, see Brown [0014-0015]. This would have reduced the risk of equipment melting and causing damage when large amounts of tissue are ablated.
Regarding claim 4, Brown-Navarro as a combination teach all of the limitations of claim 1. Navarro also teaches wherein the sleeve or catheter is replaceable. ([9] “monopolar electrocautery, and a bipolar radio frequency based energy source delivered by a disposable catheter (VNUS).”) It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brown with the teachings of Navarro, with a reasonable expectation of success, by explicitly replacing the catheter or sleeve to reduce the risk of equipment melting and inadequate tissue damage. “carbonization to the sides of the fiber tip mak[es] it weak with the possibility of falling off into the vein… preventing negative effects resulting from burn back, the invention provides improved control of fiber position”, see Brown [0014-0015]. This would have reduced the risk of equipment melting and causing damage when large amounts of tissue are ablated.
Regarding claim 5, Brown-Navarro as a combination teach all of the limitations of claim 1. Brown also teaches wherein the sleeve or catheter is re-positionable relative to a tip of the fiber. ([Figure 9] “automatic pullback on fiber” depicts a repositioning the catheter relative to the fiber)
Regarding claim 6, Brown-Navarro as a combination teach all of the limitations of claim 5. Brown also teaches wherein the sleeve or catheter is linearly or rotatably movable relative to the fiber. ([Figure 9] “automatic pullback on fiber” depicts a linear movement of the catheter relative to the fiber)
Regarding claim 8, Brown-Navarro as a combination teach all of the limitations of claim 1. Brown also teaches wherein the step of monitoring energy usage is carried out by monitoring software or circuitry included in the laser to measure the accumulated energy output of the laser overtime. ([Figure 1] Schematic of Safety Feedback Control Unit comprises laser circuitry; and [0021] “indicator/control unit may include … the laser power setting, for example in watts, a display showing the results of a calculation of the laser energy used,”)
Regarding claim 9, Brown-Navarro as a combination teach all of the limitations of claim 8. Brown also teaches wherein the monitoring software or circuit activates an alarm when the usage limited is exceeded. ([Figure 2] “External Feedback control unit with audible and/ or visual warning indicator” runs via circuitry; see also [0031-0032] “FIG. 1 is arranged to be used in an external feedback control unit. It includes an optical fiber cable input, through which are transmitted optical feedback signals indicative of charring or overheating… The outputs of the detectors are supplied to threshold detectors” where threshold detectors indicate charring and heating [i.e., a usage limit]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Brown et al. (US20090062782) in view of Navarro at al. (Pat. 6398777) and further in view of Graham et al. (US20170325886).
Graham designs a catheter-based tissue ablation apparatus that, similar to Brown, uses energy-based tissue ablation with a cannula. Graham states a “combination of increased heating and reduced cooling may overheat and thus damage the waveguide” [0148] and thus would have motivated the shared desire to “have improved handpieces to effectively access and treat selected tissue within a patient utilizing surgical energy” [Graham 0007] that avoids the common problem troubleshooted by Brown.
Regarding claim 7, Brown-Navarro as a combination teach all of the limitations of claim 1. Brown-Navarro does not explicitly teach, as taught by Graham, wherein the sleeve or catheter includes a plurality of openings, ([0087] “alternative waveguide passage 272” contains another catheter opening) and wherein re-positioning of the sleeve or catheter involves moving the sleeve or catheter, ([0154] “a computer automatically maintains a preset distance by adjusting the position of the manipulator” for the sleeve system) from a position in which one of the openings is in a path of the laser beam from an angled surface of the fiber to a targeted tissue, ([0137] “The housing 702 may include one or more bends 794 along the cannula region 714”) to a position in which another of the openings is in a path of the laser beam. ([0087] “Sight hole 241a enables viewing of a waveguide when its distal end reaches stop 294” where reaching a stop of the distal end comprises readjusting the sleeve or catheter)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brown-Navarro with the teachings of Graham, with a reasonable expectation of success, by explicitly containing two ports for angled tissue ablation. This would have allowed for easier ablation of angled tissues, as is common for non-vascular procedures.
Conclusion
The prior art made of record and not relied upon that is considered pertinent to applicant’s disclosure can be found on PTO-892 of the prior office action.
Nagase et al (Pat. 6544257) discloses a system for thermally treating by irradiating a vital tissue while adjusting the signal based on temperature sensors in the probe.
THIS ACTION IS MADE FINAL. 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.
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/R.A.S/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
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