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 .
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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/27/2026, 04/03/2026, 04/10/2026 was filed after the mailing date of the Non-Final Rejection on 05/19/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant’s arguments, see Remarks page 6-8, filed 05/19/2026, with respect to the rejection of claim 1 under 35 U.S.C. 103 as being unpatentable over De Marchena in view of Costello (WO 2022/066621) have been fully considered and are persuasive. However, a new grounds of rejection is issued in view of Rafiee (US 2022/0054185).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 10, 15, and 20 are rejected under 35 U.S.C. 103 as being anticipated by De Marchena (US Patent Publication US 2019/0183571), herein after “De Marchena”, in view of Rafiee (US 2022/0054185), herein after “Rafiee”.
Regarding claim 1 and 20, De Marchena teaches “a cutting and capture catheter comprising a first elongated control member, a cutting loop fixed at a distal portion of the first elongated control member and configured to cut tissue, (Fig. 3B, ref. 9a)”, “and, a snare catheter having a second elongated control member and a snare loop fixed at a distal portion of the second elongated control member (Fig. 3B, ref 9a)”. However, De Marchena does not teach “wherein when the snare loop is engaged around and grips the heart valve device, the cutting loop is moveable from a position distal of the snare loop, proximally so that the snare loop and heart valve therapy device pass through the cutting loop, to a position proximal of the snare loop in which the cutting loop is activatable to cut valve tissue”, but Rafiee does in an analogous heart catheter device. Rafiee teaches “wherein when the snare loop is engaged around and grips the heart valve device, the cutting loop is moveable from a position distal of the snare loop, proximally so that the snare loop and heart valve therapy device pass through the cutting loop, to a position proximal of the snare loop in which the cutting loop is activatable to cut valve tissue” in Fig. 17A-17C and p.[0047-0048]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Rafiee in view of De Marchena. The use of the snare loop is known in the art for resecting tissue and produces predictable results of removing the desired tissue from the cardiac region (p.[0047]).
Regarding claim 20 specifically, the limitations of claim 1 are taught as described above. MPEP 2112.02 states that “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. Claim 20 is the normal and usual operation of claim 1, and therefore the method of claim 20 is taught by the rejection of claim 1.
Regarding claim 10, the limitations of claim 1 are taught as described above. Figure 3B of De Marchena shows that the basket, when closed, has a rounded distal tip and therefore teaches the limitation as described.
Regarding claim 15, the limitations of claim 1 are taught as described above. Figure 2B shows that the basket 8 has a conical shape even when deployed and therefore teaches the claimed invention as described.
Claims 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over De Marchena, in view of Rafiee and Costello (WIPO Patent Publication WO 2021/007324), herein after “Costello”.
Regarding claim 2, the limitations of claim 1 are taught as described above. De Marchena/Rafiee does not teach that the snare loop is saddle shaped, however, Costello does in an analogous heart valve therapy device. Costello teaches a saddle shaped snare loop with Figure 108. Note that this specific shape for the snare loop does not appear to have any nonobvious technical effects and would be used by one of ordinary skill in the art before the effective filing date of the claimed invention as a straightforward design choice.
Regarding claim 3, the limitations of claim 1 are taught as described above. De Marchena/Rafiee does not teach that the snare loop includes sides that curve distally relative to the second elongated control member and then back proximally for form an arc shape, however, Costello does in an analogous heart valve therapy device. Costello teaches a saddle shaped snare loop with Figure 108. Note that this specific shape for the snare loop does not appear to have any nonobvious technical effects and would be used by one of ordinary skill in the art before the effective filing date of the claimed invention as a straightforward design choice and produces predictable results.
Regarding claim 4, the limitations of claim 1 are taught as described above. De Marchena/Rafiee does not explicitly teach a snare loop with a circular shape with a notch opposite the second elongated control member, however, Costello does in an analogous heart valve therapy device. Costello teaches in p.[00137-00138] and Figure 20 which shows uninsulated portion 104B which is a notch opposite the second elongated control member. Note that this configuration does not appear to have any nonobvious technical effects and would be used by one of ordinary skill in the art before the effective filing date of the claimed invention as a straightforward design choice and produces predictable results.
Regarding claim 5, the limitations of claim 1 are taught as described above. De Marchena/Rafiee does not explicitly teach an inner radial surface of the snare loop comprises a plurality of protrusions, however, Costello does in an analogous heart valve therapy device. In Figure 11, Costello shows a plurality of loops 102A that are positioned around the inner radial surface of snare loop and therefore teach the claimed limitation. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a plurality of protrusions within the inner radial surface of the snare loop, as taught in Costello, in De Marchena/Rafiee. As stated in Costello, these loops allow for a basket or other means of a capturing device to be affixed to the device for collecting the cardiac tissue as needed.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over De Marchena and Rafiee in view of Durgin (US Patent No. 6,050,995), herein after “Durgin”.
Regarding claim 6, the limitations of claim 1 are taught as described above. De Marchena/Rafiee does not teach that the snare loop is comprised of a helically wound coil, however, Durgin does. Durgin teaches in Figure 3 that the wires 11/12 are wound together in a helical manner to form a dual stranded braid (further discussed in Col. 2, lines 43-67). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the snare loop comprised of a helically wound coil, as taught in Durgin, in De Marchena/Rafiee. As stated in Durgin, the use of the helically wound coil prevents a short circuit in the snare loop when it is retracted back into the sheath and produces predictable results.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over De Marchena in view of Rafiee and Khoynezhad (WIPO Patent Publication WO 2015/031898), herein after “Khoynezhad”.
Regarding claim 11, the limitations of claim 10 are taught as described above. De Marchena/Rafiee does not teach a guidewire, only teaching a guide catheter, nor does De Marchena teach that the guide catheter passes through the basket. Khoynezhad, an analogous heart valve retrieval device, teaches that the guidewire 200 passes through the basket 106, as shown in Figure 1. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have a guidewire passage through the interior of the basket, as taught in Khoynezhad, in De Marchena/Rafiee. Allowing the guidewire to pass through the basket facilitates the accurate placement of the device and produces predictable results.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over De Marchena in view of Rafiee and Regadas (US Patent Publication US 2010/0036375), herein after “Regadas”.
Regarding claim 13, the limitations of claim 1 are taught as described above. De Marchena/Rafiee does not explicitly teach that the snare loop has electrodes for cutting tissue, however, Regadas does. Regadas teaches this limitation in an analogous surgical ablation device in p.[0012] which states "the snare portion including first and second electrodes operably mounted thereto for sealing tissue therebetween," and p.[0032] "For example, radiofrequency energy, either monopolar or bipolar may be provided to electrodes 134, 136". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include RF electrodes on the snare loop, as taught in Regadas, in De Marchena/Rafiee. The use of these electrodes allows for the device to seal or ablate tissue as needed for the procedure and produces predictable results.
Allowable Subject Matter
Claims 7-9, 12, 14, 16-19, and 30-31 are 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.
Conclusion
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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