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 Invention II (claims 7-15) in the reply filed on January 5, 2026 is acknowledged. Accordingly, claims 1-6 and 16-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 5, 2026.
Response and Amendment Filed
Applicant’s response and amendment, filed May 4, 2026, has been entered and made of record. Claim 10 has been canceled.
Previously Set Forth Objections and Rejections
The status of the objections and rejections as set forth in the previous Office action (mailed February 2, 2026) is as follows:
The objection to the drawings under 37 CFR 1.83(a) is hereby maintained and is reiterated below.
The objection to the specification is hereby withdrawn.
The 35 USC 102(a)(2) rejection of claims 7-12 and 14 as being anticipated by MacAdam et al. (U.S. Patent Application Publication No. 2008/0281391) is hereby withdrawn.
The 35 USC 103 rejection of claims 13 and 15 as being unpatentable over MacAdam et al. (U.S. Patent No. 2008/0281391) is hereby withdrawn.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) 7, 8, 11, 12 and 14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mihalik et al. (U.S. Patent Application Publication No. 2012/0283715).
In regard to claims 7, 11 and 14, Mihalik et al. teaches a medical device 12 with an elongate body 16 having an expandable element 30 at the distal portion of the elongate body 16 (see Figs. 2 and 3). The expandable element 30 may be an expandable mesh 34 (woven sheet) where the mesh is configurable into a plurality of geometric configurations, including a teardrop shape with a blunt distal end and a tapered proximal end (see Figs. 5-11 and para. 0040). The mesh 34 is an interwoven wire structure (see para. 0040) and Figure 5-11 show that the interwoven mesh 34 is comprised of a first plurality of wires interwoven with a second plurality of wires. At least a portion of the mesh 34 may be electrically conductive and portions of the mesh 34 may be electrically insulated while other portions of the mesh 34 may be exposed (this includes both the first plurality of wires and the second plurality of wires) (see para. 0042). The exposed portions of the mesh 34 (uncovered portions) may be present at one or more junctions 38 (electrode gaps) between the interwoven or intersecting wires that define the mesh 34 and each junction 38 may be electrically coupled to an output portion of a radiofrequency or electrical signal generator (see para. 0043). Each junction 38 may also include or define a sensor coupled to or in communication with the control unit 14 (see para. 0043). In regard to claim 8, Figures 5-11 show that the first plurality of wires is non-overlapping with each other and the second plurality of wires is non-overlapping with each other and at least a portion of the first plurality of wires overlaps with at least a portion of the second plurality of wires. In regard to claim 12, Figures 5-11 show that each of the first plurality of wires has a gathered first end and a second end gathered proximate the tapered proximal end and each of the second plurality of wires has a gathered first end and a second end gathered proximate the tapered proximal end.
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) 9 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mihalik et al. (U.S. Patent Application Publication No. 2012/0283715) in view of MacAdam et al. (U.S. Patent Application Publication No. 2008/0281391).
In regard to claim 9, Mihalik et al. are silent as to the mechanical connection between the sensors and the control unit 14. However, MacAdam et al. teach that a wire may run from each of the filaments 34 to a connector portion 16 that communicates with controller 8 via cable 6 (which is inherently insulated) to provide for mapping and ablation (see para. 0060). MacAdam et al. thus demonstrate that connecting the electrically-transmitting components of a device to a controller using an insulated cable is well known in the art. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Mihalik et al. with the insulated cable taught by MacAdam et al. in order to provide a mechanical connection between the sensors and the control unit 14. In regard to claim 13, MacAdam et al. teach that a number of filaments 34 may be grouped together for mapping and ablation and discloses the use of a switch box or multiplexer to configure the signals being received by filaments 34 or ablation energy send to filaments 34 (see para. 0060). In such a scenario, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to group the first plurality of filaments 34 to a first main wire and the second plurality of filaments 34 to a second main wire as a means to differentiate the two pluralities based on their grouping or configuration. It would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Mihalik et al. with the groupings of MacAdam et al. in order to differentiate the two pluralities based on their grouping or configuration (see also para. 0056 of Mihalik et al.).
Allowable Subject Matter
Claim 15 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to claim(s) 7-9 and 11-15 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.
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, 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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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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