DETAILED ACTION
Remarks
This non-final office action is in response to the application filled on 12/19/2023. Claims 1-23 are pending and examined below.
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 .
Priority
Acknowledgment is made of applicant’s claim for domestic benefit under 35 U.S.C. 119 (e). The provisional application No. 63/434,040, was filed on 12/20/2022.
Information Disclosure Statement
As of date of this action, IDS filled has been annotated and considered.
Claim Objections
Claim 7 is objected to because of the following informalities:
Claim 7, line 2 recites “a fourth assembly” should be “a fourth hub assembly”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 5 and 16 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claim 5 (and similarly claim 16), which recites “a vascular procedure” is not clear since claim 1 also recites a vascular procedure. It is not clear both vascular procedures are same or different.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2 and 5 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2014/0276389 (“Walker”).
Regarding claim 1, Walker discloses a system for performing a vascular procedure (see at least fig 1 and [0019], where system 100 is configured to aid in the insertion of a medical instrument), comprising:
a robotic drive system (see at least [0019], where “robotic catheter assembly 102”); and
one or more hub assemblies operatively coupled to the robotic drive system (see at least [0023], where “the system 100 may provide for the first and second torque device 104, 106 to be incorporated into the first and second driver 108, 110, respectively.”; see also fig 1 and fig 2), each of the one or more hub assemblies comprising:
a mount (see at least fig 2 and [0023], where drivers 108 and 110 are interpreted as mounts);
a hub removably coupled to the mount (see at least [0023], where “the torque devices 104, 106 may be configured to removably connect to the respective drivers 108, 110”); and
an interventional device coupled to the hub (see at least [0019], where “Each of the torque devices 104, 106 may be configured to selectively grip an elongate member such as a medical instrument 114”; instrument 114 is interpreted as interventional device);
wherein, for each of the one or more hub assemblies:
the mount is configured to be driven by the robotic drive system to drive the interventional device within a vasculature of a patient (see at least [0021-22], where components within catheter assembly 102 drive the drivers 108 and 110 forward and backwards on drive track 112. As a result, an instrument 114 may be controllably manipulated while inserted into the patient);
the hub is configured to be uncoupled from the mount while the interventional device is positioned within the vasculature of the patient (see at least [0031] and [0034], where device 104 and 106 are top loaded onto drivers 108 and 110 so that they can be interchanged during a procedure); and
the hub is configured to be manually manipulated to navigate the interventional device to a vascular site while the hub is uncoupled from the mount (see at least [0023], where “the outer periphery 164, 166 of devices 104, 106 may be ribbed to provide an ergonomic grasping surface.”; See also [0025], where each device 104 and 106 includes an actuator 116, 138 which may be press to release actuator allowing the instrument to be retained until the actuator is engaged. See also fig 3 and fig 5B).
Regarding claim 2, Walker further discloses a system wherein the robotic drive system comprises a drive table and one or more hub adapters axially movable within the drive table (see at least [0020-21], where the top portion of the catheter assembly 102 has a driver track 112. The first and second drivers 108, 110, which hold devices 104, 106, are mounted to mounting plates 154, 156 that slide along the driver track 112).
Regarding claim 5, as best understood in view of indefiniteness rejection explained above, Walker further discloses a system wherein the interventional device of at least one of the one or more hub assemblies is configured to perform a vascular procedure (see at least [0019], where “a medical instrument 114, for example a catheter, microcatheter, guidewire, balloon catheter, sheath, stent, or any other elongate member”).
Claim(s) 12, 14-16 and 18 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 2022/0233263 (“Canale”).
Regarding claim 12, Canale discloses a method of performing a vascular procedure (see at least [0245], where a method of inserting an elongated medical device (EMD) in a robotic drive), comprising:
coupling a plurality of hub assemblies to a robotic drive system (see at least [0247], where “the prepared set of EMDs is loaded into two or more of the device modules at substantially the same time”; two or more device modules of a robotic drive), the plurality of hub assemblies comprising:
a first hub assembly comprising a first mount (see at least [0247], where module 1142 supports a cassette), a first hub removably coupled to the first mount (see at least [0249], where an on-device adapter, such as adapter 242 of figures 24 and 25 may be removably connected to the cassette of the module 1142), and a first interventional device coupled to the first hub (see at least [0249], where the on-device adapter may releasably couple an EMD 1158 to the cassette of module 1142); and
a second hub assembly comprising a second mount (see at least [0247], where a module 1144 may hold a cassette), a second hub removably coupled to the second mount (see at least [0249], where an on-device adapter, such as adapter 242 of figures 24 and 25 may be removably connected to the cassette of the module 1444), and a second interventional device coupled to the second hub (see at least [0249], where the on-device adapter may releasably couple an EMD 1160 to the cassette of module 1144);
robotically driving the first hub assembly and the second hub assembly to drive the first interventional device and the second interventional device within a vasculature of a patient (see at least [0157], where robotic drive 24 enables an operator 11 to perform a catheter based medical procedure, such as inserting a medical device into the artery of a patient); and
uncoupling the second hub from the second mount while the second interventional device is positioned within the vasculature of the patient (see at least [0249], where each on-device adapter may be removed from us corresponding cassette while still holding its respective EMD, allowing an operator to convert a robotic procedure to a manual procedure).
Regarding claim 14, Canale further discloses a method comprising manually driving the second hub while the second hub is uncoupled from the second mount to drive the second interventional device to a vascular site (see at least [0249], where the on-device adapters remain attached to the EMDs to enable conversion to a manual procedure from a robotic procedure).
Regarding claim 15, Canale further discloses a method comprising inserting a third interventional device through a lumen of the second interventional device and manually driving the third interventional device into the vasculature of the patient (see at least [0247-249], where a set of three coaxial EMDs may be preassembled together before being loaded into the robotic device 24 and through a guide catheter already ignored within. the patient. An operator may convert the robotic procedure to a manual procedure by removing the EMDs from their cassettes so that they retain only their on-device adapters).
Regarding claim 16, as best understood in view of indefiniteness rejection explained above, Canale further discloses a method comprising performing a vascular procedure using the third interventional device (see at least [0247], where the procedure may include providing the preassembled set of EMDs to the robotic drive and through a first EMD once access to the carotid artery bas been achieved).
Regarding claim 18, Canale further discloses a method wherein the third interventional device is a stent retriever or a stent retriever catheter (see at least [0148], where the EMDs used may include stent retrievers).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US 2014/0276389 (“Walker”).
Regarding claim 3, Walker further discloses a system wherein each of the one or more hub assemblies is positioned to move axially along the drive table (see at least [0021-22] and [0033], where the assembly containing devices 104, 108 is mounted to plate 154 and the assembly containing devices 106, 110 is mounted to plate 156. See also figure 1, where each assembly moves along the rack 112).
Walker does not explicitly disclose the following limitation:
hub assemblies is magnetically coupled.
However, Walker further discloses a system comprising a magnetic coupling (see at least [0031], where a magnetic latching assembly between torque devices 104, 106 and their respective drivers 108, 110).
It would have been obvious to one of ordinary skill in the art before the priority date to modify Walker to include a magnetic coupling for each mounting plate 154, 156 since magnets are known in the art of coupling. The motivation would have been to ensure the correct positioning and to make the coupling easy to remove for cleaning.
Regarding claim 4, Walker further discloses a wherein the mount of each of the one or more hub assemblies is configured to (see at least [0020] and fig 1, where the assembly containing devices 104, 108 is mounted to plate 154 and the assembly containing devices 106, 110 is mounted to plate 156).
Walker does not explicitly disclose the following limitation:
hub assemblies is configured to magnetically couple.
However, Walker further discloses a system comprising a magnetic coupling ( see at least [0031], where a magnetic latching assembly between torque devices 104, 106 and their respective drivers 108, 110).
It would have been obvious to one of ordinary skill in the art before the priority date to modify Walker to include a magnetic coupling for each mounting plate 144, 156 since magnets are known in the art of coupling. The motivation would have been to ensure the correct positioning and to make the coupling easy to remove for cleaning.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0276389 (“Walker”), as applied to claim 5 above, and further in view of US 2020/0397451 (“Feltyberger”).
Regarding claim 6, Walker does not disclose claim 6. However, Feltyberger discloses a system wherein the vascular procedure comprises a neurovascular thrombectomy (see at least [0038] and [0063], where a neural thrombectomy procedure can be performed using apparatus 200 ).
It would have been obvious to one of ordinary ski in the art before the priority date to modify the system of Walker to be utilized during a neurovascular thrombectomy as taught by Feltyberger. The motivation would have been to use the system to assist a physician preforming a neurovascular thrombectomy.
Claim(s) 7-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0276389 (“Walker”), as applied to claim 1 above, and further in view of US 2022/0233263 (“Canale”).
Regarding claim 7, Walker further discloses a system wherein the one or more hub assemblies comprises a first hub assembly, a second hub assembly(see at least fig 1 and fig 2, where a first assembly containing devices 104, 108 and a second assembly containing devices 106, 110).
Walker does not disclose the following limitation:
a third hub assembly, and a fourth assembly.
However, Canale further discloses a system in the field of vascular procedures ( see at least [0155]) and discloses a third hub assembly, and fourth assembly (see at least [0157], where a robotic drive has four device modules 32a-32d for driving an elongated medical device).
It would have been obvious to one of ordinary skill in the art before the priority date to modify Walker to include a third hub assembly, and a fourth assembly as taught by Canale. The motivation would have been to use the system of walker for a medical procedure requiring a longer medical device.
Regarding claim 8, Canale further discloses a system wherein interventional devices of the one or more hub assemblies are coaxially nested (see at least [0182], [0247] and [0249], where the EMDs may be arranged coaxially).
It would have been obvious to one of ordinary skill in the art before the priority date to modify the system of Walker to be utilized with coaxially nested interventional devices as taught by Canale. The motivation would have been to use the system to perform more complex medical procedures.
Regarding claim 9, Walker further discloses a system wherein the one or more hub assemblies comprise one or more of an access catheter hub assembly having an access catheter, a guidewire hub assembly having a guidewire, a procedure catheter hub assembly having a procedure catheter, and a guide catheter hub assembly having a guide catheter (see at least [0019], where torque devices 104, 106 of the first and second assemblies hold a medical device 114, which may be a catheter, guidewire, balloon catheter, sheath, or stent).
Regarding claim 10, Canale further discloses a system wherein at least one of the one or more hub assemblies is configured to receive an additional interventional device therethrough (see at least [0182], where a first cassette 210 may hold a first elongated medical device configured to accept proximal medical devices within).
Regarding claim 11, Canale further discloses a system wherein the hub of the at least one of the one or more hub assemblies is configured to receive the additional interventional device therethrough (see at least [0182], where the cassettes may interface with the elongated medical devices via on-device adapters, which may hold the coaxial devices).
It would have been obvious to one of ordinary skill in the art before the priority date to modify Walker io include the hub of the at least one of the one or more hub assemblies being configured to receive the additional interventional device therethrough as taught by Canale. The motivation would have been to use the system to perform. more complex medical procedures.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0233263 (“Canale”), as applied to claim 12 above, and further in view of US 2020/0233263 (“Liu”).
Regarding claim 13, Canale does not disclose claim 13. However, Liu discloses a method wherein robotically driving the first hub assembly and the second hub assembly to drive the first interventional device and the second interventional device within the vasculature of the patient comprises driving the first interventional device and the second interventional device to achieve supra-aortic access (see at least [0076], where a guide wire 304 is introduced via supra-aortic access and advanced into the ascending aorta 302. A delivery system 306 including modular stent device 100 is introduced via supra-aortic access is advanced into the ascending aorta 302 over guidewire 304).
It would have been obvious to one of ordinary skill in the art before the priority date to modify Canale to include driving the first interventional device and the second interventional device to achieve supra-aortic access as taught by Liu. The motivation would have been to adapt the method to a selected medical procedure.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0233263 (“Canale”), as applied to claim 16 above, and further in view of US 2020/0397451 (“Feltyberger”).
Regarding claim 17, Canale does not disclose claim 17. However, Feltyberger further discloses a method wherein the vascular procedure is a neurovascular thrombectomy (see at least [0038] and [0063], where a neural thrombectomy procedure can be performed using apparatus 200 ). Same motivation of claim 6 applies.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US 2022/0233263 (“Canale”).
Regarding claim 19, Canale further discloses a method of performing vascular procedure, see citation above. Canale does not explicitly discloses a method wherein the first interventional device is a guide catheter and the second interventional device is a procedure catheter configured to extending within a lumen of the procedure catheter.
However, second embodiment of Canale (robotic drive 200) discloses a method wherein the first interventional device is a guide catheter and the second interventional device is a procedure catheter configured to extending within a lumen of the procedure catheter (see at least [0182], where a first EMD 218 may be a snide catheter configured to receive a second EMD, the second EMD 220 may be a diagnostic or distal access catheter).
It would have been obvious to an of ordinary skill in the art before the priority date to include wherein the first interventional device is a guide catheter and the second interventional device is a procedure catheter configured to extend within a lumen of the guide catheter. The motivation would have been to adapt the method to the specific procedure required by the patient.
Regarding claim 20, Second embodiment of Canale (robotic drive 200) further discloses a method wherein The method of Claim 19, wherein uncoupling the second hub from the second mount is performed while the procedure catheter is positioned within the lumen of the guide catheter and while the first hub is coupled to the first mount (see at least [0182] and [0185], where during the medical procedure in which the EMDs may be arranged coaxially, any one of the EMDs can he removed from its cassette and coupled to an unpopulated cassette to facilitate the required steps of a medical procedure).
It would have been obvious to one of ordinary skill in the art before the priority date to include uncoupling the second bub from the second mount is performed while the procedure catheter to positioned within the lumen of the guide catheter and while the first hub is coupled to the first mount. The motivation would have been to allow a selected lumen to be hand guided while maintaining its outer lumen on the robotic drive to facilitate fine navigation.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0233263 (“Canale”), as applied to claim 12 above, and further in view of US 2014/0276389 (“Walker”).
Regarding claim 21, Canale does not disclose claim 21. However, Walker further discloses a method wherein coupling the plurality of hub assemblies to the robotic drive system comprises magnetically coupling the first mount to a first hub adapter through a sterile barrier and magnetically coupling the second mount to a second hub adapter through the sterile barrier (see at least [0031], where devices 104 and 106 may be coupled to drivers 108, 110 respectively by a magnetic latching assembly and a sterile sheet may be provided between the torque devices 104, 106 and their respective drivers 108, 110; see also [0019]).
It would have been obvious to one of ordinary skill in the art before the priority date to modify the method of Canale to include magnetically coupling the first mount to a first hub adapter through a sterile barnier and magnetically coupling the second mount to a second hub adapter through the sterile barrier as taught by Walker. The motivation would have been to maintain a sterile environment between parts of the system to prevent infections.
Allowable Subject Matter
Claims 22 and 23 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SOHANA TANJU KHAYER whose telephone number is (408)918-7597. The examiner can normally be reached on Monday - Thursday, 7 am-5.30 pm, PT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Abby Lin can be reached on 571-270-3976. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SOHANA TANJU KHAYER/Primary Examiner, Art Unit 3657