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 the invention of Group I, claims 1, 2, 4, 7, 10, 12-14, 16 and newly added claims 31-38 in the reply filed on February 4, 2026 is acknowledged. Additionally, applicant has also elected the species of Figures 15A-15C and has indicated that all pending claims read on the elected species. Applicant also asserted that Figure 2 was generic to Figures 15A-15C. The examiner disagrees that claims 14, 32, 35 and 37 are drawn to the elected embodiment. Claims 14 and 37 require a cryogenic tissue contact. There is no specific disclosure of a cryogenic contact in Figures 2 and 15A-15C. While the specification makes general statements about the inclusion of a cryogenic contact in certain embodiments, there is no express disclosure of such a cryogenic contact in the elected embodiment. As such, claims 14 and 37 are withdrawn from consideration. Claim 32 recites a “living hinge”. The only mention of such a hinge is in paragraph [0007] of the printed publication, and there is no express teaching of such a hinge in the elected embodiment. Given the lack of description, it is not possible to determine what is meant by this feature or structurally where it would be located on any embodiment, and claim 32 is withdrawn from consideration. Similarly, claim 35 recites longitudinal ribs, and the only mention of such ribs is again in paragraph [0007] of the printed publication. There is no express discussion of such longitudinal ribs in the elected embodiment, and this claim is also withdrawn from consideration.
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, 2, 4, 7, 10, 12, 13, 16, 31, 33, 34, 36 and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Danitz et al (10,857,347).
Regarding claim 1, Danitz et al provide a pulsed field ablation effector (Abstract, for example) comprising an electrode (1805 – Figures 18A-18F) including a surface for delivering current to tissue and a deformable insulator (shown but not labeled) selectively covering the electrode and configured to deform when contacting tissue to expose the electrode surface (Figures 18c and 18D, for example). See, also, column 32, line 42 to column 33, line 11).
Regarding claim 2, the insulator includes slits (see Figures) that are occupied by the electrodes. Regarding claim 4, there is a rigid backer (i.e. housing 1803) to which the electrode and insulator are mounted. Regarding claim 7, the insulator includes raised features (i.e. individual sections seen in Figures 18A-18F) configured to concentrate contact force with tissue. Regarding claims 10 and 36, Danitz et al disclose the insulator may be made from an elastomer such as silicone (col. 4, lines 30-37). Regarding claims 12 and 13, the electrode is segmented into a plurality of electrodes (2 shown in Figure 18) and the insulator is segmented into a plurality of sections (on either side of the electrodes as seen in the Figures). The examiner maintains the individual insulator sections are inherently configured to independently deform when contacting tissue at any given section that would give cause to deformation. Regarding claim 16, the electrodes are RF electrodes for delivery of pulsed field ablation. Regarding claim 31, Figures 18A-18F show slits longitudinally extending is a dominant (i.e. lengthwise) direction with the electrode extending longitudinally within the slit. Regarding claim 33, the insulator is embedded in the rigid backer (i.e. housing 1803). Regarding claim 34, the raised feature (i.e. segments) comprises a plurality of raised features with at least two of the features on opposite sides of the electrodes. That is, Figure 18A shows 3 raised features (i.e. segments) for the insulator with the electrodes being located between two of the features (segments). Regarding claim 38, the electrodes are selectively covered by the deformable insulator (Figures 18A and 18B, for example).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Won (2019/0350636) discloses another electrode device that may be covered with a deformable insulator.
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 6, 2026
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