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 Apr. 29, 2026 has been entered. Claims 1-6, 9-12, 14-17, and 21-26 remain pending in the application. Applicant’s amendments to the Specification and Claims have overcome most drawing objections, and each and every specification objection and 112 rejections previously set forth in the Non-Final Office Action mailed Jan. 29, 2026.
Response to Arguments
Drawings:
Applicant amended drawings and addressed most of the previous objections and those objections have been withdrawn.
Applicant amended drawings have not addressed the following reference character(s) not mentioned in the description: Element 78 and Element 81 in Fig. 1. This objection has been maintained.
Specification:
Applicant amended specification and addressed all previous objections and the previous objections have been withdrawn.
Claim Objections:
Applicant amended claims and addressed all previous objections and the previous objections have been withdrawn.
35 USC § 112:
Applicant amended claims 14 and 15 and cancelled claim 7 and addressed all previous U.S.C. 112 rejections and the previous U.S.C. 112 rejections have been withdrawn.
35 USC § 102:
Applicant’s arguments, see pg. 13-14, filed Apr. 29, 2026, with respect to claims 1, 3-7, 9-12, and 16-17 have overcome the 35 USC 102 rejections with respect to Bogusky from the Jan. 29, 2026 Office Action. A new 35 USC 103 rejection below is being applied using Bogusky in light of the amendments to the claim.
35 USC § 103:
Applicant's arguments filed Apr. 29, 2026 have been fully considered but they are not persuasive.
On page 14 of Applicant’s response, applicant argues the PTO has not presented a prima facie case of obviousness against claims 8 and 13-15 as Romo fails to remedy the deficiencies of the rejection over Bogusky. Applicant's arguments do not provide any particular arguments with respect to Romo and a new rejection relying on Bogusky and Romo has been made below in response to the claimed amendments.
With respect to the added limitations of claim 1 addressed in applicant’s response to 102 rejections on page 14, Romo in combination with Bogusky teaches the second tendon housing. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, having two separate housings that are attached proximally to each other allows force or load to be transferred from the tendon housing to the elongate body from two separate components and also adds significant bending stiffness to the flexible elongate body by having multiple components. Additional components will still provide the same benefits.
New Claims:
On page 15 of Applicant’s response, applicant notes that the new claims include features not disclosed or suggested in the art of record. Applicant's notes have been fully considered but they are not persuasive. See rejection set forth below.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Element 78 and Element 81 in Fig. 1. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
In addition to Replacement Sheets containing the corrected drawing figure(s), applicant is required to submit a marked-up copy of each Replacement Sheet including annotations indicating the changes made to the previous version. The marked-up copy must be clearly labeled as “Annotated Sheets” and must be presented in the amendment or remarks section that explains the change(s) to the drawings. See 37 CFR 1.121(d)(1). Failure to timely submit the proposed drawing and marked-up copy will result in the abandonment of the application.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3-6, 9-12, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bogusky (US 8671817 B1, published Mar. 18, 2014, hereinafter referred to as “Bogusky”) in view of Romo et al. (US 20120071822 A1, published Mar. 22, 2012, hereinafter referred to as “Romo”).
Regarding claim 1, Bogusky teaches an apparatus (Fig. 7 “flexible and steerable elongate catheter 100” in Col. 11 ln. 54) comprising: (a) an elongate body (Fig. 7 “elongate catheter 100” in Col. 11 ln. 54) the elongate body defining a central longitudinal axis (see annotated Fig. 7 below), the elongate body including: (i) a sidewall comprising a flexible material (Fig. 7 “the catheter body 102 may be comprised of multiple layers of materials and/or multiple tube structures that exhibit a low bending stiffness, while providing a high axial stiffness along the neutral axis. Typical designs include a nitinol spine encapsulated in braid and any flexible, pliable, or suitable polymer material” in Col. 12 ln. 1-6), (ii) a proximal portion (Fig. 7 “proximal shaft section 120” in Col. 14 ln. 11), and (iii) a distal portion (Fig. 7 “distal articulating section 114” in Col. 14 ln. 2-3), the distal portion terminating at a distal end (Fig. 7 “distal tip 112” Col. 13 ln. 8); (b) a first tendon assembly (Fig. 7 “pullwires 108 housed within one or more lumens 110 extending through the catheter body 102, and a proximal adapter” in Col. 12 ln. 26-27), the first tendon assembly being operable to drive deflection of a portion of the elongate body away from the central longitudinal axis (Fig. 7 “operation of the pullwires 108 may apply force or tension to the control ring 106, which may steer or articulate (e.g., up, down, pitch, yaw, or any direction in-between) the pertinent location, section, portion, or region of the catheter 100, which may in effect provide or define various bend radii for the articulated portion of the catheter 100” in Col. 12 ln. 36-42; also see Fig. 10), the first tendon assembly including: (i) a first tendon housing extending through the sidewall at a first angular position about the central longitudinal axis (Fig. 7 “pullwires 108 housed within one or more lumens 110 extending through the catheter body 102” in Col. 12 ln. 26-27 and “the transition section 116 transitions the four lumens 110 in the distal articulating section 114 to a single hollow stiffening tube 130 in the proximal shaft section 120” in Col. 14 ln. 8-10), the first tendon housing having a distal end secured at a first longitudinal position along the elongate body (Fig. 7 “stiffening tube 130 must be laminated into the catheter body 102, thereby allowing the stiffening tube 130 to support the axial loads on the catheter 100 from the tensioning of the pullwires 108” in Col. 15 ln. 56-59), and (ii) a first tendon slidably disposed in the first tendon housing (Fig. 7 “pullwire lumens 110 … may be constructed of a low friction material or may simply be unsupported tubular cavities in which the pullwires 108 respectively float” in Col. 13 ln. 42-45 and “inner diameter of the stiffening tube 130 is preferably large enough to allow the pullwires 108 to slide freely without pinching each other” in Col. 15 ln. 47-49), the first tendon having a distal portion extending distally from the distal end of the first tendon housing, the distal portion of the first tendon being fixedly secured relative to the elongate body (Fig. 7 “the distal end of the pullwires are anchored or mounted to the control ring 106 … the control ring 106 is secured to the distal end of the catheter 100” in Col. 12 ln. 35-36 and ln. 42-44), and (c) a second tendon assembly (Fig. 7 “pullwires 108 housed within one or more lumens 110 extending through the catheter body 102, and a proximal adapter” in Col. 12 ln. 26-27), the second tendon assembly being operable to drive deflection of a portion of the elongate body away from the central longitudinal axis (Fig. 7 “operation of the pullwires 108 may apply force or tension to the control ring 106, which may steer or articulate (e.g., up, down, pitch, yaw, or any direction in-between) the pertinent location, section, portion, or region of the catheter 100, which may in effect provide or define various bend radii for the articulated portion of the catheter 100” in Col. 12 ln. 36-42; also see Fig. 10), the second tendon assembly including: a second tendon slidably disposed in the tendon housing (Fig. 7 “pullwire lumens 110 … may be constructed of a low friction material or may simply be unsupported tubular cavities in which the pullwires 108 respectively float” in Col. 13 ln. 42-45 and “inner diameter of the stiffening tube 130 is preferably large enough to allow the pullwires 108 to slide freely without pinching each other” in Col. 15 ln. 47-49), the tendon housing having a distal end secured at a second longitudinal position along the elongate body, the second longitudinal position being proximal to the first longitudinal position (Fig. 7 “stiffening tube 130 must be laminated into the catheter body 102, thereby allowing the stiffening tube 130 to support the axial loads on the catheter 100 from the tensioning of the pullwires 108” in Col. 15 ln. 56-59), and the distal portion of the second tendon being fixedly secured relative to the elongate body (Fig. 7 “the distal end of the pullwires are anchored or mounted to the control ring 106 … the control ring 106 is secured to the distal end of the catheter 100” in Col. 12 ln. 35-36 and ln. 42-44).
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Bogusky does not disclose the first longitudinal position being proximal to the distal end of the distal portion of the elongate body, and (i) a second tendon housing extending through the sidewall at a second angular position about the central longitudinal axis, and (ii) a second tendon slidably disposed in the second tendon housing, the second tendon having a distal portion extending distally from the distal end of the second tendon housing.
Romo’s invention relates to robotically controlled surgical systems, and more particularly to flexible instruments and instrument drivers that are responsive to a master controller for performing surgical procedures (¶[0017]). Referring to Fig. 33A, the distal portion of the flex tubes 306 (first tendon housing) may be secured at respective anchor points or regions 320 of the elongate instrument 300. Anchoring the flex tubes 306 to the elongate instrument 300 may provide the connections or couplings that allow force or load to be transferred from the flex tubes 306 to the elongate instrument 300 when force or load is applied to the flex tubes. The anchor points 320 may function as coupling points from one portion (e.g., distal portion) of the elongate instrument 300 to the flex tubes 306 where force or load may be transferred from one portion (e.g., distal portion) of the elongate instrument to the flex tubes (¶[0385]). Romo teaches that with the introduction of one or more flex tubes 306 (tendon housing) of Fig. 33A into the body of the elongate instrument or a section of the elongate instrument, the elongate instrument or the section of the elongate instrument with the flex tubes 306 may become less flexible; even though the flex tubes 306 are flexible in bending, they have axial stiffness. Several axially stiff members spread throughout the cross section of a catheter may add significant bending stiffness to the catheter (¶[0380]). One or more pull wires 314 (tendons) may be disposed within lumens of the support tubes 310, lumens of the flex tubes 306, and lumens of the push tubes 308 (¶[0385]). As can be seen in Fig. 33A and Fig. 33B, there are two flex tubes 306 indicating a second tendon housing and two pull wires 314 disposed in the respective tendon housings. Since the flex tubes 306 are incorporated or coupled to the wall of the elongate instrument 300 (extending through the sidewall) and the flex tubes 306 are substantially configured to support axial loading, the articulation or steering loads may be decoupled from the elongate instrument 300 at the point or location where the flex tubes 306 are incorporated or coupled to the wall of the elongate instrument 300 (¶[0383]). The distal portion of the flex tubes 306 may be secured at respective anchor points or regions 320 of the elongate instrument 300 (¶[0385]). Further, the distal end or portion of one or more pull wires 314 may be anchored or mounted to the control ring 316 (¶[0382]) where in Fig. 33A, the control ring 316 is distal from the distal portion of flex tubes 306 or region 320. A distal end or portion of the flex tubes 306 may be fixedly coupled to the elongate instrument. In some variations, a proximal end or portion of the flex tubes may also be fixedly coupled to the elongate instrument 300 as in a passively controlled configuration of the flex tubes 306 (¶[0379]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to secure the first tendon housing proximal to the distal end of the elongate body and to incorporate a second tendon assembly with a second tendon housing as taught by Romo in the device of Bogusky in order to allow force or load to be transferred from the tendon housing to the elongate body when force or load is applied to the flex tubes and add significant bending stiffness to the flexible elongate body. Further, a second tendon housing would be secured proximal to the first tendon housing as the tendons are secured proximally in Bogusky’s device.
Regarding claim 3, Bogusky teaches the flexible material comprising polyether block amide (Fig. 7 “typical designs [of the catheter body 102] include … Pebax®” in Col. 12 ln. 8).
Regarding claim 4, Bogusky teaches the first tendon housing being longitudinally non-compressible (Fig. 7 “the stiffening tube 130 may take the form of a stainless steel hypotube” in Col. 15 ln. 52-53 where stainless steel is longitudinally non-compressible). Stainless steel hypotube of Bogusky would be considered longitudinally non-compressible since the instant specification lists exemplary list of non-compressible material to include steel (¶[00052]).
Regarding claim 5, Bogusky teaches the first tendon housing comprising a coil pipe (Fig. 7 “the stiffening tube 130 may take the form of a … coil pipe” in Col. 15 ln. 52-53).
Regarding claim 6, Bogusky teaches the first tendon comprising a pull wire (Fig. 7 “pullwires 108” in Col. 12 ln. 26).
Regarding claim 9, Bogusky teaches the apparatus further comprising an anchoring element at the distal end of the distal portion of the elongate body (Fig. 7 “the distal end of the pullwires are anchored or mounted to the control ring 106 … the control ring 106 is secured to the distal end of the catheter 100” in Col. 12 ln. 35-36 and ln. 42-44).
Regarding claim 10, Bogusky teaches the first tendon assembly being operable to drive deflection of the distal portion of the elongate body away from the central longitudinal axis (Fig. 7 “operation of the pullwires 108 may apply force or tension to the control ring 106, which may steer or articulate (e.g., up, down, pitch, yaw, or any direction in-between) the pertinent location, section, portion, or region of the catheter 100, which may in effect provide or define various bend radii for the articulated portion of the catheter 100” in Col. 12 ln. 36-42; also see Fig. 10).
Regarding claim 11, Bogusky teaches the elongate body further defining an inner lumen (Fig. 7 “working lumen 104” in Col. 12 ln. 10).
Regarding claim 12, Bogusky teaches the apparatus further comprising a braid assembly (Fig. 7 “the articulatable portion 128 comprises a double braided layer” Col. 13 ln. 61-62).
Regarding claim 14, Bogusky teaches the second angular position being angularly offset from the first angular position by 90 degrees (See annotated Fig. 7A below, “In the distal articulating section 114, there are four pullwire lumens 110 that are equally spaced in an arcuate manner (i.e., ninety degrees apart), and thus, the four corresponding pullwires 108 are equally spaced as well” Col. 13 ln. 23-25).
Regarding claim 15, Bogusky teaches the second angular position being angularly offset from the first angular position by 180 degrees (See annotated Fig. 7A below, “In the distal articulating section 114, there are four pullwire lumens 110 that are equally spaced in an arcuate manner (i.e., ninety degrees apart), and thus, the four corresponding pullwires 108 are equally spaced as well” Col. 13 ln. 23-25 meaning that two of the four pullwires are 180 degrees apart).
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Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Bogusky in view of Romo as evidenced by Arkema (“PEBAX® ELASTOMERS A Polymer in Motion.”, 2022, hereinafter referred to as “Arkema”).
Regarding claim 2, Bogusky teaches the flexible material being longitudinally extensible (Fig. 7 “the distal articulating section 114 preferably allows for a moderate degree of axial compression” in Col. 13 ln. 39-40; and “typical designs [of the catheter body 102] include … Pebax®” in Col. 12 ln. 8).
While Bogusky does not explicitly teach the material property of Pebax® to be longitudinally extensible, Pebax® is a polyether block amide with enduring elasticity as evidenced by Arkema (pg. 2). Therefore, Pebax® of Bogusky would necessarily have this material property of being elastic, which would allow both longitudinally extensible and compressible.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Bogusky in view of Romo, and in further view of Wong et al. (US 20200337593 A1, published Oct. 29, 2020, hereinafter referred to as “Wong”).
Regarding claim 16, Bogusky teaches an apparatus (Fig. 7 “flexible and steerable elongate catheter 100” in Col. 11 ln. 54) comprising: (a) an elongate body (Fig. 7 “elongate catheter 100” in Col. 11 ln. 54) the elongate body defining a central longitudinal axis (see annotated Fig. 7 above), the elongate body including: (i) a sidewall comprising a flexible material (Fig. 7 “the catheter body 102 may be comprised of multiple layers of materials and/or multiple tube structures that exhibit a low bending stiffness, while providing a high axial stiffness along the neutral axis. Typical designs include a nitinol spine encapsulated in braid and any flexible, pliable, or suitable polymer material” in Col. 12 ln. 1-6), (ii) a proximal portion (Fig. 7 “proximal shaft section 120” in Col. 14 ln. 11), and (iii) a distal portion (Fig. 7 “distal articulating section 114” in Col. 14 ln. 2-3), the distal portion terminating at a distal end (Fig. 7 “distal tip 112” Col. 13 ln. 8); (b) a tendon assembly extending through the sidewall (Fig. 7 “pullwires 108 housed within one or more lumens 110 extending through the catheter body 102, and a proximal adapter” in Col. 12 ln. 26-27), the tendon assembly being operable to drive deflection of a portion of the elongate body away from the central longitudinal axis (Fig. 7 “operation of the pullwires 108 may apply force or tension to the control ring 106, which may steer or articulate (e.g., up, down, pitch, yaw, or any direction in-between) the pertinent location, section, portion, or region of the catheter 100, which may in effect provide or define various bend radii for the articulated portion of the catheter 100” in Col. 12 ln. 36-42; also see Fig. 10); and (c) a braid assembly positioned within the sidewall (Fig. 7 “the articulatable portion 128 comprises a double braided layer … embedded within the outer polymer tube” Col. 13 ln. 61-62 and 64-65), the braid assembly comprising strands (“stainless steel wires braided” in Col. 13 ln. 63), the tendon assembly being interwoven with the strands such that the tendon assembly is integrated into the braid assembly (fig. 7 “the distal ends of the pullwires 108 may be directly anchored between the two layers of the braid”).
Bogusky does not disclose wherein the strands form an elongated braided structure along at least part of the proximal portion and the distal portion of the elongate body, the tendon assembly being interwoven with the stands along at least the part of the proximal portion and the distal portion of the elongate body and positioned within a tendon lumen that is disposed in a space defined by the strands.
Romo teaches in one or more of the embodiments described herein the proximal section 438 of the catheter 412 may optionally further include a braid surrounding the coils 448 (e.g., embedded within the way of the jacket 452 or jacket 454) for strengthening and stiffening the proximal section 438. The braid can be stainless steel flat wire or round wire. The braid angle and pic count can be optimized to give the required stiffness and flexibility. The braid may have a constant pattern throughout the proximal section, or there may be a transition in the braid to enable higher bending stiffness at the proximal end (compared to the distal end) and higher flexibility at the distal end (compared to the proximal end) (¶[0409]). The sheath 414 may further include a braided layer 480 for reinforcing the structure of the sheath 414 (FIGS. 41 and 42). In such cases, the coils 474 for housing the control wires 475 may be coupled to the braided layer (¶[0418]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to form an elongated braid throughout at least part of the proximal and distal regions as taught by Romo in the apparatus of Bogusky in order to control the bending stiffness of the device at different regions.
Bogusky and Romo do not teach the tendon assembly positioned within a tendon lumen that is disposed in a space defined by the strands.
Wong’s invention relates to apparatus and methods for integrating and/or registering a shape sensing fiber in or to an instrument or device (¶[0003]). FIGS. 5C-5D illustrate cross sectional views of variations of an elongate instrument having a lumen for a fiber incorporated into the braid of the elongate instrument (¶[0031]). A braid or polyimide braid may be positioned in a proximal section or other portion of the elongate instrument (¶[0061]). FIG. 5D illustrates an alternative variation of a braid pattern. The second fiber lumen 58 and control wire lumens 60 are braided into the catheter wall with multiple layers of braid 56a and 56b, which cross and/or wind around each lumen 58, 60. In one variation, a layer of braid 56a may wind around the outer diameter of the second fiber lumen 58, between the control wire lumens 60 and the center lumen 54. Another layer of braid 56b may be wound, e.g., simultaneously, in the opposite direction as the braid 56a, around the outer diameters of the control wire lumens 60 but winding close to the center lumen 54 between each control wire lumen 60. The braid 56b winds between the second fiber lumen 58 and the center lumen 54. The braid pattern creates a diamond like pattern on or in the elongate instrument when viewed from a side view (not shown) (¶[0069]). The braid 56 and lumen 58 construct provides a mechanism or allows for a method for incorporating or integrating a fiber 59 in the wall of an elongate instrument 200 or shaft of the elongate instrument 200, such that: the fiber 59 is provided with an accurate and reliable radial positioning within the elongate instrument and has minimal twist; the fiber 59 assumes the same shape or substantially the same shape of the elongate instrument during elongate instrument bending; and/or the fiber 59 is free to float and is not impinged or minimally impinged during elongate instrument bending (¶[0071]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to incorporate a braid that is woven around the lumen as taught by Wong in the apparatus of Bogusky and Romo in order to provide accurate and reliable radial positioning within the elongate instrument with minimal twist.
Regarding claim 17, Bogusky teaches the tendon assembly including: (i) a tendon housing extending through the sidewall (Fig. 7 “hollow stiffening tube 130 in the proximal shaft section 120” in Col. 14 ln. 8-10), the tendon housing having a distal end secured at a longitudinal position along the elongate body (Fig. 7 “stiffening tube 130 must be laminated into the catheter body 102, thereby allowing the stiffening tube 130 to support the axial loads on the catheter 100 from the tensioning of the pullwires 108” in Col. 15 ln. 56-59), and (ii) a tendon slidably disposed in the tendon housing (Fig. 7 “inner diameter of the stiffening tube 130 is preferably large enough to allow the pullwires 108 to slide freely without pinching each other” in Col. 15 ln. 47-49), the tendon having a distal portion extending distally from the distal end of the tendon housing, the distal portion of the tendon being fixedly secured relative to the elongate body (Fig. 7 “the distal end of the pullwires are anchored or mounted to the control ring 106 … the control ring 106 is secured to the distal end of the catheter 100” in Col. 12 ln. 35-36 and ln. 42-44).
Romo teaches the sheath 414 may further include a braided layer 480 for reinforcing the structure of the sheath 414 (FIGS. 41 and 42). In such cases, the coils 474 for housing the control wires 475 may be coupled to the braided layer (¶[0418]). Bogusky and Romo do not disclose the tendon housing and tendon being located within the tendon lumen that is disposed in the space defined by the strands.
Wong teaches the benefit to this limitation in the USC 103 rejection from claim 16 above.
Claims 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over Bogusky in view of Romo, as applied to claim 1, and further in view of Alvarez et al. (US 20100280320 A1, published Nov. 4, 2010, hereinafter referred to as “Alvarez”).
Regarding claim 21, Bogusky and Romo teach the apparatus of claim 1.
Bogusky also teaches the elongate body (Fig. 7 “elongate catheter 100” in Col. 11 ln. 54) further including a medial portion (Fig. 7 “a transition section 116” in Col. 13 ln. 9) between the proximal portion (Fig. 7 “proximal shaft section 120” in Col. 14 ln. 11) and the distal portion of the elongate body (Fig. 7 “distal articulating section 114” in Col. 14 ln. 2-3), the first longitudinal position being in the elongate body (Fig. 7 “stiffening tube 130 must be laminated into the catheter body 102, thereby allowing the stiffening tube 130 to support the axial loads on the catheter 100 from the tensioning of the pullwires 108” in Col. 15 ln. 56-59).
Bogusky does not teach the first longitudinal position being in the distal portion of the elongate body and the second longitudinal position being in the medial portion of the elongate body.
As taught in claim 1 rejection, Romo teaches the benefits of the first longitudinal position being in the distal portion of the elongate body.
Although Romo teaches that the location of the flex tubes may be varied to change the stiffness and or bend radius (¶[0380]), Bogusky and Romo do not explicitly teach the second longitudinal position being in the medial portion of the elongate body.
Alvarez’s invention relates to robotically controlled systems, such as robotic or telerobotic surgical systems, and more particularly to flexible and steerable elongate instruments or catheters with adjustable or changeable shape and articulation control for performing minimally invasive surgical operations (¶[0001]). As shown in Fig. 10, the elongate instrument (1000) may include two flex tubes (1006-1 and 1006-2). The first flex tube (1006-1) may operate as a support structure to provide the support (e.g., lateral stiffness or support) necessary to form or maintain the straight portion of the "J". Similar to the construction of other embodiments as previously described, the distal end of flex tube (1006-1) may be anchored to the elongate body near the distal section of first section (1002-1) of the elongate body where it may not be covered by the operational tube (1004-1). In its compressed or substantially stiffened or rigid state, the flex tube (1006-1) may be used to support the deflection or articulation of the second section (1002-2) (second longitudinal position) of the elongate instrument. The second section (1002-2) may be deflected or articulated by operating the pull wire (1014-1). The distal end of the pull wire (1014-1) may be anchored to a control ring (1016-1) or an anchoring point near the distal portion of the second section (1002-2). The proximal end of the pull wire (1014-1) may be operatively coupled to a control unit or splayer (not shown) that operates the pull wire. The distal end of the second flex tube (1006-2) may be anchored to the elongate instrument near the distal portion of second section (1002-2) where it may be exposed out of the second operational tube (1004-2). The second pull wire (1014-2) may be operated to steer or articulate the third section (1002-3) into the desired curvature to form the "J" shape. The distal end of the second pull wire (1014-2) may be anchored to the second control ring (1016-2) or to an anchor point on the elongate body near the distal portion of the third section (1002-3). The proximal end of the second pull wire (1014-2) may be operatively coupled to a control unit or splayer (not shown) that operates the pull wire. Although two examples of complex shapes or curvatures may be formed by a flexible and steerable elongate body with variable or changeable shape control and support elements as illustrated and described, many other complex shapes or curvatures may be form by an elongate body in accordance with various embodiments of the present invention (¶[0076]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have the second longitudinal position being in the medial portion of the elongate body as taught by Alvarez in the apparatus of Bogusky and Romo in order to provide lateral stiffness and support in regions where less articulation is desired and allow deflection in the medial region.
Regarding claim 22, Bogusky teaches the first tendon assembly being operable to drive deflection of the distal portion of the elongate body upon tension applied to the first tendon (Fig. 7 “operation of the pullwires 108 may apply force or tension to the control ring 106, which may steer or articulate (e.g., up, down, pitch, yaw, or any direction in-between) the pertinent location, section, portion, or region of the catheter 100, which may in effect provide or define various bend radii for the articulated portion of the catheter 100” in Col. 12 ln. 36-42; also see Fig. 10).
Bogusky and Romo do not teach the first tendon housing providing isolation against compressive forces in the medial portion of the elongate body upon the tension applied to the first tendon, the second tendon assembly being operable to drive deflection of the medial portion of the elongate body upon tension applied to the second tendon, the second tendon housing providing isolation against compressive forces in the proximal portion of the elongate body upon the tension applied to the second tendon.
Alvarez teaches, as shown in Fig. 10, the elongate instrument (1000) may include two flex tubes (1006-1 and 1006-2). The first flex tube (1006-1) may operate as a support structure to provide the support (e.g., lateral stiffness or support) necessary to form or maintain the straight portion of the "J". Similar to the construction of other embodiments as previously described, the distal end of flex tube (1006-1) may be anchored to the elongate body near the distal section of first section (1002-1) of the elongate body where it may not be covered by the operational tube (1004-1). In its compressed or substantially stiffened or rigid state, the flex tube (1006-1) may be used to support the deflection or articulation of the second section (1002-2) of the elongate instrument. The second section (1002-2) may be deflected or articulated by operating the pull wire (1014-1). The distal end of the pull wire (1014-1) may be anchored to a control ring (1016-1) or an anchoring point near the distal portion of the second section (1002-2). The proximal end of the pull wire (1014-1) may be operatively coupled to a control unit or splayer (not shown) that operates the pull wire (second tendon assembly drives deflection of medial portion upon tension to second tendon and the housing providing isolation against compressive forces in the proximal portion). The distal end of the second flex tube (1006-2) may be anchored to the elongate instrument near the distal portion of second section (1002-2) where it may be exposed out of the second operational tube (1004-2). The second pull wire (1014-2) may be operated to steer or articulate the third section (1002-3) into the desired curvature to form the "J" shape (the first tendon housing providing isolation against compressive forces in the medial portion of the elongate body upon the tension applied to the first tendon). The distal end of the second pull wire (1014-2) may be anchored to the second control ring (1016-2) or to an anchor point on the elongate body near the distal portion of the third section (1002-3). The proximal end of the second pull wire (1014-2) may be operatively coupled to a control unit or splayer (not shown) that operates the pull wire. Although two examples of complex shapes or curvatures may be formed by a flexible and steerable elongate body with variable or changeable shape control and support elements as illustrated and described, many other complex shapes or curvatures may be form by an elongate body in accordance with various embodiments of the present invention (¶[0076]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have the second longitudinal position being in the medial portion of the elongate body and provide isolation against compressive forces in the proximal region and the first position providing isolation against compressive forces in the medial region as taught by Alvarez in the apparatus of Bogusky and Romo in order to provide lateral stiffness and support in regions where less articulation are desired and allow deflection in different region.
Regarding claim 23, Bogusky teaches the distal portion of the first tendon being fixedly secured at the distal end of the elongate body, the distal portion of the second tendon being fixedly secured at the distal end of the elongate body (Fig. 7 “the distal end of the pullwires are anchored or mounted to the control ring 106 … the control ring 106 is secured to the distal end of the catheter 100” in Col. 12 ln. 35-36 and ln. 42-44).
Regarding claim 24, Bogusky teaches an apparatus (Fig. 7 “flexible and steerable elongate catheter 100” in Col. 11 ln. 54) comprising: an elongate body (Fig. 7 “elongate catheter 100” in Col. 11 ln. 54) comprising a proximal portion (Fig. 7 “proximal shaft section 120” in Col. 14 ln. 11), a medial portion (Fig. 7 “a transition section 116” in Col. 13 ln. 9), and a distal portion (Fig. 7 “distal articulating section 114” in Col. 14 ln. 2-3); a first tendon assembly (Fig. 7 “pullwires 108 housed within one or more lumens 110 extending through the catheter body 102, and a proximal adapter” in Col. 12 ln. 26-27) comprising a first tendon housing and a first tendon (Fig. 7 “pullwires 108 housed within one or more lumens 110 extending through the catheter body 102” in Col. 12 ln. 26-27), the first tendon operable to drive deflection of the distal portion in a first direction (Fig. 7 “operation of the pullwires 108 may apply force or tension to the control ring 106, which may steer or articulate (e.g., up, down, pitch, yaw, or any direction in-between) the pertinent location, section, portion, or region of the catheter 100, which may in effect provide or define various bend radii for the articulated portion of the catheter 100” in Col. 12 ln. 36-42; also see Fig. 10), and a second tendon assembly with a second tendon angularly spaced from the first tendon assembly (See annotated Fig. 7A above for claims 14-15, “In the distal articulating section 114, there are four pullwire lumens 110 that are equally spaced in an arcuate manner (i.e., ninety degrees apart), and thus, the four corresponding pullwires 108 are equally spaced as well” Col. 13 ln. 23-25).
Bogusky also teaches with the stiffening tube must be laminated into the catheter body allowing the stiffening tube to support the axial loads on the catheter from tensioning the pullwires (Col. 15, ln. 56-59).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have the first longitudinal position be in the distal portion of the elongate body as taught by Bogusky as having the stiffening tube terminate at the distal portion would produce the same benefits of supporting axial loads on the catheter.
Bogusky does not teach the first tendon housing distally terminating at the distal portion and the first tendon housing providing isolation against forces in the medial portion and the proximal portion as the first tendon drives the deflection of the distal portion in the first direction; the second tendon assembly comprising a second tendon housing, the second tendon housing distally terminating at the medial portion, the second tendon operable to drive deflection of the medial portion and the distal portion in a second direction, the second tendon housing providing isolation against forces in the proximal portion as the second tendon drives the deflection of the medial portion and the distal portion in the second direction.
Referring to Fig. 33A of Romo, the distal portion of the flex tubes 306 (first tendon housing) may be secured at respective anchor points or regions 320 of the elongate instrument 300. Anchoring the flex tubes 306 to the elongate instrument 300 may provide the connections or couplings that allow force or load to be transferred from the flex tubes 306 to the elongate instrument 300 when force or load is applied to the flex tubes. The anchor points 320 may function as coupling points from one portion (e.g., distal portion) of the elongate instrument 300 to the flex tubes 306 where force or load may be transferred from one portion (e.g., distal portion) of the elongate instrument to the flex tubes (¶[0385]). Romo teaches that with the introduction of one or more flex tubes 306 (tendon housing) of Fig. 33A into the body of the elongate instrument or a section of the elongate instrument, the elongate instrument or the section of the elongate instrument with the flex tubes 306 may become less flexible; even though the flex tubes 306 are flexible in bending, they have axial stiffness. Several axially stiff members spread throughout the cross section of a catheter may add significant bending stiffness to the catheter (¶[0380]). One or more pull wires 314 (tendons) may be disposed within lumens of the support tubes 310, lumens of the flex tubes 306, and lumens of the push tubes 308 (¶[0385]). As can be seen in Fig. 33A and Fig. 33B, there are two flex tubes 306 indicating a second tendon housing and two pull wires 314 disposed in the respective tendon housings. Since the flex tubes 306 are incorporated or coupled to the wall of the elongate instrument 300 and the flex tubes 306 are substantially configured to support axial loading, the articulation or steering loads may be decoupled from the elongate instrument 300 at the point or location where the flex tubes 306 are incorporated or coupled to the wall of the elongate instrument 300 (¶[0383]). The distal portion of the flex tubes 306 may be secured at respective anchor points or regions 320 of the elongate instrument 300 (¶[0385]). Further, the distal end or portion of one or more pull wires 314 may be anchored or mounted to the control ring 316 (¶[0382]) where in Fig. 33A, the control ring 316 is distal from the distal portion of flex tubes 306 or region 320. A distal end or portion of the flex tubes 306 may be fixedly coupled to the elongate instrument. In some variations, a proximal end or portion of the flex tubes may also be fixedly coupled to the elongate instrument 300 as in a passively controlled configuration of the flex tubes 306 (¶[0379]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to secure the first tendon housing proximal to the distal end of the elongate body and to incorporate a second tendon assembly with a second tendon housing as taught by Romo in the device of Bogusky in order to allow force or load to be transferred from the tendon housing to the elongate body when force or load is applied to the flex tubes and add significant bending stiffness to the flexible elongate body.
Bogusky and Romo do not teach the first tendon housing providing isolation against forces in the medial portion and the proximal portion as the first tendon drives the deflection of the distal portion in the first direction, the second tendon housing distally terminating at the medial portion, the second tendon operable to drive deflection of the medial portion and the distal portion in a second direction, the second tendon housing providing isolation against forces in the proximal portion as the second tendon drives the deflection of the medial portion and the distal portion in the second direction.
Alvarez teaches, as shown in Fig. 10, the elongate instrument (1000) may include two flex tubes (1006-1 and 1006-2). The first flex tube (1006-1) may operate as a support structure to provide the support (e.g., lateral stiffness or support) necessary to form or maintain the straight portion of the "J". Similar to the construction of other embodiments as previously described, the distal end of flex tube (1006-1) may be anchored to the elongate body near the distal section of first section (1002-1) of the elongate body where it may not be covered by the operational tube (1004-1). In its compressed or substantially stiffened or rigid state, the flex tube (1006-1) may be used to support the deflection or articulation of the second section (1002-2) of the elongate instrument. The second section (1002-2) may be deflected or articulated by operating the pull wire (1014-1). The distal end of the pull wire (1014-1) may be anchored to a control ring (1016-1) or an anchoring point near the distal portion of the second section (1002-2). The proximal end of the pull wire (1014-1) may be operatively coupled to a control unit or splayer (not shown) that operates the pull wire (second tendon assembly drives deflection of medial portion upon tension to second tendon and the housing providing isolation against compressive forces in the proximal portion). The distal end of the second flex tube (1006-2) may be anchored to the elongate instrument near the distal portion of second section (1002-2) where it may be exposed out of the second operational tube (1004-2). The second pull wire (1014-2) may be operated to steer or articulate the third section (1002-3) into the desired curvature to form the "J" shape (the first tendon housing providing isolation against compressive forces in the medial portion of the elongate body upon the tension applied to the first tendon). The distal end of the second pull wire (1014-2) may be anchored to the second control ring (1016-2) or to an anchor point on the elongate body near the distal portion of the third section (1002-3). The proximal end of the second pull wire (1014-2) may be operatively coupled to a control unit or splayer (not shown) that operates the pull wire. Although two examples of complex shapes or curvatures may be formed by a flexible and steerable elongate body with variable or changeable shape control and support elements as illustrated and described, many other complex shapes or curvatures may be form by an elongate body in accordance with various embodiments of the present invention (¶[0076]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to have the second longitudinal position being in the medial portion of the elongate body and provide isolation against compressive forces in the proximal region and the first position providing isolation against compressive forces in the medial region as taught by Alvarez in the apparatus of Bogusky and Romo in order to provide lateral stiffness and support in regions where less articulation are desired and allow deflection in different region.
Regarding claim 25, Bogusky teaches the apparatus further comprising: a third tendon assembly angularly spaced from the second tendon assembly, the third tendon assembly comprising a third tendon, the third tendon operable to drive deflection of the distal portion in a third direction, and a fourth tendon assembly angularly spaced from the third tendon assembly, the fourth tendon assembly comprising a fourth tendon (See annotated Fig. 7A above for claims 14-15, “In the distal articulating section 114, there are four pullwire lumens 110 that are equally spaced in an arcuate manner (i.e., ninety degrees apart), and thus, the four corresponding pullwires 108 are equally spaced as well” Col. 13 ln. 23-25).
Bogusky does not disclose the third tendon assembly comprising a third tendon housing and the third tendon housing distally terminating at the distal portion, the third tendon housing providing isolation against forces in the medial portion and the proximal portion as the third tendon drives the deflection of the distal portion in the third direction; the fourth tendon assembly comprising a fourth tendon housing and the fourth tendon housing distally terminating at the medial portion, the fourth tendon operable to drive deflection of the medial portion and the distal portion in a fourth direction, the fourth tendon housing providing isolation against forces in the proximal portion as the fourth tendon drives deflection of the medial portion and the distal portion in the fourth direction.
As discussed in the 35 USC 103 rejection for claim 24 above, the benefits of having a second tendon assembly with a second housing along with the benefits of termination of the housing in the medial region versus the distal region for providing isolation forces was provided with the teachings of Romo and Alvarez. Adding third and fourth tendon assemblies with housing that terminate in the same region as the first and second tendon assemblies to the apparatus of are a result-effective way to provide more axial support to the device and provide more degrees of freedom for articulation.
Furthermore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a third and fourth tendon assembly instead of just a first and second, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 26, Bogusky teaches the first and third tendon assemblies being angularly offset 180 degrees from each other, the second and fourth tendon assemblies being angularly offset 180 degrees from each other, and the first and third tendon assemblies being angularly offset 90 degrees from the second and fourth tendon assemblies (See annotated Fig. 7A above in the rejections for claims 14-15, “In the distal articulating section 114, there are four pullwire lumens 110 that are equally spaced in an arcuate manner (i.e., ninety degrees apart), and thus, the four corresponding pullwires 108 are equally spaced as well” Col. 13 ln. 23-25 meaning that two of the four pullwires are 180 degrees apart).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/E.N.C./Patent Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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