CTNF 19/277,090 CTNF 95469 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-fti AIA The present application is being examined under the pre-AIA first to invent provisions. Specification 07-29 AIA The disclosure is objected to because of the following informalities: paragraph 0034 recites the limitation “A target line for a need can be defined using the coordinates of a point on the line and angles indicating the direction of the line from that point” should read “A target line for a needle can be defined using the coordinates of a point on the line and angles indicating the direction of the line from that point” . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-01 AIA The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. 07-31-01 Claims 24-43 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 24, 35, and 43 recite the limitation “determine a suitable pose of the distal tip for conducting the medical procedure on the target tissue based on the working configuration, the suitable pose being different from the working configuration, the distal tip pointing to the target tissue in each of the suitable pose and the working configuration”. The specification discloses in paras. 0033-0046 the steps of determining a desired working configuration and control modes to minimize the difference between the current pose of the distal tip and the desired configuration, however, lacks description of the steps of determining the suitable pose based on the desired working configuration and the suitable pose being different from the desired working configuration. The examiner questioned how the suitable pose is different from the desired working configuration if it is determined based on the desired configuration. Claims 25 and 26 recite the limitation “the position of the distal tip in the suitable pose is different from the position of the distal tip in the working configuration” and “the orientation of the distal tip in the suitable pose is different from the orientation of the distal tip in the working configuration”. As indicated above the specification disclosed that the system determines the desired working configuration of the distal tip and control modes to minimize the difference between the current pose of the distal tip and the desired working configuration, however, lacks description of the steps of determining the suitable pose based on the desired working configuration and the suitable pose that has a position and orientation different from the position and orientation in the desired working configuration. Claims 29 and 30 recite the limitation “first holding mode in which the working configuration comprises a position of the distal tip and a second holding mode in which the working configuration comprises an orientation of the distal tip”. The specification discloses in paras. 0036-0040 “A position stiffness mode compares the position of the distal tip of steerable segment 116 as measured by sensor system 160 to a desired tip position and controls the actuators to minimize the difference in desired and measured tip positions. The position stiffness mode may particularly be suitable for general manipulation tasks in which the user tries to precisely control the position of the tip and for situations where the distal tip contacts tissue. 2.) An orientation stiffness mode compares the measured orientation or pointing direction of the distal tip to a desired pointing direction of the distal tip and controls the actuators to minimize the difference in desired and actual tip pointing direction. This orientation stiffening that may be suitable, e.g., when controlling an imaging device such as vision probe 400 attached steerable segment 116 , in which case the viewing direction is kept as desired, while the exact position of steerable segment 116 may be less important. 3.) A target position stiffness mode uses a combination of the measured tip position and pointing direction to control catheter 110 to always point the distal tip of steerable segment 116 towards a specified target point some distance in front of steerable segment 116 . In case of external disturbances, control logic 140 may control the actuators to implement this target position stiffening behavior, which may be suitable, e.g., when a medical probe inserted though the catheter contains an ablation laser that should always be aimed at a target ablation point in tissue. 4.) A target axial motion stiffness mode uses a combination of the measured tip position and pointing direction to ensure that the distal tip of steerable segment 116 is always on a line in space and has a pointing direction that is also along that line. This mode can be useful, e.g., when inserting a biopsy needle along a specified line into tissue. Tissue reaction forces could cause the flexible section of catheter 110 to bend while inserting the needle, but this control strategy would ensure that the needle is always along the right line”, however, the specification lacks description of the first holding mode in which the working configuration comprises a position of the distal tip and second holding mode in which the working configuration comprises an orientation of the distal tip. The examiner questions which of the control modes would be considered the first holding mode and the second holding modes. The rest of the claims are rejected based on their dependency. 07-30-02 AIA 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. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claim 24-43 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 24 recites the term “Suitable pose” which is indefinite because the specification does not provide objective criteria for determining what constitutes “suitable”, it is unclear whether suitability is determined based on orientation, position, proximity to target, safety constrains, or other factors. Additionally, the claim recites the limitation “determine a suitable pose of the distal tip for conducting the medical procedure on the target tissue based on the working configuration, the suitable pose being different from the working configuration, the distal tip pointing to the target tissue in each of the suitable pose and the working configuration” it is unclear how the suitable pose is determined based on the working configuration and being different that the working configuration and distal tip pointing to the target tissue in each of the suitable pose and the working configuration. If the pose is different that the working configuration how can the distal tip have the same orientation in both the suitable pose and the working configuration. The examiner questions how the suitable pose is determined based on the working configuration and also different from the working configuration? Claim 35 recites the term “Suitable pose” which is indefinite because the specification does not provide objective criteria for determining what constitutes “suitable”, it is unclear whether suitability is determined based on orientation, position, proximity to target, safety constrains, or other factors. Additionally, the claim recites the limitation “determining a suitable pose of the distal tip for conducting the medical procedure on the target tissue based on the working configuration, the suitable pose being different from the working configuration, the distal tip pointing to the target tissue in each of the suitable pose and the working configuration” it is unclear how the suitable pose is determined based on the working configuration and being different that the working configuration and distal tip pointing to the target tissue in each of the suitable pose and the working configuration. If the pose is different that the working configuration how can the distal tip have the same orientation in both the suitable pose and the working configuration. The examiner questions how the suitable pose is determined based on the working configuration and also different from the working configuration? Claim 28 recites the limitation “initiate a holding mode, wherein the suitable pose is determined based on the holding mode” it is unclear how the suitable pose is determined based on the holding mode if the holding mode is a control mode to maintain the pose of the distal end at desired configuration. Claim 39 recites the limitation “initiating a holding mode, wherein the suitable pose is determined based on the holding mode” it is unclear how the suitable pose is determined based on the holding mode if the holding mode is a control mode to maintain the pose of the distal end at desired configuration. Claim 43 recites the term “Suitable pose” which is indefinite because the specification does not provide objective criteria for determining what constitutes “suitable”, it is unclear whether suitability is determined based on orientation, position, proximity to target, safety constrains, or other factors. Additionally, the claim recites the limitation “determine a suitable pose of the distal tip for conducting the medical procedure on the target tissue based on the working configuration, the suitable pose being different from the working configuration, the distal tip pointing to the target tissue in each of the suitable pose and the working configuration” it is unclear how the suitable pose is determined based on the working configuration and being different that the working configuration and distal tip pointing to the target tissue in each of the suitable pose and the working configuration. If the pose is different that the working configuration how can the distal tip have the same orientation in both the suitable pose and the working configuration. The examiner questions how the suitable pose is determined based on the working configuration and also different from the working configuration? The rest of the claims are rejected based on their dependency. The deficiencies under 35 USC 112 are of such a nature that a reasonable interpretation of the claims cannot be ascertained, and therefore a complete prior art analysis cannot be performed. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZAINAB M ALDARRAJI whose telephone number is (571)272-8726. The examiner can normally be reached Monday-Thursday7AM-5PM 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, Carey Michael can be reached at (571) 270-7235. 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. /ZAINAB MOHAMMED ALDARRAJI/ Patent Examiner, Art Unit 3797 Application/Control Number: 19/277,090 Page 2 Art Unit: 3797 Application/Control Number: 19/277,090 Page 3 Art Unit: 3797 Application/Control Number: 19/277,090 Page 4 Art Unit: 3797 Application/Control Number: 19/277,090 Page 5 Art Unit: 3797 Application/Control Number: 19/277,090 Page 6 Art Unit: 3797 Application/Control Number: 19/277,090 Page 7 Art Unit: 3797 Application/Control Number: 19/277,090 Page 8 Art Unit: 3797 Application/Control Number: 19/277,090 Page 9 Art Unit: 3797
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