DETAILED ACTION
Applicant’s amendments and remarks, filed November 7, 2025, are fully acknowledged by the Examiner. Currently, claims 1-6 are pending with claims 1, 2, 4 and 5 amended. Applicant’s amendments to claim 1 have obviated the previously-filed rejection under 35 U.S.C. 112(b). The following is a complete response to the November 7, 2025 communication.
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.
Claims 1-4 and 6 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fischer et al. (WO 2020/104679 A2).
Regarding claim 1, Fischer provides for a catheter comprising: a catheter shaft extending in an axial direction (catheter shaft at 217/317 and having a near-distal end structure including a plurality of electrodes (the near-distal end structure having the electrodes 330 thereon as in figure 3A), and
a handle attached to a proximal end side of the catheter shaft (handle 220), the handle including a handle body extending in the axial direction (outer structure at 220) and an operation mechanism configured to be rotatable with respect to the handle body about a rotation axis extending in the axial direction (transmission structure at 219 along with 215), the operation mechanism being configured to be rotationally operated when the near-distal end structure is rotationally operated about the rotation axis while a length of the near-distal end structure in the axial direction is fixed (via 219 functioning to rotate 215 and tip 214 to cause the loop 211/311 to rotate; 215, while rotating, maintains a fixed axial length), and wherein the operation mechanism is further configured to be slidable in the axial direction in the handle body and is slid in the axial direction during a deformation action in which a shape of the near-distal end structure is changed between a first shape and a second shape (via 215/315 being longitudinally advanceable/retractable as shown in figures 8A-C and 9A-C),
Regarding claim 2, Fischer provides that the first shape is a non-deployed shape in which the near-distal end structure is not deployed in the axial direction (via the non-deployed shape being with the more extended position of 215/315 to have the loop 211/311 extended as well), and the second shape is a deployed shape in which the near-distal end structure is deployed from the non-deployed shape in the axial direction (the retracted position of 215/315 to provide the deployed shape as in figures 2A-2C and 3A-3B).
Regarding claim 3, Fischer provides that the near-distal end structure is settable to any intermediate shape between the non- deployed shape and the deployed shape according to a slide position of the operation mechanism in the handle body (via the various positions between the two defined in the rejection of claim 2 above being any number of intermediate shapes between the deployed and non-deployed shapes).
Regarding claim 4, Fischer provides that a distal end side of an operation wire used in the rotation action and the deformation action is fixed to the near-distal end structure (215/315 is fixed to the near-distal end structure), and a proximal end side of the operation wire is fixed to the operation mechanism in the handle body via a gear configured to rotate in conjunction with the rotation operation (with the proximal end of 215/315 fixed to 219/319; see page 20, lines 4-12 providing for 219 to include a gear).
Regarding claim 6, Fischer provides that a rotation action of the near-distal end structure in response to the rotation operation is a torsional rotation action about the rotation axis (via 219/319 providing for torsional action to 215/315).
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Fischer et al. (WO 2020/104679 A2) as applied to claim 2 above, and further in view of Babkin et al. (US Pat. Pub. 2021/0315627 A1).
Regarding claim 5, Fischer provides that the near-distal end structure includes: a branch point of the catheter shaft (point near 213 where 211/215 branch from one another), a merge point located near a most distal end of the catheter shaft (point near 214 where 21//215 merge back together). While Fischer provides for a single branch including plurality of electrodes (211/311 with the electrodes 330 thereon) and that the non-deployed shape is a petal shape formed by the plurality of branch structures (via the non-deployed shape being with the more extended position of 215/315 to have the loop 211/311 in an extended petal shape via 211/311 forming a petal shape about the axis defining the longitudinal direction), and the deployed shape is a shape in which the petal shape is deployed in the axial direction (the retracted position of 215/315 to provide the deployed shape as in figures 2A-2C and 3A-3B wherein 211/311 is in deployed in the axial direction). Fischer fails to provide for a plurality of branch structures respectively including the plurality of electrodes, the plurality of branch structures individually connecting the branch point and the merge point in a curved shape.
Babkin provides for a similar device as that of Fischer and specifically provides for a near-distal end structure that includes a branch point of the catheter shaft (point near the distal end of 4018 where each of 4030/32/34/36/38 branch from one another), a merge point located near a most distal end of the catheter shaft (point at 4014 where 4030/32/34/36/38 merge back together), wherein a plurality of branch structures respectively including the plurality of electrodes, the plurality of branch structures individually connecting the branch point and the merge point in a curved shape (see each of 4030/32/34/36/38 having the electrodes 4060 therein).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a plurality of branches with individual electrodes as in Babkin in place of the single branch arrangement of Fischer to provide for an alternative near-distal end structure that is capable of treating tissue. Babkin readily contemplates embodiments with a single branch similar to the arrangement in Fischer and further provides for the multiple branch embodiment in figures 33A and B with such a multiple branch arrangement providing the ability to form multiple sized and shaped lesions with a single device (see [0269] of Babkin).
Response to Arguments
Applicant's arguments filed November 7, 2025 have been fully considered but they are not persuasive.
Applicant argues on pages 4-5 of the Remarks with respect to the rejection of independent claim 1. Therein, Applicant contends that Fischer fails to provide for each and every limitation set forth in claim 1 including the amended language added therein of “wherein the operation mechanism is further configured to be slidable in the axial direction on the handle body and is slid in the axial direction during a deformation action in which a shape of the near-distal end structure is changed between a first shape and a second shape”.
Applicant contends that “Fischer fails to disclose the operation mechanism configured to be slidable in the axial direction of the handle body” and alleges that a “slide operation is achieved by advancing or retracting the positioning catheter (215) itself in a longitudinal direction”. Applicant concludes on page 5 that “Fischer fails to disclose or suggest the operation mechanism that is disposed on the handle body and directly operatable by a user for both of the slide operation and the rotation”.
This is not persuasive.
As a preliminary matter, the Examiner notes that the at-issue limitations in the rejection of claim are as follows:
an operation mechanism configured to be rotatable with respect to the handle body about a rotation axis extending in the axial direction (transmission structure at 219 along with 215);
the operation mechanism being configured to be rotationally operated when the near-distal end structure is rotationally operated about the rotation axis while a length of the near-distal end structure in the axial direction is fixed (via 219 functioning to rotate 215 and tip 214 to cause the loop 211/311 to rotate; 215, while rotating, maintains a fixed axial length);
the operation mechanism is further configured to be slidable in the axial direction in the handle body and is slid in the axial direction during a deformation action in which a shape of the near-distal end structure is changed between a first shape and a second shape (via 215/315 being longitudinally advanceable/retractable as shown in figures 8A-C and 9A-C).
Accordingly, the operating mechanism has been taken as the transmission structure at 219 along with 215. The Examiner maintains that the mechanism as defined is rotationally operatable as set forth above.
While Applicant contends that Fischer “fails to disclose or suggest the operation mechanism that is disposed on the handle body and directly operatable by a user for both of the slide operation and the rotation”, the Examiner notes that there is no structural or functional limitation in the claim that requires the operation mechanism to be 1) “disposed on the handle body” or 2) “directly operatable by a user for both the slide operation and the rotation” as alleged by Applicant in the Remarks. Rather, amended claim 1 only requires the handle to include a handle body and “an operation mechanism configured to be rotatable with respect to the handle body” and “configured to be slidable in the axial direction on the handle body”. The Examiner cannot find that any of the present claim language require, either explicitly or implicitly, for the used to be capable of direct operation of the operation mechanism. Further, while the operation mechanism is required to be “slidable in the axial direction on the handle body”, the Examiner fails to find that this is the same as the alleged requirement of the operation mechanism to be specifically “disposed on the handle body”.
As a result, the Examiner notes that it is well established that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). If Applicant desires such structural/functional limitations to be imported in some manner into the interpretation of claim 1, language that positively requires one or both of the argued for points should be added to the claim. The Examiner, therefore, maintains that the longitudinal advancing and retracting of 215/315 as shown in figures 8A-C and 9A-C relative to the surrounding structure (and as noted in Applicant’s own arguments) would indeed provide for the operation mechanism being configured to be slidable in a longitudinal direction on the handle body as claimed.
As such, it is for at least the reasoning set forth above that the Examiner maintains the each of the proffered grounds of rejection in the Action remain tenable.
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 RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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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.
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/Ronald Hupczey, Jr./ Primary Examiner, Art Unit 3794
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