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 December 18, 2025, has been entered.
Information Disclosure Statement
The information disclosure statement filed August 18, 2025 has been entered and the references cited therein have been considered by the examiner.
Election/Restrictions
Newly submitted claims 21-23 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
I. Claims 21-22, drawn to a medical device with a body having splines, classified in class A61B2017/00017.
II. Clam 23, drawn to a process to perform lesions, classified in A61B2017/00243.
The inventions are independent or distinct for the invention recited in claims 1-14 and 18-20, each from the other because:
Invention I and the invention recited in claims 1-14 and 18-20 are related as subcombination and combination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because it does not require a medical device with branches that have electrical insulation on the lateral edges. The subcombination has separate utility such as a medica device that does not have splines to house the branches.
Inventions II and the invention recites in claims 1-14 and 18-20 are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case, the process of performing lesions can be practiced with another materially different product.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply: The different classifications for each invention indicate that a divergent search would be required for each invention.
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Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 21-23 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Previously Set Forth Objections and Rejections
The status of the objections and rejections as set forth in the previous Office action (mailed July 31, 2025) is as follows:
The objection to the drawings under 37 CFR 1.83(a) has been overcome by the filing of new Figure 10 with the response filed December 18, 2025.
The objection to the specification has been overcome by amendments to the specification.
The objection to claims 14 and 17 has been overcome by amendments to claim 14 and has been rendered moot by the cancellation of claim 17.
The 35 USC 112(b) rejection of claims 12-14 has been overcome by amendments to claim 12.
The 35 USC 103 rejection of claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marecki et al. (U.S. Patent Application Publication No. 2015/0351652) in view of Novichenok et al. (U.S. Patent Application Publication No. 2014/0358143) is hereby withdrawn.
The following new grounds of rejection are set forth:
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) 1-14 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marecki et al. (U.S. Patent Application Publication No. 2015/0351652) in view of Novichenok et al. (U.S. Patent Application Publication No. 2014/0358143) and further in view of Morse et al. (PCT Publication No. 2018/226751).
In regard to claims 1, 8, 11 and 19, Marecki et al. teach a catheter 10 that includes an elongate catheter body 34 with a lumen and a handle assembly 46 that has an actuation mechanism 46 to translate an expandable electrode assembly 30 from a collapsed configuration to an expanded configuration (see Figs. 2A and 2B and paras. 0075-0076). The electrode assembly 30 includes one or more electrodes that may be used for cardiac mapping or diagnosis, ablation and/or other therapies (see para. 0077). The expandable electrode assembly 30 may include at least one flexible member or spline on which the one or more electrodes may be located (see para. 0077). The electrodes 64 may be located on an outer surface of the flexible member and the flexible member 60 is substantially planar or flat (general ribbon shape) (see para. 0077). Figures 4A and 4B show an embodiment where the flexible members or splines 60 are flexed outwardly and away from a longitudinal axis of the electrode assembly 30. The flexible splines 60 may incorporate a shape memory material (see para. 0079). Figure 4C shows that the proximal end of the splines 60 is fixed along a perimeter of the lumen of the catheter body 34 and that each spline 60 forms an arc extending in a plane to which the longitudinal axis of the catheter 10 belongs. Marecki et al. are silent as to the delivery of energy through the electrodes 64 with the electrode assembly is in the retracted position. However, Novichenok et al. teach a similar medical device 12 with an elongate body 18 having a distal portion 20 with an electrode array 28 at the distal end where the electrode array 28 is adjustable from a first, linear position to a second, radially expanded position (see Figs. 3A-3C and 5A and para. 0027). When the electrode array 28 is in the linear configuration, the device may be used to create linear lesions (see para. 0034). Since Marecki et al. teach a similar, expandable electrode assembly, in view of the teachings of Novichenok et al., it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to utilize the device of Marecki et al. in the linear or retracted position to form linear lesions.
In regard to claim 2, Novichenok et al. teach that the elongate body 18 has a guidewire lumen 40 in which a guidewire 42 is rotatably and slidably disposed (see Figs. 1A-1C and para. 0029). Novichenok et al. thus demonstrates that providing an expandable electrode device with a lumen and a guidewire 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 Marecki et al. with a lumen and guidewire, in the manner disclosed by Novichenok et al. In regard to claims 3, 4 and 6, Marecki et al. teach that the electrode 64 may form at least one bipolar electrode pair and that the pairs may be distributed through the electrode assembly 30 and they may be formed between a first electrode 64 located on a first spline 60 and a second electrode 64 located on a second spline 60 (which would be external to the catheter body 34) (see para. 0084). In regard to claim 5, see paras. 0071-0072 of Marecki et al. which details how a processing system 20 controls the operation of the device, including the electrodes. With further respect to claim 1 and in regard to claims 7, 9 and 10, Marecki et al. teach that the electrode assembly 30 may be constructed from a multi-layered flexible sheet 80 including a first flexible printed circuit 82 adhesively bonded to an upper surface of a substrate and a second flexible printed circuit 84 bonded to the lower surface of the substrate (see Figs. 6-9D and para. 0096). The substrate 86 may be constructed from Nitinol and in both printer circuits 82, 84, there is a first metallic fusion layer 88a, 88b and an insulating layer 96a, 96b, and a second metallic fusion layer 102a, 102b (see para. 0097). A hole may be formed through both metallization layers 88, 102 and the insulating layer 96 and then plating the walls of the hole to form a metal connection 108a, 108b (see para. 0097). Marecki et al. do not specifically state that the insulating layer 96a, 96b covers the lateral sides of the splines. However, Morse et al. teach a similar spline subassembly 109A/B/C that has an electrically and thermally insulative over coating 111A that covers the lateral sides of the splines and thus electrically and thermally isolated each spline (see Fig. 8A). Morse et al. thus demonstrate that electrically and thermally isolating each spline 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 make the insulating layer 96a, 96b of Marecki et al. in the manner disclosed by Morse et al. (extending around the lateral sides) in order to electrically and thermally isolate each spline. In regard to claims 12-14, Marecki et al. teach that each spline 60 may have more than one electrode 64 (see para. 0077). In regard to claim 18, Marecki et al. teach forming bipolar electrode pairs 72 having a first electrode 74a and a second electrode 74b where they may be offset from one another along a spline 60 (see para. 0087). It follows that offset electrode pairs on an adjacent spline would thus be offset from the electrodes on the first spline. In regard to claim 20, Figure 4C shows a fastening ring attaching the proximal ends of the splines 60 to the perimeter of the catheter body 34.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-14 and 18-20 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