Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
The amendments to claim 15 have overcome the previously presented non-statutory double patenting rejections.
Applicant's arguments filed 9/9/2026 with respect to the amendments to claims 1, 5, and 15 distinguishing the claimed invention from the prior art of Chau have been fully considered but they are not persuasive. Applicant asserts generally that Chau fails to disclose the additional features now recited in claims 1, 5, and 15. However, the examiner respectfully disagrees. Chau discloses an upstream anchoring feature (124/424; figs. 8, 23, 33) extending from an upstream portion of the frame (102) and configured to extend radially outward when the replacement heart valve is in a radially expanded state. Chau also discloses deploying the downstream portion of the frame from the delivery device such that the tips of the plurality of downstream anchors engage tissue on a ventricular side of the native heart valve, as clearly illustrated in fig. 33 (see esp. tips 462 in fig. 33). Chau discloses further deploying the replacement heart valve from the delivery device to expand the upstream portion of the frame to an expanded configuration which causes the upstream anchoring feature to engage tissue on an atrial side of the native heart valve (see figs. 63-70, noting direction of retraction of sheath results in downstream portion of frame and downstream anchors being released and expanded prior to the upstream anchoring feature). See the rejections below for a more detailed discussion of the prior art of Chau. Applicant’s amendment to claims 13 and 20 necessitated the new interpretation of Chau with respect to the claimed skirt.
The amendments to claims 11 and 19 have overcome the previously presented rejection of claims 11 and 19. Claims 11 and 19 would be allowable if rewritten independent form including all of the limitations of the base claim and any intervening claims.
Claim Objections
Claims 5 and 20 are objected to because of the following informalities:
Claim 5: in line 10, “the radially-expanded state” should read “a radially-expanded state” as this is its first recitation in the claim.
Claim 20: in line 2, “the downstream end” should read “a downstream end” as this is its first recitation in the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 5-10, 13-18, and 20 is/are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Chau et al. (US 2011/0137397).
Regarding claims 5 and 15, Chau discloses a method of delivering a replacement heart valve to a native heart valve and securing the replacement heart valve relative to the native heart valve, the native heart valve supporting native valve leaflets, the method comprising: delivering a self-expandable replacement heart valve (100) mounted on a delivery device (2100; figs. 63-67) to the native heart valve while the replacement heart valve is in a radially-compacted state, the replacement heart valve comprising a radially expandable frame (102) and a plurality of downstream anchors (126) extending from a downstream portion of the frame, an upstream anchoring feature extending from an upstream portion of the frame, the upstream anchoring feature (124; figs. 8-10) configured to extend radially outward when the replacement heart valve is in the radially expanded state, wherein the plurality of downstream anchors are configured to extend radially outward from the frame when the replacement heart valve is in the radially-expanded state (fig. 9, 23, 33, 34); positioning the delivery device at a location within the native heart valve such that, upon deployment from the delivery device, at least a transition portion of the frame between the downstream portion and an upstream portion (e.g., 140) of the frame will engage the native valve leaflets of the native heart valve (figs. 23, 66-68); releasing at least the downstream portion of the frame from the delivery device to cause at least the downstream portion of the frame to transition towards an expanded configuration to thereby expand the plurality of downstream anchors radially outwardly and between at least some chordae tendineae (figs. 63-67; [0151]-[0153]; [0085]); moving the delivery device to cause the plurality of downstream anchors of the replacement heart valve to cause the chordae tendineae to stretch or tighten ([0087]: anchors are tensioning members that pull the leaflets toward the left atrium and pull, via the chordae, the papillary muscles; note also that movement of delivery device to expand anchors and frame stretches chordae tendineae radially outward as compared to initial position; figs. 67, 68 versus figs. 69, 70), and further releasing the replacement heart valve from the delivery device to expand the upstream portion of the frame to an expanded configuration wherein further releasing the replacement valve causes the anchoring feature to engage tissue on an trial side of the native heart valve (see fig. 70, noting upstream portion is expanded after downstream portion due to direction of sheath retraction). Further regarding claim 15, Chau discloses positioning the replacement valve so that at least a portion of the plurality of downstream anchors are on a ventricular side of the native valve leaflets beyond a location where chordae tendineae connect to free ends of the native leaflets (fig. 67), engaging at least the portion of the plurality of downstream anchors with tissue on the ventricular side of the native heart valve annulus (figs. 33, 34). Chau also discloses that the radially expandable frame may include locking tabs (1508; fig. 47a-d and [0125]); tabs 1508 are considered “locking” tabs they facilitate locking of anchors 1540 to the main body (1502) of the frame).
Regarding claim 6, moving the delivery device comprises moving the delivery device proximally ([0153]).
Regarding claims 7 and 17, the radially-expandable frame and the plurality of downstream anchors are configured to cooperate to capture the native valve leaflets (see fig. 33 and 34).
Regarding claims 8-10 and 16, at least some of the plurality of downstream anchors comprise a first bend, a second bend, and an enlarged tip (see embodiment of anchor in fig. 48b).
Regarding claims 13 and 20, the replacement heart valve further comprises a skirt (e.g., the covering material 164 wrapped around wires 150 forming downstream anchors) that extends distally beyond the prosthetic leaflets supported within the frame (noting 164 extends lower than distal end of 106 in figs. 5 and 6, wherein end 112 is the distal, downstream end of the replacement heart valve).
Regarding claim 14, the frame includes a first end (e.g., atrial end), a second end (ventricular end), a first dimension at the first end, and a second dimension at the second end, wherein the first dimension is larger than the second dimension (e.g., radius, which is larger at atrial end than at ventricular end; fig. 9, 23, 24).
Regarding claim 18, moving the delivery device comprises moving the delivery device proximally ([0153]).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-3 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chau et al. (US 2011/0137397).
Regarding claim 1, Chau discloses a method of delivering a replacement heart valve to a native heart valve and securing the replacement heart valve relative to the native heart valve, the native heart valve supporting native valve leaflets, the method comprising: delivering a self-expandable replacement heart valve (100) mounted on a delivery device (2100; figs. 63-67) to the native heart valve while the replacement heart valve is in a radially-compacted state, the replacement heart valve comprising a radially expandable frame (102) and a plurality of downstream anchors (126) extending from a downstream portion of the frame, and an upstream anchoring feature (124) extending from an upstream portion of the frame, the upstream anchoring feature configured to extend radially outward when the replacement heart valve is in a radially-expanded state, wherein the plurality of downstream anchors are spaced apart circumferentially around the downstream portion of the frame (figs. 8, 9), and wherein the plurality of downstream anchors are configured to extend radially outward from the frame when the replacement heart valve is in a radially-expanded state (fig. 9, 23, 33, 34); positioning the delivery device at a location within the native heart valve such that, upon deployment from the delivery device, at least a transition portion of the frame between the downstream portion and the upstream portion of the frame will engage the native valve leaflets of the native heart valve (figs. 23, 66-68); deploying at least the downstream portion of the frame from the delivery device to cause at least the downstream portion of the frame to transition to an expanded configuration to thereby expand the plurality of downstream anchors radially outwardly and between at least some chordae tendineae (figs. 63-67; [0151]-[0153]; [0085]) such that tips of the plurality of downstream anchors engage tissue on a ventricular side of the native heart valve (see tips 462 in fig. 33 and par. [0111]; note also fig. 23); moving the delivery device to cause the plurality of downstream anchors of the replacement heart valve to cause the chordae tendineae to stretch or tighten ([0087]: anchors are tensioning members that pull the leaflets toward the left atrium and pull, via the chordae, the papillary muscles; note also that retraction of delivery device to expand anchors and frame stretches chordae tendineae radially outward as compared to their initial position; figs. 67, 68 versus figs. 69, 70), and further deploying the replacement valve from the delivery device to expand the upstream portion of the frame to an expanded configuration, wherein further deploying the replacement valve causes the upstream anchoring feature to engage tissue on an atrial side of the heart valve (see fig. 66/67 and fig. 70, noting upstream portion is expanded after downstream portion due to direction of sheath retraction).
Chau does not expressly disclose that moving the delivery (e.g., retracting the delivery catheter to free the anchors and frame) causes the native valve leaflets to “bunch up”. However, the examiner maintains that such a step would have been considered obvious any time the length of the particular patient’s leaflets exceeds the height between the outer rim (140) and the lowermost portion (168) of the ventricular anchors (“H1” in fig. 24 of Chau, which may be about 10mm to about 40 mm; [0109]) in order allow the outer rim (140) of the frame to rest against the annulus as desired by Chau (see abstract and figs. 23, 33 and 34) while the anchors extend around the free ends of the leaflets, thereby capturing the leaflets between the frame and the ventricular anchors (126). In other words, the leaflets will bunch up in the length direction in order to fit between the outer rim (140) and the lowermost point 168 of the ventricular anchors, noting that the posterior leaflet of the mitral valve of a human is normally 11-14mm long while the anterior leaflet is normally 18-24mm long, and patients with hypertrophic cardiomyopathy have increased mitral valve leaflet lengths.
Regarding claim 2, moving the delivery device comprises moving the delivery device proximally ([0153]).
Regarding claim 3, at least some of the plurality of downstream anchors comprise at least one of a first bend, a second bend, and an enlarged tip (see embodiment of anchor in fig. 48b).
Claims 4 and 12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chau in view of Hacohen et al. (US 2012/0022639). Chau discloses the invention substantially as stated above with respect to claims 1 and 5 except for the frame further comprising tabs configured to couple the replacement heart valve to the delivery device, though it is noted that Chau discloses that the atrial end of the frame may comprise “features (not shown), such as mechanical locking features” for releasably attaching the prosthetic valve to the pusher shaft (2106) of the delivery device ([0153]).
Hacohen discloses another prosthetic heart valve comprising an expandable frame (80) having anchors (84) extending from a downstream portion of the frame of the prosthetic valve. Hacohen further discloses tabs (81; figs. 2j,3c) configured to couple the replacement heart valve to the delivery device (70) ([0241]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Chau to include tabs as taught by Hacohen in order to further facilitating coupling of the frame to the delivery device, thereby protecting against accidental or premature released of prosthetic heart valve from the delivery device.
Allowable Subject Matter
Claims 11 and 19 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KSH 10/6/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
