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 .
Response to Amendment
The amendment filed November 26, 2025 has been entered. Claims 1, 3-4, 7-8, 12, 14, 16-33, 36, 41, 49, and 53 are currently pending.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 3-4, 7, 16, 27, 32-33, and 53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morales (WO 2021/007346, hereinafter “Morales”) in view of Bonde et al. (US 2012/0323254, hereinafter “Bonde”).
Regarding claim 1, Morales discloses the invention substantially as claimed including an interventional device for implanting an electrode into the brain through a blood vessel (para [0137]; it is noted the electrode is not positively recited), the blood vessel comprising a blood vessel channel and a blood vessel wall, characterized in that the blood vessel comprises a main vessel and a branch vessel (Figs 1A-C, 8A-10, 15-18), the interventional device comprises:
a first guide member (access catheter 101/801/901) comprising a first working channel (channel having distal end opening 104/803/903) and a second working channel (channel having lateral wall working exit lumen port 103/802/902) (para [00067]), wherein a distal end of the first guide member is capable of moving distally in the blood vessel channel and establishing a first support point in the blood vessel channel (supported against tissue at first support point – see annotated Fig 10 below);
a second guide member (microcatheter 807/907) configured to pass through the first working channel (channel having distal end opening 104/803/903) of the first guide member (access catheter 101/801/901), wherein a distal end of the second guide member is capable of passing through the first guide member (Figs 8A, 9A; para [00128]), moving distally in the blood vessel channel, and establishing a second support point in the blood vessel channel (supported against tissue at second support point with balloon of microcatheter 907 – Fig 9A; fully capable of establishing second support point in the blood vessel), so that the second guide member extends in an arc shape between the first support point and the second support point, the second support point being located in the branch vessel (see annotated Fig 10 below);
and a puncture kit (810/811) configured to pass through the second working channel (channel having lateral wall working exit lumen port 103/802/902) of the first guide member (access catheter 101/801/901), wherein the puncture kit is used to carry an electrode (fully capable of carrying an electrode), and a distal end of the puncture kit can pass through the second working channel of the first guide member (para [000122, 000126, 00134]), move distally in a blood vessel channel, and puncture the blood vessel wall in a target puncture area between the first support point and the second support point, thereby implanting the carried electrode into the brain (fully capable of being used to implant a carried electrode into the brain – para [00148]).
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However, Morales teaches the first and second guide channels are joined to cooperatively form the central lumen (102/201/801/901) of the first guide member (access catheter 101/801/901) in a proximal portion thereof (para [00069]). Morales fails to disclose the first and second working channels are separated within the first guide member, as claimed.
Bonde discloses a similar interventional device for implanting an electrode including a guide member (outer catheter 102), wherein the guide member can comprise multiple lumens (Fig 1; para [0050]). Alternatively, in another embodiment the device includes a guide member (outer catheter 712) with a single body lumen (704) for delivering multiple sheaths or multiple electrodes (Fig 7B, 8B; para [0067-0068]). Bonde teaches “The assemblies include a catheter that may have features such as multiple lumens, an extended lumen adjacent other lumens, multiple sheaths within one or more of the multiple lumens, and/or a lumen having an oblong lateral cross-section. The various embodiments may utilize one or more of implantation needles, guidewires, and the like to introduce the catheter into the defined space through the single entry” (para [0049]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Morales such that the first and second working channels were separated within the first guide member since Bonde teaches it is known in the art to introduce medical leads or electrodes through a multilumen catheter or a single lumen catheter such that the leads are introduced through a single entry. Substitution of one known element for another element providing the same function to yield predictable results (single lumen or multilumen catheter to deliver various elements through a single entry) would have been obvious to one of ordinary skill in the art at the time of the invention.
Regarding claim 3, characterized in that the target puncture area is located in a transition area between the main blood vessel and the branch blood vessel (fully capable of being used to implant an electrode through a blood vessel wherein the target puncture area is located in a transition area between the main blood vessel and the branch blood vessel as claimed since first and second guide members extend away from each other) (Fig 10).
Regarding claim 4, characterized in that the first guide member (access catheter 101/801/901) is constructed as a support catheter, and the outer diameter of the distal side of the support catheter is substantially equal to the inner diameter of the blood vessel at the first support point, so as to establish the first support point in the blood vessel channel (Fig 10; see also Fig 2B with sidewall balloon 209; para [0093] – “these compliant structures can, once expanded, position the lateral wall or exit port 202 to the endoluminal surface, as well as provide support and stability to the transvascular catheter system”).
Regarding claim 7, characterized in that a distal end of the support catheter is constructed with a first imaging mark (para [000119, 000195]).
Regarding claim 27, characterized in that the puncture kit is equipped with a puncture catheter for guiding the puncture kit to a target puncture area (see Figs 8B-C with retractable needle sheath 810 or puncture catheter and needle 811; para [000122]).
Regarding claim 32, it is noted the electrode is not positively recited. The puncture kit of Morales is fully capable of carrying a flexible electrode as claimed.
Regarding claim 33, characterized in that the second guide member (1202) is supported on the blood vessel wall at the second support point so that the blood vessel wall at the second support point is stretched (supported against tissue at second support point – Fig 12; fully capable of establishing second support point in the blood vessel and fully capable of stretching the blood vessel wall at the second support point depending on the size of the blood vessel wall).
Regarding claim 53, wherein the target puncture region is located in an angular region formed by the central axis of the first guide member and the second guide member, and the direction along which the vascular wall is pierced being adjusted based on the positions of the first support point and the second support point (see annotated Fig 10 above).
Claim(s) 8, 12, 14, 16, 17-22, 36, 41, and 49 is/are rejected under 35 U.S.C. 103 as being unpatentable over Morales (WO 2021/007346) and Bonde (US 2012/0323254), as applied to claim 1 above, further in view of Malek et al. (WO 2019/173784, hereinafter “Malek”).
Regarding claim 8, Morales and Bonde disclose the invention substantially as claimed as shown above, including a second guide member (microcatheter 807/907). Morales teaches the second guide member may comprise a microcatheter (807) (Fig 8A, para [000120]), a balloon microcatheter (907) (Fig 9A; para [000128]), or an expandable mesh (913) (Fig 9D; para [000130]). Morales teaches an expandable member deployed from the distal end working lumen provides a mechanism for procedural hemostasis and in some embodiments catheters with advanced functionality may be deployed from the distal end working lumen (para [000165]). However, Morales fails to teach the second guide member comprises a stent assembly including a guide wire, guide catheter, and support stent as claimed.
Malek discloses a similar interventional device (Figs 55A-P) and teaches a second guide member (700, 780) and puncture kit (3304) for configured to pass through a first guide member (307) (para [00216-00220]). Malek teaches the second guide member (700, 780) is constructed as a stent assembly (Figs 55B-F; para [00214-00218]), and the stent assembly includes a guide wire (3333), a guide catheter (3307), and a support stent (700), wherein the guide wire is used to guide the guide catheter (Fig 55B-C), the guide catheter is used to guide the support stent (Fig 55D), and the support stent is used to support on the blood vessel wall (Fig 55E-F). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Morales such that the second guide member comprised a guide wire, guide catheter, and support stent, as taught by Malek, since Morales recognizes several types of expandable devices may be delivered through the distal end working lumen and since Malek teaches deploying a stent assembly as claimed provides the advantage of anchoring the interventional device while deploying the puncturing assembly (para [0009]).
Regarding claim 12, Malek teaches the guide catheter (3307) sleeves the guide wire (3333) and can move along the guide wire (para [00214]).
Regarding claim 14, Malek teaches the distal end of the guide catheter is constructed with a second imaging mark (para [00109]).
Regarding claim 16, Morales teaches catheters and catheter components are made of one or more of the following materials: acrylonitrile butadiene styrene (ABS), polyethylene (PE), polyvinyl chloride (PVC), polypropylene (PP), polymethylpentene (PMP), polymethyl methacrylate (PMMA); polycarbonate (PC), polyphenylene oxide (PPO), modified phenylene oxide (modified PPO), polyphenylene ether (PPE); polyimide (PI), polybenzimidazole (PBI); polyphenylene sulfide (PPS), polyetheretherketone (PEEK); fluorinated ethylene-propylene (FEP), ethylene- chlorotrifluoroethylene (ECTFE), ethylene, ethylene-tetrafluoroethylene (ETFE), polychlorotrifluoroethylene (PCTFE), polytetrafluoroethylene (PTFE), expandedpolytetrafluoroethylene (ePTFE), polyvinylidene fluoride (PVDF); elastomeric silicone polymer, polyether front segment amide or thermoplastic copolyether (PEBAX); and metals (para [00087]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination such that the guide catheter was made of one or more of the claimed materials since Morales teaches catheter components may be made of the claimed materials and 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. In re Leshin, 125 USPQ 416.
Regarding claim 17, Malek teaches the support stent is constructed as a self- expanding stent (para [00100]), and the self-expanding stent includes a proximal first push rod (780 or 3710) and a distal stent body (700), the first push rod is used to push the stent body through the guide catheter, and the stent body can radially open and support on the blood vessel wall by relying on a self-expanding force after leaving the guide catheter (Figs 55E-F, 13, 14A-E; para [00216-00217]).
Regarding claim 18, Malek teaches the stent body of the self-expanding stent (700) can leave the guide catheter (3307) by withdrawing the guide catheter or by pushing the stent body distally by the first push rod (780 or 3710) (para [00217]).
Regarding claim 19, Malek teaches the stent body (700) of the self-expanding stent is made of a memory alloy material (para [00100]).
Regarding claim 20, Malek teaches the stent body (700) of the self-expanding stent is constructed with a third imaging mark (para [00105]).
Regarding claim 21, Malek teaches the stent body of the self-expanding stent comprises a plurality of closed-loop mesh units and a plurality of open-loop mesh units (formed by interconnected struts 712 with closed or open cell pattern – para [00101]).
Regarding claim 22, Malek teaches the outer diameter of the self-expanding stent (700) in a compressed state is smaller than or equal to the inner diameter of the guide catheter (3307) (Figs E-F; para [00216-00217]).
Regarding claims 36, 41, and 49, Morales discloses the invention substantially as claimed including an interventional device for implanting an electrode into the brain through a blood vessel (para [0137]; it is noted the electrode is not positively recited), wherein the blood vessel comprises a first blood vessel segment and a second blood vessel segment connected and extending in different directions, the connection between the first blood vessel segment and the second blood vessel segment is near the brain (Figs 1A-C, 8A-10, 15-18; fully capable of delivering the interventional device of Morales to blood vessel near the brain as claimed), the interventional device comprises:
a first catheter (access catheter 101/801/901) comprising a first working channel (channel having distal end opening 104/803/903) and a second working channel (channel having lateral wall working exit lumen port 103/802/902) (para [00067]), the first catheter being configured in such a way that its distal end can reach and float at a first position located in the first blood vessel segment, and the opening of the distal end of the first catheter is substantially oriented toward a first direction, the first position being located near the connection, and the first direction being a direction in which the first blood vessel segment extends near the connection (Fig 10);
a second catheter (microcatheter 807/907) configured to pass through the first working channel (channel having distal end opening 104/803/903) of the first catheter (access catheter 101/801/901), the second catheter being configured in such a way that the second catheter (microcatheter 807/907) can reach the distal end of the first catheter (access catheter 101/801/901) along the lumen of the first catheter, pass through the connection and enter the second blood vessel segment, and be fixed at a second position located in the second blood vessel segment so that an element delivered within the second catheter can extend along the branch direction of the blood vessel between the first position and the second position, and the opening of the distal end of the first catheter can be deflected to a second direction under the action of the element delivered within the second catheter, the second direction being the direction of extension of the second blood vessel segment near the connection (fully capable of being positioned as claimed – Fig 10);
a third catheter (retractable needle sheath 810) configured to pass through the second working channel (channel having lateral wall working exit lumen port 103/802/902) of the first catheter (access catheter 101/801/901), the third catheter being configured in such a way that its distal end can reach and extend from the distal end of the first catheter along the lumen of the first catheter to approach the puncture position on the blood vessel wall (Figs 8B-C, 10; para [000122]); and
a puncture kit or electrode guide needle (needle 811) configured to pass through the third catheter (retractable needle sheath 810), the puncture kit being used to carry the electrode (fully capable of carrying electrode), and the puncture kit being configured in such a way that its distal end can approach the distal end of the third catheter along the lumen of the third catheter, wherein, the third catheter is also configured in such a way that after the distal end of the puncture kit approaches the distal end of the third catheter, the distal end of the third catheter can puncture the blood vessel wall at a puncture position and reach outside the blood vessel without entering the brain, and the puncture kit is also configured in such a way that after the distal end of the third catheter reaches outside the blood vessel, it continues to move along the lumen of the third catheter and passes through the distal end of the third catheter to enter the brain, thereby implanting the carried electrode into the brain (fully capable of being deployed as claimed depending on force applied).
However, Morales teaches the first and second guide channels are joined to cooperatively form the central lumen (102/201/801/901) of the first guide member (access catheter 101/801/901) in a proximal portion thereof (para [00069]). Morales fails to disclose the first and second working channels are separated within the first guide member, as claimed.
Bonde discloses a similar interventional device for implanting an electrode including a guide member (outer catheter 102), wherein the guide member can comprise multiple lumens (Fig 1; para [0050]). Alternatively, in another embodiment the device includes a guide member (outer catheter 712) with a single body lumen (704) for delivering multiple sheaths or multiple electrodes (Fig 7B, 8B; para [0067-0068]). Bonde teaches “The assemblies include a catheter that may have features such as multiple lumens, an extended lumen adjacent other lumens, multiple sheaths within one or more of the multiple lumens, and/or a lumen having an oblong lateral cross-section. The various embodiments may utilize one or more of implantation needles, guidewires, and the like to introduce the catheter into the defined space through the single entry” (para [0049]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Morales such that the first and second working channels were separated within the first guide member since Bonde teaches it is known in the art to introduce medical leads or electrodes through a multilumen catheter or a single lumen catheter such that the leads are introduced through a single entry. Substitution of one known element for another element providing the same function to yield predictable results (single lumen or multilumen catheter to deliver various elements through a single entry) would have been obvious to one of ordinary skill in the art at the time of the invention.
Furthermore, Morales fails to disclose the second catheter comprises the stent assembly as claimed. Morales teaches the second guide member may comprise a microcatheter (807) (Fig 8A, para [000120]), a balloon microcatheter (907) (Fig 9A; para [000128]), or an expandable mesh (913) (Fig 9D; para [000130]) and teaches an expandable member deployed from the distal end working lumen provides a mechanism for procedural hemostasis and in some embodiments catheters with advanced functionality may be deployed from the distal end working lumen (para [000165]). Malek discloses a similar interventional device (Figs 55A-P) and teaches a second guide member (700, 780) and puncture kit (3304) for configured to pass through a first guide member (307) (para [00216-00220]). Malek teaches the second guide member (700, 780) is constructed as a stent assembly (Figs 55B-F; para [00214-00218]), and the stent assembly includes a support stent (700) located at a distal end of a stent push rod (780 or 3710) connected to the stent, the stent assembly being configured in such a way that the stent can reach the distal end of the first catheter (307) along the lumen of the first catheter (Fig 55D), pass through the connection and enter the second blood vessel segment (102R), and be fixed at a second position located in the second blood vessel segment so that the stent push rod can extend along the branch direction of the blood vessel between the first position and the second position (Fig 55F), and the opening of the distal end of the first catheter can be deflected to a second direction under the action of the stent push rod (fully capable of deflecting opening of the distal end of the first catheter depending on the forces applied by the push rod), the second direction being the direction of extension of the second blood vessel segment near the connection. Malek teaches the stent assembly includes a guide wire (3333) and a guide catheter (3307) in combination with the support stent (700), wherein the guide wire is used to guide the guide catheter (Fig 55B-C), the guide catheter is used to guide the support stent (Fig 55D), and the support stent is used to support on the blood vessel wall (Fig 55E-F). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Morales such that the second catheter comprised a stent assembly, as taught by Malek, since Morales recognizes several types of expandable devices may be delivered through the distal end working lumen and since Malek teaches deploying a stent assembly as claimed provides the advantage of anchoring the interventional device while deploying the puncturing assembly (para [0009]).
Claim(s) 23-26 is is/are rejected under 35 U.S.C. 103 as being unpatentable over Morales (WO 2021/007346) and Bonde (US 2012/0323254), as applied to claim 1 above, further in view of Boggs et al. (US 2019/0060642, hereinafter “Boggs”).
Regarding claim 23, Morales discloses the invention substantially as claimed, as shown above, including a puncture kit (810/811) including a puncture needle having a pointed end at the distal end for puncturing and configured as a cavity inside. However, Morales fails to disclose the puncture kit further comprises an electrode guide needle as claimed. Boggs discloses a similar device for positioning an implanting an electrode and teaches the puncture kit comprises a puncture needle (outer needle 150) having a pointed end at the distal end for puncturing and configured as a cavity inside (para [0190]; Fig 1), a needle sheath or puncture catheter sleeving the puncture needle for protecting the pointed end of the puncture needle (introducer sheath or percutaneous sleeve, see for example 1010; Fig 26; para [0349]), and an electrode guide needle (inner needle 102) located in the cavity of the puncture needle (para [0192]; Fig 1), wherein the distal end of the electrode guide needle has a matching portion constructed to carry an electrode (130) (para [0196] – electrode has hook that matches distal end of guide needle and wraps around distal end of guide needle). Therefore, it would have been obvious to one of ordinary skill at the time of the invention to further modify the puncture kit of Morales with the puncture kit of Boggs comprising a puncture needle and electrode guide needle designed to carry and deliver an electrode through a needle sheath, as claimed and as taught by Boggs, for the purpose of delivering the electrode directly through the puncture kit and simplifying the procedure.
Regarding claim 24, Boggs teaches the matching portion of the electrode guide needle (102) is constructed as a pointed end (needle edge), and the pointed end can pass through a hole constructed in the electrode for matching with the electrode guide needle (fully capable of passing through hole in electrode or at least through spaces between coil of electrode).
Regarding claim 25, Boggs teaches the pointed end has a stepped structure or a cone-shaped structure, so that the pointed end can carry the electrode when it moves distally, and the electrode can fall off from the pointed end when the pointed end is withdrawn proximally after the electrode is implanted in the brain (Fig 1 or 2E).
Regarding claim 26, Boggs teaches the electrode guide needle is made of a metal material (para [0208]).
Claim(s) 28-31 is is/are rejected under 35 U.S.C. 103 as being unpatentable over Morales (WO 2021/007346) and Bonde (US 2012/0323254), as applied to claim 27 above, further in view of Girton (US 2002/0183786, hereinafter “Girton”). Morales discloses the invention substantially as claimed, as shown above, including a puncture kit (810/811) including a puncture needle having a pointed end at the distal end for puncturing and configured as a cavity inside and a puncture catheter for guiding the puncture kit to a target puncture area (see Figs 8B-C with retractable needle sheath 810 or puncture catheter and needle 811; para [000122]). Morales recognizes the benefit of occluding a puncture site after the initial procedure and teaches the procedure may include deploying a balloon member at the venous puncture site to tamponade the venous puncture site and produce hemostasis and/or deploying hemostatic material (para [00028, 000125])
However, Morales fails to disclose the puncture kit is equipped with an occluder as claimed. Girton discloses an implantable occluder (Figs 2-4A) deliverable through a catheter or tubular member (100), wherein the occluder is constructed as a self- expanding occluder (para [0031]), and the self-expanding occluder comprises a proximal third push rod (300) and a distal occluding structure (200), the third push rod is used to push the occluding structure through the puncture catheter, and the occluding structure can radially open and adhere to the punctured blood vessel wall by relying on a self-expanding force after leaving the puncture catheter (Figs 5A-B seal opening in tissue 105 – para [0037-0043]; fully capable of sealing punctured blood vessel), characterized in that the occluding structure of the occluder is a flower-shaped, umbrella-shaped, disc-shaped, ring-shaped, cylindrical, or funnel-shaped structure (Fig 2), and characterized in that an electric release portion is constructed at the distal end of the third push rod to cause the occluding structure to fall off from the third push rod when it is powered on (para [0034] – electrolytically severable joint). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify Morales to include the occluder and push rod, as taught by Girton, for the purpose of closing and sealing the tissue opening formed by the puncture needle after the initial procedure. Substitution of one known element for another element providing the same function to yield predictable results (mechanisms for occluding/sealing a tissue opening) would have been obvious to one of ordinary skill in the art at the time of the invention.
Response to Arguments
Applicant’s arguments, see amendment, filed November 26, 2025, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Bonde et al. (US 2012/0323254).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771