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 Invention I in the reply filed on 7/2/2026 is acknowledged. Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 7/2/2026.
In a telephone call on 8/24/2026, the Applicant further elected Species A with traverse. The traversal is on the ground(s) that the listed species are not distinct from each other. This is persuasive, and the species aspect of the Requirement for Restriction/Election of 5/6/2026 is withdrawn. The requirement regarding the Invention groups is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 102
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) 1-5 and 8-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alkhatib (Pub. No. US 2022/0287837 A1).
Alkhatib discloses the following regarding claim 1: an implant delivery system for delivering a replacement heart valve implant to a native heart valve, comprising: an elongate shaft assembly (18, 27, elements 110 as shown in Figs. 1A, 2A-2B, 2E-3) including an implant holding portion (23) comprising a proximal sheath (sheath portion near elements 118) and a distal sheath (sheath portion near elements 126); wherein the implant holding portion is configured to constrain a replacement heart valve implant (elements 130) in a radially collapsed configuration (para. 0033); wherein the elongate shaft assembly comprises a plurality of longitudinal marker elements (elements 138) configured to be visible under fluoroscopy with an imaging device (paras. 0035-0036); wherein the plurality of longitudinal marker elements is configured to rotationally align commissure posts of the replacement heart valve implant with native valve commissures of the native heart valve under fluoroscopy with the imaging device when the replacement heart valve implant is shifted to a radially expanded configuration within the native heart valve (paras. 0035-0038, 0047-0048).
Alkhatib discloses the following regarding claim 2: the implant delivery system of claim 1, wherein the plurality of longitudinal marker elements is oriented parallel to a central longitudinal (X) axis of the elongate shaft assembly (Figs. 2A-2B, 2E-3).
Alkhatib discloses the following regarding claim 3: the implant delivery system of claim 1, wherein the plurality of longitudinal marker elements is spaced radially outward from an inner shaft (central portion of elements 110) of the elongate shaft assembly (Figs. 2A-2B, 2E-3).
Alkhatib discloses the following regarding claim 4: the implant delivery system of claim 1, wherein the plurality of longitudinal marker elements is equally spaced apart from each other circumferentially about a central longitudinal axis of the elongate shaft assembly (Figs. 2A-2B, 2E-3; paras. 0036-0038).
Alkhatib discloses the following regarding claim 5: the implant delivery system of claim 1, wherein the elongate shaft assembly includes a stent holder (portion holding the frame of element 130) configured to engage an expandable framework of the replacement heart valve implant in the radially collapsed configuration (Figs. 2A-2B, 2E-3).
Alkhatib discloses the following regarding claim 8: the implant delivery system of claim 1, wherein the elongate shaft assembly includes at least one fluoroscopically transparent component disposed radially outward of the plurality of longitudinal marker elements and radially inward of the distal sheath (paras. 0034-0035).
Alkhatib discloses the following regarding claim 9: the implant delivery system of claim 1, wherein the plurality of longitudinal marker elements is only visible under fluoroscopy (paras. 0034-0035).
Alkhatib discloses the following regarding claim 10: the implant delivery system of claim 1, wherein the plurality of longitudinal marker elements is longitudinally spaced apart from the replacement heart valve implant in the radially collapsed configuration (Figs. 2A-2B, 2E-3).
Alkhatib discloses the following regarding claim 11: the implant delivery system of claim 10, wherein the plurality of longitudinal marker elements is disposed distally of the replacement heart valve implant when the replacement heart valve implant is constrained in the radially collapsed configuration within the implant holding portion (Figs. 2A-2B, 2E-3; paras. 0035-0038).
Alkhatib discloses the following regarding claim 12: an implant delivery system for delivering a replacement heart valve implant to a native heart valve, comprising: an elongate shaft assembly (10, 11) including an outer tubular member (18, elements 118), an inner shaft (27), and an implant holding portion (23) (Figs. 1A, 2A-2B, 2E-3); wherein the implant holding portion is configured to constrain a replacement heart valve implant (elements 130) in a radially collapsed configuration (para. 0033); wherein the elongate shaft assembly comprises: a stent holder (portions of elements 110 holding the frame of elements 130) configured to engage a distal portion of an expandable framework of the replacement heart valve implant when the replacement heart valve implant is constrained within the implant holding portion of the implant delivery system (Figs. 2A-2B, 2E-3); and a plurality of longitudinal marker elements (elements 138) extending distally from a distal end of the stent holder (Figs. 2A-2B, 2E-3), the plurality of longitudinal marker elements being configured to be visible under fluoroscopy with an imaging device (paras. 0035-0036); wherein the plurality of longitudinal marker elements includes a first longitudinal marker element, a second longitudinal marker element, and a third longitudinal marker element equally spaced apart from each other circumferentially around a central longitudinal axis of the elongate shaft assembly (Figs. 2A-2B, 2E-3; paras. 0036-0038); wherein the plurality of longitudinal marker elements is configured to rotationally align commissure posts of the replacement heart valve implant with native valve commissures of the native heart valve under fluoroscopy with the imaging device when the replacement heart valve implant is shifted to a radially expanded configuration within the native heart valve (paras. 0035-0038, 0047-0048).
Alkhatib discloses the following regarding claim 13: the implant delivery system of claim 12, wherein the implant holding portion includes a proximal sheath (sheath portions of elements 114 near elements 118) disposed about the inner shaft of the elongate shaft assembly and a distal sheath (sheath portions of elements 114 near elements 126) disposed about the inner shaft of the elongate shaft assembly (Figs. 2A-2B, 2E-3); wherein the proximal sheath is fixedly attached to the outer tubular member and the distal sheath is fixedly attached to the inner shaft (Figs. 2A-2B, 2E-3).
Alkhatib discloses the following regarding claim 14: the implant delivery system of claim 12, wherein the stent holder is fixedly attached to an intermediate tubular member (elements 114) disposed radially inward of the outer tubular member and radially outward of the inner shaft (Figs. 1A, 2A-2B, 2E-3); wherein the inner shaft and the outer tubular member are each axially translatable relative to the intermediate tubular member independently of each other (paras. 0026-0030).
Claim Rejections - 35 USC § 103
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.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alkhatib in view of Olson et al. (Pub. No.: US 2012/0022633; hereinafter “Olson”).
Alkhatib discloses the limitations of the claimed invention, as described above. However, it does not recite the plurality of longitudinal marker elements comprising a plurality of fingers extending distally from a body of the stent holder. Olson teaches that it is well known in the art that a delivery apparatus comprises a plurality of exactly three fingers extending distally from a body of the stent holder a distal portion (Fig. 5; paras. 0177-0179, 0192-0193), for the purpose of better controlling the expansion and position of the valve. It would have been obvious to one having ordinary skill in the art to modify the delivery apparatus of Alkhatib such that the marker elements comprise three fingers, as taught by Olson, in order to better control the expansion and position of the valve. Such a modification would be made with a reasonable expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANN HU/Primary Examiner, Art Unit 3774
Prosecution Insights