DETAILED ACTION
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 (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.
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.
Claim(s) 1-14 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hall et al., (US 20110213231; hereinafter Hall).
Regarding claim 1, Hall (Figures 1, 5, and 17-19) discloses a Nitinol basket (210) for an electrophysiological (EP) mapping catheter ([0003], [0081]), comprising: a plurality of basket splines (221), each basket spline (221) having a distalmost portion (228) and a proximal end (223), and a distal tip (251) uninterruptedly contiguous with the distalmost portions (228) of the basket splines (221) and formed from the same piece, slab or ingot comprising Nitinol as the basket splines (221), wherein the distal tip (251) comprises a solid atraumatic cap structure (13) integrally formed with the basket splines (221) without any fastening components at a junction between the basket splines (221) and the distal tip (251), ([0056]: the splines 221 are welded with the cap 13, so there are no external fastening components since the two elements are formed as one monolithic structure through welding); wherein the basket splines (221) and distal tip (251) are cut and formed from a same single length of Nitinol tubing or a Nitinol hypotube, the respective distal portions (228) of each of the Nitinol splines (221) being continuous and contiguous with, and connected to, the Nitinol distal tip (251), each spline (221) being configured to extend outwardly away from an imaginary central axis of the Nitinol basket (210) and its proximal end (223) and distal portion (228) to form a curved shape therebetween when the Nitinol basket (210) is in an undeformed and deployed state, the proximal ends (223) of the splines being configured to be grouped adjacent or near one another and to extend together in a proximal direction for incorporation into or onto a distal end or distal portion of a catheter body, and further wherein the splines (221) are configured to be spaced approximately equal distances apart from one another when the Nitinol basket (210) is in an undeformed and deployed state, and still further wherein the splines (221) collectively form a basket shape when the Nitinol basket (210) is in an undeformed and deployed state ([0081]-[0083]).
Regarding claim 2, Hall (Figures 17-19) further discloses wherein, when the Nitinol basket is in an undeformed and deployed state, the basket shape is one of a spherical shape, a near-spherical shape, a tear-drop shape, a D-shape, a bulging asymmetric shape, and a shape where the splines are helically wound ([0081]-[0083]).
Regarding claim 3, Hall (Figures 17-19) further discloses wherein the single piece of Nitinol tubing prior to cutting has an initial inner diameter and an initial outer diameter, the initial inner diameter ranging between about 0.050 inches and about 0.070 inches, the initial outer diameter ranging between about 0.070 inches and about 0.080 inches ([0081]).
Regarding claim 4, Hall (Figures 17-19) further discloses wherein the single piece of Nitinol tubing prior to cutting has an initial inner diameter and an initial outer diameter, the initial inner diameter ranging between about 0.1 inches and about 0.17 inches, the initial outer diameter ranging between about 0.1 inches and about 0.2 inches ([0081]).
Regarding claim 5, Hall (Figures 17-19) further discloses wherein the proximal ends (223) of the splines (221) are configured collectively to form a plurality of adjoining and bunched struts or splines (253) configured for insertion into or operable connection with the distal end or distal portion of the catheter body ([0082]).
Regarding claim 6, Hall (Figures 17-19) further discloses wherein at least portions of the proximal ends (223) of the splines (221) comprise one or more of holes, recesses, shoulders, undercuts, and corners (253) configured to promote attachment or securing of an adhesive or of a polymeric material (18) or flowed, reflowed or reformed therethrough, therearound, or therein ([0048], [0050], [0081]-[0083]).
Regarding claim 7, Hall (Figures 17-19) further discloses wherein the basket (210) comprises between 6 and 16 splines (221), ([0081]-[0083]).
Regarding claim 8, Hall (Figures 17-19) further discloses wherein the basket (210) comprises 8 splines (221), and the splines (221) are configured to be spaced about 45 degrees apart from one another when the Nitinol basket (210) is in an undeformed and deployed state ([0081]-[0083]).
Regarding claim 9, Hall (Figures 17-19) further discloses wherein the finished splines (221) have opposing top and bottom surfaces (corresponding to the outer and inner diameters, respectively, of the hypotube), and the thickness between the top and bottom surfaces of the finished splines ranges between about 0.005 inches and about 0.008 inches ([0081]).
Regarding claim 10, Hall (Figures 17-19) further discloses wherein the finished splines (221) have opposing top and bottom surfaces (corresponding to the outer and inner diameters, respectively, of the hypotube), and the thickness between the top and bottom surfaces is of the finished splines ranges between about 0.003 inches and about 0.012 inches ([0081]).
Regarding claim 11, Hall (Figures 17-19) further discloses wherein the finished splines (221) have opposing top and bottom surfaces, and one or more of the splines (221) have variable thicknesses configured to induce flexing or bending of the splines at one or more predetermined locations.
Regarding claim 12, Hall (Figures 17-19) further discloses wherein the finished splines (221) of the Nitinol basket (210) have widths ranging between about 0.0150 inches and about 0.0180 25 inches ([0077]).
Regarding claim 13, Hall (Figures 17-19) further discloses wherein the finished splines (221) of the Nitinol basket (210) have widths ranging between about 0.010 inches and about 0.025 inches ([0077]).
Regarding claim 14, Hall (Figures 15-19) further discloses wherein the solid atraumatic cap structure (13) of the distal tip (251) further comprises a polymeric covering or shield (element 13 is a shield) attached thereto ([0057], [0082]).
Regarding claim 18, Hall (Figures 17-19) further discloses wherein after the splines (221) and the distal tip (251) have been cut from the Nitinol tubing or Nitinol hypotube, and before flex circuits, electrodes, and polymeric materials are flowed, reflowed or reformed onto or into the splines, the splines (221) and basket (210) are at least one of heat set, quenched, media blasted, acid etched, and electropolished ([0083]).
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, 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) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hall, as applied to claim 1 above, and further in view of Jung et al., (US 20160073960; hereinafter Jung).
Regarding claims 15-16, Hall (Figures 1 and 12) discloses the Nitinol basket of claim 1, further comprising a plurality of electrodes (12) mounted on or attached to the plurality of splines (221), ([0042], [0082]). Hall fails to disclose a flex circuit mounted on or attached to each spline, each flex circuit comprising the plurality of electrodes mounted on or attached thereto; and a polymeric material flowed, reflowed or reformed onto at least portions of each spline to at least one of hold, secure and register or orient each flex circuit and its electrodes thereon or thereto. However, Jung (Figures 1 and 11) teaches a basket for a mapping catheter, comprising a flex circuit (18) mounted on or attached to each spline (16) of the catheter, each flex circuit (18) comprising a plurality of electrodes (20) mounted on or attached thereto ([0068]). A polymeric material (34) is flowed, reflowed or reformed onto at least portions of each spline (16) to at least one of hold, secure and register or orient each flex circuit (18) and its electrodes (20) thereon or thereto ([0075]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hall to include a flex circuit mounted on or attached to each spline, each flex circuit comprising the plurality of electrodes mounted on or attached thereto, as well as a polymeric material flowed, reflowed or reformed onto at least portions of each spline to at least one of hold, secure and register or orient each flex circuit and its electrodes thereon or thereto, as taught by Jung, because the modification would allow the mapping catheter to be placed in a low profile contracted configuration, allowing it to be delivered through a standard sheath into the target area (Jung, [0034]).
Regarding claim 17, Hall (Figures 1 and 12) discloses wherein the electrodes (12) are one or a combination of unipolar and bipolar electrodes ([0042], [0082]).
Response to Arguments
Applicant's arguments filed 12/10/2025, with regard to the newly amended claim limitations, have been fully considered but they are not persuasive. Hall discloses that the distal tip (251) comprises a solid atraumatic cap structure (13) integrally formed with the basket splines (221) without any fastening components at a junction between the basket splines (221) and the distal tip (251), ([0056]: the splines 221 are welded with the cap 13, so there are no external fastening components since the two elements are formed as one monolithic structure through welding). Therefore, Examiner maintains that the cited reference(s) disclose/teach the invention as recited in the newly amended set of claims.
Conclusion
THIS ACTION IS MADE FINAL. 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 CATHERINE PREMRAJ whose telephone number is (571)272-8013. The examiner can normally be reached Monday - Friday: 8:00 AM - 5:00 PM.
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/C.C.P./Examiner, Art Unit 3794
/EUN HWA KIM/Primary Examiner, Art Unit 3794