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 . Claims 1-20 are pending examination below.
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)(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.
(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.
Claims 1, 6, 8-11, 16-18, and 20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by WO 2022/2660003 A1 (hereinafter, "Lopez") ].
In regards to claim 1, Lopez teaches a delivery system (Fig. 1, delivery apparatus, 100, para 063, see also Fig. 17-21, system, 700, and system, 800, para 0177-0181)
for delivering a device to a body lumen (Fig. 1, prosthetic heart valve, 102, para 064-065 teaches delivery of prosthetic valves , stents, or grafts),
the delivery system comprising: an inner shaft (Fig. 1, inner shaft, 120, para 065 see also, Fig. 3A/B, shaft, 304, para 0125)
coupled to a distal tip (Fig. 1, nose cone, 122, para 065);
an outer sheath (Fig. 1, distal portion, 124, para 065 and para 076)
slidingly disposed over the inner shaft configured to hold the device in a radially compressed configuration (Fig. 1, distal end portion, 124, para 076, functions as a delivery sheath, in combination with inner shaft, 120, para 065),
the outer sheath having a proximal capsule with a distal end (Fig. 4/5, loading capsule, 316, in combination with distal end portion, 324, para 0129-0130),
and a distal capsule with a proximal end (Fig. 4/5, delivery capsule, 314, see also para 013),
the distal end of the proximal capsule (Fig. 8, delivery capsule 314, para 0125 teaches loading capsule, 316 can surround the delivery capsule when coupled to the coupling, 308)
configured to overlap with the proximal end of the distal capsule (Fig. 8, delivery capsule 314, para 0125 teaches loading capsule, 316 can surround the delivery capsule when coupled to the coupling, 308)
to form an overlap region (Fig. 8, para 0125 );
and a removable sleeve (Fig. 6-8, coupling, 308, para 0125, see also Fig. 12A/B, coupling 308, uncoupled from loading capsule, 316, para 0151)
configured to couple the proximal capsule (Fig. 6-8, delivery capsule, 314, para 0125, see also, Fig. 20/21, delivery capsule, 712, para 0175)
to the distal capsule at the overlap region (Fig. 6-8, para 0123, delivery capsule is arranged in the interior of the loading assembly, 310).
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In regards to claim 6, Lopez further teaches, wherein the removable sleeve (Fig. 6-8, coupling, 308, para 0125, see also Fig. 12A/B, coupling 308, uncoupled from loading capsule, 316, para 0151) includes a plurality of tab protrusions (Fig. 9-11, angled surface, 358, para 0140) for facilitating end user interaction.
In regards to claim 8, Lopez further teaches, wherein the distal end of the proximal capsule (Fig. 3A/B, loading capsule, 316, para 0125)
comprises a proximal overlap collar extending distally (Fig. 8, delivery capsule 314, para 0125 teaches loading capsule, 316 can surround the delivery capsule),
and the proximal end of the distal capsule (Fig. 3A/B, delivery capsules, 314, para 0125)
comprises a distal overlap collar extending proximally (see below annotated Fig. 7, shows overlap within collar),
and the proximal overlap collar (see below, annotated Fig. 7, proximal overlap collar, para 023)
is configured to overlap with the distal overlap collar (see below, annotated Fig. 7, distal overlap collar, para 023)
to form the overlap region (see above, annotated Fig. 3A/B).
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In regards to claim 9, Lopez further teaches, wherein the proximal overlap collar (Fig. 25/26, sleeve, 908, para 0188)
comprises a first thickness (para 0188, teaches the at the thickness of sleeve is thicker is greater at the distal end than at the proximal end),
and the distal overlap collar comprises a second thickness (para 0188, teaches the at the thickness of sleeve is thicker is greater at the distal end than at the proximal end),
such that a profile of the overlap region (see above, annotated Fig. 3B, overlap region, shows closed configuration, para 019)
created by the overlapping of the proximal overlap collar (see above, annotated Fig. 7, proximal overlap collar, para 023)
and the distal overlap collar (see above, annotated Fig. 7, distal overlap collar, para 023)
is no greater than a profile of a body portion (Fig. 7, outer surface, 378, para 0138-0139) of the proximal capsule (Fig. 3A/B, delivery capsule, 314, para 0138, capsule is taught to be flush with the outer surface and )
and/or a body portion of the distal capsule (Fig. 3A and 5, delivery capsule 314 para 0138).
In regards to claim 10, Lopez further teaches, wherein the outer sheath (Fig. 1, distal portion, 124, para 065 and para 076)
is translatable between an open configuration (Fig. 3A, shows open configurations, para 018)
where the proximal capsule (Fig. 3A-B, loading capsule, 316, para 0129-0130) and the distal capsule (Fig. 3A-B, delivery capsule, 314)
are separated from each other (Fig. 3A, para 018), and a closed configuration (Fig. 3B, shows closed configuration)
where the distal end of the proximal capsule and the proximal end of the distal capsule (Fig. 3A-B, delivery capsule, 314)
are connected to each other forming the overlap region (see above, annotated Fig. 3B, overlap region, shows closed configuration, para 019).
In regards to claim 11, Lopez teaches a delivery system (Fig. 1, delivery apparatus, 100, para 063, see also Fig. 17-21, system, 700, and system, 800, para 0177-0181)
for delivering a device to a body lumen (Fig. 1, prosthetic heart valve, 102, para 064-065 teaches delivery of prosthetic valves , stents, or grafts), the delivery system comprising:
an inner shaft (Fig. 1, inner shaft, 120, para 065 see also, Fig. 3A/B, shaft, 304, para 0125) coupled to a distal tip (Fig. 1, nose cone is connect to the distal end portion of the inner shaft, para 065);
and an outer sheath (Fig. 1, distal portion, 124, para 065 and para 076) slidingly disposed over the inner shaft (Fig. 1, outer shaft, 107, and inner shaft, 120, para 064-065),
the outer sheath (Fig. 1, outer shaft, 107 in combination with distal end portion, 124, functions as delivery sheath, para 076)
configured to hold the device in a radially compressed configuration (Fig. 1, distal end portion, 124, functions as delivery sheath, para 076),
the outer sheath having a proximal capsule (Fig. 4/5, loading capsule, 316, para 013) and a distal capsule (Fig. 4/5, delivery capsule, 314, para 013)
with a distal end configured to interlock with the distal tip (Fig. 1, nose cone is connect to the distal end portion of the inner shaft, para 065).
In regards to claim 16, Lopez further teaches, wherein the proximal capsule comprises a distal end (Fig. 4/5, loading capsule, 316, in combination with distal end portion, 324, para 0129-0130),
and the distal capsule comprises a proximal end (see above, annotated Fig. 8, distal capsule proximal end, 314),
wherein the distal end of the proximal capsule is configured to overlap with the proximal end of the distal capsule to form an overlap region (Fig. 8, delivery capsule 314, para 0125 teaches loading capsule, 316 can surround the delivery capsule when coupled to the coupling, 308).
In regards to claim 17, Lopez further teaches, further including a removable sleeve (Fig. 6-8, coupling, 308, para 0125, see also Fig. 12A/B, coupling 308, uncoupled from loading capsule, 316, para 0151)
configured to couple the proximal capsule to the distal capsule (Fig. 8, delivery capsule 314, para 0125 teaches loading capsule, 316 can surround the delivery capsule when coupled to the coupling, 308)
at the overlap region (see below, annotated Fig. 3B, overlap region, para 0125).
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In regards to claim 18, Lopez further teaches, wherein the removable sleeve (Fig. 6-8, coupling, 308, para 0125, see also Fig. 12A/B, coupling 308, uncoupled from loading capsule, 316, para 0151) includes a plurality of tab protrusions (Fig. 9-11, angled surface, 358, para 0140) for facilitating end user interaction.
In regards to claim 20, Lopez further teaches, wherein the outer sheath (Fig. 1, distal portion, 124, para 065 and para 076) is translatable between an open configuration (Fig. 3A, shows open configurations, para 018) where the proximal capsule and the distal capsule are separated from each other (Fig. 3A, para 018), and a closed configuration (Fig. 3B, shows closed configuration) where the distal end of the proximal capsule (Fig. 3A-B, loading capsule, 316, para 0129-0130) and the proximal end of the distal capsule (Fig. 3A-B, delivery capsule, 314) are connected to each other forming the overlap region (see above, annotated Fig. 3B, overlap region, shows closed configuration, para 019).
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 7 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2022/266003 A1 (hereinafter, "Lopez") in view of US 6,464, 685 B1 (hereinafter, "Suzuki").
In regards to claim 7, Lopez further teaches, wherein the removable sleeve (Fig. 6-8, coupling, 308, para 0125, see also Fig. 12A/B, coupling 308, uncoupled from loading capsule, 316, para 0151) includes at least one tab protrusion (Fig. 9-11, angled surface, 358, para 0140) for facilitating end user interaction, with the overlap region (see below, annotated Fig. 3A/B).
However Lopez does not explicitly teach the least one perforation disposed along a length of the removable sleeve for removal of the removable sleeve from the overlap region. Suzuki teaches a removable sleeve (Fig. 1A/B, inner cylinder, 1 in combination with slide cylinder, 2, removed from outer cylinder, 3, col. 3 lines 31-55) with the perforation (Fig. 5, notch, 20, in the outer cylinder, 3, col. 4 lines 20-39) disposed along a length of the removable sleeve for removal of the removable sleeve from the overlap region. Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the sleeve of Lopez in view of the perforation disclosed by Suzuki because doing so would merely involve combining prior art elements according to known methods to yield predictable results; see MPEP 2143.
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In regards to claim 19, Lopez further teaches, wherein the removable sleeve (Fig. 6-8, coupling, 308, para 0125, see also Fig. 12A/B, coupling 308, uncoupled from loading capsule, 316, para 0151) includes at least one tab protrusion (Fig. 4-8, protrusions, 338, para 0132) for facilitating end user interaction, with the overlap region (see above, annotated Fig. 3A/B).
However Lopez does not explicitly teach the least one perforation disposed along a length of the removable sleeve for removal of the removable sleeve from the overlap region. Suzuki further teaches a removable sleeve (Fig. 1A/B, inner cylinder, 1 in combination with slide cylinder, 2, removed from outer cylinder, 3, col. 3 lines 31-55) with the perforation (Fig. 5, notch, 20, in the outer cylinder, 3, col. 4 lines 20-39) disposed along a length of the removable sleeve for removal of the removable sleeve from the overlap region. Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the sleeve of Lopez in view of the perforation disclosed by Suzuki because doing so would merely involve combining prior art elements according to known methods to yield predictable results; see MPEP 2143.
Claim(s) 2-4, are rejected under 35 U.S.C. 103 as being unpatentable over WO 2022/266003 A1 (hereinafter, "Lopez") in view of WO 2021/178634 A1 (hereinafter, "Goldbert") and further in view of WO 2021/0236284 A1 (hereinafter, Taylor).
In regards to claim 2, Lopez teaches the delivery system (Fig. 1, delivery apparatus, 100, para 063, see also Fig. 17-21, system, 700, and system, 800, para 0177-0181) of claim 1,
wherein the distal tip (Fig. 4/5, distal end portion, 324, para 0129-0130 see also Fig. 21, distal end portion, 736, para 0174)
and the distal capsule (Fig. 4/5, delivery capsule, 314, para 0125) includes a distal end (see below, annotated Fig. 3A, distal end).
However, it does not explicitly disclose that the distal tip includes a flange with a groove formed therein extending from a proximal end of the distal tip, and the distal end configured to interlock with the groove of the flange of the distal tip.
Goldbert teaches a delivery system (Fig. 1, delivery assembly, 100, para 040) distal tip (Fig. 11, nosecone, 106 para 066) with a flange (Fig. 7, socket lumen, 172, para 072) with a groove (Fig. 7, outer ridge, 156, para 066) formed therein extending from the proximal end (Fig. 1, proximal end portion, 152, para 066) of the distal tip, configured to interlock (Fig. 7 para 068, teaches structure of distal end a proximal end portion are coupled together). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the delivery system of Lopez with the distal tip of Goldbert in order to couple the nosecone to the distal end portion of the delivery device and to prevent gap formation between the nosecone and the capsule (para 006 and para 084-085).
However, modified Lopez does not explicitly teach the distal end configured to interlock with the groove of the flange of the distal tip. Taylor analogous in the art teaches a delivery system (Fig. 1, delivery system, 10, para 0043) with a proximal capsule (Fig. 2, adjustable portion, 24, para 0044) and distal capsule (Fig. 2, hemostasis portion, 25, para 0044) with a distal end configured to interlock with the groove (Fig. 4B, groove, 58, para 0058) of flange (Fig. 7A, individual flanges, 100, para 0058) of the distal tip (Fig. 4B, annular tip, 61, para 0058). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the delivery system of Lopez with the distal tip of Taylor in order to enhance pushability of the prosthetic valve to the target site (para 0015).
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In regards to claim 3, Lopez further teaches, wherein the distal end of the distal capsule (see above, annotated Fig. 3A, distal end)
further comprises an interlocking flange (Fig. 4, retaining features, 382, para 0149). However, it does not explicitly teach that the interlocking flange distal capsule is configured to be received by the groove of the flange of the distal tip.
Taylor further teaches an interlocking flange (Fig. 7A, individual flanges, 100, para 0058) configured to be received by the groove of the flange (Fig. 4B, groove, 58, para 0058) of the distal tip (Fig. 4B, annular tip, 61, para 0058). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the delivery system of Lopez with the distal tip of Taylor in order to enhance pushability of the prosthetic valve to the target site (para 0015).
In regards to claim 4, Lopez further teaches, wherein the distal end of the distal capsule (see above, annotated Fig. 3A, distal end 324, of distal capsule, 314, with coupling, 308)
further includes an interlock collar (Fig. 4, collar, 318, para 0126, teaches both an unlocked/locked configuration)
overlapping the distal end (Fig. 4, collar 318, overlapping, distal end, 324)
for securing the interlocking flange (Fig. 4, retaining features, 382, para 0149) to the distal end of the distal capsule (Fig. 4 , distal end, 324, in combination with retaining features, 382, connect with slots).
Claim(s) 12-13, and 15, are rejected under 35 U.S.C. 103 as being unpatentable over WO 2022/266003 A1 (hereinafter, "Lopez") in view of WO 2021/0236284 A1 (hereinafter, Taylor).
In regards to claim 12, Lopez further teaches wherein the distal end of the distal capsule (Fig. 8, distal end of distal capsule, 314, para 013)
further comprises an interlocking flange (Fig. 4, retaining features, 382, para 0149)
However, Lopez doesn’t explicitly teach that the interlocking flange is configured to be received by a groove of a flange extending from a proximal end of the distal tip. Taylor analogous in the art teaches a delivery system (Fig. 1, delivery system, 10, para 0043) with a proximal capsule (Fig. 2, adjustable portion, 24, para 0044) and distal capsule (Fig. 2, hemostasis portion, 25, para 0044) further comprises an interlocking flange (Fig. 7A, individual flanges, 100, para 0058) configured to be received by the groove of the flange (Fig. 4B, groove, 58, para 0058) of the distal tip (Fig. 4B, annular tip, 61, para 0058). Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the delivery system of Lopez with the distal tip of Taylor in order to enhance pushability of the prosthetic valve to the target site (para 0015).
In regards to claim 13, Lopez further teaches, wherein the distal end of the distal capsule (Fig. 8, distal end of distal capsule, 314, para 013) further includes an interlock collar (Fig. 3A/B, loader, 320, para 0124) overlapping the distal end for securing the interlocking flange to the distal end of the distal capsule (Fig. 3A/B, loader, 320 in combination with delivery capsule, 314, para 0124).
In regards to claim 15, Lopez further teaches, wherein the distal tip is translatable (see below, annotated Fig. 20/21) between a loading configuration (Fig. 20, para 039) and a closed configuration (Fig. 21, para 040, shows compressed configuration), such that the distal tip is separated from the distal end of the distal capsule (see below, annotated Fig. 20, distal tip, in combination with attached end) in the loading configuration (see below, annotated Fig. 20, distal tip is separated from attached end, para 0174), and the distal tip is secured to the distal end of the distal capsule in the closed configuration (see below, annotated Fig. 21, distal tipis compressed, para 0174 ).
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Claim 5 and 14 is rejected under 35 U.S.C. 103 as being unpatentable over Lopez in view of Goldbert and Taylor, as applied to claims 2-4, 12-13 and 15 above, and further in view of US 2023/0223534 (hereinafter, "Leiba").
In regards to claim 5, Lopez further teaches, wherein the interlocking flange (Fig. 4, retaining features, 382, para 0149, and see below, annotated Fig. 12A-C, interlocking flange, para 0124-0125)
comprises a sloped face (Fig. 12A-12C, tapered portion, 321, para 0124, see also Fig. 21, tapered portion, 728, para 0174)
is displaced from a longitudinal axis (Fig. 4, longitudinal axis, 328, para 0127)
upon contacting the sloped face during the sliding interaction (Fig. 4-8, collar, 318, para 0144, designed to slide over members 326).
However, Lopez does not explicitly teach the interlocking flange for sliding interaction with the distal tip. Leiba analogous in the art teaches a delivery system (Fig. 1, delivery system, 10, para 0033) with a distal tip (Fig. 4A, nosecone, 34, para 0035) with a sliding interaction with the flange of the distal tip (Fig. 4A-D, angled projections, 68, para 0056), such that the flange of the distal tip (Fig. 3B, nosecone, 34, para 0052, shows distal tip displaced from delivery system for deployment) is displaced from a longitudinal axis.
Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the delivery system of Lopez with the distal tip of Leiba in order to support deployment into the patient’s body and avoid injury to portions contacted by the elongate shaft (para 0035).
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In regards to claim 14, Lopez further teaches, wherein the interlocking flange (Fig. 4, retaining features, 382, para 0149 and see below, annotated Fig. 12A-C, interlocking flange, para 0124-0125) comprises a sloped face (Fig. 12A-12C, tapered portion, 321, para 0124, see also Fig. 21, tapered portion, 728, para 0174)
However, Lopez does not explicitly teach the interlocking flange for sliding interaction with the distal tip. Leiba teaches a delivery system (Fig. 1, delivery system, 10, para 0033) with a distal tip (Fig. 4A, nosecone, 34, para 0035) with a sliding interaction with the flange of the distal tip (Fig. 4A-D, angled projections, 68, para 0056), such that the flange of the distal tip (Fig. 3B, nosecone, 34, para 0052, shows distal tip displaced from delivery system for deployment) is displaced from a longitudinal axis
Therefore, before the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to modify the delivery system of Lopez with the distal tip of Leiba in order to support deployment into the patient’s body and avoid injury to portions contacted by the elongate shaft (para 0035).
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Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JICHELE MONIQUE SANDERS whose telephone number is (571)272-2240. The examiner can normally be reached M-Thu 6:30-5:15.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.M.S./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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