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 .
Response and Amendment Filed
Applicant’s response and amendment, filed January 6, 2026, has been entered and made of record.
Election/Restrictions
Applicant’s election without traverse of the invention of Group I in the reply filed on October 3, 2025 is acknowledged.
Claims 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Previously Set Forth Rejections
The status of the following rejections set forth in the previous Office action (mailed October 25, 2025) is as follows:
The 35 USC 102(a)(2) rejection of claims 1-5 and 9-16 as being anticipated by Pressman et al. (U.S. Patent No. 10,398,347) is hereby withdrawn.
The 35 USC 103 rejection of claims 6 and 8 as being unpatentable over Pressman et al. (U.S. Patent No. 10,398,347) is hereby withdrawn.
The 35 USC 103 rejection of claim 7 as being unpatentable over Pressman et al. (U.S. Patent No. 10,398,347) in view of Ehninger et al. (PCT Publication No. WO 2017/219015) is hereby withdrawn.
The following new grounds of rejection are set forth:
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-7, 9 and 11-16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lichtenstein (U.S. Patent Application Publication No. 2015/0126895).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
In regard to claims 1, 5-7 and 11-15, Lichtenstein teaches a position sensing system 20 for determining the position of a catheter 22 (see para. 0030). The sensing system 20 includes a control console 24 with a probe interface/control unit 50 for relaying signals to at least one electrode disposed on the body of catheter 22 near distal tip 40 (see Fig. 1 and para. 0031). Catheter 22 may also comprise additional electrodes and/or sensors placed at any suitable positions along the length of the catheter (see para. 0031). A plurality of body surface electrodes 42 are fixed at suitable locations on the patient’s body and are connected by a cable to a body surface interface/control unit 60 in control console 24 (see Fig. 1 and para. 0031). The sensing system 20 locates the position of the at least one electrode disposed near the distal tip of catheter 20 in the body of the patient using real time impedance-based location tracking techniques and sensing system 29 performs location tracking by driving a plurality of currents between the at least one electrode disposed near the distal tip 40 of the catheter 22 and the multiple body electrodes 42 fixed to the surface of the body of the patient 28 (see para. 0031 and 0035). Lichtenstein also teaches a sheath 100 through which a catheter 120 is guided where the sheath 100 has a first tubular shaft comprising a lumen therethrough and a predetermined tubular wall region disposed near the distal end of the first tubular shaft (see Figs 2-4). Sheath 100 has multiple conducting holes 110 that are filled with metal by mixing metallic beads or any other suitable metallic object (fibers) into a polymer material (see Fig. 2 and paras. 0044-0047), or using metal rivets 240 (see Fig. 3 and para. 0050) or using metal springs 310 (conductive band) (see Fig. 4 and para. 0052). The holes 110 and electrically conductive elements (240, 310) provide an electrically conductive path between the lumen of the first tubular shaft of the sheath 100 and an external environment of the sheath 100 (see also Figs. 2-4). In regard to claims 2 and 3, see para. 0057 of Lichtenstein. In regard to claims 9 and 16, see Fig. 1 and paras. 0029, 0030 and 0035 of Lichtenstein which discuss the operator maneuvering the catheter 22 into position.
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) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lichtenstein (U.S. Patent Application Publication No. 2015/0126895).
In regard to claim 8, Lichtenstein is silent as to the distance of the holes 110 from the distal end of the sheath 100. However, Lichtenstein does teach that the holes 110 are typically 1 mm in diameter have a spacing of 0.5 mm between adjacent holes but may be any suitable geometry and any suitable hole spacing can be used (see paras. 0045-0046). Figures 2-4 also show that the holes 110 are spaced proximally from the distal end of the sheath. Thus, it would have been obvious for one of ordinary skill in the art, given the broad disclosure of Lichtenstein, it would have been routine optimization to arrive at the claimed dimensions because one of ordinary skill in the art would have had a reasonable expectation of success. In other words, one of ordinary skill in the art at the effective filing date of the invention would have found it obvious to to place the holes 110 about 1 cm to 3 cm from a distal end of the sheath 100 and extend the holes 110 over a length of about 1 mm to about 2 mm along the sheath 100 because the broad disclosure of Lichtenstein incorporates such optimization.
Claim(s) 4 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lichtenstein (U.S. Patent Application Publication No. 2015/0126895) in view of Pressman et al.(U.S. Patent No. 10,398,347).
In regard to claims 4 and 10, Lichtenstein is silent as to an irrigation port on the sheath 100. However, Pressman et al. teach a similar impedance based tracking system 10 (see Fig. 1 and col. 4, lines 15-20) comprising a guiding sheath 40 (see Fig. 2) comprising a first tubular shaft with a lumen therethrough and a predetermined wall region 60 (see Fig. 2) disposed approximate a distal end 45 of the first tubular shaft where the predetermined tubular wall region 60. Pressman et al. teach an embodiment with a hole 98 in the sheath 96 that enables conductive fluid (salt water) to be in contact with the electrodes 100, 102, 104, 106 when they are within the sheath and the hole 98 is placed 4 mm from the distal end 94 of the sheath 96 (see Fig. 12 and col. 9, lines 45-51). Pressman et al. thus demonstrate that providing a guiding sheath with ports or holes to enable the conduction of fluid is well known in the art. Accordingly, it would have been obvious for one of ordinary skill in the art to provide the sheath 100 of Lichtenstein with the hole 98 disclosed by Pressman et al. in order to equip the sheath 100 with the ability to conduct fluid.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-16 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794