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 .
Information Disclosure Statement
The information disclosure statement filed June 2, 2026 has been entered and the references cited therein have been considered by the examiner.
Response and Amendment Filed
Applicant’s response and amendment, filed July 15, 2026, has been entered and made of record.
Previously Set Forth Objections and Rejections
The status of the objections and rejections set forth in the previous Office action (mailed April 15, 2026) is as follows:
The objection to the specification is withdrawn.
The 35 USC 112(b) rejection of claims 41, 44, 46-48, 51, 52, 56, 59, 61 and 64 has been overcome by amendments to the claims.
The 35 USC 102(a)(2) rejection of claims 41, 42, 44 and 47 as being anticipated by Daulton et al. (U.S. Patent No. 6,322,559) is hereby withdrawn.
The 35 USC 103 rejection of claims 48-54 and 56-64 as being unpatentable over Daulton et al. (U.S. Patent No. 6,322,559) is hereby maintained and is applied to claims 41, 42, 44 and 47 as below.
The 35 USC 103 rejection of claims 43 and 55 as being unpatentable over Daulton et al. (U.S. Patent No. 6,322,559) in view of Imran (U.S. Patent No. 5,239,999) is hereby maintained.
The 35 USC 103 rejection of claims 45 and 46 as being unpatentable over Daulton et al. (U.S. Patent No. 6,332,559) in view of Forsyth et al. (U.S. Patent No. 10,799,283) is hereby maintained.
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) 41, 42, 44, 47-56, 58-65 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daulton et al. (U.S. Patent No. 6,322,559).
In regard to claims 41 and 42, Daulton et al. teach performing minimally invasive treatment of venous sufficiency using a catheter 10 to deliver electrodes 12 to a venous treatment site (electrode treatment device (see col. 4, lines 55-57). The catheter 10 (shaft) is supported by a sleeve 16 (elongate body) and the sleeve 16 has a distal end terminating in a tip (see Figs. 1 and 2). Electrodes 12 are positioned on a helical coil 14 and the coil 14 is attached at one end to the tip 15 of shaft 10 and at the other end to the distal end of the sleeve 16 (see Figs. 1 and 2 and col. 4, lines 64-66). Daulton et al. teach an alternate embodiment where a single electrode 12 is formed on strips 22, 24 for a substantial length along the coil (see Figs. 9 and 10 and col. 9, lines 8-10). An actuation mechanism 34 imparts both rotary and linear motion to sleeve 16 (see Figs. 1 and 2). The coil 14 is retracted toward the catheter 10 when the sleeve 16 is moved away from the tip 15 and the coil 14 is expanded away from catheter 10 when the sleeve 16 is moved towards the tip 15 (see Figs. 1 and 2 and col. 5, lines 10-15). Figure 6b and 7b show how the coil 14 is contracted around the catheter 10 to facilitate extraction from the treatment site. Thus, in the structure of Daulton et al., the sleeve 16 rotates rather than the catheter 10. However, it is well settled that the reversal of parts is an obvious modification within the skill of one of ordinary skill in the art. In re Gazda, 219 F.2d 449, 104 USPQ 400 (CCPA 1955). 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 catheter 10 of Daulton et al. rotate to deploy the coil 14 as an obvious modification of the shaft 16 rotating to deploy the coil 14. In regard to claim 44, Daulton et al. teach that strips 22, 24 are connected to electrical leads and sleeve 16 is formed from a polymer, which is insulating (see col. 5, lines 5-7 and col. 6, lines 25-30). In regard to claim 47, Daulton et al. teaches that the strips 22, 24 could be biased to return to a reduced diameter profile (see col. 6, lines 50-52 and col. 8, lines 30-35). In regard to claims 52-54, see the above rejection for claims 41 and 42. With further respect to claim 52 and in regard to claims 57-59, Figures 1 and 2 of Daulton et al. show that the coil 14 has a middle portion. Daulton et al. is silent as to the maximum expansion ratio of the coil 14. However, Figures 1 and 2 show that the coil 14 expands far beyond its original or compacted profile. Thus, it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention that the coil 14 of Daulton et al. is capable of an expansion ratio of 5:1, greater than 10:1 and in the range of 5:1 and 30:1. In regard to claim 56, see the above rejection for claim 44. In regard to claim 60, see the above rejection for claim 47. In regard to claims 48-51 and 61-64, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to utilize a robotic manipulator and a control device to control the rotation and translation of the shaft 16 in Daulton as it is well settled that automating a manual activity is within the skill of one of ordinary skill in the art. See In re Venner, 262 F.2d 91, 120 USPQ 193 (CCPA 1958). With further respect to claims 49 and 62, as shown in Figure 1 of Daulton et al., the actuation mechanism 34 integrated both rotational and translational functions. In regard to claim 65, Figure 2 of Daulton et al. shows that the coil 14 is attached to the shaft 16 along an exterior surface of the distal end portion and the coil 14 is wound around the exterior surface of the distal end portion and the tip of the shaft 16.
Claim(s) 43 and 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daulton et al. (U.S. Patent No. 6,322,559) in view of Imran (U.S. Patent No. 5,239,999).
In regard to claims 43 and 55, Daulton is silent as to the electrodes 12 comprising a flexible printed circuit. However, Imran teaches a similar helical strip 221 with electrodes 217, 218 thereon where the electrodes include a vapor deposited layer of copper 73 (printing) and conventional etching techniques are used to form circuits (see col. 4, line 52 to col. 5, line 5 and Figs. 16 and 19). Imran thus demonstrates that printed circuit electrodes are well known in the art as alternative electrode structures. 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 coil 14 of Daulton et al. with printed circuit electrodes, in the manner disclosed by Imran.
Claim(s) 45 and 46 is/are rejected under 35 U.S.C. 103 as being unpatentable over Daulton et al. (U.S. Patent No. 6,322,559) in view of Forsyth et al. (U.S. Patent No. 10,799,283).
In regard to claims 45 and 46, Daulton et al. depicts gaps between the turns of the coil 14. However, Forsyth et al. teach a similar ablation system 10 with helically wound electrodes 22 that have no gaps between the turns (see Fig. 1). Forsyth et al. thus demonstrate that helical electrodes with no gaps are 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 coil 14 of Daulton et al. without gaps between the turns.
Response to Arguments
Applicant’s arguments with respect to claim(s) 41-56 and 58-65 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.
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
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