Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Provisional Application No. 61/250738, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The above provisional application is drawn to an unrelated invention and names different inventors. The application number has been entered incorrectly. Upon reviewing the other priority documents, the examiner believes that the correct provisional application number is 61/250739. Applicant must correct the provisional application number
Double Patenting
Claims 1-10, 12-15, 17, ad 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over the indicated patents:
Claim 1: U.S. Patent No. 9,962,229 B2 (see claim 1 or 13) and U.S. Patent No 10,881474 B2 (see claim 1).
Claim 2: claim 2 of US 9,962,229 B2 and claim 2 of US 10,881474
Claim 3: claim 1 (or 13) of US 9,962,229 B2 and claim 1 of US 10,881474
Claim 4: claim 3 (or 14) of US 9,962,229 B2 and claim 3 of US 10,881474
Claim 5: claim 1 (or 13) of US 9,962,229 B2 (note that claim 1 recites advancing and retracting/rotating until the wire is in the correct branch along the desired path. Based on this, retracting and rotating repeatedly would have been obvious because the device may enter a wrong path more than once) and claim 4 of US 10,881474
Claim 6: claim 5 of US 9,962,229 B2 and claim 5 of US 10,881474
Claim 7: U.S. Patent No. 9,962,229 B2 (see claim 1) and U.S. Patent No 10,881474 B2 (see claim 1).
Claim 8: claim 1 of U.S. Patent No. 9,962,229 B2 (“retracting and automatically rotating” is in claim 1) and claim 1 of US 10,881474
Claim 9: claim 2 of US 9,962,229 B2 and claim 2 of US 10,881474
Claim 10: claim 3 of US 9,962,229 B2 and claim 3 of US 10,881474
Claim 12: US 10,881474 B2 (see claim 10).
Claim 13: claim 11 of US 10,881474 B2.
Claim 14: claim 11 of US 10,881474 B2.
Claim 15: claim 12 of US 10,881474 B2.
Claim 17: US 9,962,229 B2 (see claim 13) and US 10,881474 B2 (see claim 16).
Claim 19: claim 13 of US 9,962,229 B2 and claim 16 of US 10,881474 B2
Claim 20: claim 14 of US 9,962,229 B2
Although the claims at issue are not identical, they are not patentably distinct from each other for the reasons set forth above or in the table below (for independent claims).
Note: highlighted portions in table below are relevant portions of claims. Underlined portions of claims in instant application are differences/lacking in reference patent.
Patent(s)
Instant Application
Difference
9,962,229 B2 Claim 1.
A method for navigating a guide wire during a catheter procedure, the method comprising:
advancing a guide wire using a catheter procedure system through a desired path of an anatomy past a junction point at a correct branch and a side branch; determining if the distal end of the guide wire is in the correct branch of the desired path past the junction point based on at least one image of a region of interest;
retracting the guide wire using the catheter procedure system to a position before the junction point if the distal end of the guide wire is in the side branch and automatically
rotating a proximal end of the guide wire about a longitudinal axis of the guide wire using the catheter procedure system while the guide wire is being retracted; repeating the steps of advancing the guide wire, determining if the distal end of the guide wire is in the correct branch of the desired path, and retracting and automatically rotating the guide wire using the catheter procedure system until the guide wire is in the correct branch of the desired path; and advancing the guide wire to a desired position using the catheter procedure system.
Claim 1.
A non-transitory computer readable medium storing instructions, when executed by a system, cause the system to:
advance a guide wire through a desired path of an anatomy past a junction point at a correct branch and a side branch in response to a control signal to advance the guide wire; determine if a distal end of the guide wire is in the correct branch of the desired path past the junction point;
retract the guide wire to a position before the junction point if the distal end of the guide wire is in the side branch in response to a control signal to retract the guide wire;
rotate a proximal end of the guide wire while the guide wire is being retracted in response to the control signal to retract the guide wire; and advance the guide wire to a desired position.
The patent fails to teach the non-transitory computer readable medium storing these instructions. However, given a method of navigation, it is desirable to store these steps for automation or repetition. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention, given the teaching of the method performing claimed steps, to save these steps to such a medium.
The patent fails to teach the advancing or retracting “in response to a control signal to advance [or retract] a wire.” However the patent recites “using the guide wire advance/retract actuator” which requires a control signal of some type; and thus it would have been obvious to advance in response to a control signal to operate the actuator i.e. advance or retract the wire.
9,962,229 B2 Claim 13.
A catheter procedure system comprising: a bedside system comprising a guide wire, a guide wire advance/retract actuator coupled to the guide wire and a guide wire rotate actuator coupled to the guide wire; and a workstation coupled to the bedside system, the workstation comprising: a user interface; at least one display; a controller coupled to the bedside system, the user interface and the at least one display, the controller programmed to:
advance the guide wire through a desired path of an anatomy past a junction point at a correct branch and a side branch using the guide wire advance/retract actuator; determine if a distal end of the guide wire is in the correct branch of the path past the junction point based on at least one image of a region of interest;
retract the guide wire using the guide wire advance/retract actuator to a position before the junction point if the distal end of the guide wire is in the side branch; automatically rotate a proximal end of the guide wire about a longitudinal axis of the guide wire using the guide wire rotate actuator, wherein the guide wire is rotated while the guide wire is being retracted; repeat the steps of advancing the guide wire, determine if the distal end of the guide wire is in the correct branch past the junction point and retracting and automatically rotating the guide wire using the guide wire advance/retract actuator and the guide wire rotate actuator until the guide wire is in the correct branch; and advance the guide wire to a desired position using the guide wire advance/retract actuator.
Claim 1.
A non-transitory computer readable medium storing instructions, when executed by a system, cause the system to:
advance a guide wire through a desired path of an anatomy past a junction point at a correct branch and a side branch in response to a control signal to advance the guide wire; determine if a distal end of the guide wire is in the correct branch of the desired path past the junction point;
retract the guide wire to a position before the junction point if the distal end of the guide wire is in the side branch in response to a control signal to retract the guide wire; rotate a proximal end of the guide wire while the guide wire is being retracted in response to the control signal to retract the guide wire; and advance the guide wire to a desired position.
The patent fails to teach the non-transitory computer readable medium storing these instructions. However, given a method of navigation, it is desirable to store these steps for automation or repetition. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention, given the teaching to have a controller perform the claimed steps, to save these steps to such a medium.
The patent fails to teach the advancing or retracting “in response to a control signal to advance [or retract] a wire.” However the patent recites “using the guide wire advance/retract actuator” which requires a control signal, and thus it would have been obvious to advance in response to a control signal to operate the actuator i.e. advance or retract the wire.
US 10,881474 B2 Claim 1.
A method for navigating a guide wire during a catheter procedure, the method comprising:
advancing a guide wire through a desired path of an anatomy past a junction point at a correct branch and a side branch using a catheter procedure system;
determining if the distal end of the guide wire is in the correct branch of the desired path past the junction point based at least on at least one image of a region of interest;
retracting the guide wire using the catheter procedure system to a position before the junction point if the distal end of the guide wire is in the side branch; and automatically rotating a proximal end of the guide wire using the catheter procedure system a predetermined amount while the guide wire is being retracted; and
advancing the guide wire to a desired position using the catheter procedure system.
Claim 1.
A non-transitory computer readable medium storing instructions, when executed by a system, cause the system to:
advance a guide wire through a desired path of an anatomy past a junction point at a correct branch and a side branch in response to a control signal to advance the guide wire; determine if a distal end of the guide wire is in the correct branch of the desired path past the junction point;
retract the guide wire to a position before the junction point if the distal end of the guide wire is in the side branch in response to a control signal to retract the guide wire;
rotate a proximal end of the guide wire while the guide wire is being retracted in response to the control signal to retract the guide wire; and advance the guide wire to a desired position.
The patent fails to teach the non-transitory computer readable medium storing these instructions. However, given a method of navigation, it is desirable to store these steps for automation or repetition. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention, given the teaching of a method including the same steps, to save these steps to such a medium.
The patent fails to teach the advancing or retracting “in response to a control signal to advance [or retract] a wire.” However it would have been obvious to advance or retract in response to a control signal (this amounts to automating a manual procedure and/or the catheter procedure system would have obviously been able to send such control signals)
9,962,229 B2 Claim 1.
A method for navigating a guide wire during a catheter procedure, the method comprising:
advancing a guide wire using a catheter procedure system through a desired path of an anatomy past a junction point at a correct branch and a side branch; determining if the distal end of the guide wire is in the correct branch of the desired path past the junction point based on at least one image of a region of interest;
retracting the guide wire using the catheter procedure system to a position before the junction point if the distal end of the guide wire is in the side branch and automatically rotating a proximal end of the guide wire about a longitudinal axis of the guide wire using the catheter procedure system while the guide wire is being retracted; repeating the steps of advancing the guide wire, determining if the distal end of the guide wire is in the correct branch of the desired path, and retracting and automatically rotating the guide wire using the catheter procedure system until the guide wire is in the correct branch of the desired path; and advancing the guide wire to a desired position using the catheter procedure system.
Claim 7.
A method for navigating a guide wire during a catheter procedure, the method comprising:
advancing a guide wire through a desired path of an anatomy passing at least one junction point at a correct first branch and a side branch;
determining if a distal tip of the guide wire is in the desired path based at least on at least one image of a region of interest past the junction point;
retracting the guide wire to a position before the junction point if the distal tip of the guide wire is not in the desired path past the junction point; and
rotating the guide wire about a longitudinal axis of the guide wire while the guide wire is being retracted if the guide wire is not in the desired path.
The patent fails to teach the region of interest being past the junction point; however, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention in the patent so that the region of interest is past the junction point because otherwise the image will not allow the system to determine whether the correct path has been followed.
The patent teaches retracting if the guide wire is in the side branch, while the application claims retracting if the wire is not in the desired path past the junction point. Based on both specifications, these refer to the same phenomenon (the wire being in the undesirable side branch).
The limitation “if the guide wire is not in the desired path” while not explicitly claimed in the patent is obvious as the wire is only retracted if it is not in the desired path.
US 10,881474 B2 Claim 1.
A method for navigating a guide wire during a catheter procedure, the method comprising:
advancing a guide wire through a desired path of an anatomy past a junction point at a correct branch and a side branch using a catheter procedure system;
determining if the distal end of the guide wire is in the correct branch of the desired path past the junction point based at least on at least one image of a region of interest;
retracting the guide wire using the catheter procedure system to a position before the junction point if the distal end of the guide wire is in the side branch; and automatically rotating a proximal end of the guide wire using the catheter procedure system a predetermined amount while the guide wire is being retracted; and
advancing the guide wire to a desired position using the catheter procedure system.
Claim 7.
A method for navigating a guide wire during a catheter procedure, the method comprising:
advancing a guide wire through a desired path of an anatomy passing at least one junction point at a correct first branch and a side branch;
determining if a distal tip of the guide wire is in the desired path based at least on at least one image of a region of interest past the junction point;
retracting the guide wire to a position before the junction point if the distal tip of the guide wire is not in the desired path past the junction point; and rotating the guide wire about a longitudinal axis of the guide wire while the guide wire is being retracted if the guide wire is not in the desired path.
The patent teaches retracting if the guide wire is in the side branch, while the application claims retracting if the wire is not in the desired path past the junction point. Based on both specifications, these refer to the same phenomenon (the wire being in the undesirable side branch).
The limitation “if the guide wire is not in the desired path” while not explicitly claimed in the patent is obvious as the wire is only retracted if it is not in the desired path.
The rotation of the wire is intended to be along the longitudinal axis as indicated in Patent specification Col. 9 lines 49-68.
US 10,881474 B2 Claim 10.
A catheter procedure system comprising: a bedside system comprising a guide wire, a guide wire advance/retract actuator coupled to the guide wire and a guide wire rotate actuator coupled to the guide wire; and a workstation coupled to the bedside system, the workstation comprising: a user interface; at least one display; and a controller coupled to the bedside system, the user interface and the at least one display, the controller programmed to: determine whether the guide wire will advance into a side branch; automatically rotate the proximal end of the guide wire about a longitudinal axis of the guide wire a predetermined amount using the guide wire rotate actuator while the guide wire is being retracted; and advance the guide wire avoiding the side branch.
Claim 12.
A catheter procedure system comprising:
a controller configured to cause the system to,
determine whether a guide wire will advance into a side branch of a patient;
rotate a proximal end of the guide wire about a longitudinal axis of the guide wire while the guide wire is being retracted; and
advance the guide wire while avoiding the side branch.
Both the patent and the instant application refer to side branches inside the body of a patient, so this does not provide patentable distinction.
9,962,229 B2 Claim 13.
A catheter procedure system comprising…a controller … the controller programmed to:
… retract the guide wire using the guide wire advance/retract actuator to a position before the junction point if the distal end of the guide wire is in the side branch; … automatically rotate a proximal end of the guide wire about a longitudinal axis of the guide wire … wherein the guide wire is rotated while the guide wire is being retracted;
… determine if the distal end of the guide wire is in the correct branch past the junction point and retracting and automatically rotating the guide wire using the guide wire advance/retract actuator and the guide wire rotate actuator until the guide wire is in the correct branch; and advance the guide wire to a desired position using the guide wire advance/retract actuator.
Claim 17.
A catheter procedure system, comprising: a controller configured to cause the catheter procedure system to,
automatically rotate a proximal end of a guide wire about a longitudinal axis of the guide wire while the guide wire is being retracted;
retract the guide wire while the guide wire is being rotated;
determine if a distal tip of the guide wire is in a desired path past a junction point at a correct first branch and a side branch; and advance the guide wire if the distal tip of the guide wire is in the desired path.
The patent discloses rotating the wire while it is being retracted, and thus teaches retracting the wire while it is being rotated.
The desired path includes the “correct branch.”
The patent’s junction point refers to the junction between a correct “first” branch and a side branch.
The patent limitation “until the guide wire is in the correct branch…and advance[ing] the guide wire to a desired position” reads on the instant application’s requirement that the guide wire is advanced if the distal tip is in the desire path. Note that the patent tracks the distal end of the guide wire.
US 10,881474 B2 Claim 16.
A catheter procedure system, comprising: a bedside system comprising a guide wire, a guide wire advance/retract actuator coupled to the guide wire and a guide wire rotate actuator coupled to the guide wire; and a workstation coupled to the bedside system, the workstation comprising: a user interface; at least one display; and
a controller coupled to the bedside system, the user interface and the at least one display, the controller programmed to: automatically rotate the proximal end of the guide wire about a longitudinal axis of the guide wire a predetermined amount using the guide wire rotate actuator while the guide wire is being retracted;
wherein the controller is further programmed to determine if a distal tip of the guide wire is in a desired path based at least on at least one image of a region of interest past a junction point at a correct first branch and a side branch;
retract the guide wire using the guide wire advance/retract actuator, wherein the guide wire is rotated while the guide wire is being retracted; and repeat the steps of advance the guide wire and retract the guide wire until the guide wire is in the predetermined path past the junction point.
Claim 17.
A catheter procedure system, comprising:
a controller configured to cause the catheter procedure system to,
automatically rotate a proximal end of a guide wire about a longitudinal axis of the guide wire while the guide wire is being retracted;
retract the guide wire while the guide wire is being rotated;
determine if a distal tip of the guide wire is in a desired path past a junction point at a correct first branch and a side branch; and advance the guide wire if the distal tip of the guide wire is in the desired path.
The patent recites rotating the guide wire while it is retracted and thus also teaches retracting the guide wire while it is rotated.
The desired path extends path a junction point so adding this limitation would have been obvious.
The patent teaches advancing and retracting until the guide wire (and thus its distal tip) is in the desired “predetermined” path. And thus teaches advancing when (if) the tip is in the desired path.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1, 5-6, 12, 15, 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chen et al. [US 2012/0209359 A1, hereinafter “Chen”] in view of Wallace et al. [US 20060293643 A1, hereinafter “Wallace”].
Re. claim 1. Chen discloses: A non-transitory computer readable medium storing instructions [Par. 0069], when executed by a system [100, Fig. 4], cause the system to:
advance a catheter [110, Fig. 4, equivalent to catheter 296 in Fig. 12-15] through a desired path [“delivery path 300,” Fig. 12] of an anatomy past a junction point at a correct branch and a side branch [Figs. 12-15. In the example of Fig. 12, the correct branch is that indicated by dashed line 300 and the side branch is 342, and the junction point the point indicated near 340 at which they diverge] in response to a control signal to advance the guide wire [“The control system 120 can include an actuation mechanism 166 … used to rotate, deflect, actuate, extend, and/or retract the elongated catheter 110. The actuation mechanism 166 can be manually or automatically operated. …For example, a motor can drive a pulley system that has a plurality of cables running through the catheter. The catheter is moved when at least one of the cables is pulled proximally,” Par. 0068. When a motor drives e.g. a pulley system, the catheter is moved by a signal to operate the motor to advance the catheter];
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determine if a distal end of the catheter is in the correct branch of the desired path past the junction point [“If the elongated catheter 296 is inadvertently guided along an incorrect delivery path,” Par. 0093. This step thus requires determining whether the wire is in the correct branch]; and
retract the catheter to a position before the junction point if the distal end of the guide wire is in the side branch [“If the elongated catheter 296 is inadvertently guided along an incorrect delivery path, the elongated catheter 296 can be pulled proximally to remove the elongated catheter 296 from the incorrect delivery path,” Par. 0093. Note that retracting the apparatus so that it can go down the correct path necessarily requires it being retracted to a position before the junction point with the correct path] in response to a control signal to retract the catheter [as set forth above, the motor which operates advancing/retraction requires, inherently, some signal (e.g. an electrical signal) sent to operate the motor and cause the retraction, which is hereby mapped to a control signal];
rotate a proximal end of the catheter [“ The control system 120 can include an actuation mechanism 166 …used to rotate… and/or retract the elongated catheter 110,” Par. 0068]; and
advance the catheter to a desired position [“The retracted elongated catheter 296 can then be advanced distally along the correct delivery path,” Par. 0093].
The invention of Chen differs from the claimed invention in the following ways: 1, Chen discloses the possibility of a guide wire, but discloses the navigation in terms of the catheter only and does not discuss the guidewire in detail. 2, Chen discloses both rotating the catheter and retracting it, but is silent regarding whether these happen simultaneously.
Re. (2), Chen discloses the system is capable of both rotating and retracting the catheter [Par. 0068], and further discloses rotating a catheter in order to position the catheter along the desired navigation path [Par. 0089-0090]. Regarding rotating while the catheter is being retracted, Wallace teaches, in a robotic catheter system, rotating the catheter while the catheter is being retracted [“the controller and instrument driver configured to cause the guide instrument to undertake two or more of the desired motions substantially simultaneously,” Par. 0007, where rotation and retraction are two of the four named motions, Par. 0004] in response to the control signal to retract the catheter [“The instrument driver is configured for independently controlling each of number of desired motions of a flexible, elongate guide instrument in a body of a patient in response to control signals generated by the controller. The desired motions preferably include…axial retraction, axial rotation….,” Par. 0004]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Chen by configuring the rotation and retraction to be carried out simultaneously as taught by Wallace, so that the catheter is rotated while the catheter is being retracted, because this allows for a shorter navigation time since both these steps are carried out to re-position/re-orient the tip of the device [see Chen Par. 0089-0090], so performing them simultaneously reduces the navigation time.
Re. (1), Chen discloses the catheter may be delivered by a guidewire [“A guide wire, delivery sheath, introducer, delivery needle, or other delivery device can be used to deliver the catheter 110,” Par. 0081]. Because the guide wire “may” be used to navigate the same system as the above-cited catheter, having the guide wire perform the above operations along with or instead of the catheter would have been obvious to one of ordinary skill. Thus, having a guide wire perform the above operations of the catheter, and configuring the program to cause the guide wire to operate as set forth above, would have been obvious to one of ordinary skill in the art before the effective filing date of the invention because this allows the guide wire to deliver the catheter as is cited as a suitable alternative delivery technique vs. active advancement of the catheter [Chen Par. 0081] and thus amounts to a simple substitution of one delivery method known in the art for another (active vs. passive, with guide wire, delivery sheath, introducer, or needle as the cited alternatives in Chen) with predictable results (the guide wire allows the catheter to be navigated suitably in much the same manner).
Re. claim 5, the modified Chen discloses The non-transitory computer readable medium according to claim 1, wherein the non-transitory computer readable medium storing the instructions, when executed by the system, are configured to cause the system to advance the guide wire [as modified above] and retract and rotate the guide wire repeatedly until receiving an indication the guide wire is in the desired path [“The elongated catheter 296 can be advanced distally and pulled proximally any number of times,” Par. 0093, where “the elongated catheter 296 is inadvertently guided along an incorrect delivery path, the elongated catheter 296 can be pulled proximally to remove the elongated catheter 296 from the incorrect delivery path,” Par. 0093].
Re. claim 6, the modified Chen discloses The non-transitory computer readable medium according to claim 1, wherein the non-transitory computer readable medium storing the instructions, when executed by the system, are configured to cause the system to rotate and retract the guide wire in response to a user input [“If the elongated catheter 296 is inadvertently guided along an incorrect delivery path, the elongated catheter 296 can be pulled proximally to remove the elongated catheter 296 from the incorrect delivery path. The retracted elongated catheter 296 can then be advanced distally along the correct delivery path. The elongated catheter 296 can be advanced distally and pulled proximally any number of times during a procedure. In some embodiments, the proximal end of the elongated catheter 296 is coupled to an actuation mechanism, for example, an actuation mechanism similar to the actuation mechanism 166 described in connection with FIG. 4,” Par. 0093, where actuation mechanism 166 is described as “an actuation mechanism 166 (shown in phantom) used to rotate, deflect, actuate, extend, and/or retract the elongated catheter 110. The actuation mechanism 166 can be manually or automatically operated,” Par. 0068. In the case where the actuation mechanism is manually operated, it requires user input].
Re. claim 12, Chen discloses: A catheter procedure system [100, Fig. 4], comprising a controller [120] configured to cause the system to:
determine whether a catheter will advance into a side branch of a patient [“If the elongated catheter 296 is inadvertently guided along an incorrect delivery path,” Par. 0093, Fig. 15. Note that if the guide wire is in an incorrect branch and advancing, it will advance into the side branch of a patient];
rotate a proximal end of the catheter about a longitudinal axis of the catheter [“ The control system 120 can include an actuation mechanism 166 …used to rotate… and/or retract the elongated catheter 110,” Par. 0068, about its longitudinal axis Par. 0089];,
retract the catheter [“the elongated catheter 296 can be pulled proximally to remove the elongated catheter 296 from the incorrect delivery path,” Par. 0093]; and
advance the catheter while avoiding the side branch [“The retracted elongated catheter 296 can then be advanced distally along the correct delivery path,” Par. 0093].
The invention of Chen differs from the claimed invention in the following ways: 1, Chen discloses the possibility of a guide wire, but discloses the navigation in terms of the catheter only and does not discuss the guidewire in detail. 2, Chen discloses both rotating the catheter and retracting it, but is silent regarding whether these happen simultaneously.
Re. (2), Chen discloses the system is capable of both rotating and retracting the catheter [Par. 0068], and further discloses rotating a catheter in order to position the catheter along the desired navigation path [Par. 0089-0090]. Regarding rotating while the catheter is being retracted, Wallace teaches, in a robotic catheter system, rotating the catheter while the catheter is being retracted [“the controller and instrument driver configured to cause the guide instrument to undertake two or more of the desired motions substantially simultaneously,” Par. 0007, where rotation and retraction are two of the four named motions, Par. 0004] in response to the control signal to retract the catheter [“The instrument driver is configured for independently controlling each of number of desired motions of a flexible, elongate guide instrument in a body of a patient in response to control signals generated by the controller. The desired motions preferably include…axial retraction, axial rotation….,” Par. 0004]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Chen by configuring the rotation and retraction to be carried out simultaneously as taught by Wallace, so that the catheter is rotated while the catheter is being retracted, because this allows for a shorter navigation time since both these steps are carried out to re-position/re-orient the tip of the device [see Chen Par. 0089-0090], so performing them simultaneously reduces the navigation time.
Re. (1), Chen discloses the catheter may be delivered by a guidewire [“A guide wire, delivery sheath, introducer, delivery needle, or other delivery device can be used to deliver the catheter 110,” Par. 0081]. Thus, having a guide wire perform the above operations of the catheter, and configuring the program to cause the guide wire to operate as set forth above, would have been obvious to one of ordinary skill in the art before the effective filing date of the invention because this allows the guide wire to deliver the catheter as is cited as a suitable alternative delivery technique vs. active advancement of the catheter [Chen Par. 0081] and thus amounts to a simple substitution of one delivery method known in the art for another (active vs. passive, with guide wire, delivery sheath, introducer, or needle as the cited alternatives in Chen) with predictable results (the guide wire allows the catheter to be navigated suitably in much the same manner).
Re. claim 15, the modified Chen discloses The catheter procedure system according to claim 12, wherein the controller is configured to cause the catheter procedure system to repeatedly advance the guide wire [as modified above] and retract and rotate the guide wire until receiving an indication the guide wire is in the desired path [“The elongated catheter 296 can be advanced distally and pulled proximally any number of times,” Par. 0093, where “the elongated catheter 296 is inadvertently guided along an incorrect delivery path, the elongated catheter 296 can be pulled proximally to remove the elongated catheter 296 from the incorrect delivery path,” Par. 0093].
Re. claim 17, Chen discloses: A catheter procedure system [100, Fig. 4], comprising a controller [120] configured to cause the catheter procedure system to:
automatically [“The control system 120 can include an actuation mechanism 166 …to rotate…the elongated catheter 110. The actuation mechanism 166 can be … automatically operated,” Par. 0068. Here, the embodiment cited is that where the actuation mechanism is automatically operated] rotate a proximal end of a catheter about a longitudinal axis of the catheter [“ The control system 120 can include an actuation mechanism 166 …used to rotate… and/or retract the elongated catheter 110,” Par. 0068, about its longitudinal axis Par. 0089];
retract the catheter [“the elongated catheter 296 can be pulled proximally to remove the elongated catheter 296 from the incorrect delivery path,” Par. 0093];
determine if a distal dip of the catheter is in a desired path past a junction point at a correct first branch and a side branch [see desired path in Fig. 12, and “If the elongated catheter 296 is inadvertently guided along an incorrect delivery path,” Par. 0093, Fig. 15. Note that if the guide wire is in an incorrect branch and advancing, it will advance into the side branch of a patient];
advance the catheter if the distal tip of the guide wire is in the desired path [“The retracted elongated catheter 296 can then be advanced distally along the correct delivery path,” Par. 0093].
The invention of Chen differs from the claimed invention in the following ways: 1, Chen discloses the possibility of a guide wire, but discloses the navigation in terms of the catheter only and does not discuss the guidewire in detail. 2, Chen discloses both rotating the catheter and retracting it, but is silent regarding whether these happen simultaneously.
Re. (2), Chen discloses the system is capable of both rotating and retracting the catheter [Par. 0068], and further discloses rotating a catheter in order to position the catheter along the desired navigation path [Par. 0089-0090]. Regarding rotating while the catheter is being retracted, Wallace teaches, in a robotic catheter system, rotating the catheter while the catheter is being retracted [“the controller and instrument driver configured to cause the guide instrument to undertake two or more of the desired motions substantially simultaneously,” Par. 0007, where rotation and retraction are two of the four named motions, Par. 0004] in response to the control signal to retract the catheter [“The instrument driver is configured for independently controlling each of number of desired motions of a flexible, elongate guide instrument in a body of a patient in response to control signals generated by the controller. The desired motions preferably include…axial retraction, axial rotation….,” Par. 0004]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of Chen by configuring the rotation and retraction to be carried out simultaneously as taught by Wallace, so that the catheter is rotated while the catheter is being retracted, and the catheter is rotated while the guide wire is retracted, because this allows for a shorter navigation time since both these steps are carried out to re-position/re-orient the tip of the device [see Chen Par. 0089-0090], so performing them simultaneously reduces the navigation time.
Re. (1), Chen discloses the catheter may be delivered by a guidewire [“A guide wire, delivery sheath, introducer, delivery needle, or other delivery device can be used to deliver the catheter 110,” Par. 0081]. Thus, having a guide wire perform the above operations of the catheter, and configuring the program to cause the guide wire to operate as set forth above, would have been obvious to one of ordinary skill in the art before the effective filing date of the invention because this allows the guide wire to deliver the catheter as is cited as a suitable alternative delivery technique vs. active advancement of the catheter [Chen Par. 0081] and thus amounts to a simple substitution of one delivery method known in the art for another (active vs. passive, with guide wire, delivery sheath, introducer, or needle as the cited alternatives in Chen) with predictable results (the guide wire allows the catheter to be navigated suitably in much the same manner).
Claim 2 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chen in view of Wallace, as applied to claim 1 above, and further in view of Hastings et al. [US 20050256398 A1, hereinafter “Hastings”].
Re. claim 2, the modified Chen discloses the apparatus set forth above, but is silent regarding the system retracting the guidewire a predetermined amount. However, Hastings teaches, in a medical device navigator, a non-transitory computer readable medium storing the instructions, when executed by the system, are configured to cause the system to retract the guide wire a predetermined amount in response to the control signal to retract the guide wire [“The control unit 174 (and/or the control 72) can provide signals that cause the advancer unit to advance and retract the medical device 22, to control the speed of the advancement or retraction, or to control the advancement and retraction in specified increments for specified time periods or distances,” Par. 0059]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Chen such that the system retracts the guide wire a predetermined amount as taught by Hastings in order to allow the system to operate in a predictable manner.
Claims 3-4, 13-14, 19-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chen in view of Wallace, as applied to claim 1, 12, or 17 above, and further in view of Amundson et al. [US 6178346 B1, hereinafter “Amundson”].
Re. claim 3, the modified Chen discloses the apparatus set forth above wherein the non-transitory computer readable medium storing the instructions, when executed by the system, are configured to cause the system to determine if the distal end of the guide wire is in the correct branch of the desired path past the junction point [see Par. 0093. The system determines when the catheter is in an incorrect branch, and thus determines when it is in a correct branch (i.e., it is not in an incorrect branch]. Chen also discloses imaging a region of interest [Par. 0082], but fails to specifically teach determining the wire is in the correct branch based at least on at least one image of a region of interest. However, Amundson teaches, in a catheter navigation system, a non-transitory computer readable medium storing the instructions, when executed by the system, configured to cause the system to determine if the distal end of the guide wire is in the correct branch of the desired path past the junction point based at least on at least one image of a region of interest [“This embodiment could be accomplished by incorporating a visual guide with its own retractable guide wire. When a choice in direction is needed, the guide would extend and force the catheter to follow in a specific direction. If an image of the catheter reaching a branch in the vasculature were available, the physician could maneuver the catheter into the correct branch,” Col. 8 lines 59-64]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of the modified Chen such that the system determines if the distal end of the guide wire is in the correct branch of the desired path past the junction point based at least on at least one image of a region of interest, as taught by Amundson, because this makes the navigation procedure “considerably easier and quicker” [Amundson, Col. 8 lines 55-58].
Re. claim 4, Chen discloses the at least one image is a fluoroscopic image [Par. 0082].
Re. claim 13 and 19, the modified Chen discloses the system set forth above wherein controller is configured to cause the system to determine if the distal end of the guide wire is in the correct branch of the desired path [see Par. 0093. The system determines when the catheter is in an incorrect branch, and thus determines when it is in a correct branch (i.e., it is not in an incorrect branch)]. Chen also discloses imaging a region of interest [Par. 0082], but fails to specifically teach determining the wire is in the correct branch based at least on at least one image of a region of interest. However, Amundson teaches, in a catheter navigation system, a controller configured to cause the system to determine if the distal end of the guide wire is in the correct branch of the desired path based at least on at least one image of a region of interest [“This embodiment could be accomplished by incorporating a visual guide with its own retractable guide wire. When a choice in direction is needed, the guide would extend and force the catheter to follow in a specific direction. If an image of the catheter reaching a branch in the vasculature were available, the physician could maneuver the catheter into the correct branch,” Col. 8 lines 59-64]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of the modified Chen such that the system determines if the distal end of the guide wire is in the correct branch of the desired path past the junction point based at least on at least one image of a region of interest, as taught by Amundson, because this makes the navigation procedure “considerably easier and quicker” [Amundson, Col. 8 lines 55-58].
Re. claim 14 and 20, Chen discloses the at least one image is a fluoroscopic image [Par. 0082].
Claims 7-8, 10 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chen in view of Wallace and Amundson.
Re. claim 7, Chen discloses a method for navigating a catheter during a catheter procedure, comprising:
advance a catheter [110, Fig. 4, equivalent to catheter 296 in Fig. 12-15] through a desired path [“delivery path 300,” Fig. 12] of an anatomy past a junction point at a correct branch and a side branch [Figs. 12-15. In the example of Fig. 12, the correct branch is that indicated by dashed line 300 and the side branch is 342, and the junction point the point indicated near 340 at which they diverge];
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determine if a distal end of the catheter is in the correct branch of the desired path past the junction point [“If the elongated catheter 296 is inadvertently guided along an incorrect delivery path,” Par. 0093. This step thus requires determining whether the wire is in the correct branch past the junction point]; and
retract the catheter to a position before the junction point if the distal end of the guide wire is in the side branch [“If the elongated catheter 296 is inadvertently guided along an incorrect delivery path, the elongated catheter 296 can be pulled proximally to remove the elongated catheter 296 from the incorrect delivery path,” Par. 0093. Note that retracting the apparatus so that it can go down the correct path necessarily requires it being retracted to a position before the junction point with the correct path];
rotate the catheter about a longitudinal axis of the catheter [“ The control system 120 can include an actuation mechanism 166 …used to rotate… and/or retract the elongated catheter 110,” Par. 0068 about its longitudinal axis Par. 0089]; and
advance the catheter to a desired position [“The retracted elongated catheter 296 can then be advanced distally along the correct delivery path,” Par. 0093].
The invention of Chen differs from the claimed invention in the following ways: 1, Chen discloses the possibility of a guide wire, but discloses the navigation in terms of the catheter only and does not discuss the guidewire in detail. 2, Chen discloses both rotating the catheter and retracting it, but is silent regarding whether these happen simultaneously, and 3, Chen teaches imaging, but is silent regarding determining if the tip is in the desired path based on at least one image of a region of interest past the junction point.
Re. (2), Chen discloses the system is capable of both rotating and retracting the catheter [Par. 0068], and further discloses rotating a catheter in order to position the catheter along the desired navigation path [Par. 0089-0090]. Regarding rotating while the catheter is being retracted, Wallace teaches, in a robotic catheter system, rotating the catheter while the catheter is being retracted [“the controller and instrument driver configured to cause the guide instrument to undertake two or more of the desired motions substantially simultaneously,” Par. 0007, where rotation and retraction are two of the four named motions, Par. 0004] if the catheter is not in the desired path [The instrument driver is configured for independently controlling each of number of desired motions of a flexible, elongate guide instrument in a body of a patient in response to control signals generated by the controller. The desired motions preferably include…axial retraction, axial rotation….,” Par. 0004]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Chen by configuring the rotation and retraction to be carried out simultaneously as taught by Wallace, so that the catheter is rotated while the catheter is being retracted, because this allows for a shorter navigation time since both these steps are carried out to re-position/re-orient the tip of the device [see Chen Par. 0089-0090], so performing them simultaneously reduces the navigation time.
Re. (1), Chen discloses the catheter may be delivered by a guidewire [“A guide wire, delivery sheath, introducer, delivery needle, or other delivery device can be used to deliver the catheter 110,” Par. 0081]. Thus, having a guide wire perform the above operations of the catheter, would have been obvious to one of ordinary skill in the art before the effective filing date of the invention because this allows the guide wire to deliver the catheter as is cited as a suitable alternative delivery technique vs. active advancement of the catheter [Chen Par. 0081] and thus amounts to a simple substitution of one delivery method known in the art for another (active vs. passive, with guide wire, delivery sheath, introducer, or needle as the cited alternatives in Chen) with predictable results (the guide wire allows the catheter to be navigated suitably in much the same manner).
Re. (3), the modified Chen discloses the apparatus set forth above wherein the non-transitory computer readable medium storing the instructions, when executed by the system, are configured to cause the system to determine if the distal end of the guide wire is in the correct branch of the desired path past the junction point [see Par. 0093. The system determines when the catheter is in an incorrect branch, and thus determines when it is in a correct branch (i.e., it is not in an incorrect branch]. Chen also discloses imaging a region of interest [Par. 0082], but fails to specifically teach determining the wire is in the correct branch based at least on at least one image of a region of interest. However, Amundson teaches, in a catheter navigation system, determining if the distal end of the guide wire is in the correct branch of the desired path past the junction point based at least on at least one image of a region of interest [“This embodiment could be accomplished by incorporating a visual guide with its own retractable guide wire. When a choice in direction is needed, the guide would extend and force the catheter to follow in a specific direction. If an image of the catheter reaching a branch in the vasculature were available, the physician could maneuver the catheter into the correct branch,” Col. 8 lines 59-64] past the junction point [in order to determine that the catheter has entered the correct branch, at least some image of the region past the junction point must be imaged]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of the modified Chen by determining if the distal end of the guide wire is in the correct branch of the desired path past the junction point based at least on at least one image of a region of interest, as taught by Amundson, because this makes the navigation procedure “considerably easier and quicker” [Amundson, Col. 8 lines 55-58].
Re. claim 8, the modified Chen discloses a method retracting the guide wire occurs while the guide wire is rotated [as taught by Wallace with respect to claim 7 above].
Re. claim 10, Chen discloses the at least one image is a fluoroscopic image [Par. 0082].
Claim 9 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Chen in view of Wallace and Amundson, as applied to claim 7 above, and further in view of Hastings.
Re. claim 9, the modified Chen discloses the apparatus set forth above, but is silent regarding retracting the guidewire a predetermined amount. However, Hastings teaches, in a medical device navigator, retracting the medical device a predetermined amount in response to the control signal to retract the medical device [“The control unit 174 (and/or the control 72) can provide signals that cause the advancer unit to advance and retract the medical device 22, to control the speed of the advancement or retraction, or to control the advancement and retraction in specified increments for specified time periods or distances,” Par. 0059]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of the modified Chen to retract the guide wire a predetermined amount as taught by Hastings in order to allow the system to operate in a predictable manner.
Allowable Subject Matter
Claims 11, 16, and 18 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. The closest prior art of record fails to teach or suggest rotating the guide wire only during a first retraction when the guide wire is retracted multiple times. Nor would there have been obvious motivation to limit the operation to rotate during the first retraction given the above teachings.
Conclusion
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/ERIN MCGRATH/Primary Examiner, Art Unit 3771
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