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 January 5th 2026 has been entered. Claims 1-27 are pending in the application. Applicant’s amendments to the Claims have not overcome each and every objection previously set forth in the Non-Final Office Action mailed September 8th 2025.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the outer housing being an assembly of two or more parts that are connected in a clam shell configuration, the subject matter of claim 18, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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) 1-6, 8-10, and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cook (WO 2021236530 A1).
Regarding claim 1, Cook discloses a medical device (catheter system 100, [0041] & Fig. 1 and 6A-6B), comprising: an instrument having a proximal end and a distal end (distal portion 112 of catheter 110 having a proximal end attached to junction 116 and a distal end, [0044]-[0045] Fig. 1-3); an introducer configured to moveably receive the instrument (housing 111, portion 114, junction 116, and connector 134 of system 100, [0041]-[0044] & Fig. 1) and having:
an outer housing having a proximal end, a distal end, and a sidewall therebetween defining a passageway, wherein the passageway is curved (housing 111 having a proximal end at proximal stop 144 and a distal end at distal stop 142 and a sidewall defining internal cavity 140, [0055]-[0056] & Fig. 1-2 and 5; “the housing 111 is substantially tubular or cylindrical and defines an internal cavity 140 through which the follower 121 can translate. An internal surface of the housing 111 can be conducive to translation and/or rotation of the follower 121 , such as by being in a sliding relationship therewith.”, [0055] & Fig. 1-2 and 5; cavity 140 is curved considering housing 111 is a hollow cylinder; the Examiner notes that the limitation of “is curved” is not tied to an axis or relative to an axis or plane and there are no limitations to the extent of curvature or direction along which the passageway is curved); and
an inner housing having a proximal end, a distal end, and a sidewall therebetween defining an inner volume (proximal catheter portion 114 having a proximal end at connector 134 and a distal end connected to junction 116, [0044]-[0045] & Fig. 1-3 and 5), the inner housing slidably received within the outer housing (portion 114 can be advanced distally relative to housing 111, [0044], [0049], and [0067] & Fig. 5 and 7); and a grip arranged outside of the passageway and secured to the proximal end of the inner housing (connector 134, configured to be gripped and moved by a user, arranged outside of internal cavity 140 of housing 111 and attached to the proximal end of potion 114, [0049] & Fig. 1-2 and 4), wherein a distal end of the introducer is configured to couple the introducer to an intravenous line (interface 148 at the distal end of system 100 configured to couple system 100 to catheter system 102, [0041] and [0057] & Fig. 1-7), and
wherein the grip is movable, such that the inner housing is movable relative to the outer housing and moves the instrument between a first position, in which the instrument is disposed within the outer housing, and a second position, in which the distal end of the instrument is disposed beyond the distal end of the outer housing such that at least a portion of the instrument is disposed within the intravenous line when the introducer is coupled to the intravenous line (“the catheter system 100 can include a cannula or catheter 110 of which a portion can be inserted through the previously placed catheter system 102. The catheter 110 of the system 100… can be moved from a retracted position (FIG. 6A) and advanced through the catheter 104 of the pre-placed system 102 to a deployed position (FIG. 7) such that a distal tip of the catheter 110 extends beyond a distal tip of the catheter 104. The catheter 110 may be said to bypass or supersede the catheter 104 and can be used for functions that might otherwise have been performed directly via the catheter 104”, [0042] & Fig. 1-7; portion 112 is disposed within housing 111 in a first, retracted position (Fig. 1 and 6A) and disposed distal to interface 148 in a second, deployed position in IV line 104 (Fig. 7), [0041]-[0042], [0049], and [0067]).
Regarding claim 2, Cook discloses all the limitations of claim 1. Cook further discloses the medical device wherein the outer housing is curved (“housing 111 is substantially tubular or cylindrical”, [0055] & Fig. 1-2).
Regarding claim 3, Cook discloses all the limitations of claim 1. Cook further discloses the medical device wherein a curvature of the passageway of the outer housing follows an arc of a circle (internal cavity 140 is curved and circular considering housing 111 is cylindrical, [0055]-[0056] & Fig. 1-2 and 5; the curvature of internal cavity 140 follows an arc of a circle considering cavity 140 is circular).
Regarding claim 4, Cook discloses all the limitations of claim 1. Cook further discloses the medical device wherein a curvature of the outer housing follows an arc of a circle (“housing 111 is substantially tubular or cylindrical”, [0055] & Fig. 1-2; considering housing 111 is cylindrical, the curvature of housing 111 can be interpreted as following an arc of a circle, see Fig. 1-2).
Regarding claim 5, Cook discloses all the limitations of claim 1. Cook further discloses the medical device wherein at least a portion of the inner housing is straight (at least a portion of distal catheter portion 114 is straight, Fig. 1-2).
Regarding claim 6, Cook discloses all the limitations of claim 1. Cook further discloses the medical device wherein the inner housing is curved along an arc of a circle (distal catheter portion 114, having a lumen 117 (Fig. 3) is seen being tubular/cylindrical, similarity to housing 111 and stiffener 120, see Fig. 1-3 and [0044]; portion 114 can be interpreted as curved along an arc of a circle considering portion 114 is tubular/cylindrical; the Examiner notes that the limitation of “is curved” is not tied to an axis or relative to an axis or plane and there are no limitations to the extent of curvature or direction along which the inner housing is curved).
Regarding claim 8, Cook discloses all the limitations of claim 1. Cook further discloses the medical device wherein the inner housing and the outer housing extend along substantially equal arcs of a circle (portion 114 and housing 111 are both tubular/cylindrical, [0044] and [0055]-[0056] & Fig. 1-2 and 5; the diameter of portion 114 is smaller than the diameter of housing 111 but both housing 111 and portion 114 can be interpreted as extending along substantially equal arcs of a circle).
Regarding claim 9, Cook discloses all the limitations of claim 6. Cook further discloses the medical device wherein, when the inner housing is in the first position, the combined inner housing and outer housing extend around a partial circle (in a first, retracted position (Fig. 5 and 6A), the distal end of portion 114 is concentrically disposed in housing 111, [0042] and [0056]; the combination of potion 114 and housing 111 can be interpreted as partially extending around a partial circle since both housing 111 and portion 114 are tubular/cylindrical).
Regarding claim 10, Cook discloses all the limitations of claim 6. Cook further discloses the medical device wherein, when the inner housing is in the first position, the combined inner housing and outer housing extend around a full circle (in a first, retracted position (Fig. 5 and 6A), the distal end of portion 114 is concentrically disposed in housing 111, [0042] and [0056]; the combination of potion 114 and housing 111 can be interpreted as extending around a full circle since both housing 111 and portion 114 are tubular/cylindrical).
Regarding claim 24, Cook discloses all the limitations of claim 1. Cook further discloses the medical device wherein a length of the inner housing is approximately equal to a length of the outer housing (as illustrated in Figs. 1-2, the length of portion 114 and the length of housing 111 are illustrated to be approximately equal; the Examiner notes that the use of the term “approximately” allows for a broad interpretation of the limitation of “equal”).
Claim(s) 1-12, 16-17, and 19-27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Howell (US 20210283381 A1).
Regarding claim 1, Howell discloses a medical device (guidewire management device 1300, [0050] & Fig. 13), comprising: an instrument having a proximal end and a distal end (guidewire 102 having a proximal end at 152 and an opposite distal end, [0070] and [0086] & Fig. 13-14); an introducer configured to moveably receive the instrument (handle 1340, first and second sleeves 1310 and 1320, splitable casing 904, and guidewire conduit 1350, and casing conduit 1354 are all being interpreted as the introducer, [0071] & Fig. 13-14; device 1300 configured to advance or withdraw guidewire 102, [0072] & Fig. 13 and 14) and having: an outer housing having a proximal end, a distal end, and a sidewall therebetween defining a passageway (guidewire conduit 1350 having a proximal end, the end near stop 152, and a distal end in second sleeve 1320, [0083] & Fig. 13-14; the tubular structure of conduit 1350 is being interpreted as the sidewall defining a passageway in which guidewire 102 is disposed, [0086]), wherein the passageway is curved (conduit 1350 being in a coiled configuration, [0073] & Fig. 13-14); and
an inner housing having a proximal end, a distal end, and a sidewall therebetween defining an inner volume (splitable casing 904 having a proximal end, the end near stop 152, and a distal end opposite the proximal end, [0066] & Fig. 13-14; the tubular structure of casing 904 is being interpreted as the sidewall defining an inner volume in which guidewire 102 is disposed, [0066] & Fig. 13-14), the inner housing slidably received within the outer housing (casing 904 slidable received in conduit 1350, [0086]-[0087] & Fig. 13-14); and a grip arranged outside of the passageway and secured to the proximal end of the inner housing (thumb wheel 1342 is configured to be actuated with a thumb, or gripped, and is positioned outside the passageway defined by conduit 1350, [0072] & Fig. 13; wheel 1342 is secured to the proximal end of casing 904 when guidewire 102 is advanced as distally as possible, as casing 904 is split off guidewire 102 past wheel 1342, [0086] & Fig. 13; additionally, wheel 1342 can be interpreted as operatively secured to the proximal end of casing 904 considering wheel 1342 directly influences the movement of the proximal end of casing 904 ([0086]-[0087]); the Examiner notes that the claim language does not include limitations directed toward the type of securement, how the proximal end of the inner housing is secured to the grip, etc.; when the proximal end of casing 904 is positioned between wheel 1342 and a user’s thumb, wheel 1342 and the proximal end of casing 904 would be tightly/firmly connected, or secured, together),
wherein a distal end of the introducer is configured to couple the introducer to an intravenous line (distal end of sleeve 1311 configured to couple to a catheter assembly 1702, [0092] & Figs. 13-14 and 17; sleeve 1511 and 1311 both disclosed as similar to sleeve 1211, rendering their function synonymous, [0084] and [0089]), and wherein the grip is movable, such that the inner housing is movable relative to the outer housing and moves the instrument (thumb wheel 1342 is rotatable and casing 904, with guidewire 102 disposed inside, is movable through conduit 1350, [0076] and [0086] & Fig. 13-14; casing 904 directly connected to guidewire 102 over wheel 1342 - the movement of casing 904 is being interpreted as also moving guidewire 102, [0087]) between a first position, in which the instrument is disposed within the outer housing (first mode, the fist mode inherently including guidewire 102 disposed within the conduit 1350, see [0072] & Fig. 13), and
a second position, in which the distal end of the instrument is disposed beyond the distal end of the outer housing such that at least a portion of the instrument is disposed within the intravenous line when the introducer is coupled to the intravenous line (second mode, the second mode being an operational mode for advancing the guidewire 102 out of device 1300, [0072]; in second mode, guidewire 102 would inherently be disposed within catheter assembly 1702 when device 1300 is coupled to catheter assembly 1702, see Fig. 13 and 17).
Regarding claim 2, Howell discloses all the limitations of claim 1. Howell further discloses the medical device wherein the outer housing is curved (conduit 1350 being in a coiled configuration, [0073] & Fig. 13-14).
Regarding claim 3, Howell discloses all the limitations of claim 1. Howell further discloses the medical device wherein a curvature of the passageway of the outer housing follows an arc of a circle (a curvature of the passageway of conduit 1350 following an arc of a circle, [0073] & seen in Figs. 13-14).
Regarding claim 4, Howell discloses all the limitations of claim 1. Howell further discloses the medical device wherein a curvature of the outer housing follows an arc of a circle (a curvature of conduit 1350 following an arc of a circle, [0073] & seen in Figs. 13-14).
Regarding claim 5, Howell discloses all the limitations of claim 1. Howell further discloses the medical device wherein at least a portion of the inner housing is straight (casing 904 being straight along the bottom portion of casing 904, see Fig. 14; casing 904 also being straight along the inside of second sleeve 1320, also see Fig. 14).
Regarding claim 6, Howell discloses all the limitations of claim 1. Howell further discloses the medical device wherein the inner housing is curved along an arc of a circle (splitable casing 904 being curved along an arc of a circle, see Figs. 13-14).
Regarding claim 7, Howell discloses all the limitations of claim 1. Howell further discloses the medical device wherein the inner housing extends along an arc of the circle corresponding to an arc of the circle along which the outer housing extends (casing 904 extending along an arc of a circle corresponding to an arc of a circle along which conduit 1350 extends, see Figs. 13-14; casing 904 being disposed in conduit 1350, [0086]).
Regarding claim 8, Howell discloses all the limitations of claim 1. Howell further discloses the medical device wherein the inner housing and the outer housing extend along substantially equal arcs of the circle (casing 904 extending along an arc of a circle corresponding to a substantially equal arc of a circle along which conduit 1350 extends, see Figs. 13-14; casing 904 being disposed in conduit 1350, [0086]).
Regarding claim 9, Howell discloses all the limitations of claim 6. Howell further discloses the medical device wherein, when the inner housing is in the first position, the combined inner housing and outer housing extend around a partial circle (casing 904 and conduit 1350 partially extend around a partial circle in the coiled configuration in the first mode, see [0073] & Figs. 13-14).
Regarding claim 10, Howell discloses all the limitations of claim 6. Howell further discloses the medical device wherein, when the inner housing is in the first position, the combined inner housing and outer housing extend around a full circle (casing 904 and conduit 1350 extending around a full circle in the coiled configuration in the first mode, see [0073] & Figs. 13-14).
Regarding claim 11, Howell discloses all the limitations of claim 6. Howell further discloses the medical device wherein, when the inner housing is in the first position, the combined inner housing and outer housing extend around more than a full circle (casing 904 and conduit 1350 extending around more than a full circle in the coiled configuration in the first mode, see [0073] & Figs. 13-14).
Regarding claim 12, Howell discloses all the limitations of claim 1. Howell further discloses the medical device wherein the passageway of the outer housing is coiled having at least one rotation extending around a full circle (casing 904 and conduit 1350 extending around a full circle in the coiled configuration in the first mode, see [0073] & Figs. 13-14).
Regarding claim 16, Howell discloses all the limitations of claim 11. Howell further discloses the
medical device wherein the outer housing is a single piece housing, and wherein the passageway is coil-shaped (conduit 1350 being a single piece that defines a coil-shaped passageway, [0073] & Fig. 13-14).
Regarding claim 17, Howell discloses all the limitations of claim 16. Howell further discloses the medical device wherein an exterior of the outer housing has a shape other than a coiled shape (exterior of conduit 1350 being straight along a bottom portion of conduit 1350, see Fig. 14) and the passageway defined within the outer housing is coil shaped (the passageway in conduit 1350 having a coil shape, [0073] & Fig. 13-14).
Regarding claim 19, Howell discloses all the limitations of claim 11. Howell further discloses the medical device wherein a portion of the inner housing is straight (casing 904 being straight along the bottom portion of casing 904, see Fig. 14; casing 904 also being straight along the inside of second sleeve 1320, also see Fig. 14).
Regarding claim 20, Howell discloses all the limitations of claim 11. Howell further discloses the medical device wherein the inner housing is coiled, has a larger diameter than a diameter of the outer housing, and surrounds the outer housing (casing 904 being coiled, [0073] & Fig. 13-14; as casing 904 splits from guidewire 102 and enters casing conduit 1354, the diameter of the coil formed by casing 904 becomes greater than a diameter of the coil formed by conduit 1350 and surrounds conduit 1350, [0086] & Fig. 13-14).
Regarding claim 21, Howell discloses all the limitations of claim 11. Howell further discloses the medical device wherein the outer housing is coiled and the inner housing is coiled (both casing 904 and conduit 1350 are in a coiled configuration, [0073] & Fig. 13-14), and the inner housing has a smaller diameter than a diameter of the outer housing and is positioned within a center of the outer housing (casing 904 is disposed in conduit 1350 which necessitates the diameter of casing 904 be smaller than a diameter of conduit 1350, [0086] & Fig. 13-14; casing 904 seen positioned within the center of conduit 1350, see Fig. 13-14).
Regarding claim 22, Howell discloses all the limitations of claim 11. Howell further discloses the medical device wherein the inner housing is coiled and is positioned adjacent to the outer housing (casing 904 being coiled and positioned adjacent to conduit 1350, & see Fig. 13-14).
Regarding claim 23, Howell discloses all the limitations of claim 20. Howell further discloses the medical device wherein the inner housing comprises any number of full rotations (casing 904 comprising a full rotation in the coiled configuration, see [0073] & Figs. 13-14).
Regarding claim 24, Howell discloses all the limitations of claim 1. Howell further discloses the medical device wherein a length of the inner housing is approximately equal to a length of the outer housing (the length of casing 904 is being interpreted as approximately equal to the length of conduit 1350, see [0015] and [0066] & shown in Figs. 13 and 14; the Examiner notes that the use of the term “approximately” allows for a broad interpretation of the limitation of “equal”).
Regarding claims 25 and 27, Howell discloses a system (assembly 1700, [0092] & Fig. 17), comprising: a catheter assembly (catheter assembly 1702, [0092] & Fig. 17) comprising: a catheter adapter comprising a distal end; a proximal end; a lumen extending between the distal end and the proximal end (catheter adapter of assembly 1702 having a distal end and a proximal end with a lumen inherently extending in between, see annotated Fig. 17 below in which the catheter adapter is annotated as “Catheter Adapter”; a lumen would inherently extend through the catheter adapter and through all three proximal fluid conduits, see annotated Fig. 17 below); and a side port arranged between the distal end and the proximal end (the side port arranged between the distal and proximal ends, see annotated Fig. 17 below; side port annotated as “Side Port”), the side port in fluid communication with the lumen (the side port would inherently be in fluid communication with the lumen, see Fig. 17); and a catheter extending distally from the catheter adapter and in fluid communication with the lumen (the catheter extending distally from the catheter adapter, see annotated Fig. 17 below in which the catheter is annotated as “Catheter”; the catheter inherently in fluid communication with the lumen); and the medical device of claim 1 (see rejection of claim 1 above), coupled to the side port (device 1300 capable of fluidly coupling to the side port through sleeve 1311, which is synonymous in function to sleeve 1511, see [0092] & Fig. 13-14 and 17).
Regarding claim 26, Howell discloses all the limitations of claim 25. Howell further discloses the system wherein the medical device is coupled to the side port by a fluid conduit having a proximal end coupled to the side port and a distal end coupled to the medical device (device 1300 fluidly coupled to the side port by a fluid conduit having a proximal end coupled to the side port and a distal end coupled to device 1300, see annotated Fig. 17 below in which the fluid conduit is annotated as “Fluid Conduit”).
PNG
media_image1.png
510
737
media_image1.png
Greyscale
Claim Rejections - 35 USC § 103
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.
Claim(s) 25-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cook (WO 2021236530 A1), in view of Burkholz US 20200230353 A1
Regarding claims 25-27, Cook discloses a system (catheter system 100 and intravenous catheter system 102, [0041] & Fig. 1-2 and 6A), comprising: a catheter assembly (IV catheter system 102, [0041] & Fig. 6A-7) comprising: a catheter adapter comprising a distal end; a proximal end; a lumen extending between the distal end and the proximal end (hub 106 comprising a proximal end near seal 107 and a distal end near catheter 104 and a lumen extending in-between in which interface 148 is disposed, [0058]-[0059] & Fig. 6A); and
a catheter extending distally from the catheter adapter and in fluid communication with the lumen (catheter 104 extending distally from hub 106 and in fluid communication with the lumen, [00109] & Fig. 6A); and the medical device of claim 1 (see the rejection of claim 1 above), coupled to the catheter adapter (catheter system 100 coupled to hub 106 through interface 148, [0057] & Fig. 5-6A).
However, Cook fails to explicitly disclose a system comprising: a catheter adapter comprising a side port arranged between the distal end and the proximal end, the side port in fluid communication with the lumen; and the medical device of claim 1, coupled to the side port,
wherein the medical device is coupled to the side port by a fluid conduit having a proximal end coupled to the side port and a distal end coupled to the medical device.
However, Burkholz teaches a system (catheter system 36, including delivery device 10, [0065] & Fig. 3A) comprising: a catheter adapter (catheter assembly 38, including catheter adapter 40, [0065] and [0070] & Fig. 3A) comprising a side port arranged between the distal end and the proximal end, the side port in fluid communication with the lumen (side port 41 arranged between distal end 42 and proximal end 44 of adapter 40, [0065] and [0070] & Fig. 3A-3D; side port 41 being in fluid communication with lumen 46, [0065] & Fig. 3D; additionally, “the first fluid pathway 56 and/or the second fluid pathway 58 may extend through the side port 41 and the primary catheter 48.”, [0070] & Fig. 3D); and
a medical device coupled to the side port (device 10 coupled to side port 41 through housing distal end 16 and extension tub 53, see [0055] and [0068] & Fig. 3A-3D), wherein the medical device is coupled to the side port by a fluid conduit (device 10 coupled to side port 41 through extension tube 53, [0068] & Fig. 3A-3D) having a proximal end coupled to the side port and a distal end coupled to the medical device (proximal end of tube 53 coupled to side port 41 and a distal end of tube 53 coupled to end 16 of device 10, [0068] & Fig. 3A-3D).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the catheter adapter of Cook with Burkholz to include a side port arranged between the distal end and the proximal end, the side port in fluid communication with the lumen, and the medical device coupled to the side port, wherein the medical device is coupled to the side port by a fluid conduit having a proximal end coupled to the side port and a distal end coupled to the medical device, since Burkholz teaches connecting a catheter inserting mechanism capable of blood withdrawal to a side port of a catheter adapter to be an art effective configuration for connection, interchangeable with attachment to the proximal end of the catheter adapter, a configuration synonymous the disclosure of Cook (see [0002], [0070], and [0079] of Burkholz).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Howell (US 20210283381 A1).
Regarding claim 13, Howell discloses all the limitations of claim 12. Howell further discloses the medical device wherein the outer housing is tubular and coiled with a concentric rotation having a set shape that is provided by a material of the outer housing (conduit 1350 being tubular and coiled with a concentric rotation, see [0073] & see Figs. 13-14; the polymeric material of conduit 1350 allowing for conduit 1350 to take shape, [0086]). However, Howell fails to explicitly disclose concentric rotations.
However, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have looped conduit 1350 around multiple times, creating concentric rotations, in order to further pack the elongated conduit into a more compact space. Howell discloses channel 1341 configured to “hold a conduit in a coiled configuration, thereby packing an otherwise elongate conduit into a compact space” (see [0073]). One having ordinary skill in the art would have found it obvious to loop conduit 1350 into multiple coils to reduce the overall profile of conduit 1350 and to achieve predictable results pertaining to further conduit packing into compact space.
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Howell (US 20210283381 A1), as applied to claims 1-12 above, and further in view of Howell (US 20210283368 A1), hereinafter Howell ‘368.
Regarding claim 14, Howell discloses all the limitations of claim 12. Howell discloses conduit 1350 being tubular and coiled with a concentric rotation (see Figs. 13-14). However, Howell fails to explicitly disclose the medical device wherein concentric rotations of the outer housing are attached to one another along all or a portion of a contact area between the concentric rotations.
However, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have looped conduit 1350 around multiple times, creating concentric rotations, in order to further pack the elongated conduit into a more compact space. Howell discloses channel 1341 configured to “hold a conduit in a coiled configuration, thereby packing an otherwise elongate conduit into a compact space” (see [0073]). One having ordinary skill in the art would have found it obvious to loop conduit 1350 into multiple coils to reduce the overall profile of conduit 1350 and to achieve predictable results pertaining to further conduit packing into compact space.
Further, Howell ‘368 teaches a medical device (device 2000, [0109] & Fig. 12) wherein concentric rotations of the outer housing (guidewire conduit 2050 in a coiled configuration with multiple concentric rotations, see [0109] & Fig. 12) are attached to one another along a portion of a contact area between the concentric rotations (guidewire-conduit clips 2058 attaching portions of conduit 2050 to one another, [0109] & Fig. 12).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Howell with Howell ‘368 to include the concentric rotations of the outer housing attached to one another along a portion of a contact area between the concentric rotations since such a modification would provide structure to hold different portions of the conduit together in the coiled configuration while providing structural integrity (see [0103] and [0109] and of Howell ‘368).
Regarding claim 15, Howell discloses all the limitations of claim 12. Howell further discloses the medical device wherein the outer housing is tubular with a concentric rotation (conduit 1350 being tubular and coiled with a concentric rotation, [0073] and [0087] & Fig. 13-14). However, Howell fails to explicitly disclose the medical device wherein concentric rotations of the outer housing are attached to one another by at least one connector.
However, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to have looped conduit 1350 around multiple times, creating concentric rotations, in order to further pack the elongated conduit into a more compact space. Howell discloses channel 1341 configured to “hold a conduit in a coiled configuration, thereby packing an otherwise elongate conduit into a compact space” (see [0073]). One having ordinary skill in the art would have found it obvious to loop conduit 1350 into multiple coils to reduce the overall profile of conduit 1350 and to achieve predictable results pertaining to further conduit packing into compact space.
Further, the medical device wherein concentric rotations of the outer housing are attached to one another by at least one connector. Howell ‘368 teaches a medical device (device 2000, [0109] & Fig. 12) wherein concentric rotations of the outer housing (guidewire conduit 2050 in a coiled configuration with multiple concentric rotations, see [0109] & Fig. 12) are attached to one another by at least one connector (guidewire-conduit clips 2058 attaching the coils of conduit 2050 together, [0109] & Fig. 12).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Howell with Howell ‘368 to include the concentric rotations of the outer housing attached to one another by at least one connector since such a modification would provide structure to hold different portions of the conduit together in the coiled configuration while providing structural integrity (see [0103] and [0109] and of Howell ‘368).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Howell (US 20210283381 A1), as applied to claims 1-12 and 16-27 above, and further in view of Posey (US 4707906 A).
Regarding claim 18, Howell discloses all the limitations of claim 16. Howell fails to explicitly disclose the medical device wherein the outer housing is an assembly of two or more parts that are connected in a clam shell configuration. However, Posey teaches a medical device (abstract and Col 1 lines 21-21) wherein the outer housing is an assembly of two or more parts (the tubing 42 and tube holder 10 are being interpreted as the outer housing, see Col 2 lines 19-20 and Col 3 lines 29-30 & Fig. 1-2) that are connected in a clam shell configuration (tubing 42 is connected to tube holder 10 in a claim shell configuration, see Col 3 lines 51-63 & Fig. 1-2).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Howell with Posey to include the outer housing being an assembly of two or more parts that are connected in a clam shell configuration since such a modification would provide additional structure to securely hold the outer housing onto a bed, other instrument, sheets, or the like for confining the outer housing held in a receptacle of the tube holder and yield predictable results pertaining to tube confinement (see Col 1 lines 35-58 of Posey).
Response to Arguments
Applicant's arguments filed January 5th 2025 have been fully considered but they are not persuasive. In response to Applicant’s arguments that a “complete… outer housing using a clam shell configuration appears the same as an outer housing made of a single part” and that one of ordinary skill in the art would understand that the drawings show a complete and assembled outer housing that may use a clam shell configuration, the Examiner finds that an outer housing using a clam shell configuration would include associated structure to facilitate a clam shell connection, such as a hinge. Structure necessary to facilitate a clam shell connection, which the Examiner believes to be essential for a proper understanding of the claimed subject matter, is not illustrated in the drawings.
Applicant’s arguments with respect to the grip of claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Schaller (US 20100241177 A1). Schaller teaches a flexible bridge member 104 connected to a delivery cannula 106 configured to allow a pusher member 126 and a ferrule 129 to advance therethrough while maintain its contour (see [0051]). “Flexible bridge 104 may bend or curve to allow the operator to move the cannula 106 and housing 102 relative to one another. The ability to bend the flexible bridge 104 enhances the operator's ability to manipulate or articulate the delivery apparatus 100 into suitable or desirable positions during the procedure.” ([0047]).
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 MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783