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 .
The current application has the effective filing date of 03/07/2022 according to the priority chain on the record.
Claim Interpretation
Regarding the recited “medical device” in claims 1, 6 and 7. Firstly, under the broadest reasonable interpretation, “medical device” is not a positively recited feature because claim 1 is directed to a “medical device delivery system”, not the “medical device” itself. Secondly, with regard to the “medical device” itself, the limitation “a distal wide portion of the medical device, and wherein the distal wide portion of the medical device has a diameter wider than that of the proximal narrow portion of the medical device”; it is interpreted by the Examiner as a medical device having a distal portion that is wider than the proximal portion, and the proximal portion that is narrower than the distal portion. Since there is no particular recitation with regard to the dimensions/sizes of the “distal wide portion” and “proximal narrow portion”, the terms “wide” and “narrow” are interpreted as a size relationship of respected “distal wide portion” and “proximal narrow portion.”
Claim Rejections - 35 USC § 102
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-5, 7 and 14-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ness et al. US 2018/0318077 A1 (hereinafter “Ness”, cited in IDS).
Regarding claim 1, Ness discloses a medical device delivery system (prosthetic heart valve delivery device 10), comprising:
a delivery catheter (catheter assembly 16) comprising:
a catheter hub (operating handle 20); and
a catheter shaft (outer shaft 22 and distal sheath 24) including a medical device conduit (inner shaft 26; [0036: last sentence] “A compartment 23 defined around an inner shaft 26 in catheter assembly 16 is configured to receive a prosthetic heart valve (not shown), which is held in a collapsed condition when distal sheath 24 covers the compartment’) extending through the catheter shaft (22 and 24) and configured to slidably receive at least a portion of a medical device (i.e. prosthetic heart valve),
wherein a proximal portion (22) of the catheter shaft extends distally from the catheter hub (20) and is configured to slidably receive a proximal narrow portion of the medical device ([0036] slidably receiving “medical device”, i.e. prosthetic heart valve); and
wherein a distal portion (24) of the catheter shaft (22 and 24) is configured to slidably receive a distal wide portion of the medical device (i.e. prosthetic heart valve), and wherein the distal wide portion of the medical device has a diameter wider than that of the proximal narrow portion of the medical device (see Claim Interpretation section above, this limitation is met because “medical device”, i.e. prosthetic heart valve, is taught in [0036] as being slidable received, the heart valve is collapsible and expandable [0031-0033, 0035], thus can be interpreted as having “proximal narrow portion” and “distal wide portion”); and
an in-line sheath (introducer 100), the delivery catheter (catheter assembly 16) being preloaded within the in-line sheath (100; see Fig. 1), the in-line sheath (100) comprising:
a sheath hub (housing 130); and
a sheath shaft (hollow distal sheath 110 and hollow proximal sheath 120) including a delivery catheter conduit ([0041] implicit, because 110 and 120 are hollow, implied to have additional components for carrying 22 and 24) extending through the sheath shaft (110 and 120) and configured to slidably receive at least a portion of the catheter shaft (22 and 24), wherein a proximal portion of the sheath shaft (120) extends distally from the sheath hub (130) and is configured to slidably receive at least a portion of the proximal portion of the catheter shaft (22), and wherein an expandable distal portion (see [0041] “distal sheath 110 is expandable from a first diameter to a larger second diameter”) of the sheath shaft (110) is configured to assume an expanded state or a collapsed state (see [0041] expandible implies also collapsible; also see ‘retract’ or ‘reduced-diameter’ configurations described in [0045]), and wherein the expandable distal portion of the sheath shaft (110) is configured to slidably receive the distal portion of the catheter shaft when in its expanded state. ([0045] “sheath 110A (including coil 111A and layer 112A) may be kept in the reduced diameter configuration by being positioned within a covering sheath (not shown) having a non-expandable or minimally expandable internal diameter that is substantially equal to the outer diameter of the coil when the coil is in the reduced diameter configuration”)
Regarding claim 2, Ness discloses the system of claim 1, wherein the expandable distal portion of the sheath shaft (110) comprises a tubular configuration. (See Figs. 1 and 3: 110 is in tubular/cylindrical shape)
Regarding claim 3, Ness discloses the system of claim 2, wherein the expandable distal portion (110), while in the expanded state, comprises a cylindrical shape. (See Figs. 3 and 4A, see [0041-0042] “distal sheath 110 is expandable from a first diameter to a larger second diameter”; in here ‘diameter’ implies a circular/cylindrical; also see [0042, 0084] claim 2: cylindrical material/frame)
Regarding claim 4, Ness discloses the system of claim 2, wherein an expandable coil (wire/coil 111A) extends along a longitudinal portion of the expandable distal portion (100), coils of the expandable coil (111A) extending around a corresponding portion of the delivery catheter conduit (implicit feature, see claim 1 above). ([0041-0042] and Figs. 4A-4C)
Regarding claim 5, Ness discloses the system of claim 2, wherein the expandable distal portion (111A) comprises a shape memory material. ([0045: 1st sentence] “coil 111A may be formed of a shape-memory material shape-set to the expanded diameter…”)
Regarding claim 7, Ness discloses the system of claim 2, wherein a distal end (115) of the expandable distal portion (110) comprises a circumferential lateral portion perpendicular to a longitudinal axis of the sheath shaft (as shown in Fig. 3), the circumferential lateral portion being configured to engage with a flat portion of the medical device disposed distally of the expandable distal portion. (See [0044])
Regarding claim 14, Ness discloses the system of claim 2, wherein the proximal portion of the sheath shaft comprises a rigid portion (120) and a flexible portion (110), the rigid portion being proximal of the flexible portion (as shown in Fig. 1, 120 is proximal, and 110 is distal), and wherein the expandable distal portion extends distally from the flexible portion (as shown in Fig. 1; and see [0061] “… a substantially rigid member (not shown) may be attached to a distal end portion of sheath 110D.”).
Regarding claim 15, Ness discloses the system of claim 2, wherein the sheath hub (130) comprises a catheter engagement feature ([0040-0041] latching element 28 and 132) configured to frictionally contact with a portion of the delivery catheter (22, 16) to prevent distal and proximal translation of the delivery catheter relative to the in-line sheath (100). (see [0040-0041] “latching element 132 may be a groove, snap, aperture, or other mechanism configured to couple with latching element 28”)
Regarding claim 16, Ness discloses the system of claim 2, wherein: the expandable distal portion of the sheath shaft (110) and at least a portion of the proximal portion of the sheath shaft (120) are configured to be advanced through an outer expandable sheath (covering sheath, see [0045] “ Once fully inserted, the covering sheath may be retracted, exposing sheath 110A and allowing it to expand to the expanded diameter configuration.”); and the sheath hub (130) comprises an outer sheath engagement feature (implicit, see [0045]) configured to engage with a hub of the outer expandable sheath (implicit, see [0045] “proximal end of the covering sheath may include a longitudinal slit or other feature to help ensure the covering sheath could be temporarily pulled proximally over larger portions of other structures (such as housing 130) positioned proximal to the covering sheath”) to prevent distal and proximal translation of the in-line sheath (100) relative to the outer expandable sheath. ([0045])
Regarding claim 17, this claim is rejected by Ness, under the same rationale as discussed to claim 1 above.
Regarding claim 18, Ness discloses the method of claim 17, and further comprising advancing the distal wide portion of the medical device into a heart chamber. (see [0031-0035] prosthetic heart valve delivery device 10 is intended to be advanced into the heart chamber; also see [0045] advancing into vasculature in the heart)
Regarding claim 19, this claim is rejected under the same rationale as discussed to claim 15 above, see Ness [0040-0041] latching element.
Regarding claim 20, this claim is rejected under the same rationale as discussed to claim 16 above, see Ness [0045].
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Ness as applied to claim 2 above, and in view of Neumann et al. WO 2022/016059 A1 (hereinafter “Neumann”, submitted by the Applicant).
Regarding claim 6, Ness discloses the system of claim 2, wherein a distal end (115) of the expandable distal portion (110, as shown in Fig. 3, [0041]) comprises a circumferential tapered portion having a sloped surface oriented toward a longitudinal axis of the sheath shaft ([0041] “The distal end 115 of distal sheath 110 may also taper to a reduced diameter in some embodiments”), but Ness does not disclose the circumferential tapered portion being configured to engage with a curved portion of the medical device disposed distally of the expandable distal portion. Neumann, another prior art reference in analogous art, discloses a delivery catheter (14) comprising: a catheter hub (10) and a catheter shaft (20) including a medical device conduit extending through the catheter shaft (20) and configured to slidably receive at least a portion of a medical device (inflated balloon; 16 and 12) and an in-line sheath (90), the delivery catheter (14) being pre-loaded within the inline sheath, the inline sheath (90) comprising: a sheath hub (92) and a sheath shaft (100) configured to slidably receive at least a portion of the catheter saft (20), and wherein an expandable ([0040]) distal portion of the sheath shaft (100) is configured to assume an expanded state ([0098] Fig. 52) or a collapsed state ([0088] Fig. 51). In one embodiment, shown in Figs. 50-52, Neumann discloses wherein a distal end of the expandable distal portion (distal end of introducer 160) comprises a circumferential tapered portion having a sloped surface oriented toward a longitudinal axis of the sheath shaft (Figs. 51) the circumferential tapered portion (160) being configured to engage with a curved portion of the medical device (inflated balloon 164) disposed distally of the expandable distal portion (Figs.50-52). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Ness to adapt the distal end of the sheath in view of Neumann, the motivation is to accommodate introducing an inflated balloon medical device into the body (Neumann: [0207-0208]).
Claims 8 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Ness as applied to claim 1 above, and in view of Nguyen et al. US 2012/0083877 A1 (hereinafter “Nguyen”, cited in IDS)
Regarding claim 8, Ness teaches the system of claim 1, but does not teach wherein the expandable distal portion comprises: a plurality of discrete elongate portions circumferentially disposed around the delivery catheter conduit and partially defining a corresponding portion of the delivery catheter conduit as recited in claim 8. However, Nguyen, another prior art reference in the analogous art, discloses a medical device delivery system (10) comprising: a delivery catheter (14) comprising (Fig.1) a catheter hub and a catheter shaft including a medical device conduit ([0075]), and an in-line sheath (8 or 22), the delivery catheter (14) being preloaded within the in-line sheath (8, [0075]), comprising a sheath hub (Fig. 1) and a sheath shaft including a delivery catheter conduit, wherein an expandable distal portion of the sheath shaft is configured to assume an expanded state or a collapsed state, and wherein the expandable distal portion of the sheath shaft is configured to slidably receive the distal portion of the catheter shaft when in its expanded state ([0074, 0085]). Nyugen further discloses wherein the expandable distal portion comprises: a plurality of discrete elongate portions (defined between notches/cuts 36) circumferentially disposed around the delivery catheter conduit and partially defining a corresponding portion of the delivery catheter conduit each discrete elongate portion comprising a proximally oriented end portion and a distally oriented end portion, the proximally oriented portions being coupled to one another and the distally oriented end portions being spaced from one another, wherein, while the expandable distal portion is in the expanded state, the distally oriented end portions are configured to be disposed further apart from one another than while in the expandable distal portion is in the collapsed state (see Fig. 2D; [0087]). It would have been obvious to a person of ordinary skill in the art at the time of invention to modify Ness’s expandable distal portion of the to include the discrete elongate portion in view of Nyugen, the motivation for doing so because Nyugen discloses that this is an alternative design to a traditional uniform cylindrical tube to serve the same purpose. (Nyugen: [0085-0086] and Figs. 2A-2D)
Regarding claim 9, Ness in view of Nyugen discloses the system of claim 8, wherein, while the expandable distal portion is in the collapsed state, each discrete elongate portion extends distally along an axis parallel to a longitudinal axis of the sheath shaft to provide an expandable distal portion comprising a uniform outer diameter along a longitudinal dimension of the expandable distal portion. (See rejection to claim 8, and Nyugen: [0087] “The notches and/or cuts 36 can be separable upon radial expansion of the sheath 22. The outer polymeric tubular layer 26 can be retractable longitudinally, or able to be pulled back away from the intermediate tubular layer 28 and the inner polymeric tubular layer 24. In embodiments with a retractable outer polymeric tubular layer 26, the outer polymeric tubular layer 26 can be retracted to accommodate or facilitate passage of a delivery apparatus through the lumen 30, and then can be replaced to its original position on the sheath 22.”)
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ness and Nguyen as applied to claim 8 above, and in view of Chia et al. US 2007/0239254 A1 (hereinafter “Chia”, cited in IDS).
Regarding claims 10-13, Ness in view of Nyugen discloses the system of claim 8, but neither teaches the specific structures of the discrete elongate portions. However Chia, another prior art reference in analogous art, discloses a valve-retrieval device that comprises an expandable distal end portion that assumes an expanded shape when advanced out of the introducer sheath (Abstract). Chia discloses the retrieval device comprising an elongate shaft (252) formed with a longitudinal opening (254) extending lengthwise of the shaft made of a shape memory metal coupled to the distal end of the shaft (252) formed with a plurality of longitudinally extending fingers, or valve-engaging members (258) secured at their proximal ends to the device. To claim 10, Chia further discloses wherein each discrete elongate portion extends along a convexly curved path from a corresponding proximal end to a corresponding distal end (see Fig. 13, [0060] “to flex or bend radially inwardly toward each other to a collapsed state”). To Claim 11, Chia further discloses wherein, while the expandable distal portion is in the collapsed state, a proximally oriented portion of each discrete elongate portion comprises a curvature to provide an outer diameter of the expandable distal portion at distal ends of the plurality of discrete elongate portions that is larger than that at proximal ends of the plurality of discrete elongate portions (Figs. 13 and 14A, [0063]). To claim 12, Chia further teaches wherein a proximally oriented portion of each discrete elongate portion comprises a convex curvature to provide a proximal portion of the expandable distal portion comprising an outer diameter wider than that of a distal portion of the expandable distal portion (Fig. 15, [0064]). To claim 13, Chia further teaches wherein, while the expandable distal portion is in the collapsed state, a distal end of each discrete elongate portion is in contact with at least one other discrete elongate portion or distal ends of the plurality of discrete elongate portions are spaced from one another (Fis. 14A-14B, [0062]). To claims 10-13, it would have been obvious design choice to a person of ordinary skill in the art at the time of invention to further modify Ness to assume the various discrete elongate portion designs in view of Chia, the motivation is to adapt expandable distal portions to optimize delivery or retrieval of different types of intended medical device(s).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
June 18, 2026
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