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.
(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, 5-7, 9, 12-14, 32, 34, 37-38, 48 and 54 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Canale (WO 2021011554 note this reference was provided by the applicant in the IDS filed 3/3/2024).
Regarding Claim 1, Canale teaches (Fig 3) a robotic device for manipulation of an arrangement of a plurality of elongate surgical tools, comprising:
a first motive unit (32a) and a second motive unit (32b), each motive unit configured to receive at least one elongate surgical tool (see [0172] teaching that each of 32a-32d may receive different types of EMDs) of said arrangement, wherein an elongate surgical tool received by said first motive unit is different from an elongate surgical tool received by said second motive unit (see [0172] teaching that each of 32a-32d may receive different types of EMDs); each motive unit comprising a driving assembly (68; see [0175]) and one or more motors (94; see [0175]) configured for actuation of said driving assembly to move said at least one elongate surgical tool (see [0175] teaching translation of elongate medical devices); and
a coupler (60, 77a-b, 78a-b) attached to said first motive unit (32a) and to said second motive unit (32b), said coupler comprising two or more portions (78a, 78b) connected to each other (connected via 60); said coupler configured so that movement of said two or more portions relative to each other allows movement of at least one of said first and second motive units relative to the other motive unit, while in each of said first and second motive units said elongate surgical tool remains in operable engagement with said driving assembly (see [0168] "the corresponding device module 32a-d coupled to the stage 62a-d) may independently move relative to each other and the linear member 60.").
Regarding Claim 2, Canale teaches the robotic device according to claim 1, wherein at least said first motive unit (32a) is attached to said coupler (60, 77a-b, 78a-b) by a reversible attachment which provides for replacing at least said first motive unit as a whole (see [0168] teaching how 32a-32d and 62a-d, 64a-d all engage and disengage from each other; this is interpreted as the device is capable of "reversible attachment"; also see [0170] teaching how parts can be re-sterilized for use in multiple procedures); and
wherein said coupler is configured to hold said first motive unit relative to said second motive unit at more than one spatial configuration (See [0168] teaching that the components may independently move relative to each other and may be engage/disengage from each other).
Regarding Claim 5, Canale teaches the robotic device according to claim 1, wherein in each of said first and second motive units (32a,32b), no barrier exists between said driving assembly and said elongate surgical tool received within said motive unit (See [0172] teaching how EMD engages with 32a,32b, there is no 'barrier' due to the drive assembly).
Regarding Claim 6, Canale teaches the robotic device according to claim 1, wherein in each of said motive units (32a,32b), no barrier exists between said driving assembly and said one or more motors (See [0172] teaching how EMDs engage with 32a,32b; there is no 'barrier' due to the motors).
Regarding Claim 7, Canale teaches the robotic device according to claim 1, wherein one (78a)of said at least two portions (78a,78b) of said coupler (60, 77a-b, 78a-b) is attached to said first motive unit (32a), and the other (78b) of said at least two portions (78a,78b) of said coupler (60, 77a-b, 78a-b) is attached to said second motive unit (32b).
Regarding Claim 9, Canale teaches the robotic device according to claim 1, wherein said elongate surgical tool received within said first motive unit comprises a guidewire, said elongate surgical tool received within said second motive unit comprises a microcatheter, said arrangement comprising said guidewire at least partially inserted into a lumen of said microcatheter (See [0172] teaching variety of EMDS, including a microcatheter and guidewire; as such it is interpreted that the device is capable of the "arrangement comprising said guidewire at least partially inserted into a lumen of said microcatheter"; see [0157] teaching that the drive may be used to move a guidewire into a catheter);
wherein said driving assembly of said first motive unit is positioned to contact said guidewire when said guidewire is received within said first motive unit and to one or both move said guidewire linearly and roll said guidewire; and wherein said driving assembly of said second motive unit is positioned to contact said micro catheter when said microcatheter is received within said second motive unit and to move said microcatheter linearly (See [0172] teaching variety of EMDS, including a microcatheter and guidewire; as such it is interpreted that the device is capable of the "arrangement comprising said guidewire at least partially inserted into a lumen of said microcatheter"; see [0157] teaching that the drive may be used to move a guidewire into a catheter); and
wherein said second motive unit comprises an attachment to a guiding catheter, said microcatheter and guidewire arrangement being at least partially inserted into a lumen of said guiding catheter (See [0172] teaching variety of EMDS, including a microcatheter and guidewire; as such it is interpreted that the device is capable of the "arrangement comprising said guidewire at least partially inserted into a lumen of said microcatheter"; see [0157] teaching that the drive may be used to move a guidewire into a catheter).
Regarding Claim 12, Canale teaches the robotic device according to claim 9, wherein said second motive unit (32b) is slidably mounted on a platform (see [0171] teaching linear movement), and wherein sliding movement of said second motive unit relative to said platform linearly moves said attached guiding catheter along with said inserted microcatheter and guidewire (see [0171-0172] teaching both linear movement of 32a-d and how they engage with EMDs; as such it is interpreted that the 32a-d may move with the EMDs attached).
Regarding Claim 13, Canale teaches the robotic device according to claim 1, wherein said first motive unit (32a) is shaped as a barrel (See Fig 4 and see Fig 7, these are considered ‘barrel’ shapes), and said coupler (60, 77a-b, 78a-b) holds said first motive unit (32a) vertically above said second motive unit (32b; see Fig 3-4 and see [0169] teaching each cassette is in a vertical orientation).
Regarding Claim 14, Canale teaches the robotic device according to claim 1, wherein said two or more portions of said coupler comprise a lever portion (78a,78b) and a vertical rail (60) which are connected to each other at a joint (Fig 3; [0169]).
Regarding Claim 32, Canale teaches a method of effectively increasing a useable length of an elongate surgical tool manipulated by said robotic device according to claim 1 (See rejection above), said elongate surgical tool extending from an attachment with said first unit (See Fig 3, EMD is extending between 32a-32b), between said first (32a) and second units(32b), and then through a designated path of said second unit (See [0157] teaching the drive is used to move a guidewire into a catheter, therefore it is interpreted that the designated path is moving the guidewire into the catheter in the second unit), the method comprising:
identifying a need to increase a useable length of the elongate surgical tool (See [0177] teaching how the EMD is meant to enter the body of a patient; it is implied with the distal movement described with [0176] that the translation of the units will provide additional usable length; also see [0004] teaching how purpose is to help with the requirement of guiding a EMD to a more distal target area);
while maintaining the elongate surgical tool in attachment with said first unit and inside said designated path of said second unit, approximating an attachment of said elongate surgical tool to said first unit to an entry point of said elongate surgical tool into said designated path of said second tool, such that an additional segment of said elongate surgical tool is made available for use (See [0177] teaching how the EMD is meant to enter the body of a patient; it is implied with the distal movement described with [0176] that the translation of the units will attach the EMD to the first unit at an entry point; also see Figs 50 and 51 showing how an EMD would enter another EMD (i.e. Fig 50 shows 540 entering 536 and Fig 51 shows guidewire 560 entering 552); and
advancing said elongate surgical tool through said designated path and further into a patient body (See Figs 10-11b showing how the EMD is guided into a patient body; see [0149]).
Regarding Claim 34, Canale teaches the method according to claim 32, wherein said approximating comprises changing a spatial configuration of said first unit relative to said second unit via a coupler connected to said first and second units (See [0180] teaching the units are offset from each other based on the desired length/movement required of the EMDs; this ‘offset’ is considered a ‘spatial configuration’ of the first unit relative to the second unit (32a, 32b or any other drive modules of Fig 3)).
Regarding Claim 37, Canale teaches the method according to claim 32, comprising controlling said approximating remotely using a remote- controller (see [0158-0159] teaching the device 24 may be controlled remotely with controller 26).
Regarding Claim 38, Canale teaches the method according to claim 32, wherein said identifying comprises one or more of: identifying in response to a signal received from a controller of said robotic device (See [0192] teaching how the device may have sensors alerting the user to the proximity of the different units relative to each other), identifying in response to user input (See [0158-0159] teaching the device 24 may retract, advance or rotate based on user input in the controller 26), identifying in response to an indication obtained by one or more sensors of said robotic device (See [0192] teaching how the device may have sensors alerting the user to the proximity of the different units relative to each other).
Regarding Claim 48, Canale teaches (Fig 3) A motive unit (32a) for manipulation of a guidewire, comprising:
a housing (interpreting that outer surfaces of module of 32a in Figs 3-4 is ‘a housing’, or similar to 93 in Fig 7) including:
a guidewire pre-loaded onto a designated path (107; see [0176] teaching EMD within channel 107) inside said housing (See [0172] teaching guidewires are possible EMDs that are populating the modules 32a-32d (the housing is the module);
one or more motors (64a-64d);
a driving assembly (76) configured to move said guidewire (See [0157] teaching that the drive may be used to move a guidewire into a catheter), said driving assembly actuated by said one or more motors (See [0168] teaching motors 64a-64d are translation motors);
wherein said housing (32a-32d) defines an external attachment (62a-62d) to a coupler (60, 70, 77a-77d, 78a-78d) shaped and configured to hold said motive unit (32a) relative to at least a second motive unit (32b).
Regarding Claim 54, Canale teaches the motive unit according to claim 48, wherein said coupler (60, 70, 77a-77d, 78a-78d) comprising two or more rigid portions (78a-78d) that are adjustable in position relative to each other (see [0168] "the corresponding device module 32a-d coupled to the stage 62a-d) may independently move relative to each other and the linear member 60."), a first portion (78a) configured to attach to said motive unit (32a) and a second portion (78b) configured to attach to said second motive unit (32b), wherein movement of said rigid portions relative to each other provides for selectively positioning said motive unit relative to said second motive unit (See [0168] and Fig 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.
Claim(s) 4 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Canale (WO 2021011554) in view of Yu (US 20170105804)
Regarding Claim 4, Canale teaches the robotic device according to claim 2, wherein said more than one spatial configuration includes a vertical arrangement of said first motive unit relative to said second motive unit (See [0169] teaching a vertical arrangement), such that long axes of said driving assemblies of said units are parallel to each other (See Fig 3 and [0169]);
Canale does not specify an inclined arrangement in which a long axis of said driving assembly of said first motive unit extends at an angle relative to a long axis of said driving assembly of said second motive unit.
Yu teaches [0036] a motive unit (430) that may be rotated about axis A-A (it is interpretated this this is another arrangement that results in an ‘inclined arrangement’ when the rotational element is added to the motive unit of Canale).
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 arrangement of the motive unit of Canale such that it includes a rotatable component as taught by Yu. With this modification, the motive unit could be rotated relative to the second motive unit resulting in an inclined arrangement in which a long axis of said driving assembly of said first motive unit extends at an angle relative to a long axis of said driving assembly of said second motive unit. One of ordinary skill in the art would recognize that this is an alternative arrangement, that still allows for the same functionality of guiding/repositioning a catheter/instrument (See Yu [0036]).
Regarding Claim 35, Canale teaches all elements of claim 34 as described above. Canale further teaches the method wherein the first unit is in a vertical position (See [0169] teaching a vertical arrangement). Canale does not specify the method wherein said changing comprises moving said first unit from a vertical position relative to said second unit to an inclined or horizontal position relative to said second unit; and wherein said moving is spring actuated.
Yu teaches [0036] a motive unit (430) that may be rotated about axis A-A (it is interpretated this this is another arrangement that results in an ‘inclined arrangement’ when the rotational element is added to the motive unit of Canale).
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 arrangement of the motive unit of Canale such that it includes a rotatable component as taught by Yu. With this modification, the motive unit could be rotated relative to the second motive unit resulting in an inclined arrangement in which a long axis of said driving assembly of said first motive unit extends at an angle relative to a long axis of said driving assembly of said second motive unit. One of ordinary skill in the art would recognize that this is an alternative arrangement, that still allows for the same functionality of guiding/repositioning a catheter/instrument (See Yu [0036]).
The combination does not specify wherein said moving is spring actuated.
Canale does teach in an alternative embodiment that the coupler may be a spring type (See [0215] and [0226]).
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 coupler of Canale embodiment of Fig 3, such that the coupler is spring actuated as taught by an alternative embodiment of Canale. One of ordinary skill in the art would recognize this as an alternative actuation mechanism for the coupler of this device (Canale [0215]).
Claim(s) 8, 49 and 50 is/are rejected under 35 U.S.C. 103 as being unpatentable over Canale (WO 2021011554).
Regarding Claim 8, Canale teaches all elements of claim 1 as described above. The embodiment of Canale Fig 3 does not specify the robotic device wherein movement of said two or more portions of said coupler is spring actuated.
Canale does teach in an alternative embodiment that the coupler may be a spring type (See [0215] and [0226]).
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 coupler of Canale embodiment of Fig 3, such that two or more portions of said coupler is spring actuated as taught by an alternative embodiment of Canale. One of ordinary skill in the art would recognize this as an alternative actuation mechanism for the coupler of this device (Canale [0215]).
Regarding Claim 49, Canale teaches all elements of claim 48 as described above. Canale does not specify wherein said driving assembly comprises a plurality of wheel pairs positioned in contact with said guidewire, wherein rotation of said wheels moves said guidewire linearly and wherein rotation of said driving assembly as a single unit rolls said guidewire as said guidewire is held between opposing wheels of said plurality of wheel pairs.
Canale does teach in the embodiment of Figs 7-9 the motive unit wherein said driving assembly comprises a plurality of wheel pairs (103, 105; see Fig 8) positioned in contact with said guidewire (See [0176] teaching that 103, 105 are used to provide linear motion to an elongate medical device), wherein rotation of said wheels moves said guidewire linearly and wherein rotation of said driving assembly as a single unit rolls said guidewire as said guidewire is held between opposing wheels of said plurality of wheel pairs (See [0176] teaching that 103, 105 are used to provide linear motion to an elongate medical device within channel 107).
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 driving assembly of Canale embodiment of Fig 3 such that it includes a plurality of wheel pairs positioned in contact with said guidewire, wherein rotation of said wheels moves said guidewire linearly and wherein rotation of said driving assembly as a single unit rolls said guidewire as said guidewire is held between opposing wheels of said plurality of wheel pairs as taught by Canale Fig 8-9. One of ordinary skill in the art would recognize this as an alternative method of translating the elongate medical device within the cassette (Canale [0176]).
Regarding Claim 50, Canale teaches all elements of claim 48 as described above. Canale does not specify the motive unit, wherein said housing is shaped as a barrel and wherein a diameter of said barrel is sized according to a radius of rotation of said driving assembly as a single unit.
However, the embodiment of Canale Fig 7 teaches a housing (93) with a barrel shape (95).
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 housing of Canale embodiment Fig 3 such that it is a barrel shape as shown in the embodiment of Canale Fig 7. One of ordinary skill in the art would recognize that this is an alternative design that would still provide the same result of holding an EMD (Canale [0176]).
The modification does not specify wherein a diameter of said barrel is sized according to a radius of rotation of said driving assembly as a single unit. The instant disclosure describes the parameter of a diameter of said barrel is sized according to a radius of rotation of said driving assembly as a single unit as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as a diameter of said barrel is sized according to a radius of rotation of said driving assembly as a single unit are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of a diameter of said barrel is sized according to a radius of rotation of said driving assembly as a single unit would be dependent on the actual application of the system and, thus would be a design choice based on the actual application. Furthermore, a change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Beyar (WO 9945994) teaches a remote control device for inserting a catheter including sensors detecting movement/position of the catheter.
Clark (WO 2021011551) teaches a device used for supporting and driving an elongated medical device in a robotic catheter system.
Kidd (CN 103442660) teaches a robotic catheter system with a remote operating system.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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