DETAILED ACTION
This action is pursuant to the claims filed on December 17, 2024. Claims 1-20 are pending. A first action on the merits of claims 1-20 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 § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claims 1-5, 7-8, and 10-20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Govari et al. (hereinafter ‘Govari’, U.S. PGPub. No. 2018/0110562).
In regards to independent claim 1, Govari discloses a catheter (catheter 22 in Fig. 1), comprising:
an elongate catheter body comprising at least one lumen ([0026] & [0038]: the catheter 22 inherently comprises an elongatecatheter body as shown in Fig. 1; the distal end assembly comprises a continuous hollow insertion tube configured to form an internal lumen for leading electrical wires and/or irrigation tubes via catheter 22); and
a flexible circuit tip (flexible printed circuit board 60 & 66 in Figs. 2-3; [0030]: sheet 60 and cover 66 are made from a single piece of contiguous PCB or any other suitable flexible substrate) connected to a distal end of the elongate catheter body ([0026]: the flexible printed circuit board sheet 60 and 66 are wrapped around the member 69 of the distal end assembly 40 of the catheter 22), comprising:
a first segment comprising a base section of the flexible circuit tip (circular center of the cover 66 and a plurality of parts 70 configured to cover the distal face of the dome-support 68 of the distal end assembly 40);
a second segment comprising a lateral wall section of the flexible circuit tip (segment of the sheet 60 forming in part, a cylinder shape to cover the member 69, see annotated Figures 3 & 4 below);
a transition section between the base and lateral wall sections (one of the parts 70 of cover 66 that is directly connected to the sheet 60 & upper segment of the sheet 60, see annotated Figures 3 & 4 below), the transition section being at least partially positioned adjacent a shared region of the base and lateral wall section (parts 70 and upper segment of the sheet 50 being at least partially positioned adjacent a shared region configured to contact portion 68 of the assembly 40); and
one or more electrode regions comprising a respective electrode (tip electrode 71 and electrodes 62), the one or more electrode regions being positioned at least partially in the transition section and the second segment (annotated Figures 3 & 4 illustrate the electrodes 62 being disposed in the transitional segment and the second segment).
PNG
media_image1.png
642
1432
media_image1.png
Greyscale
In regards to claim 2, Govari further discloses the first segment comprises a generally circular shape when oriented in a planar configuration prior to being in the non-planar configuration when used with the catheter tip (see planar configuration of the cover 66 in Figs. 2 & 3 before being formed into a dome-shaped configuration).
In regards to claim 3, Govari further discloses the first segment comprises a diameter less than a diameter of the lateral wall sections formed by the second segment when oriented in a non-planar configuration (the central circular portion of cover 66 has a smaller diameter than the diameter of the cylindrical tube formed by the sheet 60 as shown in Fig. 4); and the transition section comprising a dome-like shape that transitions between the lateral wall sections and the base section (the portions 70 form a cup-like/dome-like shape and transitions between the distal face of the cover 66 to the sheet 60 in the non-planar configuration).
In regard to claims 4, 8, 11-12, Govari further discloses the second segment is generally rectangular when oriented in a planar configuration prior to being in the non-planar configuration when used as the flexible circuit tip of the catheter (annotated Figure 3 below shows a rectangular shaped second segment in the planar configuration) and further comprising: first, second and third [rectangular shaped petal] sectors (see the labeled sectors below, in the non-planar arrangement, the three sectors are radially arranged about the circular center of the cover 66), each sector comprising a respective electrode region comprising an electrode (each of the sectors comprises electrode 62), the respective electrode region being positioned at least partially in the transition section and the respective sector (half of the electrode 62 is positioned within its respective sector of the second section while the upper half of the electrode 62 is positioned within the transition section).
PNG
media_image2.png
874
1038
media_image2.png
Greyscale
In regards to claim 5, Govari further discloses the second sector being positioned between the first and third sectors (annotated figure 3 shows the second sector being disposed between the first and third sectors) and formed continuously within the first segment along an adjoining region (since the cover 66 and sheet 60 are formed from a single sheet, all the portions are formed continuously).
In regards to claim 7, Govari further discloses the first segment/base section comprises a plurality of triangle shaped sectors formed continuous with the first, second, and third sectors, respectively, of the second segment (the cover 66 comprises a plurality of triangular shaped parts 70 which are formed continuously with all the portions of the sheet 60).
In regards to claim 10, Govari further discloses the second segment comprising a plurality of lateral edges extending from at least a portion of the plurality of rectangular shaped petal sectors (lateral edges of the second segment of sheet 60 as shown in annotated Fig. 3) such that each of the plurality of lateral edges is attachable to another of the plurality of lateral edges to form the lateral wall section (the two lateral edges are attached to form the tubular wall of the to be positioned along the member 69).
In regards to claim 13 & 15, Govari further discloses the first segment comprising: a first layer comprising a substrate (central circular portion of the first segment as shown in annotated Figures 2-4 above); a second layer comprising a plurality of petals positioned adjacent or about the first segment, radially separated around a periphery of the first segment, the plurality of petals being separated by one or more spaces (multiple sections 71 forming the tip electrode which is spaced apart extending from the central circular portion of the first segment as shown in Figs. 3-4, [0034]).
In regards to claim 14, Govari further discloses an insulation layer positioned with the one or more spaces (non-metallized plastic parts 70 formed on the PCB is disposed between the part that forms the electrode 71 as shown in both the planar and non-planar configuration in Figs. 3-4, [0034]).
In regards to claim 16, Govari further discloses the first sector, the second sector, and the third sector each comprises a respective solder region comprising one or more contacts operatively coupled to a respective electrode ([0031]: each of the electrodes along the sheet 60 which can be divided into first, second and third sectors are mounted or bonded to the electrical interconnection on the sheet 60; note that bonded inherently requires soldering of the interconnect and the electrodes).
In regards to independent claim 17, Govari discloses a method of assembling a catheter ([0015] and Figs. 3 and 4 show the sheet being assembled and wrapped about the distal end of the catheter member 58), comprising:
changing a planar configuration of a flexible circuit for a catheter tip to a non-planar configuration ([0015]: the sheet of flexible substrate is configured to be wrapped around a distal end assembly to transition from a planar arrangement as shown in Figs. 2 and non-planar arrangement as shown in Fig. 4), the flexible circuit as claimed in claim 1 (see the rejection of claim 1).
In regards to claim 18, Govari further discloses positioning an electrode with each of the one or more electrode region ([0035]: at least some of the electrodes (e.g., micro-electrodes 62) may be mounted, for example, on sheet 60 on either the inside or the outside and bonded to the electrical interconnections).
In regards to claim 19, Govari further discloses forming the lateral wall section of the second segment to have a second diameter greater than a first diameter of the base section of the first segment (the central circular portion of cover 66 has a smaller diameter than the diameter of the cylindrical tube formed by the sheet 60 as shown in Fig. 4), the base section being circular and the later wall section being cylindrical (the portions 70 form a cup-like/dome-like shape and transitions between the distal face of the cover 66 to the sheet 60 in the non-planar configuration and the central circular portion forming a tubular cylindrical shape).
In regards to claim 20, Govari further discloses forming the second segment from a generally rectangular shape in the planar configuration (annotated Figure 3 above shows a rectangular shaped second segment in the planar configuration) and comprising a first sector, a second sector and a third sector (see the labeled sectors above in Fig. 3, in the non-planar arrangement, the three sectors are radially arranged about the circular center of the cover 66), each sector comprising a respective electrode region comprising an electrode (each of the sectors comprises electrode 62), the respective electrode region being positioned at least partially in the transition section and the respective sector (half of the electrode 62 is positioned within its respective sector of the second section while the upper half of the electrode 62 is positioned within the transition section).
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.
Claims 1, 5 and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5 and 7 of U.S. Patent No. 11,857,251. Although the claims at issue are not identical, they are not patentably distinct from each other.
In regards to claim 1, Patent ‘251 claims a flexible circuit tip and anticipates all the structures (see claim 1). However, the preamble claims that the flexible circuit of Patent ‘251 is configured for use with a catheter tip and therefore, it would have been obvious to one of ordinary skill in the art to incorporate the claimed flexible circuit tip of Patent ‘251 with a catheter to arrive at the claimed invention.
In regards to claim 2, claim 5 anticipates the claimed limitation.
In regards to claim 4, claim 1 anticipates the claimed limitation.
In regards to claim 5, claim 6 anticipates the claimed invention.
In regards to claim 7, claim 1 anticipates the claimed invention.
Claims 1-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7-12, 15 and 18 of U.S. Patent No. 12,186,012. Although the claims at issue are not identical, they are not patentably distinct from each other.
In regards to claim 1, Patent ‘012 claims a flexible circuit tip and anticipates all the structures (see claim 1). Although Patent ‘012 does not specifically recite ‘the first segment’, and ‘the second segment’, it calsim the base section and the lateral wall section. In addition, the preamble claims that the flexible circuit of Patent ‘012 is configured for use with a catheter tip and therefore, it would have been obvious to one of ordinary skill in the art to incorporate the claimed flexible circuit tip of Patent ‘251 with a catheter to arrive at the claimed invention.
In regards to claim 2, claim 7 anticipates the claimed limitation.
In regards to claim 3, claim 8 anticipates the claimed limitation.
In regards to claim 4, claim 9 anticipates the claimed invention.
In regards to claim 5, claim 10 anticipates the claimed invention.
In regards to claim 6, claim 11 anticipates the claimed invention.
In regards to claim 7, claim 12 anticipates the claimed invention.
In regards to claim 8, claim 15 anticipates the claimed invention.
In regards to claim 9, claim 18 anticipates the claimed invention.
Allowable Subject Matter
Claims 6 and 9 are 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.
The prior art discloses using a flexible circuit to provide an electrode array along a catheter tip (Tegg, U.S. PGPub. No. 2018/0092688, flexible circuit 290 in Figs. 29A-29C; Schultz et al., U.S. PGPub. No. 2016/0128765, sensor array 22 in Fig. 2; Honour et al., U.S. PGPub. No. 2007/0219551, Fig. 17).
In regards to claim 6, Govari discloses the invention substantially as claimed in claim 4/1 and discussed above. However, Govari does not disclose the transition section comprising three portions each extending from a respective sector of the first, second and third sector and comprising a rounded or curved upper edge that forms a dome-like shape to the transition section when the flexible circuit tip is in a non-planar configuration. Govari discloses that each of the sector of the second segment is rectangularly shaped as noted in the above annotated figure 3 and extends to a rectangular transition section. Therefore, it would be hindsight to modify the transition section to form the rounded or curved upper edge that forms a dome-like shape as Govari discloses that the dome-like shape is formed by another sheet (first segment 66 in Fig. 1).
In regards to claim 9, Govari discloses the invention substantially as claimed in claim 8/1 and discussed above. However, Govari does not disclose wherein each of the plurality of rectangular shaped petal sectors are foldable at or about demarcation between the transition section and the lateral wall section. Govari discloses that each of the sector of the second segment is rectangularly shaped as noted in the above annotated figure 3 and extends to a rectangular transition section to form a continuous tubular shape and there is no motivation to fold the sheet (60) as doing so would prevent other sheet (66) forming a dome-like shape to form the distal face of the catheter.
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.
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, JOSEPH STOKLOSA can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EUN HWA KIM/Primary Examiner, Art Unit 3794 6/12/2026
Prosecution Insights