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 .
Claim Objections
Claim 7 is objected to because of the following informalities: In line 2, “a raised lip, first end” is assumed to be a typo. The examiner suggests amending this to be “a raised lip, and the first end” and has been examined as such. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: In line 2, “fixation elements, the everted brim” is assumed to be a typo. The examiner suggests amending this to be “fixation elements, and the everted brim” and has been examined as such. Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5, 8, 10, 12-15, 17-18, 20-22, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Duffy et al. (US PG Pub No. 2018/0256326 A1) in view of Vidlund et al (US PG Pub No. 2022/0000617 A1).
Regarding claim 1, Duffy discloses a prosthesis delivery system (Figs. 12-21, delivery system 1220) comprising: a tubular capsule (Figs. 12-21, capsule segment 1229); and a prosthesis (Figs. 3A and 13-21, prosthesis 101) having a brim (Fig. 3A, brim 112), the brim having a first end (Fig. 3B, inflow portion 118), wherein the prosthesis delivery system (1220) has a delivery configuration (Paragraphs [0070, 0072, 0075, and 0079], Figs. 12-15 and 18) where a portion of the prosthesis (101) is disposed in the capsule (1229) and at least a portion of the brim (Figs. 13-15, 112) is outside the capsule (Figs. 13-15). Duffy fails to disclose wherein the brim is everted to extend toward the capsule prior to deployment of the prosthesis from the capsule.
Vidlund also discloses a prosthesis delivery system (Figs. 33-34, delivery system 505), a tubular capsule (Figs. 33-34, inner sheath 508), a prosthesis (Figs. 33-34, prosthetic heart valve 500), a brim (Figs. 33-34, outer frame 520), a first end of the brim (Figs. 33-34, 520 at loops 562), and a support structure (Figs. 33-34, inner frame 550). Vidlund teaches wherein the brim (Figs. 33-34, outer frame 520) is everted (Figs. 33-34) to extend toward the capsule (508) prior to deployment (Paragraph [0159]) of the prosthesis (500) from the capsule (508). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified wherein the brim is everted to extend toward the capsule prior to deployment of the prosthesis from the capsule, as taught by Vidlund, in order to compress and reposition the valve before deployment in the heart (Paragraph [0158]).
Regarding claim 2, Duffy as modified by Vidlund discloses wherein the tubular capsule (1229) has a closed end (Fig. 13, distal tip 1234) and an open end (see annotated Fig. 13 below).
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Regarding claim 3, Duffy as modified by Vidlund discloses wherein the first end (Fig. 3B, inflow portion 118) of the brim (112) is releasably coupled (Paragraph [0074], Figs. 13-15, suture 1252) to the capsule (1229).
Regarding claim 4, Duffy as modified by Vidlund discloses wherein the prosthesis delivery system (1220) has a partially deployed configuration (Fig. 20) where the brim (112, 118) has been released from the capsule (1229).
Regarding claim 5, Duffy as modified by Vidlund further discloses wherein the brim (Figs. 33-34, outer frame 520) is configured to move toward a reverted position when released (Paragraph [0160]).
Regarding claim 8, Duffy as modified by Vidlund discloses wherein the brim (112) is releasably coupled to the capsule (1229) with sutures (Paragraph [0074], Figs. 13-15, suture 1252).
Regarding claim 10, Duffy as modified by Vidlund discloses wherein the prosthesis (101) is a self-expanding heart valve prosthesis (Paragraph [0065]) configured to expand from a compressed configuration (Fig. 18) toward an expanded configuration (Fig. 21).
Regarding claim 12, Duffy as modified by Vidlund discloses wherein the tubular capsule has a closed end (Fig. 13, distal tip 1234) and an open end (see annotated Fig. 13 above) and further including a piston (Fig. 12B, piston 1272) positioned within the capsule (Fig. 12b, 1229).
Regarding claim 13, Duffy as modified by Vidlund discloses wherein said closed end (1234) and said piston (1272) form at least in part a chamber (Fig. 12B, cavity 1274).
Regarding claim 14, Duffy as modified by Vidlund discloses further including a fluid source coupled (Paragraphs [0071 and 0072], Fig. 12A, lumen 1227) to said chamber (1274).
Regarding claim 15, Duffy as modified by Vidlund discloses wherein said prosthesis includes a frame (Fig. 3B, anchoring member 108), said frame being coupled (Paragraph [0045]) to said brim (112) and said brim extends from said frame (Fig. 3B).
Regarding claim 17, Duffy as modified by Vidlund discloses wherein at least a portion of said frame (108) extends out (see annotated Fig. 18 below) from the capsule (1229).
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Regarding claim 18, Duffy as modified by Vidlund discloses wherein said brim (Fig. 13, first end of brim: inflow portion 118) and said capsule (1229) collectively entirely cover (Fig. 13) said frame (108).
Regarding claim 20, Duffy as modified by Vidlund discloses wherein the capsule (1229) is configured to distally advance to unsheathe the prosthesis (Paragraphs [0072 and 0073], Figs. 18-21).
Regarding claim 21, Duffy discloses a method of delivering a prosthesis (Paragraphs [0006 and 0078], Figs. 18-21), the method comprising: providing a system (Figs. 12-21, delivery system 1220) in a delivery configuration (Paragraphs [0070, 0072, 0075, and 0079], Figs. 12-15 and 18); the system including: a delivery system (1220) having a tubular capsule (Figs. 12-21, capsule segment 1229); and a prosthesis (Figs. 3A and 12-21, prosthesis 101) loaded partially (Paragraphs [0070 and 0079]) within the tubular capsule (1229) in a delivery configuration (Paragraphs [0070, 0072, 0075, and 0079], Figs. 12-15 and 18), the prosthesis (101) including: an anchoring member (Figs. 3A-3B, anchoring member 108), a brim (Fig. 3A, brim 112) connected to the anchoring member (Paragraph [0045], inflow end 107); wherein, in the delivery configuration (Paragraphs [0070, 0072, 0075, and 0079], Figs. 12-15 and 18), the prosthesis (101) is at least partially disposed (Paragraphs [0070 and 0079]) within the capsule (1229) and at least a portion of the brim (112) is outside of the capsule (Figs. 13-15) and directing the capsule (1229) to a target site (Paragraph [0080]) in the delivery configuration (Paragraphs [0070, 0072, 0075, and 0079], Figs. 12-15 and 18); and distally advancing (Paragraphs [0072 and 0073], Figs. 18-21) the capsule (1229). Duffy fails to disclose wherein the brim is everted to extend toward the capsule prior to deployment of the prosthesis from the capsule and allowing the brim to at least partially revert.
Vidlund also discloses a prosthesis delivery system (Figs. 33-34, delivery system 505), a tubular capsule (Figs. 33-34, inner sheath 508), a prosthesis (Figs. 33-34, prosthetic heart valve 500), a brim (Figs. 33-34, outer frame 520), a first end of the brim (Figs. 33-34, 520 at loops 562), and a support structure (Figs. 33-34, inner frame 550). Vidlund teaches wherein the brim (Figs. 33-34, outer frame 520) is everted (Figs. 33-34) to extend toward the capsule (508) prior to deployment (Paragraph [0159]) of the prosthesis (500) from the capsule (508) and allowing the brim to at least partially revert (Paragraph [0160]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified wherein the brim is everted to extend toward the capsule prior to deployment of the prosthesis from the capsule and allowing the brim to at least partially revert, as taught by Vidlund, in order to compress and reposition the valve before deployment in the heart (Paragraph [0158]).
Regarding claim 22, Duffy as modified by Vidlund discloses wherein the target site (Paragraph [0080]) is a heart valve (Paragraph [0080]).
Regarding claim 29, Duffy discloses a method of loading (Paragraph [0075]) a prosthesis (Figs. 3A and 12-21, prosthesis 101) into a delivery capsule (Figs. 7-11, capsule segment 529) comprising: positioning a prosthesis (Paragraph [0057], Figs. 8-11), having a support structure (Figs. 3A-3B, anchoring member 108) and a brim (Figs. 3A-3B, brim 112) extending from the support structure (Figs. 3A-3B), into a tubular capsule (529) such that a portion (Paragraph [0057], “Capsule segment 529 is of a relatively short length, covering only the first or inflow portion 118 of heart valve prosthesis 101 which includes brim 112, and does not cover the second or outflow portion 116 of heart valve prosthesis 101 which includes anchoring member 108”) of the support structure (Figs. 7-9) extends from the capsule (529). Duffy fails to disclose everting the brim such that the brim and the tubular capsule cover the support structure.
Vidlund also discloses a prosthesis delivery system (Figs. 33-34, delivery system 505), a tubular capsule (Figs. 33-34, inner sheath 508), a prosthesis (Figs. 33-34, prosthetic heart valve 500), a brim (Figs. 33-34, outer frame 520), a first end of the brim (Figs. 33-34, 520 at loops 562), and a support structure (Figs. 33-34, inner frame 550). Vidlund teaches everting the brim (Figs. 33-34, outer frame 520) such that the brim (520) and the tubular capsule (508) cover the support structure (Figs. 33-34, inner frame 550). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified brim by everting the brim such that the brim and the tubular capsule cover the support structure, as taught by Vidlund, in order to restrict expansion of the support structure until deployment (Paragraph [0145]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Duffy et al. (US PG Pub No. 2018/0256326 A1) in view of Vidlund et al (US PG Pub No. 2022/0000617 A1), as applied to claim 1 above, and further in view of Francis et al (US PG Pub No. 2019/0008636 A1).
Regarding claim 6, Duffy as modified by Vidlund fails to disclose wherein the first end of the brim is tucked inside the capsule. Francis also discloses a prosthesis delivery system (Figs. 8A-8D, prosthetic heart valve device 200 and catheter C), a tubular capsule (Figs. 8A-8D, fixation structure 130), a prosthesis (Figs. 8A-8D, prosthetic heart valve device 200), a brim (Figs. 8A-8D, extension member 270), and a first end of the brim (Figs. 8A-8D, free second terminus 288). Francis teaches wherein the first end (288) of the brim (270) is tucked inside the capsule (Fig. 8A, Catheter C). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Duffy’s as modified by Vidlund prosthesis delivery system wherein the first end of the brim is tucked inside the capsule, as taught by Francis, in order to improve maneuverability of the catheter during deployment (Paragraph [0050]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Duffy et al. (US PG Pub No. 2018/0256326 A1) in view of Vidlund et al (US PG Pub No. 2022/0000617 A1), as applied to claim 1 above, and further in view of Kusleika (US Patent No. 6,866,679 B2).
Regarding claim 7, Duffy as modified by Vidlund discloses wherein the capsule (1229) has an open end (see annotated Fig. 13 below), but fails to disclose wherein the open end has a raised lip, and the first end of the brim being tucked in the raised lip.
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Kusleika also discloses a prosthesis delivery system (Figs. 2-3, stent delivery system 60), a tubular capsule (Figs. 2-3, delivery tube 22), an open end (Figs. 2-3, distal end 42), a brim (Figs. 2-3, everted distal region 46), a first end of the brim (Figs. 2-3, everted stent distal end 47), and a prosthesis (Figs. 2-3, stent 26). Kusleika teaches wherein the open end (42) has a raised lip (see annotated Fig. 2 below), and the first end of the brim (47) being tucked (see annotated Fig. 2 below) in the raised lip (see annotated Fig. 2 below). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Duffy’s as modified by Vidlund prosthesis delivery system wherein the open end has a raised lip, and the first end of the brim being tucked in the raised lip, as taught by Kusleika, in order to firmly capture the stent (Col. 5, lines 63-65).
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Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Duffy et al. (US PG Pub No. 2018/0256326 A1) in view of Vidlund et al (US PG Pub No. 2022/0000617 A1), as applied to claim 1 above, and further in view of Quadri et al (US Patent No. 8,414,644 B2).
Duffy as modified by Vidlund further discloses wherein the prosthesis (101) has a plurality of fixation elements (Fig. 3B, tissue engaging elements 114), but fails to disclose the everted brim covering the plurality of fixation elements.
Quadri also discloses a prosthesis delivery system (Figs. 12A-12F, delivery device 220), a tubular capsule (Figs. 12A-12F), a prosthesis (Figs. 1-2, replacement heart valve 28, Figs. 12-13, valve implant 222), a brim (Fig. 1, brim 102, see annotated Fig. 12E below), and a plurality of fixation elements (Figs. 1-2, anchor 90, Figs. 12A-12E, anchor portions 226). Quadri teaches the everted brim (Fig. 1, brim 102, see annotated Fig. 12E below) covering a plurality of fixation elements (Figs. 1-2, anchor 90, Figs. 12A-12E, anchor portions 226). As seen in Quadri Fig. 1, the everted brim (102) covers the fixation element (90) until it is attached at the eyelet (92, see annotated Fig. 2B below). Therefore, it would have been obvious to one of ordinary skill in the art before effective filing date of the invention to include the everted brim covering the plurality of fixation elements, as taught by Quadri, in the prosthesis delivery system of Duffy as modified by Vidlund, in order to prevent longitudinal expansion and contraction of the valve body with the stent frame (Col. 6, line 42-62).
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Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Morriss et al. (US Patent No. 10,299,917 B2) also discloses a prosthesis delivery system (Fig. 46a, delivery system 10), a tubular capsule (Fig. 46a, delivery catheter 18), a prosthesis (Fig. 13a, device 100), a brim (Fig. 13a, flared upstream portion 112a), and a support structure (Fig. 13a, inner valve support 120).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARI L COCHRAN whose telephone number is (571)272-9637. The examiner can normally be reached Monday-Thursday 7:00-5:00.
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, Melanie Tyson can be reached at 5712729062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.L.C./ Patent Examiner, Art Unit 3774
/MELANIE R TYSON/ Supervisory Patent Examiner, Art Unit 3774
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