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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/04/2026 has been entered.
Claims 1, 3, 5, 15, 16, 17 and 20 have been amended. Claim 22 has been cancelled. Claims 1, 3, 5-11, 13, and 15-21 are currently pending in the application.
Response to Arguments
Applicant’s arguments, see pg. 8, filed 03/04/2026, with respect to the rejections of claims 3, 5, and 16-21 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejections as presented in the Final Rejection mailed 12/04/2025 have been withdrawn. However, the amendments to claims 3 and 17 introduce new clarity issues as further discussed below.
Applicant’s arguments, see pg. 8-9, filed 03/04/2026, with respect to the rejections of the claims 1, 3-11, 13, 15, 17-19 and 21 under 35 U.S.C 103 have been fully considered but they are not persuasive.
Applicant argues that claims 1, 15, 16 and 17 have been amended to include the allowable features of claim 22 as indicated in the Final Rejection mailed 12/04/2025.
The Examiner disagrees. Claims 1, 15, 16 and 17 have not been amended to include all of the limitations of cancelled claim 22. Specifically, each of the claims fail to recite the control wires being configured to transmit torque to the bendable body. Therefore, the rejections of the claims under 35 U.S.C. 103 are maintained.
Claim Objections
Claim 17 is objected to because of the following informalities:
In claim 17, line 16 “at least one of the three control wires” should read “at least one of the at least three control wires.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 3 and 17-21 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 3 contains a Markush grouping requiring a selection from an open list of alternatives as indicated by the transitional phrase “selecting from the group comprising” which renders the scope of the claim indefinite since it is unclear what other alternatives are intended to be encompassed by the claim. See MPEP 2173.05(h).
Claim 17 also recites the limitation “one of the anchors is affixed to each of the at least three wire guides” in line 20, which renders the scope of the claim indefinite as it is unclear if a plurality of anchors is affixed to each of the three wire guides or only one anchor is affixed to all three wire guides simultaneously. And if the latter, it is further unclear how one anchor could be affixed to three wire guides. For examination purposes, this limitation has been interpreted as “each anchor is affixed to one of the at least three wire guides.”
Claims 18-21 are similarly rejected by virtue of their dependency from claim 17.
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.
Claims 1, 3, 5-11, 13, 15, 17-19 and 21 are rejected under 35 U.S.C 103 as being unpatentable over Matsuda (US 20190059700) further in view of Benscoter (US 2013/0281925).
Regarding claims 1, 3, 15, 17, and 19, Masuda discloses a medical apparatus (see Fig. 1-2) comprising: a bendable body (insertion section 2 is a bendable body, see Fig. 1 and [0031]) comprising: a hollow cavity extending the length of the bendable body (insertion section 2 is formed as a tube so it necessarily has a hollow cavity extending its length, see [0031] and Fig. 2), the bendable body having a plurality of bendable segments (7a, 7b); and a wall formed about the hollow cavity and extending through the plurality of bendable segments (the plurality of interconnected bending elements 31 form a wall of the cavity and extending through portions 7a and 7b, see Fig. 2); at least one control wire (41u, 43u) slideably situated in the wall; and an anchor (wire 41u has an anchor 32 and coil 43u has an anchor 33u) configured at a distal end of at least one first control wire of the at least two control wires, wherein, the anchor is affixed within the wall (anchor 32 is fixed to the wall formed by the last bending element 31a, see Fig. 2); and wherein the wall comprises at least two wire guides (bending elements 31 can be considered wire guides) configured to slideably house the at least one control wire (operation wire 41u and coil 43u housed within the bending elements 31, see Fig, 2), wherein the wire guides are spaced a distance from one another and do not contact one another (consecutive bending elements are separated by a gap, see Fig. 2), wherein the at least two wire guides include a first wire guide having a first lumen for slideably accommodating the at least one first control wire and a second lumen for embedding the anchor, a second wire guide having at least two lumens for slideably accommodating the at least two control wires (each bending element 31 has two lumens 24 for slideably accommodating a wire or for embedding an anchor, see Fig. 2) and wherein the at least two control wires cause each of the plurality of bendable segments to be adjustable independent from each other through movement of the at least two control wires through pushing and pulling forces (sections 7a and 7b can be independently actuated by controlling the tension in wire 41 u and coil 43u, see [0050]-[0051]) and are configured to transmit the pushing and pulling forces to the bendable body to actuate the plurality of bendable segments (pushing and pulling on the wires causes the bendable body to actuate the bendable segments, see [0048], [0050] and [0051]). Further regarding claim 1, Matsuda discloses wherein the anchor extends along an axial direction of the control wire (anchor 32 extends along an axial direction of the operation wire 41u and guide coil 43u, see Fig. 2) with at least one projection element (anchor 32 forms a projection at the distal end of the operation wire 41 u, see Fig. 2). Further regarding claim 17, Matsuda teaches a plurality of at least three wire guides (there are at least 3 bending elements 31 shown in Fig. 2) and at least three control wires situated within the wire guides (41u, 43u, 44, 41d, 43d) and each wire has an anchor at the distal end (32, 33u, 34, 33d).
Matsuda fails to teach the anchor is embedded into the wall and wherein the projection element is selected from the group consisting comprising of a bead, a disk, a leaf spring, a spiral coil, derivatives thereof, and combination therefrom.
Benscoter, in the same field of art, teaches a similar apparatus (see Fig. 1 and 10) comprising a bendable body (22) comprising a wall (38), a control wire (24) and an anchor (64) at the distal end of the control wire with a projection element in the form of a bead configured for embedding into the wall (knob 64 is embedded within the wall ring 38, see Fig. 10). This manner of fixing the control wire to the wall “provide[s] a steering assembly that can withstand greater pull forces while maintaining design integrity” (see Abstract).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus of Matsuda so that the anchor is embedded into the wall and the projection element is a bead, as taught by Benscoter, since doing so would allow the apparatus to withstand greater pull forces while maintaining design integrity.
Further with respect to claim 15, Matsuda fails to expressly teach “heating the anchor configured in the wall to create a fusion between the wall and anchor; and cooling the anchor configured in the wall to set the fusion”.
Benscoter teaches a related medical apparatus (see Fig. 1 and 10) prepared by a similar process comprising providing a bendable body (22) comprising a wall (38, see Fig. 10), a control wire (24) and an anchor (64) at the distal end of the control wire, heating the anchor configured in the wall to create a fusion between the wall and anchor (pull wire 24 is embedded within the wall of ring 38 and welded at portion 54a and 54b, see Fig. 10, which is understood to included heating to create a fusion between the wall and the anchor 64, see [0039] and [0040]); and cooling the anchor configured in the wall to set the fusion (although not explicitly stated, it is understood that the anchor is cooled in order for the attachment to take place). This manner of fixing the control wire to the wall “provide[s] a steering assembly that can withstand greater pull forces while maintaining design integrity” (see Abstract).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Matsuda to include the steps of heating and cooling the anchor to create and set a fusion, as taught by Benscoter, since doing so would allow the apparatus to withstand greater pull forces while maintaining design integrity.
Regarding claim 5, Matsuda and Benscoter teach the apparatus of Claim 1. Matsuda further discloses wherein the at least two control wires comprise the at least one first control wire (41u) and a second control wire (43u, see Fig. 2) slideably situated in the wall and having an anchor (33u) for affixing the second control wire to the wall, wherein the position of the anchor for the first and the second control wires are different along the axial direction of the bendable body (the positions of anchors 32 and 33u are different along the axial direction of the insert section 2, see Fig. 2).
Regarding claim 6, Matsuda and Benscoter teach the apparatus of Claim 1. Matsuda further discloses at least a second anchor, wherein the positions of the anchor and the at least a second anchor are different along the axial direction of the bendable body (anchor 32 can be considered an anchor and anchor 33 can be considered at least a second anchor; the positions of anchor 32 and anchor 33 are different along the axial direction of insert section 2, see Fig. 2).
Regarding claim 7, Matsuda and Benscoter teach the apparatus of Claim 1. Matsuda further discloses a driving unit (operation unit 3, see Fig. 3) in communication with the at least two control wires, configured to actuate the at least two control wires in the wall (operation wire 41u is connected to pulley 45 and operation lever 13 of the operation unit 3, which controls movement of the operation wire and similarly, guide coil 43u is connected to selector lever 21 of the operation unit, see [0038] and [0048]).
Regarding claim 8, Matsuda and Benscoter teach the apparatus of Claim 1. Matsuda further discloses wherein the at least two control wires further comprise an outer wire (guide coil 43u can be considered an outer wire, see Fig. 2) and an inner wire (operation wire 41u can be considered an inner wire), wherein the inner wire is slideably nested within the outer wire (operation wire 41u is sildeably within the outer wire 43u, see Fig. 2 and [0029]).
Regarding claim 9, Matsuda and Benscoter teach the apparatus of Claim 8. Matsuda further discloses wherein the outer wire (43u) has an anchor (33u) for affixing the outer wire to the wall and the inner wire (31u) has an anchor (32) for affixing the inner wire to the wall, wherein the position of the anchor for the outer wire and the inner wires are different along the axial direction of the bendable body (the positions of the anchors 32 and 33u are different along the axial direction of the insert section 2, see Fig. 2).
Regarding claim 10, Matsuda and Benscoter teach the apparatus of Claim 1. Matsuda fails to teach wherein the at least one control wire and anchor comprise of a radio opaque material.
Benscoter teaches a control wire (24, see Fig. 10) and anchor (64) which can each be comprised of stainless steel which is a known radiopaque material (see [0039]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the apparatus of Matsuda so that the control wire and anchor comprise a radiopaque material since control wires and anchors made of radiopaque materials were known in the art, as evidenced by Benscoter, and since the selection of a material based on its suitability for its intended use involves only routine skill to yield predictable results. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)). See MPEP 2144.07.
Regarding claim 11, Matsuda and Benscoter teach the apparatus of Claim 1. Matsuda further discloses a functional probe selected from the group consisting of a position tracking sensor, a shape sensor, an endoscopic imaging probe, and combinations therefrom (tip portion 6 can include an imaging unit, see [0031]).
Regarding claim 13, Matsuda and Benscoter teach the apparatus of Claim 1, wherein affixing the anchor to the wall comprises heating the wall and anchor to create a thermal fusion. The claimed phrase “affixing the anchor to the wall comprises heating the wall and anchor to create a thermal fusion” is being treated as a product by process limitation; that is, that the anchor and the wall are joined by thermal fusion. As set forth in MPEP 2113, product-by-process claims are NOT limited to the manipulations of the recited steps, only to the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 U.S.C. 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. See MPEP 2113. Thus, even though Matsuda is silent as to the process used join the anchor and wall, it appears that the product disclosed by Matsuda would be the same or similar as that claimed; especially since both applicant’s product and the prior art product are an anchor and wall affixed to each other.
Regarding claim 18, Matsuda and Benscoter teach the apparatus of Claim 17. Matsuda further discloses wherein the hollow cavity provides bendable support to the plurality of at least three wire guides (the lumen of the device allows for bending of the insert section 2, see Fig. 2).
Regarding claim 20, Matsuda and Benscoter teach the apparatus of Claims 17. Matsuda further discloses wherein the wall comprises at least one lumen for slideably accommodating at least one control wire of the at least three control wires (the wall formed by bending elements 31 includes guides 24 which form lumens for accommodating the operation wire 41u and coil 43u, see Fig. 2).
Regarding claim 21, Matsuda and Benscoter teach the apparatus of Claim 17. Matsuda further discloses further comprising an outer lining for encompassing the apparatus (although not shown in the figures, Matsuda discloses that the outer circumference of the bending elements 31 can be covered by a braided tube, which would be considered an outer lining of encompassing the apparatus, see [0035]).
Claims 16 is rejected under 35 U.S.C 103 as being unpatentable over Jaffe (US 2002/0161281) further in view of Matsuda and Benscoter.
Regarding claim 16, Jaffe discloses a method for treating a subject (see [0008] and Fig. 4-5), comprising: providing a medical apparatus (80) comprising: a bendable body having a hollow cavity extending the length of the bendable body, the bendable body having a plurality of bendable segments (see Fig. 5) and a wall formed about the hollow cavity and extending through the bendable segments (endoscope 80 is understood to have a hollow cavity with a wall formed about the hollow cavity since it has illumination fibers 94 extending through the body, see [0030]); advancing the medical apparatus into a subject (the endoscope is inserted into a colon C, see Fig. 5 and [0008]); bending the medical apparatus to accommodate obstacles in the subject (the endoscope is bent in order to avoid contacting the walls of the colon, see [0008]); and treating the subject once the medical apparatus advances to a desired target in the subject (the device is inserted into a subject for colonoscopic treatment, see [0002]).
Jaffe fails to expressly teach at least one control wire slideably situated in the wall; and an anchor configured at a distal end of the at least two control wires wherein the anchor is affixed to the wall and extends along an axial direction of the at least two control wires with at least one projection element configured for embedding into the wall; and wherein the wall comprises at least two wire guides configured to slideably house the at least two control wires, wherein the wire guides are spaced a distance from one another and wherein the at least one control wire causes each of the plurality of bendable segments to be adjustable independent from each other.
Masuda, in the same field of art, teaches a similar medical apparatus (see Fig. 1-2) comprising: a bendable body (insertion section 2 is a bendable body, see Fig. 1 and [0031]) comprising: a hollow cavity extending the length of the bendable body (insertion section 2 is formed as a tube so it necessarily has a hollow cavity extending its length, see [0031] and Fig. 2), the bendable body having a plurality of bendable segments (7a, 7b); and a wall formed about the hollow cavity and extending through the plurality of bendable segments (the plurality of interconnected bending elements 31 form a wall of the cavity and extending through portions 7a and 7b, see Fig. 2); at least one control wire (41u, 43u) slideably situated in the wall; and an anchor (wire 41u has an anchor 32 and coil 43u has an anchor 33u) configured at a distal end of at least one first control wire of the at least two control wires, wherein, the anchor is affixed within the wall (anchor 32 is fixed to the wall formed by the last bending element 31a, see Fig. 2); and wherein the wall comprises at least two wire guides (bending elements 31 can be considered wire guides) configured to slideably house the at least one control wire (operation wire 41u and coil 43u housed within the bending elements 31, see Fig, 2), wherein the wire guides are spaced a distance from one another and do not contact one another (consecutive bending elements are separated by a gap, see Fig. 2), wherein the at least two wire guides include a first wire guide having a first lumen for slideably accommodating the at least one first control wire and a second lumen for embedding the anchor, a second wire guide having at least two lumens for slideably accommodating the at least two control wires (each bending element 31 has two lumens 24 for slideably accommodating a wire or for embedding an anchor, see Fig. 2) and wherein the at least two control wires cause each of the plurality of bendable segments to be adjustable independent from each other through movement of the at least two control wires through pushing and pulling forces (sections 7a and 7b can be independently actuated by controlling the tension in wire 41 u and coil 43u, see [0050]-[0051]), and are configured to transmit the pushing and pulling forces to the bendable body to actuate the plurality of bendable segments (pushing and pulling on the wires causes the bendable body to actuate the bendable segments, see [0048], [0050] and [0051]). Further regarding claim 16, Matsuda discloses wherein the anchor extends along an axial direction of the control wire (anchor 32 extends along an axial direction of the operation wire 41u and guide coil 43u, see Fig. 2) with at least one projection element (anchor 32 forms a projection at the distal end of the operation wire 41 u, see Fig. 2).
It would have been obvious to one of ordinary skill in the art to substitute the bendable body in the method of Jaffe for the bendable body taught by Matsuda since doing so would have yielded nothing more than predictable results, namely, the bendable body of Matsuda in the method of Jaffe would be capable of performing the advancing, bending, and treating steps as claimed. KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Jaffe and Matsuda fail to teach the anchor is embedded into the wall and wherein the projection element is selected from the group consisting comprising of a bead, a disk, a leaf spring, a spiral coil, derivatives thereof, and combination therefrom.
Benscoter, in the same field of art, teaches a similar apparatus (see Fig. 1 and 10) comprising a bendable body (22) comprising a wall (38), a control wire (24) and an anchor (64) at the distal end of the control wire with a projection element in the form of a bead configured for embedding into the wall (knob 64 is embedded within the wall ring 38, see Fig. 10). This manner of fixing the control wire to the wall “provide[s] a steering assembly that can withstand greater pull forces while maintaining design integrity” (see Abstract).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Jaffe and Matsuda so that the anchor is embedded into the wall and the projection element is a bead, as taught by Benscoter, since doing so would allow the apparatus to withstand greater pull forces while maintaining design integrity.
Conclusion
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771