DETAILED ACTION
Notice of 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 .
Response to Arguments
Applicant's arguments filed 05/15/2026 have been fully considered but they are moot in view of the new grounds of rejection.
Allowable Subject Matter
Claim(s) 5, 9, 10, 14, 16, and 17 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.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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.
Claim(s) 8 and 15 is/are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claims 8 and 15, it is unclear as to whether there is being claimed a range of the diameter of the outer body. It is also unclear as to what is meant by a, “range of a diameter of the outer body”.
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.
Claim(s) 1-3, 6, 7, 11, 12, 18, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miyoshi (US 2009/0030306) in view of Higgins (US 2008/0183073, of record).
Regarding claims 1, 11, and 18 Miyoshi discloses a system, method, and computer-read instructions comprising: an instrument; and a control system configured to: receive data indicating a position of a target in an anatomy ([0004]: a “target” is known) and a path through the anatomy to the target ([0004]: endoscopic “insertion” implies an anatomical path); identify a portion of the anatomy along the path matching a parking signature ([0105]: “shape of the scope model 130 matches a predetermined insertion completion shape”); determine a target position for parking the outer body of the instrument based on the identified portion of the anatomy ([0004]: a “target” in the anatomy is determined for placement of an endoscope); and provide feedback, via a user interface, for parking the outer body of the instrument at the target position (Figs. 8, 9, 10, 15, 19, 20 - visual feedback is provided). Miyoshi does not explicitly disclose an outer body and an inner body configured to be driven through the outer body. However, Higgins teaches an endoscopic instrument body with an outer body and an inner body configured to be driven through the outer body ([0072]: “needle or other type of tool to interact with the ROI”; Fig. 4B, [0081]: “tool that extends out of the device’s working channel”). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the endoscopic body of Higgins to the procedure of Miyoshi, as to provide a robust endoscopic instrument.
Regarding claims 2, 12, and 19, Miyoshi discloses that the feedback is visual (Figs. 8, 9, 10, 15, 19, 20 - visual feedback is provided).
Regarding claim 3, Miyoshi does not explicitly disclose that providing the feedback includes displaying an indication of the target position on a model of the anatomy. However, Higgins teaches determining and visually displaying a path to a target and identifying a portion of a luminal network having a shape matching a “park assistance signature” ([0130], [0131]: “route-planning implementation”, Figs. 7, 8ABCD, 9ABC, 10). The outlined path serves as a “park assistance signature” because the shape of the path is clearly elucidated as where an instrument would be parked. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the path planning and endoscope structure of Higgins to the endoscopic system of Miyoshi, as to provide robust navigation of an endoscope.
Regarding claim 6, while Miyoshi does not explicitly disclose that the park assistance signature is based on previously performed medical procedures, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply consideration of prior medical procedures, which may affect the present anatomy that’s relied upon to generate the model being used.
Regarding claim 7, Miyoshi does not explicitly disclose that determining the target position for parking the outer body of the instrument is further based on a user input. However, Higgins teaches that a user may manually input regions of interest that would influence the calculation of a “parking position” ([0055]: “ROI may be defined manually”; [0061]: “closest routes to the ROI”). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the manual selection of Higgins to the system of Miyoshi, as to provide robust user-input.
Claim(s) 4, 13, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miyoshi (US 2009/0030306) in view of Higgins (US 2008/0183073, of record), as applied to claims 1, 11, and 18 above, in view of Rios (US 2017/0252108, of record).
Regarding claims 4, 13, and 20, neither Miyoshi nor Higgins explicitly disclose that the control system is further configured to determine a distance from the identified portion of the anatomy to the target; and determine that the distance is less than a predetermined threshold insertion distance associated with the inner body; and providing the feedback includes: displaying an indication of the target position responsive to determining that the distance is less than the predetermined threshold insertion distance. However, Rios teaches that a proximity measurement determines an object rendering in a virtual environment ([0054]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the rendering of Rios to the modeling of Miyoshi and Higgins, as to provide robust visualization.
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 extension fee 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 date of this final action.
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/JASON M IP/Primary Examiner, Art Unit 3793