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 .
Response to Arguments
Applicant’s response/arguments dated 6/2/26 with respect to the claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Election/Restrictions
3. Newly submitted claims 32-37 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claims 32-37 are directed towards methods of implantation.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 32-37 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 102
4. 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.
5. Claim(s) 18-20, 23-24, 26, 28-31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weston et al. 2014/0330372.
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Regarding claim 18, 23-24, 26, 28-30, 31, Weston discloses an implantable prosthetic valve comprising: an annular frame (24) having an inflow end (at 41) and an outflow end (at 43); a leaflet structure (replacement 22 having leaflets 33) positioned within the frame (24); an annular skirt (66) mounted on the frame (Figs. 11-14); and a plurality of discrete radiopaque markings (60, 61, 63, 65) positioned at a plurality of circumferentially spaced locations on the skirt (Figs. 11-14), wherein the radiopaque markings (60, 61, 63, 65) are positioned to indicate an orientation of the prosthetic valve relative to a native heart valve under fluoroscopy ([0093-0099], [0102]).
Regarding claims 19, 23-24, Weston discloses the radiopaque markings comprise radiopaque sutures ([0099], [0102]). It is inherent that that the material extends along the length of the suture.
Regarding claim 20, Weston discloses the radiopaque markings comprise radiopaque dye ([0099], [0102]).
Regarding claim 26, see [0073]. Regarding claims 28-31, see fig. 11. Regarding claim 30, see [0072].
Claim Rejections - 35 USC § 103
6. 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.
7. Claim(s) 25 is rejected under 35 U.S.C. 103 as being unpatentable over Weston et al. in view of Pintor et al. 2010/0331972.
Weston et al. has been disclosed supra however does not specify that the annular skirt is an inner skirt disposed on the inside of the frame. Pintor et al. teaches a prosthetic valve with a stent frame that utilizes a fabric skirt (218) which may be placed on the inside of the stent (see 0148]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention of Weston et al. and provide a skirt on the inside of the frame in order to help prevent paravalvular leaks.
Allowable Subject Matter
8. Claims 21-22, 27 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
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Suzette Gherbi whose telephone number is (571)272-
4751. The examiner can normally be reached on Monday-Friday 7:00am-3:00pm. 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:/Avww.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Melanie Tyson can be reached on 571-272-9062. 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:/Awww.uspto.gov/patents/apply/patent- center for more information about Patent Center and https:/Awww.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197.
/SUZETTE J GHERBI/Primary Examiner, Art Unit 3774 June 12, 2026
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