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 amendments filed on 04/06/2026 have been entered. The amendments to the drawings overcome each of the drawing objections set forth in the previous office action dated 01/05/2026.
Response to Arguments
Applicant's arguments filed 04/06/2026 have been fully considered but they are not persuasive. Applicant argues that Gittard does not provide sufficient teaching to modify Chan such that the sealing surface is functionalized by a primer.
Applicant argues 1) that the tubular member 102 of Gittard is made of a polymer, not a metallic material, and therefore Gittard provides not teaching regarding functionalizing a sealing surface between a metallic material and a polymer material as claimed. Examiner agrees that Gittard teaches using Silane as a primer between a polymer (tubular member 102, [0099]) and another polymer (126, which [0095] discloses comprises a polymer backbone). However, it is the examiners position that one of ordinary skill recognizes silane as a primer commonly known in the art form bonding metal to polymer equally as well and commonly as bonding polymer to polymer. It is the examiners position that because Chan already teaches the control structure being metallic and the polymer material, that GIttard is only being relied upon to teach functionalization of a surface with a primer. Therefore, there is sufficient teaching from Gittard to provide silane as a primer layer between the control structure and polymer material layer of Chan.
Applicant argues 2) that Gittard fails to teach functionalization of the surface with the primer. It is the examiners position that the process of adding the primer to the sealing surface of the control structure of Chan is itself a functionalization of the surface. Functionalization in its broadest sense can be interpreted as the process of adding, modifying, or replacing surface or molecular groups to impart new properties, such as changing solubility, reactivity, or electronic characteristics. Therefore, adding the primer which imparts a new property to the surface (increasing adhesion) is considered functionalizing the surface.
Applicant argues 3) that the purpose of the primer in Gittard would not be applicable to the device of Chan. It is the examiners position that the point of emphasis with the teaching of layer 126 of Gittard “conductive ink portion” is less regarding the purpose of the conductive ink particles and more pertaining to the fact that 126 is a polymer layer. The conducting ink is simply particles suspended in the polymer, but the focus of the teaching is that Silane is a known primer to attach a polymer to a surface. Gittards disclosure of the purpose of attaching the conductive ink particles to the tubular member is not pertinent to the teaching being applied in the modification of Chan, which is only the concept that silane is a known primer for facilitating an adhesion between a polymer and another surface. Examiner believes that sufficient evidence has been provided that one of ordinary skill in the art at the time of filing would be motivated based on the teachings of Gittard to use silane as a primer between the sealing surface and the polymer material, particularly since Chan teaches treating various layers of the device to increase adhesion between adjacent layers ([0099, 0129]).
For at least the reasons stated above, applicants’ arguments are not found to be persuasive.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-6 and 10 are rejected under 35 U.S.C. 103 as being obvious over Chan (US 2020/0222666) in view of Gittard et al. (US 2017/0042609).
Regarding claim 1-3, Chan discloses a flexible elongate device (400, FIG 4A, including distal section 600, FIGs 6A, which is disclosed as being a distal section of device 400, [0090], and distal mount 900, FIG 9, which is discloses as being a distal mount of device 400, [0111]), comprising: an articulable body portion (Distal section 404, which can be steered via control elements 421, [0069]); a control structure (Distal mount 422, particularly distal mount 900 of FIG 9, [0112] comprising control ring 910) attached with one or more pull wires that control articulation of the articulable body portion (940, [0113]), the control structure comprising a metallic material ([0112] discloses 910 can be composed of stainless steel) defining a sealing surface (The proximal end and outer annular surface of ring 910); and a polymer material (Outer jacket layer 633) disposed onto the sealing surface of the control structure to create a seal between the control structure and polymer material (FIG 9 shows where 930 and control wires 940 abut and connect to the proximal end of 910. These elements are equivalent to the layers and segments taught in distal section 600 of FIGs 6A-6B, including outer jacket layer 633, which is understood to surround and form a seal with 910).
Chan teaches that adhesion between various layers and components can be improved via treatment such a chemical etching or mechanical roughening, but is silent regarding the sealing surface being functionalized by a primer comprising a phosphonate or a silane (claim 2) and comprising a reacted primer covalently bonded with the sealing surface of the control structure (Claim 3).
However, Gittard et al teaches functionalizing the sealing surface of a tubular member (102) with a primer layer (1702, [0102]) to improve adhesion, wherein the primer comprises silane ([0102]) and creates a covalent bond ([0104-0106]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the sealing surface of the control structure such that it is functionalized by a primer, specifically silane, and therefore resulting in a covalent bond upon adhesion, as taught by Gittard, for the purpose of utilizing a technique commonly known in the art for preparing a surface to form a stronger bond with the outer jacket.
Regarding claim 4, Chan/Gittard disclose the invention substantially as claimed, as set forth above in claim 1. Chan further discloses the polymer material comprises an outer jacket defining an exterior surface of the articulable body portion ([0097]); and the sealing surface comprises an exterior surface portion of the control structure (As defined above, the sealing surface is interpreted as an exterior surface of control structure 910).
Regarding claim 5, Chan/Gittard disclose the invention substantially as claimed, as set forth above in claim 4. Chan further discloses an inner liner (922, FIG 9, [0112]) defining an interior channel of the articulable body portion (The liner 922 forms an annular shape which surrounds the lumen, therefore it is interpreted as defining an interior channel thereof); and a tip ring (920, [0112]) coupled to a distal end of the articulable body portion (FIG 9), the inner liner including a portion captured between the tip ring and the control structure ([0112] discloses liner 922 would provide a seal between the control ring 910 and tip ring 920).
Regarding claim 10, Chan/Gittard disclose the invention substantially as claimed, as set forth above in claim 1. Chan further discloses a tie layer disposed between the polymer material and the control structure ([0098] discloses a tie layer 639 which is disposed in at least some layer between the polymer layer and the control structure).
Regarding claims 1 and 6, Chan discloses in an alternative interpretation, a flexible elongate device (400, FIG 4A, including distal section 600, FIGs 6A, which is disclosed as being a distal section of device 400, [0090], and distal mount 900, FIG 9, which is discloses as being a distal mount of device 400, [0111]), comprising: an articulable body portion (Distal section 404, which can be steered via control elements 421, [0069]); a control structure (Distal mount 422, particularly distal mount 900 of FIG 9, [0112] comprising control ring 910) attached with one or more pull wires that control articulation of the articulable body portion (940, [0113]), the control structure comprising a metallic material ([0112] discloses 910 can be composed of stainless steel) defining a sealing surface (The inner annular surface of ring 910); and a polymer material (liner 922, [0112]) disposed onto the sealing surface of the control structure to create a seal between the control structure and polymer material ([0112] discloses liner 922 would provide a seal between the control ring 910 and tip ring 920), wherein the polymer material comprises an inner liner defining an interior channel of the articulable body portion (The liner 922 forms an annular shape which surrounds the lumen, therefore it is interpreted as defining an interior channel thereof); and the sealing surface comprises an interior surface portion of the control structure ([0112], FIG 9, polymer liner layer 922 is positioned at an interior surface portion of 910).
Chan teaches that adhesion between various layers and components can be improved via treatment such a chemical etching or mechanical roughening, but is silent regarding the sealing surface being functionalized by a primer.
However, Gittard et al teaches functionalizing the sealing surface of a tubular member (102) with a primer layer (1702, [0102]) to improve adhesion, wherein the primer comprises silane ([0102]) and creates a covalent bond ([0104-0106]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the sealing surface of the control structure such that it is functionalized by a primer, as taught by Gittard, for the purpose of utilizing a technique commonly known in the art for prepping a surface to form a stronger bond with the inner liner.
Claim(s) 7-9 are rejected under 35 U.S.C. 103 as being obvious over Chan (US 2020/0222666) in view of Gittard et al. (US 2017/0042609), further in view of Van Hoven et al. (US 2016/0367787).
Regarding claims 7-9, Chan/Gittard disclose the invention substantially as claimed, as set forth above in claim 1. Chan further discloses the control structure comprises a tubular body having a proximal section with an exterior surface defining the sealing surface (910 is a tubular structure wherein the proximal end is interpreted as the proximal section and the exterior surface defines the sealing sureface0.
The control structure of Chan is a continuous tubular ring shape and therefore fails to disclose an intermediate section defining a lateral surface disposed adjacent to and extending away from the sealing surface, and the polymer material is disposed onto the control structure to abut the lateral surface, wherein the intermediate section defines a second sealing surface functionalized by the primer on the lateral surface, and the polymer material is disposed on the second sealing surface such that the seal extends to the second sealing surface, and wherein the tubular body of the control structure further comprises a distal section extending longitudinally from the intermediate section and defining a third sealing surface functionalized by the primer, and the polymer material is disposed on the third sealing surface such that the seal extends to the third sealing surface.
However, Van Hoven teaches in the same field of endeavor a control structure (tip ring 380 (FIGs 3A-3C) positioned at the distal end of a flexible elongate member (Steerable guide catheter 1000, [0030]) which receives pull wires (90) to control articulation ([0035-0045]), wherein the control section comprises a proximal section (See annotated FIG 3A below) with an exterior surface defining the sealing surface (This surface is on the exterior of the ring and forms a sealing surface because it forms part of the pathway which is configured to receive an adhesive and/or polymer for attaching the tip ring 380 to a catheter or strengthening the attachment to a catheter, [0045]), an intermediate section defining a lateral surface disposed adjacent to and extending away from the sealing surface (See annotated FIG 3A, the intermediate surface is interpreted as a section of the lateral wall which extends radially outward from the proximal section) wherein the intermediate section defines a second sealing surface (This surfaces is also a part of the channel which receives polymer layer, therefore it forms a second sealing surface), and a distal section extending longitudinally from the intermediate section (See annotated FIG 3A) and defining a third sealing surface (This surfaces is also a part of the channel which receives polymer layer, therefore it forms a second sealing surface).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the shape of the control structure of Chan with that taught by Van Hoven, including the channel which defines intermediate and distal sections as claimed, for the purpose of substituting a commonly known structure shape and thereby achieving the predictable result of forming a ring which connects to the pull wires for articulation and which attached to an outer polymer liner. In the device as modified by Gittard, the entire control structure is functionalized by the primer. Therefore, the limitations of the second sealing surface being functionalized by the primer on the lateral surface and the third sealing surface being functionalized by the primer are met. Further, in the device as modified by Van Hoven, the polymer material is connected to the exterior surfaces of the control structure, specifically within the channels that form the proximal. Intermediate, and distal sections. Therefore, the limitations of the polymer material being disposed on the second sealing surface such that the seal extends to the second sealing surface and the polymer material being disposed on the third sealing surface such that the seal extends to the third sealing surface are met.
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Claim(s) 11 is rejected under 35 U.S.C. 103 as being obvious over Chan (US 2020/0222666) in view of Gittard et al. (US 2017/0042609), further in view of Taha et al. (US 2023/0263957).
Regarding claim 11, Chan/Gittard disclose the invention substantially as claimed, as set forth above in claim 10.
Chan is silent regarding the material of the tie layer, specifically the tie layer comprising oxide layer.
However, Taha teaches a tubular medical device (210, FIG 3) comprising a tie layer (289, [0364]) in the form of an oxide layer ([0364] discloses due to its adhesion to polymeric films, zinc oxide (ZnO) in particular may serve as a high-quality tie coating or layer 289) in order to enhance the adhesion to polymeric film layers.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to select zinc oxide as the tie layer, as taught by Taha, for the purpose of utilizing a material commonly known in the art for improving bonding/adhesion to a polymeric layer.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being obvious over Chan (US 2020/0222666) in view of Gittard et al. (US 2017/0042609), further in view of Wang et al. (US 2024/0033482).
Regarding claim 12, Chan/Gittard disclose the invention substantially as claimed, as set forth above in claim 1.
Chan further teaches the polymer layer 633 can be a thermoplastic ([0097]) but is silent regarding said thermoplastic being a high durometer polyurethane.
However, Wang teaches a flexible elongate device (12010, FIG 3) comprising a polymer outer layer (12020, [0058]) formed of a high durometer polyurethane ([0058] discloses polyurethane and discloses “the hardness of the elastomer of the outer layer 12020…is 55D”).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to select a high density polyurethane as the polymer layer, as taught by Wang, for the purpose of utilizing a material commonly known in the art for forming a polymeric outer layer of a flexible elongate device and having the desired hardness and flexibility properties such that bending properties are optimized.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771
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