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 preliminary amendment filed October 11, 2024 has been entered. Claims 21-57 are currently pending.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/602,469, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. In particular, the earlier application at least fails to provide support for:
Figures 1A-1L
A plurality of inactive segments as recited in the specification
Third and fourth pull wires
Method steps of withdrawing an inner catheter from the medical device, returning the medical device to a normal configuration, advancing the medical device to a different target vessel, applying a force to a second, third, or fourth pull wire to reconfigure the medical device from the normal configuration into a deflected configuration and thereby steer the distal end of the medical device into a third target vessel, and further advancing the inner catheter through the medical device and into a fourth or fifth target vessel.
Sequentially applying force to different pull wires.
Accordingly, claims 23-31, 35, 45-47, 52-56 are not entitled to the benefit of the earlier application, 16/602,469.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/423,502, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. In particular, the earlier application at least fails to provide support for:
Method steps of withdrawing an inner catheter from the medical device, returning the medical device to a normal configuration, advancing the medical device to a different target vessel, applying a force to a second, third, or fourth pull wire to reconfigure the medical device from the normal configuration into a deflected configuration and thereby steer the distal end of the medical device into a third target vessel, and further advancing the inner catheter through the medical device and into a fourth or fifth target vessel.
Sequentially applying force to different pull wires.
Accordingly, claims 23-31, 35, 45-47, 52-56 are not entitled to the benefit of the earlier application, 17/423,502.
It is noted the earlier applications provide support for accessing several different vessels separately. However, the earlier applications do not provide support for the claimed method steps of repositioning and steering the medical device to combine the positions of Figures 2-19.
This application repeats a substantial portion of prior Application No. 16/602,469, filed October 11, 2019, and adds disclosure not presented in the prior application. Because this application names the inventor or at least one joint inventor named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
This application repeats a substantial portion of prior Application No. 17/423,502, filed October 11, 2019, and adds disclosure not presented in the prior application. Because this application names the inventor or at least one joint inventor named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The specification fails to provide support for at least the subject matter of claims 23-31, 35, 45-47, and 52-56, as amended in the preliminary amendment filed on the filing date of the instant application, October 11, 2024.
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 32-33 is 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.
Claim 32 recites the limitation "the second pull wire" in line 1 and “the first steerable segment”. There is insufficient antecedent basis for this limitation in the claim. It is noted claim 32 depends on claim 21, which only introduces “at least one pull wire” and “at least one steerable segment”.
Claim 33 recites the limitation "the second pull wire" in line 1 and “the first steerable segment”. There is insufficient antecedent basis for this limitation in the claim. It is noted claim 32 depends on claim 21, which only introduces “at least one pull wire” and “at least one steerable segment”.
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 39 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 39 depends from canceled claim 16. 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 § 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.
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.
Claim(s) 21-35, 37-47, and 49-57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boury (US 5,916,147, hereinafter “Boury”) in view of Chou et al. (US 2021/0330332, hereinafter “Chou”).
Regarding claim 21, Boury discloses the invention substantially as claimed including a method of establishing access to a vascular target site in a patient (para []), the method comprising:
introducing a medical device (10), wherein the medical device includes: a proximal end; a distal end; at least one steerable segment (30) (col 3, ln 66 – col 4, ln 2); and at least one pull wire (34) connected to the at least one steerable segment (30) to thereby facilitate reconfiguration of the medical device between a normal configuration (Fig 1A), in which the medical device is generally linear in configuration, and a deflected configuration, in which the at least one steerable segment of the medical device is non-linear in configuration (Fig 1B) (col 5, ln 10-16; col 6, ln 8-61).
Boury teaches the medical device is a generic catheter adaptable to a variety of uses, including selective cerebral angiography (col 4, ln 25-27). The steerability of the catheter allows it to be more readily positioned in a variety of vessels and can be manipulated by the physician even after the catheter is placed in the body (col 2, ln 53-59). Furthermore, Boury teaches an inner catheter or second device may be delivered through the medical device (10) (col 9, ln 2). However, Boury fails to disclose the specific steps of establishing trans-radial access to a vascular target site in a patient, introducing the medical device via a percutaneous opening into the patient's right radial artery, advancing the distal end of the medical device into the patient's right subclavian artery, and advancing an inner catheter through the medical device and into the patient's right vertebral artery.
Chou discloses a method of endovascular interventions in neurovascular anatomy and teaches establishing trans-radial access to a vascular target site in a patient (para [0195]), introducing a medical device (sheath or catheter ) via a percutaneous opening into the patient's right radial artery (para [0195]), advancing the distal end of the medical device into a variety of vessels including the right or left subclavian artery (para [0102-0103,0111]), right or left vertebral artery (para [0111]), and the right or left common carotid artery (para [0102-0103]). Chou teaches the method comprises advancing the distal end of the medical device (sheath 905) into a first target area of the vasculature and advancing an inner catheter (stent delivery system 915) through the medical device into a second target area of the vasculature (para [0095]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boury such that the medical device (10) was used in a method of establishing trans-radial access to a vascular target site in a patient and comprised the steps introducing the medical device via a percutaneous opening into the patient's right radial artery, advancing the medical device into the patient’s right subclavian artery, and advancing an inner catheter through the medical device into the patient’s right vertebral artery since Boury teaches the catheter may be adapted to a variety of uses and Chou teaches the target vessels and since Boury and Chou teach advancing an inner catheter through the medical device to a second target area. Additionally, a person with ordinary skill has good reason to pursue the known options within his or her technical grasp, and it is obvious to choose from a finite number of identified, predictable solutions with a reasonable expectation of success.
Regarding claim 22, Boury teaches applying force to a first pull wire (34) to reconfigure the medical device from the normal configuration into the deflected configuration and thereby steer the distal end of the medical device into or towards the target anatomy (col 5, ln 10-16; col 6, ln 8-61). As discussed above, in the combination of Boury and Chou it would be obvious the target anatomy can include the patient's right vertebral artery.
Regarding claims 23-30, Boury teaches the steerability of the catheter with the plurality of pull wires and the ability of a “physician to control the shape of the catheter from a proximal position is particularly advantageous because it enables the physician to manipulate the catheter during the course of a procedure. For example, if angiograms from several different sites need to be taken, one need not use a separate, specially shaped catheter for each angiogram. Instead, the catheter can remain in the patient's body and be reformed into a different optimized shape to reach each of the different sites. The same capabilities can also allow a physician to adapt the shape of the catheter to meet actual conditions when a patient's vasculature differs from the anticipated shape or condition.” (col 9, ln 36-49). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination to include the steps of withdrawing the inner catheter; returning the medical device to the normal configuration; advancing the distal end of the medical device into a different third target area; and applying force to a second pull wire to reconfigure the medical device from the normal configuration into deflected configuration and thereby steer the distal end of the medical device into a fourth target area, and advancing the inner catheter to a fifth target area, repositioning medical device and repeating the withdrawing and steering steps to reach another target area, wherein the target areas include the patient's right vertebral artery, innominate artery, right common carotid artery, right internal carotid artery, right external carotid artery, aortic arch, proximal left common carotid artery, left internal carotid artery, left external carotid artery, proximal left subclavian artery, and left vertebral artery since Boury teaches the catheter may be reconfigured and reshaped to be adapted to a variety of uses and Chou teaches the target vessels. Additionally, a person with ordinary skill has good reason to pursue the known options within his or her technical grasp, and it is obvious to choose from a finite number of identified, predictable solutions with a reasonable expectation of success.
Regarding claim 31, wherein applying force to the first pull (34D) wire includes deflecting a first steerable segment (36D) (control wire 34D attached to node 32D to form first steerable segment 36D) (col 5, ln 39-45; col 6, ln 33-61; see also Figs 1A-B).
Regarding claim 32, wherein applying force to the second pull wire (34B) includes deflecting a second steerable segment (36B) (control wire 34B attached to node 32B to form second steerable segment 36B) such that the first steerable segment (36D) and the second steerable segment are deflected in similar directions (col 5, ln 39-45; col 6, ln 33-61; Fig 1B).
Regarding claim 33, wherein applying force to the second pull wire (34C) includes deflecting a second steerable segment (36C) (control wire 34C attached to node 32C to form second steerable segment 36C) such that the first steerable segment (36D) and the second steerable segment are deflected in generally opposite directions (col 5, ln 39-45; col 6, ln 33-61; Fig 1B).
Regarding claim 34, further comprising: applying force to the at least one pull wire (34A-D) to reconfigure the medical device from the normal configuration (Fig 1A) into the deflected configuration (Fig 1B) (col 5, ln 39-45; col 6, ln 33-61).
Regarding claim 35, wherein applying force to the at least one pull wire includes: applying force to a first pull wire and/or a second pull wire connected to a first steerable segment such that the first steerable segment is deflectable in opposite directions; and applying force to a third pull wire and/or a fourth pull wire connected to a second steerable segment such that the second steerable segment is deflectable in opposite directions (col 5, ln 39-45; col 6, ln 33-61).
Regarding claim 37, Boury discloses the invention substantially as claimed including a method of establishing access to a vascular target site in a patient, the method comprising: introducing a medical device (10) via an opening, wherein the medical device includes: an outer wall; a plurality of steerable segments (segments of 30 – see for example 36A-D); and a plurality of pull wires (34A-D) connected to the plurality of steerable segments and extending substantially within the outer wall (Figs 1A-B and 3; col 5, ln 10-16; col 6, ln 8-61; col 9, ln 7-27);
advancing a distal end of the medical device (10); reconfiguring the medical device from a normal configuration (Fig 1A), in which the medical device is generally linear in configuration, into a deflected configuration (Fig 1B), in which the medical device is non-linear in configuration, by applying force to one or more of the plurality of pull wires to thereby steer the medical device towards the vascular target site (col 5, ln 10-16; col 6, ln 8-61).
Boury teaches the medical device is a generic catheter adaptable to a variety of uses, including selective cerebral angiography (col 4, ln 25-27). The steerability of the catheter allows it to be more readily positioned in a variety of vessels and can be manipulated by the physician even after the catheter is placed in the body (col 2, ln 53-59). Furthermore, Boury teaches an inner catheter or second device may be delivered through the medical device (10) (col 9, ln 2). However, Boury fails to disclose the specific steps of establishing trans-radial access to a vascular target site in a patient, introducing the medical device via a percutaneous opening into an orifice of a target vessel, and advancing an inner catheter through the medical device to deliver the inner catheter to the vascular target site.
Chou discloses a method of endovascular interventions in neurovascular anatomy and teaches establishing trans-radial access to a vascular target site in a patient (para [0195]), introducing a medical device (sheath or catheter 905) via a percutaneous opening into the patient's right radial artery (para [0195]), advancing the distal end of the medical device into an orifice of a target vessel, and advancing an inner catheter (stent delivery system 915) through the medical device to deliver the inner catheter to the vascular target site (Figs 1D-E; para [0096]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boury such that the medical device (10) was used in a method of establishing trans-radial access to a vascular target site in a patient and comprised the steps introducing the medical device via a percutaneous opening into an orifice of a target vessel, and advancing an inner catheter through the medical device to delivery the inner catheter to the vascular target site since Boury teaches the catheter may be adapted to a variety of uses and Chou teaches the target vessels and since Boury and Chou teach advancing an inner catheter through the medical device to a second target area. Additionally, a person with ordinary skill has good reason to pursue the known options within his or her technical grasp, and it is obvious to choose from a finite number of identified, predictable solutions with a reasonable expectation of success.
Regarding claims 38-39, Boury teaches “In positioning a catheter within a patient's vasculature, for example, the physician will typically guide a thin, relatively steerable guidewire into position adjacent the desired location and then urge the catheter over the guidewire. The catheter will ostensibly track the guidewire and can be placed in the desired location in that manner” (col 1, ln 26-31). Chou additionally teaches the use of a guidewire (910) through the medical device (905) to guide the inner catheter (915) (Fig 1E; para [0096]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination such that introducing the medical device includes introducing the medical device over a rail wire (or guide wire) such that the wire extends through medical device and such that advancing the inner catheter includes advancing the inner catheter over the rail wire (or guide wire) to assist in guiding the device and inner catheter through the vasculature.
Regarding claim 40, wherein reconfiguring the medical device includes deflecting the plurality of steerable segments in similar directions (36B and 36D deflected in similar directions – Fig 1B; col 4, ln 51-60).
Regarding claim 41, wherein reconfiguring the medical device includes deflecting the plurality of steerable segments in dissimilar directions (36C and 36D deflected in dissimilar directions; col 4, ln 51-60).
Regarding claim 42, wherein reconfiguring the medical device includes deflecting the plurality of steerable segments in a single direction (single curve – col 4, ln 51-60).
Regarding claim 43, wherein reconfiguring the medical device includes deflecting the plurality of steerable segments in multiple directions (Fig 1B; col 4, ln 51-60).
Regarding claim 44, wherein reconfiguring the medical device includes: deflecting a first steerable segment in a first direction; and deflecting a second steerable segment in a second direction generally opposite to the first direction (36C and 36D deflected in opposite directions; col 4, ln 51-60).
Regarding claim 45, wherein reconfiguring the medical device includes: sequentially applying force to a first pull wire and/or a second pull wire connected to a first steerable segment such that the first steerable segment is deflectable in different directions; and applying force to a third pull wire and/or a fourth pull wire connected to a second steerable segment such that the second steerable segment is deflectable in different directions (col 4, ln 51-60; col 9, ln 36-49).
Regarding claim 46, wherein reconfiguring the medical device includes: deflecting a first steerable segment; and sequentially deflecting a second steerable segment spaced axially from the first steerable segment (col 4, ln 51-60; col 9, ln 36-49; it is noted steerable segments may be interpreted as any portion along the length of the deflectable section 30 including spaced apart segments such as 36B and 36D).
Regarding claim 47, wherein reconfiguring the medical device includes: deflecting a first steerable segment; and sequentially deflecting a second steerable segment, wherein the first steerable segment and the second steerable segment at least partially overlap along a length of the medical device (col 4, ln 51-60; col 9, ln 36-49; it is noted steerable segments may be interpreted as any portion along the length of the deflectable section 30 including overlapping segments).
Regarding claim 49, Boury discloses the invention substantially as claimed including a method of establishing access to a vascular target site in a patient, the method comprising: introducing a medical device via an opening, wherein the medical device (10) includes: a body defining a working lumen and including at least one steerable segment (segments of 30 – see for example 36A-D); at least one pull wire (34A-D) connected to the at least one steerable segment and located substantially within an outer wall of the medical device such that the at least one pull wire is embedded within the medical device (Fig 3; col 9, ln 7-27); and applying force to the at least one pull wire to reconfigure the medical device (Figs 1A-B) and thereby steer the medical device towards the vascular target site (col 5, ln 10-16; col 6, ln 8-61).
Boury teaches the medical device is a generic catheter adaptable to a variety of uses, including selective cerebral angiography (col 4, ln 25-27). The steerability of the catheter allows it to be more readily positioned in a variety of vessels and can be manipulated by the physician even after the catheter is placed in the body (col 2, ln 53-59). Furthermore, Boury teaches an inner catheter or second device may be delivered through the medical device (10) (col 9, ln 2). However, Boury fails to disclose the specific steps of establishing trans-radial access to a vascular target site in a patient, introducing the medical device via a percutaneous, and subsequent to reconfiguration of the medical device, advancing an inner catheter through the medical device to deliver the inner catheter to the vascular target site.
Chou discloses a method of endovascular interventions in neurovascular anatomy and teaches establishing trans-radial access to a vascular target site in a patient (para [0195]), introducing a medical device (sheath or catheter 905) via a percutaneous opening into the patient's right radial artery (para [0195]), advancing the distal end of the medical device into an orifice of a target vessel, and advancing an inner catheter (stent delivery system 915) through the medical device to deliver the inner catheter to the vascular target site (Figs 1D-E; para [0096]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Boury such that the medical device (10) was used in a method of establishing trans-radial access to a vascular target site in a patient and comprised the steps of establishing trans-radial access, introducing the medical device via a percutaneous opening into an orifice of a target vessel, and subsequent to reconfiguration of the medical device, advancing an inner catheter through the medical device to deliver the inner catheter to the vascular target site, since Boury teaches the catheter may be adapted to a variety of uses and Chou teaches the target vessels and since Boury and Chou teach advancing an inner catheter through the medical device to a second target area. Additionally, a person with ordinary skill has good reason to pursue the known options within his or her technical grasp, and it is obvious to choose from a finite number of identified, predictable solutions with a reasonable expectation of success.
Regarding claim 50, Boury teaches “In positioning a catheter within a patient's vasculature, for example, the physician will typically guide a thin, relatively steerable guidewire into position adjacent the desired location and then urge the catheter over the guidewire. The catheter will ostensibly track the guidewire and can be placed in the desired location in that manner” (col 1, ln 26-31). Chou additionally teaches the use of a guidewire (910) through the medical device (905) to guide the inner catheter (915) (Fig 1E; para [0096]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination such that advancing the inner catheter includes advancing the inner catheter over a rail wire (or guide wire) to assist in guiding the device and inner catheter through the vasculature.
Regarding claim 51, wherein applying force to the at least one pull wire includes: applying force to a first pull wire (34A) connected to a first steerable segment (36A); or applying force to a second pull wire (34B) connected to a second steerable segment (36B) (col 5, ln 10-16; col 6, ln 8-61).
Regarding claim 52, wherein applying force to the at least one pull wire includes: applying force to a first pull wire connected to a first steerable segment; and sequentially applying force to a second pull wire connected to a second steerable segment (col 5, ln 10-16; col 6, ln 8-61; col 4, ln 51-60; col 9, ln 36-49 - reconfiguring).
Regarding claim 53, wherein applying force to the first pull wire and sequentially applying force to the second pull wire includes retracting the first pull wire and retracting the second pull wire within a common channel extending substantially through the outer wall of the medical device in generally parallel relation to the working lumen (col 5, ln 10-16; col 6, ln 8-61; col 4, ln 51-60; col 9, ln 36-49).
Regarding claim 54, wherein applying force to the first pull wire includes retracting the first pull wire within a first channel extending substantially through the outer wall of the medical device in generally parallel relation to the working lumen, and sequentially applying force to the second pull wire includes retracting the second pull wire substantially within a second channel extending through the outer wall of the medical device in generally parallel relation to the working lumen (col 5, ln 10-16; col 6, ln 8-61; col 4, ln 51-60; col 9, ln 36-49).
Regarding claim 55, wherein applying force to the first pull wire and sequentially applying force to the second pull wire includes deflecting the first steerable segment and deflecting the second steerable segment in generally different directions (Fig 1B; col 5, ln 10-16; col 6, ln 8-61; col 4, ln 51-60; col 9, ln 36-49).
Regarding claim 56, wherein applying force to the first pull wire and sequentially applying force to the second pull wire includes deflecting the first steerable segment and deflecting the second steerable segment in similar directions (Fig 1B; col 5, ln 10-16; col 6, ln 8-61; col 4, ln 51-60; col 9, ln 36-49).
Regarding claim 57, wherein applying force to the at least one pull wire includes: applying force to a first pull wire and/or a second pull wire connected to a first steerable segment such that the first steerable segment is deflectable in different directions; and applying force to a third pull wire and/or a fourth pull wire connected to a second steerable segment such that the second steerable segment is deflectable in different directions (Fig 1B; col 5, ln 10-16; col 6, ln 8-61; col 4, ln 51-60; col 9, ln 36-49).
Claim(s) 36 and 48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Boury (US 5,916,147) and Chou (US 2021/0330332), as applied to claims 21 and 37 above, further in view of Camarillo (US 2008/0243063, hereinafter “Camarillo”).
Boury and Chou disclose the invention substantially as claimed, as shown above. However, Boury fails to disclose the actuation mechanism for controlling the movement of the pull wires (34) and thus fails to disclose the wheel as claimed. Camarillo discloses a similar steerable catheter and teaches “the actuator 240 may be an automated instrument driver 1040 (as generally illustrated in FIGS. 10-12), which may include one or more servo motors that drive one or more wheels or pulleys 1042a-d around which deflection members 150 in the form of wires may be wrapped. Thus, during use, the motors may be actuated according to the control model 120, thereby rotating one or more pulleys 1042 which, in turn, adjusts the tension on deflection members 250 to impart the desired distal portion 232 bending to place the distal tip of the catheter 230 into a position corresponding to the position of the kinematics model input 701.” (para [0064]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination such that the actuation mechanism included a wheel for the wires to wrap around to more controllably control the tension in the pull wires when actuating the steering mechanism.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Fifer et al. (US 2012/0172920) and Kiemeneij (US 6,273,881) disclose a similar catheterization method using a transradial access approach.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE MARIE RODJOM whose telephone number is (571)272-3201. The examiner can normally be reached Monday - Thursday 8-5.
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/KATHERINE M RODJOM/Primary Examiner, Art Unit 3771