DETAILED ACTION
The following is a Final Office Action on the merits.
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.
Response to Amendment
Acknowledgment is made to the amendment received 3/13/2026.
Applicant’s amendments and/or arguments are sufficient to overcome the claim objections and/or 35 USC 112(b)/second paragraph rejections set forth in the previous office action.
Applicant’s amendments are sufficient to overcome the double patenting rejections set forth in the previous office action.
Claim Objections
Claim 8 is objected to because of the following informalities: delete “each spine of the plurality of spines configured to turn inwardly toward the longitudinal axis such that the second end is disposed near the first end and” in ll. 1-3 as this limitation recites the same limitation as claim 1. Appropriate correction is required.
Applicant is advised that should claims 8-11 be found allowable, claims 12-15 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 1 recites the limitation “each spine…, in the expanded configuration, comprising…(i) a second region….bending inwardly so as to face towards the longitudinal axis such that the second ends of the plurality of spines converge near the first ends of the plurality of spines”.
Claim 8 recites the limitation “each spine of the plurality of spines configured to turn inwardly toward the longitudinal axis such that the second end is disposed near the first end”. Thus, claim 8 recites the same limitation as claim 1 (e.g., the spines turn inwardly and the second ends are disposed near the first ends). Claim 8 further recites “each spine bows radially outward from the longitudinal axis when deployed from an insertion sheath”.
Claim 12 recites the limitation “each spine of the plurality of spines configured to bow radially outward from the longitudinal axis when deployed from an insertion sheath” which is the same limitation as claim 8.
Thus, since the first limitation of claim 8 is duplicative of a limitation in claim 1, upon which claim 8 directly depends, and the second limitation of claim 8 is duplicative of the limitation in claim 12, which also directly depends from claim 1, claim 12 is a substantial duplicate of claim 8. Claims 13-15 follow claims 9-11 as also being substantial duplicates.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 5-15 & 17 is/are rejected under 35 U.S.C. 102(b) as being anticipated by Tegg (2020/0060569).
Concerning claim 1, as illustrated in at least Figs. 1, 4 & 6, Tegg discloses a medical probe (high density electrode mapping catheter 200; [0067]) comprising:
a tube comprising a proximal end and a distal end, the tube extending along a longitudinal axis (catheter shaft 214 has a proximal end 216 and distal end 218 extending along a longitudinal axis gg; [0069]);
a plurality of spines disposed at the distal end of the tube (side-by-side arms 206, 208, 210, 212 form flexible framework 204; [0068]), each spine of the plurality of spines comprising a first end that is fixed in relation to the tube (distal end 218 can include a connector 220, which can couple the distal end 218 of the catheter shaft 214 to a proximal end of the flexible framework 204; [0069]) and a second end that is unattached in relation to the tube (electrode-carrier arms are not connected to one another at the distal ends; [0068]), each spine of the plurality of spines configured to transition between a collapsed configuration and an expanded configuration (flexible framework 204 can be protracted and/or retracted from a distal end 218 of a catheter shaft 214, which can also include a proximal end 216, or, in some embodiments, the flexible framework 204 can be deployed from an introducer into a body; [0069]), the plurality of spines forming a basket when each spine of the plurality of spines is in the expanded configuration (flexible framework 204 forms a basket; [0069]), each spine of the plurality of spines, in the expanded configuration, comprising (i) a first region that bends outwardly away from the longitudinal axis so as to bow radially outward from the longitudinal axis (proximal ends of arms 206, 208, 210, 212 bend outwardly away from the longitudinal axis gg; Fig. 4) and (ii) a second region extending from the first region and bending inwardly so as to face towards the longitudinal axis such that the second ends of the plurality of spines converge near the first ends of the plurality of spines (distal ends of arms 206, 208, 210, 212 bend inwardly toward the longitudinal axis gg and converge near the proximal ends of arms 206, 208, 210, 212; Fig. 4); and
a plurality of electrodes attached to the plurality of spines (electrodes 202 are disposed on arms 206, 208, 210, 212; [0067-0068]).
Concerning claim 5, Tegg discloses the plurality of electrodes (202) being disposed along each spine of the plurality of spines (206, 208, 210, 212) ([0067-0068]; Fig. 4).
Concerning claim 6, Tegg discloses the plurality of electrodes (202) being configured to detect electrophysiological signals ([0078]).
Concerning claim 7, Tegg discloses the plurality of electrodes (202) being configured to deliver ablative energy to tissue ([0078]).
Concerning claim 8, Tegg discloses each spine of the plurality of spines (206, 208, 210, 212) configured to turn inwardly toward the longitudinal axis such that the second end is disposed near the first end and each spine bows radially outward from the longitudinal axis when deployed from an insertion sheath (introducer) ([0069]; Fig. 4).
Concerning claim 9, Tegg discloses the plurality of electrodes (202) being disposed along the plurality of spines (206, 208, 210, 212) from the first end to a point along the spine approximately at a distal end of the basket when in the expanded configuration (e.g., electrode 202-7) (Fig. 4).
Claim 10 is rejected upon the same rationale as applied to claim 6.
Claim 11 is rejected upon the same rationale as applied to claim 7.
Claim 12 is rejected upon the same rationale as applied to claim 8.
Claim 13 is rejected upon the same rationale as applied to claim 9
Claim 14 is rejected upon the same rationale as applied to claim 6.
Claim 15 is rejected upon the same rationale as applied to claim 7.
Concerning claim 17 Tegg discloses each spine of the plurality of spines (206, 208, 210, 212) comprising a shape memory material ([0050], [0073]).
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) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tegg (2020/0060569), as applied to claim 1, in further view of Thompson et al. (6,071,274).
Concerning claim 16, while Tegg discloses alternative embodiments with distal ends tethered to the shaft (Fig. 3A-E), Tegg fails to specifically disclose each spine of the plurality of spines comprising an anchor disposed at the second end, each anchor configured to attach to the insertion sheath when in the expanded configuration. However, Thompson et al. disclose a medical probe comprising a spline (454) comprising an anchor (threaded distal end 470) disposed at a second end (470) of the spline and configured to attach to an insertion sheath (472) when in an expanded position. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Tegg such that each spine of the plurality of spines comprising an anchor disposed at the second end, each anchor configured to attach to the insertion sheath when in the expanded position in order to provide the benefit of forming a loop that can readily adopt to different contours and geometries within the body region and is capable of exerting a force on the tissue surface of interest as taught by Thompson et al. (Col. 1, II. 49-53, Col. 33-34, II. 52-45; Fig. 94-96)
Response to Arguments
Applicant’s arguments 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.
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 JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794