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 .
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed 06/23/2023 has been considered by the Examiner.
Response to Arguments
Applicant's arguments filed 10/15/2025 have been fully considered but they are not persuasive.
In the Remarks filed 10/15/2025, Applicant argues that the prior art of Wendlandt cited in the Non-Final Office Action filed 07/29/2025 does not teach a first, second, and third catheter translation module where the second and third catheter translation modules can translate longitudinally with respect to the first translation module to perform a longitudinal translation of a respective second or third flexible elongated medical element.
Applicant argues that Wendlandt discloses that only the flexible elongated medical elements translate longitudinally rather than the catheter translation module as a whole, namely actuation modules 70 as seen in Wendlandt Fig. 3.
Examiner understands the arguments as presented by the Applicant, but respectfully disagrees on the interpretation of the limitations as claimed.
As presented in the Non-Final Office Action, the Examiner considers each of the catheter translation modules to be comprised of one of a plurality of tubes 76, 78, or 80 and an actuator 70 which corresponds to each tube. Each of the modules had a coupling system 82, 84, 86 used to clamp a flexible elongated medical element to the tube of each module so that the translation of the tube resulted in the translation of the flexible elongated medical element. By this interpretation, the module itself, in the form of tubes 76, 78, and 80, which are distinct from the elongated medical element itself (guidewire 10’ and catheters 12’ and 14’), does translate longitudinally with respect to the first catheter translation module comprising tube 80. Additionally, the second and third translation modules, in the form of tubes 76 and 78 are capable of longitudinal translation with respect to the first translation module 80, as disclosed in Wendlandt Column 5, lines 44-58, wherein the tubes 76 and 78 may travel freely without interfering with the travel of the other tubes, and the innermore tubes 76 and 78 extend beyond their respective outermore tubes 78 and 80.
With this in consideration, the rejections as presented in the Non-Final Office Action are maintained.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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, 3-5, 7, 11, 13, 16, and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wendlandt et al (US 6375471 B1).
Regarding claim 1 Wendlandt teaches a catheter robot (catheter actuation assembly 50-1) comprising:
a base (72),
at least three catheter translation modules (see Fig. 3; translation modules comprising actuators 70 and corresponding tubes 76, 78, 80) supported by said base,
each catheter translation module comprising at least one pair of movable pads (see Fig. 3; couplers 82, 84, and 86 with their respective tubes 76, 78, and 80, [Col 5, lines 38-42]; the couplers may be pieces of tape or automated mechanical devices to secure coupling between the tubes and catheter, it can be appreciated that under its broadest reasonable interpretation the limitation of the movable pads can be met by a pair of elements facing one another that secure the medical element in between and able to be moved, the couplers and their respective tubes as described above meet these requirements as they can be removably fashioned to face one another to secure the catheter element):
said pads of a same pair at least partly facing each other,
said pair clamping therebetween a flexible elongated medical element so as to then translate longitudinally said flexible elongated medical element (see [Col 5, lines 38-43]; couplers 82, 84, and 86 provide secure mechanical coupling between each of the corresponding tubes 76, 78, and 80 and the respective catheter),
said catheter translation modules being successively longitudinally disposed (see annotated Fig. 3 below) so that:
a first catheter translation module has the first catheter translation module's pair of pads performing a longitudinal translation of a first flexible elongated medical element which is a catheter guide (see Figs. 3-4; tube 80 and coupler 86 interfacing with catheter guide 14 to cause longitudinal translation),
second catheter translation module:
can translate longitudinally with respect to said first catheter translation module (see [Col 5, lines 44-58]; each tube can freely travel without interfering with the travel of the other tubes),
its pair of pads performing a longitudinal translation of a second flexible elongated medical element (see Figs. 3-4; tube 78 and catheter 12),
third catheter translation module: can translate longitudinally with respect to said first catheter translation module (see [Col 5, lines 44-58]; each tube can freely travel without interfering with the travel of the other tubes),
its pair of pads performing a longitudinal translation of the second flexible elongated medical element or a third flexible elongated medical element (see Figs. 3-4; tube 76 and wire 10).
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Regarding claim 3, Wendlandt teaches the catheter robot according to claim 1, wherein said catheter translation modules are all structurally identical (see Figs. 3-4, [Col 5, lines 26-36]; translation modules all comprising identical actuators 70 and corresponding tube assemblies).
Regarding claim 4, Wendlandt teaches the catheter robot according to claim 1, wherein said catheter translation modules are successively longitudinally spaced apart from one another (see annotated Fig. 3 above having the first, second, and third translation modules successively longitudinally spaced).
Regarding claim 5, Wendlandt teaches the catheter robot according to claim 1, wherein said third catheter translation module can translate longitudinally with respect both to said first catheter translation module and to said second catheter translation module (see [Col 5, lines 44-58]; each tube can freely travel between a retracted position and an extended position without interfering with the travel of the other tubes).
Regarding claim 7, Wendlandt teaches the catheter robot according to claim 1, wherein the second catheter translation module drives a catheter and the third catheter translation module drives a guide, said guide of catheter translates within said catheter itself translating within said catheter guide, for at least part of their respective lengths. See annotated Figs. 3-4 below.
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Regarding claim 11, Wendlandt teaches the catheter robot according to claim 1, wherein said first catheter translation module is fixed with respect to said base (see Fig. 3, [Col 5, lines 26-30]; actuator 70 is fixed in relation to base 72).
Regarding claim 13, Wendlandt teaches the catheter robot according to claim 1, wherein said catheter translation modules are successively longitudinally disposed from one another, in an order which is: first then second and then third catheter translation module. See annotated Fig. 3 below.
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Regarding claim 16, Wendlandt teaches the catheter robot according to claim 1, wherein each catheter translation module is also a catheter rotation module alternatively, each pair clamping between its facing pads, a flexible elongated medical element (couplers 82, 84, 86 interfacing with tubes 76, 78, 80 to hold guide wire 10, catheter 12, catheter guide 14) so as to then rotate around longitudinal axis said flexible elongated medical element, by making said flexible elongated medical element rolling between its facing pads (see [Col 6, lines 49-65]; rotation control wheel 104 allows for the rotation of tubes 76, 78, 80).
Regarding claims 19 and 20 please see the rejections above regarding claims 2-4, which addresses each and every limitation of claims 19 and 20.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2, 8, and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wendlandt et al (US 6375471 B1) in view of Lewis et al (US 20140277334 A1).
Regarding claims 2 and 8 Wendlandt teaches the catheter robot according to claim 1 having a control unit (see [Col 4, lines 48-55]; actuator assembly 50-1 receives drive signals 52 from driver/amplifier circuit controlled from workstation 60). They are silent regarding wherein the control unit is specifically configured for:
commanding the translation of the second catheter translation module by following the translation of the first flexible elongated medical element, and for controlling the translation of the second flexible elongated medical element by compensating the translation of the second catheter translation module so as to maintain the second flexible elongated medical element stationary with respect to said base; and
commanding the translation of the third catheter translation module by following the translation of the second flexible elongated medical element, and for controlling the translation of the third flexible elongated medical element by compensating the translation of the third catheter translation module so as to maintain the third flexible elongated medical element stationary with respect to said base.
However, Lewis teaches an active drive system for robotic catheter manipulators in which the system is configured to:
command the translation of the second catheter translation module by following the translation of the first flexible elongated medical element, and for controlling the translation of the second flexible elongated medical element by compensating the translation of the second catheter translation module so as to maintain the second flexible elongated medical element stationary with respect to said base (see Lewis [0107]; active catheter driver 80 advances and/or retracts the second flexible elongated medical element, leader catheter 38 within the first elongated medical element, guide sheath 36, in coordination with the translation of the second catheter translation module, catheter carriage 76); and
command the translation of the third catheter translation module by following the translation of the second flexible elongated medical element, and for controlling the translation of the third flexible elongated medical element by compensating the translation of the third catheter translation module so as to maintain the third flexible elongated medical element stationary with respect to said base (see Lewis [0195]; active catheter feeder system 100 as described above can also be used to advance/retreat the third flexible elongated medical element, the guidewire 40, with respect to the leader catheter and guide sheath).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Wendlandt’s catheter robot with the control unit configured for commanding the translation of the translation modules with respect to the catheter as taught by Lewis. One of ordinary skill in the art would have been motivated to make this modification in order to prevent axial buckling of the catheter members as they are advanced with respect to one another and the patient (Lewis [0107]).
Regarding claim 12, Wendlandt teaches the catheter robot according to claim 1. They are silent regarding wherein said base is an end of an articulated robotic arm.
Lewis teaches a robotic catheter having an articulating driver assembly wherein the base is an end of an articulated robotic arm (see Fig. 3, [0101]; robotic catheter assembly having an instrument driver 34, guide sheath 36, catheter 38, and guidewire 40 located on robotic arm 14).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to use Wendlandt’s catheter robot in conjunction with a robotic arm as taught by Lewis. One of ordinary skill in the art would have been motivated to make this modification in order to movably support the robotic catheter assembly above an operating table to provide access to the desired portions of a patient (Lewis [0100]).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wendlandt et al (US 6375471 B1) in view of Falb et al (US 20220125533 A1).
Regarding claim 6, Wendlandt teaches the catheter robot of claim 5. They are silent regarding a first connector located between said first and second catheter translation modules, and a second connector located between said second and third catheter translation modules.
However, Falb teaches a robotic catheter system having a triaxial system (Abstract) comprising a translatable catheter, intermediate catheter, and controlled catheter ([0129]) wherein a first connector is located between said first and second catheter translation modules (see Fig. 43; first y-connector 504), a second connector is located between said second and third catheter translation modules (see Fig. 43; second y-connector 586).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Wendlandt’s catheter robot with the connectors located between the first and second and second and third translation modules as taught by Falb. One of ordinary skill in the art would have been motivated to make this modification in order to operably attach a hemostasis value to the catheter assembly (Falb [0130]).
Claim(s) 9, 10, 14, 15, 17, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wendlandt et al (US 6375471 B1) in view of Canale et al US 20220233263 A1.
Regarding claim 9, Wendlandt teaches the catheter robot according to claim 1. They are silent regarding wherein said second and third catheter translation modules are fastened together so as to be able to translate longitudinally with respect to said first catheter translation module only jointly.
However, Canale teaches a drive system for an elongated medical device, including a catheter, having multiple translatable portions wherein said second and third catheter translation modules are fastened together so as to be able to translate longitudinally with respect to said first catheter translation module only jointly (see [0193]; drive modules can be nested together, and the control system may couple the linear movement of the nested module to the linear movement of the module connected to the cassette under which the nested module is positioned).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Wendlandt’s catheter robot with the nested drive modules as taught by Canale. One of ordinary skill in the art would have been motivated to make this modification in order to modulate the number of translation modules in accordance with the number of translatable elements of the catheter system without changing the length of the stage and drive module system (Canale [0190]).
Regarding claim 10 Wendlandt teaches the catheter robot according to claim 1. They are silent regarding said pair of pads of said third catheter translation module being transversely shifted from said pair of pads of said second catheter translation module.
It can be appreciated that if the second and third translation modules were fastened together into a conjoined module as taught by Canale, it would have been obvious for the pads of the third translation module to have been shifted transversely from the pads of the second translation module (see Canale [0190]; to facilitate the nesting of modules offset brackets may be used to connect the modules to the stage, Fig. 34; showing transversely offset brackets 350, 352, and 354 corresponding to translation modules 356, 358, and 360).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Wendlant’s catheter robot having Canale’s nested modules with offset attachment brackets. One of ordinary skill in the art would have been motivated to make this modification in order to allow the modules to get close enough to nest properly without changing the dimensions of the existing system (Canale [0190]).
Regarding claim 14, Wendlandt teaches the catheter robot according to claim 1. Wendlandt is silent regarding at least 4 catheter translation modules supported by said base, which are successively longitudinally disposed.
However, Canale teaches a drive system for an elongated medical device, including a catheter, having multiple translatable portions wherein there are at least 4 catheter translation modules supported by said base, which are longitudinally disposed (see Fig. 17 having four translation modules 150 longitudinally disposed along rail 158, which acts as the base).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Wendlandt’s catheter robot by having at least four translation modules as taught by Canale. One of ordinary skill in the art would have been motivated to make this modification in order to support the translation of multiple necessary percutaneous interventional devices and accessories via a translation module (Canale [0157]).
Regarding claims 17 and 18, Wendlandt teaches the catheter robot according to claim 1. Wendlandt is silent regarding at least five said catheter translation modules supported by the base, which are successively longitudinally disposed; and exactly five said catheter translation modules supported by the base, which are successively longitudinally disposed.
However, Canale discloses the catheter robot having at least four catheter translation modules supported by a base which are successively longitudinally disposed (see Fig. 3), therefore teaching the limitations of the claimed invention except for an additional fifth translation module. It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Canale’s four module catheter robot with additional modules in order to guide additional elements including a balloon or stent, a micro-catheter, and/or an additional catheter guide. The inclusion of these additional modules would merely be a duplication of the existing structurally identical translation modules. It has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In the present case the inclusion of a duplicate translation module would not produce any new or unexpected result over the device of the prior art as the additional module would simply amount to the guidance and translation of an element of the catheter device as taught. See MPEP 2144.04(VI)(B); In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wendlandt et al (US 6375471 B1) in view of Duffy et al (US 20040059369 A1).
Regarding claim 15, Wendlandt teaches the catheter robot according to claim 14. Wendlandt is silent regarding wherein the second and third catheter translation modules are configured as rapid exchange catheter translation modules, and fourth and fifth catheter translation modules are configured as over the wire catheter translation modules, or all second to fifth catheter translation modules are configured as over the wire catheter translation modules.
Duffy teaches a catheter and guide wire exchange system for an over-the-wire catheter having a guide wire, catheter, and catheter guide (Duffy [0011]). It can be appreciated by one of ordinary skill in the art that there are four general types of catheters: over the wire (OTW) catheters, over the wire catheters with short wire capability, rapid exchange catheters and fixed wire catheters (Duffy [0006]). With this in consideration, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to combine the known prior art elements of an over the wire catheter with the catheter robot as taught by Wendlandt. The use of known catheter technology with the teachings of Wendlandt would have been obvious to try as there are a finite number of identifiable solutions (the four general catheter types as named above) that could be used to yield predictable results of catheterizing a patient and having a reasonable expectation of success.
Conclusion
THIS ACTION IS MADE FINAL. 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 ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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/A.J.S./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792