Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Acknowledgments
This office action is in response to the reply filed on 12/11/25. In the reply, the applicant amended claims 1 and 12 and added new claims 21-23. Claims 1-23 are pending.
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. Claim 11 is further objected to based on its dependency on claim 10.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Due to the amended claim language adding first and second pluralities of circumferentially-spaced irrigation holes, the last wherein clause is unclear which plurality of circumferentially-spaced irrigation holes to face radially outward are being claimed. However, all sets of irrigation holes in Bicher face radially outward but clarity to the language is required. Claims 2-11 and 13-23 are further rejected based on dependency.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 1-4, 6-9, 12-14, 18-23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Panescu et al. (US 5,810,802) (“Panescu”) in view of Imran et al. (US 5,348,554) (“Imran”) further in view of Bicher et a. (WO 81/03616) (“Bicher”).
(claims 1,12) Panescu discloses: An ablation catheter apparatus and method 14 comprising: an elongated body 12 comprising a distal end 10 and a proximal end; and a plurality of segmented ablation electrodes 30 (see Figs. 3, 4) on a distal portion 10(1) of the elongated body 32, the plurality of segmented ablation electrodes being spaced from each other longitudinally by a set of electrically nonconductive segments C5L11-27. Supplying energy to the plurality of segmented ablation electrodes to ablate tissue C2L8-19
Panescu does not directly disclose at least one fluid lumen extending longitudinally through the elongated body and a tip electrode disposed at the distal end of the elongated body and distal to the plurality of segmented ablation electrodes, and a plurality of circumferentially spaced irrigation holes disposed in the tip electrode and in fluid communication with the at least one fluid lumen. Imran, in the analogous art, teaches these elements of a fluid lumen 26-29 extending longitudinally, a tip electrode 16 and a plurality of circumferentially spaced irrigation holes 106, 107, 108 disposed in the tip electrode and in fluid communication with the at least one fluid lumen (Figs. 1, 6-8). However, the plurality of irrigation holes having a first plurality circumferentially-spaced at a first longitudinally spaced location in a longitudinally-extending sidewall of the tip electrode and a second plurality circumferentially-spaced at a second longitudinally spaced location in the longitudinally-extending sidewall of the tip electrode is clearly taught by Bicher, Fig. 1 at 28 (three rows of irrigation holes in the jacket for cooling, see claim 21). The plurality of circumferentially-spaced irrigation holes face radially outward, Fig. 1. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to modify Panescu with the fluid lumen as taught by Imran and the distribution as taught by Bicher to dissipate heat created in the electrode by the cooled electrode tip and fluid lumen as taught by Imran and Bicher (claim 21).
(claims 2,18) the plurality of segmented ablation electrodes include at least one of a coil ring electrode and/or a ring electrode C5L23-27
(claims 3,19) the plurality of circumferentially spaced irrigation holes comprise at least three circumferentially spaced irrigation holes (Fig. 6, Imran)
(claims 4,20) the tip electrode is an ablation tip electrode C3L22-31 Imran
(claim 6) further comprising one or more conducting wires 58 coupled with and supplying energy to the plurality of segmented ablation electrodes 30, see Fig. 16.
(claims 7, 13,14) further comprising: one or more conducting wires 58 coupled with the plurality of segmented ablation electrodes 30; an energy source supplying energy via the one or more conducting wires to the plurality of segmented ablation electrodes; and a controller configured to control the energy source to supply energy to the plurality of segmented ablation electrodes in one of an independent manner, a sequential manner, or a simultaneous manner. See claim 27 of Panescu, C2L1-30
(claim 8) further comprising: a plurality of temperature sensors 80 disposed on and in contact with the plurality of segmented ablation electrodes at the electrode ends. (see e.g., Figs. 3,4,16)
(claim 9) further comprising: one or more conducting wires coupled with the plurality of segmented ablation electrodes; an energy source supplying energy via the one or more conducting wires to the plurality of segmented ablation electrodes; and a controller configured to control the energy source to supply energy to the plurality of segmented ablation electrodes based on signals received from the plurality of temperature sensors so as to control temperatures of the plurality of segmented ablation electrodes. See claim 27 of Panescu
(claims 21, 22) Panescu discloses at least one temperature sensor 80 coupled to the elongated body proximal of the tip electrode (see Fig. 4)
(claim 23) the plurality of circumferentially-spaced irrigation holes comprises circular irrigation holes, see Bicher Fig. 1
Claims 5, 15-17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Panescu in view of Imran in view of Bicher further in view of Yang et al. (US 6,332,880) (“Yang”).
Panescu/Imran/Bicher discloses the invention as substantially claimed, see above, but does not directly disclose the distal portion of the elongated body includes a material which is preformed into a substantially closed loop having the plurality of longitudinally spaced segmented ablation electrodes and the electrically nonconductive segments. Yang, in the analogous art, teaches a similar ablation catheter having a preformed distal loop of alternating ablation electrodes and electrically nonconductive segments, see e.g., Fig. 25, C16L44. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to have modified the pull wires of Panescu to have a shape memory as taught by Yang to conform to different areas of treatment (see Yang C17L46-55, Panescu C5L17-22.
The substantially closed loop of Panescu/Yang can be placed around at least one vessel ostium in a chamber of a patient to ablate the tissue on a chamber wall of the chamber around the at least one vessel ostium as a matter of design choice depending on the procedure to be performed (Panescu C1L27-35, Yang Figs. 80a-d—pulmonary vein, C26L46-48)
Response to Arguments
Applicant's amendments and arguments filed in response have been fully considered but they are not persuasive. Apparently applicant does not agree that the slots 107, 108 and the holes 106 support the newly amended language. Arguendo, Examiner has provided a new rejection for this amendment, above. All other rejections maintained.
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 DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783
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