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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on December 18, 2023 and on August 27, 2025 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Amendment
The amendment filed March 18, 2026 has been entered. Claims 1-13 and 20-24 remain pending in the application. Claims 14-19 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse.
Response to Arguments
Applicant’s arguments with respect to Claims 1-13 and 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.
Claim Objections
Claim 24 is objected to because of the following informalities: the limitation “in the expanded configuration” in line 1 and the same in line 2 appear to be duplicative of each other. Appropriate correction is required.
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) 1-2, 4-5, and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Altmann et al. (US 20210162210 A1).
Regarding Claim 1, Altmann teaches a distal tip of a medical probe [40], the distal tip comprising a spine framework [54] having a proximal end, an intermediate section, and a distal-most end and extending along a longitudinal axis, the spine framework comprising: a neck extending from the proximal end (see annotated Fig. 2 below); and a plurality of spines [54] connected to the neck and extending along the intermediate section to the distal-most end, the spines being movable between: a collapsed configuration, where the spines extend along the longitudinal axis; and an expanded configuration, where each spine comprises a curved section that bends away from the longitudinal axis and a planar section extending from the curved section to the distal-most end, each planar section extending along a plane that is approximately orthogonal to the longitudinal axis, the distal-most end lying in the plane (see annotated Fig. 2 below; see also para 0061, “The catheter 40 is inserted through the sheath 23, with the deflectable arms 54 gathered together, and only after the catheter 40 is retracted from the sheath 23, the deflectable arms 54 are able to spread and regain their intended functional shape”).
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Regarding Claim 2, Altmann teaches each spine extending approximately parallel to the longitudinal axis in the collapsed configuration (see para 0061).
Regarding Claim 4, Altmann teaches a plurality of electrodes [55] connected to the spine framework (see annotated Fig. 2 above).
Regarding Claim 5, Altmann teaches each planar section terminating at the distal-most end (see annotated Fig. 2 above).
Regarding Claim 21, Altmann teaches each planar section linearly extending from the corresponding curved section to the distal-most end in the expanded configuration, the distal-most end defining a terminal-most extent of the respective spine of the plurality of spines (see annotated Fig. 2 above)
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.
Claims 3, 6-8, 20, and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Altmann et al. (US 20210162210 A1) in view of Basu et al. (US 2017/0100187 A1).
Regarding Claim 3, Altmann does not explicitly disclose a spine framework defining a lumen therethrough. However, Basu teaches a spine framework defining a lumen therethrough (see e.g. Fig. 6A; see also para. 0099, “a guidewire G may also be used to facilitate advancement of the catheter through the patient's vasculature”). It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Altmann and Basu and provide a lumen in the spine framework of Altmann. Doing so could allow for a guidewire to be passed therethrough and facilitate advancement of the catheter through the patient’s vasculature, as is the case in Basu.
Regarding Claim 6, Altmann does not disclose a flexible membrane connected to the planar sections of the spines, the flexible membrane comprising a first portion that extends along the plane in the expanded configuration. However, Basu teaches a flexible membrane [18] connected to the planar sections of the spines [17], the flexible membrane comprising a first portion that extends along the plane in the expanded configuration (see Fig. 2A). It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Altmann and Basu and provide a flexible membrane connected to the planar sections of the spines, the flexible membrane comprising a first portion that extends along the plane in the expanded configuration. Doing so could allow for surface electrodes on the membrane that could contact regions between the spines, as is the case in Basu (see e.g. para. 0053).
Regarding Claim 7, Basu teaches the flexible membrane [18] further being connected to the curved sections of each spine (see e.g. Fig. 5A). As such, it would have been obvious for the combination of Altmann and Basu as in Claim 6 described above to have the membrane connected to the curved sections of each spine.
Regarding Claim 8, Basu teaches one or more electrodes [30] connected to the first portion of the flexible membrane (see e.g. Fig. 2A). As such, it would have been obvious for the combination of Altmann and Basu as in Claim 6 described above to have the electrodes connected to the first portion of the flexible membrane.
Regarding Claim 20, Altmann teaches a system comprising a medical probe [40] comprising: an elongated shaft [22] extending along a longitudinal axis (see annotated Fig. 2 above); and a distal tip of a medical probe, the distal tip comprising a spine framework [54] having a proximal end, an intermediate section, and a distal-most end and extending along a longitudinal axis, the spine framework comprising: a neck extending from the proximal end (see annotated Fig. 2 above); and a plurality of spines [54] connected to the neck and extending along the intermediate section to the distal-most end, the spines being movable between: a collapsed configuration, where the spines extend along the longitudinal axis; and an expanded configuration, where each spine comprises a curved section that bends away from the longitudinal axis and a planar section extending from the curved section to the distal-most end, each planar section extending along a plane that is approximately orthogonal to the longitudinal axis, the distal-most end lying in the plane(see also para 0061, “The catheter 40 is inserted through the sheath 23, with the deflectable arms 54 gathered together, and only after the catheter 40 is retracted from the sheath 23, the deflectable arms 54 are able to spread and regain their intended functional shape”); and a guiding sheath that is slidable relative to the distal tip to cause the spines to move between the collapsed configuration and the expanded configuration (see para. 0061, “The catheter 40 is inserted through the sheath 23, with the deflectable arms 54 gathered together, and only after the catheter 40 is retracted from the sheath 23, the deflectable arms 54 are able to spread and regain their intended functional shape”).
Altmann does not teach a guidewire extending through the elongated shaft and the distal tip. However, Basu teaches a guidewire extending through the elongated shaft and the distal tip (see e.g. Fig. 6A; see also para. 0099, “a guidewire G may also be used to facilitate advancement of the catheter through the patient's vasculature”). It would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Altmann and Basu and provide a guidewire extending through the elongated shaft and the distal tip of Altmann. Doing so could facilitate advancement of the catheter through the patient's vasculature, as is the case in Basu.
Regarding Claim 22, the combination of Altmann and Basu as described in Claim 6 above would provide that the distal-most end and the planar sections of the plurality of spines and the flexible membrane collectively define, in the expanded configuration, a distally-facing planar contact surface extending parallel to the plane (see annotated Fig. 2 above; the membrane from Basu would follow the structure of the spine framework of Altmann in the combination).
Regarding Claim 23, Altmann teaches each planar section linearly extending from the corresponding curved section to the distal-most end in the expanded configuration, the distal-most end defining a terminal-most extent of the respective spine of the plurality of spines (see annotated Fig. 2 above).
Regarding Claim 24, Altmann teaches that the distal-most end and the planar sections of the plurality of spines collectively define, in the expanded configuration, a distally-facing planar contact surface extending parallel to the plane (see annotated Fig. 2).
Claims 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Altmann et al. (US 20210162210 A1) in view of Basu et al. (US 2017/0100187 A1) and further in view of Schwartz (WO 2017/070322 A1).
Regarding Claim 11, the combination of Altmann and Basu as discussed in Claim 6 above does not explicitly disclose a spine framework with a plurality of rods, each rod comprising: a first end; a second end; and a loop portion connecting the first end and the second end, the first ends and the second ends of the rods conjunctively forming the neck, and the loop portions forming the spines. However, Schwartz teaches a spine framework [1202] with a plurality of rods [1205], each rod comprising: a first end [1205p]; a second end [1205d]; and a loop portion connecting the first end and the second end [1205], the first ends and the second ends of the rods conjunctively forming the neck [N], and the loop portions forming the spines [1205] (see annotated Figs. 12a and 12b below). However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Altmann and Basu as described in Claim 6 above to further incorporate the teachings of Schwartz and provide for a plurality of rods comprising a first end; a second end; and a loop portion connecting the first end and the second end, the first ends and the second ends of the rods conjunctively forming the neck, and the loop portions forming the spines, to more closely resemble a petal-shaped spine framework rather than each spine terminating at a distal end. Doing so would allow the spine framework to conform to the heart’s anatomy.
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Regarding Claims 9 and 12, the combination of Altmann and Basu as discussed in Claim 6 above does not teach a plurality of flexible membranes, each flexible membrane surrounding a respective spine. However, Schwartz discloses a plurality of flexible membranes [1208] each flexible membrane surrounding a respective spine [1205] (see Fig. 12a; see also para. 00337, “substrate 1208 may be formed from a flexible material”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the combination of Altmann and Basu to further incorporate the teachings of Schwartz to provide a plurality of membranes surrounding each spine as opposed to Basu’s unitary membrane. Doing so could provide the spine framework increased flexibility for precise tissue targeting. Additionally, it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art (see Nerwin v. Erlichman, 168 USPQ 177, 179).
Regarding Claims 10 and 13, Altmann teaches one or more ring electrodes [55] connected to each spine (see annotated Fig. 2 above).
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 CHRISTIAN M SARCENO ROBLES whose telephone number is (571)272-8786. The examiner can normally be reached M-F: 8:30AM - 5:00PM.
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/C.S./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794