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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/7/2026 has been entered. Claims 1-20 are currently pending and under examination.
Claim Objections
Claims 11-17 are objected to because of the following informalities: Claim 11, line 8 should recite similar to –percutaneous device therethrough—in order to provide proper antecedent basis. Appropriate correction is required. Claims 12-17 directly or indirectly depend from claim 11 and are also objected to for the reasons stated above regarding claim 11.
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(s) 1-5, 8-12 and 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0197668 to Korkuch (Korkuch) in view of US 2019/0380563 to Sanghvi (Sanghvi) and US 2002/0111585 to Lafontaine (Lafontaine) (all previously cited).
In reference to at least claim 1
Korkuch discloses an introducer sheath for use in delivering percutaneous circulatory support devices (e.g. sheath assembly 430; “Blood pump assemblies are introduced surgically or percutaneously during a cardiac procedure through the vascular system.”, para. [0001]-[0002], “percutaneous heart pump”, [00017]-[0018], [0058], “implantable heart pumps or implantable cardiac assist devices”, para. [0088]), the introducer sheath comprising: a hub (e.g. “In certain implementations, a hub (not shown) may be coupled to the proximal end 425 of the sheath assembly 430. In other implementations, the first lumen 120 or the second lumen 130 or both may be configured with an elastomer valve.”, para. [0065]), an elongate tubular shaft extending distally from the hub (e.g. sheath assembly 430 has a sheath body 110 extending from the proximal end), the tubular shaft including a proximal portion opposite a distal portion and a body portion extending between the proximal portion and the distal portion (e.g. sheath assembly 430 has a sheath body 110 extending between the proximal and distal portion), the body portion defining a lumen of the tubular shaft configured for receiving at least one percutaneous circulatory support device (e.g. lumen 120 is configured to for passage of medical device 550, para. [0069]; medical device includes “percutaneous heart pump”, [00017]-[0018], [0058], “implantable heart pumps or implantable cardiac assist devices”, para. [0088]); at least one bypass opening positioned in the proximal portion of the tubular shaft (e.g. apertures “bypass openings” 505-508) such that the bypass opening extends from an exterior of the tubular shaft to the lumen of the tubular shaft (e.g. apertures 505-508 from an exterior of the tubular shaft to the lumen of the tubular shaft Figs. 5A-5B). Korkuch discloses a stylet (e.g. 200) positioned within another lumen of the tubular shaft (e.g. 200) and inhibiting the flow of blood proximal of the stylet (e.g. stylet 200 can occlude the apertures to resist blood flow, para. [0068], [0070]).
However, Korkuch does not disclose at least one plug being positioned within a lumen configured for receiving the at least one percutaneous circulatory support and being positioned proximally relative to the at least one bypass opening of the tubular shaft and distal of the hub.
Sanghvi discloses an introducer sheath (e.g. sheath 100) the introducer sheath comprising: a proximal portion (e.g. portion containing 102) opposite a distal portion (e.g. portion containing 104) and a body portion extending between the proximal portion and the distal portion (e.g. sheath 100 includes a flexible body 110 extending between the proximal and distal portion), the body portion defining a lumen of the tubular shaft configured for receiving at least one percutaneous circulatory support device (e.g. lumen 112 for receiving “dilator 150 and other tools, repair, rehabilitation or replacement devices that will be transported from outside a patient's body to the vasculature. “, para. [0019]) at least one bypass opening positioned in the proximal portion of the tubular shaft (e.g. holes 120 located in a proximal portion) such that the bypass opening extends from an exterior of the tubular shaft to the lumen of the introducer sheath (e.g. holes 120 extend from an exterior of the introducer sheath to the lumen of the introducer sheath Fig. 4) and at least one plug positioned within the lumen (e.g. hemostasis valve, para. [0019]), the at least one plug positioned proximally relative to the at least one bypass opening of the tubular shaft (e.g. “having a hemostasis valve to limit blood and/or air transport, the hub being disposed adjacent proximal end 102,”, which is proximal the holes 120, para. [0019]), wherein the at least one plug is configured to inhibit the flow of blood into the lumen proximal of the plug (e.g. “having a hemostasis valve to limit blood and/or air transport,”, para. [0019]).
Therefore, utilizing the combined teachings, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sheath of Korkuch to include a plug that includes a hemostasis valve located within a proximal portion of the lumen proximally relative one of the bypass opening, as taught by Sanghvi, in order to provide a fluid seal about an inserted device which limits blood transport inhibiting back-bleeding prior to, during and subsequent to device insertion (e.g. ‘563, para. [0019], ‘585, para. [0004]).
Further, regarding the plug being distal a hub, Lafontaine discloses that it was well known in the art before the effective filing date to provide within an introducer sheath a hemostasis valve such as a gasket with a hole or slit to form a fluid seal about inserted devices to inhibit back-bleeding (e.g. para. “inhibits blood loss as guide wires, catheters and the like are introduced, passed through and manipulated in the sheath” para. [0002], “The gasket 30 of the hemostasis valve assembly 18 forms a fluid seal about devices inserted therein to inhibit back-bleeding.”, para. [0004]-[0005)) but that such arrangement can cause back-bleeding to occur when no device is present or have a significant amount of friction (e.g. “A disadvantage of the slit 32 design is that a significant amount of friction may be encountered when sliding devices therethrough. An advantage of the hole 34 design is that relatively little friction is encountered when sliding devices therethrough. A disadvantage of the hole 34 design is that back-bleeding may occur when no device is inserted therein (i.e., prior to and subsequent to device insertion)”,para. [0005]). LaFontaine discloses an embodiment that includes a hemostasis value 130/140 that can be incorporated into any portion of a tubular device including the tubular shaft of an introducer sheath that prevent back-bleeding at all times while providing reduce friction (e.g. “The hemostasis valves 130/140 may be incorporated into a wide variety of intravascular tubular devices such as an introducer sheath, a catheter or the like. The hemostasis valves 130/140 may be incorporated into any portion of the tubular device (e.g., hub or shaft), at a common position or at different positions.”, para. [0028]; the hemostasis valve is longitudinally actuated between an open position to reduce friction during device insertion and a closed position to prevent back-bleeding when no devices are inserted therein.”, para. [0007]-[0008]).
Therefore, utilizing the combined teachings, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the sheath of Korkuch modified by Sanghvi to include a hemostasis valve “plug” incorporated into the tubular shaft of the introducer distal of the hub, as taught by Lafontaine, in order to provide a hemostasis valve that prevents back-bleeding at all times while providing reduced friction (‘585, para. [0007]-[0008]).
In reference to at least claim 2
Korkuch modified by Sanghvi and Lafontaine renders obvious a sheath according to claim 1. Korkuch further discloses wherein the at least one bypass opening comprises a plurality of bypass openings arranged at the proximal portion of the tubular shaft (e.g. plurality of apertures “bypass openings” 505-508).
In reference to at least claims 3-4
Korkuch modified by Sanghvi and Lafontaine renders obvious a sheath according to claim 1. The modified introducer would have the hemostasis valve positioned within the shaft of the introducer sheath distal the hub and proximal the holes 120, see rejection of claim 1 above, which is adjacent and proximal the holes 120.
In reference to at least claim 5
Korkuch modified by Sanghvi and Lafontaine renders obvious a sheath according to claim 1. Korkuch modified by Sanghvi and Lafontaine does not explicitly teach the plug being composed of a silicone. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include the plug being composed of a silicone, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, see MPEP 2144.07.
In reference to at least claim 8
Korkuch modified by Sanghvi and Lafontaine renders obvious a sheath according to claim 1. Sanghvi discloses the opening being lined by a radiopaque material (e.g. “ the proximal-most hole may have a radio-opaque marker”, para. [0022], claim 6). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Korkuch to include at least one bypass opening being lined by a radiopaque material, as taught by Sanghvi, in order to provide visualization of the bypass opening(s) during the insertion procedure for accurate positioning.
In reference to at least claim 9
Korkuch modified by Sanghvi and Lafontaine renders obvious a sheath according to claim 1. Lafontaine further discloses wherein the at least one plug comprises a central opening for sealingly engaging with a catheter positioned within the tubular shaft (e.g. gasket 30 has a central opening such as slit 32 or hole 34, Figs. 2A,2B and hemostasis valve 130 has a central opening between a plurality of leaflets or flaps 132 and opening between hemostasis valve 140, Figs. 5A,5B).
In reference to at least claim 10
Korkuch modified by Sanghvi and Lafontaine renders obvious a sheath according to claim 1. Lafontaine further discloses wherein the central opening is composed of a plurality of slits. (e.g. gasket 30 has a central opening such as slit 32, Figs. 2A,2B and hemostasis valve 130 has a central opening between a plurality of leaflets or flaps 132, Figs. 5A,5B).
In reference to at least claim 11
Korkuch discloses a percutaneous device delivery system for delivering a percutaneous device (e.g. systems shown within Figs. 4-7), the system comprising: a percutaneous device comprising an impeller housing for supporting an impeller, a motor configured to rotatably drive the impeller (e.g. used to deliver percutaneous heart pump, para. [0056], [0058]; discloses heart pump with motor and impeller, para. [0001]-[0002]); an introducer sheath for receiving the percutaneous device (e.g. sheath assembly 430, “also illustrates the passage of a medical device 550”, para. [0068]), the introducer sheath having a proximal portion opposite a distal portion and a body portion extending between the proximal portion, distal portion and a body portion extending between the proximal and distal portion (e.g. sheath body 110 extending between the proximal and distal portion), the body portion defining a lumen (e.g. lumens 120 and 130 are present within the sheath body 110, lumen 130 is the claimed “a lumen”) configured for advancing the percutaneous therethrough (e.g. lumen 120 is configured to for passage of medical device 550, para. [0069]; medical device includes “percutaneous heart pump”, [00017]-[0018], [0058], “implantable heart pumps or implantable cardiac assist devices”, para. [0088]), a hub positioned at a proximal end of the introducer sheath (e.g. “In certain implementations, a hub (not shown) may be coupled to the proximal end 425 of the sheath assembly 430. In other implementations, the first lumen 120 or the second lumen 130 or both may be configured with an elastomer valve.”, para. [0065]), wherein the proximal portion comprises at least one bypass opening (e.g. apertures “bypass openings” 505-508) extending from an exterior of the introducer sheath to the lumen of the introducer sheath (e.g. apertures 505-508 extend from an exterior of the introducer sheath to lumen 130 of the introducer sheath Figs. 5A-5B). Korkuch discloses a stylet (e.g. 200) positioned within another lumen of the tubular shaft (e.g. 200) and inhibiting the flow of blood proximal of the stylet (e.g. stylet 200 can occlude the apertures to resist blood flow, para. [0068], [0070]).
However, Korkuch does not disclose at least one plug being positioned within a lumen configured for receiving the at least one percutaneous circulatory support and being positioned proximally relative to the at least one bypass opening of the tubular shaft and distal of the hub.
Sanghvi discloses an introducer sheath (e.g. sheath 100) the introducer sheath comprising: a proximal portion (e.g. portion containing 102) opposite a distal portion (e.g. portion containing 104) and a body portion extending between the proximal portion and the distal portion (e.g. sheath 100 includes a flexible body 110 extending between the proximal and distal portion), the body portion defining a lumen of the tubular shaft configured for receiving at least one percutaneous circulatory support device (e.g. lumen 112 for receiving “dilator 150 and other tools, repair, rehabilitation or replacement devices that will be transported from outside a patient's body to the vasculature. “, para. [0019]) at least one bypass opening positioned in the proximal portion of the tubular shaft (e.g. holes 120 located in a proximal portion) such that the bypass opening extends from an exterior of the tubular shaft to the lumen of the introducer sheath (e.g. holes 120 extend from an exterior of the introducer sheath to the lumen of the introducer sheath Fig. 4) and at least one plug positioned within the lumen (e.g. hemostasis valve, para. [0019]), the at least one plug positioned proximally relative to the at least one bypass opening of the tubular shaft (e.g. “having a hemostasis valve to limit blood and/or air transport, the hub being disposed adjacent proximal end 102,”, which is proximal the holes 120, para. [0019]), wherein the at least one plug is configured to inhibit the flow of blood into the lumen proximal of the plug (e.g. “having a hemostasis valve to limit blood and/or air transport,”, para. [0019]).
Therefore, utilizing the combined teachings, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sheath of Korkuch to include a plug that includes a hemostasis valve located within a proximal portion of the lumen proximally relative one of the bypass opening, as taught by Sanghvi, in order to provide a fluid seal about an inserted device which limits blood transport inhibiting back-bleeding prior to, during and subsequent to device insertion (e.g. ‘563, para. [0019], ‘585, para. [0004]).
Further, regarding the plug being distal a hub, Lafontaine discloses that it was well known in the art before the effective filing date to provide within an introducer sheath a hemostasis valve such as a gasket with a hole or slit to form a fluid seal about inserted devices to inhibit back-bleeding (e.g. para. “inhibits blood loss as guide wires, catheters and the like are introduced, passed through and manipulated in the sheath” para. [0002], “The gasket 30 of the hemostasis valve assembly 18 forms a fluid seal about devices inserted therein to inhibit back-bleeding.”, para. [0004]-[0005)) but that such arrangement can cause back-bleeding to occur when no device is present or have a significant amount of friction (e.g. “A disadvantage of the slit 32 design is that a significant amount of friction may be encountered when sliding devices therethrough. An advantage of the hole 34 design is that relatively little friction is encountered when sliding devices therethrough. A disadvantage of the hole 34 design is that back-bleeding may occur when no device is inserted therein (i.e., prior to and subsequent to device insertion)”,para. [0005]). LaFontaine discloses an embodiment that includes a hemostasis value 130/140 that can be incorporated into any portion of a tubular device including the tubular shaft of an introducer sheath that prevent back-bleeding at all times while providing reduce friction (e.g. “The hemostasis valves 130/140 may be incorporated into a wide variety of intravascular tubular devices such as an introducer sheath, a catheter or the like. The hemostasis valves 130/140 may be incorporated into any portion of the tubular device (e.g., hub or shaft), at a common position or at different positions.”, para. [0028]; the hemostasis valve is longitudinally actuated between an open position to reduce friction during device insertion and a closed position to prevent back-bleeding when no devices are inserted therein.”, para. [0007]-[0008]).
Therefore, utilizing the combined teachings, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the sheath of Korkuch modified by Sanghvi to include a hemostasis valve “plug” incorporated into the tubular shaft of the introducer distal of the hub, as taught by Lafontaine, in order to provide a hemostasis valve that prevents back-bleeding at all times while providing reduced friction (‘585, para. [0007]-[0008]).
In reference to at least claim 12
Korkuch modified by Sanghvi and Lafontaine renders obvious a system according to claim 11. Sanghvi discloses the opening being lined by a radiopaque material (e.g. “ the proximal-most hole may have a radio-opaque marker”, para. [0022], claim 6). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Korkuch to include at least one bypass opening being lined by a radiopaque material, as taught by Sanghvi, in order to provide visualization of the bypass opening(s) during the insertion procedure for accurate positioning.
In reference to at least claim 14
Korkuch modified by Sanghvi and Lafontaine renders obvious a system according to claim 11. Korkuch further discloses wherein the at least one bypass opening comprises a plurality of bypass openings arranged at the proximal portion of the tubular shaft (e.g. plurality of apertures “bypass openings” 505-508).
In reference to at least claim 15
Korkuch modified by Sanghvi and Lafontaine renders obvious a system according to claim 11. Korkuch modified by Sanghvi and Lafontaine does not explicitly teach the plug being composed of a silicone. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include the plug being composed of a silicone, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice, see MPEP 2144.07.
In reference to at least claim 16
Korkuch modified by Sanghvi and Lafontaine renders obvious a system according to claim 11. Lafontaine further discloses wherein the at least one plug comprises a central opening for sealingly engaging with a catheter positioned within the tubular shaft (e.g. gasket 30 has a central opening such as slit 32 or hole 34, Figs. 2A,2B and hemostasis valve 130 has a central opening between a plurality of leaflets or flaps 132 and opening between hemostasis valve 140, Figs. 5A,5B).
In reference to at least claim 17
Korkuch modified by Sanghvi and Lafontaine renders obvious a system according to claim 11. Lafontaine further discloses wherein the central opening is composed of a slit. (e.g. gasket 30 has a central opening such as slit 32, Figs. 2A,2B and hemostasis valve 130 has a central opening between a plurality of leaflets or flaps 132, Figs. 5A,5B).
In reference to at least claim 18
Korkuch discloses a method for delivering a percutaneous device into a patient (e.g. systems used to deliver a percutaneous device shown within Figs. 4-7), inserting an introducer sheath into a vessel of the patient (e.g. sheath assembly 430 introduced into the patient, Fig. 4), the introducer sheath comprising a proximal portion opposite a distal portion (e.g. sheath assembly 430 has a proximal portion and a distal portion, Fig. 4), a body portion extending between the proximal portion and the distal portion (e.g. sheath assembly 430 includes a sheath body 110 extending between the proximal and distal portion) and the body portion defining a lumen (e.g. lumens 120 and 130 are present within the sheath body 110, lumen 130 is the claimed “a lumen”), a hub positioned at a proximal end of the introducer sheath (e.g. “In certain implementations, a hub (not shown) may be coupled to the proximal end 425 of the sheath assembly 430. In other implementations, the first lumen 120 or the second lumen 130 or both may be configured with an elastomer valve.”, para. [0065]), and at least one bypass opening arranged at the proximal portion of the introducer sheath (e.g. apertures “bypass openings” 505-508); the at least one bypass opening extending from an exterior of the introducer sheath to the lumen of the tubular shaft (e.g. apertures 505-508 from an exterior of the tubular shaft to the lumen of the tubular shaft Figs. 5A-5B), inserting the percutaneous device into the lumen of the introducer sheath and advancing the device to a target position in the patient (e.g. lumen 120 is configured to for passage of medical device 550, para. [0069]; medical device includes “percutaneous heart pump”, [00017]-[0018], [0058], “implantable heart pumps or implantable cardiac assist devices”, para. [0088]). Korkuch discloses a stylet (e.g. 200) positioned within another lumen of the tubular shaft (e.g. 200) and inhibiting the flow of blood proximal of the stylet (e.g. stylet 200 can occlude the apertures to resist blood flow, para. [0068], [0070]).
However, Korkuch does not disclose inserting a plug into the introducer sheath arranged such that the plug is positioned distal of the hub and adjacent to and proximally relative to the at least one bypass opening, wherein the plug is configured to inhibit the flow of blood into the lumen proximal of the plug.
Sanghvi discloses an introducer sheath (e.g. sheath 100) the introducer sheath comprising: a proximal portion (e.g. portion containing 102) opposite a distal portion (e.g. portion containing 104) and a body portion extending between the proximal portion and the distal portion (e.g. sheath 100 includes a flexible body 110 extending between the proximal and distal portion), the body portion defining a lumen of the tubular shaft configured for receiving at least one percutaneous circulatory support device (e.g. lumen 112 for receiving “dilator 150 and other tools, repair, rehabilitation or replacement devices that will be transported from outside a patient's body to the vasculature. “, para. [0019]) at least one bypass opening positioned in the proximal portion of the tubular shaft (e.g. holes 120 located in a proximal portion) such that the bypass opening extends from an exterior of the tubular shaft to the lumen of the introducer sheath (e.g. holes 120 extend from an exterior of the introducer sheath to the lumen of the introducer sheath Fig. 4) and at least one plug positioned within the lumen (e.g. hemostasis valve, para. [0019]), the at least one plug positioned proximally relative to the at least one bypass opening of the tubular shaft (e.g. “having a hemostasis valve to limit blood and/or air transport, the hub being disposed adjacent proximal end 102,”, which is proximal the holes 120, para. [0019]), wherein the at least one plug is configured to inhibit the flow of blood into the lumen proximal of the plug (e.g. “having a hemostasis valve to limit blood and/or air transport,”, para. [0019]).
Therefore, utilizing the combined teachings, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sheath of Korkuch to include inserting a plug that includes a hemostasis valve located within a proximal portion of the lumen proximally relative one of the bypass opening, as taught by Sanghvi, in order to provide a fluid seal about an inserted device which limits blood transport inhibiting back-bleeding prior to, during and subsequent to device insertion (e.g. ‘563, para. [0019], ‘585, para. [0004]).
Further, regarding the plug being distal a hub, Lafontaine discloses that it was well known in the art before the effective filing date to provide within an introducer sheath a hemostasis valve such as a gasket with a hole or slit to form a fluid seal about inserted devices to inhibit back-bleeding (e.g. para. “inhibits blood loss as guide wires, catheters and the like are introduced, passed through and manipulated in the sheath” para. [0002], “The gasket 30 of the hemostasis valve assembly 18 forms a fluid seal about devices inserted therein to inhibit back-bleeding.”, para. [0004]-[0005)) but that such arrangement can cause back-bleeding to occur when no device is present or have a significant amount of friction (e.g. “A disadvantage of the slit 32 design is that a significant amount of friction may be encountered when sliding devices therethrough. An advantage of the hole 34 design is that relatively little friction is encountered when sliding devices therethrough. A disadvantage of the hole 34 design is that back-bleeding may occur when no device is inserted therein (i.e., prior to and subsequent to device insertion)”,para. [0005]). LaFontaine discloses an embodiment that includes a hemostasis value 130/140 that can be incorporated into any portion of a tubular device including the tubular shaft of an introducer sheath that prevent back-bleeding at all times while providing reduce friction (e.g. “The hemostasis valves 130/140 may be incorporated into a wide variety of intravascular tubular devices such as an introducer sheath, a catheter or the like. The hemostasis valves 130/140 may be incorporated into any portion of the tubular device (e.g., hub or shaft), at a common position or at different positions.”, para. [0028]; the hemostasis valve is longitudinally actuated between an open position to reduce friction during device insertion and a closed position to prevent back-bleeding when no devices are inserted therein.”, para. [0007]-[0008]).
Therefore, utilizing the combined teachings, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the method of Korkuch modified by Sanghvi to include a hemostasis valve “plug” incorporated into the tubular shaft of the introducer such that the plug is positioned distal of the hub, wherein the plug is configured to inhibit the flow of blood into the lumen proximal of the plug, as taught by Lafontaine, in order to provide a hemostasis valve that prevents back-bleeding at all times while providing reduced friction (‘585, para. [0007]-[0008]).
In reference to at least claim 19
Korkuch modified by Sanghvi and Lafontaine renders obvious a method according to claim 18. Korkuch discloses removing the plug from the introducer sheath and removing the percutaneous device through the introducer sheath (e.g. withdraws…the medical device, para. [0119]).
In reference to at least claim 20
Korkuch modified by Sanghvi and Lafontaine renders obvious a method according to claim 18. Korkuch further discloses wherein the at least one bypass opening comprises a plurality of bypass openings arranged at the proximal portion of the tubular shaft (e.g. plurality of apertures “bypass openings” 505-508). The modified introducer would have the hemostasis valve positioned within the shaft of the introducer sheath distal the hub and proximal the holes 120, see rejection of claim 11 above, which is adjacent and proximal the holes 120, i.e. plug being positioned proximally of a proximal-most bypass opening of the plurality of bypass openings.
Claim(s) 6-7 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0197668 to Korkuch (Korkuch) in view of US 2019/0380563 to Sanghvi (Sanghvi) and US 2002/0111585 to Lafontaine (Lafontaine) as applied to claims 1 and 11 further in view of US 2007/0244544 to Birdsall et al. (Birdsall) (previously cited).
In reference to at least claim 6
Korkuch modified by Sanghvi and Lafontaine renders obvious a sheath according to claim 1. The use of a radiopaque marker “material” to visualize certain elements of an implanted device or catheter to provide visualization was well known in the art as evidence by Birdsall (e.g. para. [0039]), therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Korkuch modified by Sanghvi and Lafontaine to include the hemostasis valve being coated with a radiopaque material in order to provide visualization of the hemostasis valve assembly during the insertion procedure for accurate positioning.
In reference to at least claim 7
Korkuch modified by Sanghvi and Lafontaine renders obvious a sheath according to claim 1. The use of a radiopaque marker “material” to visualize certain elements of an implanted device or catheter to provide visualization was well known in the art as evidence by Birdsall (e.g. para. [0039]), therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Korkuch modified by Sanghvi and Lafontaine to include the hemostasis valve assembly being composed of a radiopaque material in order to provide visualization of the hemostasis valve assembly during the insertion procedure for accurate positioning.
In reference to at least claim 13
Korkuch modified by Sanghvi and Lafontaine renders obvious a system according to claim 11. The use of a radiopaque marker “material” to visualize certain elements of an implanted device or catheter to provide visualization was well known in the art as evidence by Birdsall (e.g. para. [0039]), therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the device of Korkuch modified by Sanghvi and Lafontaine to include the hemostasis valve assembly being composed of a radiopaque material in order to provide visualization of the hemostasis valve assembly during the insertion procedure for accurate positioning.
Response to Arguments
Claim Rejections – 35 USC 102
Applicant’s arguments, see pgs. 6-7, filed 2/9/2026, with respect to the rejection(s) of claim(s) 11,13-14,16 and 18-19 under 35 USC 102 using Korkuch have been fully considered and are persuasive in view of the claim amendments. Therefore, the rejections against claims 11,13-14,16 and 18-19 under 35 USC 102 using Korkuch have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 2019/0380563 to Sanghvi and US 2002/0111585 to Lafontaine, see claim rejections above.
Claim Rejections – 35 USC 103
Applicant's arguments filed 2/9/2026 have been fully considered but they are not persuasive. It is noted that applicant has not provided separate arguments from the ones made within the after-final received on 2/9/2026 which were fully addressed within the advisory action mailed 3/12/2026 and are repeated herein. Applicant argues that there would be no motivation to modify Korkuch to add a plug as proposed, see pg. 7-8 of response filed 2/9/2026, the examiner respectfully disagrees. As stated within the rejection the purpose of the hemostasis valve is to limit blood transport and inhibit back-bleeding which is not disclosed as being performed by Korkuch. Further, as mentioned within the rejection, the prior art discloses the use of a hemostasis valve along any portion of a tubular device including the tubular shaft of an introducer sheath to prevent back-bleeding at all times even when other devices/components are not located within the lumen of the catheter. Therefore, it would be obvious to use the hemostasis valve within Korkuch as such technique was known within the art and would have prevented back-bleeding at all times even when the stylet is not present. Applicant argues that none of the references teach a plug positioned within the lumen configured for receiving the percutaneous device, see pg. 8 of response filed 2/9/2026, the examiner respectfully disagrees. Lafontaine discloses that a hemostasis value 130/140 can be incorporated into any portion of a tubular device including the tubular shaft of an introducer sheath that prevent back-bleeding at all times while providing reduce friction, see "The hemostasis valves 130/140 may be incorporated into a wide variety of intravascular tubular devices such as an introducer sheath, a catheter or the like. The hemostasis valves 130/140 may be incorporated into any portion of the tubular device (e.g., hub or shaft), at a common position or at different positions.", para. [0028]. Therefore placing the hemostasis valve within a lumen within the shaft of the tubular device distal of the hub is disclosed by Lafontaine and the combined teachings of Korkuch, Sanghvi and Lafontaine renders obvious the plug positioned as claimed.
Separate arguments are not provided for claims 2-10 and 20, therefore claims 2-10 and 20 are believed to be addressed within the response to 102 and 103 rejections above.
Separate arguments are not provided for claims 12, 15 and 17 but instead relies on the amendments made to claim 11, therefore claims 12,15 and 17 are believed to be addressed within the response to 102 rejections above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER L GHAND whose telephone number is (571)270-5844. The examiner can normally be reached Mon-Fri 7:30AM - 3:30PM ET.
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, JENNIFER MCDONALD can be reached at (571)270-3061 or CARL LAYNO can be reached at (571)272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JENNIFER L GHAND/Examiner, Art Unit 3796
Prosecution Insights