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 .
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.
Specification
The disclosure is objected to because of the following informalities:
a. In paragraph [0051], line 3, “the braided material 412 may comprises two or more” should read “ the braided material 412 may comprise two or more”
b. In paragraph [0055], line 14, “In this examples, five welds” should read “In this example, five welds”
c. In paragraph [0067], line 1, “Pebax, nylon et’ should read “Pebax, nylon etc.”
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, 2, 3, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Bishop et al. (US 2010/0145267) in view of Zhou et al. (US 2020/0353221).
Regarding claim 1, Bishop et al. discloses an introducer sheath extending from a proximal end to a distal end (see [0025] disclosing an expandable spinal introducer sheath system having a proximal end extending to a distal end), comprising: a hub disposed at the proximal end (see [0060] disclosing a sheath hub (112) coupled to the proximal end of a non-expandable tubing region (110)); and a body coupled to the hub and extending between the proximal end and the distal end (see Fig. 1A illustrating the sheath hub (112) at the proximal end, and the access sheath system with its distal expandable region), the body defining a lumen (see [0058] disclosing the sheath having a lumen extending partially or completely therethrough) and having a collapsed condition and an expanded condition (see [0010] disclosing a smaller cross-sectional (collapsed) and expanded configurations), the body having a braided material and an elastomeric material covering the braided material (see [0026] disclosing the sheath comprising a flexible shaft configured with an elastomeric outer membrane (covering) and a reinforcing layer configured as a braided structure).
Bishop et al. fails to disclose the body having a flared distal end.
Zhou et al. also discloses an expandable introducer sheath (8) including an outer and inner tubular layer of a delivery apparatus (10) (see Fig. 1). Zhou et al. teaches the body having a flared distal end (see [0086] disclosing a flared portion (78) at the distal end of the tubular wall structure (34)).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Bishop et al.’s expandable introducer sheath, with the body having a flared distal end, as further taught by Zhou et al. Doing so would provide a means to incorporate a flared distal end into the expandable, braid-reinforces body, in order to reduce snags or interference during the delivery or retrieval of a medical device through the distal end of the introducer sheath (see [0086]).
Regarding claim 2, Bishop et al. further teaches wherein the braided material comprises a nitinol braid (see [0021] disclosing nitinol and other materials used for the braided material).
Regarding claim 3, Bishop et al. further teaches wherein the braided material comprises at least one of flat wires and round wires of a thickness between 0.001” to 0.008” (see [0069] disclosing the mesh (160, 166) can be fabricated into flat or round strands (wires), with the lateral size of the strands ranging between 0.001” and 0.010”).
Regarding claim 7, Zhou et al. further teaches wherein the flared distal end defines an angle of between 5 and 45 degrees with a longitudinal axis of the body (see [0086] disclosing the flared portion (78) at the distal end of the tubular wall structure (34), which is configured to wrap, fold, or interface with a tapered distal end, thereby establishing the wall transitions through a tapered profile requires encompassing angular transition ranges (e.g., 5 and 45 degrees) along a longitudinal axis of the body).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Bishop et al.’s modified expandable introducer sheath, wherein the flared distal end defines an angle of between 5 and 45 degrees with a longitudinal axis of the body, as further taught by Zhou et al. Doing so would provide a means to configure the expandable distal portion of the tubular structure such that the flared distal end defines an angle of between 5 and 45 degrees with a longitudinal axis of the body, in order to optimize percutaneous tracking, reduce insertion resistance, and minimize tissue trauma when advancing the sheath through muscle tissue to a target region of the spine (see [0086]).
Claims 4-6, and 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Bishop et al. (US 2010/0145267) in view of Zhou et al. (US 2020/0353221) as applied to claim 1 above, and further in view of Ren et al. (US 2015/0165158).
Regarding claim 4, Bishop et al. in view of Zhou et al., fails to disclose wherein the braided material comprises a single length of braided tubing that is doubled over to form two layers.
Ren et al. also discloses an expandable introducer sheath with a dual expandable layer (44) (see [0084]). Ren et al. teaches wherein the braided material comprises a single length of braided tubing that is doubled over to form two layers (see [0084] disclosing the dual expandable layer (44) can be formed by folding a single expandable back over on itself (e.g., folding a distal end back over itself externally to create an outer layer over an inner layer).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Bishop et al.’s modified expandable introducer sheath, wherein the braided material comprises a single length of braided tubing that is doubled over to form two layers, as further taught by Ren et al. Doing so would provide a means to fold a single continuous length of braided tubing back over itself to form a seamless tow-layer braided reinforcement within the sheath wall, in order to increase the radial strength, kink resistance, and structural integrity of the sheath while preventing loose wire ends from fraying or delaminating the surrounding polymeric layers (see [0084]).
Regarding claim 5, Ren et al. further teaches wherein the braided tubing includes freetails that are disposed at the proximal end when the braided tubing is doubled over (see [0084] disclosing when the expandable mesh layer (28) is folded over along the shaft length, the ends of both the inner layer (44A) and the outer layer (44B) create sharp edges or stray strands (freetails)), therefore the ends of both the inner and outer layers terminate together at the proximal end).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Bishop et al.’s modified expandable introducer sheath, wherein the braided tubing includes freetails that are disposed at the proximal end when the braided tubing is doubled over, as further taught by Ren et al. Doing so would provide a means to fold a single continuous length of braided tubing back over itself so that its loose stray ends (freetails) are disposed at the proximal end, in order to form a smooth distal transition that prevents exposed wire ends from fraying or delaminating surrounding polymeric layers while increasing radial strength and kink resistance along the sheath (see [0084]).
Regarding claim 6, Bishop et al. further teaches wherein the braided material is heat-set in the collapsed condition (see [0076] disclosing that shape memory elements, which includes the braided material, can be heat set to a collapsed, small diameter configuration).
Regarding claims 8-11, Bishop et al. further teaches wherein the elastomeric material is coupled to the braided material at segmented reflow attachment regions that are spaced from one another (see [0068] disclosing the manufacturing process where the inner (168) and outer layer (170) are fused and bounded together through spaces in the underlying reinforcement layers (coil layers (162, 164), and mesh layers (160, 166)) create integrated attachment points); wherein the elastomeric material is coupled to the braided material via a reflow of the elastomeric material along an entire length of the body (see [0021] disclosing the reinforcing structure comprising a coil and/or braided layers, fabricated from materials such as nitinol and other materials, is generally sandwiched between an outer and an inner layer of polymeric wall, to which the sandwiching creates a reflow through the fusion of the layers along a length to form a composite tubular structure); wherein the elastomeric material is coupled to the braided material via a reflow of the elastomeric material along an axial spine (see [0021] disclosing the manufacturing process in which the inner polymer layer (168) is overlaid with mesh and coil reinforcement layers, followed by an outer polymeric layer, to which the incorporation of the layers along the length of the catheter shaft, provides a continuous longitudinal backbone (axial spine) that imparts tensile strength, torqueability, and structural integrity); wherein the elastomeric material is coupled to the braided material via reflowed spot welds of the elastomeric material (see [0068] disclosing the manufacturing process of applying heat to the layers in order to shrink, melt, fuse and bond the layers, thereby creating localized fusion points or spot welds).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Bishop et al. (US 2010/0145267) in view of Zhou et al. (US 2020/0353221) as applied to claim 1 above, in further view of Backus et al. (US 2016/0220365).
Bishop et al. in view of Zhou et al., fails to disclose wherein the elastomeric material is coupled to the braided material via one or more sutures.
Backus et al. also discloses an expandable member with one or more braided wires and a plurality of sutures (see [0006]). Backus et al. teaches wherein the elastomeric material is coupled to the braided material via one or more sutures (see [0006] disclosing an expandable member formed of braided wires with intersecting wire segments and a tubular seal comprising an elastomeric material secured to the expandable member via a plurality of sutures).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Bishop et al.’s modified expandable introducer sheath, wherein the elastomeric material is coupled to the braided material via one or more sutures, as further taught by Backus et al. Doing so would provide a means to couple an elastomeric material to a braided material via one or more sutures, in order to increase attachment strength, achieve improved load transfer to the braided member, and ensure a secure, reliable seal within an expandable medical device (see [0006]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Bishop et al. (US 2010/0145267) in view of Zhou et al. (US 2020/0353221) as applied to claim 1 above, in further view of Schaefer et al. (US 6709429).
Bishop et al. in view of Zhou et al., fails to disclose further comprising at least one axial buttressing wire interwoven with the braided material and extending parallel with a longitudinal axis of the body.
Schaefer et al. also discloses an intravascular catheter with a braid reinforcement and a plurality of axial members (see Col. 2, lines 50-52). Schaefer et al. teaches further comprising at least one axial buttressing wire interwoven with the braided material and extending parallel with a longitudinal axis of the body (see Col. 3, lines 24-31 disclosing a reinforcement layer comprising a tubular braid with two or more interwoven helical members and a plurality of axial members disposed between the helical members and retained within the tubular braid structure, to which the axial members may be wires, fibers, filaments, cables, etc., thereby effectively functioning as a buttressing wire along the longitudinal axis of the tubular body).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Bishop et al.’s modified expandable introducer sheath, further comprising at least one axial buttressing wire interwoven with the braided material and extending parallel with a longitudinal axis of the body, as further taught by Schaefer et al. Doing so would provide a means to incorporate at least one axial buttressing wire interwoven with the braided material and extending parallel with a longitudinal axis of the body, in order to limit axial elongation, maintain precise one-to-one control during push and pull manipulation, and prevent friction causing surface protrusions during the radial expansion and retraction of the sheath (see Col. 3, lines 24-31).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Bishop et al. (US 2010/0145267) in view of Zhou et al. (US 2020/0353221) as applied to claim 1 above, in further view of Waldhauser et al. (US 2004/0122360).
Bishop et al. in view of Zhou et al., fails to disclose wherein the braided material defines at least one peripheral lumen, and further comprising at least one stabilizing wire disposed within the at least one peripheral lumen and removable therefrom.
Waldhauser et al. also discloses a catheter body with a reinforced wire braid and a lumen liner (see [0016]). Waldhauser et al. teaches wherein the braided material defines at least one peripheral lumen (see [0049] disclosing the structural arrangement of the tubular wire braid (28) surrounding the delivery lumen liner (44)), and further comprising at least one stabilizing wire disposed within the at least one peripheral lumen and removable therefrom (see [0071]-[0073] disclosing the fabrication steps of inserting the pull wire mandrel into the wire coil lumen and subsequently removing/withdrawing the pull wire mandrel from the wire coil lumen, to which the pull wire mandrel effectively functions as the stabilizing wire).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Bishop et al.’s modified expandable introducer sheath, wherein the braided material defines at least one peripheral lumen, and further comprising at least one stabilizing wire disposed within the at least one peripheral lumen and removable therefrom, as further taught by Waldhauser et al. Doing so would provide a means to dispose at least one stabilizing wire within at least one peripheral lumen defined by a braided material and subsequently remove or withdraw it therefrom, in order to provide temporary structural and shape retention during sheath fabrication or delivery while allowing selective adjustment of flexibility and profile upon the wire’s removal (see [0071]-[0073]).
Claims 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bishop et al. (US 2010/0145267) in view of Zhou et al. (US 2020/0353221), and further in view of Korkuch et al. (US 2019/0247627).
Regarding claim 15, Bishop et al. in view of Zhou et al. discloses a system comprising:
the introducer sheath of claim 1, but fails to disclose a dilator having a flared distal end retaining feature.
Korkuch et al. also discloses a dilator assembly and expandable sheath configuration (see [0010]). Korkuch et al. teaches a dilator having a flared distal end retaining feature (see [0010] disclosing the distal end of the expandable sheath interfaces with both dilators such that the sheath’s distal end is prevented from moving in the proximal direction by an abutment against the dilator end surface, to which the distal body portion of the dilator has a transition between a smaller-diameter shaft of the dilator and its broader distal body creates the flared profile, in order to hold the distal tip of the expandable sheath, establishing the retaining feature).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Bishop et al.’s modified expandable introducer sheath, with a dilator having a flared distal end retaining feature, as further taught by Korkuch et al. Doing so would provide a means to mechanically engage and secure the distal tip of the sheath against the dilator’s flared transition zone, in order to prevent proximal displacement of the sheath during percutaneous insertion and maintain a smooth, continuous, atraumatic profile as the system advances through the vasculature (see [0010]).
Regarding claim 16, Korkuch et al. further teaches wherein the dilator includes a retaining feature that comprises at least one of (i) an angled butt with a maximum outer diameter closer to the flared distal end (see [0010] disclosing the distal end of the expandable sheath interfaces with both dilators such that the sheath’s distal end is prevented from moving in the proximal direction by an abutment against the dilator end surface, to which the distal body portion of the dilator has a transition between a smaller-diameter shaft of the dilator and its broader maximum outer diameter at the distal body, creating a flared profile), (ii) an encapsulating segment configured to slide over and receive the flared distal end therein (see [0198] disclosing the structural arrangement involving inner and outer dilator components where one component slides over, entraps and captures the distal tip by utilizing the smaller diameter at one end and a broader outer diameter at another end of the dilator, establishing the flared end), (iii) a channel for accepting the flared distal end (see [0198], [0199] disclosing the inner and outer dilator components including tip wings (6406) and transition portions (6413) that define a receiving space or channel to entrap and hold the distal tip (6402) of the expandable sheath under tension), and (iv) a radially undercut slot defined radially inward of an outer diameter of the dilator (see [0199] disclosing the tip wings (6406) and transition portions (6413) that define a channel or slot positioned radially inward from the maximum outer diameter of the dilator end to securely entrap and retain the distal tip of the expandable sheath under axial tension).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Bishop et al.’s modified expandable introducer sheath, wherein the dilator includes a retaining feature that comprises at least one of (i) an angled butt with a maximum outer diameter closer to the flared distal end, (ii) an encapsulating segment configured to slide over and receive the flared distal end therein, (iii) a channel for accepting the flared distal end, and (iv) a radially undercut slot defined radially inward of an outer diameter of the dilator, as further taught by Korkuch et al. Doing so would provide a means to utilize a dilator retaining feature comprising at least one of an angled butt, an encapsulating segment, a channel, or a radially undercut slot to engage and secure a flared distal end of an expandable sheath, in order to maintain axial tension and a low-profile configuration during insertion while preventing the dilator body from exiting the distal end of the sheath (see [0010]).
Regarding claim 17, Korkuch et al. further teaches wherein the dilator includes a distal segment and a proximal segment coupleable to the distal segment (see [0198], [0199] disclosing a multi-part dilator structure combining an inner dilator (distal segment) and an outer dilator (proximal segment) that cooperate to define transition portions and retain the expandable sheath tip, to which the inner dilator equipped with the inner dilator tip wings, combines with the outer dilator featuring a distal end surface and transition portion), the distal segment and the proximal segment being configured and arranged to sandwich the flared distal end of the body therebetween (see [0199] disclosing the multipart dilator configuration with its proximal (outer dilator) and distal (inner dilator tip)components or segments, couple together to define a channel or slot to capture, sandwich and retain the flared distal end of the dilator body established by the broader maximum outer diameter).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Bishop et al.’s modified expandable introducer sheath, wherein the dilator includes a distal segment and a proximal segment coupleable to the distal segment, the distal segment and the proximal segment being configured and arranged to sandwich the flared distal end of the body therebetween, as further taught by Korkuch et al. Doing so would provide a means to configure the inner dilator tip (distal segment) and outer dilator (proximal segment) to mechanically capture, entrap, and sandwich the flared distal end (tip) of the sheath body, in order to prevent the expandable sheath from slipping, buckling, or moving in the proximal direction relative to the dilator assembly (see [0198], [0199]).
Regarding claim 18, Korkuch et al. further teaches wherein the proximal segment comprises a bulbous region (see [0221] disclosing a semi-elastic compression band (3404) which effectively functions as a bulbous region, is positioned on the dilator body (3402), thereby creating the geometric profile of a band encircling the dilator body which typically creates a raised, bulb-like protrusion necessary to engage with the corresponding recesses or pockets (3414) on the dilator tip (3406) on the mating segment, providing a detent feature), wherein the distal segment comprises one or more recesses (see [0221] disclosing the dilator tip (3406) which functions at the distal segment, as having pockets (3414), to which these pockets serve as structural recesses designed to receive the compression band (3404) to facilitate the locking engagement of the assembly), and the proximal segment comprises one or more locking pins that are coupleable to the one or more recesses (see [0221] disclosing the compression band (3404) at the proximal end of the dilator body (3402), forms a protrusion designed to engage the corresponding pockets (3414) that functions as a recess, to provide a cooperative fit which constrains relative axial movement between the coupled segments, directly replicating the secure mechanical interlock achieved by pins engaging recesses).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Bishop et al.’s modified expandable introducer sheath, wherein the proximal segment comprises a bulbous region, wherein the distal segment comprises one or more recesses, and the proximal segment comprises one or more locking pins that are coupleable to the one or more recesses, as further taught by Korkuch et al. Doing so would provide a means configure the proximal segment comprising a bulbous region and one more locking pins and the distal segment comprising one or more recesses coupleable to the locking pins to mechanically capture and sandwich the flared distal end of the expandable sheath body in order to prevent the sheath from slipping, buckling, or moving proximally relative to the dilator assembly (see [0221]).
Regarding claim 19, Korkuch et al. further teaches wherein the flared distal end retaining feature comprises a split sheath disposed over the flared distal end of the body (see [0024], [0025] disclosing the inner and outer dilator configuration where a distal tip forms a cavity having an inner wall, a closed end, and an open proximal end to receive the distal end of the outer dilator, thereby forming a sheath tip receptacle).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Bishop et al.’s modified expandable introducer sheath, wherein the flared distal end retaining feature comprises a split sheath disposed over the flared distal end of the body, as further taught by Korkuch et al. Doing so would provide a means to incorporate a split sheath over the flared distal end of the boy to establish an interlocking retaining structure, in order to securely capture the sheath tip and prevent proximal displacement or slippage during delivery and insertion of the catheter or dilator assembly (see [0024], [0025]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Bishop et al. (US 2010/0145267) in view of Ren et al. (US 2015/0165158).
Bishop et al. discloses an introducer sheath extending from a proximal end to a distal end (see [0025] disclosing an expandable spinal introducer sheath system having a proximal end extending to a distal end), comprising:
a hub disposed at the proximal end (see [0060] disclosing a sheath hub (112) coupled to the proximal end of a non-expandable tubing region (110)); and
a body having a lumen and extending between the proximal end and the distal end (see [0058] disclosing the sheath having a lumen extending partially or completely therethrough), the body having a collapsed condition and an expanded condition (see [0010] disclosing a smaller cross-sectional (collapsed) and expanded configurations).
Bishop et al. fails to disclose the body having a double layer of a braided material and an elastomeric material covering the braided material.
Ren et al. also discloses an expandable introducer sheath with a dual expandable layer (44) (see [0084]). Ren et al. teaches the body having a double layer of a braided material (see [0084] disclosing the dual expandable mesh layer (44), to which the mesh layer can have a braided configuration, thereby establishing a double braided layer) and an elastomeric material covering the braided material (see [0081] disclosing the mesh layer can be fully or partially coated with an elastic coating).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided Bishop et al.’s modified expandable introducer sheath, with the body having a double layer of a braided material and an elastomeric material covering the braided material, as further taught by Ren et al. Doing so would provide a means to incorporate inner and outer braided layers encapsulated within an elastomeric or polymeric material, in order to form a dual layer expandable sheath body capable of transitioning between collapsed and expanded conditions while maintaining structural integrity and impermeability (see [0084]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEFAN BRADLEY CAMPBELL whose telephone number is (571)272-3498. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/STEFAN BRADLEY CAMPBELL/Examiner, Art Unit 3774
/KATRINA M STRANSKY/Primary Examiner, Art Unit 3700
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