CTNF 19/305,476 CTNF 85889 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Rejections - 35 USC § 112 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. Claims 5, 10, 13 and 14-20 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 5 is rejected because it is unclear if “a skill level” (line 2) is the same skill level set forth in Claim 1. Claim 13 appears to have a similar issue. Claim 10 is rejected because “the movement scaling factor” lacks proper antecedent basis. Claim 14 is rejected because it is unclear if the surgical console is the apparatus comprising one or more processors or if the console comprises the processors. Claim 15 is rejected because it is unclear what system component the image is displayed on. Claim 14 only includes one or more processors. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-21-aia AIA Claim (s) 14-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2018/0271603 to Nir et al. “Nir” in view of U.S. Patent No. 9,649,164 to Kim et al. “Kim” , U.S. Publication No. 2016/0331474 to Lacal et al. “Lacal” and U.S. Publication No. 2014/0094968 to Taylor et al. “Taylor” . As for Claims 14 and 18, Nir discloses an intelligent laparoscopic surgical tool control system, method and computer program for performing a surgical procedure on a patient (Abstract). Nir makes it clear that the laparoscopic procedure may include manual or robotic control of instruments (Paragraphs [0002], [0183] and [0243]) according to “allowed” and “restricted” movement defined, at least in part by historical movement of the surgical tool in a previous surgery (Paragraph [0044]). Nir also uses predefined “rules” (Paragraphs [0048]) to define boundaries of allowed/restricted regions to avoid hazards (Paragraphs [0049]-[0066]) and to activate/deactivate a portion of at least one surgical tool based on, at least in part, whether the tool is in a correct position (Paragraphs [0012], [0016], [0030], [0075], [0097] and [0231]). Nir’s system detects the current position of the tool with a sensor or imaging means (Paragraphs [0034]-[0040]). Examiner notes that the set boundaries of the allowed and restricted regions and the activation/deactivation of the tool based on its position are considered to read on determining a surgical activity based on a “state” of an actuator in its broadest reasonable interpretation. Nir discloses the system may convey messages including information about the patient, information about the surgical tool, information about the procedure, suggestion of a procedure, a warning or any combination thereof (Paragraph [0029]). However, Nir does not expressly disclose where the medical robotic system uses the processor to identify a safety actuation state of the robotic device and transitioning the robot to a safety state in response an identified “surgical skill level of the surgeon”. Kim teaches from within a similar field of endeavor with respect to robotic medical systems and methods (Abstract) where a surgical region is divided into a plurality of “procedure regions” and where each region is associated with a level of “risk” (Column 3, Lines 3-67; Column 5, Lines 30-55). A driver is configured to increase or decrease the operating speed of the robot based on the procedure region and risk level (Column 3, Lines 30-67; Column 4, Lines 30-67). In one embodiment, a change unit may automatically switch a surgery mode between an automatic mode and a collaborative mode based on the determined risk and/or an input from the user (Column 7, Line 40-Column 8, Line 15). Kim explains that the change unit may display a message which allows to user to check a surgery mode via the display (Column 8, Lines 1-10). Accordingly, one skilled in the art would have been motivated to have modified the surgical system and method described by Nir to define various “procedure regions” for the robot each region associated with a different risk as described by Kim in order to enhance patient safety during various stages of the navigated procedure. As for the “skill” of the surgeon, Lacal teaches from within a similar field of endeavor with respect to robotic surgical procedures (Abstract) where a procedure optimizer is configured to receive input regarding the user’s prior experience (Paragraphs [0007], [0009], [0040], [0043], [0047]) in order to tailor a robotic procedure according to the surgeon’s experience (Paragraphs [0052] and [0056]-[0057]). Lacal’s procedure optimizer also includes input regarding patient information and type of procedure which includes information identifying which tools will be used during the procedure (Paragraph [0045]). Taylor teaches from within a similar field of endeavor with respect to medical robotic systems and methods (Abstract) where a controller can employ various motion scaling schemes (Paragraphs [0081], [0093] and [0096]). In one embodiment, Taylor’s controller may provide different levels of contribution for inputs and by adjusting relative gains, one of the operators may be a dominate operator (Paragraph [0100]; Claim 5). Taylor explains that motion scaling may be a useful education tool where a trainer (e.g. more experienced) may guide a trainee (e.g. novice) through common surgical tasks (Paragraph [0100]). Accordingly, one skilled in the art would have been motivated to have modified the robotic surgical system described by Nir and Kim to include a procedure optimizer configured to accept inputs regarding the surgeon’s skill and adjust procedure parameters (e.g. display message instructions, approach, scaled rate of movement) as described by Lacal and Taylor to provide different instrument actuations based on, at least in part, operator skill/experience in order to enhance patient safety. Moreover, such a modification merely involves combining prior art elements according to known techniques to yield predictable results (MPEP 2143). As for Claims 15-17, Examiner notes the displayed messages in the modified system would be in real time as the instrument transitions from one surgical stage to another. Regarding Claims 19-20, Examiner notes the messages would be predefined in its broadest reasonable interpretation and would relate to the identified skill of the user in the modified device. Examiner notes that any identified “skill” would be relative to other skills (e.g. novices vs. experts) in its broadest reasonable interpretation . Double Patenting 08-33 AIA The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. 08-34 AIA Claim s 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-26 of U.S. Patent No. 11,931,122 . Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed toward controlling a surgical instrument according to, at least in part the surgical skill level of the surgeon using the instrument. Examiner notes that the presently pending claims represent an obvious broadening of the patented claims . 08-34 AIA Claim s 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-23 of U.S. Patent No. 12,133,702 . Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed toward a robotic system and method configured to transition to a safety state associated with a surgical procedure stage (e.g. activity). Examiner notes that while the presently pending claims specifically relate to transitioning to the safety state based on, at least in part, surgical skill of the surgeon, such a limitation is an obvious broadening of the ‘702 patent relating to “patient safety”. Thus, the claims are not considered to be patentably distinct . 08-34 AIA Claim s 1-20 rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-18 of U.S. Patent No. 12,414,828 . Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed toward a robotic system and method configured to transition to a safety state associated with a surgical procedure stage (e.g. activity) based on, at least in part, an identified surgeon’s skill level. Thus, the claims are not considered to be patentably distinct . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L COOK whose telephone number is (571)270-7373. The examiner can normally be reached M-F approximately 8AM-5PM. 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, Anne Kozak can be reached at 571-270-0552. 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. /CHRISTOPHER L COOK/Primary Examiner, Art Unit 3797 Application/Control Number: 19/305,476 Page 2 Art Unit: 3797 Application/Control Number: 19/305,476 Page 3 Art Unit: 3797 Application/Control Number: 19/305,476 Page 4 Art Unit: 3797 Application/Control Number: 19/305,476 Page 5 Art Unit: 3797 Application/Control Number: 19/305,476 Page 6 Art Unit: 3797 Application/Control Number: 19/305,476 Page 7 Art Unit: 3797 Application/Control Number: 19/305,476 Page 8 Art Unit: 3797 Application/Control Number: 19/305,476 Page 9 Art Unit: 3797
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