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 .
Status of Claims
Claims 1, 3-13, and 15-16 are pending, claims 2 and 14 have been cancelled, and claims 1, 3-13, and 15-16 are currently under consideration for patentability under 37 CFR 1.104. Previous claim objections and 35 USC 112 Rejections have been withdrawn in light of Applicant’s arguments and amendments.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 1, 6, and 16 are objected to because of the following informalities:
In claim 1, on line 14, change “extending projecting” to “extends projecting”.
In claim 1, on line 23, change “by a heel” to “by the heel” (i.e., previously recited).
In claim 6, on line 3, change “surfacdes” to “surfaces”.
In claim 16, on line 21, change “by a heel” to “by the heel” (i.e., previously recited).
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.
Claim 16 is 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.
Regarding claim 16, the limitation “adjacent one of the tubular vertebrae” is unclear. It is unclear what feature the “one” is referring to within the context of the limitation.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3-9, 13, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Tanii (US 2014/0180009), in view of Salahieh (US 2012/0277730) and Heimberger (US 5,807,241).
Regarding claim 1, Tanii discloses a bending structure (13, figure 4) for an insertion tube (11, figure 4) of a medical device (endoscope 10, figure 4), having tubular vertebrae (15, figure 4) with a proximal tubular vertebra (18, figure 4) and a distal tubular vertebra (17, figure 4), and a diametrical bending plane (see arrows x, y, and y5, figure 6 | interpreted the bending plane can be a plane created by x and y5 and/or a plane created by y and y5) of the structure, the bending structure comprising: a tube (rigid pipe [0025]) with a longitudinal axis (see central axis in figure 4), cut by cutting lines of an energy beam (laser beam…[0025]) to produce tubular vertebrae nested in one another by diametrically opposed male cut-out areas (21, figure 15 | see 21, figure 6) and diametrically opposed female cut-out areas (see 22, figure 6) forming pivots of rotation along axes of rotation (x and/or y axes, figure 6) located in a plane of symmetry (can be the x and/or y plane, figure 6), the cutting lines being arranged to delimit, between the tubular vertebrae, notches (33a-b, figure 15) cut in the tube to form bending zones for the tubular vertebrae in order to obtain the bending of the bending structure in the diametrical bending plane perpendicular to the axes of rotation (see figure 15), and a system (see 20, figure 15) for retaining the tubular vertebrae together between two opposite extreme positions, the system for retaining comprising: at least one lug (see 31d, figures 14-15) extending projecting from the male cut-out areas and engaged in a slot (30c, figures 14-15) in the female cut-out areas and having two rotation limiting surfaces (see surface ends of 30c, figures 14-15) located on either side of the plane of symmetry (on either end of 30c, figure 14). Tanii is silent regarding at least one actuation wire extending in the diametrical bending plane of the structure; and a pair of hooks extending projecting from the tubular vertebrae, outside the diametrical bending plane and in orthogonal symmetry relative to the longitudinal axis, each hook having an L shape with a rectilinear shank curved at an end of the shank, on one side to present a heel delimiting, opposite the end of the shank, a retaining surface, the hooks each being engaged in a housing arranged in a neighbouring tubular vertebra opening in an outer edge of the neighbouring tubular vertebra by a narrowed part for guiding the rectilinear shank bordered by a retaining stop on which the hook comes to rest by a heel of the hook in the two extreme positions, wherein the tubular vertebrae include a tubular vertebra with the pair of hooks on one side of the diametrical bending plane and a neighbouring tubular vertebra with the pair of hooks on the other side of the diametrical bending plane, such that positions of the pairs of hooks alternate from the tubular vertebra to the neighbouring tubular vertebra.
Salahieh teaches a steerable delivery device (10, figure 1) with slots (22, figure 1). The steerable portion (258, figure 14) of a steerable tubular member can be steered by actuating a pull wire (264, figure 14). The steerable portion can have interlocking features (298, figure 15) with a first interlocking member (300, figure 15) and a second interlocking member (302, figure 15). The interlocking features allow for movement between the two interlocking elements (300 and 302, figure 15) in the axial direction ([0107]).
Heimberger teaches a tube (figure 1) with a gap (3, figure 1) that is cut into the tube that connecting tube sections (1-2, figure 1 | see 1’’-2’’, figures 7-10) arise. There are two essentially rectangular lugs (43, figures 7-10) that are displaced about 180 degrees to one another (see figures 7-10). The part circular shaped lugs (41, figures 7-10) are each displaced about 90 degrees. Lugs (42, figures 7-10) are arranged between the lugs (41 and 43, figures 7-10). The recesses of a tube section are arranged to the corresponding lugs of the same tube section not on the same axes, but arranged displaced about 90 degrees to one another so that consecutive tube sections can be bendable in other planes (Col. 6, lines 54-58).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the bending structure of Tanni with the pull wire (264, figure 14) and interlocking features (300 and 302, figure 15) between tubular vertebra as taught by Salahieh. Doing so would provide steering for the bending structure ([0103]) and locking features that have axial movement ([0107]). Further, it would have been obvious to displace the pair of hooks, male cut-out areas, and female cut-out areas to be displaced 90 degrees to one another in consecutive tubular vertebra as taught by Heimberger (Col. 6, lines 54-58). Doing so would provide consecutive tubular vertebra that are bendable in other planes (Col. 6, lines 54-58). The modified structure would have at least one actuation wire (264, figure 14; Salahieh) extending in the diametrical bending plane of the structure; and a pair of hooks (see hook of 302, figure 15; Salahieh) extending projecting from the tubular vertebrae, outside the diametrical bending plane (302 may be located outside the diametrical bending plane, which is the plane created by x and y5 and/or the plane created by y and y5 in figure 6 of Tanii) and in orthogonal symmetry relative to the longitudinal axis (see figure 15; Salahieh), each hook having an L shape with a rectilinear shank (see 302, figure 15; Salahieh) curved at an end of the shank, on one side to present a heel (see hook portion of 302, figure 15) delimiting, opposite the end of the shank, a retaining surface (see surface of the hook portion of 302, figure 15), the hooks each being engaged in a housing (see how 302 connects with 300, figure 15) arranged in a neighbouring tubular vertebra opening in an outer edge (see figure 15) of the neighbouring tubular vertebra by a narrowed part (see the narrow part to hold the shank of 302, figure 15) for guiding the rectilinear shank bordered by a retaining stop (see the surface of 300 that connects with the hook portion of 302, figure 15) on which the hook comes to rest by a heel of the hook in the two extreme positions (see figure 15), wherein the tubular vertebrae include a tubular vertebra with the pair of hooks on one side of the diametrical bending plane (see hook of 302, figure 15; Salahieh | 302 may be located on one side of the diametrical bending plane) and a neighbouring tubular vertebra with the pair of hooks on the other side of the diametrical bending plane (the modified pair of hooks would be displaced 90 degrees to one another in consecutive tubular vertebra; Col. 6, lines 54-58 of Heimberger | the pair of hooks on the neighbouring tubular vertebra can be on the other side of the diametrical bending plane), such that positions of the pairs of hooks alternate from the tubular vertebra to the neighbouring tubular vertebra (90 degrees…in consecutive tubular vertebra; Col. 6, lines 54-58 of Heimberger).
Regarding claim 3, Salahieh further teaches the retaining surface (see surface of the hook portion of 302, figure 15; Salahieh) has a flat wall.
Regarding claim 4, Tanii and Salahieh further disclose the retaining system is arranged such that for each extreme position between two neighbouring tubular vertebrae, the two lugs of two male cut-out areas that are diametrically opposed are supported on the rotation limiting surfaces (see surface ends of 30c, figures 14-15; Tanii) of the slots located on one side of the plane of symmetry located opposite the bending direction (see figure 15 of Tanii | broadly interpreted “supported” as holding up or serve as a foundation for; see the surface ends of 30c engage with the lugs of 31c) and the hook located on the side of this plane of symmetry is supported on the retaining stop (see the hook portion of 302 engage with 300, figure 15; Salahieh).
Regarding claim 5, Tanii further discloses the two lugs extend projecting from each of the male cut-out areas (see 21, figures 14-15 | there are two male cut-out areas for each tubular vertebra, see figure 6, with each male cut-out area having two lugs (31c, figure 14) and are each engaged in a slot (30c, figure 14) in the female cut-out areas (22, figure 14 | there are two female cut-out areas for each tubular vertebra, see figure 6 with each female cut out area having a slot 30c, figure 14) and have a first bearing surface and a second bearing surface (see surface of 31d, figures 14-15) intended to cooperate with the rotation limiting surfaces (see surface ends of 30c, figures 14-15).
Regarding claim 6, Tanii further discloses each lug (see 21, figures 14-15 of Tanii | there are two male cut-out areas for each tubular vertebra, see figure 6, with each male cut-out area having two lugs 31c, figure 14) has at least one bearing surface (see surface of 31d, figures 14-15) not passing through the axis of rotation (see figure 15) and intended to cooperate in an extreme position (see figure 15), with the rotation limiting surfacdes (see surface ends of 30c, figures 14-15) extending along a plane not passing through the axis of rotation (figure 15), so as to nest one inside the other (see figure 15).
Regarding claim 7, Tanii further discloses the at least one bearing surface (see surface of 31d, figures 14-15; Tanii) of each lug (see 21, figures 14-15 of Tanii) extends projecting from the male cut-out areas and up to the outer edge of the lug (see 21 and 31d, figures 14-15).
Regarding claim 8, Tanii further discloses each male cut-out area (21, figures 14-15; Tanii ) has a connecting neck (see narrow portion/neck of 21, figures 14-15) with a part forming a rotation pivot (see figure 15).
Regarding claim 9, Tanii further discloses each female cut-out area (22, figures 14-15; Tanii) is arranged to connect with an outer edge of the tubular vertebra (see 22 and 33a, figure 15), using non-pointed reinforcing heels (see 32, figures 14-15) extending on either side of the part forming the rotation pivot (see figure 15) and configured to engage in the connecting neck (see figure 15).
Regarding claim 13, Tanii further discloses the medical device is an endoscope (endoscope 10, figure 4; Tanii) or catheter with the insertion tube, the insertion tube having, on one side, a proximal part (14, figure 4) connected to an operating handle (operation apparatus [0005] | interpreted there to be a handle in the endoscope connected to the proximal part/flexible tube portion), and on an opposite side, a distal part which is equipped with a distal head (12, figure 4).
Regarding claim 15, Tanii and Salahieh and Heimberger further disclose the heels of the hooks of the tubular vertebra are orientated in a first direction (302, figure 15 of Salahieh may be located to the diametrical bending plane, which is the plane created by x and y5 and/or the plane created by y and y5 in figure 6 of Tanii) relative to the diametrical bending plane, and the heels of the hooks of the neighbouring tubular vertebra are oriented in a second direction (the modified pair of hooks would be displaced 90 degrees to one another in consecutive tubular vertebra; Col. 6, lines 54-58 of Heimberger | the pair of hooks on the neighbouring tubular vertebra can be on the other/opposite side of the diametrical bending plane), opposite to the first direction, relative to the diametrical bending plane, thereby defining alternating orientations of the heels from the tubular vertebra to the neighbouring tubular vertebra (bendable in other planes; Col. 6, lines 54-58; Heimberger).
Regarding claim 16, Tanii discloses a medical device (10, figure 4) comprising: tubular vertebrae (15, figure 4) including a proximal tubular vertebra (18, figure 4) and a distal tubular vertebra (17, figure 4) and a diametrical bending plane (see arrows x, y, and y5, figure 6 | interpreted the bending plane can be a plane created by x and y5 and/or a plane created by y and y5) of the tubular vertebrae, wherein the tubular vertebrae are nested in one another by diametrically opposed male cut-out areas (21, figure 15 | see 21, figure 6) and diametrically opposed female cut-out areas (see 22, figure 6) forming pivots of rotation along axes of rotation (x and/or y axes, figure 6) located in a plane of symmetry (can be the x and/or y plane, figure 6), the tubular vertebrae include notches (33a-b, figure 15) that form bending zones in the diametrical bending plane perpendicular to the axes of rotation (see figure 15), at least one lug (see 31d, figures 14-15) extends from the male cut-out areas and engages in a slot (30c, figures 14-15) in the female cut-out areas and has two rotation limiting surfaces (see surface ends of 30c, figures 14-15) on either side of the plane of symmetry (on either end of 30c, figure 14). Tanii is silent regarding at least one actuation wire extending in the diametrical bending plane of the tubular vertebrae; a pair of hooks extends from the tubular vertebrae, outside the diametrical bending plane and in orthogonal symmetry relative to a longitudinal axis of the tubular vertebrae, each of the pair of hooks has an L shape with a rectilinear shank curved at an end of the shank on one side so that the hook has a heel delimiting, opposite the end of the shank, a retaining surface, each of the hooks is engaged in a housing in a neighbouring tubular vertebra opening in an outer edge of the neighbouring tubular vertebra by a narrowed part configured to guide the rectilinear shank, which is bordered by a retaining stop on which the hook comes to rest by a heel of the hook in two opposite extreme positions of the tubular vertebrae, and the tubular vertebrae alternate the pair of hooks from on one side of the diametrical bending plane to on the other side of the diametrical bending plane, such that positions of the pairs of hooks alternate between adjacent one of the tubular vertebrae.
Salahieh teaches a steerable delivery device (10, figure 1) with slots (22, figure 1). The steerable portion (258, figure 14) of a steerable tubular member can be steered by actuating a pull wire (264, figure 14). The steerable portion can have interlocking features (298, figure 15) with a first interlocking member (300, figure 15) and a second interlocking member (302, figure 15). The interlocking features allow for movement between the two interlocking elements (300 and 302, figure 15) in the axial direction ([0107]).
Heimberger teaches a tube (figure 1) with a gap (3, figure 1) that is cut into the tube that connecting tube sections (1-2, figure 1 | see 1’’-2’’, figures 7-10) arise. There are two essentially rectangular lugs (43, figures 7-10) that are displaced about 180 degrees to one another (see figures 7-10). The part circular shaped lugs (41, figures 7-10) are each displaced about 90 degrees. Lugs (42, figures 7-10) are arranged between the lugs (41 and 43, figures 7-10). The recesses of a tube section are arranged to the corresponding lugs of the same tube section not on the same axes but arranged displaced about 90 degrees to one another so that consecutive tube sections are to be bendable in other planes (Col. 6, lines 54-58).
It would have been obvious to one of ordinary skill in the art before the time of filing to modify the bending structure of Tanni with the pull wire (264, figure 14) and interlocking features (300 and 302, figure 15) between tubular vertebra as taught by Salahieh. Doing so would provide steering for the bending structure ([0103]) and locking features that have axial movement ([0107]). Further, it would have been obvious to displace the pair of hooks, male cut-out areas, and female cut-out areas to be displaced 90 degrees to one another in consecutive tubular vertebra as taught by Heimberger (Col. 6, lines 54-58). Doing so would provide consecutive tubular vertebra that are bendable in other planes (Col. 6, lines 54-58). The modified endoscope would have at least one actuation wire (264, figure 14; Salahieh) extending in the diametrical bending plane of the tubular vertebrae; a pair of hooks (see hook of 302, figure 15; Salahieh) extends from the tubular vertebrae, outside the diametrical bending plane (302 may be located outside the diametrical bending plane, which is the plane created by x and y5 and/or the plane created by y and y5 in figure 6 of Tanii) and in orthogonal symmetry relative to a longitudinal axis (see figure 15; Salahieh) of the tubular vertebrae, each of the pair of hooks has an L shape with a rectilinear shank (see 302, figure 15; Salahieh) curved at an end of the shank on one side so that the hook has a heel (see hook portion of 302, figure 15) delimiting, opposite the end of the shank, a retaining surface (see surface of the hook portion of 302, figure 15), each of the hooks is engaged in a housing (see how 302 connects with 300, figure 15) in a neighbouring tubular vertebra opening in an outer edge (see figure 15) of the neighbouring tubular vertebra by a narrowed part (see the narrow part to hold the shank of 302, figure 15) configured to guide the rectilinear shank, which is bordered by a retaining stop (see the surface of 300 that connects with the hook portion of 302, figure 15) on which the hook comes to rest by a heel of the hook in two opposite extreme positions of the tubular vertebrae (see figure 15), and the tubular vertebrae alternate the pair of hooks from on one side of the diametrical bending plane to on the other side of the diametrical bending plane (the modified pair of hooks would be displaced 90 degrees to one another in consecutive tubular vertebra; Col. 6, lines 54-58 of Heimberger | the pair of hooks on the neighbouring tubular vertebra can be on the other side of the diametrical bending plane), such that positions of the pairs of hooks alternate between adjacent one of the tubular vertebrae (90 degrees…in consecutive tubular vertebra; Col. 6, lines 54-58 of Heimberger).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Tanii (US 2014/0180009) and Salahieh (US 2012/0277730) and Heimberger (US 5,807,241) as applied to claim 1 above, and further in view of Solomon (US 5,749,828).
Regarding claim 10, Tanii and Salahieh and Heimberger disclose all of the features in the current invention as shown above in claim 1. They are silent regarding the retaining system has, for at least one tubular vertebra, two pairs of tongues arranged symmetrically on either side and outside the diametrical bending plane, each being engaged in a groove provided in a neighbouring tubular vertebra.
Solomon teaches a bending neck with a series of cascaded links (2, figures 3) and sleeves (12, figures 3). The sleeves have a pair of diametrically opposed finger joints (17, figure 3c) that are rotationally aligned with a pair of finger sockets (19, figure 3c). The finger joints and the finger sockets act as bending stops, limiting the amount of curvature of the bending neck (Col. 4, lines 56-58).
It would have been obvious to modify the bending structure of Tanii and Salahieh and Heimberger with the finger joints (17, figure 3c) and finger sockets (19, figure 3c) as taught by Solomon. Doing so would provide bending stops, limiting the amount of curvature of the bending structure (Col. 4, lines 56-58). The modified bending structure would have the retaining system has, for at least one tubular vertebra, two pairs of tongues (17, figure 3c; Solomon) arranged symmetrically on either side and outside the diametrical bending plane (see figure 3c), each being engaged in a groove (19, figure 3c) provided in a neighbouring tubular vertebra.
Claim(s) 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Tanii (US 2014/0180009) and Salahieh (US 2012/0277730) and Heimberger (US 5,807,241) as applied to claim 1 above, and further in view of Nelson (US 2021/0321857).
Regarding claim 11, Tanii and Salahieh and Heimberger disclose all of the features in the current invention as shown above in claim 1. They are silent regarding the tube has a diameter less than or equal to 10 mm.
Nelson teaches an articulated segment instrument with an elongated body with a plurality of interconnected links (abstract). The articulated segment instrument can be produced using laser cutting ([0015]) and can have a diameter of 10 mm or smaller ([0016]). The segments being made in one single piece each allow a simplified manufacturing process and avoids cumbersome bridging connections ([0016]).
It would have been obvious to modify the bending structure to have the tube have a diameter of 10 mm or less as taught by Nelson ([0016]). Doing so would provide structurally robust segments at smaller scales ([0016]).
Regarding claim 12, Tanii and Salahieh and Heimberger disclose all of the features in the current invention as shown above in claim 1. They are silent regarding the tube has a wall thickness comprised between 0.05 and 1.5 mm.
Nelson teaches an articulated segment instrument with an elongated body with a plurality of interconnected links (abstract). The articulated segment instrument can be produced using laser cutting ([0015]) and can have a diameter of 10 mm or smaller ([0016]). The segments being made in one single piece each allow a simplified manufacturing process and avoids cumbersome bridging connections ([0016]). The tube wall thickness is 1 mm or more, creating a more mechanically stable segment ([0021]).
It would have been obvious to modify the bending structure to have the tube have a wall thickness of 1 mm or more as taught by Nelson ([0021]). Doing so would provide a more mechanically stable bending structure ([0021]). The modified bending structure would have the tube has a wall thickness comprised between 0.05 and 1.5 mm (1 mm or more…[0021]).
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 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 PAMELA F WU whose telephone number is (571)272-9851. The examiner can normally be reached M-F: 8-4 PM.
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PAMELA F. WU
Examiner
Art Unit 3795
September 16, 2026
/RYAN N HENDERSON/Primary Examiner, Art Unit 3795
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