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 .
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.
Claims 28-31 and 33-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated under Fischer (WO 2016059026 A1).
Regarding claim 28, Fischer discloses an implantable device (1) comprising: a tubular member defining a lumen having a longitudinal axis from a proximal end to a distal end of the tubular member (fig. 2 annotated below illustrates a tubular member 1 defining a lumen having a longitudinal axis from a proximal to distal ends), the tubular member configured to transition from an unexpanded configuration towards a fully expanded, deployed configuration (pg. 2, ¶ 4 discloses a tubular member 1 transitioning from a unexpanded/compressed configuration to an expanded configuration), wherein the unexpanded configuration has a first cross-sectional shape taken perpendicular to the longitudinal axis that is substantially round without sides (pg. 2, ¶ 4 discloses an unexpanded stent with a circular cross-section and fig. 2 illustrates a stent with a round cross-section, perpendicular to the longitudinal axis, without sides) and the deployed configuration has a second cross-sectional shape taken perpendicular to the longitudinal axis that is substantially non-round and multi-sided (pg. 2 ¶ 4 discloses that upon expansion of the stent the stent assumes a non-circular cross-section and pg. 3 ¶ 2 discloses a stent with a rectangular cross-section and four sides).
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Regarding claim 29, Fischer discloses the invention as claimed as discussed with respect to claim 28. Fischer further discloses that the first cross-sectional shape is circular, oval, or elliptical (pg. 5, ¶ 3 discloses a stent having first circular cross-sectional or rounded shape during expansion which then deviates to a shape that is non-round or deviates from a circular cross-sectional shape).
Regarding claim 30, Fischer discloses the invention as claimed as discussed with respect to claim 28. Fischer further discloses that the second cross-sectional shape is square or triangular (pg. 3, ¶ 1 discloses that the second, expanded, or non-round cross-section may be the cross-section of a polygonal, rectangular, square, or oval shape).
Regarding claim 31, Fischer discloses the invention as claimed as discussed with respect to claim 30. Fischer further discloses that the second cross-sectional shape has rounded corners and generally flat sides (pg. 3, ¶ 1 discloses that the second, expanded, or non-round cross-section may have rounded corners and ¶ 2 discloses a stent with rectangular cross-section with flattened sides).
Regarding claim 33, Fischer discloses the invention as claimed as discussed with respect to claim 28. Fischer further discloses that the tubular member (1) is capable of transitioning from the unexpanded configuration to a transitional configuration before transitioning into the deployed configuration (due to self-expanding design comprising shape-memory materials).
Regarding claim 34, Fischer discloses the invention as claimed as discussed with respect to claim 33. Fischer further discloses that the tubular member is capable of being reoriented relative to the anatomy when in the transitional configuration and before transitioning to the deployed configuration (due to stents ability to be retracted back in case of incorrect positioning before full expansion Fischer pg. 6, ¶ 3).
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chou (US 20200289136 A1), in view of Goyal (US 20190070387 A1) and Diethrich et al. (Diethrich et al., Percutaneous techniques for endoluminal carotid interventions, 1996, J. Endovasc. Surg. 3, 182-202).
Regarding claim 1, Chou discloses a method of performing a medical procedure at a treatment site (¶ 0008 discloses a system and method to restore flow of blocked vessels) the method comprising: positioning a system of devices into an advancement configuration (¶ 0009 discloses a catheter system including catheter advancement elements), the system of devices comprising: a catheter having a catheter lumen, an inner diameter and a distal end (¶ 0009 discloses a catheter 200 having a lumen and distal ends); and an inner member sized and shaped to slide within the catheter lumen (¶ 0207 discloses sliding/accommodating the inner member 360 relative to the catheter 200), wherein the inner member defines a single lumen and has a distal portion (fig. 2a illustrates an inner member 360 and fig. 2b illustrates an inner member 360 disposed within the lumen of a catheter 200), the distal portion (346) having a first outer diameter that tapers distally to a second outer diameter that is smaller than the first outer diameter (fig. 2b illustrates a distal member 346 that tapers distally to a second diameter smaller than the first outer diameter), wherein the inner member transitions in flexibility from a proximal end of the inner member to a distal end of the inner member (¶ 0178 discloses an inner member 360 with transitions in flexibility from very flexible distal regions and less flexible proximal regions), the distal end of the inner member being more flexible than the distal end of the catheter (¶ 0178), and wherein, when positioned in the advancement configuration, the inner member extends coaxially through the catheter lumen until the distal portion of the inner member is positioned distal to the distal end of the catheter (¶ 0009 discloses the catheter advancement element/inner member 360 has an advancement configuration in which the inner member 360 extends coaxially within the lumen of the distal catheter portion and its snug point or distal portion is aligned with the distal catheter portion); advancing the catheter and the flexible inner member while the system of devices is positioned in the advancement configuration (¶ 0014 discloses advancing a first assembled coaxial system of devices, including a flexible inner member 360 with as disclosed in ¶ 0178, towards a treatment site within a cerebral blood vessel comprising an occlusion); positioning the catheter at the treatment site, the treatment site comprising an occlusion; removing the inner member from the patient; and treating the occlusion through the catheter to restore outflow of blood from the brain (¶ 0014 discloses advancing a first assembled coaxial system of devices, including a flexible inner member 360 with as disclosed in ¶ 0178, towards a treatment site within a cerebral blood vessel comprising an occlusion. ¶ 0014 further discloses removing an inner member or first delivery element and treating the site by anchoring the occlusion via aspiration pressure. ¶ 0008 discloses accessing an occlusion site and restoring the vessels blood flow).
Chou does not specifically disclose that the catheter treatment site is the dural venous sinus, advancing a catheter and flexible member retrograde specifically to a target location distal to the sigmoid sinus, or that treatment specifically restores the outflow of blood from the brain through the dural venous sinus. Goyal also discloses a method of performing a medical procedure at a treatment site in a dural venous sinus of a patient (abstract). Goyal teaches advancing a catheter to a target location distal to a sigmoid sinus (fig. 5a illustrates a distal access catheter and ¶ 0053 discloses that a catheter system is advances through the sigmoid sinus to a desired location to conduct a recanalization procedure), positioning the catheter at the treatment site in the dural venous sinus (¶ 0022 discloses methods of accessing cerebral venous vessels in the dural venous sinus with catheter systems), and treating the occlusion through the catheter to restore outflow of blood from the brain though the dural venous sinus (fig. 5a and 5b illustrate treating an occlusion with a distal access catheter by engulfing, macerating, and withdrawing the clot via suction and ¶ 0053 – ¶ 0056 disclose accessing the desired location in the dural venous sinus and performing techniques for clot removal and recanalization/blood flow restoration). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the methods of Chou to include advancing the catheter to the target location distal specifically to a sigmoid sinus, positioning the catheter at the treatment site in the dural venous sinus, and treating the occlusion through the catheter to restore outflow of blood from the brain though the dural venous sinus as taught by Goyal in order to enable dural venous sinus thrombosis treatment (Goyal ¶ 0015).
Chou in view of Goyal fails to disclose that advancing the catheter and flexible member specifically in retrograde to the target location. Diethrich also discloses methods for performing endoluminal carotid interventions used for thrombolytic therapies and stent deployments (pg. 183, col. 1) as described in the present application. Diethrich teaches advancing a catheter retrograde to a target relative to an access point of entry (pg. 192 col. 2 discloses and fig. 17 on pg. 193 illustrates a retrograde approach with a femoral artery as the access point in which a catheter is guided into an aortic arch and manipulated into the vessel of choice). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Chou in view of Goyal and perform the step of advancing the catheter and the flexible inner member retrograde to the target as taught by Diethrich in order to have easier access for stent deployment (pg. 190, col. 1).
Regarding claim 2, Chou in view of Goyal further in view of Diethrich disclose the invention as claimed as discussed above with respect to claim 1. Chou also discloses that the step of treating comprises removing thrombotic material by applying aspiration to the catheter (¶ 0092 discloses devices configured to provide thrombotic treatments such as an aspiration embolectomy).
Regarding claim 3, Chou in view of Goyal further in view of Diethrich further discloses that the step of treating comprises stenting the occlusion in the dural venous sinus with a stent delivered through the catheter (Chou ¶ 0005 discloses stenting/engaging a clot/occlusion in the cerebral anatomy. ¶ 0006-0007 disclose accessing cerebral anatomy and delivering interventional devices such stents by using catheters and guide sheaths; Goyal ¶ 0015).
Regarding claim 4, Chou in view of Goyal further in view of Diethrich disclose the invention as claimed as discussed above with respect to claim 1. Chou also discloses that the inner member further comprises a proximal segment, wherein the proximal segment comprises a hypotube (¶ 0178 discloses that the inner member 300 includes an extension or proximal segment 366 that is a hypotube).
Regarding claim 5, Chou in view of Goyal further in view of Diethrich disclose the invention as claimed as discussed above with respect to claim 1. Chou also discloses that the inner member (300) further comprises an intermediate segment (371) comprising an unreinforced polymer (¶ 0197 discloses that the intermediate segment 371 is an unreinforced polymer) having a first durometer and the distal portion comprises a polymer different from the unreinforced polymer of the intermediate segment (¶ 0196 discloses an intermediate segment 371 having a different polymer or a different material with a higher durometer compared to the distal portion).
Regarding claim 6, Chou in view of Goyal further in view of Diethrich disclose the invention as claimed as discussed above with respect to claim 5. Chou also discloses that the polymer of the distal portion has a second durometer less than the first durometer (¶ 0196 discloses a distal tip 346 with a material hardness (e.g., 62A and 35D) that transitions proximally towards increasingly harder materials with higher durometers (e.g., 55D and 72D)).
Regarding claim 7, Chou in view of Goyal further in view of Diethrich disclose the invention as claimed as discussed above with respect to claim 1. Chou also discloses that the distal portion has a tapered portion that tapers distally from the first outer diameter of between 0.048” and 0.080” to the second outer diameter of about 0.031” up to about 0.048” over a length between 0.5 cm and 4.0 cm (¶ 0188 discloses and fig. 2a illustrates a distal portion 346 that tapers from a diameter of 0.048" to a diameter of 0.031" over a length of 1.0 cm).
Regarding claim 8, Chou in view of Goyal further in view of Diethrich disclose the invention as claimed as discussed above with respect to claim 1. Chou also discloses that the inner member has a length capable of extending from outside a patient’s body, through a femoral artery and beyond the sigmoid sinus (¶ 0006 discloses accessing cerebral anatomy and guiding interventional devices from a femoral artery to the target anatomy and that the length of each element in the coaxial assemblage takes into account the length of the guide, proximal connectors on the catheters, and the length needed to extend from the distal end to target anatomy).
Regarding claim 9, Chou in view of Goyal further in view of Diethrich disclose the invention as claimed as discussed above with respect to claim 1. Chou also discloses that the inner member tapered portion has a taper angle of a wall of the tapered portion relative to a center line of the tapered portion is between 0.9 to 1.6 degrees (¶ 0188 discloses that the angle of the taper can be between 0.9 and 1.6 relative to horizontal or centerline).
Regarding claim 10, Chou in view of Goyal further in view of Diethrich disclose the invention as claimed as discussed above with respect to claim 9. Chou also discloses that the inner member tapered portion has a flexibility, shape, and taper length configured to be atraumatically delivered to a venous sinus (¶ 0190 discloses a tapered distal tip 346 with an atraumatic and flexible characteristic not only a result of its taper/shape but in addition a result of its material property).
Regarding claim 11, Chou in view of Goyal further in view of Diethrich disclose the invention as claimed as discussed above with respect to claim 1. Chou also discloses that the first outer diameter of the inner member and the inner diameter of the catheter lumen have a close fit (¶ 0185 discloses the diameter of an inner member 360 having a close/snug fit with the lumen 222 of a catheter 200) configured to allow the catheter and the inner member to be advanced in the advancement configuration through tortuous, branched venous anatomy to reach the target location for treatment in the distal venous sinuses and aids in preventing the distal end of the catheter from catching on branches and tributaries (¶ 0191 discloses an inner member 360 with an outer diameter smaller and the inner diameter of the catheter 200 lumen 222 and that having a gap that is too loose forms a lip making the device prone to catching onto branching vessels during advancement).
Regarding claim 12, Chou in view of Goyal further in view of Diethrich disclose the invention as claimed as discussed above with respect to claim 1. Chou also discloses that the second outer diameter is about ½ of the first outer diameter, about 40% of the first outer diameter, or about 65% of the first outer diameter (¶ 0188 discloses a distal tip 346 with a taper that may be from an outer diameter of 0.048" down to 0.031" equating to about 65%, an outer diameter of 0.062" down to 0.031 equating to 50%, or an outer diameter of 0.080" down to 0.031" equating to about 40%).
Regarding claim 13, Chou in view of Goyal further in view of Diethrich disclose the invention as claimed as discussed above with respect to claim 1. Chou also discloses that the second outer diameter is at a distal-most terminus of the inner member (annotated fig. 2a illustrates a distal tip 346 with a second or smaller diameter at the distal-most terminus of the inner member).
Regarding claim 14, Chou in view of Goyal further in view of Diethrich discloses the invention as claimed as discussed above with respect to claim 1. Chou also discloses that the single lumen of the flexible elongate body has an inner diameter of less than 0.024 inches (¶ 0195 discloses an inner member 360 and single lumen 368 with an inner luminal diameter between 0.020" and 0.024").
Regarding claim 15, Chou in view of Goyal further in view of Diethrich disclose the invention as claimed as discussed above with respect to claim 1. Chou also discloses extending a guidewire within the single lumen so that a distal-most end of the guidewire is housed within the inner member proximal to a distal opening from the single lumen (¶ 0195 discloses that a guidewire may extend through a single lumen 368 from a proximal opening to a distal opening).
Regarding claim 16, Chou in view of Goyal further in view of Diethrich disclose the invention as claimed as discussed above with respect to claim 1. Chou also discloses that the lengths of the catheter and the inner member are capable of extending to the venous sinus (due to a coaxial assemblage that takes into account the length of the guide, proximal connectors on the catheters, and the length needed to extend from the distal end to target cerebral anatomy, ¶ 0006). Chou further discloses a catheter advancement device with a flexibility sufficient/capable of reaching the venous sinus (due to a degree of flexibility suitable to advance through cerebral vasculature anatomy without kinking or ovalizing even when navigating hairpin turns, ¶ 0116).
Regarding claim 17, Chou discloses a method for performing a medical procedure (¶ 0008 discloses a system and method to restore flow of blocked vessels), the method comprising: advancing a catheter and a flexible inner member positioning the catheter at the treatment site removing the inner member from the patient; and advancing a treatment device through the catheter to the treatment site (¶ 0014 and ¶ 0178 disclose advancing a first assembled coaxial system of devices, including a catheter 200 and flexible inner member 360 towards a treatment site within a cerebral blood vessel comprising an occlusion. ¶ 0014 further discloses removing an inner member or first delivery element and advancing a second delivery element or treatment device and applying pressure through the lumen of the second delivery element to treat the site).
Chou fails to disclose that the treatment site is specifically in the dural venous sinus of a brain of a patient and advancing the catheter specifically to the target location distal to a sigmoid sinus relative to an access point of entry. Goyal also discloses a method of performing a medical procedure (abstract). Goyal teaches positioning a catheter at a treatment site in the dural venous sinus (¶ 0053 discloses that a catheter system is advanced through the sigmoid sinus to a desired location to conduct a recanalization procedure. Goyal further teaches advancing a catheter specifically to a target location distal to a sigmoid sinus relative to an access point of entry (fig. 5a illustrates a distal access catheter and ¶ 0049-0053 disclose that after gaining access a distal access catheter system is advanced through the sigmoid sinus). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of performing a medical procedure of Chou to include positioning the catheter at a treatment site in the dural venous sinus and advancing the catheter specifically to the target location distal to a sigmoid sinus relative to an access point of entry as taught by Goyal in order to enable dural venous sinus thrombosis treatment (Goyal ¶ 0015).
Chou in view of Goyal fails to disclose advancing a catheter and flexible inner member specifically in retrograde. Diethrich also discloses methods for performing endoluminal carotid interventions used for thrombolytic therapies and stent deployments (pg. 183, col. 1) as described in the present application. Diethrich teaches advancing a catheter retrograde to a target location (pg. 192 col. 2 discloses and fig. 17 on pg. 193 illustrates a retrograde approach with a femoral artery as the access point in which a catheter is guided into an aortic arch and manipulated into the vessel of choice). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Chou in view of Goyal to include advancing the catheter and the flexible inner member retrograde to the target as taught by Diethrich in order to have easier access for stent deployment (pg. 190, col. 1)
Regarding claim 18, Chou in view of Goyal further in view of Diethrich disclose the invention as claimed as discussed with respect to claim 17. Chou also discloses that the treatment device comprises an aspiration device, an implant delivery device, or a cerebral treatment device (¶ 0014 discloses a second delivery element or treatment device that is used to apply aspiration pressure and ¶ 0119 discloses that the catheter is not limited to only aspiration but that it may be used to deliver a stent retriever or other working/treatment devices).
Regarding claim 19, Chou discloses a method of performing a medical procedure at a treatment site (¶ 0008 discloses a system and method to restore flow of blocked vessels), the method comprising: advancing a system of devices, the system of devices (¶ 0014 discloses advancing a first assembled coaxial system of devices) comprising: a catheter having a catheter lumen, an inner diameter and a distal end (¶ 0009 discloses a catheter 200 having a lumen and distal ends); and an inner member sized and shaped to slide within the catheter lumen (¶ 0207 discloses sliding/accommodating the inner member 360 relative to the catheter 200), wherein the inner member (360) has a distal portion (346) having a first outer diameter that tapers distally to a second outer diameter that is smaller than the first outer diameter (fig. 3b illustrates a distal member 346 that tapers distally to a second diameter smaller than the first outer diameter), and wherein, when positioned in the advancement configuration, the inner member extends coaxially through the catheter lumen and the distal portion of the inner member is positioned distal to the distal end of the catheter (¶ 0009 discloses the catheter advancement element/inner member 360 has an advancement configuration in which the inner member 360 extends coaxially within the lumen of the distal catheter portion and its snug point or distal portion is aligned with the distal catheter portion); positioning the catheter at the treatment site, the treatment site comprising an occlusion; and treating the occlusion with an expandable implant (¶ 0014 discloses advancing a first assembled coaxial system of devices, including a flexible inner member 360 with as disclosed in ¶ 0178, towards a treatment site within a cerebral blood vessel comprising an occlusion. ¶ 0005 further discloses treating the site by stenting/engaging a clot/occlusion in the cerebral anatomy. ¶ 0008 discloses accessing an occlusion site and restoring the vessels blood flow).
Chou fails to disclose performing a medical procedure at a treatment site specifically in the dural venous sinus of a brain of a patient, advancing a system of devices specifically to a target location distal to a sigmoid sinus relative to an access point of entry, and positioning a catheter at the treatment site specifically in the dural venous sinus, and that an expandable implant restores outflow of blood from the brain specifically through the dural venous sinus. Goyal also discloses a method of performing a medical procedure and teaches that the treatment site is specifically the dural venous sinus of a patient (abstract). Goyal teaches advancing a system of devices to a target location distal to a sigmoid sinus (fig. 5a illustrates a distal access catheter system and ¶ 0053 discloses that a catheter system is advances through the sigmoid sinus to a desired location to conduct a recanalization procedure), positioning the catheter at the treatment site in the dural venous sinus (¶ 0022 discloses methods of accessing cerebral venous vessels in the dural venous sinus with catheter systems), and treating the occlusion to restore outflow of blood from the brain though the dural venous sinus (¶ 0053 – ¶ 0056 disclose accessing the desired location in the dural venous sinus and performing techniques for clot removal and recanalization/blood flow restoration). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the methods of Chou to include advancing the catheter to the target location distal specifically to a sigmoid sinus, positioning the catheter at the treatment site in the dural venous sinus, and treating the occlusion through the catheter to restore outflow of blood from the brain though the dural venous sinus as taught by Goyal in order to enable dural venous sinus thrombosis treatment (Goyal ¶ 0015).
Chou as modified Goyal also fails to disclose advancing a system of devices specifically in retrograde to a target location. Diethrich also discloses methods for performing endoluminal carotid interventions used for thrombolytic therapies and stent deployments (pg. 183, col. 1) as described in the present application. Diethrich teaches advancing a catheter in retrograde relative to an access point of entry (pg. 192 col. 2 discloses and fig. 17 on pg. 193 illustrates a retrograde approach with a femoral artery as the access point in which a catheter is guided into an aortic arch and manipulated into the vessel of choice). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the methods of Chou in view of Goyal to include advancing the catheter and the flexible inner member in retrograde relative to an access point of entry as taught by Diethrich in order to have easier access for stent deployment (pg. 190, col. 1).
Regarding claim 20, Chou in view of Goyal further in view of Diethrich disclose the invention as claimed as discussed with respect to claim 19. Chou further discloses that the expandable implant is a stent deployable from a delivery system from a compressed configuration to a first expanded configuration having a first cross-sectional shape (¶ 0087 discloses a self-expanding stent that may be delivered/deployed with a delivery/access system i.e., having an expanded configuration with a cross-sectional shape).
Claims 21-27 are rejected under 35 U.S.C. 103 as being unpatentable over Chou (US 20200289136 A1) in view of Goyal (US 20190070387 A1) and Diethrich et al. (Diethrich et al., Percutaneous techniques for endoluminal carotid interventions, 1996, J. Endovasc. Surg. 3, 182-202) as applied to claim 20 above, and further in view of Fischer (WO 2016059026 A1).
Regarding claim 21, Chou in view of Goyal and Diethrich disclose the invention as claimed as discussed with respect to claim 20. Chou in view of Goyal and Diethrich fails to disclose that the stent is designed to be formed from the first expanded configuration having the first cross-sectional shape into a second expanded configuration having a second cross-sectional shape. Fischer also discloses an expandable stent (12). Fischer teaches that the stent is designed to be formed from the first expanded configuration having the first cross-sectional shape into a second expanded configuration having a second cross-sectional shape (pg. 5, ¶ 3 discloses a stent having a first circular cross-section during expansion which then deviates to a shape deviating from a circular cross-sectional shape).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified method and system of Chou in view of Goyal and Diethrich to include a stent designed to be formed from the first expanded configuration having the first cross-sectional shape into a second expanded configuration having a second cross-sectional shape as taught by Fischer in order to distribute forces on a stent over a larger area (Fischer pg. 2, ¶ 2) and improving the contact area between the stent and surrounding anatomical structures.
Regarding claim 22, Chou in view of Goyal, Diethrich, and Fischer further discloses that the second cross-sectional shape is different from the first cross-sectional shape (Fischer pg. 5, ¶ 3 discloses a stent having a first circular cross-section during expansion which then deviates to a shape deviating from a circular cross-sectional shape).
Regarding claim 23, Chou in view of Goyal, Diethrich, and Fischer further discloses that the first cross-sectional shape is rounded and the second cross-sectional shape is non-round (Fischer pg. 5, ¶ 3 discloses a stent having first circular cross-sectional or rounded shape during expansion which then deviates to a shape that is non-round or deviates from a circular cross-sectional shape).
Regarding claim 24, Chou in view of Goyal, Diethrich, and Fischer further discloses that the non-round second cross-sectional shape is a multi-sided shape having a plurality of rounded corners and a plurality of substantially flat sides (Fischer pg. 3, ¶ 1 discloses that the second, expanded, or non-round cross-section may be the cross-section of a polygonal, rectangular, square, or oval shape and that their plurality corners may be rounded and ¶ 2 discloses a stent rectangular cross-section with a plurality of flattened sides).
Regarding claim 25, Chou in view of Goyal, Diethrich, and Fischer further discloses that wherein the non-round second cross-sectional shape is oval, square, or triangular (Fischer pg. 3, ¶ 1 discloses that the second, expanded, or non-round cross-section may be the cross-section of a polygonal, rectangular, square, or oval shape).
Regarding claim 26, Chou in view of Goyal, Diethrich, and Fischer further discloses that the second cross-sectional shape is a distortion of the first cross-sectional shape (Fischer pg. 5, ¶ 3 discloses a stent having first circular cross-sectional or rounded shape during expansion which then deviates/distorts from a shape with a circular cross-section).
Regarding claim 27, Chou in view of Goyal, Diethrich, and Fischer further discloses that the second cross-sectional shape is larger in diameter than the first cross-sectional shape (Fischer pg. 2, ¶ 4 discloses a stent in a compressed state having a circular cross-section and expanding/enlarging radially i.e., transitioning to a larger diameter. Figs. 6-7 illustrate a stent with a second diameter larger than the first and figs. 13-14 illustrate a stent with a second cross section larger than the first).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Fischer (WO 2016059026 A1) as applied to claim 31 above, and further in view of Denison et al. (US 10500074 B2).
Regarding claim 32, Fischer discloses the invention as claimed as discussed with respect to claim 31. Fischer discloses that the rounded corners have a tighter bend radius upon expansion of the tubular member (pg. 2, ¶ 4 discloses a stent in a compressed state having a circular cross-section and once expanded/enlarged it assumes a non-circular cross section with corners having a tighter bend radius as illustrated in fig. 10). Fischer fails to disclose that the rounded corners are specifically formed by thinner, more malleable struts and that the struts forming the generally flat sides are formed by thicker, less malleable struts.
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Denison also discloses an implantable device (10) and that the implantable device transitions from a collapsed configuration to an expanded configuration (figs. 1-2, col. 11 lines 46-48). Denison teaches thinner, and more malleable struts as well as thicker, less malleable struts (col. 9 lines 29-31 disclose that two struts may have unequal thicknesses such as a first strut having a thickness less than a second strut and col. 9 lines 34-35 disclose that the first strut is configured to be more flexible than the second strut).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implantable device of Fischer to include thinner, more malleable struts and thicker, less malleable struts in order to have a first more flexible/malleable section that is responsible to for most, if not all, of the expansion of the stent and a second section that acts as a relatively rigid support for the more flexible/malleable section (Denison col. 9 lines 25-28).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Fischer (WO 2016059026 A1).
Regarding claim 35, Fischer discloses the invention as claimed as discussed with respect to claim 33. Fischer teaches an alternate configuration/embodiment of the stent in which a transitional configuration has a transitional cross-sectional shape taken perpendicular to the longitudinal axis that is substantially round without sides (pg. 5 ¶ 3 discloses that during expansion the circular cross-sectional shape of a stent only changes shortly before reaching its final expanded state into a cross-sectional shape deviating from a circular shape i.e., a shape with flattened long sides, such as the stent in fig. 8 annotated below which illustrates cross-sectional shape and longitudinal axis – therefore the stent in a transitional configuration may have a transitional cross-section that is substantially round without sides before reaching its final expanded state), the transitional cross-sectional shape being the same shape or a distorted version of the first cross-sectional shape (pg. 5 ¶ 3 discloses that upon expansion the stent deviates from a cross-sectional shape/comprises a distorted shape) and having a transitional diameter that is larger than a diameter across the first cross-sectional shape (pg. 5 ¶ 3 discloses that the stent in its final expansion provides support over its enlarged areas).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stent of Fischer to include a transitional cross-sectional shape taken perpendicular to the longitudinal axis that is substantially round without sides and that the transitional cross-sectional shape would be the same shape or a distorted version of the first cross-sectional shape and have a diameter larger than the diameter across the first cross-sectional shape as taught by Fischer’s alternate configuration/embodiment in order to provide support upon enlarged surfaces (pg. 5 ¶ 3) and given that the stent may comprise a shape memory material known to undergo shape transition from a compressed to an expanded state as it responds to changes in temperatures (e.g. responding to body temperature once deployed, pg. 3 ¶ 6).
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Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Fischer (WO 2016059026 A1) as applied to claim 28 above, and further in view of Yachia et al. (US 9333102 B2).
Regarding claim 36, Fischer discloses the invention as claimed as discussed with respect to claim 28. Fischer fails to disclose that the second cross-sectional shape is configured to mate specifically with luminal dimensions of a venous sinus. Yachia also discloses an implantable device (300). Yachia teaches the implantable device (300) having a shape that conforms to the non-round/A/I shape of a urethral lumen an analogous structure to a venous sinus given its tubular shape (col. 4 lines 38-41). Yachia further teaches that the stent may be used in other organs and that dimensions and cross-sectional shapes may be modified to suit such organs (col. 7 lines 24-26). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implantable device of Fischer to include a second cross-sectional shape configured to mate specifically with a non-round shaped venous sinus as taught by Yachia so that the entire surface of the stent contacts the surrounding tissues (col. 4 lines 40-42) and maintains patency of the lumen (col. 1 lines 6-7).
Claims 37, 42-44, and 46-47 are rejected under 35 U.S.C. 103 as being unpatentable over Limon et al. (US 6077295 A) in view of Fischer (WO 2016059026 A1).
Regarding claim 37, Limon discloses a system for implantation (col. 1 lines 6-8), the system comprising: a delivery system comprising: an inner member (24); and an outer member (25); a tubular member (28) formed by a plurality of struts (col. 4 line 38 discloses a stent 28 having a lattice structure) that define a lumen having a longitudinal axis from a proximal end to a distal end of the tubular member (see annotated fig. 6 below), the tubular member mounted on the inner member and constrained by the outer member during delivery (fig. 6 illustrates a catheter assembly provided to deliver a stent or tubular member 28 in which the tubular member 28 is mounted on the inner member 24 and col. 4 lines 43-48 disclose that the inner surface 31 of the outer member 25 compresses the tubular member 28), wherein the tubular member is configured to transition from an unexpanded configuration towards a fully expanded, deployed configuration (col. 2 lines 55-58 disclose that once the stent is exposed and no longer retained by the outer member 25 it deploys/transitions from an expanded to an unexpanded configuration). Limon further discloses that an outer catheter configured to receive the tubular member constrained by the outer member in the unexpanded configuration for delivery (Col. 4 lines 65-67 disclose an outer member 25 that receives and retains a tubular member 28 in an unexpanded configuration. Col. 5 lines 48-49 disclose the expansion of tubular member 28 upon delivery).
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Limon fails to disclose that the unexpanded configuration has a first cross-sectional shape taken perpendicular to the longitudinal axis that is substantially round without sides and the deployed configuration has a second cross-sectional shape taken perpendicular to the longitudinal axis that is substantially non-round and multi-sided.
Fischer also discloses a tubular member (fig. 2 annotated above illustrates a tubular member 1 defining a lumen). Fischer teaches that the unexpanded configuration has a first cross-sectional shape taken perpendicular to the longitudinal axis that is substantially round without sides (pg. 2, ¶ 4 discloses an unexpanded stent with a circular cross-section and fig. 2 illustrates a stent with a round cross-section, perpendicular to the longitudinal axis, without sides) and the deployed configuration has a second cross-sectional shape taken perpendicular to the longitudinal axis that is substantially non-round and multi-sided (pg. 2 ¶ 4 discloses that upon expansion of the stent the stent assumes a non-round cross-section and pg. 3 ¶ 2 discloses a stent with a rectangular cross-section and four sides).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified system of Limon to include that an unexpanded configuration has a first cross-sectional shape taken perpendicular to the longitudinal axis that is substantially round without sides and the deployed configuration has a second cross-sectional shape taken perpendicular to the longitudinal axis that is substantially non-round and multi-sided as taught by Fischer in order to distribute forces on a stent over a larger area (Fischer pg. 2, ¶ 2) and improving the contact area between the stent and surrounding anatomical structures.
The intended use recited in the preamble (“for implantation of a device in a venous sinus luminal space”) has been considered but deemed not to impose any structural difference between the claimed invention and Limon’s modified device. Limon’s device as modified by Fischer is structured as claimed and is capable of being used for implantation of a device in a venous sinus luminal space as claimed.
Regarding claim 42, Limon in view of Fischer disclose the device as claimed as discussed with respect to claim 37. Fischer further discloses that the first cross-sectional shape is circular, oval, or elliptical (pg. 5, ¶ 3 discloses a stent having first circular cross-sectional or rounded shape during expansion).
Regarding claim 43, Limon in view of Fischer disclose the device as claimed as discussed with respect to claim 37. Fischer further discloses that the second cross-sectional shape is square or triangular (pg. 3, ¶ 1 discloses that the second, expanded, or non-round cross-section may be the cross-section of a polygonal, rectangular, square, or oval shape).
Regarding claim 44, Limon in view of Fischer disclose the device as claimed as discussed with respect to claim 43. Fischer further discloses that the second cross-sectional shape has rounded corners and generally flat sides (pg. 3, ¶ 1 discloses that the second, expanded, or non-round cross-section may have rounded corners and ¶ 2 discloses a stent rectangular cross-section with flattened sides).
Regarding claim 46, Limon in view of Fischer disclose the device as claimed as discussed with respect to claim 37. Fischer further discloses that the tubular member is capable of transitioning from the unexpanded configuration to a transitional configuration before transitioning into the deployed configuration (due to self-expanding design comprising shape-memory materials).
Regarding claim 47, Limon in view of Fischer disclose the device as claimed as discussed with respect to claim 46. Fischer teaches an alternate configuration/embodiment of the stent in which a transitional configuration has a transitional cross-sectional shape taken perpendicular to the longitudinal axis that is substantially round without sides (pg. 5 ¶ 3 discloses that during expansion the circular cross-sectional shape of a stent only changes shortly before reaching its final expanded state into a cross-sectional shape deviating from a circular shape i.e., a shape with flattened long sides, such as the stent in fig. 8 annotated below which illustrates cross-sectional shape and longitudinal axis – therefore the stent in a transitional configuration may have a transitional cross-section that is substantially round without sides before reaching its final expanded state), the transitional cross-sectional shape being the same shape or a distorted version of the first cross-sectional shape (pg. 5 ¶ 3 discloses that upon expansion the stent deviates from a cross-sectional shape/comprises a distorted shape) and having a transitional diameter that is larger than a diameter across the first cross-sectional shape (pg. 5 ¶ 3 discloses that the stent in its final expansion provides support over its enlarged areas).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the stent of Limon as modified by Fischer to include a transitional cross-sectional shape taken perpendicular to the longitudinal axis that is substantially round without sides and that the transitional cross-sectional shape would be the same shape or a distorted version of the first cross-sectional shape and have a diameter larger than the diameter across the first cross-sectional shape as taught by Fischer’s alternate configuration/embodiment in order to provide support upon enlarged surfaces (pg. 5 ¶ 3) and given that the stent may comprise a shape memory material known to undergo shape transition from a compressed to an expanded state as it responds to changes in temperatures (e.g. responding to body temperature once deployed, pg. 3 ¶ 6).
Claims 38 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Limon et al. (US 6077295 A) in view of Fischer (WO 2016059026 A1) as applied to claim 37 above and further in view of Green et al. (US 5807327 A).
Regarding claim 38, Limon in view of Fischer disclose the invention as claimed as discussed with respect to claim 37. Limon in view of Fischer fail to disclose that inner member comprises a recessed area located a distance away from a distal-most end of the inner member, the recessed area having an outer diameter that is less than an outer diameter of the inner member proximal to the recessed area. Green also discloses a system for implantation (fig. 6a). Green teaches that the inner member inner member comprises a recessed area located a distance away from a distal-most end of the inner member, the recessed area having an outer diameter that is less than an outer diameter of the inner member proximal to the recessed area (fig. 4a and 6a illustrate a inner member 228 with a recessed area located a distance away from the distal-most end of the inner member) and the recessed area having an outer diameter that is less than an outer diameter of the inner member proximal to the recessed area (col. 3 lines 62-67 disclose a recessed area having a reduced outer diameter less than the diameter of the inner member 228 proximal to the recessed area).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Limon in view of Fischer to include a recessed area located a distance away from a distal-most end of the inner member, the recessed area having an outer diameter that is less than an outer diameter of the inner member proximal to the recessed area, as taught by Green, in order to assure positive retention of the stent (col. 3 lines 20-22).
Regarding claim 39, Limon in view of Fischer and Green further discloses that the outer member is configured to be retracted and the tubular member is self-expandable upon retraction of the outer tubular member towards the deployed configuration. (Limon col.5 lines 41-49 discloses that the self-expanding tubular member 28 is deployed from the outer member 25 upon moving/retracting the outer member 25 in a proximal direction).
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Limon et al. (US 6077295 A) in view of Fischer (WO 2016059026 A1) and Green et al. (US 5807327 A) as applied to claim 38 above, and further in view of Chou (US 20200289136 A1).
Regarding claim 40, Limon in view of Fischer and Green fails to disclose that the recessed area comprises at least one radiopaque marker configured to identify a location of the tubular member within the recessed area. Chou also discloses a system for implantation of a device (100). Chou teaches a radiopaque marker capable of identifying the location of a tubular member (¶ 0205 discloses that a radiopaque marker can vary in size, shape, and location along an inner member 300). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Limon in view of Fischer and Green to include radiopaque markers configured to identify a location of the tubular member within the recessed area as taught by Chou in order to provide various information regarding the relative position of the catheter or its components i.e., an implantable device, tubular member, and/or stent (Chou ¶ 0205).
Claim 41 is rejected under 35 U.S.C. 103 as being unpatentable over Limon et al. (US 6077295 A) in view of Fischer (WO 2016059026 A1) as applied to claim 37 above, and in further view of Chou (US 20200289136 A1).
Regarding claim 41, Limon in view of Fischer disclose the device as claimed as discussed with respect to claim 37. Limon in view of Fischer fail to disclose that the inner member comprises an atraumatic distal end region. Chou also discloses a system for implantation of a device (100). Chou teaches an inner member that comprises an atraumatic distal end region (¶ 0190 discloses a tapered distal region 346 with an atraumatic and flexible characteristic not only a result of its taper/shape but in addition a result of its material property).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Limon in view of Fischer to include an inner member comprising an atraumatic distal end region as taught by Chou in order to facilitate endovascular navigation to an embolus in tortuous anatomy without damaging tissue (Chou ¶ 0190).
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Limon et al. (US 6077295 A) in view of Fischer (WO 2016059026 A1) as applied to claim 44 above, and further in view of Denison et al. (US 10500074 B2).
Regarding claim 45, Limon in view of Fischer disclose the device as claimed as discussed with respect to claim 44. Fischer discloses that the rounded corners have a tighter bend radius upon expansion of the tubular member (pg. 2, ¶ 4 discloses a stent in a compressed state having a circular cross-section and once expanded/enlarged it assuming a non-circular cross section with corners having a tighter bend radius as illustrated in fig. 10 annotated above). Fischer fails to disclose that the rounded corners are specifically formed by thinner, more malleable struts and that the struts forming the generally flat sides are formed by thicker, less malleable struts.
Denison also discloses an implantable device (10) and that the implantable device transitions from a collapsed configuration to an expanded configuration (figs. 1-2, col. 11 lines 46-48). Denison teaches thinner, and more malleable struts as well as thicker, less malleable struts (col. 9 lines 29-31 disclose that two struts may have unequal thicknesses such as a first strut having a thickness less than a second strut and col. 9 lines 34-35 disclose that the first strut is configured to be more flexible than the second strut).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implantable device of Limon in view of Fischer to include thinner, more malleable struts and thicker, less malleable struts as taught by Denison in order to have a first more flexible/malleable section that is responsible to for most, if not all, of the expansion of the stent and a second section that acts as a relatively rigid support for the more flexible/malleable section (Denison col. 9 lines 25-28).
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Limon et al. (US 6077295 A) in view of Fischer (WO 2016059026 A1) as applied to claim 37 above, and further in view of Yachia et al. (US 9333102 B2).
Regarding claim 48, Limon in view of Fischer disclose the device as claimed as discussed with respect to claim 37. Fischer fails to disclose that the second cross-sectional shape is configured to mate specifically with luminal dimensions of a venous sinus.
Yachia also discloses an implantable device (300). Yachia teaches the implantable device (300) having a shape that conforms to the non-round/A/I shape of a urethral lumen an analogous structure to a venous sinus given its tubular shape (col. 4 lines 38-41). Yachia further teaches that the stent may be used in other organs and that dimensions and cross-sectional shapes may be modified to suit such organs (col. 7 lines 24-26). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the implantable device of Limon in view of Fischer to include a second non-round cross-sectional shape configured to mate specifically with a non-round shaped venous sinus, as taught by Yachia, so that the entire surface of the stent contacts the surrounding tissues (col. 4 lines 40-42) and maintains patency of the lumen (col. 1 lines 6-7).
Conclusion
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/A.G.B./Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774