DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant’s election without traverse of Group/Invention II - claims 17-21 (drawn to a method) in the reply filed on 29 April 2026 is acknowledged.
3. Applicant’s election without traverse of COUPLING MEMBER – Species B (embodied in Figure 17A) in the reply filed on 29 April 2026 is acknowledged.
4. Applicant’s election without traverse of DISTAL END of DELIVERY CATHETER – Species B (embodied in Figures 16A, 16B) in the reply filed on 29 April 2026 is acknowledged.
Drawings
5. The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims.
a. Therefore, the “after the delivery catheter approaches the right atrium, withdrawing a volume of inflation medium from the nosecone so that the nosecone has a second length smaller than the first length” (lines 8-9 of independent claim 1) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
6. Claim 29 is objected to because of the following informalities: please substitute “wherein the at least one lumen comprises a plurality of lumens and wherein a number and positioned of the plurality of channels matches a number and a position of the plurality of lumens” with --wherein the at least one lumen comprises a plurality of lumens and wherein a number and [[a position of the plurality of channels matches a number and a position of the plurality of lumens--. Appropriate correction is required.
Claim Rejections - 35 USC § 102
7. 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.
8. Claims 17-19, 21, and 25 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Hariton et al. (US PG Pub No. 2021/0196461 A1).
Regarding independent claim 17, and referring to Figures 1A-1F, Hariton et al. ‘6461 discloses a method, comprising:
introducing a delivery catheter (110) into a femoral vein of a patient ([0214], [0216], [0217], [0218], [0255]) while a prosthetic heart valve (prosthetic mitral valve 20, see claim 77 and paragraph [0203]) is contained in a collapsed condition within a valve cover (126, see [0210], [0211], [0216]) of the delivery catheter;
advancing the delivery catheter through the femoral vein toward a right atrium of the patient while a nosecone (118 + 128) at a leading end (114) of the delivery catheter has a first length (Figure 1A);
continuing to advance the delivery catheter through the femoral vein until the nosecone approaches the right atrium ([0214], [0216], [0217], [0218], [0255]);
after the delivery catheter approaches the right atrium, withdrawing a volume of inflation medium ([0204], [0218], [0222], [0235]) from the nosecone so that the nosecone has a second length smaller than the first length (compare Figure 1B to Figure 1C, wherein portion 128 of nosecone 118 + 128 is deflated and withdrawn, thereby defining a second length smaller than the first/original length; further, see [0217]-[0219] and [0223]);
while the nosecone has the second length, maneuvering the valve cover to a position within or adjacent to an atrioventricular valve of the patient (Figure 1D); and
after maneuvering the valve cover to the position within or adjacent to the atrioventricular valve of the patient, deploying the prosthetic heart valve into the atrioventricular valve (Figure 1E and Figure 1F).
Regarding claim 18, Hariton et al. ‘6461 teaches wherein the prosthetic heart valve is a prosthetic mitral valve ([0203], [0217]), and the method further comprises:
advancing the delivery catheter through the right atrium and across an atrial septum (7) while the nosecone has the first length (compare Figure 1A to Figure 1B; further, see [0204], [0218], [0222], [0235]); and
wherein withdrawing the volume of inflation medium from the nosecone is not performed until the delivery catheter crosses the atrial septum ([0204], [0218], [0222], [0235]).
Regarding claim 19, paragraph [0203] of Hariton et al. ‘6461 teaches “For some applications, and as shown, implant 20 is a prosthetic heart valve (e.g., a prosthetic mitral valve). However, implant 20 may alternatively be a different type of implant”. Based on this teaching, and looking at Figures 1A-1C, the prosthetic heart valve of Hariton et al. ‘6461 is a prosthetic tricuspid valve, and the volume of inflation medium is withdrawn from the nosecone upon or immediately after the delivery catheter enters the right atrium ([0204], [0218], [0222], [0235]).
Regarding claim 21, Hariton et al. ‘6461 does not teach utilizing “an introducer catheter that has previously been introduced into the femoral vein”. Therefore, Hariton et al. ‘6461 teaches wherein introducing the delivery catheter into the femoral vein is performed without passing the delivery catheter through an introducer catheter that has previously been introduced into the femoral vein.
Regarding claim 25, Hariton et al. ‘6461 teaches wherein withdrawing the volume of inflation medium from the nosecone includes withdrawing the volume of inflation medium through at least one lumen defined by a nosecone adapter (Figure 1B – adapter 116 includes a lumen) that is coupled to the nosecone.
Allowable Subject Matter
9. Claims 20, 22-24, and 26-36 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
10. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Becerra et al. (US PG Pub No. 2024/0245511 A1) – Figures 4A and 4B, Figures 6A and 6B, and Figures 12A and 12B
Bowe (US PG Pub No. 2012/0277845 A1)- Figures 2, 10, 11, 21, and 22
Quill (US PG Pub No. 2018/0289478 A1) – Figures 5, 6, 13, and 14
Mas (US PG Pub No. 2009/0264859 A1) - Figures 4A and 4B, and Figures 9A and 9B
Manash et al. (US PG Pub No. 2020/0253731 A1) – Figures 34, 36A, 36B, and 37
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Javier G. Blanco whose telephone number is (571)272-4747. The examiner can normally be reached on M- F (10am-7:30pm).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE Jerrah C. Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAVIER G BLANCO/ Primary Examiner, Art Unit 3774
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