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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/14/2025 has been entered.
Response to Amendment
Applicant has amended claims 21, 26, 31, and 36 which were previously objected to and/or rejected under 35 U.S.C. §112(b); Examiner accordingly withdraws the previous objections and/or rejections under 35 U.S.C. §112(b) for claims 21, 26, 31, and 36.
Claims 21-28 and 30-40 remain pending.
Claim Objections
Claims 21, 31, and 36 are objected to because of the following informalities:
Each of claims 21, 31, and 36 are objected to where they have a typographical error wherein there is improper antecedent basis in the claim where it recites “located within the at least one stud and operable connected to the stud” and should instead recite “located within the at least one stud and operable connected to the at least one stud”.
Claim 21 additionally is objected to where it has a typographical error wherein it recites “wherein tension on the first pull wire causes the shaft to bend in the first direction; and wherein the tension on the second pull wire causes the shaft to bend in the second direction; a handle assembly” and should instead recite “wherein tension on the first pull wire causes the shaft to bend in the first direction; wherein the tension on the second pull wire causes the shaft to bend in the second direction; and a handle assembly”.
Claim 31 additionally is objected to where it has a typographical error wherein it recites “wherein tension on one of the first and second pull wires causes the shaft to bend in one of a first and second directions; and wherein the tension on one of the third and fourth pull wires causes the shaft to bend in one of a third and fourth directions; a handle assembly” and should instead recite “wherein tension on one of the first and second pull wires causes the shaft to bend in one of a first and second directions; wherein the tension on one of the third and fourth pull wires causes the shaft to bend in one of a third and fourth directions; and a handle assembly”.
Claim 36 additionally is objected to where it has a typographical error wherein it recites “wherein tension on one of the first and second pull wires causes the shaft to bend in one of a first and second directions; and wherein the tension on one of the third and fourth pull wires causes the shaft to bend in one of a third and fourth directions; a handle assembly” and should instead recite “wherein tension on one of the first and second pull wires causes the shaft to bend in one of a first and second directions; wherein the tension on one of the third and fourth pull wires causes the shaft to bend in one of a third and fourth directions; and a handle assembly”.
Appropriate correction is required.
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.
Claims 21-28, 30-32, and 34-40 are rejected under 35 U.S.C. 103 as being unpatentable over Intoccia et al. (US 20080300462, henceforth Intoccia) in view of Kauphusman et al. (US 20120130218, henceforth Kauphusman), Tegg (US 20120203169, henceforth Tegg), McDaniel et al. (US 20040181136, henceforth McDaniel), and Bednarek et al. (US 20090105640, henceforth Bednarek).
Regarding claim 21, Intoccia discloses a steerable introducer (endoscope 10, fig. 1) comprising: a shaft (flexible shaft 50, fig. 1) with a proximal end portion (the half of shaft 50 closer to handle 20, see fig. 1), a distal end portion (half of shaft 50 closer to distal portion 60, fig. 1), and a shaft longitudinal axis (centerline of shaft shown in fig. 1) extending between the proximal end portion and the distal end portion (see fig. 1); a steerable distal tip section (distal end 62 and distal portion 60, fig. 2b) attached to the distal end portion of the shaft (see figs. 1 and 2b), the steerable distal tip section comprising: an articulation support member (articulation layer 80, fig. 5), wherein the articulation support member comprises one or more apertures (slots 82 and 84, fig. 5) defined along the articulation support member (see fig. 5); an outer layer (inner shaft 68, which is an outer layer with respect to working channel 46) comprising one or more minor lumens (smaller lumens 72, 74, 76, 78, fig. 9) for receiving respective one or more pull wires (pull wires 28, 30, 32, 34, fig. 3); and a first pull wire (pull wire 28, fig. 3) extending from the proximal end portion of the shaft to the distal end portion of the shaft (see [0055] and [0060]), wherein the first pull wire is anchored at a first anchor position on the articulation support member (in light of [0051] and fig. 9, it is understood that pull wire 28 is attached to the top side of deflection section 66 of distal portion 60, which includes articulation layer 80), the first anchor position being laterally offset from the shaft longitudinal axis in a first direction (see fig. 9, and note that pull wire 28 is again understood to be at the top attachment position); a second pull wire (pull wire 30, fig. 3) extending from the proximal end portion of the shaft to the distal end portion of the shaft (see [0055] and [0058]), wherein the second pull wire is anchored at a second anchor position on the articulation support member (in light of [0058] and fig. 9, it is understood that pull wire 30 is attached to the right side of deflection section 64 of distal portion 60, which includes articulation layer 80), the second anchor position being (i) laterally offset from the shaft longitudinal axis in a second direction (see fig. 9, and note that pull wire 30 is at the right attachment position) and (ii) angularly offset from the first anchor position by a specified angle (see fig. 9, they are offset from each other by approximately 90 degrees), wherein the first direction is different from the second direction (an upward direction and a rightward direction, respectively, are different); wherein tension on the first pull wire causes the shaft to bend in the first direction ([0060]); and wherein the tension on the second pull wire causes the shaft to bend in the second direction ([0058]); a handle assembly (handle 20, fig. 1) operably attached to the shaft (see fig. 1, the handle 20 and shaft 50 are attached).
Intoccia does not disclose an inner liner or that the articulation support member is disposed between the inner liner and the outer layer. Kauphusman teaches the use of an inner liner (inner liner 24, fig. 3), and that this inner liner is beneficial for creating a lubricious inner lumen which other medical devices can be easily passed through ([0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the inner liner of Kauphusman to the introducer of Intoccia for providing a lubricious inner lumen which other medical devices can be easily passed through (Kauphusman [0031]).
Intoccia as modified by Kauphusman discloses the articulation support member being disposed exterior to the inner liner and outer layer (see Intoccia fig. 9, articulation layer 80 is disposed radially exteriorly to inner shaft 68 which is disposed radially exteriorly to the added inner liner of Kauphusman).
Intoccia as modified by Kauphusman does not disclose that the articulation support member is disposed radially between the inner liner and outer layer. Tegg teaches a steerable introducer (catheter 10, fig. 2) comprising an inner liner (inner layer 34, fig. 4), outer layer (outer layer 44, fig. 4) comprising pull wires (see fig. 5 showing deflection wires 50 and see [0079] and [0089]-[0090]), and articulation support member (second wire reinforcing layer 42, fig. 5). Tegg additionally teaches that its layers can be radially rearranged such that the articulation support member can either be radially between the inner liner and outer layer (see fig. 4, second wire reinforcing layer 42 is shown to be radially between inner layer 34 and outer layer 44) or can be exterior to the inner liner and outer layer and pull wires thereof (see fig. 3, second wire reinforcing layer 42 is shown being radially outside of pull ring 40 which is connected to deflection wires 50 as shown in fig. 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the layers of Intoccia as modified by Kauphusman such that the articulation layer disposed radially between the inner liner and outer layer as claimed as Tegg teaches this arrangement as an art effective equivalent to the arrangement disclosed in Intoccia (see [0084], Tegg teaches that second wire reinforcing layer 42 may be formed over the proximal segment steering mechanism; thus it can also be arranged interior to the proximal segment steering mechanism) and because such a modification would have yielded the same, predictable result of a steerable introducer comprising an inner liner, articulation member, and outer layer having pull wires which can be tensioned to deflect a distal portion of the introducer for steering.
Intoccia as modified by Kauphusman and Tegg discloses that the apertures of the articulation support member can be variably shaped and sized such as to provide desired bending characteristics (Intoccia [0057], “As will be appreciated, the shape, size, geometry (e.g., rounded or squared), and angle of the slots 82 may be uniform or may vary along the length of the articulation layer 80. Similarly, the distance between adjacent slots 82 may be uniform or may vary in order to tailor the bending and torque fidelity characteristics of the distal portion 60 of the flexible shaft 50.”).
Intoccia as modified by Kauphusman and Tegg does not disclose the articulation member wherein each of the one or more apertures is defined by a plurality of arcs, each of the plurality of arcs defined by a radius, wherein a first radius is greater than at least a second radius. McDaniel teaches an articulation member (hinge 40, fig. 5) comprising one or more apertures (slots 44, fig. 5) wherein each of the one or more apertures is defined by a plurality of arcs (see figs. 5 and 7, slots 44 are considered to have 4 arcs as shown in annotated figs. 5 and 7; a first arc which is the top of slot 44, a second arc which is the bottom of slot 44, a third arc which is at the left of slot 44, and a fourth arc which is at the right of slot 44), each of the plurality of arcs defined by a radius (see annotated fig. 7; the first and second arcs appear to have the same radius, and the third and fourth arcs appear to have the same radius), wherein a first radius (the radius for the first and second arcs) is greater than at least a second radius (the radius for the third and fourth arcs; as shown in annotated figs. 5 and 7, the approximated first radius is much greater than the approximated second radius).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of the apertures of Intoccia to have been the shape of the apertures of McDaniel for reducing the tendency of the interior of the introducer to kink (McDaniel [0030]) and for providing bending characteristics of the introducer as desired (McDaniel [0032]-[0037]).
Intoccia as modified discloses the introducer comprising a handle assembly (handle 20, fig. 1) operably attached to the shaft (see fig. 1, the handle 20 and shaft 50 are attached).
Intoccia as modified by Kauphusman, Tegg, and McDaniel does not disclose that the handle assembly comprises at least one stud, wherein at least one of the first pull wire and the second pull wire are anchored to a peg connection, the peg connection located within the at least one stud and operably connected to the stud. Bednarek teaches a handle assembly (assembly of fig. 2) operably attached to a shaft (flexible tubular body 4, fig. 2) of a steerable introducer (catheter 5, fig. 1, which shows body 4 connected to handle 2) wherein the handle assembly comprises at least one stud (slides 30 and 32 are each considered to be studs, see figs. 2 and 4), wherein at least one of a first pull wire and a second pull wire are anchored to a peg connection (see [0063] and [0066], each of a pair of steering pull wires 38 is anchored to a retention screw 42 which is a peg connection), the peg connection located within the at least one stud (see figs. 2 and 10 and see [0066], screws 42 are arranged in slides 30 and 32 in the assembled handle 2) and operably connected to the stud (screws 42 are operatively connected to their respective slides as in [0066] where they anchor their respective wires 38 in the complete assembly).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the pull wire anchoring assembly of Intoccia as modified with the assembly of Bednarek for providing an operator with adequate control, preventing permanent deformation of pull wires, and eliminating the need for conscious maintenance of the catheter at the desired deflection as in Bednarek ([0009]), and further because making such a substitution would have yielded the same, predictable result of a handle assembly which can be operated by a user or a clinician to cause deflection of the pull wires of Intoccia and thus cause deflection of the shaft of the introducer.
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Annotated fig. 7 calling out the approximately equivalent radii of the first and second arcs; note that each slot 44 has each of the 4 respective arcs; for clarity, the first arc (A1), second arc (A2), third arc (A3), and fourth arc (A4) are called out on one slot 44
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Annotated fig. 5 calling out the different radii of the first and third arcs; note that only one first arc and one third arc are called out, but each slot 44 has first through fourth arcs as shown in annotated fig. 7
Regarding claim 22, Intoccia as modified by Kauphusman, Tegg, and McDaniel (henceforth Intoccia as modified) discloses the introducer wherein the specified angle is about 90 degrees (see fig. 9, upward and rightward are 90 degrees apart) and wherein the first direction is perpendicular to the second direction (the upward and rightward directions being separated by approximately 90 degrees provides for them being perpendicular, see fig. 9).
Regarding claim 23, Intoccia as modified discloses the introducer wherein a cross-sectional area of a lumen of the shaft is maintained during bending (see [0057], bending but not collapsing means that the cross-sectional area of the inner shaft 68 is maintained).
Regarding claim 24, Intoccia as modified discloses the introducer further comprising a third pull wire (pull wire 34, fig. 3) and a fourth pull wire (pull wire 32, fig. 3); wherein the third pull wire extends from the proximal end portion of the shaft to the distal end portion of the shaft (see [0055] and [0058]) and is anchored at a third anchor position on the articulation support member (in light of [0050] and fig. 9, it is understood that pull wire 34 is attached to the left side of deflection section 64 of distal portion 60, which includes articulation layer 80), the third anchor position being (i) laterally offset from the shaft longitudinal axis in a third direction (see fig. 9, and note that pull wire 34 is again understood to be at the left attachment position) and (ii) angularly offset from the first anchor position by about 90 degrees (see fig. 9, they are offset from each other by approximately 90 degrees since a direction of upward is about 90 degrees from a direction of leftward); wherein the fourth pull wire extends from the proximal end portion of the shaft to the distal end portion of the shaft (see [0055] and [0060]) and is anchored at a fourth anchor position on the articulation support member (in light of [0051] and fig. 9, it is understood that pull wire 32 is attached to the bottom side of deflection section 66 of distal portion 60, which includes articulation layer 80), the fourth anchor position being (i) laterally offset from the shaft longitudinal axis in a fourth direction (see fig. 9, and note that pull wire 32 is again understood to be at the bottom, or downward, attachment position) and (ii) angularly offset from the second anchor position by about 90 degrees (see fig. 9, they are offset from each other by approximately 90 degrees since a direction of leftward is about 90 degrees from a direction of downward); wherein tension on the third pull wire causes the shaft to bend in the third direction ([0058]); and wherein the tension on the fourth pull wire causes the shaft to bend in the fourth direction ([0060]).
Regarding claim 26, Intoccia as modified discloses the introducer the articulation support member comprises a first region (second deflection section 66, fig. 2b) and a second region (first deflection section 64, fig. 2b); wherein the first region defines a first bending plane (upward and downward along a plane, see [0054] and [0059]); the second region defines a second bending plane (leftward and rightward along a plane, see [0054] and [0056]); and the first bending plane is perpendicular to the second bending plane ([0054]).
Regarding claim 30, Intoccia as modified discloses the introducer wherein the one or more apertures defined in the articulation support member are configured to allow the articulation support member to bend (see McDaniel [0030]-[0037]).
In an alternative interpretation, please see below for claims 21, 23-28, and 30.
Regarding claim 21, Intoccia discloses a steerable introducer (endoscope 10, fig. 1) comprising: a shaft (flexible shaft 50, fig. 1) with a proximal end portion (the half of shaft 50 closer to handle 20, see fig. 1), a distal end portion (half of shaft 50 closer to distal portion 60, fig. 1), and a shaft longitudinal axis (centerline of shaft shown in fig. 1) extending between the proximal end portion and the distal end portion (see fig. 1); a steerable distal tip section (distal end 62 and distal portion 60, fig. 2b) attached to the distal end portion of the shaft (see figs. 1 and 2b), the steerable distal tip section comprising an articulation support member (articulation layer 80, fig. 5) , wherein the articulation support member comprises one or more apertures (slots 82 and 84, fig. 5) defined along the articulation support member (see fig. 5); an outer layer (inner shaft 68, which is an outer layer with respect to working channel 46) comprising one or more minor lumens (smaller lumens 72, 74, 76, 78, fig. 9) for receiving respective one or more pull wires (pull wires 28, 30, 32, 34, fig. 3); and a first pull wire (pull wire 30, fig. 3) extending from the proximal end portion of the shaft to the distal end portion of the shaft (see [0055] and [0058]), wherein the first pull wire is anchored at a first anchor position on the articulation support member (in light of [0050] and fig. 9, it is understood that pull wire 30 is attached to the right side of deflection section 64 of distal portion 60, which includes articulation layer 80), the first anchor position being laterally offset from the shaft longitudinal axis in a first direction (see fig. 9, and note that pull wire 30 is again understood to be at the right attachment position); a second pull wire (pull wire 34, fig. 3) extending from the proximal end portion of the shaft to the distal end portion of the shaft (see [0055] and [0058]), wherein the second pull wire is anchored at a second anchor position on the articulation support member (in light of [0058] and fig. 9, it is understood that pull wire 34 is attached to the left side of deflection section 64 of distal portion 60, which includes articulation layer 80), the second anchor position being (i) laterally offset from the shaft longitudinal axis in a second direction (see fig. 9, and note that pull wire 34 is again understood to be at the left attachment position) and (ii) angularly offset from the first anchor position by a specified angle (see fig. 9, they are offset from each other by approximately 180 degrees), wherein the first direction is different from the second direction (an rightward direction and a leftward direction, respectively, are different); wherein tension on the first pull wire causes the shaft to bend in the first direction ([0058]); and wherein the tension on the second pull wire causes the shaft to bend in the second direction ([0058]); a handle assembly (handle 20, fig. 1) operably attached to the shaft (see fig. 1, the handle 20 and shaft 50 are attached).
Intoccia does not disclose an inner liner or that the articulation support member is disposed between the inner liner and the outer layer. Kauphusman teaches the use of an inner liner (inner liner 24, fig. 3), and that this inner liner is beneficial for creating a lubricious inner lumen which other medical devices can be easily passed through ([0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the inner liner of Kauphusman to the introducer of Intoccia for providing a lubricious inner lumen which other medical devices can be easily passed through (Kauphusman [0031]).
Intoccia as modified by Kauphusman discloses the articulation support member being disposed exterior to the inner liner and outer layer (see Intoccia fig. 9, articulation layer 80 is disposed radially exteriorly to inner shaft 68 which is disposed radially exteriorly to the added inner liner of Kauphusman in the modified device).
Intoccia as modified by Kauphusman does not disclose that the articulation support member is disposed radially between the inner liner and outer layer. Tegg teaches a steerable introducer (catheter 10, fig. 2) comprising an inner liner (inner layer 34, fig. 4), outer layer (outer layer 44, fig. 4) comprising pull wires (see fig. 5 showing deflection wires 50 and see [0079] and [0089]-[0090]), and articulation support member (second wire reinforcing layer 42, fig. 5). Tegg additionally teaches that its layers can be radially rearranged such that the articulation support member can either be radially between the inner liner and outer layer (see fig. 4, second wire reinforcing layer 42 is shown to be radially between inner layer 34 and outer layer 44) or can be exterior to the inner liner and outer layer and pull wires thereof (see fig. 3, second wire reinforcing layer 42 is shown being radially outside of pull ring 40 which is connected to deflection wires 50 as shown in fig. 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the layers of Intoccia as modified by Kauphusman such that the articulation layer disposed radially between the inner liner and outer layer as claimed as Tegg teaches this arrangement as an art effective equivalent to the arrangement disclosed in Intoccia (see [0084], Tegg teaches that second wire reinforcing layer 42 may be formed over the proximal segment steering mechanism; thus it can also be arranged interior to the proximal segment steering mechanism) and because such a modification would have yielded the same, predictable result of a steerable introducer comprising an inner liner, articulation member, and outer layer having pull wires which can be tensioned to deflect a distal portion of the introducer for steering.
Intoccia as modified by Kauphusman and Tegg discloses that the apertures of the articulation support member can be variably shaped and sized such as to provide desired bending characteristics (Intoccia [0057], “As will be appreciated, the shape, size, geometry (e.g., rounded or squared), and angle of the slots 82 may be uniform or may vary along the length of the articulation layer 80. Similarly, the distance between adjacent slots 82 may be uniform or may vary in order to tailor the bending and torque fidelity characteristics of the distal portion 60 of the flexible shaft 50.”).
Intoccia as modified by Kauphusman and Tegg does not disclose the articulation member wherein each of the one or more apertures is defined by a plurality of arcs, each of the plurality of arcs defined by a radius, wherein a first radius is greater than at least a second radius. McDaniel teaches an articulation member (hinge 40, fig. 5) comprising one or more apertures (slots 44, fig. 5) wherein each of the one or more apertures is defined by a plurality of arcs (see figs. 5 and 7, slots 44 are considered to have 4 arcs as shown in annotated figs. 5 and 7; a first arc which is the top of slot 44, a second arc which is the bottom of slot 44, a third arc which is at the left of slot 44, and a fourth arc which is at the right of slot 44), each of the plurality of arcs defined by a radius (see annotated fig. 7; the first and second arcs appear to have the same radius, and the third and fourth arcs appear to have the same radius), wherein a first radius (the radius for the first and second arcs) is greater than at least a second radius (the radius for the third and fourth arcs; as shown in annotated figs. 5 and 7, the approximated first radius is much greater than the approximated second radius).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of the apertures of Intoccia to have been the shape of the apertures of McDaniel for reducing the tendency of the interior of the introducer to kink (McDaniel [0030]) and for providing bending characteristics of the introducer as desired (see McDaniel [0032]-[0037]).
Intoccia as modified discloses the introducer comprising a handle assembly (handle 20, fig. 1) operably attached to the shaft (see fig. 1, the handle 20 and shaft 50 are attached).
Intoccia as modified by Kauphusman, Tegg, and McDaniel does not disclose that the handle assembly comprises at least one stud, wherein at least one of the first pull wire and the second pull wire are anchored to a peg connection, the peg connection located within the at least one stud and operably connected to the stud. Bednarek teaches a handle assembly (assembly of fig. 2) operably attached to a shaft (flexible tubular body 4, fig. 2) of a steerable introducer (catheter 5, fig. 1, which shows body 4 connected to handle 2) wherein the handle assembly comprises at least one stud (slides 30 and 32 are each considered to be studs, see figs. 2 and 4), wherein at least one of a first pull wire and a second pull wire are anchored to a peg connection (see [0063] and [0066], each of a pair of steering pull wires 38 is anchored to a retention screw 42 which is a peg connection), the peg connection located within the at least one stud (see figs. 2 and 10 and see [0066], screws 42 are arranged in slides 30 and 32 in the assembled handle 2) and operably connected to the stud (screws 42 are operatively connected to their respective slides as in [0066] where they anchor their respective wires 38 in the complete assembly).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the pull wire anchoring assembly of Intoccia as modified with the assembly of Bednarek for providing an operator with adequate control, preventing permanent deformation of pull wires, and eliminating the need for conscious maintenance of the catheter at the desired deflection as in Bednarek ([0009]), and further because making such a substitution would have yielded the same, predictable result of a handle assembly which can be operated by a user or a clinician to cause deflection of the pull wires of Intoccia and thus cause deflection of the shaft of the introducer.
Regarding claim 23, Intoccia as modified by Kauphusman, Tegg, and McDaniel (henceforth Intoccia as modified) discloses the introducer wherein a cross-sectional area of a lumen of the shaft is maintained during bending (see [0057], bending but not collapsing means that the cross-sectional area of the inner shaft 68 is maintained).
Regarding claim 24, Intoccia as modified discloses the introducer further comprising a third pull wire (pull wire 28, fig. 3) and a fourth pull wire (pull wire 32, fig. 3); wherein the third pull wire extends from the proximal end portion of the shaft to the distal end portion of the shaft (see [0055] and [0060]) and is anchored at a third anchor position on the articulation support member (in light of [0060] and fig. 9, it is understood that pull wire 28 is attached to the top side of deflection section 66 of distal portion 60, which includes articulation layer 80), the third anchor position being (i) laterally offset from the shaft longitudinal axis in a third direction (see fig. 9, and note that pull wire 28 is again understood to be at the top, or upward, attachment position) and (ii) angularly offset from the first anchor position by about 90 degrees (see fig. 9, they are offset from each other by approximately 90 degrees since a direction of upward is about 90 degrees from a direction of rightward); wherein the fourth pull wire extends from the proximal end portion of the shaft to the distal end portion of the shaft (see [0055] and [0060]) and is anchored at a fourth anchor position on the articulation support member (in light of [0060] and fig. 9, it is understood that pull wire 32 is attached to the bottom side of deflection section 66 of distal portion 60, which includes articulation layer 80), the fourth anchor position being (i) laterally offset from the shaft longitudinal axis in a fourth direction (see fig. 9, and note that pull wire 32 is again understood to be at the bottom, or downward, attachment position) and (ii) angularly offset from the second anchor position by about 90 degrees (see fig. 9, they are offset from each other by approximately 90 degrees since a direction of leftward is about 90 degrees from a direction of downward); wherein tension on the third pull wire causes the shaft to bend in the third direction ([0060]); and wherein the tension on the fourth pull wire causes the shaft to bend in the fourth direction ([0060]).
Regarding claim 25, Intoccia as modified discloses the introducer wherein: the third anchor position is longitudinally offset from the fourth anchor position (in a configuration disclosed in [0060] where pull wire 28 is contracted and pull wire 32 is released and the shaft is deflected upwards, the third anchor position is longitudinally offset from the fourth anchor position relative to handle 20 as the third anchor position is deflected to be closer to the handle and the fourth anchor position is deflected to be further from the handle; this constitutes a longitudinal offset); the first anchor position is longitudinally offset from the third anchor position and the fourth anchor position (see fig. 2b, the first anchor position at deflection section 64 is distal to the third and fourth anchor positions at deflection section 66 which is a longitudinal offset); and the second anchor position is longitudinally offset from the first anchor position and the fourth anchor position (see fig. 2b, the second anchor position at deflection section 64 is distal to the third and fourth anchor positions at deflection section 66 which is a longitudinal offset).
Regarding claim 26, Intoccia as modified discloses the introducer wherein: the articulation support member comprises a first region (second deflection section 66, fig. 2b) and a second region (first deflection section 64, fig. 2b); wherein the first region defines a first bending plane (upward and downward along a plane, see [0054] and [0059]); the second region defines a second bending plane (leftward and rightward along a plane, see [0054] and [0056]); and the first bending plane is perpendicular to the second bending plane ([0054]).
Regarding claim 27, Intoccia as modified discloses the introducer wherein the first anchor position and the second anchor position are located distally with respect to each of the third anchor position and the fourth anchor position (see fig. 2b, the first and second anchor positions at deflection section 64 are distal to the third and fourth anchor positions at deflection section 66 of distal portion 60, which includes articulation layer 80).
Regarding claim 28, Intoccia as modified discloses the introducer wherein a bending plane defined by the first direction and the second direction is perpendicular to a bending plane defined by the third direction and fourth direction (the first claimed bending plane is defined at deflection section 64 and the second claimed bending plane is defined at deflection section 66, and these are perpendicular as shown, see [0055] and figs. 2a and 2b).
Regarding claim 30, Intoccia as modified discloses the introducer wherein the one or more apertures defined in the articulation support member are configured to allow the articulation support member to bend (see McDaniel [0030]-[0037]).
Regarding claim 31, Intoccia discloses a steerable introducer (endoscope 10, fig. 1) comprising: a shaft (flexible shaft 50, fig. 1) with a proximal end portion (the half of shaft 50 closer to handle 20, see fig. 1), a distal end portion (half of shaft 50 closer to distal portion 60, fig. 1), and a shaft longitudinal axis (centerline of shaft shown in fig. 1) extending between the proximal end portion and the distal end portion (see fig. 1); a steerable distal tip section (distal end 62 and distal portion 60, fig. 2b) attached to the distal end portion of the shaft (see figs. 1 and 2b), the steerable distal tip section comprising an articulation support member (articulation layer 80, fig. 5), wherein the articulation support member comprises one or more apertures (slots 82 and 84, fig. 5) defined along the articulation support member (see fig. 5); an outer layer (inner shaft 68, which is an outer layer with respect to working channel 46) comprising one or more minor lumens (smaller lumens 72, 74, 76, 78, fig. 9) for receiving respective one or more pull wires (pull wires 28, 30, 32, 34, fig. 3); and a first (pull wire 30, fig. 3) and second pull wire (pull wire 34, fig. 3) extending from the proximal end portion of the shaft to the distal end portion of the shaft (see [0055] and [0060]), wherein the first and second pull wires are anchored at first and second anchor positions on the articulation support member, respectively (in light of [0050] and fig. 9, it is understood that pull wire 30 is attached to the right side of deflection section 64 of distal portion 60, which includes articulation layer 80; in light of [0058] and fig. 9, it is understood that pull wire 34 is attached to the left side of deflection section 64 of distal portion 60, which includes articulation layer 80), the first and second anchor positions being laterally offset from the shaft longitudinal axis (see fig. 9, and note that pull wire 30 is again understood to be at the right attachment position; see fig. 9, and note that pull wire 34 is again understood to be at the left attachment position); a third (pull wire 28, fig. 3) and fourth pull wire (pull wire 32, fig. 3) extending from the proximal end portion of the shaft to the distal end portion of the shaft (see [0055] and [0060]), wherein the third and fourth pull wires are anchored at third and fourth anchor positions on the articulation support member, respectively (in light of [0060] and fig. 9, it is understood that pull wire 28 is attached to the top side of deflection section 66 of distal portion 60, which includes articulation layer 80; in light of [0060] and fig. 9, it is understood that pull wire 32 is attached to the bottom side of deflection section 66 of distal portion 60, which includes articulation layer 80), the third and fourth anchor positions being (i) laterally offset from the shaft longitudinal axis (see fig. 9, and note that pull wire 28 is again understood to be at the top, or upward, attachment position; see fig. 9, and note that pull wire 32 is again understood to be at the bottom, or downward, attachment position) and (ii) angularly offset from the first and second anchor positions by a specified angle (see fig. 9, the third and fourth wires on the top and bottom are offset from the first and second wires on the left and right by approximately 90 degrees); wherein tension on one of the first and second pull wires causes the shaft to bend in one of a first and second directions ([0058]); and wherein the tension on one of the third and fourth pull wires causes the shaft to bend in one of a third and fourth directions ([0060]); a handle assembly (handle 20, fig. 1) operably attached to the shaft (see fig. 1, the handle 20 and shaft 50 are attached).
Intoccia does not disclose an inner liner or that the articulation support member is disposed between the inner liner and the outer layer. Kauphusman teaches the use of an inner liner (inner liner 24, fig. 3), and that this inner liner is beneficial for creating a lubricious inner lumen which other medical devices can be easily passed through ([0031]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the inner liner of Kauphusman to the introducer of Intoccia for providing a lubricious inner lumen which other medical devices can be easily passed through (Kauphusman [0031]).
Intoccia as modified by Kauphusman discloses the articulation support member being disposed exterior to the inner liner and outer layer (see Intoccia fig. 9, articulation layer 80 is disposed radially exteriorly to inner shaft 68 which is disposed radially exteriorly to the added inner liner of Kauphusman in the modified device).
Intoccia as modified by Kauphusman does not disclose that the articulation support member is disposed radially between the inner liner and outer layer. Tegg teaches a steerable introducer (catheter 10, fig. 2) comprising an inner liner (inner layer 34, fig. 4), outer layer (outer layer 44, fig. 4) comprising pull wires (see fig. 5 showing deflection wires 50 and see [0079] and [0089]-[0090]), and articulation support member (second wire reinforcing layer 42, fig. 5). Tegg additionally teaches that its layers can be radially rearranged such that the articulation support member can either be radially between the inner liner and outer layer (see fig. 4, second wire reinforcing layer 42 is shown to be radially between inner layer 34 and outer layer 44) or can be exterior to the inner liner and outer layer and pull wires thereof (see fig. 3, second wire reinforcing layer 42 is shown being radially outside of pull ring 40 which is connected to deflection wires 50 as shown in fig. 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have rearranged the layers of Intoccia as modified by Kauphusman such that the articulation layer disposed radially between the inner liner and outer layer as claimed as Tegg teaches this arrangement as an art effective equivalent to the arrangement disclosed in Intoccia (see [0084], Tegg teaches that second wire reinforcing layer 42 may be formed over the proximal segment steering mechanism; thus it can also be arranged interior to the proximal segment steering mechanism) and because such a modification would have yielded the same, predictable result of a steerable introducer comprising an inner liner, articulation member, and outer layer having pull wires which can be tensioned to deflect a distal portion of the introducer for steering.
Intoccia as modified by Kauphusman and Tegg discloses that the apertures of the articulation support member can be variably shaped and sized such as to provide desired bending characteristics (Intoccia [0057], “As will be appreciated, the shape, size, geometry (e.g., rounded or squared), and angle of the slots 82 may be uniform or may vary along the length of the articulation layer 80. Similarly, the distance between adjacent slots 82 may be uniform or may vary in order to tailor the bending and torque fidelity characteristics of the distal portion 60 of the flexible shaft 50.”).
Intoccia as modified by Kauphusman and Tegg does not disclose the articulation member wherein each of the one or more apertures is defined by a plurality of arcs, each of the plurality of arcs defined by a radius, wherein a first radius is greater than at least a second radius. McDaniel teaches an articulation member (hinge 40, fig. 5) comprising one or more apertures (slots 44, fig. 5) wherein each of the one or more apertures is defined by a plurality of arcs (see figs. 5 and 7, slots 44 are considered to have 4 arcs as shown in annotated figs. 5 and 7; a first arc which is the top of slot 44, a second arc which is the bottom of slot 44, a third arc which is at the left of slot 44, and a fourth arc which is at the right of slot 44), each of the plurality of arcs defined by a radius (see annotated fig. 7; the first and second arcs appear to have the same radius, and the third and fourth arcs appear to have the same radius), wherein a first radius (the radius for the first and second arcs) is greater than at least a second radius (the radius for the third and fourth arcs; as shown in annotated figs. 5 and 7, the approximated first radius is much greater than the approximated second radius).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shape of the apertures of Intoccia to have been the shape of the apertures of McDaniel for reducing the tendency of the interior of the introducer to kink (McDaniel [0030]) and for providing bending characteristics of the introducer as desired (see McDaniel [0032]-[0037]).
Intoccia as modified discloses the introducer comprising a handle assembly (handle 20, fig. 1) operably attached to the shaft (see fig. 1, the handle 20 and shaft 50 are attached).
Intoccia as modified by Kauphusman, Tegg, and McDaniel does not disclose that the handle assembly comprises at least one stud, wherein at least one of the first pull wire, the second pull wire, the third pull wire, and the fourth pull wire are anchored to a peg connection, the peg connection located within the at least one stud and operably connected to the stud. Bednarek teaches a handle assembly (assembly of fig. 2) operably attached to a shaft (flexible tubular body 4, fig. 2) of a steerable introducer (catheter 5, fig. 1, which shows body 4 connected to handle 2) wherein the handle assembly comprises at least one stud (slides 30 and 32 are each considered to be studs, see figs. 2 and 4), wherein at least one of a first pull wire and a second pull wire are anchored to a peg connection (see [0063] and [0066], each of a pair of steering pull wires 38 is anchored to a retention screw 42 which is a peg connection), the peg connection located within the at least one stud (see figs. 2 and 10 and see [0066], screws 42 are arranged in slides 30 and 32 in the assembled handle 2) and operably connected to the stud (screws 42 are operatively connected to their respective slides as in [0066] where they anchor their respective wires 38 in the complete assembly).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have replaced the pull wire anchoring assembly of Intoccia as modified with the assembly of Bednarek for providing an operator with adequate control, preventing permanent deformation of pull wires, and eliminating the need for conscious maintenance of the catheter at the desired deflection as in Bednarek ([0009]), and further because making such a substitution would have yielded the same, predictable result of a handle assembly which can be operated by a user or a clinician to cause deflection of the pull wires of Intoccia and thus cause deflection of the shaft of the introducer.
Regarding claim 32, Intoccia as modified by Kauphusman, Tegg, and McDaniel (henceforth Intoccia as modified) discloses the introducer wherein the first and second anchor positions are disposed distally with respect to the third and fourth anchor positions, along the articulation support member (see fig. 2b, the first and second anchor positions at deflection section 64 are distal to the third and fourth anchor positions at deflection section 66).
Regarding claim 34, Intoccia as modified discloses the introducer wherein the first and second anchor positions are angularly offset from one another (see fig. 9 and [0058], the positions are understood to be on the left and right sides of deflective section 64, and thus are offset from one another at 180 degrees) and the third and fourth anchor positions are angularly offset from one another (see fig. 9 and [0060], the positions are understood to be on the top and bottom sides of deflective section 66, and thus are offset from one another at 180 degrees).
Regarding claim 35, Intoccia as modified discloses the introducer wherein a first bending plane defined by the first and second direction is perpendicular to a second bending plane defined by the third and fourth direction (the first claimed bending plane is defined at deflection section 64 and the second claimed bending plane is defined at deflection section 66, and these are perpendicular as shown, see [0055] and figs. 2a and 2b).
Regarding claim 36, Intoccia discloses a steerable introducer (endoscope 10, fig. 1) comprising: a shaft (flexible shaft 50, fig. 1) with a proximal end portion (the half of shaft 50 closer to handle 20, see fig. 1), a distal end portion (half of shaft 50 closer to distal portion 60, fig. 1), and a shaft longitudinal axis (centerline of shaft shown in fig. 1) extending between the proximal end portion and the distal end portion (see fig. 1); a steerable distal tip section (distal end 62 and distal portion 60, fig. 2b) attached to the distal end portion of the shaft (see figs. 1 and 2b), the steerable distal tip section comprising an articulation support member (articulation layer 80, fig. 5), wherein the articulation support member comprises one or more apertures (slots 82 and 84, fig. 5) defined along the articulation support member (see fig. 5); an outer layer (inner shaft 68, which is an outer layer with respect to working channel 46) comprising one or more minor lumens (smaller lumens 72, 74, 76, 78, fig. 9) for receiving respective one or more pull wires (pull wires 28, 30, 32, 34, fig. 3); and a first (pull wire 30, fig. 3) and second pull wire (pull wire 34, fig. 3) extending from the proximal end portion of the shaft to the distal end portion of the shaft (see [0055] and [0060]), wherein the first and second pull wires are anchored at first and second anchor positions located on the articulation support member, respectively (in light of [0050] and fig. 9, it is understood that pull wire 30 is attached to the right side of deflection section 64 of distal portion 60, which includes articulation layer 80; in light of [0058] and fig. 9, it is understood that pull wire 34 is attached to the left side of deflection section 64 of distal portion 60, which includes articulation layer 80), the first and second anchor positions being diametrically opposed to one another (see fig. 9, pull wires are shown as being diametrically across from one another, and also since the anchor positions are on the right and left sides, it is understood that they would have been diametrically opposed since a right side is diametrically opposed from a left side); a third (pull wire 28, fig. 3) and fourth pull wire (pull wire 32, fig. 3) extending from the proximal end portion of the shaft to the distal end portion of the shaft (see [0055] and [0060]), wherein the third and fourth pull wires are anchored at third and fourth anchor positions located on the articulation support member, respectively (in light of [0060] and fig. 9, it is understood that pull wire 28 is attached to the top side of deflection section 66 of distal portion 60, which includes articulation layer 80; in light of [0060] and fig. 9, it is