DETAILED ACTION
This action is pursuant to the claims filed on May 5, 2024. Claims 1-13 are pending. A first action on the merits of claims 1-13 is as follows.
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 . 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 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.
Claim Rejections - 35 USC § 103
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1 -7 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Edwards (U.S. Pat. No. 6,071,280), and further in view of Morris et al. (hereinafter ‘Morris’, U.S. PGPub. No. 2002/0120260).
In regards to independent claim 1 and claim 13, Edwards discloses a catheter (ablation apparatus 10 in Fig. 1 includes a delivery catheter 12, col. 6, ln. 11-14) comprising:
an elongated catheter body defining a longitudinal axis (catheter 12 in Figs. 1-2 defines a longitudinal axis);
a distal electrode assembly (three electrodes 20 in Figs. 1-3), the distal electrode assembly comprising at least three spines extending generally parallel to the longitudinal axis (each of the electrodes 20(a) extends generally parallel to the longitudinal axis of catheter 12 as shown in Fig. 2), each spine having at least one electrode (distal end of the electrodes 20(a) are exposed for transmitting current), a proximal spine portion (proximal end of electrode 20 adjacent to the distal end of the catheter 12), a distal spine portion (distal end of electrode 20(a)), and a free distal end (the distal-most end of the electrode 20(a) are unattached end).
However, Edwards does not disclose a connector tubing connected to the catheter body and the distal electrode assembly comprising the at least three spines extending generally parallel to the longitudinal axis in a common plane.
Morris teaches an apparatus for ablating tumor mass similar to Edwards ([0081]: surface treatment apparatus 10 to superficially treat a tumor mass 5” in a target tissue site 5’… by delivering energy to produce an ablation volume). Specifically, the embodiment of Fig. 37 discloses three splines (elements 18) extending from the distal end of the apparatus ([0145]-[0146]). Note that the apparatus is a catheter (10) as shown in exemplary Fig. 20A ([0106]). Furthermore, Morris discloses a connector tubing (a housing comprising an advancement member 16 which connects the proximal ends of the elements 18 as shown in Fig. 37) connecting proximal end of each of the spines and positioned within the catheter (10) for advancing and retracting the spines from and towards the catheter ([0151]). Additionally, Morris further explains that the geometric configuration of the spines can be selected to create a desired geometric ablation volume ([0146]). Therefore, given that Edwards is concerned with ablating a tissue volume, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the spines of Edwards and to arrange along a common plane as contemplated by Morris, as doing so involves routine skill in the art and a predictable result of selective tissue ablation confined to a plane, as opposed to volumetric ablation would ensue ([0145]). In addition, it would have been obvious to one of ordinary skill in the art to modify the connector tubing positioned along a proximal end of the catheter body configured for advancing and retracting the spines of Edwards (see cam 22 in Fig. of Edwards), and provide it at the distal end of the catheter body as taught by Morris, as doing so involves routine skilled in the art, as doing so provides the same functionality of retracting and advancing the plurality of spines.
In regards to claim 2, in view of the combination in claim 1, the examiner notes it is a matter of routine skill in the art to arrange the proximal ends of the spines Edwards/Morris combination to extend from a small distal catheter tip at an angle that ensures the distal ends remain spaced and parallel to provide a plane, since it has been held that the provision of adjustability, where needed, to provide a planar spine arrangement, involves only routine skill in the art. In re Stevens, 101 USPQ 284 (CCPA 1954).
In regards to claim 3, in view of the combination in claim 2/1, Morris further discloses that position sensors can be providing along the connector tube ([0151]: one or more sensors 22 such as position sensors can be positioned on the housing 12 or advancement member 16 to determine the penetration depth of element 18). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to further incorporate the position sensor along the connector tubing of Edwards/Morris combination as doing so provides penetration depth information of the spines ([0151]).
In regards to claim 4, Edwards/Morris combination further discloses the connector tubing houses an anchor (the housing comprises advancing member 16 which anchors the proximal ends of the elements 18).
In regard to claims 5-6, in view of the combination in claim 2/1 above, Morris further discloses a puller wire to deploy and retract spines (pull wire attached to the advancing member 16 such as a push rod or stiffened cable, [0106]). Morris discloses that the puller wire is coupled to the anchor (advancing member 16, [0106]) but is silent as to how the puller wire is connected to the surface of the anchor. Note that the anchor (16) is considered to be a washer since it is a flat material which couples the puller wire to the splines (see in exemplary Figs. 27 and 28 in which the advancing member is disposed within the housing 12). However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the anchor such that it comprises a through-hole and disposing the puller wire within the through-hole to reliably attach the puller wire to the anchor as either directly attaching the puller wire to the surface or via a through-hole of the anchor involves routine skill in the art and a predictable result of ensuring reliable attachment between the anchor and the puller wire would ensue.
In regards to claim 7, in view of the combination in claim 2/1 above, Morris further discloses the connector tubing (housing 12 in Fig. 37) comprises a lumen (space formed by the housing 12) in which the proximal spine portion of each of the at least three spines is anchored (the proximal ends of the elements 18 are anchored to the advancement member 16 which is disposed within the housing 12 in Fig. 37).
Claim 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Edwards and Morris as applied to claim 2/1 above, and further in view of Werneth et al. (hereinafter ‘Werneth’, U.S. PGPub. No. 2006/0089637).
In regards to claim 8, Edwards/Morris combination discloses the invention substantially as claimed in claim 2/1 and discussed above.
However, Edwards/Morris combination does not disclose a ring electrode mounted onto the connector tubing.
Werneth discloses providing a return electrode proximal to an end effector and at a distal end of a catheter shaft ([0066]: band 104 in Fig. 6a is a ground electrode during monopolar ablation; the band 104 is at a distal end of the catheter 101). Given that Edwards discloses being configured for unipolar ablation, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the connector tubing which is positioned adjacently proximal to the distal end effector of Edwards/Morris combination and incorporate a return electrode as taught by Werneth, as providing a return electrode adjacently proximal to the distal electrode assembly for unipolar ablation is well-established in the ablation art.
In regards to claim 9, Edwards/Morris combination discloses the invention substantially as claimed in claim 2/1 and discussed above.
However, Edwards/Morris combination does not disclose an intermediate section disposed between the catheter body and the distal electrode assembly, the intermediate section including a tubing onto which the connector tubing is mounted.
Werneth teaches providing a catheter (distal end of the catheter is shown in Fig. 11b) comprising a catheter shaft (catheter shaft 150) and a distal electrode assembly (assembly 120) comprising an intermediate section (coupler 140) disposed between the catheter and the distal end assembly, where the proximal ends of the distal electrode assembly (proximal end 144 of the assembly 120) is received by and fixedly attached to the intermediate section (coupler 140). Werneth explains that the coupler prevents undesirable rotation of the distal electrode assembly by fixedly attaching to the distal end of the shaft ([0061]). Given that Edwards/Morris combination discloses the connector tubing is essentially the proximal end of the electrode assembly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the connector tubing of Edwards/Morris combination such that the connector tubing is received by the intermediate section which is fixedly connected to the catheter as taught by Werneth, as doing so prevents the distal end assembly from rotating ([0061]).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No.9,820,664 and in view of Morris. Although the claims at issue are not identical, they are not patentably distinct from each other.
In regards to independent claim 1, Patent ‘664 claims a catheter (claim 1) comprising: an elongated catheter body defining a longitudinal axis (claim 1: an elongated catheter body… wherein the catheter body defines a longitudinal axis); a distal electrode assembly (claim 1: a distal electrode assembly), the distal electrode assembly comprising at least three spines extending generally parallel to the longitudinal axis in a common plane (claim 1: the distal electrode assembly comprising at least three spines extending in a common plane), each spine having at least one electrode, a proximal spine portion, a distal spine portion, and a free distal end (claim 1: each spine having at least one electrode, a proximal spine portion, a distal spine portion, and a free distal end).
However, Patent ‘664 does not claim the distal electrode assembly comprising a connector tubing connected to the catheter body.
Morris discloses a connector tubing (a housing comprising an advancement member 16 which connects the proximal ends of the elements 18 as shown in Fig. 37) connecting proximal end of each of the spines and positioned within the catheter (10) for advancing and retracting the spines from and towards the catheter ([0151]). In addition, it would have been obvious to one of ordinary skill in the art to modify the connector tubing positioned along a proximal end of the catheter body configured for advancing and retracting the spines of Patent ‘664 simultaneously as taught by Morris, as doing so involves routine skilled in the art.
Allowable Subject Matter
Claim 10 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.
In regards to claim 10, Edwards/Morris/Werneth combination fail to disclose that the distal electrode assembly has an electrode density ranging between about 12 and 15 electrodes per square centimeter. The examiner notes that Edwards and Morris both disclose that the entire spine is a single electrode.
Kuzma et al. (U.S. Pat. No. 6,415,187) discloses a paddle-type electrode array (Fig. 4A-4B) extending from an insertion tool (50) comprising a large electrode surface formed from a flexible single substrate to contact the body tissue for stimulation (col. 1, ln. 13-21; col. 5, ln. 1-25). Kuzma discloses three rows of spaced-apart electrode contacts (fingers 42a, 42b, and 42c comprises electrode contacts 48) that extend generally parallel to a longitudinal axis of the insertion tool (50) forming a common plane (see claim 2: the parallel fingers 42a, 42b and 42c integrally formed on the surface of the flexible substrate and connected via thin webbing 44 define a planar flat shape).
However, there is no motivation to provide this paddle-type electrode array arrangement to the splines of Edwards/Morris/Werneth combination as Kuzma is concerned with stimulation and not ablation and providing the array arrangement yields a different ablation volume.
Accordingly, claim 11 is allowed as being dependent upon claim 10.
In regards to claim 12, Edwards/Morris/Werneth combination does not disclose wherein each of the at least three spines comprises a shape memory member and a nonconductive covering. Edwards and Morris disclose the splines are configured for piercing tissue. However, incorporating a shape memory member would render the splines of Edwards/Morris/Werneth combination inoperable for its intended purpose of piercing into the tissue as shape memory members are generally known to be flexible in the catheter art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EUNHWA KIM whose telephone number is (571)270-1265. The examiner can normally be reached 9AM-5:30PM.
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/EUN HWA KIM/Primary Examiner, Art Unit 3794 2/5/2026