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 .
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 02/28/2025 are being considered by the examiner.
Priority
The priority of this application is back to 11/23/2021 (PRO 63/282662)
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 9 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 9 again: “anchored … by only the anchoring protrusions.” The specification does disclose embodiments with:
anchor arms engaging tissue internally,
other embodiments with additional anchor structures,
sealing skirts,
second sets of anchor arms.
If claim 9 is intended to exclude all other anchoring mechanisms, it is unclear whether the specification clearly supports that exclusive limitation. “only” can create uncertainty:
Does it exclude all contribution from frame friction?
Does it exclude sealing skirt contact?
Does it exclude leaflet capture by other structures?
Does it mean only the anchoring protrusions provide the anchoring force, even if other structures contact tissue?
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for anchor arms engaging tissue internally, other embodiments with additional anchor structures, sealing skirts, and second sets of anchor arms, does not reasonably provide enablement for “anchored … by only the anchoring protrusions” as claimed in claim 9. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims. Examiner suggests applicant to revise claim 9 to avoid “only.”
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lamphere (8,070,802).
Lamphere teaches:
“A prosthetic valve” - Lamphere discloses valve prosthesis 102 / 2200. See Abstract; para. (17); para. (73).
“a plurality of prosthetic valve leaflets” - Lamphere discloses leaflet membranes 108 / 2204 mounted with respect to the resilient ring. See paras. (23)-(24), (73), (77).
“an expandable valve frame for supporting the plurality of prosthetic valve leaflets” - Lamphere discloses resilient ring 106 / 2202 supporting the leaflet membranes and being compressible/collapsible for catheter delivery and expandable upon deployment. See paras. (21)-(22), (40), (42), (73), (83).
“a plurality of elongate anchor arms/position elements extending from an outlet end portion of the valve frame” -Lamphere discloses a plurality of elongate anchor arms/position elements 120 / 2100 movably mounted with respect to the resilient ring and extending from the prosthesis frame/ring region. See paras. (17), (22), (31), (61), (73), (76).
“each elongate anchor arm having a first end portion coupled to the valve frame” - Lamphere discloses anchor arms/position elements 120 / 2100 attached to corresponding legs 116 / 2212, which are movably mounted with respect to the resilient ring 106 / 2202 via mounting elements. See paras. (22), (29), (31), (75)-(76), (80)-(81).
“each elongate anchor arm extending distally in an undeployed configuration and adapted to extend proximally in a deployed configuration” - Lamphere discloses the anchor arms/position elements are adapted to substantially completely invert by rotating relative to the resilient ring between a first position for facilitating positioning within a delivery catheter and a second position for engaging tissue. See Summary para. (20); claim 7 of Lamphere. Further, Lamphere discloses that in the inverted orientation within the catheter the tissue-engaging regions are directed inwardly toward the delivery tube, and upon deployment the anchor arms/position elements overturn/rotate outwardly and downwardly into tissue-engaging positions. See paras. (40), (42), (43), (86)-(88), FIGS. 3A-3B, 4C-4I, 26A-26G.
“anchoring protrusions positioned along a surface of at least one of the elongate anchor arms/position elements” - Lamphere discloses the intermediate region 2106 of positioning element 2100 includes an outward-facing side or surface 2148 defining a plurality of outwardly and downwardly extending barbs 2150 terminating in points 2152. See para. (70).
“such that the anchoring protrusions face in a radially inward direction when the respective elongate anchor arm is in the undeployed configuration” - Lamphere discloses that, in the inverted orientation for catheter delivery, the anchor arms/position elements are directed inwardly toward the delivery tube. See para. (40). Lamphere further teaches the anchor arms/position elements invert/rotate between the catheter position and the tissue-engaging position. See Summary para. (20); paras. (40), (43), (86).
“and face in a radially outward direction when the respective elongate anchor arm is in the deployed configuration” - Lamphere discloses that upon exiting the catheter, the anchor arms/position elements overturn/rotate outwardly and downwardly and their outer surfaces face generally outward again, with the barbed portions extending generally outwardly and/or upwardly. See paras. (42), (86).
“wherein the anchoring protrusions are positioned to engage tissue of a native heart valve” -Lamphere discloses that the barbs 2150 and hooked regions 2114 / 2134 are used to pierce, connect with, anchor with, and/or become lodged within tissue of the annulus and valve leaflets. See paras. (70), (88).
Claim 2: Lamphere teaches hooks/barbs, including barb portions 2114, 2134 and intermediate barbs 2150. See paras. (61)-(70).
Claim 3: Lamphere teaches the anchor arms/position elements are inverted/rotated for delivery and then assume a bent/overturned deployed configuration. See paras. (40), (42), (86).
Claim 4: Lamphere teaches hook structures 2108 and 2130 having bend portions and barb portions, i.e., hook shapes. See paras. (62), (66).
Claim 5: Lamphere discloses the anchor arms/position elements extend around the periphery of the valve prosthesis and define an outward tissue-engaging region around the ring/frame. See FIGS. 22-25, 26A-26G.
Claim 6: Lamphere teaches a plurality of separate anchor arms/position elements circumferentially spaced around the ring. See paras. (23), (31), (73), (75).
Claim 7: Lamphere teaches a skirt 110 / 2206 mounted with respect to the ring and extending around the prosthesis. See paras. (24), (25), (78)-(79).
Claim 8: Lamphere teaches distal tissue engaging regions configured to hook and anchor into leaflet tissue. See paras. (61)-(65), (88).
Claim 9: Lamphere teaches anchoring of the prosthesis by the tissue-piercing elements engaging annulus/leaflet tissue. See paras. (35)-(37), (88).
Claim 10: Lamphere teaches multiple protrusions along a positioning element, including plural barbs 2150 on surface 2148. See para. (70); FIG. 21.
Claim 11: Lamphere teaches the resilient ring is collapsible for catheter delivery and self-expands/returns to its non-deformed shape upon deployment. See paras. (40), (42), (73), (83).
Claim 12: Lamphere teaches a resilient ring defining a circular or elliptical peripheral geometry. See Summary para. (21); claim 10 of Lamphere.
Claim 13: Lamphere expressly concerns a mitral valve prosthesis. See Abstract; Summary para. (16); para. (39).
Claim 14: Lamphere further teaches a system for implantation of the prosthetic valve including a delivery apparatus. Specifically, Lamphere discloses: a prosthetic valve as discussed above; a delivery structure / delivery catheter for delivering the prosthetic valve to the native heart valve; an elongate delivery tube / catheter; the valve prosthesis retained in a compressed/inverted state within the catheter; the catheter/sheath retracting or the prosthesis being advanced out of the catheter to permit deployment and inversion/rotation of the anchor arms/position elements 2100. See paras. (32)-(37), (40)-(45), (41)-(43), (84)-(88), and FIGS. 3A-3B, 4A-4I, 26A-26G. Lamphere teaches:
“a delivery apparatus … including an elongate shaft” delivery tube 202 and delivery catheter 400 / catheter 302.
“having a capsule for retaining the prosthetic valve in the undeployed configuration within an implant retention area” - Lamphere teaches the prosthesis is contained within lumen 300 of catheter 302 and positioned within delivery catheter 400 for delivery in the collapsed/inverted state. See paras. (40)-(41).
“the capsule adapted to retract relative to the prosthetic valve to allow the plurality of elongate anchor arms/position elements to move from the undeployed configuration to the deployed configuration” - Lamphere teaches the prosthesis is advanced outward of the catheter and, upon exiting the distal end, the anchor arms/position elements rotate/invert into their deployed tissue-engaging state. See paras. (41)-(45), (86)-(88).
Claim 15: Lamphere teaches the anchor arms/position elements are bent/overturned between delivery and deployed states. See paras. (40), (42), (86).
Claim 16: Lamphere teaches each positioning element rotates/inverts relative to the ring between positions. See Summary para. (20); claim 7 of Lamphere; paras. (40), (42), (43), (86).
Claim 17, Lamphere teaches: (See, e.g., paras. (20), (40), (42), (61)-(70), (73)-(88), FIGS. 21-26G)
a prosthetic valve (2200);
a plurality of leaflet membranes (2204);
an expandable resilient ring/frame (2202);
a plurality of elongate anchor arms/position elements corresponding to the claimed elongate anchor arms/position elements (2100);
Each elongate anchor arm (2100) having a first end portion coupled to the valve frame (2202) and a second end portion positioned radially outwardly from the ring in the deployed configuration (Paras. (42), (86)-(88), FIGS. 26E-26G);
each positioning element extending in a delivery orientation in the undeployed configuration and rotating/inverting into a deployed tissue-engaging orientation (Para. (40), FIGS. 3A-3B, 19);
protrusions/hooks/barbs 2114 / 2134 /2150 positioned along a surface of the anchor arms/position elements;
protrusions that are directed inwardly in the delivery/inverted state and outwardly in the deployed state (Para. 40);
protrusions positioned to engage native heart valve tissue (Fig. 26G).
Claim 18: Lamphere teaches hook structures with bend portions and rotational inversion of the anchor arms/position elements. See paras. (62), (66), (86).
Claim 19: Lamphere teaches bend portions 2112 and 2132 in the hook structures. See paras. (62), (66).
Claim 20: Lamphere teaches a plurality of anchor arms/position elements circumferentially spaced about the ring. See paras. (23), (31), (73), (75).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAN-UYEN THI HO whose telephone number is (571)272-4696. The examiner can normally be reached Normal Schedule M-F Between 7:00 am and 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, TAN-UYEN T HO can be reached at 7034745263. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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