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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. There is no specific support for a conductive body having a length of 1-30cm as recited in claim 1. Paragraph [0007] of the printed publication states the length of the needle may be between 5 and 15 cm. Claims 2-13 are rejected based on their dependency from claim 1.
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 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Wegrzyn, III et al (10,194,971) in view of the teaching of Ping et al (CN 203208117).
Regarding claim 1, Wegrzyn, III et al. provide an ablation needle comprising a conductive body (120) having an outer diameter within applicant’s claimed range (col. 10, lines 32-36, for example) and a length within applicant’s claimed range (col. 10, lines 44-47, for example). There is an insulation layer (130) extending from the proximal end to the distal end. Wegrzyn fails to expressly disclose that the insulation provides an exposed portion formed by a gap in the insulation that has a circumferential angle of 1-180 degrees to produce a directional field as claimed. Rather, Wegrzyn exposes the distal tip of the needle for treatment of tissue.
Ping et al disclose another ablation needle and specifically teach that it is known to provide the insulation layer (2) extending to the distal end of the needle with a circumferential gap (Figure 2) to provide a directional field to treat a desired tissue area and protect other tissues. While Ping shows a gap of 180 degrees in Figure 2, Ping et al specifically state the gap may be any desired size and shape determined according to the clinical needs. See attached English translation of the Ping et al document. The use of any particular radial exposure is deemed an obvious design variant that would have predictable and intuitive results on the treatment of tissue.
To have provided the Wegrzyn, III et al needle electrode with an insulation layer that creates a gap for the directional treatment of tissue to protect non-targeted tissues from treatment would have been an obvious modification for one of ordinary skill in the art at the time of the invention since Ping et al fairly teach it is known to provide an insulation layer over and ablation needle electrode, the insulation layer forming a gap for the directional treatment of tissue with the needle electrode.
Regarding claims 2 and 3, Ping et al teach that the exposed opening may be any desired size/shape, and the examiner maintains claimed length of the opening would be an obvious design consideration for one of ordinary skill in the art dependent on the needs of the specific procedure. Regarding claim 4, see Wegrzyn at column 10, lines 44-47. Regarding claim 5, see Wegrzyn column 12, lines 1-10 which discloses a thickness for the insulation layer in the same range as claimed. Regarding claims 6-8, see again the disclosure of Ping et al who discloses the size and shape of the gap may be any desired range. The examiner maintains the specific size/shape of the exposed portion would be an obvious design consideration dependent on the specific needs of the procedure. Regarding claim 9, Wegrzyn discloses an RF generator (270) connected to the proximal end of the conductive body for delivery of energy by the needle electrode. Regarding claims 10 and 11, see column 12, lines 10-15 which disclose various different materials, including some recited in the claims. The examiner maintains the use of any well-known insulation material would be and obvious design consideration for one of ordinary skill in the art. Regarding claim 12, see column 19, lines 30-35 of Wegrzyn who discloses the use of a thermocouple attached to the needle electrode. Regarding claim 13, Wegrzyn in view of Ping et al meets the limitations of claim 1 as asserted above, and Wegrzyn further provides an RF generator (270) connected to the electrode as well as a controller that controls the switching of the generator to control the energy delivery based on the sensed temperature (col. 19, line 55 to col. 20, line 26, for example).
Response to Arguments
Applicant's arguments filed January 27, 2026 have been fully considered but they are not persuasive. The arguments that Ping’s statement that the size and shape of the gap can be determined according to clinical needs is “boilerplate language that does not specifically teach or suggest the full claimed range of 1-180o “ are not persuasive. Ping’s broad recitation is no less vague than applicant’s own disclosure which presents the entire range of 1-180o as potential angles of exposure, with no criticality or unexpected results associated with any particular value in that range. The examiner maintains that one of ordinary skill in the art would readily recognize the effects of modifying the exposure angle to any desired value, and the exposure angle would obviously be selected dependent on the tissue site being treated. Smaller exposure angles would intuitively and obviously have a more focused treatment area so as to protect a larger portion of tissue, and larger exposure angles would treat a larger volume of tissue. There is no unexpected result that would transpire from the use of any particular exposure angle, and Ping fairly mentions that the exposure angle may be adjusted as deemed necessary for a particular clinical need. Applicant’s arguments that there is no suggestion or motivation to use a smaller exposure angle, nor a reasonable expectation of success that such a gap would produce an effective field without compromising performance or requiring undue experimentation are also not found persuasive. Again, applicant has disclosed no particular criticality for the broadly described range, nor addressed any need for “undue experimentation” that would be required to determine the use of a smaller exposure angle. Rather, applicant merely broadly recites the entire range from 1-180o with no rationale for the precise range being selected. The examiner maintains that clearly there would be no undue experimentation required to determine that a smaller exposure angle would treat a smaller portion of tissue. And while applicant asserts there is an “unexpected precision” associated with the smaller exposure angle (page 3 of the response), there is no mention of such an unexpected precision anywhere in applicant’s disclosure. The examiner maintains Ping fairly teaches the exposure angle may be adjusted to any desired range based on the clinical needs of the procedure, and the examiner further maintains that any particular angle of exposure would yield predictable results. As such, the rejection is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/March 27, 2026