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 .
Applicant’s amendments and comments, received June 30, 2026, have been fully considered by the examiner. The amendments to claim 1 have made the claim allowable over the prior art of record. As such, claims 14, 32, 35 and 37, previously withdrawn from consideration, have been rejoined and examined. The following is a complete response to the June 30, 2026 communication.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the cryogenic conduit (claims 14 and 37), the living hinge (claim 32) and the longitudinal ribs (claim 35) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 14, 32, 35 and 37 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.
Regarding claims 14 and 37, the specification fails to adequately describe, or show, the cryogenic conduit to a tissue contact portion of the device for treating tissue. While there are several references to cryogenic application, there is no express disclosure, or depiction, of the conduit means and how it relates to the tissue contacting portion to effectively treat tissue with cryogenic energy.
Regarding claim 32, there is only one reference to a “living hinge” at paragraph [0007] of the printed publication. There is no description of what constitutes a “living hinge”, and there is no element depicted in the drawings to indicate a living hinge.
Regarding claim 35, the only reference to “longitudinal ribs” is in paragraph [0007] of the printed publication. There is no description of the longitudinal ribs, and there is no representation in the figures to depict the longitudinal ribs.
Allowable Subject Matter
Claims 1, 4, 7, 10, 12, 13, 16, 33, 34, 37 and 37-40 are allowed. The prior art fails to disclose the specific pulsed field ablation effector comprising an electrode and a deformable insulator as claimed. The Danitz et al device cited in the previous Office action has needle electrodes designed to penetrate into tissue, unlike application claim 1 which requires the electrodes to be configured to not pierce tissue. Additionally, Danitz et al fails to disclose the specific longitudinal dimensions for the insulator and the electrode as well as the deformation direction for the insulator relative to the longitudinal dimensions as recited in the claims.
Baker (6,113,598) discloses a jaw with a deformable jaw surface (Figures 3A and 3B) but the deformable insulative portion (i.e. lower jaw) is deformed by actuation of the upper jaw into engagement with the lower jaw and not in response to tissue contact as recited in application claim 1. Rioux (10,912,602) discloses another device having a deformable substrate (42 – Figure 3). However, the electrode (46) extends across the surface of the deformable member and the deformable member does not selectively expose the electrode surface upon deformation as required by the claims.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. 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/August 19, 2026
