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 .
Notice of Amendment
The Amendment filed 1/14/2026 has been entered. Claims 1, 6, 7, 9, 10, 12-19, 21-28 are pending in the application with claims 1, 6, 7, 9, 13, 16, 17, amended, claims 2-5, 8, 11, 20 cancelled, and claims 21-28 newly added. The previous 35 USC 112 rejection of claim 19 has been withdrawn.
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.
Claims 1, 6, 9, 10, 12-19, 21-23 and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Hinman et al. (US Patent Application Publication No. 2005/0273085, hereinafter Hinman) in view of Salahieh et al. (US Patent Application Publication No. 2012/0277730, hereinafter Salahieh).
In regard to claim 1, Hinman discloses a medical device (100, Figs. 1A,1B), comprising:
a shaft (100), wherein the shaft has a corrugated body (122), and wherein the body includes:
a plurality of hoops (102, 104, 106) extending around an entire circumference of the body (Figs. 1A-1B);
a plurality of indentations (via gaps/cutouts between the links/hoops (102,104,106), Figs. 1A-1B), wherein the plurality of indentations extend around a portion of the circumference of the body (Figs. 1A-1B, the gaps/cutouts extend between hinge portions (108,110)), and wherein each of the plurality of hoops is spaced apart from an adjacent hoop of the plurality of hoops by at least one of the plurality of indentations (Figs. 1A-1B); and
a plurality of nodes (108,110), wherein each node extends between and connects adjacent hoops of the plurality of hoops (Figs. 1A-1B),
wherein each hoop of the plurality of hoops has a centerline extending around the corrugated body, wherein, between nodes of the plurality of nodes, the centerline has a first portion that is proximal of a second portion of the centerline (Figs. 1A-1B illustrate the centerline of each of hoops (102,104,106) having first and second portions which meet the claim limitation).
Hinman does not expressly teach the shaft having a corrugated body and the plurality of indentations of the corrugated body defining a reduced-diameter portion of the corrugated body relative to a diameter of the plurality of hoops.
Salahieh teaches an analogous steerable medical device having a steerable/bendable shaft, wherein Salahieh teaches of a plurality of embodiment in which the steerable/bendable shaft can be formed. A first embodiment teaches a tubular shaft (80) formed of a plurality of hoops/rings connected together via a spine/nodes (80) shown in Fig. 5 and a spine/nodes shown in Fig. 6 with cutouts disposed between the spine/nodes separating the hoops/rings. Alternatively, Salahieh teaches the tubular portion (210) of Figs. 12A-12B having a plurality of hoops/rings connected to teach other via spine (216) and teaches the hoops/rings can be separated from each other via grooves (212, i.e. reduced diameter portion) instead of cutouts thereby forming a fluid tight barrier and lubricious liner (Par. 100).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the shaft body (122) of Hinman with grooves instead of cutouts as taught by Salahieh as a matter of design choice since Salahieh teaches of forming tubular members with cutout between adjacent hoops/rings and alternatively grooves between adjacent hoops/rings, wherein forming the tubular member with grooves between adjacent hoops/rings provides a fluid tight barrier and lubricious liner (Par. 100).
In regard to claim 16, Hinman discloses a medical device (100, Figs. 1A-1B), comprising:
a shaft (100) including;
a plurality of hoops (102, 104, 106) extending around an entire circumference of the shaft (Figs. 1A-1B), and
a plurality of indentations (via gaps/cutouts between the links/hoops (102,104,106), Figs. 1A-1B), wherein adjacent hoops of the plurality of hoops are spaced apart from one another by a pair of indentations (Figs. 1A-1B),
wherein each of the plurality of indentations spans less than 180° around a circumference of the shaft (Figs. 1A-1B of Hinman illustrate the indentations connected via a pair of nodes therefore each indentation extends less than 180° around a circumference of the shaft),
wherein a first indentation of a pair of indentations is separated from a second indentation of the pair of indentations by two nodes (108,108 or 110,110) extending between and connecting adjacent hoops of the plurality of hoops (Figs. 1A-1B),
wherein, adjacent to the two nodes, centerlines of the adjacent hoops are separated by a first distance, wherein, midway between the two nodes, the centerlines of the adjacent hoops are separated by a second distance, and wherein the second distance is greater than the first distance (Figs. 1A-1B illustrate a distance between centerlines of the hoops (102,104,106) adjacent a node is less than a distance between centerlines of the hoops at a midway point between nodes).
Hinman does not expressly teach the shaft being a corrugated shaft.
Salahieh teaches an analogous steerable medical device having a steerable/bendable shaft, wherein Salahieh teaches of a plurality of embodiment in which the steerable/bendable shaft can be formed. A first embodiment teaches a tubular shaft (80) formed of a plurality of hoops/rings connected together via a spine/nodes (80) shown in Fig. 5 and a spine/nodes shown in Fig. 6 with cutouts disposed between the spine/nodes separating the hoops/rings. Alternatively, Salahieh teaches the tubular portion (210) of Figs. 12A-12B having a plurality of hoops/rings connected to teach other via spine (216) and teaches the hoops/rings can be separated from each other via grooves (212, i.e. reduced diameter portion) instead of cutouts thereby forming a fluid tight barrier and lubricious liner (Par. 100).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the shaft body (122) of Hinman with grooves instead of cutouts as taught by Salahieh as a matter of design choice since Salahieh teaches of forming tubular members with cutout between adjacent hoops/rings and alternatively grooves between adjacent hoops/rings, wherein forming the tubular member with grooves between adjacent hoops/rings provides a fluid tight barrier and lubricious liner (Par. 100).
In regard to claim 6, Hinman teaches wherein each indentation of the plurality of indentations extends around less than 50% of the circumference of the shaft, and wherein adjacent hoops of the plurality of hoops are separated by a pair of indentations and are connected to one another by a pair of nodes of the plurality of nodes (Figs. 1A-1B of Hinman illustrate the indentations connected via a pair of nodes therefore each indentation extends less than 50% of the circumference of the shaft).
In regard to claims 9 and 17, Hinman teaches wherein each hoop of the corrugated body plurality of hoops further includes at least a first set of openings aligned along a first plane and a second set of openings aligned along a second plane, wherein the first set of openings and the second set of openings are each configured to receive at least one steering wire (Figs. 1A-1B illustrate a plurality of openings extending through the corrugated body which receive steering wires therethrough, with the sets of openings formed along different planes).
In regard to claim 10, Hinman teaches wherein the corrugated body is configured to articulate along two planes, in four different directions (the corrugated body can articulate in two planes, four different directions due to the 90° offset relationship of the hinges (108,110), Figs. 1A-1B).
In regard to claim 12, Hinman teaches further comprising a first end including a first connective portion and a second end including a second connective portion (Hinman teaches the shaft can form a medical instrument having an end effector at the distal end and a handle at the proximal end as shown in Fig. 8A).
In regard to claim 13, Hinman teaches wherein the corrugated body is an articulation joint configured to be connected to an end effector (Fig. 8A).
In regard to claim 14, Hinman and Salahieh teaches wherein a pitch of each of the plurality of indentations is perpendicular relative to a central longitudinal axis of the shaft (Figs. 12A-12B of Salahieh illustrate the pitch of the groove (i.e. indentations) being perpendicular to the central longitudinal axis).
In regard to claim 15, Hinman teaches wherein the corrugated body comprises a thermoplastic resin (Par. 52, such as polyethylene).
In regard to claim 18, Hinman teaches wherein each of the plurality of indentations spans greater than 160° but less than 180° around the circumference of the shaft (Figs. 1A-1B).
In regard to claim 19, Hinman teaches wherein the corrugated shaft further includes a lumen and a wall surrounding the lumen, wherein a thickness of the wall is about 5 to about 30 thou (Hinman teaches of the shaft having a diameter between 0.5 mm (0.019 inch) to 15mm and therefore can have a wall thickness between 5 to about 30 (0.03inch) thou, Par. 51).
In regard to claim 21, Hinman teaches wherein a centerline of each hoop is not circular (Figs. 1A-1B).
In regard to claim 22, Hinman teaches wherein the centerlines of the adjacent hoops of the plurality of hoops are (a) closer to one another at nodes (108) of the plurality of nodes that connect the adjacent hoops and (b) further from one another between the nodes (110) of the plurality of nodes that connect the adjacent hoops (Figs. 1A-1B).
In regard to claim 23, Hinman discloses wherein a first hoop (106) of the plurality of hoops is proximal of a second hoop (104) of the plurality of hoops, wherein the second hoop is proximal of a third hoop (102) of the plurality of hoops (Figs. 1A-1B), wherein the first hoop is connected to the second hoop by a first node (110) and a second node (110) of the plurality of nodes, wherein the second hoop is connected to the third hoop by a third node (108) and a fourth node (108) of the plurality of nodes, wherein a first portion of the second hoop extends between the first node and the third node, a second portion of the second hoop extends between the third node and the second node, a third portion of the second hoop extends between the second node and the fourth node, and a fourth portion of the second hoop extends between the fourth node and the first node, wherein the first portion of the second hoop has a non-zero angle relative to the second portion of the second hoop, wherein the second portion of the second hoop has a non-zero angle relative to the third portion of the second hoop, and wherein the third portion of the second hoop has a non-zero angle relative to the fourth portion of the second hoop (the first to fourth portions of the second hoop would satisfy the claim limitations based on Fig. 1B).
In regard to claim 25, Hinman teaches wherein a distalmost end of the first node is proximal of a proximalmost end of the third node (Fig. 1B).
In regard to claim 26, Hinman teaches wherein each hoop of the plurality of hoops does not define a plane (Figs. 1A-1B).
In regard to claim 27, Hinman teaches wherein the centerlines of the adjacent hoops are not circular (Figs. 1A-1B).
Claims 1, 6, 7, 12-16, 18 and 21-28 are rejected under 35 U.S.C. 103 as being unpatentable over Boulais (US Patent Application Publication No. 2012/0245418) in view of Salahieh et al. (US Patent Application Publication No. 2012/0277730, hereinafter Salahieh).
In regard to claim 1, Boulais discloses a medical device (300, Fig. 6), comprising:
a shaft (300), wherein the shaft has a body (300), and wherein the body includes:
a plurality of hoops (the hoops are defined as the circumferential sections of the body that contain slots (314)) extending around an entire circumference of the body (Fig. 6);
a plurality of indentations (310, via cutouts between the hoops), wherein the plurality of indentations extend around a portion of the circumference of the body (Fig. 6), and wherein each of the plurality of hoops is spaced apart from an adjacent hoop of the plurality of hoops by at least one of the plurality of indentations (Fig. 6); and
a plurality of nodes (the nodes are defined as sections in which adjacent circumferentially extending indentation (310) meet forming a hinge point), wherein each node extends between and connects adjacent hoops of the plurality of hoops (Fig. 6),
wherein each hoop of the plurality of hoops has a centerline extending around the corrugated body, wherein, between nodes of the plurality of nodes, the centerline has a first portion that is proximal of a second portion of the centerline (Figs. 3B, 6, wherein Fig. 3B shows a better view illustrating the centerline having first and second portions with the first portion being proximal than a second portion of the centerline).
Boulais does not expressly teach the shaft having a corrugated body and the plurality of indentations of the corrugated body defining a reduced-diameter portion of the corrugated body relative to a diameter of the plurality of hoops.
Salahieh teaches an analogous steerable medical device having a steerable/bendable shaft, wherein Salahieh teaches of a plurality of embodiment in which the steerable/bendable shaft can be formed. A first embodiment teaches a tubular shaft (80) formed of a plurality of hoops/rings connected together via a spine/nodes (80) shown in Fig. 5 and a spine/nodes shown in Fig. 6 with cutouts disposed between the spine/nodes separating the hoops/rings. Alternatively, Salahieh teaches the tubular portion (210) of Figs. 12A-12B having a plurality of hoops/rings connected to teach other via spine (216) and teaches the hoops/rings can be separated from each other via grooves (212, i.e. reduced diameter portion) instead of cutouts thereby forming a fluid tight barrier and lubricious liner (Par. 100).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the shaft body (300) of Boulais with grooves instead of cutouts as taught by Salahieh as a matter of design choice since Salahieh teaches of forming tubular members with cutout between adjacent hoops/rings and alternatively grooves between adjacent hoops/rings, wherein forming the tubular member with grooves between adjacent hoops/rings provides a fluid tight barrier and lubricious liner (Par. 100).
In regard to claim 16, Boulais discloses a medical device (300, Fig. 6), comprising:
a shaft (300) including;
a plurality of hoops (the hoops are defined as the circumferential sections of the body that contain slots (314)) extending around an entire circumference of the shaft (Fig. 6), and
a plurality of indentations (310), wherein adjacent hoops of the plurality of hoops are spaced apart from one another by a pair of indentations (Fig. 6),
wherein each of the plurality of indentations spans less than 180° around a circumference of the shaft (Fig. 6),
wherein a first indentation of a pair of indentations is separated from a second indentation of the pair of indentations by two nodes (the nodes are defined as sections in which adjacent circumferentially extending indentation (310) meet forming a hinge point) extending between and connecting adjacent hoops of the plurality of hoops (Fig. 6),
wherein, adjacent to the two nodes, centerlines of the adjacent hoops are separated by a first distance, wherein, midway between the two nodes, the centerlines of the adjacent hoops are separated by a second distance, and wherein the second distance is greater than the first distance (Figs. 3B,6 illustrate a distance between centerlines of the hoops adjacent a node is less than a distance between centerlines of the hoops at a midway point between nodes).
Boulais does not expressly teach the shaft being a corrugated shaft.
Salahieh teaches an analogous steerable medical device having a steerable/bendable shaft, wherein Salahieh teaches of a plurality of embodiment in which the steerable/bendable shaft can be formed. A first embodiment teaches a tubular shaft (80) formed of a plurality of hoops/rings connected together via a spine/nodes (80) shown in Fig. 5 and a spine/nodes shown in Fig. 6 with cutouts disposed between the spine/nodes separating the hoops/rings. Alternatively, Salahieh teaches the tubular portion (210) of Figs. 12A-12B having a plurality of hoops/rings connected to teach other via spine (216) and teaches the hoops/rings can be separated from each other via grooves (212, i.e. reduced diameter portion) instead of cutouts thereby forming a fluid tight barrier and lubricious liner (Par. 100).
It would’ve been obvious to one of ordinary skill in the art at the effective filing date of the invention to modify the shaft body (300) of Boulais with grooves instead of cutouts as taught by Salahieh as a matter of design choice since Salahieh teaches of forming tubular members with cutout between adjacent hoops/rings and alternatively grooves between adjacent hoops/rings, wherein forming the tubular member with grooves between adjacent hoops/rings provides a fluid tight barrier and lubricious liner (Par. 100).
In regard to claim 6, Boulais teaches wherein each indentation of the plurality of indentations extends around less than 50% of the circumference of the shaft, and wherein adjacent hoops of the plurality of hoops are separated by a pair of indentations and are connected to one another by a pair of nodes of the plurality of nodes (Fig. 6).
In regard to claim 7, Boulais teaches wherein each indentation of the plurality of indentations are includes two V-shaped radially inwards portions, wherein each of the V-shaped portions is narrower adjacent to the a node of the pair of nodes and wider in between the pair of nodes (Figs. 3B,6).
In regard to claim 12, Boulais teaches further comprising a first end including a first connective portion and a second end including a second connective portion (Proximal and distal ends of the shaft body (300), Fig. 6).
In regard to claim 13, Boulais teaches wherein the corrugated body is an articulation joint configured to be connected to an end effector (the corrugated body is capable of forming a shaft of an end effector).
In regard to claim 14, Boulais and Salahieh teaches wherein a pitch of each of the plurality of indentations is perpendicular relative to a central longitudinal axis of the shaft (Figs. 12A-12B of Salahieh illustrate the pitch of the groove (i.e. indentations) being perpendicular to the central longitudinal axis).
In regard to claim 15, Boulais teaches wherein the corrugated body comprises a thermoplastic resin (Par. 42).
In regard to claim 18, Boulais teaches wherein each of the plurality of indentations spans greater than 160° but less than 180° around the circumference of the shaft (Fig. 6).
In regard to claim 21, Boulais teaches wherein a centerline of each hoop is not circular (Fig. 6).
In regard to claim 22, Boulais teaches wherein the centerlines of the adjacent hoops of the plurality of hoops are (a) closer to one another at nodes of the plurality of nodes that connect the adjacent hoops and (b) further from one another between the nodes of the plurality of nodes that connect the adjacent hoops (Fig. 6).
In regard to claim 23, Boulais discloses wherein a first hoop of the plurality of hoops is proximal of a second hoop of the plurality of hoops, wherein the second hoop is proximal of a third hoop of the plurality of hoops, wherein the first hoop is connected to the second hoop by a first node and a second node of the plurality of nodes, wherein the second hoop is connected to the third hoop by a third node and a fourth node of the plurality of nodes, wherein a first portion of the second hoop extends between the first node and the third node, a second portion of the second hoop extends between the third node and the second node, a third portion of the second hoop extends between the second node and the fourth node, and a fourth portion of the second hoop extends between the fourth node and the first node, wherein the first portion of the second hoop has a non-zero angle relative to the second portion of the second hoop, wherein the second portion of the second hoop has a non-zero angle relative to the third portion of the second hoop, and wherein the third portion of the second hoop has a non-zero angle relative to the fourth portion of the second hoop (see annotated Fig. 6 below, wherein the V-shaped nature of the indentations cause the first and second portions to have a non-zero angle relative to each other, the second and third portions to have a non-zero angle relative to each other and the third and fourth portions to have a non-zero angle relative to each other).
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In regard to claim 24, Boulais teaches wherein the first portion of the second hoop and the third portion of the second hoop are parallel to one another (the first and third portions would be parallel, Fig. 6).
In regard to claim 25, Boulais teaches wherein a distalmost end of the first node is proximal of a proximalmost end of the third node (see annotated Fig. 6 above).
In regard to claim 26, Boulais teaches wherein each hoop of the plurality of hoops does not define a plane (Fig. 6).
In regard to claim 27, Boulais teaches wherein the centerlines of the adjacent hoops are not circular (Fig. 6).
In regard to claim 28, Boulais teaches wherein each indentation of the pair of indentations includes two V-shaped portions, wherein the V-shaped portions taper from a larger longitudinal width between the two nodes to smaller longitudinal widths adjacent to a node of the two nodes (Fig. 6).
Response to Arguments
Applicant’s arguments with respect to claims 1 6, 7, 9, 10, 12-19, 21-28 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RYAN N HENDERSON whose telephone number is (571)270-1430. The examiner can normally be reached Monday-Friday 6am-5pm (PST).
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/RYAN N HENDERSON/Primary Examiner, Art Unit 3795 March 18, 2026