Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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) 5-11 and 13-20 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 anchors (126) extending from a downstream portion of the frame, wherein the plurality of anchors are configured to extend radially outward from the frame when the frame 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 an upstream portion (e.g., 140) of the frame will engage the native valve leaflets of the native heart valve (figs. 23, 66-68); deploying (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 to the radially-expanded state to thereby expand the plurality of 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 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). Further regarding claim 15, Chau discloses positioning the replacement valve so that at least a portion of the plurality of 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 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 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 anchors comprise a first bend, a second bend, and an enlarged tip (see embodiment of anchor in fig. 48b).
Regarding claims 11 and 19, the method further comprising fully releasing the replacement heart valve from the delivery device to cause a proximal portion of the frame to transition to the radially- expanded state ([0155]).
Regarding claims 13 and 20, the replacement heart valve further comprises a skirt (e.g., 142; fig. 5).
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, Chau discloses moving the delivery device to cause the anchors (126) to cause the chordae tendineae to stretch or tighten to facilitate capture of the replacement heart valve ([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).
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 anchors (126) extending from a downstream portion of the frame, wherein the plurality of anchors are spaced apart circumferentially around the downstream portion of the frame (figs. 8, 9), and wherein the plurality of anchors are configured to extend radially outward from the frame when the frame 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 an 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 the radially- expanded state to thereby expand the plurality of 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 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).
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 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 15-16, 19, and 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,949,827 in view of Hacohen et al. (US 2012/0022639). Claim 1 of ‘827 claims the invention of instant claim 15 except for the frame including locking tabs. 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 invention of claim 1 of ‘827 to include locking 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. Regarding claim 19, the second plurality of anchors extending from the frame that engages tissue on an atrial side of the native mitral valve annulus as recited in claim 1 of ‘827 is considered the claimed “proximal portion” of instant claim 19 and it would have been obvious to fully release the replacement heart valve from the delivery device in order to allow the delivery device to be removed from the body while the replacement heart valve remains implanted therein.
Regarding claim 16, Hacohen teaches that the anchors (84) comprise an enlarged tip (see annular tip, best shown in fig. 2K) and such a modification to the invention of claim 1 of ‘827 would have been obvious in order to provide increased contact area between the tips of the anchors and the native tissue, and to ensure that the tip has a rounded, atraumatic shape.
Regarding claim 20, Hacohen further teaches a skirt covering the frame (not illustrated, but described in [0238]) and such a modification to the device of claim 1 of ‘827 would have been considered obvious in order to facilitate a better seal between the frame and the native tissue as is known in the art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Maron et al. Mitral Valve Abnormalities Identified by Cardiovascular Magnetic Resonance Represent a Primary Phenotypic Expression of Hypertrophic Cardiomyopathy. Circulation. 2011; 124 40-47: discloses the typical lengths of posterior and anterior mitral valve leaflets in control subjects and in subjects with HCM.
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KSH 6/8/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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