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 Arguments
Applicant's arguments filed 12/01/2025 have been fully considered but they are not persuasive. With respect to claim 1, Applicant asserts that the amendments have overcome the prior art of McArthur, noting that the torque assembly now requires a rotatable valve releasably coupled to a proximal end of the hub assembly and a main body coupled to a proximal end of the rotatable valve. This is not found persuasive, noting that the term “coupled” does not require a direct connection. Although the main body (130) of McArthur connects directly to a distal portion (140) of the rotatable valve (140/152), the main body is considered coupled to a proximal end of the rotatable valve through the rest of the rotatable valve. The rotatable valve (140/152) releasably couples to a proximal end of the hub assembly (enlarged portion at end of shaft 104 of catheter that is received in 120; see annotated drawing below) via their common connection to main body 130 and connector 120.
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In view of the amendments to claim 16 requiring that the actuatable cap is rotatably coupled to an exterior of the main body, a new interpretation of the prior art of McArthur is being used for claim 16 as discussed in more detail in the rejections below.
Regarding claims 1, 16, and 20, Applicant also asserts that McArthur fails to disclose a catheter system that meets the limitation “wherein in a first configuration the torque assembly is configured to simultaneously torque the elongate shaft and the guidewire and in a second configuration the torque assembly is configured to torque the guidewire independent of the elongate shaft”. It is noted that this limitation is a recitation of intended use and the prior art must only be capable of carrying out this recitation of intended use in order to meet this limitation. Torque is caused by a user rotating various parts of the device and thus rotation of the various parts of the system depends in part on how the system is grasped by the user. In a first configuration (e.g., 150/110 in configuration shown in fig. 4b, with hub assembly of the catheter coupled to 120) the torque assembly is configured to simultaneously torque the elongate shaft and the guidewire. For example, while in this first configuration, a user can grip 150, 110, and 120 and rotate them together, thus resulting in torquing of the elongate shaft of the catheter (which connects to 110 via 120) and the guidewire. Applicant’s attention is also drawn to claim 16 of McArthur, which discloses that 150 (“torque device” of McArthur) and 110 (“hemostasis valve” of McArthur), when coupled together, provide sufficient friction such that a rotational force applied to one of the torque device and the hemostasis valve rotates both. While in a second configuration (150/110 in configuration shown in fig. 4b, with hub assembly of catheter uncoupled from 120), the torque assembly is configured to torque the guidewire independent of the elongate shaft. That is to say, a user may grasp and rotate (150) of the torque assembly to cause rotation of the guidewire without rotation of the catheter hub since the hub is uncoupled from 110, 120 and 150 in this second configuration.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-4 and 6-20 is/are rejected under 35 U.S.C. 102a1 as being anticipated by McArthur et al. (US 2018/0326197). McArthur discloses a catheter system, comprising: a catheter (104; fig. 1) having an elongate shaft extending from a proximal end to a distal end and defining a catheter lumen extending from the proximal end to the distal end; a hub assembly (unnumbered, but illustrated in fig. 2; see examiner-annotated figure below) coupled to the proximal end of the elongate shaft, the hub assembly including a hub assembly lumen in fluid communication with the catheter lumen (as understood by guidewire extending through all of 150/110/104 in fig. 1); a torque assembly (150,110) comprising a rotatable valve (140,152; noting this is consistent with rotatable valve of instant invention, which comprises a rotatable connection between two tubular portions, 36 and 40 in instant application, and a passage therethrough) releasably coupled to a proximal end of the hub assembly (noting “coupled” does not require a direct connection; at 120; [0031]), a main body (130) coupled to a proximal end of the rotatable valve (noting 130 is coupled to a proximal end of the rotatable valve via the remainder of the rotatable valve), a collet (168), an actuatable cap (158), and a torque assembly lumen (figs. 4a,4b) in selective fluid communication with the hub assembly lumen. the torque assembly including a torque assembly lumen in selective fluid communication with the hub assembly lumen (figs. 1, 4a,4b; [0031]); and a guidewire (102), the guidewire co-axially disposed within the catheter lumen, hub assembly lumen, and torque assembly lumen (fig. 1); wherein in a first configuration (e.g., 150/110 in configuration shown in fig. 4b, with hub assembly of the catheter coupled to 120) the torque assembly is configured to simultaneously torque the elongate shaft and the guidewire and in a second configuration the torque assembly is configured to torque the guidewire independent of the elongate shaft (150/110 in configuration shown in fig. 4b, with hub assembly of catheter uncoupled from 120).
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Regarding claim 2, a length of the guidewire extending distally from the distal end of the elongate shaft is adjustable (any time 110/150 is in configuration shown in fig. 4a, guidewire can move freely with respect to 110/150 and 104; [0046]).
Regarding claim 3, in the first configuration the torque assembly is coupled to the hub assembly (150/110 positioned relative to each other as shown in fig. 4b, with hub assembly of catheter coupled to torque assembly as illustrated in fig. 2).
Regarding claim 4, in the second configuration the torque assembly is uncoupled from the hub assembly (hub assembly is removable from portion 120 of torque assembly 110/150; as understood in view of par. [0031]).
Regarding claim 6, the rotatable valve comprises a first coupling portion (140) rotatably coupled to a second coupling portion (152), wherein the second coupling portion is configured to rotate independently of the first coupling portion when the first coupling portion is held in a fixed position (note also claim 19 of McArthur).
Regarding claim 7, when in the first configuration (fig. 4b, with hub assembly coupled to 120) the torque assembly (110,150) is configured to torque the guidewire independently of the catheter shaft when the first coupling portion (140) is held in the fixed position (e.g. when 158 is rotated once in configuration shown in fig. 4b, while 140 is held in fixed position, noting this is a functional limitation and the prior art need only be capable of performing the function in order to meet the limitation).
Regarding claim 9, the collet (168) is configured to selectively lock to the guidewire (see figs. 4a,4b; [0048]).
Regarding claim 10, the actuatable cap (158) is actuated to selectively lock the collet to the guidewire (by rotating cap 158).
Regarding claim 11, the actuatable cap is configured to selectively bias a proximal end region of the collet radially inwards to lock the collet to the guidewire (e.g.; see fig. 4b versus 4a, where cap has been screwed further into 152).
Regarding claim 12, when the guidewire is unlocked from the collet (see fig. 4a), the guidewire is actuatable independent of the torque assembly.
Regarding claims 13-15, the main body (130) includes a flush port (132; fig. 2) in fluid communication with the torque assembly lumen. Regarding claims 14 and 15, the torque assembly further comprises a hemostasis seal (164) configured to form a fluid tight seal between the guidewire and the main body of the torque assembly.
Regarding claim 20, McArthur discloses a catheter system, comprising: a catheter (104) having an elongate shaft extending from a proximal end to a distal end and defining a catheter lumen extending from the proximal end to the distal end; a hub assembly (see examiner-annotated reproduction of fig. 2 above; shaded portion at end of shaft 104) coupled to the proximal end of the elongate shaft, the hub assembly including a hub assembly lumen in fluid communication with the catheter lumen; a torque assembly (110/150) comprising a rotatable valve releasably coupled to the hub assembly (via 120; [0031]) and including a first coupling portion (140) rotatably coupled to a second coupling portion (152), the torque assembly further comprising a main body (130), a collet (168), and an actuatable cap (158) and including a torque assembly lumen in selective fluid communication with the hub assembly lumen; and a guidewire (102), the guidewire co-axially disposed within the catheter lumen, hub assembly lumen, and torque assembly lumen (see fig. 2) and selectively secured relative to the torque assembly (see figs. 4a, 4b); wherein in a first configuration (110/150 in configuration shown in fig. 4b, with catheter hub assembly coupled to 120 as shown in fig. 1) the torque assembly (110/150) is coupled to the hub assembly and is configured to simultaneously torque the elongate shaft and the guidewire, and in a second configuration (110/150 in configuration shown in fig. 4b, with catheter hub assembly uncoupled from 120 of torque assembly 110/150) the torque assembly is uncoupled from the hub assembly and is configured to torque the guidewire independent of the elongate shaft; wherein a length of the guidewire extending distally from the distal end of the elongate shaft is adjustable (e.g., when 110/150 in configuration shown in fig. 4a, guidewire free to move axially relative to 110, 150 and 104); and wherein when in the first configuration the torque assembly is configured to torque the guidewire independently of the catheter shaft when the first coupling portion (140) is held in a fixed position (note claim 19 of McArthur).
Regarding claim 16, McArthur discloses a catheter system, comprising: a catheter (104) having an elongate shaft extending from a proximal end to a distal end and defining a catheter lumen extending from the proximal end to the distal end; a hub assembly (shaded in examiner-annotated reproduction of fig. 2 above) coupled to the proximal end of the elongate shaft, the hub assembly including a hub assembly lumen in fluid communication with the catheter lumen; a torque assembly (110/150) releasably coupled to the hub assembly, the torque assembly comprising a rotatable valve (140/152) releasably coupled to the hub assembly (via 120), a main body (130), a collet (168), and an actuatable cap (now considered 120; considered actuatable as it can be coupled and uncoupled from the catheter hub) rotatably coupled to an exterior of the main body (130; noting there is no structure preventing relative rotation of the two elements 120/130 if one part were held stationary while the other was rotated) and including a torque assembly lumen in selective fluid communication with the hub assembly lumen (as understood by guidewire extending out either end of device as shown in fig. 2); and a guidewire (102), the guidewire co-axially disposed within the catheter lumen, hub assembly lumen, and torque assembly lumen and selectively secured relative to the torque assembly (see fig. 4a, 4b); wherein in a first configuration (fig. 4b, with catheter hub assembly attached to 120) the torque assembly (110/150) is configured to simultaneously torque the elongate shaft and the guidewire, and in a second configuration (fig. 4b, with catheter hub assembly uncoupled from 120) the torque assembly is configured to torque the guidewire independent of the elongate shaft; and wherein a length of the guidewire extending distally from the distal end of the elongate shaft is adjustable (e.g., when device in configuration of 4a, guidewire free to axially translate relative to 110, 150, and 104).
Regarding claim 17, the torque assembly further comprises a hemostasis seal (164).
Regarding claim 18, in the first configuration the torque assembly is coupled to the hub assembly and in the second configuration the torque assembly is uncoupled from the hub assembly as discussed above.
Regarding claim 19, the rotatable valve comprises a first coupling portion (140) rotatably coupled to a second coupling portion (152), wherein the second coupling portion is configured to rotate independently of the first coupling portion when the first coupling portion is held in a fixed position (see at least claim 19 of McArthur) and when in the first configuration (fig. 4b, with catheter hub assembly coupled to 120) the torque assembly is configured to torque the guidewire independently of the catheter shaft when the first coupling portion (140) is held in the fixed position.
Regarding claim 8, a different interpretation of McArthur is being set forth for claim 8, which depends from claim 1 (in which actuatable cap is considered element 158). See the examiner-annotated reproduction of figure 4a below. The rotatable valve is now being considered the connection between 120/130, the valve releasably coupled to a proximal end of the hub assembly, the valve comprising a first coupling portion (120) and a second coupling portion (portion of 130 left of dotted line in 1st examiner-annotated figure below) configured to rotate independently of the first coupling portion when the first coupling portion is held in a fixed position (noting there is no structure preventing relative rotation of the two elements). A distal end region of the main body (main body considered portion of 130 right of dotted line in 1st annotated figure below) is fixedly secured to the second coupling portion (noting the two elements are monolithic and therefore fixedly secured to each other). An examiner-annotated reproduction of fig. 3 is also included below, on which the 2nd coupling portion and the main body have been labelled. The rotatable “valve” of the instant application (“rotating valve 28”) comprises a rotatable connection between tubular portions (“first connector portion 36”, “second connector portion 38” and “coupling portion 40”) with a fluid passage therethrough (see fig. 2 of instant application) and thus consideration of the joint between tubular portions 120/130 as a valve appears consistent with the instant application’s use of the term.
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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 KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KSH 1/27/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771