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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 04/07/2026 is acknowledged.
Claims 14-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 04/07/2026.
Claim Objections
Claims 1-13 and 19-20 are objected to because of the following informalities:
Claim 1, line 2-3, “a” before “stented prosthetic heart valve” should read “the”.
Claim 19, line 2-3, “a” before “stented prosthetic heart valve” should read “the”.
Appropriate correction is required.
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.
Claim(s) 1-7, 11-13, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2023/0024690 (Cohen).
1. A delivery device (delivery apparatus 12) for percutaneously delivering a stented prosthetic heart valve (prosthetic valve 60), the delivery device comprising:
an inner shaft assembly (shaft 22) including a valve retainer (actuation assembly 32) configured for temporary connection to a stented prosthetic heart valve in a loaded state of the delivery device (FIG. 6A; P0139 and P0141);
an outer shaft assembly (shaft assembly 11) co-axially received over the inner shaft assembly and including a capsule (capsule 16) configured to contain the stented prosthetic heart valve in the loaded state (FIG. 1 and 5A; P0129 and P0147);
a handle assembly (handle 100) coupled to a proximal region of the outer shaft assembly (FIG. 1; P0129); and
an axial force adjustment assembly (force limiting mechanism 634) connecting a proximal section of the inner shaft assembly to the handle assembly, the axial force adjustment assembly configured to selectively move the proximal section relative to the handle assembly (FIG. 22A-23F and 46A-46E; P0158-P0159, P0190, P0200-P0201, and P0335-P0336).
2. The inner shaft assembly defines a longitudinal axis, and further wherein the axial force adjustment assembly is configured to selectively move the proximal section axially along the longitudinal axis (FIG. 22A-23F and 46A-46E; P0158-P0159, P0190, and P0335-P0336).
3. The axial force adjustment assembly is configured to selectively alter an axial force in the inner shaft assembly, the axial force being one of tension and compression (FIG. 22A-23F and 46A-46E; P0158-P0159, P0190, and P0335-P0336).
4. The axial force adjustment assembly includes an actuator member (knob 122) linked to a driver member (plate 650), and further wherein the driver member directly interfaces with the proximal section of the inner shaft assembly, and ever further wherein the axial force adjustment assembly is configured to selectively transfer a force applied to the actuator member onto the proximal section via the driver member (FIG. 11, 17-19, 23A-23B; P0178, P0182, P0184, P0202, and P0204-P0205).
5. The axial force adjustment assembly is further configured to not transfer a force applied to the actuator member onto the proximal section via the driver member when a longitudinal force in the inner shaft assembly exceeds a predetermined level (P0315 and P0391).
6. The actuator member is rotatably connected to the handle assembly, and further wherein the axial force adjustment assembly is configured to translate a rotational force applied to the actuator member into longitudinal movement of the proximal section (FIG. 11, 17-19, 23A-23B; P0178, P0182, P0200-P0201, and P0184).
7. The inner shaft assembly includes a shaft maintaining a threaded surface (tooth 628), and further wherein the driver member defines a complementary threaded surface (teeth 652), the complementary threaded surface in meshed engagement with the threaded surface (FIG. 23A-23C; P0202, P0204-P0205, and P0208).
11. The delivery device has a sensor (load cell 182) configured and arranged to sense a parameter indicative of an axial force in the inner shaft assembly (FIG. 16A-16B; P0177).
12. The sensor is located proximate the valve retainer (FIG. 16A-16B; P0177).
13. The delivery device has an output device (cable 184) carried by the handle assembly and configured to display an axial force reading based upon information signaled by the sensor (FIG. 16A-16B; P0177).
19. A delivery device (delivery apparatus 12) for percutaneously delivering a stented prosthetic heart valve (prosthetic valve 60), the delivery device comprising:
an inner shaft assembly (shaft 22) including a valve retainer (actuation assembly 32) configured for temporary connection to a stented prosthetic heart valve in a loaded state of the delivery device (FIG. 6A; P0139 and P0141);
an outer shaft assembly (shaft assembly 11) co-axially received over the inner shaft assembly and including a capsule (capsule 16) configured to contain the stented prosthetic heart valve in the loaded state (FIG. 1 and 5A; P0129 and P0147);
a handle assembly (handle 100) coupled to a proximal region of the outer shaft assembly (FIG. 1; P0129); and
a sensor (load cell 182) configured and arranged to sense a parameter indicative of an axial force in the inner shaft assembly (FIG. 16A-16B; P0177).
20. The sensor is located proximate the valve retainer (FIG. 16A-16B; P0177).
Allowable Subject Matter
Claims 8-10 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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD J SCHERBEL whose telephone number is (571)270-7085. The examiner can normally be reached Mon - Fri 9:00-6:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
TJ SCHERBEL
Primary Examiner
Art Unit 3771
/TODD J SCHERBEL/Primary Examiner, Art Unit 3771
Prosecution Insights