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 .
Response to Arguments
Applicant’s arguments, see pgs. 3 and 6, filed 8/6/2026, with respect to the objection to the abstract have been fully considered and are persuasive. The objection of 5/7/2026 has been withdrawn.
Applicant's arguments filed 8/6/2026 in regards to the 103 rejection of claim 1 have been fully considered but they are not persuasive.
In regards to the applicant’s arguments that Tilson does not expressly teach that “the second region is softer than the second state of the first region,” the Examiner disagrees. Tilson is clear in teaching multiple vacuum chambers each with its own pressure line. Tilson further states that the overtube includes “multiple zones of rigidization (via chambers 5775)”. Tilson continues on to state that “Any vacuum zones that are in the flexible state can be steered or deflected in the direction of cable tension while the zones that are rigidized will remain in their position and not be deflected.” Therefore Tilson, at the very least, has taught a flexible state (first state of the first region) and a rigid state (second state of the first region). Tilson goes on further to state that “this design allows alternating of which zones are under vacuum and/or direction of steering to form very complex shapes and provide navigation through the anatomy with minimal looping.” Thus, in an alternating design with the first region being taught as 5775a and the second region being the adjacent vacuum zone 577b, Tilson teaches having a first region in a rigid state and second region in a flexible state. This second region is then “softer” that the second state (rigid state) of the first region.
In regards to the applicant’s argument that the Examiner used impermissible hindsight to make the combination of Sugiyama, the Examiner has demonstrated that it is a fact that Tilson discloses the second region being softer than the second state of the first region. The Examiner in no way used the applicant’s disclosure to form this combination as Tilson not only teaches the limited structure of claim 1, but also the advantage of employing their design in an overtube used to navigate difficult anatomical paths.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1 and 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over WIPO Publication WO2012/043034 to Sugiyama (hereinafter “Sugiyama”) in view of US Patent Application Publication 2020/0178763 to Tilson (hereinafter “Tilson”). In regard to claim 1, Sugiyama discloses an overtube comprising:
a supply and discharge port that is located on a proximal end side and through which a fluid is supplied and discharged (Elements 23a-b); a first region (Fig. 2, 20) that is located on a distal end side with respect to the supply and discharge port (see Fig. 1) and includes an outer tube (Element 27) having a flexibility, an inner tube (Element 26) having a flexibility, and a shape-deformable body (Element 25) that is deformable and is provided between the outer tube and the inner tube (see Fig. 2); wherein the first region is switchable between a first state in which the fluid is supplied to a space between the outer tube and the inner tube via the supply and discharge port and a second state that is stiffer than the first state and in which the fluid is discharged (see highlighted and underlined section of Sugiyama’s English translation which has been provided with this action)
However, Sugiyama does not disclose a second region that is located on the distal end side of the first region. In regards to claims 1 and 4-5, Tilson discloses a dynamically rigidizing medical instrument comprising:
Regarding claim 1, a first region (Element 5775a), a second region that is located on the distal end side with respect to the first region and includes the outer tube and the inner tube (Element 5775b-c, [0123][0124]), wherein the first region is switchable between a first state a second state that is stiffer than the first state and in which the fluid is discharged, and the second region is softer than the second state of the first region ([0123] [0124] teaches the use of multiple chambers supplied by a fluid to control the stiffness of multiple sections of the device. Therefore, Tilson has taught that multiple regions along the device can have stiffer or softer regions depending on the insertion path of the device.)
Regarding claim 4, wherein the second region includes the shape-deformable body, and the second region is switchable between the first state in which the fluid is supplied to the space between the outer tube and the inner tube via the supply and discharge port and the second state in which the fluid is discharged ([0123][0124])
wherein the first state of the second region is softer than the first state of the first region, and the second state of the second region is softer than the second state of the first region ([0123] [0124] teaches the use of multiple chambers supplied by a fluid to control the stiffness of multiple sections of the device. Therefore, Tilson has taught that multiple regions along the device can have stiffer or softer regions depending on the insertion path of the device.)
It would have been obvious before the effective filing date of the claimed invention to include the deformable second region such as that taught by Tilson in order to prevent the endoscope from looping which can cause damage within the colon (Tilson [0003]).
Allowable Subject Matter
Claims 6-13 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.
The following is an examiner’s statement of reasons for allowance: The prior art does not disclose the interlayer as described in Applicant’s claim 6. Specifically, Tilson is the closest piece of prior art showing an interlayer in Element 4399a, but does not disclose that this interlayer comes into contact with shape-deformable body in the second state so that the first region becomes stiff.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
THIS ACTION IS MADE FINAL. 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 MICHAEL JAMES CAREY whose telephone number is (571)270-7235. The examiner can normally be reached Monday-Friday (8am-5pm).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey 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.
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/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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