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 July 18, 2025 has been entered. Claims 61-67, 77-97, 100-112, and 114-118 are currently pending.
Priority
Claim limitations regarding trans-radial access, an access needle, pulley wires, pulley steering systems, and steerable segments do not have support in the parent applications and thus are given a priority date of October 11, 2019, corresponding to the filing date of the instant application.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 61-63, 77-83, 85-90, 93-97, 100-103, 106-112, and 114-118 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hofmann (US 2005/0228402) in view of Boury (US 5,916,147) and Sheldon (US 2,975,785).
Regarding claims 61, 63, 86-89, 100-101, 106-112, and 114-118, Hoffmann discloses the invention substantially as claimed including
a system for establishing trans-radial arterial access to a multitude of precerebral arteries, via a single site of radial artery access (fully capable of being inserted through a radial artery to access a plurality of vessels as claimed) comprising:
a) an access needle (para [0025] – needle first introduced into blood vessel to provide access to target location); a rail access wire (para [0025] – interpreted as a guide wire, which is inserted through the needle); a primary catheter (Fig 1) (para [0025] – interpreted as the catheter device inserted over the guide wire); at least one secondary catheter (para [0063] – the primary catheter (Figs 1-2) is used as a conduit for passage of catheters, guide wires, and instruments and thus the secondary catheter is interpreted as one of the catheters inserted through the primary catheter); and at least one second wire (para [0063] – the primary catheter (Figs 1-2) is used as a conduit for passage of guide wires and thus the second wire is interpreted as a guide wire inserted through the primary catheter) separate from said primary catheter, wherein said access needle is configured for delivering said rail access wire for delivery of said primary catheter (para [0025] – “For example, when the anatomical structure is a blood vessel, a needle is introduced through the incision into the blood vessel. A guide wire is then inserted through the needle into the blood vessel using a retrograde approach. The device is then inserted over the guide wire and is passed into the blood vessel to a desired depth using a retrograde approach.”); said primary catheter configured for one or both of a right radial artery approach and a left radial artery approach (fully capable of being used in a right or left radial artery approach as claimed);
b) said primary catheter having a central working lumen (3), a proximal end hole, a distal end hole (Fig 1; para [0061]), an outer wall extending continuously between the proximal end and the distal end hole, and at least three steerable segments (proximal, intermediate and distal segments fully capable of being steered through the vasculature), wherein said at least three steerable segments are arranged in an alternating pattern and at least two of the at least three steerable segments are separated by at least one generally linear segment, wherein at least two of said at least three steerable segments at least partially overlap along a length of said primary catheter (segments may be defined as any portion of the length of the catheter and thus may be defined as claimed);
c) wherein said central working lumen is configured to act as a conduit for the delivery therethrough of:
i) said at least one second wire (para [0063] – the primary catheter (Figs 1-2) is used as a conduit for passage of guide wires and thus the second wire is interpreted as a guide wire inserted through the primary catheter); and
d) an external termination device (8) which is in communication with said proximal end hole (para [0061]).
However, Hofmann fails to disclose the primary catheter comprises an activating mechanism near its proximal end and control wires or pulley wires for steering separate steerable segments of the primary catheter as claimed. Boury discloses a steerable catheter having an outer wall extending continuously between a proximal end and a distal end hole (“The catheter 10 is generally tubular in shape and desirably includes at least one lumen 12” — col 3, In 61-62; “The catheter extends from a proximal end 20 to a distal end 14.” —col 3, In 66-67. It is noted catheter 10 includes the outer body that is generally tubular in shape which is devoid of any links. However, links 40 are located within the body. Thus the “catheter” is interpreted as the outer body, wherein the inner links and the pull wires are located within the catheter.) and having a plurality of steerable segments or steerable sites for actively bending the catheter (abstract; Figs 1-2). Boury teaches at least a primary steering segment (forming curve 36D), secondary steering segment (forming curve 36C), and tertiary steering segment (forming curve 36B), wherein each steering segment comprises a control wire or pulley wire (34) extending through the wall of the catheter and attached to a separate node (see annotated Figs 1A-B below; col 4, ln 61-col 5, ln 16; col 5, ln 40-col 7, ln 13). Control wire 34D is attached to node 32D to form the primary steerable segment 36D, control wire 34C is attached to node 32C to from the secondary steerable segment 36C, and control wire 34B is attached to node 32B to form the tertiary steerable segment 36B (col 5, ln 39-45; col 6, ln 33 - 61; see also Figs 1A-1B). “As these nodes are spaced from one another along the length of the catheter, the control wires will extend a different length along the length of the catheter before reaching the associated node.” (col 5, ln 45-48). As shown in the annotated Figs 1A-1B below, the steerable segments may be defined such that they are arranged in an alternating pattern with at least two of the at least three steerable segments separated by at least one generally linear segment and at least two of said at least three steerable segments at least partially overlap. In particular, primary steering segment/site is spaced axially from the secondary steering segment/site by a generally linear segment. The tertiary steering segment/site is spaced axially from the primary steering segment/site by at least the second steering segment/site. The tertiary steering segment/site at last partially overlaps with the secondary steering segment/site. The secondary steerable segment/site is configured to steer the secondary steering segment (to form curve 36C) in a different direction than the primary steering segment (to form curve 36D) and the tertiary steering segment forms a third distinct curve (curve 36B) (col 6, ln 33-61; Figs 1A-1B).
First Annotated Version of Figs 1A and 1B:
[AltContent: textbox (Tertiary steering
segment)][AltContent: textbox (Secondary steering segment)][AltContent: textbox (Generally linear
segment)][AltContent: textbox (Primary steering segment)]
[AltContent: arrow][AltContent: oval][AltContent: ][AltContent: ][AltContent: ][AltContent: ][AltContent: arrow][AltContent: arrow][AltContent: textbox (Partially overlapping)][AltContent: textbox (Generally linear
segment)][AltContent: textbox (Primary steering segment)][AltContent: textbox (Secondary steering segment)][AltContent: textbox (Tertiary steering
segment)][AltContent: ][AltContent: oval][AltContent: ][AltContent: ][AltContent: connector][AltContent: connector][AltContent: ][AltContent: arrow][AltContent: arrow]
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[AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (Tertiary bend)][AltContent: textbox (Secondary bend)][AltContent: textbox (Primary bend)]
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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 Hofmann such that the primary catheter was a steerable catheter, as taught by Boury, and included at least three steerable segments or steerable sites having three distinct pulley or control wires to actively bend the primary catheter, wherein the steerable segments at least two steerable segments/sites are separated by at least one generally linear segment/site, at least steerable segments/site at least partially overlap along a length of the primary catheter, and form three distinct curve for the purpose of “providing an improved catheter system which allows a physician to shape a length of the catheter to permit it to be more readily positioned within a body channel of a patient” (Boury col 2, ln 53-56).
However, Boury teaches the proximal ends of the control wires (34A-D) extend from the proximal end of the catheter to be directly pulled by a physician. Boury fails to teach the claimed pulley steering system configured for steering each control wire in a single direction of pulley wire pull. Sheldon discloses a steerable medical instrument comprising a plurality of control or pulley wires (22) and teaches the proximal ends of the pulley wires (22) were each wound around pulleys (32) of a pulley steering system (Fig 1; col 2, ln 54-58 and 61-67). 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 of Hofmann and Boury such that each control wire was a pulley wire that had a proximal end wound around a pulley or rotating wheel attached to a control knob to simplify the control of the wires and assist with wire management and prevent tangling of the proximal ends of the wires and improve the activating mechanism near the proximal end of the catheter.
Regarding claim 62, the combination of Hoffman, Boury and Sheldon teach the at least three steerable segments create a plurality of bends (see annotated Fig 1B above), wherein at least one of the bends is fully capable of resting along a vascular arch when placed in the vasculature at the location of the vascular arch. It is noted a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 77, wherein a catheter wall is configured to bend in a continuous curve (the catheter is flexible and fully capable of bending in a continuous curve).
Regarding claim 78, wherein each pulley wire steers the segment only in a single direction of wire pull (Boury teaches separate control wires 34A-D for each node 32A-D and thus each pulley wire steers the segment only in a single direction of wire pull – col 5, ln 40- col 6, ln -61).
Regarding claim 79, Boury teaches the degree of curvature of the first and second active segments (36A, 36B) can be controlled by the tension placed on the associated control wire (34) (col 8, In 12-26) and Fig 1B shows the secondary steering segment is configured to create a bend up to 270 degrees. Alternatively, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the combination such that secondary steering segment was configured to create a bend up to 270 degrees, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Inre Aller, 105 USPQ 233.
Regarding claim 80, Boury teaches the secondary bend created by the secondary steering segment is on a different side as the primary bend created by the primary steering segment (see annotated Fig 1B above).
Regarding claim 81, Boury teaches the catheter bends to a C-shape (Boury teaches separate control wires 34A-D for each node 32A-D wherein the curvature can be controlled by the degree of tension on each control wire and thus teaches the three pulley wires are fully capable of configuring the catheter to have a C-shape as claimed – col 5, ln 40- col 6, ln -61). It would have been obvious to modify the combination to have the C-shape bending configuration as taught by Boury for the purpose of “providing an improved catheter system which allows a physician to shape a length of the catheter to permit it to be more readily positioned within a body channel of a patient” (Boury col 2, ln 53-56).
Regarding claim 82, Boury teaches the secondary steering segment is configured to steer the secondary steering segment in a different direction than the primary steering segment (see annotated Fig 1B above) due to the circumferential positioning of where the first control wire (34D) is connected to the first node (32D) and where the second control wire (34C) is connected to the second node (32C) (col 5, ln 40- col 6, ln -61).
Regarding claim 83, Boury teaches wherein the at least three pulley wires configure the catheter to have a U-shape (Boury teaches separate control wires 34A-D for each node 32A-D wherein the curvature can be controlled by the degree of tension on each control wire and thus teaches the three pulley wires are fully capable of configuring the catheter to have a U-shape as claimed – col 5, ln 40- col 6, ln -61).
Regarding claim 85, Boury teaches wherein segments of the catheter forming left and right sides of the U are of different lengths since the proximal end forming one side may extend out of the patient and thus be of a longer length (col 4, ln 6-38).
Regarding claim 90, wherein each steering site, when activated to steer, deflects the primary catheter in a substantially different direction than the other sites (Boury teaches separate control wires 34A-D for each node 32A-D and thus depending on the tension applied to each control wire, the primary catheter can be deflected in different directions – col 5, ln 40- col 6, ln -61).
Regarding claim 93, the steering segments may alternatively be interpreted as shown below in the second annotated version of Figs 1A and 1B such that the primary steering segment and the secondary steering segment at least partially overlap along the length of the primary catheter.
Second Annotated Version of Figs 1A and 1B:
[AltContent: textbox (Generally linear
segment)][AltContent: textbox (Tertiary steering
segment)][AltContent: textbox (Secondary steering segment)][AltContent: textbox (Primary steering segment)][AltContent: ][AltContent: ]
[AltContent: ][AltContent: arrow][AltContent: arrow][AltContent: textbox (Partially overlapping)][AltContent: oval][AltContent: arrow][AltContent: ][AltContent: arrow][AltContent: arrow][AltContent: connector][AltContent: ][AltContent: connector][AltContent: ][AltContent: textbox (Primary steering segment)][AltContent: oval][AltContent: ][AltContent: textbox (Generally linear
segment)][AltContent: textbox (Secondary steering segment)][AltContent: textbox (Tertiary steering
segment)]
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[AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (Tertiary bend)][AltContent: textbox (Secondary bend)][AltContent: textbox (Primary bend)]
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Regarding claim 94, further comprising an additional steering segment (proximal segment) configured to make an additional bend (Figs 1A-B, tertiary bend).
Regarding claims 95-97, further comprising a removable inner dilator to aid with percutaneous insertion, wherein said access needle is configured for delivering said rail access wire for delivery of said dilator and said primary catheter, said dilator having a length greater than a length of said primary catheter and outer diameter less than an inner diameter of said primary catheter such that the dilator is configured to be inserted with the primary catheter (para [0025]).
Regarding claims 102-103, further comprising at least one tertiary catheter capable of being advanced over said primary catheter (para [0025] – vascular sheath advanced over guide catheter).
Claim(s) 64-67, 84, 91-92, and 104-105 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hofmann (US 2005/0228402), Boury (US 5,916,147), Sheldon (US 2,975,785), or alternatively further in view of Sheps et al.(US 2014/0309661, hereinafter “Sheps”), as applied to claims 61, 64-65, 88-89, and 117 above, further in view of Kiemeneij (US 6,273,881, hereinafter “Kiemeneij”).
Hofmann, Boury, and Sheldon disclose the invention substantially as claimed as shown above. Hoffmann teaches a method for establishing arterial access to a multitude of end vessels, via a single site of access (para [0025, 0105]), the method comprising the steps of: inserting the access needle through a percutaneous tissue tract leading to an artery (para [0025, 0105]), inserting a wire through said needle, into said artery, removing said needle (para [0025, 0105]), inserting the primary catheter of the device of Claim 1 over said wire, removing said wire, advancing said primary catheter of the device of Claim 1 over another wire, near a target vessel, removing said wire (para [0025, 0105]), steering, moving, and repositioning said primary catheter of the device of Claim 1 into target location (taught by Boury - plurality of steering segments and pulley wires, wherein each is adjusted as needed to achieve the desired curvature for the target anatomy – col 6, ln 62 – col 7, ln 14).
However, Hoffmann teaches the method comprises accessing the target vessel through a femoral access point. Hoffmann fails to teach the method establishes trans-radial arterial access via a single site of radial access and comprises the step of inserting the needle through a percutaneous tissue tract leading to a radial artery. In discussing the background of the invention, Kiemeneij states “a femoral approach is currently used in which the preshaped catheter is introduced into the aorta via the femoral artery, and the catheter is then manipulated at its proximal end, by push or pull and/or torque motions, for steering its distal end into the lumen of the selected vessel” (col 1, ln 16-21). Kiemeneij further teaches “A percutaneous transradial approach to catheterization is now being investigated because of favorable anatomical relations of the radial artery to its surrounding structures and the double blood supply to the hand. Potential benefits of this approach are safe transarterial coronary interventions combining rapid mobilization of the patient after intervention, with the resulting reduced hospitalization, and easy, safe, and effective hemostasis leading to a marked reduced incidence of access-site related major complications.” (col 3, ln 17-26). 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 the combination of Hoffmann, Boury, and Sheldon such that method of using the device was a percutaneous trans-radial access method and comprised the steps of inserting the access needle and primary catheter through a percutaneous tissue tract leading to a radial artery to reach the target vessel as claimed. By modifying the method of Hoffmann, Boury, and Sheldon to use a trans-radial approach, it may also have the benefit of “safe transarterial coronary interventions combining rapid mobilization of the patient after intervention, with the resulting reduced hospitalization, and easy, safe, and effective hemostasis leading to a marked reduced incidence of access-site related major complications”, as taught by Kiemeneij (col 3, ln 17-26).
Furthermore, Hoffmann teaches “it will be appreciated that the vascular sheath 1 is usable for any type of surgical procedure wherein a vascular sheath is needed to provide communication of medical devices with a patient's blood vessel, body organ, or body cavity” (para [0116]). Kiemeneij discloses a similar device for establishing access to a multitude of end vessels (sheath) and teaches the sheath may be positioned in a variety of ways (Figs 3-6) to reach a target portion of the anatomy with different patient anatomical variations. In particular, Kiemeneij teaches an embodiment in which the method comprises positioning at least one segment of said device to abut a vascular arch, and subsequently curve away from said vascular arch (Fig 6). 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 be positioned as claimed and taught by Kiemeneij to assist in directing the sheath to desired coronary artery, including to aortic arch, the right vertebral artery, right common carotid artery, left common carotid artery, left subclavian artery and/or left vertebral artery, and since Hoffmann teaches the device may be used for any type of surgical procedure wherein a vascular sheath is needed to provide communication of medical devices with a patient's blood vessel (para [0116]). 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.
Response to Arguments
Applicant's arguments filed July 18, 2025, regarding the rejection of the claims under 35 U.S.C. 103 as being unpatentable over Hofmann (US 2005/0228402) in view of Boury (US 5,916,147) and Sheldon (US 2,975,785), have been fully considered but they are not persuasive.
Applicant argues the prior art fails to teach the steerable segments or steerable sites are arranged in an alternating pattern separated by generally linear segments, as amended. The Examiner agrees the previous interpretation of the prior art teaches overlapping steerable segments. However, it is noted the segments may be defined as any portion of the length of the catheter that performs the function of each respective claimed segment or site. Thus, a new rejection is made in view of an updated interpretation of the prior art.
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.
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