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 . Claims 1-34 are currently pending with claims 4, 12-27, and 32 being withdrawn via the Election (03/03/2026).
Election/Restrictions
Applicant’s election without traverse of the species relating to Figures 2 and 2A in the reply filed on 03/03/2026 is acknowledged. In addition to the suggested withdrawn claims 4, 12-17, 22-25 provided in the response, claims 18-21 are withdrawn as they are drawn to the non-elected circular cross-section, claims 22 and 26 along with their dependents are not drawn to Figure 2A which shows a single rectangular/square cross section. Claim 27 includes a square however it also requires other cross sections along the spines that are not covered by Figure 2A. Claim 32 is not drawn to Figure 2 which has the central loop extend outward radially beyond the first and second loops shown in Figure 3 where the central loop begins within the confines of the other two loops then extends beyond it. At present claims 1, 5-8, 28, 30, and 33-34 are generic to all species.
Claim Rejections - 35 USC § 102
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 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 1-3, 5-10, 28-31, and 33-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Selkee et al. US Publication 2020/0345262 (hereinafter Selkee).
Regarding claim 1, Selkee discloses a catheter for electrophysiology applications, comprising: (a) a shaft extending along a longitudinal axis to a distal end (12 and 14, see Figure 1); and (b) an end effector coupled to the distal end of the shaft (100), the end effector including: (i) a plurality of loop members (Figure 1), each loop member of the plurality of loop members including a corresponding pair of spines (Figure 4A where each loop includes two spines one of A and B, see [0040][0043]), the spines of each loop member of the plurality of loop members being arranged along a transverse axis that is perpendicular to the longitudinal axis (Figures 1 and 4A), the transverse axis and the longitudinal axis collectively defining a plane, and (ii) a plurality of electrodes affixed to the plurality of loop members (37), the plurality of electrodes being arranged asymmetrically relative to the plane (which electrodes shown in Figure 2F are entirely up to the reader with some electrodes at 37R not being symmetrical with other electrodes at other locations, further as the loops are made with nitinol the structure is held together with a circular clip as soon as contact is made with tissue the electrodes would not be symmetrical, meaning the device is fully capable of being compressed into a structural configuration to meet the functional language as it is relative to a plane without any additional structural modifications).
Further, the loops as per Figure 1 are not in a perfect line along the exact same plane, they extend along the transverse axis which makes up a portion of the plane on are not 100% through the axis the entire time due to the nature of the loops taking up physical space. As they are not all in the plane itself as they are stacked on top of each other, the electrodes (depending on which ones the reader picks) are not going to be symmetrical to the plane, even when not taking into account that the
Regarding claim 2, Selkee discloses that the plurality of loop members including three loop members (Figures 1-2B).
Regarding claim 3, Selkee discloses that the plurality of loop members including a pair of outer loop members and an inner loop member positioned radially inwardly of the pair of outer loop members relative to the longitudinal axis (Figures 1-2B which shows the loop members in the claimed configuration).
Regarding claim 5, Selkee discloses that each loop member of the plurality of loop members including an elongate structural member (the cover 64 for the spine or the lead wires 40s which extend to their respective electrodes from the distal end of the shaft, see Figure 6A).
Regarding claim 6, Selkee discloses that each electrode of the plurality of electrodes being affixed to the elongate structural member of the corresponding loop member of the plurality of loop members ([0053] which details electrodes can be formed directly onto the cover).
Regarding claim 7, Selkee discloses that each loop member of the plurality of loop members including a cover disposed about the corresponding elongate structural member (cover 64 as per [0047] where the elongate structural member would be the lead 40s for this claim pathway).
Regarding claim 8, Selkee discloses that each electrode of the plurality of electrodes being affixed to the cover of the corresponding loop member of the plurality of loop members ([0053]).
Regarding claim 9, Selkee discloses that each of the spines is configured with a rectangular cross-sectional shape ([0043] which details a rectangular or square shaping for the nitinol spine).
Regarding claim 28, Selkee discloses an end effector of a catheter (100), the end effector comprising: (a) a plurality of loop members (Figures 1-2B elements 1-3 at sections A-C), each loop member of the plurality of loop members including a corresponding pair of spines ([0040] which details a pair of spines A being one, and B being the second connected via C, see Figures 2A-B), the spines of each loop member of the plurality of loop members including at least a portion extending parallel to a longitudinal axis (sections A and B for each of loops 1-3 in Figures 2A-B), the spines of each loop member of the plurality of loop members being arranged along a transverse axis that is perpendicular to the longitudinal axis (Figures 1-2B), the transverse axis and the longitudinal axis collectively defining a plane (a plane can be drawn along those axes with the device of Figures 1-2B); and (b) a plurality of electrodes affixed to the plurality of loop members (37), the plurality of electrodes being arranged asymmetrically relative to the plane (as mentioned above in rejected claim 1).
Regarding claim 29, Selkee discloses that the spines is configured with at least
one of a rectangular cross-sectional shape, a triangular cross-sectional shape, or a circular cross-sectional shape ([0043] which details a rectangular or square shaping for the nitinol spine).
Regarding claim 30, Selkee discloses an end effector of a catheter, the end effector comprising: (a) a central loop member extending along a longitudinal axis (loop 2C of Figures 2A-B); (b) a first side loop member at least partially disposed on a first side of the longitudinal axis (loop 1C);(c) a second side loop member at least partially disposed on a second side of the longitudinal axis (loop 3C of Figures 2A-B), the second side loop member, the first side loop member, and the central loop member being arranged along a transverse axis that is perpendicular to the longitudinal axis (Figures 2A-B), the transverse axis and the longitudinal axis collectively defining a plane (see Figures 2A-B); and (d) a plurality of electrodes (37), each of the plurality of electrodes being affixed to a corresponding one of the central loop member (Figures 2A-B show electrodes 37 on said loop members), the first side loop member, or the second side loop member, the plurality of electrodes being arranged asymmetrically relative to the plane (the loops are flexible and deflectable due to the nitinol spines, see contents of rejected claim 1 above for further detail, see also Figure 5C where the electrodes even though they are rings are also technically asymmetric to the plane as the loops only have to run along the plane not through it)
Regarding claim 31, Selkee discloses that the central loop member being positioned radially inwardly of each of the first and second side loop members relative to the longitudinal axis (Figures 2A-B which shows the central loop outermost portions being within the confines of the two side loops’ outermost portions).
Regarding claim 33, Selkee discloses an electrode of the plurality of
electrodes is asymmetric relative to the plane (the electrodes 37 are placed upon a nitinol spine, and as parts of the spine can bend and deflect upon contact with tissue while the rest of the plane remains aligned with the longitudinal axis, the electrode(s) of Selkee are fully capable of being asymmetric relative to the plane without any additional structural modification).
Regarding claim 34, Selkee discloses an electrode of the plurality of
electrodes is asymmetric relative to a first plane that extends through the electrode (electrodes 37; a plane can be drawn anywhere and is not a structural element, even with perfectly symmetrical ring electrodes a plane can be drawn not through the middle of the electrode and the “plane” language would be met) and that is parallel to the plane defined by the end effector (Figures 1-2B, the electrodes are designed to sit parallel to the end effector plane when at rest, even then it depends on which electrode is chosen to meet the plurality of electrodes and which of the loops is considered the center point for the plane going through the end effector as the loops as per Figure 5C which shows the loops along the transverse axis; the loops are stacked and may have overlap with the plane but again the flexible and deflectable material will afford movement).
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 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 non-obviousness.
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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Selkee in view of Sterrett et al. US Publication 2020/0229726 (hereinafter Sterrett).
Regarding claim 10, Selkee is silent on the electrode’s location. Sterrett teaches a looped end effector for a catheter that includes that each of the spines is configured with a pair of flat surfaces oriented parallel to each other (Figures 19A, D, 20), the plurality of electrodes being arranged on only one of the pair of flat surfaces of each of the spines (Figure 19D shows that the electrodes 502 can be on top as well as the bottom, see also [0189]-[0190]). Sterrett also shows the same electrode location/configuration that Selkee utilizes in Figures 1A-B. Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the electrode configuration as taught by Sterrett in lieu of the configuration of Selkee as they are art recognized equivalents of each other and would have produced predictable results (affording near/far field sensing, filtering).
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Allowable Subject Matter
Claim 11 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 details that the electrodes are on two surfaces in a specific configuration, and even though having distinct [micro]electrodes on different surfaces of a spine were well-known (Sterrett Figures 19A,D) which have electrodes on a top and bottom of the spine, there is no reason to move one of them to the side of the spine (in the claimed first and second surfaces).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brian M Antiskay whose telephone number is (571)270-5179. The examiner can normally be reached M-F 10am-6pm EST.
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/BRIAN M ANTISKAY/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794