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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/08/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/19/2025 was filed after the mailing date of the Final Rejection on 10/08/2025. 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 6-11, filed 1/8/2026, with respect to the rejection of claim 1 under 35 U.S.C. 103 as being unpatentable over De Marchena in view of Nakao have been fully considered and are persuasive. Neither De Marchena nor Nakao teach “so that the snare loop and the heart valve therapy device pass through the cutting loop”. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Costello (WIPO 2022/066621).
With regards to the argument that one of ordinary skill in the art would not be motivated to combine De Marchena with Nakao, the Examiner is not persuaded. In response to applicant's argument that Nakao is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Nakao is teaching an invention that is directed to the problem of removing tissue or a part of tissue from the human body in a procedure involving the navigation of internal systems and structures, which is the same problem that the claimed invention is attempting to solve (and moreover, the same problem that De Marchena is also attempting to solve). Therefore, it is the Examiner’s position that one of ordinary skill in the art would be motivated to view Nakao for a potential solution to the same problem as presented by the applicant and De Marchena.
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) in view of Costello ‘621 (WIPO 2022/066621).
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 Costello does in an analogous heart valve therapy device. Costello teaches in Figure 110-111 and p.[00266-00275] that the snare loop is engaged around and grips the heart valve device and the cutting loop is moveable from a position distal the snare loop, proximally so that the snare loop and heart valve therapy device pass through the cutting loop and is activatable to cut valve tissue, and therefore teaches the limitation as described. 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 same configuration as described in Costello in De Marchena. As stated in Costello, the use of this configuration creates counter force that is desirable for cutting and removing the heart valve device and produces predictable results ([p.00266]).
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 (US Patent Publication US 2019/0183571) in view of Costello ‘621 (WIPO Patent Publication WO 2022/066621) and Costello (WIPO Patent Publication WO 2021/007324).
Regarding claim 2, the limitations of claim 1 are taught as described above. De Marchena 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 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 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 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/Nakao. 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 (US Patent Publication US 2019/0183571) and Costello ‘621 (WIPO Patent Publication WO 2022/066621) in view of Durgin (US Patent No. 6,050,995).
Regarding claim 6, the limitations of claim 1 are taught as described above. De Marchena 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. 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 (US Patent Publication US 2019/0183571) in view of Costello ‘621 (WIPO Patent Publication WO 2022/066621) and Khoynezhad (WIPO Patent Publication WO 2015/031898).
Regarding claim 11, the limitations of claim 10 are taught as described above. De Marchena 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. 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 (US Patent Publication US 2019/0183571) in view of Costello ‘621 (WIPO Patent Publication WO 2022/066621) and Regadas (US Patent Publication US 2010/0036375).
Regarding claim 13, the limitations of claim 1 are taught as described above. De Marchena 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/Nakao. 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
/LINDA C DVORAK/Primary Examiner, Art Unit 3794