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 .
Election/Restrictions
Claims 9-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/06/2026.
Claim Objections
Claim 8 is objected to because of the following informalities: “wherein the application further perform step” should be “wherein the application further perform[s] step”.
Claim 18 is objected to because of the following informalities: “the application when executed determining steps of” should be “the application when executed performs the determining steps of”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-8 and 18-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 contains the term “the articulation region” in lines 15, 17, and 19. There is insufficient antecedent basis for this term. The same issue is present in claim 2. It is recommended the term “an articulating region” in line 3 of claim 1 be amended to say “an articulation region” and the term “the articulating region” in lines 5 and 8 of claim 1 be amended to say “the articulation region”.
Claim 18 contains the term “a proximity sensor associated with the catheter” in line 6. It is unclear if this is a different proximity sensor than the one in line 2 of the same claim. It is recommended the claim be amended to say “wherein the proximity sensor is associated with the catheter”.
Claims not explicitly rejected above are rejected because they depend from claims rejected above as indefinite.
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.
Claims 1-8, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Au (US 20210228293 A1) in view of Kelly (US 20190224451 A1).
In regards to claim 1 Au teaches a system for navigation of a catheter to a location within a patient comprising:
a catheter including a lumen ([0027] “main lumen 312, which continues back through catheter 210”)
a position sensor at or adjacent a distal portion ([0034] “fiber optic shape sensor 264”)
and an articulating region ([0026] “steerable segment 216”);
an articulation mechanism including at least one pull-wire for articulating the articulating region of the catheter ([0026] “Steerable segment 216 is remotely controllable and particularly has a pitch and a yaw that can be controlled using actuating tendons, e.g., pull wires”);
a tool for performing a procedure at a target site and translatable within the lumen of the catheter, ([0027] a tool such as a biopsy needle inserted through main lumen 312 can extend past distal tip 314 to interact with tissue during a medical procedure)
and an application stored in a memory and executed by a processor of a computing device, wherein the application when executed performs steps of:
determine properties of the tool based on a received an indication of a type of tool ([0038] shape analysis module 243 determines whether radius of curvature is too great for the radius of curvature of a specific tool, therefore the indication and storage of the properties of the specific tool must have been determined beforehand);
record a position, articulation and vector to a target of the catheter ([0037] wherein the target shape of the guide tube at target region is recorded and saved; figures 4 and 5a, block 415);
determine an amount of de-articulation necessary for the tool to pass through the articulation region([0040] after determining there are sharp turns, automatically backs guide tube back to insertion/removal position where the tool can be inserted; blocks 420 and 430, figures 4 and 5b);
adjust the articulation of the catheter ([0040] after determining the shape bends, the system and automatically retract and adjust to the acceptable insertion/removal configuration; block 430, figures 4 and 5b);
articulate the catheter to the recorded position ([0042] after the insertion tool is inserted and is proximal to the distal end, the guide tube is automatically articulated along the saved target back to put back into the target position; block 440, figure 5d);
detect that the catheter has returned to the recorded position ([0042] “Once the guide tube with the tool reaches the target configuration, block 445 can be performed to use the tool at the target site” command logic knows the position of the catheter, and therefore detects when it is in the target position; figures 4 and 5d);
and display an indication of realignment on a user interface ([0033] user interface can indicate the status of the system, indication of when the guide tube has returned to the target position or to a insertion position is a status of the guide tube).
Au also teaches electromagnetic sensing coils ([0025] electromagnetic sensing coils 262, Figure 3a), and that the user can determine how far the insertion tool can/should be inserted based on the target path in and pushing a button to put in the insertion/removal position and the target position, and to manually insert the insertion tool after the button is pushed ([0040] “If decision block 420 determines that the target configuration of the guide tube is unacceptable for insertion of the tool, e.g., the target configuration includes bends that are too sharp for insertion of the tool, a physician or other user may be informed and may press a button or otherwise select to retract the guide tube to the identified insertion configuration”)
Au fails to teach a proximity sensor, wherein the proximity sensor is configured to detect the tool is proximate the articulating region; and detecting the tool has passed the articulation region and is proximate a distal portion of the catheter.
Kelly teaches a proximity sensor, wherein the proximity sensor is configured to detect the tool is proximate the articulating region; and detecting the tool is proximate a distal portion of the catheter ([0019-0020] “the coil is disposed proximate the catheter distal end to sense the guidewire in proximity to the catheter distal end”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the processor and coil of Au to perform the proximity detection of Kelly. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of automating the step of determining how far the insertion tool can/should be inserted in order to avoid user error.
In regards to claim 2 modified Au teaches the system of claim 1, wherein the application further performs a step of presenting an indication on the user interface of a required amount of de-articulation necessary to allow the tool to pass through the articulation region (Au [0040] “If decision block 420 determines that the target configuration of the guide tube is unacceptable for insertion of the tool, e.g., the target configuration includes bends that are too sharp for insertion of the tool, a physician or other user may be informed and may press a button or otherwise select to retract the guide tube to the identified insertion configuration”).
In regards to claim 3 modified Au teaches the system of claim 1, wherein the articulation mechanism is a motorized mechanism (Au [0031] “Control logic 240 controls actuators 222 in steering drive mechanism 220 to selectively pull on the tendons as needed to actuate distal steerable segment 216 and control the pitch and yaw of the distal tip of catheter 210 and controls actuators 232 to control movement in the insertion direction of the distal tip of catheter 210”).
In regards to claim 4 modified Au teaches the system of claim 3, wherein the motorized mechanism is robotically controlled ([0035] “Automatic retract module 244 can then be employed to automatically”).
In regards to claim 5 modified Au teaches the system of claim 3, wherein the motorized mechanism is manually operated (Au [0018] “During the navigation, a computer system can mediate pitch, yaw, and insertion movement of distal tip 114, or some or all of the movement of catheter 110 may be under direct manual or tactile control” system can be manually controlled).
In regards to claim 6 modified Au teaches the system of claim 1, wherein the articulation mechanism is manually operated (Au [0018] “During the navigation, a computer system can mediate pitch, yaw, and insertion movement of distal tip 114, or some or all of the movement of catheter 110 may be under direct manual or tactile control” system can be manually controlled).
In regards to claim 7 modified Au teaches the system of claim 1, wherein the application further performs a step of determining if de-articulation is required to remove the tool ([0021] “If the target configuration is unsuited to insertion or removal of the tool, the control system can inform a physician and determine a tool insertion/removal configuration suitable for insertion or removal of the tool”).
In regards to claim 8 modified Au teaches the system of claim 7, wherein the application further perform steps of de- articulating the catheter and displaying an indication on the user interface that the tool can be safely removed ([0043] “Step 630 can then use the recorded shape data to automatically navigate the guide tube and the inserted replacement tool back to the target configuration of the guide tube”; [0033] user interface can indicate the status of the system, indication of when the guide tube can be safely removed is a status of the guide tube).
In regards to claim 18 Au teaches catheter system comprising:
a catheter having a lumen ([0027] “main lumen 312, which continues back through catheter 210”),
a position sensor located at or adjacent a distal portion ([0034] “fiber optic shape sensor 264”),
and at least one pull-wire configured to articulate an articulation region([0026] “Steerable segment 216 is remotely controllable and particularly has a pitch and a yaw that can be controlled using actuating tendons, e.g., pull wires”);
a tool including a metal tip at a distal end ([0027] a tool such as a biopsy needle inserted through main lumen 312 can extend past distal tip 314 to interact with tissue during a medical procedure, needles are inherently metal);
an articulation mechanism configured to apply pressure to the pull-wire to articulate and de-articulate the catheter ([0026] “Steerable segment 216 is remotely controllable and particularly has a pitch and a yaw that can be controlled using actuating tendons, e.g., pull wires”);
and a computing device, storing in a memory an application executable by a processor, the application when executed determining steps of ([0032] “A combination of hardware and software includes hardware only (i.e., a hardware element with no software elements), software hosted at hardware (e.g., software that is stored at a memory and executed or interpreted or at a processor), or hardware and software hosted at hardware”):
determining that the tool cannot pass through the articulation region based on the articulation of the catheter and properties of the tool ([0038] shape analysis module 243 determines whether radius of curvature is too great for the radius of curvature of a specific tool, therefore the indication and storage of the properties of the specific tool must have been determined beforehand);;
de-articulating the catheter to allow the tool to pass through the articulation region ([0040] after determining the shape bends, the system and automatically retract and adjust to the acceptable insertion/removal configuration; block 430, figures 4 and 5b);
and re-articulating the catheter to a position and orientation of the catheter prior to de-articulation ([0042] after the insertion tool is inserted and is proximal to the distal end, the guide tube is automatically articulated along the saved target back to put back into the target position; block 440, figure 5d).
Au also teaches electromagnetic sensing coils ([0025] electromagnetic sensing coils 262, Figure 3a), and that the user can determine how far the insertion tool can/should be inserted based on the target path in and pushing a button to put in the insertion/removal position and the target position, and to manually insert the insertion tool after the button is pushed ([0040] “If decision block 420 determines that the target configuration of the guide tube is unacceptable for insertion of the tool, e.g., the target configuration includes bends that are too sharp for insertion of the tool, a physician or other user may be informed and may press a button or otherwise select to retract the guide tube to the identified insertion configuration”)
Au fails to teach a proximity sensor, wherein the proximity sensor is configured to detect the tool is proximate the articulating region; and detecting the tool has passed the articulation region and is proximate a distal portion of the catheter.
Kelly teaches a proximity sensor, wherein the proximity sensor is configured to detect the tool is proximate the articulating region; and detecting the tool is proximate a distal portion of the catheter ([0019-0020] “the coil is disposed proximate the catheter distal end to sense the guidewire in proximity to the catheter distal end”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the processor and coil of Au to perform the proximity detection of Kelly. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of automating the step of determining how far the insertion tool can/should be inserted in order to avoid user error.
In regards to claim 20 modified Au teaches the catheter system of claim 18, wherein the proximity sensor is an electromagnetic field sensor configured to detect interference in the electromagnetic field as the metal tip is advanced into proximity of the proximity sensor (Kelley [0019-0020] “the coil is disposed proximate the catheter distal end to sense the guidewire in proximity to the catheter distal end”, coil is an electromagnetic field sensor).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Au (US 20210228293 A1) in view of Krimsky (US 20170325895 A1).
In regards to claim 18 Au teaches catheter system comprising:
a catheter having a lumen ([0027] “main lumen 312, which continues back through catheter 210”),
a position sensor located at or adjacent a distal portion ([0034] “fiber optic shape sensor 264”),
and at least one pull-wire configured to articulate an articulation region([0026] “Steerable segment 216 is remotely controllable and particularly has a pitch and a yaw that can be controlled using actuating tendons, e.g., pull wires”);
a tool including a metal tip at a distal end ([0027] a tool such as a biopsy needle inserted through main lumen 312 can extend past distal tip 314 to interact with tissue during a medical procedure, needles are inherently metal);
an articulation mechanism configured to apply pressure to the pull-wire to articulate and de-articulate the catheter ([0026] “Steerable segment 216 is remotely controllable and particularly has a pitch and a yaw that can be controlled using actuating tendons, e.g., pull wires”);
and a computing device, storing in a memory an application executable by a processor, the application when executed determining steps of ([0032] “A combination of hardware and software includes hardware only (i.e., a hardware element with no software elements), software hosted at hardware (e.g., software that is stored at a memory and executed or interpreted or at a processor), or hardware and software hosted at hardware”):
determining that the tool cannot pass through the articulation region based on the articulation of the catheter and properties of the tool ([0038] shape analysis module 243 determines whether radius of curvature is too great for the radius of curvature of a specific tool, therefore the indication and storage of the properties of the specific tool must have been determined beforehand);;
de-articulating the catheter to allow the tool to pass through the articulation region ([0040] after determining the shape bends, the system and automatically retract and adjust to the acceptable insertion/removal configuration; block 430, figures 4 and 5b);
and re-articulating the catheter to a position and orientation of the catheter prior to de-articulation ([0042] after the insertion tool is inserted and is proximal to the distal end, the guide tube is automatically articulated along the saved target back to put back into the target position; block 440, figure 5d).
Au also teaches that the user can determine how far the insertion tool can/should be inserted based on the target path in and pushing a button to put in the insertion/removal position and the target position, and to manually insert the insertion tool after the button is pushed ([0040] “If decision block 420 determines that the target configuration of the guide tube is unacceptable for insertion of the tool, e.g., the target configuration includes bends that are too sharp for insertion of the tool, a physician or other user may be informed and may press a button or otherwise select to retract the guide tube to the identified insertion configuration”)
Au fails to teach a proximity sensor, wherein the proximity sensor is configured to detect the tool is proximate the articulating region; and detecting the tool has passed the articulation region and is proximate a distal portion of the catheter.
Krimsky teaches a proximity sensor, wherein the proximity sensor is configured to detect a tool is proximate a distal portion of a catheter ([0021] “EM sensors 102, 120 may be any number of types of location sensors, including ring sensors, optical sensors, radiofrequency sensors, ferromagnetic sensors, hollow sensors, and the like. In an embodiment where EM sensor 120 is a hollow sensor, the hollow sensor can be configured to measure a distance that the tool 100 advances past the distal end 118 of the EWC 116.”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the processor and coil of Au to perform the proximity detection of Krimsky in order to know the location of the needle within the catheter. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of automating the step of determining how far the insertion tool can/should be inserted in order to avoid user error.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Au (US 20210228293 A1) in view of Krimsky (US 20170325895 A1) as applied to claim 18, further in view of Clem (US 20150351959 A1).
In regards to claim 19 modified Au teaches the catheter system of claim 18, wherein the proximity sensor is an optical sensor configured to read markings on the tool (Krimsky [0021] optical sensor checks for the presence, if there is a marking on the tool the sensor would inherently read it). Modified Au fails to teach markings on the tool. Clem teaches a needle with marks to indicate various depths of insertion ([0184] “Although not shown, it should be understood that in some examples needle (400, 500, 600) may include one or more markers on the exterior surfaces of needle (400, 500, 600) to indicate various depths of insertion”). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filling date of the claimed invention to modify the needle of modified Au to have depth markers like the needle of Clem. Doing so would merely be combining prior art elements according to known methods to yield the predictable result of indicating that the needle is inserted at the proper depth.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUCY EPPERT whose telephone number is (571)270-0818. The examiner can normally be reached M-F 7:30-5:00 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LUCY EPPERT/ Examiner, Art Unit 3791
/ADAM J EISEMAN/ Primary Examiner, Art Unit 3791
Prosecution Insights