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 .
Status of the Application
Upon review of the prior art, applicable art was found and has been used to reject claims 1-30. As such, the present rejection remains a Non-Final rejection.
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 approaches]; 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].
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 (column 11; 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.
Response to Arguments
With regards to the double patenting and subsequent Terminal Disclaimer. The applicant can choose to withdraw the terminal disclaimer once allowed claims have been issued if the subject matter diverges from the parent patent application.
As discussed above, during review of the claims for allowance, prior art was found, Davalos, which anticipates the targeted voltage range and use of a dispersive electrode to apply electroporation non thermal energy to cause cell death.
Conclusion
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/A.L.Z/ Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/ Primary Examiner, Art Unit 3794