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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 9/10/2026 has been entered.
Response to Amendment
The amendment filed 9/10/2026 has been entered. Claims 1-27 are pending in the application.
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 (US 20220161003 A1), hereafter referred to as Cook ‘003.
Regarding claim 1, Cook ‘003 discloses a medical device (access system 200, [0096] & Fig. 2-5), comprising: an instrument having a proximal end and a distal end (cannula 204 having a proximal end and a distal tip 227, [0098] and [0110] & Fig. 2-5); an introducer configured to moveably receive the instrument (connector 202, proximal segment 222, element 240, and connector 229 of system 200, [0098], [0102], [0133] & Fig. 2-5) and having:
an outer housing having a proximal end, a distal end, and a sidewall therebetween defining a passageway, wherein the passageway is curved (connector 202 having a proximal end, a distal end at region 203, and sheath 205 therebetween defining a channel 212, [0100] & Fig. 2-5; connector 202 being “substantially tubular in shape”, [0100]; channel 212 is curved considering connector 202 is tubular; 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 curve rendering channel 212 curved); and an inner housing having a proximal end, a distal end, and a sidewall therebetween defining an inner volume, the inner housing slidably received within the outer housing (proximal segment 222 having a proximal end at connector 229, a distal end at annular channel 244, and a sidewall therebetween defining lumen 221, [0102]-[0103] and [0133] & Fig. 2-6; segment 222 configured to slide within connector 202, [0098] & Fig. 2-6);
at least one septa disposed about the instrument within the outer housing (friction or resistance element 240, which may be an O-ring, disposed about cannula 204 within connector 202, [0133] & Fig. 2-7), the at least one septa being configured to vent air within the outer housing (element 240 capable of venting air within connector 202 as the air present in connector 202 must escape as cannula 204 is slid through connector 202, [0098] and [0133] & Fig. 3-5);
and a grip arranged outside of the passageway and secured to the proximal end of the inner housing (connector 229 configured to be gripped by a user and arranged outside channel 212 and secured to a proximal end of segment 222, [0098] and [0103] & Fig. 2-6), wherein a distal end of the introducer is configured to couple the introducer to an intravenous line (coupling interface 210 configured to couple the introducer to an IV line, [0092] and [0099] & Fig. 1A-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 (connector 229 is movable such that segment 222 is movable relative to connector 202 and moves cannula 204 between an undeployed state (Fig. 2-3), in which cannula 204 is disposed in connector 202, and a deployed state (Fig. 4-5), in which distal tip 227 of cannula 204 is disposed beyond region 203 of connector 202, [0096], [0098], and [0105]) such that at least a portion of the instrument is disposed within the intravenous line when the introducer is coupled to the intravenous line ([0096] and [0109]).
Regarding claim 2, Cook ‘003 discloses all the limitations of claim 1. Cook ‘003 further discloses the medical device wherein the outer housing is curved (“The connector 202 may be longitudinally elongated so as to be substantially tubular in shape.”, [0100] & Fig. 2-5).
Regarding claim 3, Cook ‘003 discloses all the limitations of claim 1. Cook ‘003 further discloses the medical device wherein a curvature of the passageway of the outer housing follows an arc of a circle (channel 212 is curved and circular considering connector 202 is tubular, [0100] & Fig. 2-5; the curvature of channel 212 follows an arc of a circle considering channel 212 is circular).
Regarding claim 4, Cook ‘003 discloses all the limitations of claim 1. Cook ‘003 further discloses the medical device wherein a curvature of the outer housing follows an arc of a circle (considering connector 202 is tubular, the curvature of connector 202 can be interpreted as following an arc of a circle, see [0100] and Fig. 2-5).
Regarding claim 5, Cook ‘003 discloses all the limitations of claim 1. Cook ‘003 further discloses the medical device wherein at least a portion of the inner housing is straight (at least a portion of segment 222 is straight, Fig. 2-6).
Regarding claim 6, Cook ‘003 discloses all the limitations of claim 1. Cook ‘003 further discloses the medical device wherein the inner housing is curved along an arc of a circle (segment 222, having a lumen 221 (Fig. 5) is seen being tubular/cylindrical, similarity to connector 202, see Fig. 2-6 and [0100] and [0103]; segment 222 can be interpreted as curved along an arc of a circle considering segment 222 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 ‘003 discloses all the limitations of claim 1. Cook ‘003 further discloses the medical device wherein the inner housing and the outer housing extend along substantially equal arcs of a circle (segment 222 and connector 202 are both tubular/cylindrical, [0100] and [0103] & Fig. 2-6; the diameter of segment 222 is smaller than the diameter of connector 202 but both connector 202 and segment 222 can be interpreted as extending along substantially equal arcs of a circle).
Regarding claim 9, Cook ‘003 discloses all the limitations of claim 6. Cook ‘003 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 the undeployed state (Fig. 2-3), the distal end of segment 222 is concentrically disposed in connector 202, [0098]; the combination of segment 222 and connector 202 can be interpreted as partially extending around a partial circle since both segment 222 and connector 202 are tubular/cylindrical).
Regarding claim 10, Cook ‘003 discloses all the limitations of claim 6. Cook ‘003 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 the undeployed state (Fig. 2-3), the distal end of segment 222 is concentrically disposed in connector 202, [0098]; the combination of segment 222 and connector 202 can be interpreted as partially extending around a full circle since both segment 222 and connector 202 are tubular/cylindrical).
Regarding claim 24, Cook ‘003 discloses all the limitations of claim 1. Cook ‘003 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. 2-5, the length of segment 222 and the length of connector 202 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 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) 1-6, 8-10, and 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cook (WO 2021236530 A1), in view of Cook ‘003 (US 20220161003 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 and a sidewall therebetween defining an inner volume as catheter portion 114 is hollow to facilitate blood collection, [0042] and [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]).
However, Cook fails to explicitly disclose at least one septa disposed about the instrument within the outer housing, the at least one septa being configured to vent air within the outer housing.
However, Cook ‘003 teaches a medical device (access system 200, [0096] & Fig. 2-7) comprising at least one septa disposed about the instrument within the outer housing (friction or resistance element 240, which may be an O-ring, disposed about cannula 204 within connector 202, [0133] & Fig. 2-7), the at least one septa being configured to vent air within the outer housing (element 240 capable of venting air within connector 202 as the air present in connector 202 must escape as cannula 204 is slid through connector 202, [0098] and [0133] & Fig. 3-5).
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 Cook with Cook ‘003 to include at least one septa since such a modification would provide structure to adjust or temper relative movement of the inner and outer housing and would yield predictable results pertaining to regulated movement ([0133] of Cook ‘003).
Regarding claim 2, Cook, as modified, 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, as modified, 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, as modified, 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, as modified, 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, as modified, 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, as modified, 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, as modified, 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, as modified, 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) 7, 11-13, 16-17, and 19-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cook (WO 2021236530 A1), in view of Cook ‘003 (US 20220161003 A1), and further in view of Devgon (US 20210052851 A1).
Regarding claim 7, Cook, as modified, discloses all the limitations of claim 1. Cook further discloses the medical device wherein the inner housing is flexible (“the proximal catheter portion 114 may be formed of, for example, polyurethane, Pebax, or a flexible transparent or translucent thermoplastic. The material may be selected for such properties as transparency or translucence, which can facilitate viewing of blood flow therethrough, and/or flexibility.”, [0061]).
However, Cook fails to explicitly disclose the medical device wherein the inner housing extends along an arc of a circle corresponding to an arc of a circle along which the outer housing extends.
However, Devgon teaches a medical device (fluid transfer device 300, [0068] & Fig. 5-6) wherein the inner housing extends along an arc of a circle corresponding to an arc of a circle along which the outer housing extends (proximal end portion 331 extends along an arc of a circle corresponding to an arc of a circle along which housing 310 extends, [0068]-[0069] & Fig. 5-6), in which the outer housing is flexible or rigid and formed into a looped or coiled shape ([0068]-[0069] & Fig. 5-6).
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 Cook, as modified, with Devgon to include the outer housing being made of a relatively rigid member that is formed or molded into a looped or coiled shape or made of a relatively flexible material that can be bent, formed, curved, and/or otherwise reconfigured since such a modification would allow a user to manipulate the device to place the housing in any suitable shape and/or configuration to reduce an overall length and/or size of the device ([0068] of Devgon).
As modified, housing 111 of Cook could be formed of a relatively rigid member that is formed into a looped or coiled shape or from a relatively flexible material that allows housing 111 of Cook to be bent, formed, or curved, and/or otherwise reconfigured onto a looped, circular, coiled, or other suitable shape/configuration. The housing can include any number of loops or turns, thereby allowing for any suitable catheter length (see [0068]-[0069] of Devgon). As combined, the flexible catheter proximal portion 114, when inserted into housing 111, would extend along an arc of a circle corresponding to an arc of a circle along which housing 111 extends, synonymously to catheter portion 331 in housing 310 of Devgon.
Regarding claim 11, Cook, as modified, discloses all the limitations of claim 6. Cook further discloses the medical device wherein the inner housing is flexible (“the proximal catheter portion 114 may be formed of, for example, polyurethane, Pebax, or a flexible transparent or translucent thermoplastic. The material may be selected for such properties as transparency or translucence, which can facilitate viewing of blood flow therethrough, and/or flexibility.”, [0061]).
However, Cook fails to explicitly disclose 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.
However, Devgon teaches a medical device (fluid transfer device 300, [0068] & Fig. 5-6) wherein, when the inner housing is in the first position, the combined inner housing and outer housing extend around more than a full circle (in a first position (Fig. 5), proximal portion 331 and housing 310 extend around more than a full circle, [0068]-[0069] & Fig. 5), in which the outer housing is flexible or rigid and formed into a looped or coiled shape ([0068]-[0069] & Fig. 5-6).
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 Cook, as modified, with Devgon to include the outer housing being made of a relatively rigid member that is formed or molded into a looped or coiled shape or made of a relatively flexible material that can be bent, formed, curved, and/or otherwise reconfigured since such a modification would allow a user to manipulate the device to place the housing in any suitable shape and/or configuration to reduce an overall length and/or size of the device ([0068] of Devgon).
As modified, housing 111 of Cook could be formed of a relatively rigid member that is formed into a looped or coiled shape or from a relatively flexible material that allows housing 111 of Cook to be bent, formed, or curved, and/or otherwise reconfigured onto a looped, circular, coiled, or other suitable shape/configuration. The housing can include any number of loops or turns, thereby allowing for any suitable catheter length (see [0068]-[0069] of Devgon). As combined, in the first position, catheter proximal portion 114 and housing 111 combined would extend around more than a full circle, synonymously to catheter portion 331 and housing 310 of Devgon as seen in Fig. 5-6.
Regarding claim 12, Cook, as modified, discloses all the limitations of claim 1. Cook further discloses the medical device wherein the inner housing is flexible (“the proximal catheter portion 114 may be formed of, for example, polyurethane, Pebax, or a flexible transparent or translucent thermoplastic. The material may be selected for such properties as transparency or translucence, which can facilitate viewing of blood flow therethrough, and/or flexibility.”, [0061]).
However, Cook fails to explicitly disclose the medical device wherein the passageway of the outer housing is coiled having at least one rotation extending around a full circle.
However, Devgon teaches a medical device (fluid transfer device 300, [0068] & Fig. 5-6) wherein the passageway of the outer housing is coiled having at least one rotation extending around a full circle (housing 310 is coiled having at least one rotation extending around a full circle, [0068]-[0069] & Fig. 5-6; “While the housing 310 is shown as forming a single loop, circle, coil, turn, etc., it should be understood that a housing can include any number of loops or turns, thereby allowing for any suitable catheter length.”, [0069]; housing 310 may have multiple loops or turns), in which the outer housing is flexible or rigid and formed into a looped or coiled shape ([0068]-[0069] & Fig. 5-6).
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 Cook, as modified, with Devgon to include the outer housing being made of a relatively rigid member that is formed or molded into a looped or coiled shape or made of a relatively flexible material that can be bent, formed, curved, and/or otherwise reconfigured since such a modification would allow a user to manipulate the device to place the housing in any suitable shape and/or configuration to reduce an overall length and/or size of the device ([0068] of Devgon).
As modified, housing 111 of Cook could be formed of a relatively rigid member that is formed into a looped or coiled shape or from a relatively flexible material that allows housing 111 of Cook to be bent, formed, or curved, and/or otherwise reconfigured onto a looped, circular, coiled, or other suitable shape/configuration. The housing can include any number of loops or turns, thereby allowing for any suitable catheter length (see [0068]-[0069] of Devgon). As combined, internal cavity 140 of housing 111 would be coiled having at least one rotation extending around a full circle as housing 111 would be coiled having at least one rotation extending around a full circle, similarly to housing 310 of Devgon.
Regarding claim 13, Cook, as modified, discloses all the limitations of claim 12. Cook, as modified, further discloses the medical device wherein the outer housing is tubular (housing 111 being tubular, [0055] & Fig. 2-5 of Cook) and coiled with concentric rotations having a set shape that is provided by a material of the outer housing (as modified, housing 111 of Cook is coiled with concentric rotations having a set shape that is provided by the material of housing 111, see Fig. 2-5 of Cook and [0068]-[0069] & Fig. 5-6 of Devgon).
Regarding claim 16, Cook, as modified, discloses all the limitations of claim 11. Cook, as modified, further discloses the medical device wherein the outer housing is a single housing, and wherein the passageway is coil-shaped (as modified, housing 111 of Cook is a single housing with internal cavity 140 following the coiled shape provide by coiled housing 111, see Fig. 2-5 of Cook and [0068]-[0069] & Fig. 5-6 of Devgon).
Regarding claim 17, Cook, as modified, discloses all the limitations of claim 16. Cook, as modified, further discloses the medical device wherein an exterior of the outer housing has a shape other than a coiled shape (the exterior of housing 111 being straight along its proximal and distalmost ends, see Fig. 2-5 of Cook and Fig. 5-6 of Devgon) and the passageway defined within the outer housing is coil shaped (as modified, internal cavity 140 would follow the coil shape of housing 111, see Fig. 2-5 of Cook and [0068]-[0069] & Fig. 5-6 of Devgon).
Regarding claim 19, Cook, as modified, discloses all the limitations of claim 11. Cook, as modified, further discloses the medical device wherein a portion of the inner housing is straight (the exterior of housing 111 being straight along its proximal and distalmost ends, see Fig. 2-5 of Cook and Fig. 5-6 of Devgon).
Regarding claims 20 and 22-23, Cook, as modified, discloses all the limitations of claim 11. Cook further discloses wherein the inner housing is positioned adjacent to the outer housing (portion 114 is positioned adjacent housing 111, [0044] & Fig. 1).
However, Cook fails to explicitly disclose the medical device wherein the inner housing is coiled, has a larger diameter than a diameter of the outer housing, surrounds the outer housing, and wherein the inner housing comprises any number of full and/or partial rotations.
However, Devgon further teaches the medical device wherein the inner housing is coiled (proximal portion 331 is seen coiled in Fig. 6 as proximal portion 331 assumes the coiled shape of housing 310), has a larger diameter than a diameter of the outer housing, and comprises a partial rotation (“In some embodiments, the turned or looped configuration of the housing 310 can be such that a length of the catheter 330 is longer than a length or distance between the first port 311 and the second port 312. Accordingly, the catheter 330 can have any desirable length or “reach” without substantially increasing an overall length of the device 300.”, [0069] & Fig. 5; catheter proximal portion 331 is longer than housing 310 with the overall diameter of coiled portion 331 being larger than the diameter of housing 310, housing 310 being tubular, see Fig. 5-6; portion 331 is seen comprising a partial rotation in Fig. 5-6).
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 Cook, as modified, with Devgon to include the inner housing being coiled, having a larger diameter than a diameter of the outer housing, and comprising a partial rotation, since such a modification would allow the instrument to be displaced further distally into and/or past a peripherical intravenous catheter or other therapy device that can be used in conjunction with the medical device (see [0005], [0030], and [0068]-[0069] of Devgon).
Further, 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 the inner housing surrounding the outer housing in order to maintain the device in a more compact space. Devgon teaches that “the housing 310 can be formed and/or placed into a shape or configuration that reduces, for example, an overall length and/or size of the device 300… the catheter 330 can have any desirable length or “reach” without substantially increasing an overall length of the device 300” ([0068]-[0069). One of ordinary skill in the art would have found it obvious to loop the proximal portion of the catheter around the outer housing, surrounding the outer housing, to reduce the overall profile of the device and to achieve predictable results pertaining to a reduction in overall device length and/or size.
Regarding claim 21, Cook, as modified, discloses all the limitations of claim 11. Cook, as modified, further discloses the medical device wherein the outer housing is coiled (as modified, housing 111 is coiled, see [0068]-[0069] & Fig. 5-6 of Devgon) and the inner housing has a smaller diameter than a diameter of the outer housing (portion 114 has a smaller diameter than a diameter of housing 111 as portion 114 is slidably disposed inside of housing 111, [0042] and [0044] & Fig. 1-2 and 5) and is positioned within a center of the outer housing (portion 114 is seen positioned coaxially with housing 111, Fig. 1 and 5).
However, Cook fails to explicitly disclose the medical device wherein the inner housing is coiled. However, Devgon further teaches the medical device wherein the inner housing is coiled (proximal portion 331 is seen coiled in Fig. 6 as proximal portion 331 assumes the coiled shape of housing 310).
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 Cook, as modified, with Devgon to include the inner housing being coiled since such a modification would allow the instrument to be displaced further distally into and/or past a peripherical intravenous catheter or other therapy device that can be used in conjunction with the medical device and would reduce the overall profile of the device (see [0005], [0030], and [0068]-[0069] of Devgon).
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cook (WO 2021236530 A1), in view of Cook ‘003 (US 20220161003 A1), in view of Devgon (US 20210052851 A1), and further in view of Howell (US 20210283368 A1).
Regarding claims 14-15, Cook, as modified, discloses all the limitations of claim 12. Cook further discloses the medical device wherein the outer housing is tubular (housing 111 being tubular, [0055] & Fig. 2-5 of Cook). However, Cook 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, and concentric rotations of the outer housing are attached to one another by at least one connector.
However, Howell 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, wherein concentric rotations of the outer housing are attached to one another by at least one connector (guidewire-conduit clips 2058 attaching the coils of conduit 2050 together along a contact area between concentric rotations, [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 Cook, as modified, with Howell to include the concentric rotations of the outer housing attached to one another along a portion of a contact area between the concentric rotations 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 Cook (WO 2021236530 A1), in view of Cook ‘003 (US 20220161003 A1), in view of Devgon (US 20210052851 A1), and further in view of Posey (US 4707906 A).
Regarding claim 18, Cook, as modified, discloses all the limitations of claim 16. However, Cook 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 Cook, as modified, 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).
Claim(s) 25-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cook (WO 2021236530 A1), in view of Cook ‘003 (US 20220161003 A1), and further 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, as modified, 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).
Response to Arguments
Applicant's arguments filed 9/10/2026 have been fully considered but they are not persuasive.
In response to Applicant’s arguments to the drawing objection, the Examiner finds that a “swaged connection” or “corresponding features that have tolerances that create a frictional fit” are not clam shell configurations as would be understood by one of ordinary skill in the art. Applicant has provided examples of different types of connections between tubular structures, but not “a clam shell configuration”. The 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 prior art rejections of the claims 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
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/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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