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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/11/2025 has been entered.
Response to Arguments
Applicant's arguments, see pages 3-4, filed 11/11/2025 have been fully considered but they are not persuasive.
Applicant argues that Shelton fails to teach or suggest “the asymmetrical shape having a geometry that increases contact of a continuous circumferential length of contact between the proximal and corresponding distal linear edges of the at least one of the plurality of cutouts, relative to an otherwise corresponding symmetrical shape when in the fully flexed configuration, the continuous circumferential length of contact extending for at least half of a circumference of the tubular member configured to increase rigidity of the shaft in the fully flexed configuration.” as required by amended claims 1 and 8.
The examiner respectfully disagrees. The limitation “the asymmetrical shape having a geometry that increases contact of a continuous circumferential length of contact between the proximal and corresponding distal linear edges of the at least one of the plurality of cutouts, relative to an otherwise corresponding symmetrical shape when in the fully flexed configuration, the continuous circumferential length of contact extending for at least half of a circumference of the tubular member configured to increase rigidity of the shaft in the fully flexed configuration.” although provides some structure is still interpreted as functional language. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. The claim structural only requires the “asymmetrical shape” to meet the functional limitation. According to the specification of the instant application, the increased contact of the continuous circumferential length of contact between the proximal and corresponding distal linear edges of the at least one of the plurality of cutouts when in the fully flexed configuration is due to the difference in length of the proximal linear edge and the distal of linear edge of the asymmetrical shape. The specification describes that the distal linear edge is longer than the proximal linear edge such that in the fully flexed configuration the edges are aligned with each other to meet the functional language described above (see para. 0067-0070 of the PGPUB US 20230031313).
As shown in annotated Fig. 15 below, Shelton teaches an asymmetrical cutout having a geometry analogous to applicants such that the distal linear edge is longer than the proximal linear edge to thereby increase contact of a continuous circumferential length of contact between corresponding proximal and distal linear edges of the at least one of the plurality of cutouts that extends for at least half of a circumference of the tubular member when the flexible portion is in the fully flexed configuration (see Fig. 17 of Shelton which illustrates the flexible portion in the fully flexed configuration). Because the structure of the asymmetrical shape of Shelton is arranged in the same way and is substantially identical to the claimed invention, it is inherently configured to have the geometry that increases contact of the continuous circumferential length of contact between the proximal and corresponding distal linear edges of the at least one of the plurality of cutouts, relative to the otherwise corresponding symmetrical shape when in the fully flexed configuration, the continuous circumferential length of contact extending for at least half of the circumference of the tubular member configured to increase rigidity of the shaft in the fully flexed configuration.
Applicant argues that Shelton fails to teach or suggest terracing as illustrated in Fig. 4B of the instant application.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the feature upon which applicant relies (i.e., terracing of the symmetrical shape) is not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Figs. 4A-B of the instant application illustrates the symmetrical shape transitioning from an unflexed to a fully flexed configuration which results in the terracing described in the remarks. Shelton teaches and illustrates the asymmetrical shape adjacent to a corresponding symmetrical shape that is also designed to transition from an unflexed to a fully flexed configuration (see Figs. 15 and 17 of Shelton). Although the drawings of Shelton may not be drawn to scale, the prior art has the structural features arranged in a way substantially identical to the claimed invention; therefore, it is inherently configured to result in terracing as well. Therefore, the rejection is maintained. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
PNG
media_image1.png
302
522
media_image1.png
Greyscale
Annotated Fig. 15 of Shelton
Specification
The disclosure is objected to because of the following informalities:
Page 16, lines 7-30, reference Fig. 4 of the drawings. However, the drawings only include Figs. 4A and 4B.
Appropriate correction is required.
Claim Objections
Claims 2-12 and 21-26 are objected to because of the following informalities:
Throughout claim (2-7, 9-12, and 22-26) there is a comma missing after the claim numbers such as “The surgical instrument of claim 1”. For grammatical purposes, the examiner suggests to include a comma after the claim number i.e. “The surgical instrument of claim 1,”.
Claim 4, lines 2-3: “tapered portion” should recite “the tapered portion”.
Claim 5, line 4: “forms” should recite “and forms”.
Claim 6 (line 4) and claim 24 (line 4): “the tubular member first side” should recite “the first side of the tubular member”.
Claim 7, line 4: “plurality of radial cutouts” should recite “plurality of cutouts”.
Claim 8 (line 18) and claim 21 (line 16): “the spine” should recite “the continuous spine”.
Claim 26, line 2: “the first side” should recite “the first side of the tubular member”.
Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 6-12, and 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Swaney et al. (US 20160346513) [hereinafter Swaney] in view of Phan et al. (US 20160331443) [hereinafter Phan] and Shelton et al. (US 20050263562) [hereinafter Shelton].
Regarding claim 1, Swaney discloses a surgical instrument 10 (Figs. 1A-B, para. 0040, 0062; Note: the flexible portion embodiment of Figs. 3A-B is relied upon. However, Figs. 1A-B and 2A-D are relied upon for like features not described in Figs. 3A-B) comprising:
an elongate shaft assembly 22, 24 defining a longitudinal axis, the elongated shaft assembly configured to articulate between a fully flexed configuration and a lesser flexed configuration (Figs. 1B, 2A-D, para. 0040, 0045, 0049), the elongated shaft assembly 22, 24 comprising:
a tubular member 24 including a flexible portion 12 with a first preferential bending direction (Figs. 1A-B, 3A-B, para. 0040, 0051);
a flexible portion comprising a plurality of cutouts 50 (Fig. 3A-B, para. 0051), wherein each of the cutouts have a keyhole shape (Figs. 3A-B, para. 0051), each cutout terminating with a bulbous closed end 52 (Figs. 3A-B, para. 0051) wherein the flexible portion 12 is defined by a plurality of cutouts 50 along a first side of the tubular member 24 (Fig. 3A-B, para. 0051) and a spine (formed by bend joints 52) extending along a second, opposing side of the tubular member 24 (Fig. 3A-3B, para. 0048, 0051), each cutout of the plurality of cutouts defining a cutout longitudinal axis (see annotated Fig. 3A of Swaney below), and wherein each cutout of the plurality of cutouts includes a tapered portion defined by a proximal linear edge and a distal linear edge corresponding to each cutout (see annotated Fig. 3A of Swaney below).
PNG
media_image2.png
291
475
media_image2.png
Greyscale
Annotated Fig. 3A of Swaney
However, Swaney fails to disclose a handle, the elongate shaft assembly extending distally from the handle and an elongate member coaxially disposed within the tubular member and directly coupled to the tubular member at a location distal the flexible portion.
Phan teaches a surgical instrument 100 (Fig. 1, para. 0073) comprising: a handle 115 (Fig. 1, para. 0074); and an elongate shaft assembly 105 (para. 0074) extending distally from the handle and defining a longitudinal axis (Fig. 1, para. 0074), the elongated shaft assembly 105 configured to articulate between a fully flexed configuration (Figs. 6B, 7B) and a lesser flexed configuration (Figs. 6A, 7A, para. 0078, 0082), the elongated shaft assembly comprising: a tubular member 120 including a flexible portion (interpreted as portion comprising slots 162, best shown in Figs. 7A-B) with a first preferential bending direction (Figs. 6B, 7B, para. 0078, 0082); an elongate member 122 coaxially disposed within the tubular member 120 and directly coupled to the tubular member 120 at a location distal the flexible portion (see weld 160 which is distal to the flexible portion, Figs. 6A-B, para. 0074, 0078).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device in Swaney to include the handle of Phan since the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention, namely a way to articulate, bend, and control the elongate shaft assembly (para. 0074, 0082 of Phan); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the elongate shaft assembly of Swaney to include the elongate member Phan in order to provide the tubular member with support such that the tubular member is capable of bending in a substantially tight radius (para. 0078) and to permit bending in multiple directions (para. 0081).
However, Swaney in view of Phan fails to disclose wherein at least one of the plurality of cutouts defines an asymmetrical shape about the cutout longitudinal axis, the asymmetrical shape having a geometry that increases contact of a continuous circumferential length of contact between the proximal and corresponding distal linear edges of the at least one of the plurality of cutouts, relative to an otherwise corresponding symmetrical shape when in the fully flexed configuration, the continuous circumferential length of contact extending for at least half of a circumference of the tubular member configured to increase rigidity of the shaft in the fully flexed configuration.
Shelton in the same field of endeavor teaches a flexible portion 300 (Fig. 15, para. 0054) defined by a plurality of cutouts 304 (Fig. 15, para. 0054), each cutout defining a cutout longitudinal axis (see annotated Fig. 15 below); and wherein at least one of the plurality of cutouts 304 defines an asymmetrical shape about the cutout longitudinal axis (see Fig. 15, para. 0054), the asymmetrical shape having a geometry that increases contact of a continuous circumferential length of contact between the proximal and corresponding distal linear edges of the at least one of the plurality of cutouts (see annotated Fig. 15 below), relative to an otherwise corresponding symmetrical shape when in the fully flexed configuration (see Fig. 17 which illustrates the continuous circumferential length of contact between the proximal and corresponding distal linear edges in the fully flexed configuration, see note below), the continuous circumferential length of contact extending for at least half of a circumference of the tubular member (see Fig. 17) configured to increase rigidity of the shaft in the fully flexed configuration (see note below).
The substitution of one known cutout configuration (plurality of cutouts comprising at least one asymmetrical shape as shown in Shelton) for another (plurality of cutouts comprising only a symmetrical shape as shown in Swaney) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the plurality of cutouts comprising the at least one asymmetrical shape shown in Shelton would have yielded predictable results, namely, an alternative way to configure the plurality of cutouts of a flexible portion used to transition from a non-flexed configuration to a fully flexed configuration (Figs. 15, 17, para. 0054 of Swaney).
PNG
media_image1.png
302
522
media_image1.png
Greyscale
Annotated Fig. 15 of Shelton
Note: The limitation “the asymmetrical shape having a geometry that increases contact of a continuous circumferential length of contact between the proximal and corresponding distal linear edges of the at least one of the plurality of cutouts, relative to an otherwise corresponding symmetrical shape when in the fully flexed configuration, the continuous circumferential length of contact extending for at least half of a circumference of the tubular member configured to increase rigidity of the shaft in the fully flexed configuration” is interpreted as functional language. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. The claim structurally only requires the “asymmetrical shape” to meet the functional limitation. According to the specification of the instant application, the increased contact of the continuous circumferential length of contact between the proximal and corresponding distal linear edges of the at least one of the plurality of cutouts when in the fully flexed configuration is due to the difference in length of the proximal linear edge and the distal of linear edge of the asymmetrical shape. The specification describes that the distal linear edge is longer than the proximal linear edge such that in the fully flexed configuration the edges are aligned with each other to meet the functional language described above (see para. 0067-0070 of the PGPUB US 20230031313).
As shown in annotated Fig. 15 above, Shelton teaches an asymmetrical cutout having a geometry analogous to applicants such that the distal linear edge is longer than the proximal linear edge to thereby increase contact of a continuous circumferential length of contact between corresponding proximal and distal linear edges of the at least one of the plurality of cutouts that extends for at least half of a circumference of the tubular member when the flexible portion is in the fully flexed configuration (see Fig. 17 of Shelton which illustrates the flexible portion in the fully flexed configuration). Because the structure of the asymmetrical shape of Shelton is arranged in the same way and is substantially identical to the claimed invention, it is inherently configured to have the geometry described in the limitation above. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 6, modified Swaney discloses wherein the elongate member 122 is a second tubular member (Figs. 6A-B, para. 0074 of Phan), coaxially disposed within the tubular member 120 (Figs. 6A-B, para. 0074 of Phan), the second tubular member 122 defining a plurality of cutouts 164 located along a side of the second tubular member that is opposite the tubular member 120 first side (Figs. 6A-B, para. 0078 of Phan).
Regarding claim 7, modified Swaney discloses wherein the plurality of cutouts each define an angular opening when the elongate shaft assembly is in a less articulated configuration (Fig. 15 of Shelton), and wherein a distal- most cutout of the plurality of cutouts has a smaller angular opening than all of the remaining plurality of radial cutouts (Fig. 2B illustrates cutouts in a less articulated configuration with the distal-most cutout having a smaller angular opening during articulation, para. 0049, 0051 of Swaney).
Regarding claim 8, Swaney discloses a surgical instrument 10 (Figs. 1A-B, para. 0040, 0062; Note: the articulable portion embodiment of Figs. 3A-B is relied upon. However, Figs. 1A-B and 2A-D are relied upon for like features not described in Figs. 3A-B) comprising:
an elongate shaft assembly 22, 24 defining a longitudinal axis (Figs. 1B, 2A-D, para. 0040, 0045, 0049), the elongated shaft assembly 22, 24 comprising:
a tubular member 24 including an articulable portion 12 defined by at least one cutout 50 (Figs. 1A-B, 3A-B, para. 0040, 0051) through a first side of the tubular member 24 (Fig. 3A-B, para. 0051) and a continuous spine (formed by bend joints 52) along an opposing side of the tubular member 24 (Fig. 3A-3B, para. 0048, 0051), wherein the at least one cutout 50 defines a longitudinal axis transverse a shaft longitudinal axis (see annotated Fig. 3A [1] below).
PNG
media_image3.png
291
585
media_image3.png
Greyscale
Annotated Fig. 3A [1] of Swaney
However, Swaney fails to disclose a handle, the elongate shaft assembly extending distally from the handle and an elongate member located along the tubular member and coupled to the tubular member at a position distal from the articulable portion, the elongate member configured to flex the articulable portion to axially offset a distal end of the tubular member relative to a proximal end of the elongate shaft assembly.
Phan teaches a surgical instrument 100 (Fig. 1, para. 0073) comprising: a handle 115 (Fig. 1, para. 0074); and an elongate shaft assembly 105 (para. 0074) extending distally from the handle and defining a longitudinal axis (Fig. 1, para. 0074), the elongated shaft assembly 105 comprising: a tubular member 120 including an articulable portion (interpreted as portion comprising slots 162, best shown in Figs. 7A-B) defined by at least one cutout 162 through a first side of the tubular member (Figs. 6A-B, para. 0078) and a continuous spine along an opposing side of the tubular member (best shown in Figs. 7A-B, para. 0074, 0078); an elongate member 122 coaxially located along the tubular member 120 and coupled to the tubular member 120 at a position distal from the articulable portion (see weld 160 which is distal from the articulable portion, Figs. 6A-B, para. 0074, 0078), the elongate member 122 configured to flex the articulable portion to axially offset a distal end of the tubular member 120 relative to a proximal end of the elongate shaft assembly (Figs. 6B, 7B, para. 0078, 0082).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Swaney to include the handle of Phan for the drive/control system of Swaney, since the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention, namely a way to articulate, bend, and control the elongate shaft assembly (para. 0074, 0082 of Phan); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the elongate shaft assembly of Swaney to include the elongate member Phan in order to provide the tubular member with support such that the tubular member is capable of bending in a substantially tight radius (para. 0078) and to permit bending in multiple directions (para. 0081).
However, Swaney in view of Phan fails to disclose wherein the at least one cutout defines an asymmetrical shape about the cutout longitudinal axis, the asymmetrical shape having a geometry that provides an increased continuous circumferential contact length between a proximal circumferential edge and a corresponding distal circumferential edge of the at least one cutout relative to a corresponding symmetrical shape, the increased contact length extending for a continuous arc length of at least 180 degrees when the spine is flexed at a maximum offset angle, and thereby increases a rigidity of the articulable portion when located at the maximum offset angle.
Shelton in the same field of endeavor teaches an articulable portion 300 (Fig. 15, para. 0054) defined by a plurality of cutouts 304 (Fig. 15, para. 0054), each cutout defining a cutout longitudinal axis (see annotated Fig. 15 below); and wherein at least one of the plurality of cutouts 304 defines an asymmetrical shape about the cutout longitudinal axis (see Fig. 15, para. 0054), the asymmetrical shape having a geometry that provides an increased continuous circumferential contact length between a proximal circumferential edge and a corresponding distal circumferential edge of the at least one cutout (see annotated Fig. 15 [1] of Shelton below) relative to a corresponding symmetrical shape (see Figs. 15 and 17 of Shelton which illustrates the asymmetrical shape adjacent to a corresponding symmetrical shape, see note below), the increased contact length extending for a continuous arc length of at least 180 degrees when a spine is flexed at a maximum offset angle (see Fig. 17 of Shelton, see note below), and thereby increases a rigidity of the articulable portion when located at the maximum offset angle (see note below in regards to functional language).
The substitution of one known configuration (plurality of cutouts comprising at least one asymmetrical shape as shown in Shelton) for another (plurality of cutouts comprising a symmetrical shape only as shown in Swaney) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the plurality of cutouts comprising the at least one asymmetrical shape shown in Shelton would have yielded predictable results, namely, an alternative way to configure the plurality of cutouts of the articulable portion used to transition from a non-flexed configuration to a fully flexed configuration (Figs. 15, 17, para. 0054 of Swaney).
PNG
media_image4.png
302
522
media_image4.png
Greyscale
Annotated Fig. 15 [1] of Shelton
Note: The limitation ““the asymmetrical shape having a geometry that provides an increased continuous circumferential contact length between a proximal circumferential edge and a corresponding distal circumferential edge of the at least one cutout relative to a corresponding symmetrical shape, the increased contact length extending for a continuous arc length of at least 180 degrees when the spine is flexed at a maximum offset angle, and thereby increases a rigidity of the articulable portion when located at the maximum offset angle” is interpreted as functional language. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. The claim structurally only requires the “asymmetrical shape” to meet the functional limitation. According to the specification of the instant application, the increased contact of the continuous circumferential length of contact between the proximal and corresponding distal circumferential edges of the at least one of the plurality of cutouts when in the fully flexed configuration is due to the difference in length of the proximal circumferential edge and the distal circumferential edge of the asymmetrical shape. The specification describes that the distal circumferential edge is longer than the proximal circumferential edge such that in the fully flexed configuration the edges are aligned with each other to meet the functional language described above (see para. 0067-0070 of the PGPUB US 20230031313). As shown in annotated Fig. 15 below, Shelton teaches an asymmetrical cutout having a geometry analogous to applicants such that the distal circumferential edge is longer than the proximal circumferential edge to thereby increase “continuous circumferential contact length between the proximal circumferential edge and the corresponding distal circumferential edge of the at least one cutout relative to the corresponding symmetrical shape, the increased contact length extending for the continuous arc length of at least 180 degrees when the spine is flexed at the maximum offset angle, and thereby increases the rigidity of the articulable portion when located at the maximum offset angle”. Because the structure of the asymmetrical shape of Shelton is arranged in the same way and is substantially identical to the claimed invention, it is inherently configured to have the geometry described in the limitation above. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 9, modified Swaney discloses wherein the at least one cutout defines a keyhole shape terminating with a bulbous closed end (Figs. 3A-B, para. 0051 of Swaney; Figs. 15, 17 of Shelton), the bulbous closed end defining a concave proximal surface and a concave distal surface facing, the concave proximal surface and different to the concave proximal surface (see annotated Fig. 15 [1] above of Shelton).
Regarding claim 10, modified Swaney discloses wherein the concave proximal surface defines a larger radius of curvature than the concave distal surface (see annotated Fig. 15 [1] of Shelton above which illustrates the proximal concave surface having a larger size than the distal concave surface such that the combination of modified Swaney and Shelton would yield an asymmetrical cutout having a proximal concave surface with a larger radius of curvature than the distal concave surface).
Regarding claim 11, modified Swaney discloses wherein the asymmetrical shape is configured to form a continuous uninterrupted curve along the articulable portion when the distal end of the tubular member is flexed at the maximum offset angle (Figs. 3A-B, para. 0051 of Swaney and Fig. 17, para. 0054 of Shelton, see note below).
Note: The limitation “the asymmetrical shape configured form a continuous uninterrupted curve along the articulable portion when the distal end is flexed at the maximum offset angle” is interpreted as functional language. Therefore, the limitation is not interpreted as a structural component of the claimed invention, but interpreted as a functional component that the claimed invention is capable of doing. Modified Swaney discloses all of the structural components required for the functional limitation i.e. an asymmetrical shape (see Figs. 15, 17, para. 0054 of Shelton) having a bulbous closed end (Figs. 3A-B, para. 0051 of Swaney). Therefore, the asymmetrical shape of modified Swaney is capable of forming a continuous uninterrupted curve along the articulable portion when the distal end is flexed at the maximum offset angle. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 12, modified Swaney discloses wherein the at least one cutout comprises at least two cutouts (see Figs. 3A-B, para. 0051 of Swaney), each of the at least two cutouts defining an angular opening (interpreted as opening defined by the tapered portion of the cutout, see annotated Fig. 15 of Shelton above), and wherein when the elongate shaft assembly is in a less articulated configuration (interpreted as the configuration shown in Fig. 2B of Swaney), the angular opening of a distal-most cutout of the at least two cutouts has a smaller angular opening than all remaining cutouts (Fig. 2B, para. 0049, 0051 of Swaney).
Regarding claim 21, Swaney discloses a surgical instrument 10 (Figs. 1A-B, para. 0040, 0062; Note: the articulable portion embodiment of Figs. 3A-B is relied upon. However, Figs. 1A-B and 2A-D are relied upon for like features not described in Figs. 3A-B) comprising:
an elongate shaft assembly 22, 24 defining a longitudinal axis (Figs. 1B, 2A-D, para. 0040, 0045, 0049), the elongated shaft assembly 22, 24 comprising:
a tubular member 24 including an articulable portion 12 defined by at least one cutout 50 (Figs. 1A-B, 3A-B, para. 0040, 0051) through a first side of the tubular member 24 (Fig. 3A-B, para. 0051) and a continuous spine (formed by bend joints 52) along an opposing side of the tubular member 24 (Fig. 3A-3B, para. 0048, 0051), wherein the at least one cutout 50 defines a longitudinal axis transverse a shaft longitudinal axis (see annotated Fig. 3A [1] below).
PNG
media_image3.png
291
585
media_image3.png
Greyscale
Annotated Fig. 3A [1] of Swaney
However, Swaney fails to disclose a handle, the elongate shaft assembly extending distally from the handle and an elongate member coaxially located along the tubular member and coupled to the tubular member at a position distal from the articulable portion, the elongate member configured to flex the articulable portion to axially offset a distal end of the tubular member relative to a proximal end of the elongate shaft assembly.
Phan teaches a surgical instrument 100 (Fig. 1, para. 0073) comprising: a handle 115 (Fig. 1, para. 0074); and an elongate shaft assembly 105 (para. 0074) extending distally from the handle and defining a longitudinal axis (Fig. 1, para. 0074), the elongated shaft assembly 105 comprising: a tubular member 120 including an articulable portion (interpreted as portion comprising slots 162, best shown in Figs. 7A-B) defined by at least one cutout 162 through a first side of the tubular member (Figs. 6A-B, para. 0078) and a continuous spine along an opposing side of the tubular member (best shown in Figs. 7A-B, para. 0074, 0078); an elongate member 122 coaxially located along the tubular member 120 and coupled to the tubular member 120 at a position distal from the articulable portion (see weld 160 which is distal from the articulable portion, Figs. 6A-B, para. 0074, 0078), the elongate member 122 configured to flex the articulable portion to axially offset a distal end of the tubular member 120 relative to a proximal end of the elongate shaft assembly (Figs. 6B, 7B, para. 0078, 0082).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Swaney to include the handle of Phan for the drive/control system of Swaney, since the combination would have yielded nothing more than predictable results to one of ordinary skill in the art before the effective filing date of the claimed invention, namely a way to articulate, bend, and control the elongate shaft assembly (para. 0074, 0082 of Phan); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the elongate shaft assembly of Swaney to include the elongate member Phan in order to provide the tubular member with support such that the tubular member is capable of bending in a substantially tight radius (para. 0078) and to permit bending in multiple directions (para. 0081).
However, Swaney in view of Phan fails to disclose wherein the at least one cutout defines an asymmetrical shape about the cutout longitudinal axis, the asymmetrical shape wherein the asymmetrical shape defines a proximal and distal circumferential edge that align for a longer continuous circumferential contact length when the spine is flexed at a maximum offset angle, than a corresponding symmetrical shaped cutout and thereby increases a rigidity of the articulable portion when at the maximum offset angle.
Shelton in the same field of endeavor teaches an articulable portion 300 (Fig. 15, para. 0054) defined by a plurality of cutouts 304 (Fig. 15, para. 0054), each cutout defining a cutout longitudinal axis (see annotated Fig. 15 [1] above); and wherein at least one of the plurality of cutouts 304 defines an asymmetrical shape about the cutout longitudinal axis (see Fig. 15, para. 0054), wherein the asymmetrical shape defines a proximal and distal circumferential edge (see annotated Fig. 15 [1] of Shelton above) that align for a longer continuous circumferential contact length when a spine is flexed at a maximum offset angle (see Fig. 17 and annotated Fig. 15 [1] of Shelton above), than a corresponding symmetrical shaped cutout (see Fig. 17 of Shelton which illustrates the asymmetrical cutout adjacent to a corresponding symmetrical shaped cutout, see note below for further explanation) and thereby increases a rigidity of the articulable portion when at the maximum offset angle (see note below).
The substitution of one known configuration (plurality of cutouts comprising at least one asymmetrical shape as shown in Shelton) for another (plurality of cutouts comprising a symmetrical shape only as shown in Swaney) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the plurality of cutouts comprising the at least one asymmetrical shape shown in Shelton would have yielded predictable results, namely, an alternative way to configure the plurality of cutouts of the articulable portion used to transition from a non-flexed configuration to a fully flexed configuration (Figs. 15, 17, para. 0054 of Swaney).
Note: According to the specification of the instant application, the increased contact of the continuous circumferential length of contact between the proximal and corresponding distal circumferential edges of the at least one of the plurality of cutouts when in the fully flexed configuration is due to the difference in length of the proximal circumferential edge and the distal circumferential edge of the asymmetrical shape. The specification describes that the distal circumferential edge is longer than the proximal circumferential edge such that in the fully flexed configuration the edges are aligned with each other to result in the longer continuous circumferential contact length when the spine is flexed at the maximum offset angle, than the corresponding symmetrical shaped cutout. Shelton teaches and illustrates the asymmetrical shape adjacent to a corresponding symmetrical shape that is also designed to transition from an unflexed to a fully flexed configuration (see Figs. 15 and 17 of Shelton). Although the drawings of Shelton may not be drawn to scale, the prior art has the structural features arranged in a way substantially identical to the claimed invention; therefore, it is inherently configured to result in the proximal and distal circumferential edges aligning for a longer continuous circumferential contact length when the spine is flexed at a maximum offset angle, than a corresponding symmetrical shaped cutout and thereby increases a rigidity of the articulable portion when at the maximum offset angle.
Regarding claim 22, modified Swaney discloses wherein the at least one cutout defines a keyhole shape terminating with a bulbous closed end (Figs. 3A-B, para. 0051 of Swaney; Figs. 15, 17 of Shelton), wherein the bulbous closed end is asymmetrical about the cutout longitudinal axis (see annotated Figs. 15 [1] of Shelton above).
Regarding claim 23, modified Swaney discloses wherein the at least one cutout defines a keyhole shape terminating with a bulbous closed end (Figs. 3A-B, para. 0051 of Swaney; Figs. 15, 17 of Shelton), the bulbous closed end defining a proximal concave surface and a distal concave surface, continuous with each other and wherein the distal concave surface defines a tighter radius of curvature than the proximal concave surface (see annotated Fig. 15 [2] of Shelton below).
PNG
media_image5.png
267
499
media_image5.png
Greyscale
Annotated Fig. 15 [2] of Shelton
Regarding claim 24, modified Swaney discloses wherein the elongate member 122 is a second tubular member (Figs. 6A-B, para. 0074 of Phan), coaxially disposed within the tubular member 120 (Figs. 6A-B, para. 0074 of Phan), the second tubular member 122 defining a plurality of cutouts 164 located along a side of the second tubular member that is opposite the tubular member 120 first side (Figs. 6A-B, para. 0078 of Phan).
Regarding claim 25, modified Swaney discloses wherein the at least one cutout is a plurality of cutouts (see Fig. 17 of Shelton). However, modified Swaney fails to disclose wherein a proximally located cutout of the plurality of cutouts has a shorter maximum length extending transverse the shaft longitudinal axis than a corresponding distally located cutout of the plurality of cutouts, defining a thicker continuous spine proximal region relative to a distal continuous spine region.
Phan further teaches a plurality of cutouts 932 (Figs. 27A-C, para. 0117-0118), wherein a proximally located cutout of the plurality of cutouts 932 has a shorter maximum length extending transverse a shaft longitudinal axis than a corresponding distally located cutout of the plurality of cutouts 932 (Figs. 27A-27C, para. 0118), defining a thicker continuous spine proximal region relative to a distal continuous spine region (Figs. 27A-B, para. 0117-0119).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the plurality of cutouts in modified Swaney to include the proximally located cutout of the plurality of cutouts having the shorter maximum length extending transverse the shaft longitudinal axis than the corresponding distally located cutout of the plurality of cutouts, as taught by Phan, in order to provide additional support to the spine during articulation and use of the device (para. 0005, 0118 of Phan).
Claim(s) 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Swaney et al. (US 20160346513) [hereinafter Swaney] in view of Phan et al. (US 20160331443) [hereinafter Phan] and Shelton et al. (US 20050263562) [hereinafter Shelton], as applied to claim 1 above, and further in view of Yu et al. (US 20130035551) [hereinafter Yu].
Regarding claims 2 and 3, modified Swaney discloses all of the limitations set forth above in claim 1. Modified Swaney further discloses wherein each of the plurality of cutouts have a keyhole shape, terminating with a bulbous closed end (Figs. 3A-B, para. 0051 of Swaney; Figs. 15, 17 of Shelton), wherein the bulbous closed ends of at least one of the cutouts of the plurality are asymmetrical about the cutout longitudinal axis (see Fig. 15 of Shelton) (claim 2)/ the bulbous closed ends of at least one of the cutouts of the plurality of cutouts define a proximal concave surface and a distal concave surface, continuous with each other and wherein the distal concave surface defines a tighter radius of curvature than the proximal concave surface (see annotated Fig. 15 [a] of Shelton below) . However, modified Swaney fails to disclose wherein the bulbous closed ends of each of the cutouts of the plurality of cutouts are asymmetrical about the cutout longitudinal axis (claim 2)/the bulbous closed ends of each of the cutouts of the plurality of cutouts define a proximal concave surface and a distal concave surface, continuous with each other and wherein the distal concave surface defines a tighter radius of curvature than the proximal concave surface.
Yu in the same field of endeavor of articulation devices teaches that it is known in the art to have a flexible portion 20D comprising a plurality of cutouts, wherein each of the cutouts define an asymmetrical shape about a cutout longitudinal axis (Fig. 3D, para 0021).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify each of the plurality of cutouts in modified Swaney to include the plurality of cutouts each having the asymmetrical shape of Shelton, as taught by Yu, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
PNG
media_image5.png
267
499
media_image5.png
Greyscale
Annotated Fig. 15 [a] of Shelton
Note: see annotated Fig. 15 [a] of Shelton above which illustrates the proximal concave surface having a larger size than the distal concave surface such that the combination of modified Swaney and Shelton would yield an asymmetrical cutout having a proximal concave surface with a tighter radius of curvature than the proximal concave surface.
Regarding claim 4, modified Swaney discloses wherein the bulbous closed end defines a maximum axial length that is less than 50% larger than a maximum axial length of tapered portion when the instrument is in a lesser flexed configuration (see annotated Fig. 15 [b] of Shelton below).
PNG
media_image6.png
267
357
media_image6.png
Greyscale
Annotated Fig. 15 [b] of Shelton
Regarding claim 5, modified Swaney discloses all of the limitations set forth above in claim 1. Modified Swaney further discloses that the asymmetrical shape forms a continuous inner curved shaft surface, free of terracing between the plurality of cutouts (as taught by Shelton, see Fig. 17 and annotated Fig. 15 of Shelton above. The examiner notes that the geometry of the asymmetrical cutouts of Shelton are analogous to the geometry of the asymmetrical cutouts of applicants such that it forms the continuous inner curved shaft surface, free of terracing between the plurality of cutouts). However, modified Swaney fails to disclose wherein the plurality of cutouts are all asymmetrically shaped.
Yu in the same field of endeavor of articulation devices teaches that it is known in the art to have a flexible portion 20D comprising a plurality of cutouts, wherein each of the cutouts define an asymmetrical shape about a cutout longitudinal axis (Fig. 3D, para 0021).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify all of the plurality of cutouts in modified Swaney to include the plurality of cutouts each having the asymmetrical shape of Shelton, as taught by Yu, since such a modification would have involved a mere change in the form or shape of a component. A change in form or shape is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Claim(s) 26 are rejected under 35 U.S.C. 103 as being unpatentable over Swaney et al. (US 20160346513) [hereinafter Swaney] in view of Phan et al. (US 20160331443) [hereinafter Phan] and Shelton et al. (US 20050263562) [hereinafter Shelton], as applied to claim 21 above, and further in view of Baxter, III et al. (US 20150173789) [hereinafter Baxter].
Regarding claim 26, modified Swaney discloses all of the limitations set forth above in claim 21. Modified Swaney further discloses wherein the at least one cutout has a keyhole shape defining an angular opening at the first side (Figs. 3A-B, para. 0051 of Swaney), and wherein the at least one cutout is a plurality of cutouts (Figs. 3A-B, para. 0051 of Swaney; Figs. 15 and 17 of Shelton). However, modified Swaney fails to disclose wherein a distal most cutout of the plurality of cutouts has a smaller angular opening than a proximally located cutout of the plurality of cutouts, when the articulable portion is in a straight configuration.
Baxter in the same field of endeavor of articulatable devices (Figs. 17-18, para. 0080) teaches a plurality of cutouts 515 (Fig. 17, para. 008), wherein a distal most cutout 515D’ of the plurality of cutouts 515 has a smaller opening than a proximally located cutout 515P’ of the plurality of cutouts 515 (Fig. 17, para. 0080), when an articulable portion 260 is in a straight configuration (Fig. 17, para. 0080).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the plurality of cutouts in modified Swaney to include the distal most cutout of the plurality of cutouts having the smaller angular opening than the proximally located cutout of the plurality of cutouts, as taught by Baxter, in order to increase the rate of flexure at the distal end of the articulable portion (para. 0080 of Baxter), thereby preventing the articulable portion from twisting during use (para. 0078, 0080 of Baxter).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771