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 .
Response to Amendment
The Amendment filed March 2, 2026 has been entered. Claims 1-9, 11 and 13-22 remain pending in the application.
Claim Objections
Claim 9 is objected to because of the following informalities: it appears there is a period in the middle of the claim instead of a comma. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-9, 11 and 13-14 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kowshik et al. (US 2016/0256230 A1) (“Kowshik”) in view of Nishijima (US 2016/0306165 A1) (“Nishijima”).
Regarding claim 1, Kowshik discloses An apparatus comprising (Abstract and entire document):
(a) a proximal elongate portion, the proximal elongate portion being flexible (FIGS. 2-3 and associated paragraphs see at least FIG. 3 and [0049], “proximal portion 302” and [0051] flexible);
(b) a distal elongate portion, the distal elongate portion being flexible, the proximal and distal elongate portions sharing a central longitudinal axis (FIGS. 2-3 and associated paragraphs see at least FIG. 3 and [0049], “distal portion 304” portion 302 and 304 share a central longitudinal axis as shown);
(c) a coupler longitudinally interposed between the proximal elongate portion and the distal elongate portion, the coupler including a first channel (FIGS. 2-3 and associated paragraphs see at least FIG. 3 and [0049], “transition section 306” and [0051], “The coil pipes 316 house the tendons 318 along the length of the flexible body, and the tendons 318 can slide longitudinally within the coil pipes 316. The coil pipes 316 terminate at the transition section 306, proximal to the steerable segment 307 within the distal portion 304. The tendons 318 extend out of the coil pipes 316 at the transition section 306, enter the proximal end 308, extend through the segment 307, and attach to the distal end 309.” Portion 306 has a channel in which a wire can extend through to the distal end);
(d) a first proximal tendon assembly extending through the proximal elongate portion, the first proximal tendon assembly including a proximal portion of a first tendon positioned at a first radial distance from the central longitudinal axis (FIGS. 2-3 and associated paragraphs see at least FIG. 3 and [0051], “Bowden cables 314 extend down the length of a catheter flexible body (e.g., flexible body 216) of the catheter system 300 to the distal segment 300. In this embodiment, the Bowden cables 314 extend entirely within or at least partially within the wall 305. The Bowden cables 314 comprise conduits or coil pipes 316 through which control wires or tendons 318 extend. The coil pipes 316 house the tendons 318 along the length of the flexible body, and the tendons 318 can slide longitudinally within the coil pipes 316. The coil pipes 316 terminate at the transition section 306, proximal to the steerable segment 307 within the distal portion 304. The tendons 318 extend out of the coil pipes 316 at the transition section 306, enter the proximal end 308, extend through the segment 307, and attach to the distal end 309.” Tendons 318 extend from proximal to distal sections, the proximal and distal sections each include a assembly as discussed in [0051] each having a radial distance from the axis); and
(e) a first distal tendon assembly extending through the distal elongate portion, the first distal tendon assembly including a distal portion of the first tendon positioned at a second radial distance from the central longitudinal axis (FIGS. 2-3 and associated paragraphs see at least FIG. 3 and [0051], “Bowden cables 314 extend down the length of a catheter flexible body (e.g., flexible body 216) of the catheter system 300 to the distal segment 300. In this embodiment, the Bowden cables 314 extend entirely within or at least partially within the wall 305. The Bowden cables 314 comprise conduits or coil pipes 316 through which control wires or tendons 318 extend. The coil pipes 316 house the tendons 318 along the length of the flexible body, and the tendons 318 can slide longitudinally within the coil pipes 316. The coil pipes 316 terminate at the transition section 306, proximal to the steerable segment 307 within the distal portion 304. The tendons 318 extend out of the coil pipes 316 at the transition section 306, enter the proximal end 308, extend through the segment 307, and attach to the distal end 309.” Tendons 318 extend from proximal to distal sections, the proximal and distal sections each include a assembly as discussed in [0051] each having a radial distance from the axis);
the first tendon passing through the first channel of the coupler (FIGS. 2-3 and associated paragraphs see at least FIG. 3 and [0051], Portion 306 has a channel in which tendon 318 can extend out of the proximal section, through the first channel of the coupler, to the distal end of the distal portion);
Kowshik fails to disclose the first channel of the coupler accommodating repositioning of the first tendon from the first radial distance to the second radial distance as the first tendon passes through the first channel of the coupler, the second radial distance being larger than the first radial distance.
However, in the same field of endeavor, Nishijima teaches the first channel of the coupler accommodating repositioning of the first tendon from the first radial distance to the second radial distance as the first tendon passes through the first channel of the coupler, the second radial distance being larger than the first radial distance (FIG. 2-9 and associated paragraphs, bending wire 31 extends to greater radial distance in section 8, the bending portion).
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 apparatus as taught by Kowshik to include the first channel of the coupler accommodating repositioning of the first tendon from the first radial distance to the second radial distance as the first tendon passes through the first channel of the coupler, the second radial distance being larger than the first radial distance as taught by Nishijima to not reduce length and avoid compression to allow bending as desired ([0009], [0043]).
Regarding claim 2, Kowshik as modified discloses The apparatus of claim 1, Kowshik as modified further discloses the coupler providing a mechanical ground between a distal end of the first elongate portion and a proximal end of the second elongate portion (Kowshik FIGS. 2-3 and associated paragraphs, the coupler provides a mechanical couple between the portions).
Regarding claim 3, Kowshik as modified discloses The apparatus of claim 2, Kowshik as modified further discloses the coupler abutting the distal end of the proximal elongate portion, the coupler further abutting the proximal end of the distal elongate portion (Kowshik FIGS. 2-3 and associated paragraphs, the coupler provides a mechanical couple between the portions).
Regarding claim 4, Kowshik as modified discloses The apparatus of claim 1, Kowshik as modified further discloses the first distal tendon assembly being operable to drive articulation of the distal elongate portion (Kowshik FIGS. 2-3 and associated paragraphs, see at least [0024 – 0025] and [0048] and [0055] discussing articulation).
Regarding claim 5, Kowshik as modified discloses The apparatus of claim 1, Kowshik as modified further discloses the first proximal tendon assembly comprising a housing, the proximal portion of the first tendon being slidably disposed in the housing of the first proximal tendon assembly (Kowshik FIG. 2-4 and [0050], “A lumen 310 (e.g., lumen 225) extends centrally through the proximal portion 320, the transition section 306 and distal portion 304 of the catheter system 300” the tendon assemblies are within the housing as claimed).
Regarding claim 6, Kowshik as modified discloses The apparatus of claim 5, Kowshik as modified further discloses the housing having a distal end, the distal end of the housing abutting a surface of the coupler (Joseph FIG. 1-2 and associated paragraphs see at least [0026], “Distal of the nested articulating hubs 20 is a tapered hub 26. The tapered hub 26 provides a transition from the nested articulating hubs 20 to the diameter of the catheters 28 which is distal of the tapered hub. Channels or lumens 27 formed in the periphery of the tapered hub 26 receive the pull wires 12.” The proximal portion housing ends at the coupler 26 which has a housing and the distal portion also has a housing).
Regarding claim 7, Kowshik as modified discloses The apparatus of claim 5, Kowshik as modified further discloses the housing comprising a coil pipe (Kowshik [0047] discussing coil pipes).
Regarding claim 8, Kowshik as modified discloses The apparatus of claim 1, Kowshik as modified further discloses the proximal elongate portion defining a proximal portion of an inner lumen (Kowshik As shown in FIG. 3).
Regarding claim 9, Kowshik as modified discloses The apparatus of claim 8, Kowshik as modified further discloses the first proximal tendon assembly being positioned in the inner lumen. the first proximal tendon assembly being movable within the inner lumen (Kowshik As shown in FIG. 3; Kowshik FIG. 2-4 and [0050], “A lumen 310 (e.g., lumen 225) extends centrally through the proximal portion 320, the transition section 306 and distal portion 304 of the catheter system 300” the tendon assemblies are within the housing as claimed).
Regarding claim 11, Kowshik as modified discloses The apparatus of claim 8, Kowshik as modified further discloses the distal elongate portion defining a distal portion of the inner lumen, the inner lumen extending continuously from the proximal elongate portion to the distal elongate portion via the coupler (Kowshik As shown in FIG. 3).
Regarding claim 13, Kowshik as modified discloses The apparatus of claim 11, Kowshik as modified further discloses the first distal tendon assembly being positioned radially outwardly from the inner lumen (Kowshik As shown in FIG. 3.
Regarding claim 14, Kowshik as modified discloses The apparatus of claim 13, Kowshik as modified further discloses the distal elongate portion including an inner shaft, the inner shaft defining the distal portion of the inner lumen, the first distal tendon assembly being positioned radially outwardly from the inner shaft (Kowshik FIG. 2-4 and [0050], “A lumen 310 (e.g., lumen 225) extends centrally through the proximal portion 320, the transition section 306 and distal portion 304 of the catheter system 300” the tendon assemblies are within the housing as claimed).
Regarding claim 16, Kowshik as modified discloses The apparatus of claim 1, Kowshik as modified further discloses the first distal tendon assembly comprising a housing, the distal portion of the first tendon being slidably disposed in the housing of the first distal tendon assembly (Kowshik FIG. 2-4 and [0050], “A lumen 310 (e.g., lumen 225) extends centrally through the proximal portion 320, the transition section 306 and distal portion 304 of the catheter system 300” the tendon assemblies are within the housing as claimed).
Regarding claim 17, Kowshik as modified discloses The apparatus of claim 1, Kowshik as modified further discloses the coupler including a second channel, the apparatus further comprising: (a) a second proximal tendon assembly extending through the proximal elongate portion, the second proximal tendon assembly including a proximal portion of a second tendon positioned at the first radial distance from the central longitudinal axis; and (b) a second distal tendon assembly extending through the distal elongate portion, the second distal tendon assembly extending including a distal portion of the second tendon positioned at the second radial distance from the central longitudinal axis; the second tendon passing through the second channel of the coupler; the second channel of the coupler accommodating repositioning of the second tendon from the first radial distance to the second radial distance as the second tendon passes through the second channel of the coupler (See claim 1 mapped above and FIG. 2-4, the components are all duplicated as claimed.).
Regarding claim 18, Kowshik discloses An apparatus comprising (Abstract and entire document):
(a) a proximal elongate portion, the proximal elongate portion being flexible (FIGS. 2-3 and associated paragraphs see at least FIG. 3 and [0049], “proximal portion 302” and [0051] flexible);
(b) a distal elongate portion, the distal elongate portion being flexible, the proximal and distal elongate portions sharing a central longitudinal axis (FIGS. 2-3 and associated paragraphs see at least FIG. 3 and [0049], “distal portion 304” portion 302 and 304 share a central longitudinal axis as shown);
(c) a coupler longitudinally interposed between the proximal elongate portion and the distal elongate portion, the coupler including a plurality of channels (FIGS. 2-3 and associated paragraphs see at least FIG. 3 and [0049], “transition section 306” and [0051], “The coil pipes 316 house the tendons 318 along the length of the flexible body, and the tendons 318 can slide longitudinally within the coil pipes 316. The coil pipes 316 terminate at the transition section 306, proximal to the steerable segment 307 within the distal portion 304. The tendons 318 extend out of the coil pipes 316 at the transition section 306, enter the proximal end 308, extend through the segment 307, and attach to the distal end 309.” Portion 306 has a channel in which a wire can extend through to the distal end);
(d) a plurality of proximal tendon assemblies extending through the proximal elongate portion, each proximal tendon assembly of the plurality of proximal tendon assemblies including a proximal portion of a respective tendon positioned at a first radial distance from the central longitudinal axis (FIGS. 2-3 and associated paragraphs see at least FIG. 3 and [0051], “Bowden cables 314 extend down the length of a catheter flexible body (e.g., flexible body 216) of the catheter system 300 to the distal segment 300. In this embodiment, the Bowden cables 314 extend entirely within or at least partially within the wall 305. The Bowden cables 314 comprise conduits or coil pipes 316 through which control wires or tendons 318 extend. The coil pipes 316 house the tendons 318 along the length of the flexible body, and the tendons 318 can slide longitudinally within the coil pipes 316. The coil pipes 316 terminate at the transition section 306, proximal to the steerable segment 307 within the distal portion 304. The tendons 318 extend out of the coil pipes 316 at the transition section 306, enter the proximal end 308, extend through the segment 307, and attach to the distal end 309.” Tendons 318 extend from proximal to distal sections, the proximal and distal sections each include a assembly as discussed in [0051] each having a radial distance from the axis); and
(e) a plurality of distal tendon assemblies extending through the distal elongate portion, each distal tendon assembly of the plurality of distal tendon assemblies including a distal portion of a respective tendon positioned at a second radial distance from the central longitudinal axis (FIGS. 2-3 and associated paragraphs see at least FIG. 3 and [0051], “Bowden cables 314 extend down the length of a catheter flexible body (e.g., flexible body 216) of the catheter system 300 to the distal segment 300. In this embodiment, the Bowden cables 314 extend entirely within or at least partially within the wall 305. The Bowden cables 314 comprise conduits or coil pipes 316 through which control wires or tendons 318 extend. The coil pipes 316 house the tendons 318 along the length of the flexible body, and the tendons 318 can slide longitudinally within the coil pipes 316. The coil pipes 316 terminate at the transition section 306, proximal to the steerable segment 307 within the distal portion 304. The tendons 318 extend out of the coil pipes 316 at the transition section 306, enter the proximal end 308, extend through the segment 307, and attach to the distal end 309.” Tendons 318 extend from proximal to distal sections, the proximal and distal sections each include a assembly as discussed in [0051] each having a radial distance from the axis);
each tendon passing through a respective channel of the plurality of channels of the coupler (FIGS. 2-3 and associated paragraphs see at least FIG. 3 and [0051], Portion 306 has a channel in which tendon 318 can extend out of the proximal section, through the first channel of the coupler, to the distal end of the distal portion);
Kowshik fails to disclose each respective channel of the coupler accommodating repositioning of a respective tendon from the first radial distance to the second radial distance as the respective tendon passes through the respective channel of the coupler, the second radial distance being larger than the first radial distance;
However, in the same field of endeavor, Nishijima teaches each respective channel of the coupler accommodating repositioning of a respective tendon from the first radial distance to the second radial distance as the respective tendon passes through the respective channel of the coupler, the second radial distance being larger than the first radial distance (FIG. 2-9 and associated paragraphs, bending wire 31 extends to greater radial distance in section 8, the bending portion);
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 apparatus as taught by Kowshik to include each respective channel of the coupler accommodating repositioning of a respective tendon from the first radial distance to the second radial distance as the respective tendon passes through the respective channel of the coupler, the second radial distance being larger than the first radial distance as taught by Nishijima to not reduce length and avoid compression to allow bending as desired ([0009], [0043]).
Regarding claim 19, the rejections as applied to claims 1 and 18 are applied to claim 19.
Regarding claim 20, Kowshik as modified discloses The method of claim 19, Kowshik as modified further discloses the proximal tendon assemblies further including a plurality of housings, each tendon being slidably disposed in a respective housing of the plurality of housings (Kowshik FIG. 2-4 and [0050], “A lumen 310 (e.g., lumen 225) extends centrally through the proximal portion 320, the transition section 306 and distal portion 304 of the catheter system 300” the tendon assemblies are within the housing as claimed).
Claims 15 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Kowshik in view of Nishijima in further view of Sutermeister et al. (US 2015/0174363 A1) (“Sutermeister”).
Regarding claim 15, Kowshik as modified discloses The apparatus of claim 1, Kowshik as modified fails to disclose the distal elongate portion including a braid assembly, the first distal tendon assembly being interposed between strands forming the braid assembly.
However, in the same field of endeavor, Sutermeister teaches the distal elongate portion including a braid assembly, the first distal tendon assembly being interposed between strands forming the braid assembly (FIG. 1-2 and [0029 – 0030] discussing the first distal tendon assembly being interposed between strands forming the braid assembly).
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 apparatus as taught by Kowshik to include the distal elongate portion including a braid assembly, the first distal tendon assembly being interposed between strands forming the braid assembly as taught by Sutermeister to enhance control and strength ([0030], “In some embodiments, the reinforcing braid 108 may enhance torque control, column strength, crush and/or radial collapse resistance, and/or anti-kink ability of the guide catheter 100 for proper positioning of the guide catheter 100 within the patient's vasculature.”).
Regarding claims 21 and 22, Kowshik as modified discloses The method of claim 19/apparatus of claim 18, Kowshik as modified fails to disclose the distal elongate portion including a braid assembly, each of the tendons extending through a respective lumen in the distal elongate portion that is embedded between inner and outer wire strands of the braid assembly.
However, in the same field of endeavor, Sutermeister teaches the distal elongate portion including a braid assembly, each of the tendons extending through a respective lumen in the distal elongate portion that is embedded between inner and outer wire strands of the braid assembly (FIG. 1-2 and [0029 – 0030] discussing the first distal tendon assembly being interposed between strands forming the braid assembly).
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 apparatus as taught by Kowshik as modified to include the distal elongate portion including a braid assembly, each of the tendons extending through a respective lumen in the distal elongate portion that is embedded between inner and outer wire strands of the braid assembly as taught by Sutermeister to enhance control and strength ([0030], “In some embodiments, the reinforcing braid 108 may enhance torque control, column strength, crush and/or radial collapse resistance, and/or anti-kink ability of the guide catheter 100 for proper positioning of the guide catheter 100 within the patient's vasculature.”).
Response to Arguments
Applicant’s arguments with respect to claims 1-9, 11 and 13-22 have been considered but are moot because the new ground of rejection does not solely 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.A.T./Examiner, Art Unit 3791
/TSE W CHEN/ Supervisory Patent Examiner, Art Unit 3791
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