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 .
Election/Restrictions
Applicant’s election without traverse of species 4, subspecies A, directed to claims 1, 3, 4, 6-16 and 21-25 in the reply filed on December 23, 2025 is acknowledged.
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, 3, 4, 6-8, 13, 14 and 21-25 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 21 are unclear in the recitation of “through which a fluid passes”, particularly in that there is no positive recitation of a fluid source or means to provide a fluid. The dependent claims are rejected based on their dependency from a rejected base claim. Claim 25 is unclear with the recitation of the connector and its relationship to the electrode, particularly in that the specification does not appear to provide a clear description of this feature. The term “connector” appears to be used for the connection to the electrical/fluid source at the proximal end of the device. It appears the terminology used in the claims is not consistent with the terminology used in the specification making it unclear as to what elements are specifically being referenced.
Claim Rejections - 35 USC § 102
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, 3 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Durgin et al (6,325,800).
Regarding claim 1, Durgin et al provide a treatment tool for use with an endoscope comprising a sheath (12) having proximal and distal ends with an electrode (29A, 29B) provided on a distal end portion of the sheath. A rod (23) is provided at a position away from the electrode in a radial direction (i.e. radially inward), the rod being advanceable and retractable with respect to the sheath (Figures 3 and 4, for example) whereby when the rod protrudes from the sheath a flow path is formed (i.e. through the needle) to a space between the electrode and the rod.
Regarding claim 3, see Figure 4 which clearly shows the rod has a diameter smaller than the diameter of the electrode. Regarding claim 9, see above discussion regarding claims 1 and 3 which address all the limitations of claim 9.
Claims 1, 3, 4, 6-14 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hancock et al (10,251,697).
Regarding claim 1, Hancock et al provide a treatment tool for use with an endoscope comprising a sheath (102) having proximal and distal ends with an electrode (105,107) provided on the distal end portion of the sheath. There is a rod (136) provided at a position radially away from the electrode, the rod being advanceable and retractable with respect to the sheath (Figures 6 and 7). A flow path is created such that fluid may be provided in a space between the rod and opening (110) such that fluid is provided between the rod and the electrode (col. 6, lines 34-57, for example).
Regarding claim 3, the rod diameter is smaller than the electrode diameter (figure 2, for example). Regarding claim 4, the sheath includes a first opening in the sheath for the electrode and a second opening (e.g. 110) through which the rod is configured to advance/retract. Regarding claim 6, the distal end of the electrode passes through the first opening (Figures 1 and 2) and both protrudes from the sheath and is accommodated in the sheath. Regarding claim 7, the rod passes through the second opening (101) and may protrude from the sheath (Figure 6) and accommodate in the sheath (Figure 7). Regarding claim 8, the diameter of the rod is smaller than a diameter of the electrode (Figure 2).
Regarding claim 9, Hancock et al provide a tool having a sheath, an electrode and a rod as addressed with respect to claim 1 above, whereby the diameter of the rod is smaller than the diameter of the electrode as addressed with respect to claim 3 above.
Regarding claim 10, see discussion of claim 4 above. Regarding claims 11 and 12, see above discussion with respect to claims 6 and 7. Regarding claim 13, see column 6, lines 34-57 as addressed above. Regarding claim 14, a gap may be provided between the rod and the second opening (110) to create the flow path (col. 10, lines 12-19, for example).
Regarding claim 21, Hancock et al again provide a tool comprising a sheath (102) and an electrode (105/107) provided on the distal end, the rod having a sold distal end for puncturing tissue (i.e. needle point). The electrode passes through a first opening in the sheath (Figures 2 and 3) and the rod is configured to advance and retract relative to the sheath through a second opening (110) formed at a distal end of the sheath and radially spaced from the first opening (Figure 2, for example). A part of a flow path is provided between the electrode and the rod, with the flow path defined by a gap between the rod and the inner surface of the second opening (col. 10, lines 12-19, for example).
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.
Claims 1, 3, 4, 6-16 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Yamamoto et al (9,526,562) in view of the teaching of Hancock et al (‘697).
Yamamoto et al discloses a treatment tool for an endoscope comprising a sheath (2b) having proximal and distal ends and an electrode (3) provided on a distal end portion and retractable/advanceable relative to the sheath. Yamamoto et al also disclose providing a fluid directed around the electrode, but fail to expressly disclose a rod positioned adjacent the electrode (i.e. radially away), the rod being advanceable/retractable relative to the sheath and also providing part of the flow path.
As addressed previously, Hancock et al provide a device comprising a sheath with an electrode provided at the distal end of the sheath. Hancock et al provide the additional teaching of the advantages of providing an advanceable/retractable rod located radially adjacent to the electrode to provide the additional function of providing an injection needle to enhance treatment with the electrode.
To have provided the Yamamoto et al device with an advanceable/retractable rod located adjacent the electrode to allow for the injection of material adjacent the electrode to enhance the functionality of the device would have been an obvious design modification for one of ordinary skill in the art at the time of the invention since Hancock et al fairly teach it is known to provide an additional advanceable/retractable rod adjacent a treatment electrode.
Regarding claim 3, the needle of Hancock et al would obviously have a smaller diameter than the Yamamoto et al electrode, similar to the arrangement taught by Hancock et al. Regarding claim 4, Yamamoto et al provides a first opening for the electrode, and would obviously include a second opening to accommodate the electrode as taught by Hancock et al. Regarding claim 6, see Figures 3 and 4 of Yamamoto et al which shows the electrode in the extended and retracted states. Regarding claim 7, as per the teaching of Hancock et al, the rod would pass through a second opening in the distal end of the Yamamoto sheath and would be configured to advance/retract as taught by Hancock et al. Regarding claim 8, again the rod would obviously have a smaller diameter relative to the electrode as provided by Hancock et al.
Regarding claim 9, Yamamoto et al provide a tool comprising a sheath and an electrode as addressed with respect to claim 1 above. Further, Hancock et al provide the teaching of providing an advanceable/retractable rod radially separated from the electrode and having a diameter smaller than the electrode diameter.
To have provided the Yamamoto et al device with an advanceable/retractable rod located adjacent the electrode to allow for the injection of material adjacent the electrode to enhance the functionality of the device would have been an obvious design modification for one of ordinary skill in the art at the time of the invention since Hancock et al fairly teach it is known to provide an additional advanceable/retractable rod adjacent a treatment electrode.
Regarding claim 10, Yamamoto et al provides a first opening for the electrode, and would obviously provide a second opening for passage of the rod as fairly taught by Hancock et al. Regarding claims 11 and 12, Yamamoto et al discloses an advanceable/retractable electrode as addressed previously, and Hancock et al teach the rod may be advanceable/retractable relative to the sheath as well. Regarding claim 13, Yamamoto et al provides a fluid path for the electrode (which fluid path would be between the electrode and the rod), and Hancock et al also disclose a fluid path for the rod member. Regarding claim 14, Hancock et al disclose a gap between the opening and the rod to provide a fluid (col. 10, lines 12-19). Regarding claim 15, Yamamoto et al disclose the distal end portion of the shaft has a distal end member (6) formed of an insulating material. The first opening (9) for the electrode is in the distal end member, and a second opening would obviously be provided to extend/retract the rod member as taught by Hancock et al. Yamamoto et al also disclose a flange (7) for controlling the extension of the electrode, and inclusion of such a flange on the rod of Hancock et al to control the extension range of the rod is deemed an obvious design consideration for one of ordinary skill in the art. Regarding claim 16, the relative protrusion amounts for the electrode and the rod is deemed to be an obvious design consideration for one of ordinary skill in the art dependent upon the desired results.
Regarding claim 21, Yamamoto et al provide a tool comprising a sheath and an electrode as addressed previously. The electrode passes through a first opening in the sheath. Yamamoto et al fail to disclose a rod having a sharp tip that is advanceable relative to the sheath and electrode. As addressed previously, Hancock et al provide a device comprising a sheath with an electrode provided at the distal end of the sheath. Hancock et al provide the additional teaching of the advantages of providing an advanceable/retractable rod located radially adjacent to the electrode to provide the additional function of providing an injection needle to enhance treatment with the electrode.
To have provided the Yamamoto et al device with an advanceable/retractable rod located adjacent the electrode to allow for the injection of material adjacent the electrode to enhance the functionality of the device would have been an obvious design modification for one of ordinary skill in the art at the time of the invention since Hancock et al fairly teach it is known to provide an additional advanceable/retractable rod adjacent a treatment electrode. Providing a second opening to accommodate the rod would be an obvious consideration for the skilled artisan, and both Yamamoto et al and Hancock et al disclose providing a flow path as addressed previously.
Regarding claim 22, the Yamamoto et al sheath includes a tube (2) and a distal end member (6) provided at the distal end of the tube, the distal end member including an opening to accommodate the electrode. Providing a second opening to accommodate the rod as taught by Hancock et al would be an obvious consideration for one of ordinary skill in the art, and a necessity to accommodate the probe. Regarding the flange, Yamamoto et al teach of providing the electrode with a flange as addressed previously, and including a similar flange on the rod to control the extension of the rod would be an obvious consideration for one of ordinary skill in the art. Regarding claim 23, the distal end member of Yamamoto et al has been addressed previously, and the examiner maintains it would be intuitive and obvious to the skilled artisan to include a second opening for the rod as fairly taught by Hancock et al. Regarding claim 24, see discussion of claim 22 above and the teaching of a flange by Yamamoto et al.
Allowable Subject Matter
Claim 25 would be allowable if 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 to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Long (8,216,234), Sartor (7,537,594), Dahla et al (7,270,661) and Rydell (5,007,908) disclose other devices deemed to have a sheath with a distal electrode and a rod advanceable relative to the sheath.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL PEFFLEY whose telephone number is (571)272-4770. The examiner can normally be reached Mon-Fri 8 am-5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached at (571) 272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/ January 12, 2026