DETAILED ACTION
Response to Amendment
This Office Action is responsive to the amendment filed on 12/23/2025. As indicated by the amendment: claims 1 and 16 have been amended, claim 5 has been cancelled, and new claim 21 has been added. Claims 1-4 and 6-21 are presently pending in the application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-4, 6-8, 10-14 and 16-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hansen et al. (US 2022/0233054 A1) in view of Hinman et al. (US 2005/0273085 A1).
Regarding claim 1, Hansen discloses an articulating joint for an endoscopic device, comprising: a body (Fig. 1) extending longitudinally from a proximal end (14; Fig. 1) to a distal end (9; Fig. 1) and shaped into a plurality of links (8; Fig. 1) including a first link at the proximal end (8 distal 14; Fig. 1), a last link at the distal end (8 proximal 9; Fig. 1), and a plurality of interior links (8) between the first link (8 distal 14; Fig. 1) and the last link (8 proximal 9; Fig. 1), wherein the body is formed as a single tube with gaps formed in the tube (Fig. 2 – gaps between adjacent links 8; par. [0058]), wherein each interior link (8) is connected on a proximal end to a further proximal link (8; Fig. 1) or the first link via first flexible members (15; Fig. 2; par. [0042]) extending longitudinally between the interior link (8) and the further proximal link (8; Figs. 1 and 2) and connected on a distal end to a further distal link (8) or the last link via second flexible members (15; Fig. 2; par. [0042]) extending longitudinally between the interior link (8) and the further distal link (8; Figs. 1 and 2), wherein each interior link (8) is shaped so that: [[a]] proximal gaps are (Fig. 2 – gaps formed between the proximal side of an interior link and the distal side of an adjacent proximal link on either side of the flexible member) formed between the interior link and the further proximal link to permit the interior link to rotate toward the further proximal link or vice versa and [[a]] distal gaps are (Fig. 2 – gaps formed between the distal side of an interior link and the proximal side of an adjacent distal link on either side of the flexible member) is formed between the interior link and the further distal link to permit the further distal link to rotate toward the interior link or vice versa, and at least one pull wire (11; Fig. 2; par. [0043]) extending longitudinally through the plurality of links (8) from the proximal end to the distal end (Fig. 1), wherein applying tension to the pull wire causes at least one link to rotate toward another link about the transverse axis and articulate the articulating joint (abstract, par. [0004]).
Although Hansen teaches first and second flexible members, it does not specifically disclose a recess is formed on both sides of each of the flexible members to permit the flexible members to bend and permit rotation between the interior links about a transverse axis, wherein each recess is continuous with a respective gap and extends from the respective gap in only a distal direction. Various configurations of hinge members for connecting links in an articulating joint for endoscopic devices are well-known in the art. Hinman teaches an analogous articulating joint for an endoscopic device having a variety of different configurations of flexible hinge members (246/266/286; Figs. 3A-5C; par. [0044]-[0056]). Hinman teaches that flexible hinge members without recesses (Fig. 4A), like that of Hansen. Hinman also teaches flexible hinge members (286) with recesses (Fig. 5A), such a recess is formed on both sides of the flexible members (Fig. 5A-5B) to permit the flexible members to bend and permit rotation between the interior links about a transverse axis, wherein each recess is continuous with a respective gap (Fig. 5A-5B) and extends from the respective gap in only one direction (Fig. 5A-5B). Hinman teaches using this configuration of a flexible hinge member when it is desirable to control the degree of bending (par. [0046]). It would have been obvious to one having ordinary skill in the art to substitute a flexible hinge member of Hinman for the flexible hinge member of Hansen, being a simple substitution of one known hinge member of another, having the predictable result of aiding the links to rotate when the joint is articulation. Moreover, such modification provides increased control over the degree of bending, as taught by Hinman.
Regarding claim 2, Hansen in view of Hinman disclose the articulating joint of claim 1, wherein progressively applying further tension to the pull wire causes further links to rotate and further articulate the articulating joint into a desired shape or to a desired curvature (abstract, par. [0004], [0043] and [0050]).
Regarding claim 3, Hansen in view of Hinman disclose the articulating joint of claim 1, wherein a size and a shape of the links and a size and a shape of the flexible members are selected to permit bending of the flexible members up to a maximum curvature when the tension is applied to the pull wire (Figs. 1 and 2; abstract, par. [0004] and [0043]; Hinman: par. [0044]-[0046]).
Regarding claim 4, Hansen in view of Hinman disclose the articulating joint of claim 3, wherein the maximum curvature of the flexible members is selected so that elastic deformation is maintained during articulation (abstract, par. [0004] and [0043]; Hinman: par. [0044]-[0046]).
Regarding claim 6, Hansen in view of Hinman disclose the articulating joint of claim 3, wherein a size and a shape of the gaps and a size and a shape of the recesses are selected so that a given link is able to rotate only until the link contacts an adjacent proximal link and the maximum curvature is achieved (abstract, par. [0004], [0043] and [0050]; Hinman: par. [0044]-[0046]), whereupon the adjacent proximal link can rotate until it contacts a further adjacent proximal link (abstract, par. [0004], [0043] and [0050]; Hinman: par. [0044]-[0046]).
Regarding claim 7, Hansen in view of Hinman disclose the articulating joint of claim 1. Hansen teaches the articulating joint is made from a polymer by injection molding (par. [0058]). Hinman also teaches its articulating joint is made from a polymer (par. [0052]). Hansen does not specifically disclose wherein the proximal and distal gaps and the recesses are formed by laser cutting the tube. At the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to laser cut the tube because Applicant has not disclosed that spacing the laser cutting the tube provides an advantage, is used for a particular purpose, or solves a stated problem. Applicant explicitly states that the articulating joints according to the disclosed embodiments may be formed using any of a variety of manufacturing techniques including, e.g., micro-molding, 3D printing, extrusion, and/or laser cutting (see par. [0052] of the published application). One of ordinary skill in the art, furthermore, would have expected Hansen’s articulating joint, and applicant’s invention, to perform equally well with either the manufacturing technique taught by Hansen or the claimed laser cutting technique because both manufacturing techniques would perform the same function of shaping the tube into the desired configuration of gaps and recesses. Therefore, it would have been prima facie obvious to modify Hansen to obtain the invention as specified in claim 7 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Hansen.
Regarding claim 8, Hansen in view of Hinman disclose the articulating joint of claim 7, but does not specifically disclose wherein the tube is formed of stainless-steel. At the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to form the tube out of stainless-steel because Applicant has not disclosed that spacing the stainless-steel tube provides an advantage, is used for a particular purpose, or solves a stated problem. Applicant explicitly states that the articulating joint can be formed from materials including, e.g., stainless-steel, Nitinol, plastics, polymers (e.g., PEBAX®, Polyurethane, Polyamide or PEEK), or other materials (see par. [0052] of the published application). One of ordinary skill in the art, furthermore, would have expected Hansen’s articulating joint, and applicant’s invention, to perform equally well with either the material taught by Hansen or the claimed stainless-steel because both materials would perform the same function of forming the articulating joint. Therefore, it would have been prima facie obvious to modify Hansen to obtain the invention as specified in claim 8 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Hansen.
Regarding claim 10, Hansen in view of Hinman disclose the articulating joint of claim 1, but does not specifically disclose wherein the interior links include further gaps on a circumference of the link forming a crimp. At the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to include gaps on the circumference of the link forming a crimp to create a pull wire lumen because Applicant has not disclosed that gaps on the circumference of the link forming a crimp provides an advantage, is used for a particular purpose, or solves a stated problem. Applicant discloses that a pull wire lumen (120/220; Figs. 4 and 9) can be formed using a crimp (Figs. 3 and 4; see par. [0065] of the published application) or without a crimp (Figs. 8 and 9; see par. [0067] and [0071] of the published application). One of ordinary skill in the art, furthermore, would have expected Hansen’s articulating joint, and applicant’s invention, to perform equally well with either the lumen formed without a crimp by Hansen or the claimed crimp providing the lumen because both configurations would perform the same function of providing a pull wire lumen. Therefore, it would have been prima facie obvious to modify Hansen to obtain the invention as specified in claim 10 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Hansen.
Regarding claim 11, Hansen in view of Hinman disclose the articulating joint of claim 1, wherein a profile of the links and the flexible members are selected based on at least one of a desired bending radius, an articulating force, an articulating angle, or a coplanarity of the articulating joint (abstract, par. [0004] and [0043]; Hinman: par. [0044]-[0046]).
Regarding claim 12, Hansen in view of Hinman disclose the articulating joint of claim 1, wherein a profile of the links and the flexible members are selected so that cyclic stresses imposed during articulation of the articulating joint are insufficient to cause failure of the articulating joint (abstract, par. [0004] and [0043]; Hinman: par. [0044]-[0046]).
Regarding claim 13, Hansen in view of Hinman disclose the articulating joint of claim 1, further comprising lumens (19; par. [0044] and [0046]; Fig. 6) extending through the links (8) offset from a longitudinal axis of the links (Figs. 2 and 6), wherein the pull wire (11) is run through the lumens (19; par. [0044]) so that applying the tension to the pull wire applies a bending force to the links (abstract, par. [0004], [0043] and [0050]; Hinman: par. [0044]-[0046]).
Regarding claim 14, Hansen in view of Hinman disclose the articulating joint of claim 1, wherein the body is formed from one of Nitinol, a plastic, or a polymer and from one of a micro-molding, 3D printing, or and extrusion process (par. [0058]; Hinman: par. [0052]).
Regarding claim 16, Hansen discloses a method for an endoscopic procedure, comprising: guiding an endoscopic device to a target site (par. [0005]), the endoscopic device including an articulating joint (Fig. 1) comprising a body (Fig. 1) extending longitudinally from a proximal end (14; Fig. 1) to a distal end (9; Fig. 1) and shaped into a plurality of links (8; Fig. 1) including a first link at the proximal end (8 distal 14; Fig. 1), a last link at the distal end (8 proximal 9; Fig. 1), and a plurality of interior links (8) between the first link (8 distal 14; Fig. 1) and the last link (8 proximal 9; Fig. 1), wherein the body is formed as a single tube with gaps formed in the tube (Fig. 2 – gaps between adjacent links 8; par. [0058]), wherein each interior link (8) is connected on a proximal end to a further proximal link (8; Fig. 1) or the first link via first flexible members (15; Fig. 2; par. [0042]) extending longitudinally between the interior link (8) and the further proximal link (8; Figs. 1 and 2) and connected on a distal end to a further distal link (8) or the last link via second flexible members (15; Fig. 2; par. [0042]) extending longitudinally between the interior link (8) and the further distal link (8; Figs. 1 and 2), wherein each flexible member (15) extends parallel to a longitudinal axis of the body along an entire length of the flexible member (Figs. 1 and 2), wherein each interior link (8) is shaped so that a proximal gap is (Fig. 2 – gap formed between the proximal side of an interior link and the distal side of an adjacent proximal link) formed between the interior link and the further proximal link to permit the interior link to rotate toward the further proximal link or vice versa and a distal gap is (Fig. 2 – gap formed between the distal side of an interior link and the proximal side of an adjacent distal link) is formed between the interior link and the further distal link to permit the further distal link to rotate toward the interior link or vice versa, and at least one pull wire (11; Fig. 2; par. [0043]) extending longitudinally through the plurality of links (8) from the proximal end to the distal end (Fig. 1), and applying tension to the pull wire causes at least one link to rotate toward another link about the transverse axis and articulate the articulating joint (abstract, par. [0004]).
Although Hansen teaches first and second flexible members, it does not specifically disclose a recess is formed on both sides of each of the flexible members to permit the flexible members to bend and permit rotation between the interior links about a transverse axis. Various configurations of hinge members for connecting links in an articulating joint for endoscopic devices are well-known in the art. Hinman teaches an analogous articulating joint for an endoscopic device having a variety of different configurations of flexible hinge members (246/266/286; Figs. 3A-5C; par. [0044]-[0056]). Hinman teaches that flexible hinge members without recesses (Fig. 4A), like that of Hansen. Hinman also teaches flexible hinge members (286) with recesses (Fig. 5A), such a recess is formed on both sides of the flexible members (Fig. 5A-5B) to permit the flexible members to bend and permit rotation between the interior links about a transverse axis, wherein each recess is continuous with a respective gap (Fig. 5A-5B) and extends from the respective gap in only one direction (Fig. 5A-5B). Hinman teaches using this configuration of a flexible hinge member when it is desirable to control the degree of bending (par. [0046]). It would have been obvious to one having ordinary skill in the art to substitute a flexible hinge member of Hinman for the flexible hinge member of Hansen, being a simple substitution of one known hinge member of another, having the predictable result of aiding the links to rotate when the joint is articulation. Moreover, such modification provides increased control over the degree of bending, as taught by Hinman.
Regarding claim 17, Hansen in view of Hinman disclose the method of claim 16, wherein progressively applying further tension to the pull wire causes further links to rotate and further articulate the articulating joint into a desired shape or to a desired curvature (abstract, par. [0004], [0043] and [0050]).
Regarding claim 18, Hansen in view of Hinman disclose the method of claim 16, wherein a size and a shape of the links and a size and a shape of the flexible members are selected to permit bending of the flexible members up to a maximum curvature when the tension is applied to the pull wire (Figs. 1 and 2; abstract, par. [0004] and [0043]; Hinman: par. [0044]-[0046]).
Regarding claim 19, Hansen in view of Hinman disclose the method of claim 18, wherein a size and a shape of the gaps and a size and a shape of the recesses are selected so that a given link is able to rotate only until the link contacts an adjacent proximal link and the maximum curvature is achieved (abstract, par. [0004], [0043] and [0050]; Hinman: par. [0044]-[0046]), whereupon the adjacent proximal link can rotate until it contacts a further adjacent proximal link (abstract, par. [0004], [0043] and [0050]; Hinman: par. [0044]-[0046]).
Regarding claim 20, Hansen in view of Hinman disclose the method of claim 19, but does not specifically disclose wherein the tube is formed of stainless-steel. Hansen teaches the articulating joint is made from a polymer by injection molding (par. [0058]). Hinman also teaches its articulating joint is made from a polymer (par. [0052]). Hansen does not specifically disclose wherein the proximal and distal gaps and the recesses are formed by laser cutting the tube. At the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to form the tube from stainless steel and laser cut the tube because Applicant has not disclosed that spacing using stainless-steel and laser cutting the tube provides an advantage, is used for a particular purpose, or solves a stated problem. Applicant explicitly states that the articulating joint can be formed from materials including, e.g., stainless-steel, Nitinol, plastics, polymers (e.g., PEBAX®, Polyurethane, Polyamide or PEEK), or other materials (see par. [0052] of the published application). Applicant also explicitly states that the articulating joints according to the disclosed embodiments may be formed using any of a variety of manufacturing techniques including, e.g., micro-molding, 3D printing, extrusion, and/or laser cutting (see par. [0052] of the published application). One of ordinary skill in the art, furthermore, would have expected Hansen’s articulating joint, and applicant’s invention, to perform equally well with either the material and manufacturing technique taught by Hansen or the claimed stainless-steel material and laser cutting technique because both materials manufacturing techniques would perform the same function of forming and shaping the tube into the desired configuration of gaps and recesses. Therefore, it would have been prima facie obvious to modify Hansen to obtain the invention as specified in claim 20 because such a modification would have been considered a mere design consideration which fails to patentably distinguish over the prior art of Hansen.
Regarding claim 21, Hansen in view of Hinman disclose the articulating joint of claim 1, wherein each flexible member (15) extends parallel to a longitudinal axis of the body along an entire length of the flexible member (Figs. 1 and 2).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hansen in view of Hinman as applied to the claims above, and further in view of Gareiss et al. (US 2022/0133335 A1).
Regarding claim 9, Hansen in view of Hinman disclose the articulating joint of claim 7, but does not specifically disclose wherein the tube is annealed before or after the laser cutting to increase the flexibility of the flexible members. Gareiss teaches an analogous articulating joint (104) that is made from stainless-steel (par. [0061]). Gareiss teaches that the articulating joint can be formed from various stainless-steels including an annealed stainless steel (par. [0061]). It is well known in the art that annealing stainless-steel makes it easy to deform. Thus, it would have been obvious to one having ordinary skill in the art to anneal the stainless-steel tube of modified Hansen in order to make the articulating joint easier to deform thereby improving flexibility and maneuverability of the device as it navigates the body.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hansen in view of Hinman as applied to the claims above, and further in view of Hansen (US 2024/0225428 A1, hereinafter referred to as “Hansen-2”).
Regarding claim 15, Hansen in view of Hinman disclose the articulating joint of claim 1, but does not specifically disclose wherein a profile of the links and the flexible members are selected so that articulation causes the distal end of the articulating joint to rotate 180 degrees into a cane shape, rotate 270 degrees into a P shape, or rotate 360 degrees into an O shape. Hansen-2 teaches an analogous articulating joint (Figs 2-3) wherein a profile of the links (20; Fig. 3) and the flexible members (28; Fig. 3) are selected so that articulation causes the distal end of the articulating joint to rotate 180 degrees into a cane shape, rotate 270 degrees into a P shape, or rotate 360 degrees into an O shape (par. [0081]-[0082]; Figs. 4-5). Hansen-2 teaches that the lengths and widths of flexible members (28) can remain constant or can be varied from the proximal end of the bending section to the distal end of the bending section to achieve a variety of bending angles (par. [0081]-[0082]; Figs. 4-5). It would have been obvious to one having ordinary skill in the art to modify the length and width of the flexible members from the proximal end of the bending section to the distal end of the bending section in order to achieve the desired bending angle, as taught by Hansen-2, thereby improving navigation through tortuous pathways.
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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.
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.
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/RYNAE E BOLER/Examiner, Art Unit 3795
/ANH TUAN T NGUYEN/Supervisory Patent Examiner, Art Unit 3795
1/29/26