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 .
Claims 1-22 are hereby under examination.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-4, 6-13 and 15-22 are rejected under 35 U.S.C. 103 as being unpatentable over US20170014194A1 (Duindam et. al), previously cited and hereto referred as Duindam and in view of US20100280449A1 (Alvarez et. al), hereto referred as Alvarez, and in view of US20190125164A1 (Roelle et. al), previously cited and hereto referred as Roelle.
As to claims 1 and 9, Duindam teaches a medical apparatus comprising: a bendable body and a control wire situated in the bendable body and configured to bend the bendable body ([0043], "FIG. 2B shows another embodiment of needle 110 in which one or more control cables 215 are provided to which tension and/or extension forces can be applied to cause desired bending of needle 110.");
one or more sensors that detect a position of the bendable body ([0040], “For example, sensor 315 can be a position sensor (e.g., EM sensor, accelerometer, etc.) providing localized position data that can be used with the shape data from shape sensor 120 to model the in-situ pose and/or shape of needle 110.”); and
a controller for causing movement of the medical apparatus ([0053], “optional control planning module 146 can be included to generate the appropriate control signals for actuator 130”); wherein the controller:
defines a reference element ([0054], “In other embodiments, the measured data can be compared to target data (e.g., comparing actual trajectory of needle 110 to a desired trajectory) to avoid excessive deviation from a desired behavior”);
determines an acceptable deviation between the reference element and the position of the bendable body ([0061], “The deviation can then be assessed in an Exceeds Threshold? step 622”), wherein the position of the bendable body is provided by the one or more sensors ([0054] “In various other embodiments, an optional error detection module 147 can be included to compare measured shape, pose, and/or position data against expected values (e.g., desired values or values predicted from a mathematical model).”); and
causes bendable body to maintain a trajectory toward a region of interest that stays within the acceptable deviation ([0063], “Similarly, if steps 420 and/or 430 indicate that the trajectory of the needle is sub-optimal for completion of the desire procedure, the needle can be adjusted towards a more optimized path in step 440 (e.g., by changing needle shape, by changing the needle orientation (e.g., rotation), retracting the needle, and/or any other trajectory-impacting action).”).
However, Duindam does not teach that the details of the control wire or the bendable body. Alvarez teaches a similar art of catheter medical apparatus (Alvarez, abstract). Alvarez teaches bendable body having at least a first bendable section at a distal end of the bendable body and a second bendable section adjacent to the first bendable section (Alvarez, Fig. 10, sections 1002-3 and 1002-2);
at least a first control wire slideably situated in the bendable body, terminated in the first bendable section (Alvarez, Fig. 10, control wire 1014-2 is anchored at the end 1016-2), and configured to bend the first bendable section; at least a second control wire slideably situated in the bendable body, terminated in the second bendable section (Alvarez, Fig. 10, control wire 1014-1 is anchored at the end 1016-1). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Duindam in view of Alvarez to include bendable body having at least a first bendable section at a distal end of the bendable body and a second bendable section adjacent to the first bendable section and at least a first control wire slideably situated in the bendable body, terminated in the first bendable section and configured to bend the first bendable section, and at least a second control wire slideably situated in the bendable body, terminated in the second bendable section because doing so would allow controlling the catheter for navigating in the body as suggested by Alvarez (Alvarez, [0002], “may have the necessary skills to proficiently manipulate and control the extension tools for performing complex minimally invasive surgical procedures”).
Duindam also does not necessarily teach controller is configured to cause the at least the second control wire to bend at least the second bendable section in order to maintain a trajectory toward a region of interest that stays within the acceptable deviation. Roelle teaches a relevant art of steerable catheter (Roelle, abstract). Roelle teaches a trajectory causing the at least the second control wire to bend at least the second bendable section (Roelle, Fig. 56A). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Duindam in view of Roelle to include second control wire to bend at least the second bendable section, countering external forces on the bendable body to maintain a trajectory toward a region of interest that stays within the acceptable deviation because Duindam already teaches causing the bendable body to maintain a trajectory toward a region of interest that stays within the acceptable deviation and a second control wire situated in the bendable body and configured to bend the second bendable section as described above, and Roelle teaches a curved trajectory that necessitates bending of the second section.
As to claims 2 and 10, Duindam-Alvarez-Roelle teaches the reference element is a referent trajectory from the bendable body to the region of interest (Duindam, [0060], “For example, step 430 can include using the needle shape information determined in step 420 to determine one or more target trajectories for the continuing advance of the needle”).
As to claim 3, Duindam-Alvarez-Roelle teaches the one or more sensors is an electromagnetic sensor that determines the position of the medical device and the reference element (Duindam, [0040], “For example, sensor 315 can be a position sensor (e.g., EM sensor, accelerometer, etc.) providing localized position data”).
As to claims 4 and 12, Duindam-Alvarez-Roelle teaches the bendable body has a hollow cavity extending the length of the bendable body, and a wall at least partially formed about the hollow cavity (Duindam, Fig. 3A – 3C).
As to claims 6 and 15, Duindam-Alvarez-Roelle teaches the controller causes the at least one control wire to bend at least the second bendable section (Roelle, [0125], “it has pullwires or similar control elements (10) associated distally with a more flexible section (8) configured to steer or bend when the control elements (10) are tensioned in various configurations, as compared with a less steerable proximal portion (7) configured to be stiffer and more resistant to bending or steering”; the examiner notes, manipulation of one of the control wires 10 would result in bending of the second section because the second section is materially different from the first section), such that
the reference element stays within or returns to the acceptable deviation in order to maintain a trajectory toward the region of interest (Duindam, [0063], “Similarly, if steps 420 and/or 430 indicate that the trajectory of the needle is sub-optimal for completion of the desire procedure, the needle can be adjusted towards a more optimized path in step 440 (e.g., by changing needle shape, by changing the needle orientation (e.g., rotation), retracting the needle, and/or any other trajectory-impacting action).”), and
thereby counters external forces on the bendable body (Duindam, [0013], “Depending on the shape and mechanical properties of the needle, interaction forces between the needle and the patient anatomy (i.e., the target tissue and/or any intervening anatomy between the surgical entry point and the target tissue) can cause the needle to deflect and move along curved trajectories.”; the examiner notes, as the needle moves along the trajectory including returning to acceptable deviation, it encounters external forces on the bendable body).
As to claims 7 and 16, Duindam-Alvarez-Roelle teaches the bendable body has at least the first, second, and a third bendable section from the distal end to the proximal end (Duindam, Fig. 2A, sections 210A-210D; refer to rejection of claims 1 and 9 above), wherein
the controller causes at least the second bendable section to bend (Roelle, [0125], “it has pullwires or similar control elements (10) associated distally with a more flexible section (8) configured to steer or bend when the control elements (10) are tensioned in various configurations, as compared with a less steerable proximal portion (7) configured to be stiffer and more resistant to bending or steering”; the examiner notes, manipulation of one of the control wires 10 would result in bending of the second section because the second section is materially different from the first section), and
thereby counters external forces on the bendable body (Duindam, [0013], “Depending on the shape and mechanical properties of the needle, interaction forces between the needle and the patient anatomy (i.e., the target tissue and/or any intervening anatomy between the surgical entry point and the target tissue) can cause the needle to deflect and move along curved trajectories.”; the examiner notes, as the needle moves along the trajectory including returning to acceptable deviation, it encounters external forces on the bendable body).
As to claim 8, Duindam-Alvarez-Roelle teaches the controller uses a feedback from the one or more sensors to determine the trajectory of the medical apparatus (Duindam, [0040], “For example, sensor 315 can be a position sensor (e.g., EM sensor, accelerometer, etc.) providing localized position data that can be used with the shape data from shape sensor 120 to model the in-situ pose and/or shape of needle 110.”) and maintain the reference element within the acceptable deviation (Duindam, [0063], “Similarly, if steps 420 and/or 430 indicate that the trajectory of the needle is sub-optimal for completion of the desire procedure, the needle can be adjusted towards a more optimized path in step 440 (e.g., by changing needle shape, by changing the needle orientation (e.g., rotation), retracting the needle, and/or any other trajectory-impacting action).”).
As to claim 11, Duindam-Alvarez-Roelle teaches the one or more sensors is an electromagnetic sensor (Duindam, [0042], “The input transducer 25 may comprise a microphone”).
As to claim 13, Duindam-Alvarez-Roelle teaches defining at least a second reference element and defining an acceptable deviation between the first location and the at least a second reference element (Duindam, Claim 50: “comprising determining an adjustment to the current shape of the flexible needle to reduce the deviation when the deviation exceeds a second predetermined threshold level and does not exceed the first predetermined threshold level”).
As to claim 17, Duindam-Alvarez-Roelle teaches countering the external forces on the medical apparatus comprises one or more of rotating and translating the medical apparatus such that the reference element stays within or returns to the acceptable deviation (Duindam, [0007], “Depending on the shape and mechanical properties of the needle, interaction forces between the needle and the patient anatomy (i.e., the target tissue and/or any intervening anatomy between the surgical entry point and the target tissue) can cause the needle to deflect, such that steering can be provided by simply applying rotation to the base of the needle.”).
As to claim 18, Duindam-Alvarez-Roelle teaches a feedback from the one or more sensors as to the external forces on the bendable body (Duindam, [0041] “depending on the shape and mechanical properties of needle 110, interaction forces between needle 110 and the patient anatomy (i.e., the target tissue and/or any intervening anatomy between the surgical entry point and the target tissue) can cause needle 110 to deflect as it is advanced through that patient anatomy. The mechanism may be actuated, manually or automatically, using information from the shape sensor as input.”) is used in conjunction with a feedback on the position of the bendable body (Duindam, [0040], “For example, sensor 315 can be a position sensor (e.g., EM sensor, accelerometer, etc.) providing localized position data that can be used with the shape data from shape sensor 120 to model the in-situ pose and/or shape of needle 110.” ) to maintain the reference element within the acceptable deviation (Duindam, [0031], “Actuator 130 can manipulate needle 110, for example, by steering needle 110 along a desired surgical trajectory to a target location within the patient, changing the shape of needle 110”).
As to claim 19, Duindam-Alvarez-Roelle teaches the advancing of the medical apparatus to the first location in the subject is an advancement based on directions from a manipulation unit controlled by a user (Duindam, [0044], “user interface for providing control inputs to actuator 130”).
As to claims 20 and 21, Duindam-Alvarez-Roelle teaches a bendable body and a control wire situated in the bendable body and configured to bend the bendable body (Duindam [0043], "FIG. 2B shows another embodiment of needle 110 in which one or more control cables 215 are provided to which tension and/or extension forces can be applied to cause desired bending of needle 110.");
one or more sensors that detect a position of the bendable body ([0040], “For example, sensor 315 can be a position sensor (e.g., EM sensor, accelerometer, etc.) providing localized position data that can be used with the shape data from shape sensor 120 to model the in-situ pose and/or shape of needle 110.”); and
a controller for causing movement of the medical apparatus ([0053], “optional control planning module 146 can be included to generate the appropriate control signals for actuator 130”); wherein the controller:
defines a reference element ([0054], “In other embodiments, the measured data can be compared to target data (e.g., comparing actual trajectory of needle 110 to a desired trajectory) to avoid excessive deviation from a desired behavior”);
determines an acceptable deviation between the reference element and the position of the bendable body ([0061], “The deviation can then be assessed in an Exceeds Threshold? step 622”), wherein the position of the bendable body is provided by the one or more sensors ([0054] “In various other embodiments, an optional error detection module 147 can be included to compare measured shape, pose, and/or position data against expected values (e.g., desired values or values predicted from a mathematical model).”); and
causes bendable body to maintain a trajectory toward a region of interest that stays within the acceptable deviation ([0063], “Similarly, if steps 420 and/or 430 indicate that the trajectory of the needle is sub-optimal for completion of the desire procedure, the needle can be adjusted towards a more optimized path in step 440 (e.g., by changing needle shape, by changing the needle orientation (e.g., rotation), retracting the needle, and/or any other trajectory-impacting action).”).
However, Duindam does not teach that the details of the control wire or the bendable body. Alvarez teaches a similar art of catheter medical apparatus (Alvarez, abstract). Alvarez teaches bendable body having at least a first bendable section at a distal end of the bendable body and a second bendable section adjacent to the first bendable section (Alvarez, Fig. 10, sections 1002-3 and 1002-2);
at least a first control wire slideably situated in the bendable body, terminated in the first bendable section (Alvarez, Fig. 10, control wire 1014-2 is anchored at the end 1016-2), and configured to bend the first bendable section; at least a second control wire slideably situated in the bendable body, terminated in the second bendable section (Alvarez, Fig. 10, control wire 1014-1 is anchored at the end 1016-1). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Duindam in view of Alvarez to include bendable body having at least a first bendable section at a distal end of the bendable body and a second bendable section adjacent to the first bendable section and at least a first control wire slideably situated in the bendable body, terminated in the first bendable section and configured to bend the first bendable section, and at least a second control wire slideably situated in the bendable body, terminated in the second bendable section because doing so would allow controlling the catheter for navigating in the body as suggested by Alvarez (Alvarez, [0002], “may have the necessary skills to proficiently manipulate and control the extension tools for performing complex minimally invasive surgical procedures”).
Duindam also does not necessarily teach controller is configured to cause the at least the second control wire to bend at least the second bendable section in order to maintain a trajectory toward a region of interest that stays within the acceptable deviation. Roelle teaches a trajectory causing the at least the second control wire to bend at least the second bendable section (Roelle, Fig. 56A). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Duindam in view of Roelle to include second control wire to bend at least the second bendable section, countering external forces on the bendable body to maintain a trajectory toward a region of interest that stays within the acceptable deviation because Duindam already teaches causing the bendable body to maintain a trajectory toward a region of interest that stays within the acceptable deviation and a second control wire situated in the bendable body and configured to bend the second bendable section as described above, and Roelle teaches a curved trajectory that necessitates bending of the second section.
Duindam-Alvarez-Roelle teaches inserting a treating tool into the medical apparatus to a location within the acceptable deviation from the reference element; and treating the subject, wherein treating the subject comprises taking a biopsy from the subject (Duindam, Claim 38: “The surgical system of claim 16 wherein the flexible needle is a transcutaneous biopsy needle.”).
As to claim 22, Duindam-Alvarez-Roelle teaches the reference element is a referent trajectory from the bendable body to an area from which a biopsy is to be obtained (Duindam, [0013], “The shape and/or direction of these trajectories can be influenced through the control inputs. Steerable needles can be used in minimally invasive clinical procedures for diagnosis and treatment of difficult to reach targets, e.g., in prostate biopsy and brachytherapy.”).
Claims 5 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Duindam-Alvarez-Roelle as applied to claims 1 and 9 above, and further in view of US20190175062A1 (Rafii-Tari et. al), previously cited and hereto referred as Rafii-Tari.
Claims 1 and 9 are taught as above.
As to claims 5 and 14, Duindam-Alvarez-Roelle teaches acceptable deviation. However, Duindam-Alvarez-Roelle does not teach wherein the acceptable deviation is determined by one or more of: setting an angle value for an error cone extending from the distal end of the bendable body; selecting a point in space relative to the distal end, and setting a size of a zone that the reference element must stay within; and selecting an area of the surface of the region of interest in which the reference element must stay within. Rafii-Tari teaches a relevant art of medical apparatus with elongated body for navigation and targeting (Rafii-Tari, Abstract). Rafii-Tari teaches setting an angle value for an error cone extending from a distal end of the bendable body; selecting a point in space relative to the distal end, and setting the size of the zone that the reference element must stay within; and selecting an area of the surface of the region of interest in which the reference element must stay within (Rafii-Tari, [0165], “As just mentioned, in the embodiment of FIG. 32, the graphical indicator 1020 is a cone. The cone may be formed with an angle defining an aperture of the cone, where the aperture is based on an estimated error ranges of the orientation of the distal end 910 of the medical instrument.”). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Duindam-Alvarez-Roelle in view of Rafii-Tari to include the error cone zone because Duindam-Alvarez-Roelle already teaches determining needle deviation limit, and Rafii-Tari teaches in detail a use of known device in a similar way (Rafii-Tari, [0165], “For example, the system may be able to determine an estimated error of the orientation of the distal end 910 of the medical instrument based on EM data detected using one or more EM sensors located on the medical instrument.”).
Response to Arguments
Applicant’s arguments, filed 5/14/2025, with respect to the 112 rejections and art rejections have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Duindam-Alvarez-Roelle.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ELINA S JANG whose telephone number is (571)272-7019. The examiner can normally be reached M-F 9:00 am - 6:00 pm.
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/ELINA SOHYUN JANG/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
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