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 .
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.
The disclosure is objected to because of the following informalities: The first paragraph of the specification should be amended to include updated patent information.
Appropriate correction is required.
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.
Claim(s) 1-3, 14-19 and 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davalos (US 2010/0261994).
Regarding claim 1, Davalos discloses a method of treating a target tissue of a patient, comprising: positioning at least one energy delivery body near the target tissue (in vivo treatment); positioning a dispersive electrode upon the patient at a location that causes the at least one energy delivery body to function in a monopolar fashion [Para 0014, 0020, 0036 and 0057 discuss monopolar and bipolar pulse approaches; Para 0080, 0082, 0117, 0124 and 0128 also discuss various arrangements of active electrodes and ground electrodes, while many of the Davalos approaches show active and ground electrodes internally, a monopolar approach would require a separate ground electrode placed away from an active electrode for the electric to be given a path to travel from the active to a ground, it is not necessary for the ground or dispersive electrode to be placed on the external surface of the body for it to be a monopolar application; separately, Para 0020, 0026, 0029, 0128 and claim 21 all discuss placing an electrode outside of the body]; and delivering pulsed high voltage energy through the energy delivery body, wherein the pulsed high voltage energy causes disruption of at least intracellular organelles [Para 0060] of the target tissue leading to cell death by at least one non-thermal mechanism, wherein the pulsed high voltage energy has a voltage of 500 to 5000 volts and packets of pulses [Para 0021]. It is noted that the prior art should be evaluated in its entirety and not limited to the cited sections of specification alone.
Regarding claims 2 and 18, Davalos discloses the method of claim 1, wherein the non-thermal mechanism comprises programmed cell death [Para 0022 and 0054].
Regarding claims 3 and 19, Davalos discloses the method of claims 1 and 16, wherein the cell death causes an inflammatory cascade to ensue [Para 0054-0057 and 0060, the cell death performed by Davalos would lead to an inflammatory cascade as the voltage parameters and targeted area are the same].
Regarding claims 4 and 20, Davalos discloses the method of claim 1, wherein the target tissue resides within a lung of the patient (Para 0065 discuss various issue/organ types including the lungs).
Regarding claims 14 and 30, Davalos discloses the method of claim 1, further comprising repositioning the at least one energy delivery body after delivering the pulsed high voltage energy and thereafter delivering another dose of the pulsed high voltage energy, wherein the pulsed high voltage energy and the another dose of the pulsed high voltage energy are delivered to overlapping areas of the target tissue [Para 0021, 0129].
Regarding claim 15, Davalos discloses the method of claim 1, wherein the pulsed high voltage energy causes disruption of both cell membranes and the intracellular organelles of the target tissue, and wherein the pulsed high voltage energy has only a partial effect on the cell membranes or the intracellular organelles, and wherein a cumulative effect on the cell membranes or the intracellular organelles ultimately yields the cell death [Para 0054-0057 and 0060].
Regarding claim 16, Davalos discloses a method for treating a target tissue of a patient, comprising: positioning at least one energy delivery body near the target tissue (in vivo treatment); positioning a dispersive electrode upon the patient at a location that causes the at least one energy delivery body to function in a monopolar fashion fashion [Para 0014, 0020, 0036 and 0057 discuss monopolar and bipolar pulse approaches; Para 0080, 0082, 0117, 0124 and 0128 also discuss various arrangements of active electrodes and ground electrodes, while many of the Davalos approaches show active and ground electrodes internally, a monopolar approach would require a separate ground electrode placed away from an active electrode for the electric to be given a path to travel from the active to a ground, it is not necessary for the ground or dispersive electrode to be placed on the external surface of the body for it to be a monopolar application; separately, Para 0020, 0026, 0029, 0128 and claim 21 all discuss placing an electrode outside of the body]; and delivering pulsed high voltage energy through the energy delivery body, wherein the pulsed high voltage energy comprises packets of pulses that cause disruption of both cell membranes and intracellular organelles of the target tissue, thereby leading to cell death by at least one non-thermal mechanism [Para 0021-0022 and 0054].
Regarding claim 17, Davalos discloses the method of claim 16, wherein the pulsed high voltage energy has only a partial effect on the cell membranes or the intracellular organelles, and wherein a cumulative effect on the cell membranes or the intracellular organelles ultimately yields the cell death [Para 0022 and 0054].
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.
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.
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.
Claim(s) 5-13 and 21-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davalos (US 2010/0261994) in view of Litscher (US 2015/0045788).
Regarding claims 5-13 and 21-29, Davalos discloses the method of claim 1, but fails to explicitly disclose the various features of the instrument and its usage in various areas of the body. However, Litscher discloses wherein positioning the at least one energy delivery body comprises advancing the at least one energy delivery body into a body passageway, wherein the body passageway comprises a lung passageway [Para 0040], wherein the body passageway comprises a blood vessel, a lymphatic vessel, a kidney tubule, an esophagus, a stomach, a small intestine, a large intestine, an appendix, a rectum, a bladder, a ureter, a pharynx, a mouth, a vagina, a urethra, or a duct of a gland [Para 0058], wherein the at least one energy delivery body comprises one or more prongs (view figure 5 with elements where electrodes 10-13 are placed, the elongated legs are considered prongs), wherein the one or more prongs comprise an insulating substrate [Para 0019 discloses insulation], further comprising withdrawing a sheath proximally so as to expose the one or more prongs [Para 0042 discusses and introduction sheath and would be withdrawn for exposure], wherein the at least one energy delivery body comprises a plurality of tines (view figure 5), further comprising expanding the at least one energy delivery body (electrodes 10-13), wherein the at least one energy delivery body comprises a plurality of wires forming a basket (view figure 5). It would have been obvious to one having ordinary skill in the art at the time the invention was effectively filed to have the method of Davalos be used with the various treatment areas and device as taught by Litscher. Doing so would allow for an improved catheter design that permits different configurations including monopolar or bipolar configurations for the delivery of electrical energy to body lumens.
Claim(s) 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davalos (US 2010/0261994) in view of Eggers (US 7,445,618).
Regarding claims 31 and 32, Davalos discloses the method of claims 1 and 16 but fails to explicitly disclose wherein the pulses of the packets of pulses have a frequency of 100kHz to 1MHz. However, Eggers discloses a frequency range of 100kHz to 1MHz (claims 12, 14 and 15). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to have the energy application of Davalos utilize an energy range as taught by Eggers. Doing so minimizes stimulation of muscle or nerve tissue in the vicinity of the body being treating as well as minimizing the risk of interfering with the natural pacing of the heart in circumstances where the pulses are used near the heart.
Response to Arguments
Applicant's arguments filed 04/20/2026 have been fully considered but they are not persuasive. On Page 7 of applicant’s remarks, with regards to claims 1-3, 14-19 and 30, applicant has argued that the invention of Davalos does not “cause the at least one energy delivery body to function in a monopolar fashion”. The examiner respectfully disagrees. As stated in the rejection above, while certain paragraphs were cited previously the cited prior art is considered in its entirety. Additionally, as discussed above, Para 0014, 0020, 0036 and 0057 discuss monopolar and bipolar pulse approaches; Para 0080, 0082, 0117, 0124 and 0128 also discuss various arrangements of active electrodes and ground electrodes, while many of the Davalos approaches show active and ground electrodes internally, a monopolar approach would require a separate ground electrode placed away from an active electrode for the electric to be given a path to travel from the active to a ground, it is not necessary for the ground or dispersive electrode to be placed on the external surface of the body for it to be a monopolar application; separately, Para 0020, 0026, 0029, 0128 and claim 21 all discuss placing an electrode outside of the body. It is the opinion of the examiner that while Davalos is silent as to whether it is a bipolar or monopolar application of energy, the arrangement of the electrodes give support for monopolar application, specifically in Para 0020 which allows for electrodes to be placed outside the body as presented in arguments by the applicant. While Davalos does provide various other electrode arrangements that do not require an external body electrode, separate ground electrodes are found separated from active electrodes around the epithelial layer and are considered to be a monopolar application.
With regards to claims 5-13 and 21-29 rejected under Davalos and Litscher, applicant has presented arguments with regards to the supplemental prior art of Litscher using thermal energy and not non-thermal as claimed. The examiner respectfully disagrees. The application of Litscher is to provide a structure that capable of accessing various parts of the body in different electrode arrangements not found in Davalos. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). While the generator and energy application methodology used by Litscher is different than that of Davalos, the prior art is used to show that one having ordinary skill in the art would be able to create a device with the various features such as tines or prongs with the methodology provided by Davalos rather than bodily incorporating those features and uses together. The obviousness rejection of claims 5-13 and 21-29 remain.
Conclusion
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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/A.L.Z/ Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/ Primary Examiner, Art Unit 3794
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