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 5, 2023 has been entered. Claims 1-18 and 20-21 are currently pending.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 6-18, and 20-21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Salazar et al. (US 2020/0108236, hereinafter “Salazar”).
Regarding claim 1, Salazar discloses a multi-function catheter shaft tool (810; Figs 6, 17a, 17b) (Although the tool 810 is referred as guidewire actuation mechanism in paragraph [078], paragraph [079] discloses: "Guidewire actuation mechanism (810) is configured to lock and unlock upon various outer diameter elongate members (802, 803), as shown in FIGS. 17A-18B and described in greater detail below. In the present example, elongate member (802) is a guidewire, though other versions of elongate member (802) may include (but are not limited to) a dilation catheter, a suction instrument cannula, an endoscope, and/ or various other kinds of elongate members as will be apparent to those skilled in the art in view of the teachings herein". It is therefore evident that the tool 810 is also a tool to be used with a catheter shaft.), comprising:
a tool distal end (850; Fig 17a), ;
a tool proximal end (826; Fig 17a);
a lumen (856) that extends from the tool distal end to said the tool proximal end, wherein the lumen is sized to accommodate a catheter shaft (as explained before, the tool 810 is capable of accommodating a catheter shaft. It is also noted that the catheter shaft is not positively recited);
a catheter shaft straightener comprising the tool distal end (the hollow shaft 814 is a shaft straightener since it comprises an elongated lumen in which the catheter shaft can be introduced and, due to the straight configuration of the lumen, straightened);
a catheter shaft actuator (the engagement member 812, as seen in figure 17a), wherein the catheter shaft straightener extends proximally from the tool distal end (see figure 17a) and at least to a distal end of the catheter shaft actuator, wherein the catheter shaft straightener and the catheter shaft actuator are configured to be collectively rotatable (the engagement member 812 and the shaft straightener are monolithically fixed, and therefore are collectively rotatable); and
a catheter shaft clamp (the resilient gripping member 816, as seen in figure 17a and paragraph [078]) disposable in each of a clamping configuration (the one shown in figure 17b, see paragraphs [079], [084] and [086]) and a released configuration (the one shown in figure 17a) relative to the lumen.
Regarding claim 2, wherein the catheter shaft straightener comprises a flared distal (flared portion formed by ring 852) end section, which in turn comprises the tool distal end (Figs 6, 17A-B).
Regarding claim 3, further comprising a clamping actuator (812) operatively interconnected with the catheter shaft clamp (resilient gripping member 816) (Figs 6, 17A-B; paragraph [0083]).
Regarding claim 4, in an alternative interpretation, the catheter shaft clamp of claim 1 may be interpreted as the compression member (820). Further, the catheter shaft straightener comprises: a liner (resilient member 816), wherein the lumen extends through the liner; and an outer housing (shaft 814) disposed about the liner along at least part of a length of the liner, wherein said the liner comprises a first hardness and the outer housing comprises a second hardness that is greater than the first hardness, and wherein the outer housing is more rigid than the liner (liner 816 is resilient, shaft 816 is more rigid; Figs 17A-B).
Regarding claim 6, wherein the catheter shaft clamp (820) comprises a clamping section (compression element 818) that is interconnected with a proximal end of a liner (816) (Figs 17A-B; paragraph [0078]).
Regarding claim 7, wherein the clamping section (compression element 818) is of a hardness that is greater than a hardness of the liner (816) (compression element 818 is capable of deforming the resilient liner 816 in the clamping configuration – paragraph [0079]; Figs 17A-B).
Regarding claim 8, wherein the clamping section (compression element 818) comprises at least two inwardly deflectable sections (at least two balls or detents – paragraph [0078, 0083]), and wherein an interior of the catheter shaft actuator is configured to engage both the outer housing and the at least two inwardly deflectable sections of the clamping section (Figs 17A-B; paragraph [0078, 0086-0087]).
Regarding claim 9, wherein advancement of the catheter shaft actuator toward the tool distal end and relative to the catheter shaft straightener moves the at least two inwardly deflectable sections of the clamping section (818) in a radially inward direction (Figs 17A-B; paragraph [0078, 0086-0087]).
Regarding claim 10, in an alternative embodiment (Figs 21-27B), the catheter shaft actuator is detachably engageable with the outer housing (para [0094]), wherein a proximal end section of the outer housing (1812) comprises external threads (1844) and the catheter shaft actuator (1830) comprises internal threads (1846) that are configured to threadably engage with the external threads of said the proximal end section of the outer housing (Figs 21-22; paragraph [0099]), and wherein threading the catheter shaft actuator toward the tool distal end exerts a radially inwardly directed force on the at least two inwardly deflectable sections of the clamping section (compressible body 1840) (Figs 27A-27B; paragraph [0101-0104]).
Regarding claim 11, wherein the catheter shaft actuator is operable to at least one of torque a catheter shaft or advance the catheter shaft when the catheter shaft extends through the lumen and when the catheter shaft clamp is disposed in the clamping configuration (in the clamping configuration, the catheter shaft actuator and catheter or other member 802 inserted within the lumen are capable of being moved together, including advancement or torque).
Regarding claim 12, further comprising a catheter (elongate member 802), wherein the catheter comprises a catheter shaft (paragraph [0079] – elongate member may include dilation catheter) that in turn comprises a first non-linear section, wherein the non-linear section of the catheter shaft is configured to be forced into a straighter profile when disposed within the catheter shaft straightener compared to when the non-linear section of the catheter shaft is disposed distally beyond the catheter shaft straightener (due to the straight configuration of the lumen of the hollow shaft 814 when catheter is introduced through the lumen, the catheter will also assume a straighter profile).
Regarding claim 13, wherein the catheter comprises a catheter handle, and wherein the catheter shaft actuator is disposed distally of the catheter handle when the catheter shaft is positioned in the lumen (catheter shaft actuator is disposed along the length of the elongate member or elongate portion of the catheter, which is distal to the proximal catheter handle).
Regarding claim 14, Salazar discloses a method of manipulating a catheter (paragraph [0079] – elongate member may include dilation catheter), the catheter comprising a catheter shaft that in turn comprises a non-linear section, the method comprising:
directing the non-linear section (flexible catheter shaft may have any portion flexed into a non-linear section) of the catheter shaft (802) into a distal end of a multi-function catheter shaft tool (810) to dispose the non-linear section of within a catheter shaft straightener (hollow shaft 814) of the multi-function catheter shaft tool, wherein directing the non-linear section into the catheter shaft straightener forces the non-linear section toward a straighter profile (the hollow shaft 814 is a shaft straightener since it comprises an elongated lumen in which the catheter shaft can be introduced and, due to the straight configuration of the lumen, straightened);
after directing the non-linear section into the catheter shaft straightener, executing a first moving step comprising moving the multi-function catheter shaft tool in a proximal direction along and relative to the catheter shaft, and with the multi-function catheter shaft tool being in a released configuration (Fig 17A) (adjust longitudinal position when in the released configuration – see paragraph [0074, 0120]);
after moving the multi-function catheter shaft tool in the proximal direction, disposing the multi-function catheter shaft tool in a clamping configuration (Fig 17B) where the multi- function catheter shaft tool engages an exterior of the catheter shaft (paragraph [0079]); and
moving the catheter shaft with the multi-function catheter shaft tool being in the clamping configuration and by exerting an external force on the multi-function catheter shaft tool (paragraph [0079]).
Regarding claim 15, wherein the non-linear section of the catheter shaft is in an expanded configuration without any force being exerted on the non-linear section (Fig 17A), and wherein directing the non-linear section into the catheter shaft straightener reduces a profile step of the non-linear section (compresses with compression members 818 – Fig 17B; paragraph [0079]).
Regarding claim 16, wherein the multi-function catheter shaft tool is mounted on the catheter shaft with the multi- function catheter shaft tool being located proximally of the non-linear section of the catheter shaft, and wherein directing the non-linear section into the distal end of the multi-function catheter shaft tool comprises distally advancing the multi-function catheter shaft tool along the catheter shaft in a direction of the non-linear section of the catheter shaft (adjust longitudinal position when in the released configuration – see paragraph [0074, 0120]; Fig 17A).
Regarding claim 17, wherein moving the multi-function catheter shaft tool in the proximal direction comprises torquing the catheter shaft, and wherein moving an entirety of the multi-function catheter shaft tool, including the catheter shaft straightener, in a rotational direction (move tool in any position including longitudinally or rotationally when in clamped configuration - paragraph [0079]; Fig 17B).
Regarding claim 18, further comprising: loading a guidewire into a distal end of the catheter shaft after directing the non-linear section into the catheter shaft straightener (paragraph [0079] - elongate member 802 may include catheter and guidewire).
Regarding claim 20, wherein an outer diameter of the catheter shaft actuator (812) is greater than a maximum outer diameter of the catheter shaft straightener (814) (Figs 17A-B).
Regarding claim 21, wherein the non-linear section of the catheter shaft defines a distal section of the catheter shaft (any portion of the catheter shaft may be non-linear if flexed into a non-linear position).
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 5, the prior art fails to teach or disclose wherein the liner extends distally beyond a distal end of the outer housing, and wherein the liner comprises the tool distal end.
Conclusion
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