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 .
Status of Claims
Claims 1-20 are currently pending and under consideration.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-17, drawn to an apparatus, classified in A61B 34/71.
II. Claims 18-20, drawn to a method, classified in A61B 1/0057.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as process of making and product made. The inventions are distinct if either or both of the following can be shown: (1) that the process as claimed can be used to make another and materially different product or (2) that the product as claimed can be made by another and materially different process (MPEP § 806.05(f)). In the instant case the product as claimed can be made by a materially different process such as extrusion.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
During a telephone conversation with Jonathan Siderits on Nov. 7, 2025 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-17. Affirmation of this election must be made by applicant in replying to this Office action. Claims 18-20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 20, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "22" and "213" have both been used to designate “end effector”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “90” has been used to designate both “alternating EM field” and “access sheath”. Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: element 90 in Fig. 3. Corrected drawing sheets in compliance with 37 CFR 1.121(d) 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.
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.
Specification
The disclosure is objected to because of the following informalities:
“at only one ore at more than two” in ¶[00055] should be changed to “at only one or at more than two”;
“control ring (504)” appears three times in ¶[00057] and should be changed to “control ring (506)”.
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 3 objected to because of the following informalities: “flexile” is misspelled and should be changed to “flexible”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14 and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “approximately” in claim 14 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the claim limitation of “approximately 90 degrees” is rendered indefinite. For the purpose of examination, “approximately 90 degrees” has been interpreted as 89-91 degrees.
The term “approximately” in claim 15 is a relative term which renders the claim indefinite. The term “approximately” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the claim limitation of “approximately 180 degrees” is rendered indefinite. For the purpose of examination, “approximately 180 degrees” has been interpreted as 179-181 degrees.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 7 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 7 depends on claim 1, however, the claim fails to further limit the subject matter of claim 1. Claim 7 recites “the first tendon assembly forming a Bowden cable assembly”. Bowden cable is an internal cable typically coaxially surrounded by a housing or sleeve through which the cable is free to move and can be used to apply either tensile or compressive forces in order to articulate the device and can be actuated to deliver forces as desired at locations on a device (see ¶[0010] Ohline et al. (US 20030045778 A1, published Mar. 6, 2003, hereinafter referred to as “Ohline”)). As such, the limitation of claim 7 does not seem to further limit claim 1 since limitations of “the first tendon assembly being operable to drive deflection of a portion of the elongate body away from the central longitudinal axis, the first tendon assembly including: (i) a first tendon housing extending through the sidewall at a first angular position about the central longitudinal axis, the first tendon housing having a distal end secured at a first longitudinal position along the elongate body, and (ii) a first tendon slidably disposed in the first tendon housing, 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” seems to be the actual description of Bowden cable structure and how it functions.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-7, 9-12, and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bogusky (US 8671817 B1, published Mar. 18, 2014, hereinafter referred to as “Bogusky”).
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); and (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).
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Regarding claim 3, Bogusky teaches the flexile 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 7, as the claim does not further limit claim 1, the claim is rejected for the same reason as claim 1.
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 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”).
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).
Claim 2 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bogusky as evidenced by Arkema (“PEBAX® ELASTOMERS A Polymer in Motion.” Arkema. 2022. Date accessed: 21 Jan. 2026 https://page.arkema.com/rs/253-HSZ-754/images/pebax-elastomer-brochure.pdf?mkt_tok=MjUzLUhTWi03NTQAAAGfgJmCtc2wXYKDPU8o1ty84mLLV2fO7BW91WeuHSdZn0y70Ulehs3WK2n8_kOieh2xmnGTCVd7dtLUfPGMeqZNSj3fFOZuMRj0F3Jv9FrEQQ, 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.
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 8 and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Bogusky in view of Romo et al. (US 20120071822 A1, published Mar. 22, 2012, hereinafter referred to as “Romo”).
Regarding claim 8, Bogusky teaches the apparatus of claim 1, however the embodiment relied on for claim 1 does not include the first longitudinal position being proximal to the distal end of the distal portion of the elongate body.
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]).
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 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.
Regarding claim 13, Bogusky teaches the apparatus of claim 1. Bogusky also teaches the apparatus further comprising 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), 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).
The embodiment relied on for claim 1 does not include the second tendon assembly including: (i) a second tendon housing extending through the sidewall at a second angular position about the central longitudinal axis, the second tendon housing having a distal end secured to the elongate body, and (ii) a second tendon 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 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.
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to incorporate a second tendon assembly with a second tendon housing as taught by Romo in the device of Bogusky in order to add significant bending stiffness to the flexible elongate body.
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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Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Brushenko et al. (US 3572325 A, published Mar. 23, 1971) – flexible tubes with multiple coils
Banik et al. (US 20050197536 A1, published Sept. 8, 2005) – women wires through stent
Macnamara et al. (US 20070232858 A1, published Oct. 4, 2007) – additional definition with Bowden cables
Alvarez et al. (US 20100280320 A1, published Nov. 4, 2010) – depicts cables that terminate at separate locations
Ataollahi et al. (US 20140350462 A1, published Nov. 27, 2014) – discusses limitations in claim 1
Wong et al. (US 20200337593 A1, published Oct. 29, 2020) – integrated braid
Romo et al. (US 20200406002 A1, published Dec. 31, 2020) – discusses limitations in claim 1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emily N Cirulnick whose telephone number is (571)272-9734. The examiner can normally be reached M-Th 8-5 ET and every other F 8-4 ET.
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.
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/E.N.C./Patent Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792