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 § 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 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 31-41, 44, 50, 51, 59 and 60 are rejected under 35 U.S.C. 103 as being unpatentable over Malek; Adel M. (US 20200375766 A1) in view of Malek ‘819; Adel M. et al. (US 20230233819 A1) in view of Heilman; Carl et al. (US 20190298977 A1).
Regarding claim 31, Malek discloses a method (¶ [0002], minimally invasive endovascular surgical procedures and devices; ¶ [0006], [0009], [0022], [0026]);
comprising: navigating a catheter system within a vasculature of a patient to a sinus (¶ [0028] With reference to FIG. 2, wherein the stent 100 is shown positioned in a venous sinus 120 and a tool in the form of a catheter 122, is directed through the stent 100 to make contact with the wall of the venous sinus 120);
the catheter system including a catheter (¶ [0028], FIG. 2 … a catheter 122); and
a perforating element (¶ [0034] In FIG. 5D, the tool 122 punctures a sidewall of the venous sinus 204);
anchoring a portion of the catheter against a first wall of the sinus to provide proximal support to the catheter (¶ [0027] FIG. 1 depicts a stent 100 having a hollow cylindrical body 102; ¶ [0029], FIG. 3, the stent 100 is depicted with the tool (catheter) 122 disposed therein. As discussed above, the stent 100 includes inner structures 144 that are located and rigid enough to provide a pathway for guiding the tool (catheter) 122 to traverse through the stent 100);
directing a distal end of the catheter toward a second wall of the sinus (¶ [0033] In FIG. 5C … The stent 100 may be rotated, as indicated by arrow 206, relative to the venous sinus 204 before, during, or after deployment in order to position the stent 100 so that the tool exit point 126 is in a desired location);
perforating, by extending the perforating element distal to the distal end of the catheter, the second wall of the sinus to form a transvascular passageway from the sinus into the extravascular space (¶ [0034] In FIG. 5D, the tool 122 punctures a sidewall of the venous sinus 204 in order to access the brain tissue 200 and/or ventricle 202. After completion of the procedure, the tool 122 is withdrawn from the brain tissue 200 and back into the stent 100, as shown in FIG. 5E); and
advancing the catheter through the transvascular passageway and into the extravascular space (¶ [0034] In FIG. 5D, the tool 122 punctures a sidewall of the venous sinus 204 in order to access the brain tissue 200 and/or ventricle 202).
Malek lacks a movable shaft including a perforating element and does not access the SSS. Malek ‘819 discloses an intracranial intervention system and method (¶ [0002], [0015], [0078] A micro catheter assembly 50, referring to FIGS. 15A-15C; ¶ [0098] FIGS. 3A-J illustrate exemplary anchor 700; ¶ [0100] FIGS. 4A-I depict an embodiment of a delivery assembly 300);
comprising: navigating a catheter system within a vasculature of a patient to a sinus; the catheter system including a catheter (¶ [0088] FIG. 1 … an inferior petrosal sinus (IPS) 102 connects a cavernous sinus (CS) 104 to a jugular vein 106 and/or a jugular bulb 108; ¶ [0114] FIGS. 7A-O illustrate an exemplary shunt implant procedure; ¶ [0115], The clinician then navigates a guide wire … and a guide catheter 307 … through the femoral vein access point … The clinician can position the distal end of the guide catheter 307 about the JV-IPS junction 118 as shown in FIG. 7A, and in certain patient anatomies, the distal end of the guide catheter can access the proximal portion of the IPS 102; ¶ [0160], FIGS. 19-26 illustrate an intracranial intervention system 201 and methods … For instance, the catheter 222 may be a delivery catheter used with or without a guide catheter, similar to delivery catheters 304 and 3304, or it may be a guide catheter similar to guide catheters 307 and 3307); and
a shaft movably disposed in the catheter; the shaft including a perforating element at a distal end thereof (¶ [0101] With reference to FIG. 4A, the distal portion 3344 of delivery catheter 3304 comprises penetrating element 3350 and a radiopaque marker 3354; ¶ [0102], penetrating element 3350 and distal portion 3344 of the delivery catheter);
anchoring a portion of the catheter against a first wall of the sinus to provide proximal support to the catheter (¶ [0098] FIGS. 3A-J illustrate exemplary anchor 700; ¶ [0106], a clinician can deploy an anchor 700 distal to a target penetration site along IPS wall 114);
perforating, by extending the perforating element distal to the distal end of the catheter, the second wall of the sinus to form a transvascular passageway from the sinus into the extravascular space; and advancing a distal portion of the shaft through the transvascular passageway and into the extravascular space (¶ [0114], the clinician selects the patient’s right IPS 102R and a target penetration site 5000 along the first curve 102A of the IPS; ¶ [0121] The clinician can confirm the orientation of the delivery catheter 3304 and the trajectory of penetrating element 3350 through IPS wall 114 into CP angle cistern 138 relative to the target penetration site 5000 using one or more of the previously disclosed imaging techniques).
Malek ‘819 more accurately targets a site in the patient’s vasculature by penetrating a sinus wall with a separate tool (¶ [0118], easier and more precise … without unintentionally disturbing … the position of the distal tip of the micro catheter 3307). A skilled artisan would have been able to modify Malek with Malek ‘819’s movable shaft by delivering a shaft and perforating element through the catheter instead of perforating the sinus directly with the catheter tip. One would be motivated to modify Malek with Malek ‘819’s movable shaft since Malek targets multiple vascular sites which are located close to each other (Figs. 13-16). Therefore, it would have been obvious to modify Malek with Malek ‘819’s movable shaft in order to more accurately select a vascular site to perforate.
Malek and Malek ‘819 do not explicitly navigate the catheter system to the SSS, anchor the catheter against a first wall of the SSS or perforate the second wall of the SSS. Heilman discloses implantable shunt devices and methods (¶ [0002], [0007], [0008], [0047] As shown in FIG. 3, one embodiment of the endovascular CSF shunt 20);
comprising: navigating a catheter system within a vasculature of a patient (¶ [0049] Referring to FIGS. 4-6 and as described above, a delivery catheter 40 is delivered to the venous system proximate the brain via the femoral or jugular vein; ¶ [0052] Thereafter, delivery catheter 40 can be removed and shunt 20 is implanted as shown in FIG. 6);
to the superior sagittal sinus (SSS) (¶ [0044], Alternatively … the other large diameter dural venous sinuses disclosed herein: the transverse sinus, straight sinus, or sagittal sinus shown in FIG. 1; ¶ [0054], implantation and stabilization of endovascular cerebral spinal fluid shunt (eCSFS) devices within the sigmoid sinus, transverse sinus, straight sinus, or sagittal sinus of a patient);
the catheter system including a catheter (¶ [0049], FIGS. 4-6 … a delivery catheter 40); and
a shaft movably disposed in the catheter (¶ [0051] As shown in FIG. 5, internal catheter 48 facilitates twisting of shunt 20).
Heilman demonstrates that the SSS is another relevant site for maneuvering a catheter and draining fluid. A skilled artisan would have been able to modify Malek and Malek ‘819 with Heilman’s SSS location by redirecting Malek’s catheter system towards the SSS instead of other sites within the patient’s brain vasculature. One would be motivated to modify Malek and Malek ‘819 with Heilman’s SSS location since it branches from other major vessels in the brain and provides access to further brain regions. Alternatively, a physician would have needed to access the SSS in cases where a subdural hematoma appears near the SSS. Therefore, it would have been obvious to modify Malek and Malek ‘819 with Heilman’s SSS location in order to access more areas of the brain, especially when a hematoma appears near the SSS.
Regarding claims 32, 44 and 51, Malek and Malek ‘819 do not direct the distal end of the catheter toward a lateral wall of the SSS. Heilman discloses a method including orienting the catheter towards the SSS (¶ [0044], Alternatively … the other large diameter dural venous sinuses disclosed herein: the transverse sinus, straight sinus, or sagittal sinus shown in FIG. 1; ¶ [0054], implantation and stabilization of endovascular cerebral spinal fluid shunt (eCSFS) devices within the sigmoid sinus, transverse sinus, straight sinus, or sagittal sinus of a patient). The remaining features of the claims address inherent features of the SSS including its shape, and the regions which face towards the brain.
Heilman accesses brain regions where a hematoma may also emerge, along with other brain regions. Regarding the rationale and motivation to modify Malek and Malek ‘819 with Heilman’s SSS location, see the discussion of claim 31 above.
Regarding claims 33-38 and 40-41, Malek discloses a method and apparatus further comprising: navigating one or more devices through the catheter and into the extravascular space (¶ [0040] As shown in FIG. 9, the stent 100 may be used in a brain tumor biopsy procedure … Forceps 318 deployed through the catheter 316 are used to obtain a sample of tissue from the tumor 314; ¶ [0041], FIG. 10, the stent 100 may be used for an intra-tumor radioactive seed treatment … Radioactive seeds 326 are then deployed out of the distal end of the catheter 324 and into the tumor 322);
further comprising: deploying a hemostatic closure element at the transvascular passageway as the catheter system is removed (¶ [0035] As shown in FIG. 6, the stent 100 may include an inner coating 302 and/or an outer coating 304 on the sidewall 108 of the stent 100. For example, the outer coating 304 may be thrombogenic in order to seal the dura when the tool 122 punctures the wall of the venous sinus 204 and the dura);
further comprising: applying a vacuum force in the extravascular space to remove a hematoma from the extravascular space (¶ [0044] FIG. 13 depicts the stent 100 being used in an intracranial hemorrhage suction procedure … Suction can be applied through the distal end of the catheter 352, as indicated by arrows 354);
further comprising: expanding an expandable member coupled to the catheter system to anchor the portion of the catheter against the first wall of the sinus; wherein the anchoring the catheter against the first wall of the sinus prevents the shaft from being pushed proximally through the transvascular passageway (¶ [0028] With reference to FIG. 2, wherein the stent 100 is shown positioned in a venous sinus 120; ¶ [0030], FIGS. 4A and 4B, the stent 100 includes an inner structure 140 made out of wires 142 or other similarly rigid structure(s));
wherein the perforating the second wall includes at least one of penetration through the second wall to form the transvascular passageway, thermoablation of the second wall to form the transvascular passageway, or core punching through the second wall to form the transvascular passageway (¶ [0034] In FIG. 5D, the tool 122 punctures a sidewall of the venous sinus 204 in order to access the brain tissue 200 and/or ventricle 202);
further including: deflecting the catheter such that the catheter self-orients against a base of the sinus to anchor the portion of the catheter against the first wall of the sinus and to direct the distal end of the catheter toward the second wall of the sinus (¶ [0030], FIGS. 4A and 4B, the stent 100 includes an inner structure 140 made out of wires 142 or other similarly rigid structure(s) … Structures 140 within the lumen 110 of the stent 100 guide the tool 122 from the proximal loop 144a towards the middle loop 144b; ¶ [0033] In FIG. 5C … The distal end of the tool 122, steered by the stent 100 makes contact with the sidewall of the venous sinus 204).
Regarding the movable shaft and SSS location, see the disclosures of Malek ‘819 and Heilman above.
Regarding claims 39, 50, 51, 59 and 60, Malek discloses that directing the distal end of the catheter toward the second wall of the sinus includes: deflecting the catheter into a curved configuration having a curve angle near 90 degrees from a longitudinal axis of the catheter (¶ [0030], In this manner, a tool (such as a catheter) 122 inserted into the proximal end 106 of the stent 100 will be aligned with (orthogonal to), and subsequently inserted into, the proximal loop 144a).
Malek and Malek ‘819 do not explicitly direct the distal end of the catheter toward the SSS or deflect the catheter more than 90 degrees.
Heilman discloses a method that directs a catheter toward the SSS (¶ [0044], Alternatively … the other large diameter dural venous sinuses disclosed herein: the transverse sinus, straight sinus, or sagittal sinus shown in FIG. 1; ¶ [0054], implantation and stabilization of endovascular cerebral spinal fluid shunt (eCSFS) devices within the sigmoid sinus, transverse sinus, straight sinus, or sagittal sinus of a patient).
Heilman does not explicitly disclose that the catheter deflects more than 90 degrees. However, maneuvering a catheter through the vasculature and SSS implies that the catheter will need to navigate through any passages or intermediate vessels, including curves that extend greater than 90 degrees.
Regarding the rationale and motivation to modify Malek and Malek ‘819 with Heilman’s SSS location, see the discussion of claim 31 above.
Claims 42, 43, 45-49, 52-54 and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Malek; Adel M. (US 20200375766 A1) in view of Malek ‘819; Adel M. et al. (US 20230233819 A1).
Regarding claim 42, Malek discloses a method (¶ [0002], minimally invasive endovascular surgical procedures and devices; ¶ [0006], [0009], [0022], [0026]);
comprising: navigating a catheter system within a vasculature to an intracranial vessel of a patient (¶ [0028] With reference to FIG. 2, wherein the stent 100 is shown positioned in a venous sinus 120 and a tool in the form of a catheter 122, is directed through the stent 100 to make contact with the wall of the venous sinus 120);
the catheter system including a catheter (¶ [0028], FIG. 2 … a catheter 122); and
a perforating element (¶ [0034] In FIG. 5D, the tool 122 punctures a sidewall of the venous sinus 204);
anchoring a portion of the catheter against a first wall of the intracranial vessel to provide proximal support to the catheter (¶ [0027] FIG. 1 depicts a stent 100 having a hollow cylindrical body 102; ¶ [0029], FIG. 3, the stent 100 is depicted with the tool (catheter) 122 disposed therein. As discussed above, the stent 100 includes inner structures 144 that are located and rigid enough to provide a pathway for guiding the tool (catheter) 122 to traverse through the stent 100);
directing a distal end of the catheter toward a second wall of the intracranial vessel (¶ [0033] In FIG. 5C … The stent 100 may be rotated, as indicated by arrow 206, relative to the venous sinus 204 before, during, or after deployment in order to position the stent 100 so that the tool exit point 126 is in a desired location);
perforating, by using the perforating element, the wall of the intracranial vessel to form a durotomy site (¶ [0034] In FIG. 5D, the tool 122 punctures a sidewall of the venous sinus 204 in order to access the brain tissue 200 and/or ventricle 202. After completion of the procedure, the tool 122 is withdrawn from the brain tissue 200 and back into the stent 100, as shown in FIG. 5E);
advancing the catheter through the durotomy site and into the subdural space (¶ [0034] In FIG. 5D, the tool 122 punctures a sidewall of the venous sinus 204 in order to access the brain tissue 200 and/or ventricle 202); and
navigating one or more devices through the catheter and into the subdural space (¶ [0040] As shown in FIG. 9, the stent 100 may be used in a brain tumor biopsy procedure … Forceps 318 deployed through the catheter 316 are used to obtain a sample of tissue from the tumor 314; ¶ [0041], FIG. 10, the stent 100 may be used for an intra-tumor radioactive seed treatment … Radioactive seeds 326 are then deployed out of the distal end of the catheter 324 and into the tumor 322).
Malek does not explicitly advance a movable shaft through the durotomy site. Malek ‘819 discloses an intracranial intervention system and method (¶ [0002], [0015], [0078] A micro catheter assembly 50, referring to FIGS. 15A-15C; ¶ [0098] FIGS. 3A-J illustrate exemplary anchor 700; ¶ [0100] FIGS. 4A-I depict an embodiment of a delivery assembly 300);
a catheter system including a catheter (¶ [0115], The clinician then navigates a guide wire … and a guide catheter 307 … through the femoral vein access point … The clinician can position the distal end of the guide catheter 307 about the JV-IPS junction 118 as shown in FIG. 7A, and in certain patient anatomies, the distal end of the guide catheter can access the proximal portion of the IPS 102; ¶ [0160], FIGS. 19-26 illustrate an intracranial intervention system 201 and methods … For instance, the catheter 222 may be a delivery catheter used with or without a guide catheter, similar to delivery catheters 304 and 3304, or it may be a guide catheter similar to guide catheters 307 and 3307); and
a shaft movably disposed in the catheter, the shaft including a perforating element at a distal end thereof a shaft movably disposed in the catheter; the shaft including a perforating element at a distal end thereof (¶ [0101] With reference to FIG. 4A, the distal portion 3344 of delivery catheter 3304 comprises penetrating element 3350 and a radiopaque marker 3354; ¶ [0102], penetrating element 3350 and distal portion 3344 of the delivery catheter);
anchoring a portion of the catheter against a first wall of the intracranial vessel to provide proximal support to the catheter (¶ [0098] FIGS. 3A-J illustrate exemplary anchor 700; ¶ [0106], a clinician can deploy an anchor 700 distal to a target penetration site along IPS wall 114);
perforating, by extending the perforating element distal to the distal end of the catheter, the wall of the intracranial vessel to form a durotomy site; and advancing a distal portion of the shaft through the durotomy site and into the subdural space (¶ [0114], the clinician selects the patient’s right IPS 102R and a target penetration site 5000 along the first curve 102A of the IPS; ¶ [0121] The clinician can confirm the orientation of the delivery catheter 3304 and the trajectory of penetrating element 3350 through IPS wall 114 into CP angle cistern 138 relative to the target penetration site 5000 using one or more of the previously disclosed imaging techniques).
Malek ‘819 improves the accurately of an intravascular procedure (¶ [0118]). Regarding the rationale and motivation to modify Malek with Malek ‘819’s movable shaft, see the discussion of claim 31 above.
Regarding claim 53, Malek discloses an apparatus (¶ [0002], minimally invasive endovascular surgical procedures and devices; ¶ [0006], [0009], [0022], [0026]);
comprising: a catheter capable of being navigated through a vasculature of a patient into a superior sagittal sinus (SSS) of the patient (¶ [0028] With reference to FIG. 2, wherein the stent 100 is shown positioned in a venous sinus 120 and a tool in the form of a catheter 122, is directed through the stent 100 to make contact with the wall of the venous sinus 120);
a perforating element at a distal end thereof (¶ [0034] In FIG. 5D, the tool 122 punctures a sidewall of the venous sinus 204); and
a deflecting element configured to deflect the catheter into a curved configuration to (1) anchor a portion of the catheter against a first wall of the SSS to provide proximal support to the catheter (¶ [0027] FIG. 1 depicts a stent 100 having a hollow cylindrical body 102; ¶ [0029], FIG. 3, the stent 100 is depicted with the tool (catheter) 122 disposed therein. As discussed above, the stent 100 includes inner structures 144 that are located and rigid enough to provide a pathway for guiding the tool (catheter) 122 to traverse through the stent 100); and
(2) direct a distal end of the catheter toward a second wall of the SSS (¶ [0033] In FIG. 5C … The stent 100 may be rotated, as indicated by arrow 206, relative to the venous sinus 204 before, during, or after deployment in order to position the stent 100 so that the tool exit point 126 is in a desired location);
such that the perforating element is oriented toward a subdural space of the patient (¶ [0034] In FIG. 5D, the tool 122 punctures a sidewall of the venous sinus 204 in order to access the brain tissue 200 and/or ventricle 202. After completion of the procedure, the tool 122 is withdrawn from the brain tissue 200 and back into the stent 100, as shown in FIG. 5E).
Malek does not explicitly disclose a movable shaft. Malek ‘819 discloses an intracranial intervention system and method (¶ [0002], [0015], [0078] A micro catheter assembly 50, referring to FIGS. 15A-15C; ¶ [0098] FIGS. 3A-J illustrate exemplary anchor 700; ¶ [0100] FIGS. 4A-I depict an embodiment of a delivery assembly 300);
comprising: a catheter capable of being navigated through a vasculature of a patient into a superior sagittal sinus (SSS) of the patient (¶ [0115], The clinician then navigates a guide wire … and a guide catheter 307 … through the femoral vein access point … The clinician can position the distal end of the guide catheter 307 about the JV-IPS junction 118 as shown in FIG. 7A, and in certain patient anatomies, the distal end of the guide catheter can access the proximal portion of the IPS 102; ¶ [0160], FIGS. 19-26 illustrate an intracranial intervention system 201 and methods … For instance, the catheter 222 may be a delivery catheter used with or without a guide catheter, similar to delivery catheters 304 and 3304, or it may be a guide catheter similar to guide catheters 307 and 3307); and
a shaft movably disposed in the catheter, the shaft including a perforating element at a distal end thereof; (¶ [0101] With reference to FIG. 4A, the distal portion 3344 of delivery catheter 3304 comprises penetrating element 3350 and a radiopaque marker 3354; ¶ [0102], penetrating element 3350 and distal portion 3344 of the delivery catheter).
Malek ‘819 improves the accurately of an intravascular procedure (¶ [0118]). Regarding the rationale and motivation to modify Malek with Malek ‘819’s movable shaft, see the discussion of claim 31 above.
Malek and Malek ‘819 do not explicitly configure the catheter to navigate into the SSS. However, Malek’s catheter system is fully capable of accessing any region in the patient’s cerebral vasculature, including the SSS. For example, Malek redirects a catheter through cerebral vasculature to multiple sites (Figs. 8-16). This claim describes an apparatus and not necessarily a method of using the apparatus. A skilled artisan would have been able to operate Malek’s catheter system by redirecting the catheter tip to other locations in the vasculature such as the SSS. Depending on the location of a hematoma or a desired location for a biopsy or implant, the surgeon will redirect the catheter to the SSS or other brain regions.
Regarding claims 43, 45-48, 52, 54 and 58-59, Malek discloses a method and apparatus wherein the intracranial vessel is a vein (¶ [0028], FIG. 2 … a tool in the form of a catheter 122, is directed through the stent 100 to make contact with the wall of the venous sinus 120);
further comprising: navigating one or more devices through the catheter and into the subdural space (¶ [0040] As shown in FIG. 9, the stent 100 may be used in a brain tumor biopsy procedure … Forceps 318 deployed through the catheter 316 are used to obtain a sample of tissue from the tumor 314; ¶ [0041], FIG. 10, the stent 100 may be used for an intra-tumor radioactive seed treatment … Radioactive seeds 326 are then deployed out of the distal end of the catheter 324 and into the tumor 322);
further comprising: deploying a hemostatic closure element at the durotomy site as the catheter system is removed (¶ [0035] As shown in FIG. 6, the stent 100 may include an inner coating 302 and/or an outer coating 304 on the sidewall 108 of the stent 100. For example, the outer coating 304 may be thrombogenic in order to seal the dura when the tool 122 punctures the wall of the venous sinus 204 and the dura);
further comprising: applying a vacuum force in the subdural space to remove a hematoma from the subdural space (¶ [0044] FIG. 13 depicts the stent 100 being used in an intracranial hemorrhage suction procedure … Suction can be applied through the distal end of the catheter 352, as indicated by arrows 354);
further comprising: expanding an expandable member coupled to the catheter system to anchor the portion of the catheter against the first wall of the intracranial vessel; wherein the anchoring the catheter against the first wall of the intracranial vessel prevents the catheter from being pushed proximally (¶ [0028] With reference to FIG. 2, wherein the stent 100 is shown positioned in a venous sinus 120; ¶ [0030], FIGS. 4A and 4B, the stent 100 includes an inner structure 140 made out of wires 142 or other similarly rigid structure(s));
wherein the perforating the second wall includes at least one of penetration through the second wall to form the durotomy site, thermoablation of the second wall to form the durotomy site, or core punching through the second wall to form the durotomy site; wherein the perforating element is tapered from a proximal end to a distal end thereof (¶ [0034] In FIG. 5D, the tool 122 punctures a sidewall of the venous sinus 204 in order to access the brain tissue 200 and/or ventricle 202).
Regarding the movable shaft and SSS location, see the disclosures of Malek ‘819 and Heilman above.
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Malek and Malek ‘819 in view of Nguyen; Duy et al. (US 20070270679 A1).
Regarding claim 55, Malek and Malek ‘819 lack pull-wires and ring anchors. Nguyen discloses a deflecting element including one or more pull-wires coupled to one or more ring anchors arranged circumferentially around an inner lumen of a catheter (¶ [0047] FIG. 3 is a view of the pull ring section as shown in FIG. 2. Each of two pull rings (23) are connected to control wires (20) (pull wires) by weld joints (24), such as laser weld joints).
Nguyen describes how to maneuver and steer a deformable catheter. One would be motivated to modify Malek and Malek ‘819 with Nguyen’s pull-wires and ring anchors since both Malek and Malek ‘819 require a catheter that can deform and steer through cerebral vessels. Therefore, it would have been obvious to modify Malek and Malek ‘819 with Nguyen’s pull-wires and ring anchors in order to steer a catheter with a known mechanism.
Claims 56 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Malek and Malek ‘819 in view of Heilman ‘398; Carl et al. (US 20160136398 A1).
Regarding claims 56 and 57, Malek and Malek ‘819 lack an RF perforating element. Heilman ‘398 discloses a perforating element including an electrically conductive material and an electrical insulator disposed on a portion thereof; wherein the perforating element is configured to be coupled to a radiofrequency (RF) generator such that RF energy is delivered through an uninsulated portion of the perforating element to a sinus wall to form a durotomy site (¶ [0246] In some embodiments, the tissue penetrating member 250 may be coupled to an energy source (not shown) to facilitate the piercing and/or advancement through the IPS wall 114 and arachnoid layer 115 that separates the lumen of IPS 102 from the subarachnoid space 116/CP angle cistern 138. The energy source can provide one or more energy types, including, but not limited to, radio frequency energy (RF), thermal energy, acoustic energy or the like; ¶ [0249], As will be appreciated by those of skill in the art, all but the distal most portion of the tissue penetrating member 250 (e.g., distal most 1 mm to 15 mm) may be insulated such that only the distal tip 255′ or distal portion 255 of the tissue penetrating member 250 delivers RF energy to IPS wall 114 (and not the delivery assembly 300 and/or delivery catheter 304)).
Heilman ‘398 provides an alternative perforating element that can be selectively activated instead of relying on physical force to penetrate a vessel. One would be motivated to modify Malek and Malek ‘819 with Heilman ‘398’s RF perforating element to penetrate a sinus wall with less physical force. Therefore, it would have been obvious to modify Malek and Malek ‘819 with Heilman ‘398’s RF perforating element in order to penetrate the sinus wall with an alternative technique.
Double Patenting
Savastano ‘777; Luis E. et al. (US 12102777 B1) and Savastano ‘058; Luis E. et al. (US 12151058 B2) are relevant to the claimed invention and claim various methods and devices for draining a subdural hematoma. However, neither of these patents claims steps of anchoring a catheter against a first wall of the superior sagittal sinus (SSS) and directing a distal end of the catheter toward a second wall of the SSS; or a deflecting element that anchors and deflects the catheter through the SSS. Therefore these references are not cited in a double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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McCormick, Paul et al. US 20050245891 A1
Cruise; Gregory M. US 20060105014 A1
Cheng; Eric et al. US 20060247677 A1
Nguyen; Duy et al. US 20070270679 A1
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Branch; Charles L. et al. US 20130218101 A1
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/Adam Marcetich/
Primary Examiner, Art Unit 3781
Prosecution Insights