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 .
Specification
The disclosure is objected to because of the following informalities: on page 12 line 21, the inner cone surface is referenced as numeral 107, this should be changed to numeral 108.
Appropriate correction is required.
Claim Objections
Claims 6 and 9 are objected to because of the following informalities:
Regarding claim 6, “the receiving” should be corrected to “a receiving” for claim language consistency.
Regarding claim 9, “the bearing portion” should be corrected to “the proximally arranged bearing portion” for claim language consistency.
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-8 and 10-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Braun Melsungen AG (DE 29503750 U1), hereafter referred to as “Braun”.
Regarding claim 1, Braun discloses a catheter arrangement for use in peripheral regional anesthesia (an instrument for anesthesia, [0024]-[0025] & Fig. 3 and 4), the catheter arrangement comprising: a capillary with a capillary tube and a capillary attachment that is joined to a proximal tube end of the capillary tube (outer tubular part 10, which is being interpreted as a capillary tube, and attachment/projection 111, which is being interpreted as a capillary attachment, are being interpreted as a capillary, [0030] and [0032] & Fig. 3; the proximal end of outer tubular part 10 joined to attachment 111, Fig. 3); a catheter hose that is pushed in a distal direction through the capillary attachment into the capillary tube (inner elongated part 15, which may be a catheter, protrudes through attachment 111 and into outer tubular part 10, [0026] and [0032] & Fig. 3), a distal hose end of the catheter hose protruding from a distal tube end of the capillary tube by an axial length (a distal end of inner spiral cannula 36, synonymous to part 15, protruding from the distal end of cannula 35, synonymous to part 10, [0033] & Fig. 4); and a fixing device with an actuation element and a clamping element mounted on the capillary attachment (clamping element 120 including a cap-shaped handle 125 and a soft elastic body in the form of a cone 121 and a circular cylindrical coaxial extension 122, [0031] & Fig. 3; handle 125 and cone 121 and extension 122 mounted on attachment 111, [0032]), the actuation element being mounted on the capillary attachment movably relative to the capillary attachment and operatively connected to the clamping element in a force-transmitting and/or movement-transmitting manner (handle 125 screwed onto projection 111 and operative to rotate and compress cone 121 and extension 122, [0032] & Fig. 3; “Such a cap not only increases the axial compressive force against the rubber-elastic outer cone to compress its soft tip in the slope of the inner cone, but it also holds the outer cone firmly in the set compression state.”, [0017]), and the clamping element being transferrable, by a movement of the actuation element, between a clamping configuration, in which an axial mobility of the catheter hose is fixed under an action of the clamping element, and an enabling configuration, in which the action is cancelled and the axial mobility of the catheter hose is enabled (“The moment a blockage of the two parts against axial relative movement is desired, the user presses the rubber-elastic outer cone deep into the inner cone of the outer part's projection, thereby compressing the outer cone axially and radially and narrowing its central passage, in which the elongated part is inserted, until the elongated part is clamped tightly around it.”, [0011]; “Such a cap not only increases the axial compressive force against the rubber-elastic outer cone to compress its soft tip in the slope of the inner cone, but it also holds the outer cone firmly in the set compression state. Only by loosening the screw connection is the inner elongated part released at the desired moment.”, [0017] & Fig. 3).
Regarding claim 2, Braun discloses all the limitations of claim 1. Braun further discloses the catheter arrangement wherein the clamping element is dimensionally conformable and has a lumen which is oriented coaxially with respect to the capillary tube and through which the catheter hose extends (soft elastic body defined by cone 121 and extension 122 is compressible and has a passage 124 oriented coaxially with outer tubular part 10, through which catheter 15 extends, [0031]-[0032] and [0017] & Fig. 3), wherein the clamping element, by means of the movement of the actuation element, is elastically deformable in such a way that the lumen, in the clamping configuration, is radially narrowed by frictionally engaged fixing of the catheter hose (“To secure the inner elongated part 15 in a specific position relative to the outer tubular part 10 against axial movement, the clamping element 20 is advanced towards the inner cone 12 of the projection 11 and the outer cone 21 is forcefully pressed into the inner cone 12. In this process, the outer cone 21 deforms axially and radially and is pressed firmly radially against the outer circumference of the inner elongated part 15, particularly in the area of its front end. This pressure causes the inner elongated part 15 to be fixed axially immovably in the arrangement 10, 11 and to be so firmly seated that it can be moved”, [0027] & Fig. 1-3), and the frictional engagement is cancelled in the enabling configuration. (“The body is penetrated along its entire length by a passage 124 open at both ends, which is narrowed for about half the length of the outer cone 121 so that it tightly encloses the outer circumference of the inner elongated part 15 without clamping it in the uncompressed state.”, [0031])
Regarding claims 3-4, Braun discloses all the limitations of claim 1. Braun further discloses the catheter arrangement wherein the actuation element is mounted on the capillary attachment in such a way as to be axially movable by screwing (handle 125 including threads 30 to screw onto attachment 111, [0032] & Fig. 3) and has a threaded portion which interacts with a complementary threaded portion of the capillary attachment (threads 30 interacting with lugs 113, 113a of attachment 111, [0032] & Fig. 3;” The edge-side coupling element consists of two opposing radially outwardly directed noses 113, 113a, the undersides of which are chamfered in opposite orientations to each other, so that they form a partial external thread. Another option is to use a circumferential thread.”, [0030]), wherein the threaded portion is designed as an inner thread and the complementary threaded portion is designed as an outer thread (“…internal thread 30…”, [0032], and “…outwardly directed noses 113, 113a…”, [0030] & Fig. 3).
Regarding claim 5, Braun discloses all the limitations of claim 2. Braun further discloses the catheter arrangement wherein the actuation element has a collar portion which is oriented coaxially with respect to the lumen (circular cylindrical mantle 32 of cap-shaped handle 125 oriented coaxially with passage 124, [0032] & see Fig. 3) and engages in a circumferential direction around a proximal end of the capillary attachment (threads 30 on the inner surface of mantle 32 engage in a circumferential direction around the proximal end of attachment 111 defined by lugs 113, 113a, [0032] & Fig. 3).
Regarding claim 6, Braun discloses all the limitations of claim 2. Braun further discloses the catheter arrangement wherein the clamping element has an outer cone surface oriented coaxially with respect to the lumen and tapering in the distal direction (the soft elastic body including an outer cone 121 which is oriented coaxially with passage 124, [0031] & Fig. 3; cone 121 tapers in a distal direction, from cylindrical extension 122 to front tip 123, [0031] & Fig. 3), wherein, in the clamping configuration, the outer cone surface is pressed against an inner cone surface of the receiving recess (when compressed, outer cone 121 is pressed against inner cone 112, which partially defines a receiving recess, [0032] & Fig. 3 and see [0027]).
Regarding claim 7, Braun discloses all the limitations of claim 2. Braun further discloses the catheter arrangement wherein the lumen extends between a proximal insertion opening with a first diameter and a distal outlet opening with a second diameter (passage 124 extends between a proximal opening near socket 31 with a first diameter and a distal opening at tip 123 with a second diameter, [0031] & Fig. 3; “The body is penetrated along its entire length by a passage 124 open at both ends, which is narrowed for about half the length of the outer cone 121”, [0031]), wherein the first diameter is greater than the second diameter (first diameter is greater than the second diameter, [0031] and [0026] & see Figs. 1-3).
Regarding claim 8, Braun discloses all the limitations of claim 7. Braun further discloses the catheter arrangement wherein the proximal insertion opening leads into a distally tapering inner cone of the lumen (passage 124/24 described as “narrowed” and seen distally tapering, [0026] and [0031] & Fig. 1-3).
Regarding claim 10, Braun discloses all the limitations of claim 1. Braun further discloses the catheter arrangement wherein the clamping element is produced from an elastomeric plastic material (soft elastic body defined by cone 121 and extension 122 is disclosed as a “rubber-elastic outer cone”, [0017] and [0031] & Fig. 3; “the material of the outer cone is a softly adjusted plastic”, [0011]) and/or the actuation element is produced from a plastic material that is dimensionally stable compared to the clamping element (“attachment 11 made of rigid plastic material”, [0025]; attachment 111 intended to deform the soft elastic body, [0017] & Fig. 3).
Regarding claim 11, Braun discloses all the limitations of claim 1. Braun further discloses the catheter arrangement wherein the clamping element is received in a proximally open receiving recess of the capillary attachment (the soft elastic body defined by cone 121 and extension 122 is received in inner cone 112 of attachment 111, which is being interpreted as the open receiving recess, [0032] & Fig. 3).
Regarding claim 12, Braun discloses all the limitations of claim 1. Braun further discloses the catheter arrangement wherein the actuation element is mounted on the clamping element in such a way as to be fixed axially by form-fit engagement (handle 125 is mounted on the soft elastic body defined by cone 121 and extension 122 through socket 31, [0031] & Fig. 3; “extension 122 is inserted into a socket 31 of a cap-shaped handle 125 and is in this attached by welding or gluing.”, [0031]; the insertion of extension 122 into socket 31 is being interpreted as form-fit engagement, with further welding/gluing facilitating axially fixation) and to be movable by sliding in the circumferential direction (handle 125 movable by being screwed, which is being interpreted as sliding in the circumferential direction, [0032] & Fig. 3).
Claim(s) 1-2 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McArthur (US 20180326197 A1).
Regarding claim 1, McArthur discloses a catheter arrangement for use in peripheral regional anesthesia (hemostasis torque assembly 100 coupled to an introducer 104, [0026] and [0031] & Fig. 1; the assembly contemplated for use in a variety of medical procedures and would be capable of use in peripheral regional anesthesia, [0010]-[0011] & Fig. 1), the catheter arrangement comprising: a capillary with a capillary tube and a capillary attachment that is joined to a proximal tube end of the capillary tube (hemostasis valve 110 with a introducer 104 and a body 130 with nut 140, which is being interpreted as a capillary attachment, [0030] & Fig. 1-3); a catheter hose that is pushed in a distal direction through the capillary attachment into the capillary tube (guidewire 102 inserted through nut 140 into introducer 104, [0039] & Fig 1-4B; guidewire 102 may be a catheter, see [0010]-[0011] and [0013]), a distal hose end of the catheter hose protruding from a distal tube end of the capillary tube by an axial length (catheter 102 operable to protrude past introducer 104, see [0010]-[0011] and [0031]); and a fixing device with an actuation element and a clamping element mounted on the capillary attachment (torque device 150 including handle 158 and torque nut 152, which are being interpreted as the actuation element, and collet 168, which is being interpreted as the clamping element, [0029] and [0041] & Fig. 4A-4B), the actuation element being mounted on the capillary attachment movably relative to the capillary attachment (handle 158 mounted on nut 140, through nut 152, [0041] & Fig. 4A-4B; nut 152 coupled to nut 140 through ridge 153 which facilitates coupling and decoupling, [0038] and [0040] & Fig. 4A-4B and 5) and operatively connected to the clamping element in a force-transmitting and/or movement-transmitting manner (handle 158 rotatable to impart a compressing force on collet 168 to compress it and move it distally, [0029] and [0047]-[0048] & Fig. 4A-4B), and the clamping element being transferrable, by a movement of the actuation element, between a clamping configuration, in which an axial mobility of the catheter hose is fixed under an action of the clamping element, and an enabling configuration, in which the action is cancelled and the axial mobility of the catheter hose is enabled (“A collet within the torque nut may selectively provide a clamping force to maintain a position of a guidewire extending through the collet. A collet handle may couple to the torque nut and selectively alter the clamping force of the collet based on the axial position of the collet handle relative to the torque nut.”, [0017]; a first position allowing for catheter 102 to move axially and a second position in which catheter 102 is fixed, [0046]-[0048] & Fig. 4A-4B; “The collet may be a collar with a segmented portion. A diameter of the segmented portion may be adjusted by applying or removing a compressing force. The handle 158 and the torque nut 152 may provide the compressing force.”, [0029]).
Regarding claim 2, McArthur discloses all the limitations of claim 1. McArthur further discloses catheter arrangement wherein the clamping element is dimensionally conformable and has a lumen which is oriented coaxially with respect to the capillary tube (collet 168 being compressible and having a lumen through which catheter 102 is seen disposed, [0017], [0029], and [0046] & Figs. 4A-4B) and through which the catheter hose extends (catheter 102 extending through the lumen of collet 168, [0046] & Fig. 4A-4B), wherein the clamping element, by means of the movement of the actuation element, is elastically deformable in such a way that the lumen, in the clamping configuration, is radially narrowed by frictionally engaged fixing of the catheter hose, and the frictional engagement is cancelled in the enabling configuration (“The collet may be a collar with a segmented portion. A diameter of the segmented portion may be adjusted by applying or removing a compressing force. The handle 158 and the torque nut 152 may provide the compressing force. For example, when the handle 158 is axially displaced relative to the torque nut 152, the compressing force may be altered. In some embodiments, the axial displacement may be controlled via a threaded interface between the handle 158 and the torque nut 152… In some embodiments, the interface may facilitate a direct push or pull of the handle 158 in the axial direction to alter the compression force.”, [0017], [0029], [0046], and [0048] & Fig. 4A-4B).
Regarding claim 9, McArthur discloses all the limitations of claim 2. McArthur further discloses the catheter arrangement wherein the clamping element has a proximally arranged bearing portion (the bulbous end of collet 168 is being interpreted as the proximally arranged bearing portion, [0041] & Fig. 4A-4B; the Examiner notes that the bulbous end is disclosed as a “bulbous distal end” but may be interpreted as arranged proximally to the distal aperture of collet 168, see Fig. 4A) with a slide surface oriented coaxially with respect to the lumen (“The chamfered surfaces of the collet 168… may be forced along sloped surfaces of the torque nut 152…, causing the openings of… the collet 168 to close.”, [0048] & Fig. 4A-4B; the chamfered surface of the bulbous end is being interpreted as the slide surface, seen oriented coaxially with the lumen of collet 168, considering it facilitates sliding of collet 168 distally or, alternatively, sliding of nut 152 proximally, [0041] and [0048]) and with a run-on shoulder distally delimiting the slide surface (the tip end of the bulbous end is being interpreted as a run-on shoulder, delimiting the chamfered surface, [0048] & Fig. 3-4A-4B), wherein the bearing portion engages axially through a bore of the actuation element oriented coaxially with respect to the lumen (the bulbous end of collet 168 engages axially through the lumen of handle 158 and torque nut 152, which is coaxial to the lumen of collet 168, see Figs. 4A-4B & [0041] and [0047]-[0048]), and wherein an inner circumferential surface of the bore is supported slidably on the slide surface (the inner “sloped surfaces of the torque nut 152” are being interpreted as an inner circumferential surface of the bore, see Figs. 3-4A-4B and [0048]; the Examiner notes that the handle is disclosed as transitioning toward the torque nut: “Because the collet 168 does not entirely fit within the handle 158, the handle 158 forces the bulbous distal end further into the torque nut 152 when the handle 158 transitions toward the torque nut 152”, [0047]; however, the opposite configuration is possible, in which handle 158 remains stationary and valve 110 and nut 152 are rotated toward handle 158; therefore, the inner surface of nut 152 is capable of sliding, with respect to collet 168, along the chamfered surface of the bulbous end, [0017], [0029], and [0048]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Woehr (US-20140276453-A1), Stevens (US-5935112-A), Yamamoto (US-5059186-A), Russell (US-4857062-A).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783