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 .
Election/Restrictions
Applicant’s election without traverse of group in the reply filed on 01/20/2026 is acknowledged.
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) 1-6 and 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Le (US Patent No.: 10,639,152) in view of Kirt (US Pub No.: 2020/0078571).
Regarding claim 1, Le (US Patent No.: 10,639,152) teaches an expandable sheath (in the abstract and column 3 lines 31-47) comprising: an outer layer (the outer surface in column 3 lines 31-47. This is shown as part 50 in figure 19) including an elongated tubular member (being part 50) with integrated axial support extending longitudinally therein (part 102 in column 16 lines 17-35), the outer layer movable between a non-expanded configuration and an expanded configuration (part 50 is expandable in column 16 lines 36-48, where an expansion indicates that a configuration where an expansion has happened and not happened is present), where the outer layer is biased to the non-expanded configuration (as the device is expanded via a balloon in column 7 lines 39-63, the device is biased in a non-expanded configuration before a balloon causes the expansion) and an inner layer received within a central lumen of the outer layer (part 20 shown in figure 19) and movable therein (“movability in the axial direction between the members 20 and 50 in column 15 lines 42-61. In figures 17-18 in view of column 10 lines 55-67 in column 11 lines 1-3, part 20 comprises part 38 that moves independently of part 50 when the device expands), wherein receipt of the inner layer within the central lumen of the outer layer causes the outer layer to transition from the non-expanded configuration to the expanded configuration (shown from figures 17 into 18).
However, Le does not teach and the axial support includes a plurality of axial supports spaced circumferentially around the tubular member.
Instead, Kirt (US Pub No.: 2020/0078571) teaches the axial support includes a plurality of axial supports spaced circumferentially around the tubular member (supports part 44 in [0052] and figure 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate support parts 44 of Kirt into Le for the purpose of providing a reinforcing means in [0052] that will reinforce an outer sheath member in [0013].
Regarding claim 2, Le in view of Kirt teach the expandable sheath of claim 1, wherein Le discloses insertion of the inner layer within the central lumen of the outer layer causes the outer layer to locally expand from the non-expanded configuration to the expanded configuration by a radially outward force exerted on a surface of the central lumen of the outer layer by the inner layer (as a balloon for expansion is present in column 7 lines 39-63, with part 30 promoting an expandability in column 11 lines 20-33) wherein removal of the inner layer from the central lumen of the outer layer causes the outer layer to locally contract from the expanded configuration at least partially back to the non-expanded configuration (in column 2 lines 29-46, as the outer elastomeric member biases the inner member into a folded configuration, a removal of the inner layer will cause the outer layer to contract),
From here, Kirt teaches wherein, when the outer layer transitions from the non-expanded configuration to the expanded configuration, a circumferential spacing between each of the plurality of axial supports increases (as part 20 expands, as disclosed in [0054], the spacing between parts 44 will increase in figure 2, as parts 40 are attached to part 20 in [0072], where parts 44 are part of the reinforcing member 40), wherein, when the outer layer transitions from the expanded configuration to the non- expanded configuration, a circumferential spacing between each of the plurality of axial supports decreases (with parts 44 of Kirt being on the outer layer of Le, when the outer layer of Le contracts, the spacing between the different parts 44 decreases compared to the spacing in an expanded configuration).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate support parts 44 of Kirt into Le for the purpose of providing a reinforcing means in [0052] that will reinforce an outer sheath member in [0013].
Regarding claim 3, Le in view of Kirt teach the expandable sheath of claim 1, wherein Le discloses the tubular member is composed of an elastic material (being the inner and outer elastomeric members in column 9 lines 24-45), and wherein a column strength of the inner layer is equal to or greater than a column strength of the outer layer (as both the inner and outer layer of Le are disclosed as being elastomeric, with a plurality of materials disclosed in column 9 lines 13-23, the strength of both layers will be the same if the same materials in column 9 lines 13-23 are chosen. In column 10 lines 55-66, the inner layer 20 may be stiffer than the outer layer 50).
From here, Kirt teaches wherein a column strength of at least one of the plurality of axial supports is greater than a column strength of the tubular member (as the reinforcing members may include fabric, textile, and alloy materials in [0095]-[0096] of Kirt, the reinforcing members of Kirt can be configured to have a higher strength than the elastomeric materials detailed in Le above). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate support parts 44 of Kirt into Le for the purpose of providing a reinforcing means in [0052] that will reinforce an outer sheath member in [0013].
Regarding claim 4, Le in view of Kirt teach the expandable sheath of claim 1, wherein Lee discloses at least one of the plurality of axial supports is composed of a material that stretches/elongates less than 1% under tension (as parts 40 and 44 are not disclosed as extending, stretching, or elongating in Kirt, no stretching under tension is provided for by the device of Kirt), wherein an overall length of the outer layer does not change when the outer layer transitions between the non-expanded and the expanded configuration (Le does not disclose that the overall length of the outer layer changes during an expansion of said outer layer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate support parts 44 of Kirt into Le for the purpose of providing a reinforcing means in [0052] that will reinforce an outer sheath member in [0013].
Regarding claim 5, Le in view of Kirt teach the expandable sheath of claim 1, wherein Le discloses a portion of an outer surface of at least one of the plurality of axial supports protrudes from an inner surface of the central lumen of the outer layer such that the outer surface of the axial support facilitates relative movement between the outer layer and the inner layer moving within the central lumen of the outer layer (examiner argues that parts 40 with spines 44 of Kirt can extend from an inner surface (being inner liner 20 of figure 12 of Kirt) toward the outer layer 30, defined in [0052] of Kirt to secure both an inner liner and outer liner of Le together to facilitate a movement between the liners of Le during expansion. Said placement of the reinforcing member 40 and spines 44 of Kirt have to be placed in a central lumen of the outer layer of Le to maintain the structure shown in figure 12 of Kirt).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate support parts 44 of Kirt into Le for the purpose of providing a reinforcing means in [0052] that will reinforce an outer sheath member in [0013].
Regarding claim 6, Le in view of Kirt teach the expandable sheath of claim 1, wherein Le discloses the inner layer includes a reinforcing member that extends circumferentially around the inner layer (shown in figure 12 with the inner layer being part 20 and the reinforcing members being the spines 44 of part 40), wherein the reinforcing member maintains a diameter of the central lumen of the reinforcing member when traversing bends in a patient's vasculature and prevents kinking (in [0003]-[0004], the reinforcing members of Kirt are used in the vasculature of a patient, with the materials disclosed in [0088] of Kirt that will prevent a kinking of the device in [0004]).
Regarding claim 9, Le in view of Kirt teach the expandable sheath of claim 1, wherein Le discloses when the inner layer is fully received within the central lumen of the outer layer (shown in figures 17 and 18), a length of the inner layer extends through and/or beyond a distal opening of the central lumen of the outer layer (in Le, column 4 lines 6-12, and shown in figure 3, the inner layer 20 extends just beyond the outer layer 50 in figure 3).
Regarding claim 10, Le in view of Kirt teach the expandable sheath of claim 1, wherein Le discloses the outer layer and the inner layer are coupled together at a proximal end of the inner layer when the inner layer is fully received within the central lumen of the outer layer (where the proximal end of the outer cavity is the rightmost end of part 50 of figure 2, part 20 of Le is fully received in part 20. This is partially shown in figure 22A).
Regarding claim 11, Le in view of Kirt teach the expandable sheath of claim 1, wherein Le discloses a proximal end of the inner layer is coupled to an inner layer hub (being the hub at the proximal end of the sheath 10 in figure 2, disclosed but not labeled in column 10 lines 10 and 23).
However, Le does not teach that the hub is having a proximal end and a distal end and defining a central lumen extending longitudinally between the proximal and distal end, wherein a proximal end of the outer layer is coupled to an outer layer hub having a proximal end and a distal end and defining a central lumen extending longitudinally between the proximal and distal end, wherein the central lumen of the inner layer hub and the outer layer hub each includes a seal for preventing unwanted fluid from advancing in a proximal and/or distal direction within the central lumen of the respective hub, wherein the outer layer hub and the inner sheath hub are removably coupled when the inner layer is fully received within the central lumen of the outer layer.
Instead, Kirt teaches that the hub (being part 12) is having a proximal end and a distal end (being the left and rightmost ends of part 12 in figure 1) and defining a central lumen extending longitudinally between the proximal and distal end (in [0051], as a valve or seal is in part 12, a lumen for a fluid transfer or irrigation is present in Kirt), wherein a proximal end of the outer layer is coupled to an outer layer hub having a proximal end and a distal end and defining a central lumen extending longitudinally between the proximal and distal end (shown in figure 1, where the fluid sealing in [0051] implies that a passage of fluid from a hub to a tubular member 14 is present), wherein the central lumen of the inner layer hub and the outer layer hub each includes a seal for preventing unwanted fluid from advancing in a proximal and/or distal direction within the central lumen of the respective hub (seal in [0051]), wherein the outer layer hub and the inner sheath hub are removably coupled when the inner layer is fully received within the central lumen of the outer layer (the sheaths may be removed from a mandrel in [0068], which removes the inner layer and outer layer from the hub parts).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the hub details of Kirt into Le to provide further details to the hub of Le that allows for a fluid control, as presented in [0051] of Kirt.
Regarding claim 12, Le in view of Kirt teach the expandable sheath of claim 1, with Le further including: a delivery catheter assembly (disclosed in column 1 lines 21-28 of Le, column 7 lines 64-67 into column 8 lines 1-6) comprising: a proximal region comprising a hub (column 10 lines 10-23 discloses a hub), where the outer layer of the expandable sheath is coupled to and extending distally from the hub (shown in figure 2 with the rightmost portion being a hub); a guide catheter (part 114 of Lee) slidably positionable within the central lumen of the inner layer (in column 7 lines 64-67 into column 8 lines 1-28); a balloon catheter positionable within the guide catheter (part 116 disclosed in column 7 lines 64-67 into column 8 lines 1-28 ), a distal region of the balloon catheter comprising an inflatable balloon (as Le discloses a balloon catheter, an inflatable balloon is implied to be at an end of the balloon); an implantable device configured to be coupled to the inflatable balloon (a balloon on a sheath in column 7 lines 39-63), and a capsule configured to extend over the implantable device (part 30 in figures 3-5).
However, Le does not teach details with respect to a hemostasis valve. Instead, Kirt teaches a proximal region comprising a hub (column 10 lines 10-23 discloses a hub) with a hemostasis valve, where the outer layer of the expandable sheath is coupled to and extending distally from the hub (shown in figure 2 with the rightmost portion being a hub) and fluidically coupled to the hemostasis valve.
Instead, Kirt teaches a proximal region comprising a hub (proximal hub 12 in [0051]) with a hemostasis valve (in [0051]), where the outer layer of the expandable sheath is coupled to and extending distally from the hub (shown in figure 1 with sheath part 30) and fluidically coupled to the hemostasis valve (as the valve of [0051] is used to provide a fluid seal, a fluid coupling is present). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the hub details of Kirt into Le to provide further details to the hub of Le that allows for a fluid control, as presented in [0051] of Kirt.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Le (US Patent No.: 10,639,152) in view of Kirt (US Pub No.: 2020/0078571) in further view of McNiven (US Pub No.: 2018/0126119).
Regarding claim 7, Le in view of Kirt teach the expandable sheath of claim 6.
However, Le in view of Kirt does not teach wherein the reinforcing members is at least one of a coil, a braid, or a mesh, wherein the coil is wound to resist axial compression applied to the inner layer, while facilitating bending of the inner layer in a direction away from a longitudinal axis of the inner layer, the coil including a coil winding which provides compressive stiffness to the inner layer during axial compressive loads, the coil winding extending helically about a longitudinal axis of the inner layer and defines a central lumen between its proximal and distal ends.
Instead, McNiven (US Pub No.: 2018/0126119) teaches wherein the reinforcing members is at least one of a coil, a braid, or a mesh (coil in [0012] and [0059]-[0060]), wherein the coil is wound to resist axial compression applied to the inner layer (in [0060], a partial compression and a transmission of compression forces is present, which imply a degree of compression resistance), while facilitating bending of the inner layer in a direction away from a longitudinal axis of the inner layer (coil elements bending in [0066]), the coil including a coil winding (shown in figure 6, where a spiral coil 222 is shown. Coil 222 in [0065]-[0066]) which provides compressive stiffness to the inner layer during axial compressive loads (the coil withstands compressive forces in [0059]-[0060]), the coil winding extending helically about a longitudinal axis of the inner layer and defines a central lumen between its proximal and distal ends (shown in figure 6-3 where coil 222 defined a central lumen and extends helically about part 214. Coil 222 also extends about part 224 in figure 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the coil of McNiven into the combination involving Le and Kirt for the purpose of providing a reinforcing means disclosed to “withstand high compression forces” in [0059] while allowing a bending in [0060] to allow for a navigation in a patient body.
Regarding claim 8, Le in view of Kirt teach and McNiven teach the expandable sheath of claim 7, wherein McNiven teaches the coil winding has a varying pitch along an entire length of the coil winding, wherein a pitch of the coil winding at a distal portion of the coil can be less than a pitch of the coil winding at a proximal portion of the coil (as per [0071], the pitch of the coil is related to an outer layer angle 430 and an inner layer angle 432, shown in figure 9. As the angle of 430 and 432 in figure 9 are different, a varying pitch is implied in [0070]-[0071]. As the outer angle 430 can be 20 degrees with the inner angle 432 ranging up to 85 degrees in [0070], if the proximal and distal ends of the coil are defined as being between parts 430 and 432, a distal pitch can be less than a proximal pitch of the coil) .
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the coil of McNiven into the combination involving Le and Kirt for the purpose of providing a reinforcing means disclosed to “withstand high compression forces” in [0059] while allowing a bending in [0060] to allow for a navigation in a patient body.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Franano (US Pub No.: 2017/0245864) considered for a support structure with coiled wires disclosed in the abstract. Mas (US Pub No.: 2009/0264859) considered for a catheter with an elongated outer an dinner members in the abstract and [0012].
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/AREN PATEL/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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