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 .
Election/Restrictions
Applicant’s election without traverse of claims 1-11 and 16-24 in the reply filed on 24 March 2026 is acknowledged.
Status of Claims
This office action is responsive to the amendment filed 24 March 2026.
Claims 12-15 are withdrawn.
Claims 1-11 and 16-24 are presently pending in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 8 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites the limitation “a split, tear-off ring”. It is unclear if this is the same “tear-off ring” of claim 7. The specifications and drawings do not disclose two different tear-off rings. For the purposes of examination, Examiner interprets “a split, tear-off ring” as --the frangible, tear-off ring--.
Claim 8 also recites the limitation “a monolithic structure, end cap assembly”. It is unclear if this is the same “tamper evident, selectively removable end cap assembly” of claim 6. The specifications and drawings do not disclose two different end cap assemblies. For the purposes of examination. Examiner interprets “a monolithic structure, end cap assembly” as --the tamper evident, end cap assembly--.
Claim 8 also recites the limitations “a plurality of integrally formed, first, shear-off connectors” and “a plurality of integrally formed, second, shear-off connectors”. It is unclear if these limitations are the same as the “at least one first, shear-off connector” and the “second, at least one shear-off connector” of claim 7. The specifications and drawings do not disclose two different pluralities of the first and second shear-off connector(s). For the purposes of examination. Examiner interprets “a plurality of integrally formed, first, shear-off connectors” and “a plurality of integrally formed, second, shear-off connectors” as –the at least one first, shear-off connector—and –the at least one, second, shear-off connector--.
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.
Claims 1 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Shultz (US Patent Publication No. 20140276651 A1) in view of Mide et al. (US Patent Publication No. 20210268203 A1), hereinafter Mide.
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Regarding claim 1, Shultz discloses a flush syringe (Shultz: Fig. 2, medical product 103) for intravenous fluid administration to a patient (para. 0029), comprising: a syringe barrel (Fig. 2 shown above, syringe barrel A) with a distal end (Fig. 2 shown above, distal end B), an open proximal end (Fig. 2 shown above, open proximal end A), and a syringe cavity (Fig. 3 shown above, syringe cavity E) within the syringe barrel (A); a syringe plunger (Fig. 2 shown above, syringe plunger D) translatable within the syringe cavity (E); a male, barrel Luer connector (Fig. 4, male Luer-type connector 107) oriented on the distal end (B) of the syringe barrel (Fig. 4, connector 107 is shown on the distal end of the barrel A), having a male, barrel Luer tip (Fig. 5B, male distal tip 104) defining an outlet lumen (Fig. 5B shown above, outlet lumen F) in communication with the syringe cavity (Fig. 5B shown above, lumen F is in communication with cavity E); a syringe coupler (Fig. 3 and 4, reduced-touch contamination device 102) including: a housing (Fig. 5A, collar 116 of the device 102) having proximal (Fig. 72 above, proximal end N) and distal axial ends (Fig. 72 above, distal end M), and a central axis (Fig. 72 above, a central axis is shown extending from the male shield to the female shield as a line); a female, first Luer connector (Fig. 5A, female Luer-type connector 110) on the proximal axial end (N) of the housing (116), coaxial with the central axis (Fig. 72, female Luer is shown coaxial with the axis) having a first lumen (Fig. 5A above, first lumen G) defined therein; a male, second Luer connector (Fig. 5A, comprising male distal tip 104 and locking portion 144) on the distal end (Fig. 72 above, distal end M) of the housing (116), coaxial with the central axis (Fig. 72, male Luer is shown coaxial with the central axis), a male Luer tip (Fig. 5A, male distal tip 104) thereof having a second lumen (Fig. 5A shown above, second lumen H) defined therein that is in fluid communication with the first (Fig. 5A shown above, passage I is in fluid communication with lumen G); the female, first Luer connector (110) of the housing (116) coupled to the male, barrel Luer connector (Fig. 4, connector 110 is shown able to connect to connector 107) for delivery of a flushing solution (medical fluid delivery; para. 0029) retained within the syringe cavity (medical product may be pre-filled with medicament; para. 0079) through the outlet lumen (F) of the male, barrel luer connector (107), into the first and second lumens (G and H) of the housing (Fig. 2, fluid must pass through second lumen H to be delivered via device 102); the male, second Luer connector (104 and 144) of the housing (116) adapted for coupled insertion into a corresponding needle-free IV connector (Fig. 2, connector 110 present on line 114, which can be a needleless IV port; table 1) of a patient for delivery through the second lumen (Fig. 2, fluid must pass through second lumen H to be delivered via device 102) of at least a portion of the flushing solution (para. 0029) retained within the syringe cavity (para. 0079) into the IV connector (engagement of needless IV port; table 1); and the syringe coupler (102) selectively removeable from the male, barrel Luer connector (Fig. 2, 102 can be removed), thereby allowing direct coupling of the latter to the corresponding needle-free IV connector (Fig. 2, connector 110 present on line 114, which can be a needleless IV port, can directly connect to connector 107) for delivery of additional flushing solution (para. 0029) retained within the syringe cavity (para. 0079) into the IV connector (table 1).
Shultz does not expressly disclose a storage cap, coupled to the housing, covering the male, second Luer connector and sealing the second lumen.
Mide teaches a storage cap (Mide: Fig. 24, disinfecting cap 1394) coupled to a housing, covering a male second Luer connector (Fig. 25A, cap 1394 is shown coupled to separable collar 1412, which is a male luer shown in Fig. 25C) and sealing a lumen.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Shultz to include a selectively removeable storage cap coupled to the male, second Luer connector of the syringe coupler as taught by Mide in order to seal the syringe and block ingress of pathogens and contaminants (Mide: para. 0131).
Regarding claim 16, Shultz discloses a syringe coupler (Shultz: Fig. 3 and 4, reduced-touch contamination device 102) for intravenous fluid administration to a patient (para. 0029), comprising: a syringe coupler (Fig. 3 and 4, reduced-touch contamination device 102) including: a housing (Fig. 5A, collar 116 of the device 102) having proximal (Fig. 72 above, proximal end N) and distal axial ends (Fig. 72 above, distal end M), and a central axis (Fig. 72 above, a central axis is shown extending from the male shield to the female shield as a line); a female, first Luer connector (Fig. 5A, female Luer-type connector 110) on the proximal end (N) of the housing (116), coaxial with the central axis (Fig. 72, female Luer is shown coaxial with the axis) having a first lumen (Fig. 5A above, first lumen G) defined therein; a male, second Luer connector (Fig. 5A, comprising male distal tip 104 and locking portion 144) on the distal axial end (Fig. 72 above, distal end M) of the housing (116), coaxial with the central axis (Fig. 72, male Luer is shown coaxial with the central axis), a male Luer tip (Fig. 5A, male distal tip 104) thereof having a second lumen (Fig. 5A shown above, second lumen H) defined therein that is in fluid communication with the first (Fig. 5A shown above, passage I is in fluid communication with lumen G); the female, first Luer connector (110) of the housing (116) adapted for coupled receipt of a male Luer tip of a Luer connector of a flush syringe (Fig. 4, connector 110 is shown able to connect to connector 107), whereby an outlet lumen (F) formed within the syringe's male Luer tip (104) is in fluid communication with the first and second lumens (Fig. 5A shown above, passage I is in fluid communication with lumen G, which is in communication with 104) of the housing (116), for delivery of flushing solution from the flush syringe through the second lumen (para. 0079); and the male, second Luer connector (104 and 144) of the housing (116) adapted for coupled insertion into a corresponding needle-free IV connector (Fig. 2, connector 110 present on line 114, which can be a needleless IV port; table 1) of a patient for delivery (para. 0079) of flushing solution therefrom into the IV connector (para. 0079).
Shultz does not expressly disclose a storage cap, coupled to the housing, covering the male, second Luer connector and sealing the second lumen.
Mide teaches a storage cap (Mide: Fig. 24, disinfecting cap 1394) coupled to a housing, covering a male second Luer connector (Fig. 25A, cap 1394 is shown coupled to separable collar 1412, which is a male luer shown in Fig. 25C) and sealing a lumen.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Shultz to include a selectively removeable storage cap coupled to the male, second Luer connector of the syringe coupler as taught by Mide in order to seal the syringe and block ingress of pathogens and contaminants (Mide: para. 0131).
Claims 2 are rejected under 35 U.S.C. 103 as being unpatentable over Shultz in view of Mide, in further view of Higgins et al. (US Patent Publication No. 20150258321 A1), hereinafter Higgins.
Regarding claim 2, Shultz in view of Mide discloses the syringe above.
Shultz in view of Mide does not expressly disclose a hollow sleeve retained within the first passage, a proximal axial end of the hollow sleeve projecting out of the first passage and the first lumen towards the proximal axial end of the housing; with the proximal axial end of the hollow sleeve inserted within the outlet of the male, barrel Luer tip.
Higgins teaches a hollow sleeve (Higgins: Fig. 2, tube 28) retained within a first passage (passageway 60), a proximal axial end (Fig. 3, distal end 74) of the hollow sleeve (28) projecting out of the first passage (Fig. 3, distal end 74 projects out of passageway 60) and a first lumen (Fig. 3, distal end 74 projects out of passageway 76) towards a proximal axial end (Fig. 3, distal end 58) of a housing (Fig. 3, housing 26); with the proximal axial end (74) of the hollow sleeve (28) inserted within an outlet of a male, barrel Luer tip (Fig. 3 and 5, tube 28 is inserted within a male luer connector 30; para. 0019).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Shultz in view of Mide such that it included a hollow sleeve retained within the first passage, a proximal axial end of the hollow sleeve projecting out of the first passage and the first lumen towards the proximal axial end of the housing; with the proximal axial end of the hollow sleeve inserted within the outlet of the male, barrel Luer tip as taught by Higgins in order to form a seal between the connected device and the assembly (Higgins: para. 0019).
Claims 3, 4, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Shultz in view of Mide, in further view of Mahmoodian et al. (US Patent Publication No. 20190231984 A1), hereinafter Mahmoodian.
Regarding claim 3, Shultz in view of Mide discloses the syringe above.
Shultz in view of Mide does not expressly disclose the storage cap further comprising a selectively removeable flip cap coupled to the distal end of the syringe coupler.
Mahmoodian teaches a storage cap (Mahmoodian: Fig. 1, cap 40) comprising a selectively removeable flip cap (Fig. 1, cap 40 is a flip cap) coupled to a distal end of the syringe coupler (Fig. 1, cap 40 is coupled to a distal end of a syringe coupler).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Shultz such that the storage cap further comprising a selectively removeable flip cap coupled to the distal end of the syringe coupler as taught by Mahmoodian in order to allow a clinician to open the cap with one hand (Mahmoodian: para. 0004).
Regarding claim 4, Shultz in view of Mide discloses the syringe above.
Shultz does not expressly disclose a cap hinge coupled to the flip cap and the coupler housing, for tethering the flip cap to the coupler housing.
Mahmoodian teaches a cap hinge (Mahmoodian: Fig. 1, hinge 50) coupled to a flip cap (40) and a coupler housing (Fig. 1 and 7, hinge 50 is coupled to both cap 40 and collar 30), for tethering the flip cap (40) to the coupler housing (30).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Shultz such that a cap hinge coupled to the flip cap and the coupler housing, for tethering the flip cap to the coupler housing as taught by Mahmoodian in order to allow a clinician to open the cap with one hand (Mahmoodian: para. 0004).
Regarding claim 17, Shultz in view of Mide discloses the syringe above.
Shultz in view of Mide does not expressly disclose the storage cap further comprising a selectively removeable flip cap coupled to the distal end of the syringe coupler.
Mahmoodian teaches a storage cap (Mahmoodian: Fig. 1, cap 40) comprising a selectively removeable flip cap (Fig. 1, cap 40 is a flip cap) coupled to a distal end of the syringe coupler (Fig. 1, cap 40 is coupled to a distal end of a syringe coupler).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Shultz such that the storage cap further comprising a selectively removeable flip cap coupled to the distal end of the syringe coupler as taught by Mahmoodian in order to allow a clinician to open the cap with one hand (Mahmoodian: para. 0004).
Claims 5 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Shultz in view of Mide and Higgins, in further view of an alternate embodiment of Shultz.
Regarding claim 5, Shultz in view of Mide discloses the syringe above.
Shultz does not expressly disclose a circumferential cup projecting axially away from the distal end of the housing, defining a distal axial surface.
The alternative embodiment of Shultz teaches a circumferential cup (Shultz2: Fig. 50, shield 108) projecting axially away from the distal end of the housing (Fig. 50, shield 108 projects axially away from housing), defining a distal axial surface (Fig. 50, shield 108 is shown defining distal axial surface of Luer).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Shultz such that a circumferential cup projecting axially away from the distal end of the housing, defining a distal axial surface as taught by the alternative embodiment of Shultz in order to assist in targeting of the female connector to the male conical fitting and reducing interference issues during connection (Shultz2: para. 0075).
Furthermore, It would have been an obvious matter of design choice to make the distal axial surface of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Additionally, applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with other designs. Absent a teaching as to criticality of a circumferential cup projecting axially away from the distal end of the housing, defining a distal axial surface, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Shultz in view of the alternative embodiment of Shultz does not expressly disclose a peel lid-type storage cap coupled to the distal axial surface of the circumferential cup and the second lumen.
Mide teaches a peel lid-type storage cap (Mide: Fig. 24, disinfecting cap 1394 is a peel lid-type) coupled to a distal axial surface and a lumen (Fig. 25A, cap 1394 is shown coupled to separable collar 1412, which is a male luer shown in Fig. 25C).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Shultz in view of the alternative embodiment of Shultz such that a peel lid-type storage cap coupled to the distal axial surface of the circumferential cup and the second lumen as taught by Mide in order to seal the syringe and block ingress of pathogens and contaminants (Mide: para. 0131).
Regarding claim 18, Shultz in view of Mide discloses the syringe above.
Shultz does not expressly disclose a circumferential cup projecting axially away from the distal end of the housing, defining a distal axial surface.
The alternative embodiment of Shultz teaches a circumferential cup (Shultz2: Fig. 50, shield 108) projecting axially away from the distal end of the housing (Fig. 50, shield 108 projects axially away from housing), defining a distal axial surface (Fig. 50, shield 108 is shown defining distal axial surface of Luer).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Shultz such that a circumferential cup projecting axially away from the distal end of the housing, defining a distal axial surface in order to assist in targeting of the female connector to the male conical fitting and reducing interference issues during connection (Alternative embodiment of Shultz: para. 0075). Furthermore, It would have been an obvious matter of design choice to make the distal axial surface of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Additionally, applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with other designs. Absent a teaching as to criticality of a circumferential cup projecting axially away from the distal end of the housing, defining a distal axial surface, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Shultz in view of the alternative embodiment of Shultz does not expressly disclose a peel lid-type storage cap coupled to the distal axial surface of the circumferential cup and the second lumen.
Mide teaches a peel lid-type storage cap (Mide: Fig. 24, disinfecting cap 1394 is a peel lid-type) coupled to a distal axial surface and a lumen (Fig. 25A, cap 1394 is shown coupled to separable collar 1412, which is a male luer shown in Fig. 25C).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Shultz in view of the alternative embodiment of Shultz such that a peel lid-type storage cap coupled to the distal axial surface of the circumferential cup and the second lumen as taught by Mide in order to seal the syringe and block ingress of pathogens and contaminants (Mide: para. 0131).
Claims 6-8 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Shultz in view of Mide, in further view of Tidwell et al. (US Patent Publication No. 20220106082 A1), hereinafter Tidwell.
Regarding claim 6, Shultz in view of Mide discloses the syringe above.
Shultz does not expressly disclose a storage cap.
Mide teaches a storage cap (Mide: Fig. 24, disinfecting cap 1394 is a peel lid-type).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Shultz such that it comprised a storage cap as taught by Mide in order to seal the syringe and block ingress of pathogens and contaminants (Mide: para. 0131).
Shultz in view of Mide does not expressly disclose a tamper evident, selectively removeable end cap assembly.
Tidwell teaches a tamper evident, selectively removeable end cap assembly (Tidwell: Fig. 1, lid 1 is temper evident; para. 0026).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Shultz in view of Mide such that it comprised a tamper evident, selectively removeable end cap assembly as taught by in order to have a seal that indicates if the cap has been opened and prevent accidental opening (Tidwell: para. 0026).
Regarding claim 7, Shultz in view of Mide and Tidwell discloses the syringe above.
Shultz in view of Mide does not expressly disclose an end cap; a frangible, tear-off ring connected to the end cap by at least one first, shear-off connector and connected by second, at least one shear-off connector to the syringe coupler.
Tidwell teaches an end cap (Tidwell: Fig. 1, cover 5); a frangible, tear-off ring (Fig. 1, seal strip 2) connected to the end cap (5) by at least one first, shear-off connector (Fig. 5, seal strip 2 is connected to the cover 5 via thin strips created via upper perforations in the lid 1; para. 0026) and connected by second, at least one shear-off connector (Fig. 5, seal strip 2 is connected to base 4 via thing strips created by lower perforations in the lid 1; para. 0026) to a container (Fig. 11, example of the lid 1 connected to any particular container. The base 4 connects the lid 1 to any particular container).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Shultz in view of Mide such that it comprised an end cap; a frangible, tear-off ring connected to the end cap by at least one first, shear-off connector and connected by second, at least one shear-off connector to the syringe coupler as taught by Tidwell in order to allow the user easy access to grab and open the cap and to have a seal that indicates if the cap has been opened and prevent accidental opening (Tidwell: para. 0026).
Regarding claim 8, Shultz in view of Mide and Tidwell discloses the syringe above.
Shultz in view of Mide does not expressly disclose the tamper evident, end cap assembly comprising a snap-on band circumscribing the syringe coupler; the frangible, tear-off ring incorporating a finger tab; at least one first, shear-off connector joining the end cap and the frangible, tear-off ring; and at least one second, shear-off connector joining the frangible, tear-off ring and the snap-on band.
Tidwell teaches a tamper evident, end cap assembly (Tidwell: 1) comprising a snap-on band (Fig. 1, base 4 is snap-on; para. 0026) circumscribing a container (Fig. 11); a frangible, tear-off ring (Tidwell: 2) incorporating a finger tab (Fig. 1, tab 3); at least one first, shear-off connector (Fig. 5, seal strip 2 is connected to the cover 5 via thin strips created via upper perforations in the lid 1; para. 0026) joining the end cap (5) and the frangible, tear-off ring (2); and at least one second, shear-off connector (Fig. 5, seal strip 2 is connected to base 4 via thing strips created by lower perforations in the lid 1; para. 0026) joining the frangible, tear-off ring (2) and the snap-on band (4).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Shultz in view of Mide such that the tamper evident, end cap assembly comprising a snap-on band circumscribing the syringe coupler; the frangible, tear-off ring incorporating a finger tab; at least one first, shear-off connector joining the end cap and the frangible, tear-off ring; and at least one second, shear-off connector joining the frangible, tear-off ring and the snap-on band as taught by Tidwell in order to allow the user easy access to grab and open the cap and to have a seal that indicates if the cap has been opened and prevent accidental opening (Tidwell: para. 0026).
Regarding claim 19, Shultz in view of Mide discloses the syringe above.
Shultz does not expressly disclose a storage cap.
Mide teaches a storage cap (Mide: Fig. 24, disinfecting cap 1394 is a peel lid-type).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Shultz such that it comprised a storage cap as taught by Mide in order to seal the syringe and block ingress of pathogens and contaminants (Mide: para. 0131).
Shultz in view of Mide does not expressly disclose a tamper evident, selectively removeable end cap assembly.
Tidwell teaches a tamper evident, selectively removeable end cap assembly (Tidwell: Fig. 1, lid 1 is temper evident; para. 0026).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Shultz in view of Mide such that it comprised a tamper evident, selectively removeable end cap assembly as taught by in order to have a seal that indicates if the cap has been opened and prevent accidental opening (Tidwell: para. 0026).
Regarding claim 20, Shultz in view of Mide and Tidwell discloses the syringe above.
Shultz in view of Mide does not expressly disclose an end cap; a frangible, tear-off ring connected to the end cap by at least one first, shear-off connector and connected by second, at least one shear-off connector to the syringe coupler.
Tidwell teaches an end cap (Tidwell: Fig. 1, cover 5); a frangible, tear-off ring (Fig. 1, seal strip 2) connected to the end cap (5) by at least one first, shear-off connector (Fig. 5, seal strip 2 is connected to the cover 5 via thin strips created via upper perforations in the lid 1; para. 0026) and connected by second, at least one shear-off connector (Fig. 5, seal strip 2 is connected to base 4 via thing strips created by lower perforations in the lid 1; para. 0026) to a container (Fig. 11, example of the lid 1 connected to any particular container. The base 4 connects the lid 1 to any particular container).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Shultz in view of Mide such that it comprised an end cap; a frangible, tear-off ring connected to the end cap by at least one first, shear-off connector and connected by second, at least one shear-off connector to the syringe coupler as taught by Tidwell in order to allow the user easy access to grab and open the cap and to have a seal that indicates if the cap has been opened and prevent accidental opening (Tidwell: para. 0026).
Regarding claim 21, Shultz in view of Mide and Tidwell discloses the syringe above.
Shultz in view of Mide does not expressly disclose the tamper evident, end cap assembly comprising a snap-on band circumscribing the syringe coupler; the frangible, tear-off ring incorporating a finger tab; at least one first, shear-off connector joining the end cap and the frangible, tear-off ring; and at least one second, shear-off connector joining the frangible, tear-off ring and the snap-on band.
Tidwell teaches a tamper evident, end cap assembly (Tidwell: 1) comprising a snap-on band (Fig. 1, base 4 is snap-on; para. 0026) circumscribing a container (Fig. 11); a frangible, tear-off ring (Tidwell: 2) incorporating a finger tab (Fig. 1, tab 3); at least one first, shear-off connector (Fig. 5, seal strip 2 is connected to the cover 5 via thin strips created via upper perforations in the lid 1; para. 0026) joining the end cap (5) and the frangible, tear-off ring (2); and at least one second, shear-off connector (Fig. 5, seal strip 2 is connected to base 4 via thing strips created by lower perforations in the lid 1; para. 0026) joining the frangible, tear-off ring (2) and the snap-on band (4).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Shultz in view of Mide such that the tamper evident, end cap assembly comprising a snap-on band circumscribing the syringe coupler; the frangible, tear-off ring incorporating a finger tab; at least one first, shear-off connector joining the end cap and the frangible, tear-off ring; and at least one second, shear-off connector joining the frangible, tear-off ring and the snap-on band as taught by Tidwell in order to allow the user easy access to grab and open the cap and to have a seal that indicates if the cap has been opened and prevent accidental opening (Tidwell: para. 0026).
Claims 9 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Shultz in view of Mide, further in view of Capitaine et al. (US Patent Publication No. 20130103003 A1), hereinafter Capitaine.
Regarding claim 9, Shultz in view of Mide disclose the syringe above.
Shultz in view of Mide does not expressly disclose a twist-lock mechanism coupling the proximal end of housing to the barrel Luer connector, which when engaged in a first position, prevents their axial separation and disengages in a second position when removing the female, first Luer connector of the housing from the male, barrel Luer connector, which allows such axial separation.
Capitaine teaches a twist-lock mechanism (Capitaine: Fig. 3, comprising lugs 17 and 18, crown 16, and threads 13) coupling a proximal end of a housing (Fig. 3, proximal end of collar 19) to a Luer connector (Fig. 3, male Luer fitting 14), which, when engaged in a first position (male and female Luers connected; para. 0070), prevents their axial separation (para. 0070) and disengages in a second position (disconnected; para. 0070) when removing a female, first Luer connector (Fig. 3, female Luer 15) of the housing (19) from the male, barrel Luer connector (14), which allows such axial separation.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Shultz in view of Mide such that it comprised a twist-lock mechanism coupling the proximal end of housing to the barrel Luer connector, which when engaged in a first position, prevents their axial separation and disengages in a second position when removing the female, first Luer connector of the housing from the male, barrel Luer connector, which allows such axial separation as taught by Capitaine in order to provide an error-proof element that prohibits assembly of luer connectors without an unlocking body (Capitaine: para. 0033).
Regarding claim 22, Shultz in view of Mide disclose the syringe above.
Shultz in view of Mide does not expressly disclose a twist-lock mechanism adapted for coupling the proximal end of housing to the barrel Luer connector of a flush syringe, which when engaged in a first position, prevents their axial separation and disengages in a second position when removing the female, first Luer connector of the housing from the male, barrel Luer connector, which allows such axial separation.
Capitaine teaches a twist-lock mechanism (Capitaine: Fig. 3, comprising lugs 17 and 18, crown 16, and threads 13) coupling a proximal end of a housing (Fig. 3, proximal end of collar 19) to a Luer connector (Fig. 3, male Luer fitting 14), which, when engaged in a first position (male and female Luers connected; para. 0070), prevents their axial separation (para. 0070) and disengages in a second position (disconnected; para. 0070) when removing a female, first Luer connector (Fig. 3, female Luer 15) of the housing (19) from the male, barrel Luer connector (14), which allows such axial separation.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Shultz in view of Mide such that it comprised a twist-lock mechanism coupling the proximal end of housing to the barrel Luer connector, which when engaged in a first position, prevents their axial separation and disengages in a second position when removing the female, first Luer connector of the housing from the male, barrel Luer connector, which allows such axial separation as taught by Capitaine in order to provide an error-proof element that prohibits assembly of luer connectors without an unlocking body (Capitaine: para. 0033).
Claims 10, 11, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Shultz in view of Mide and Capitaine, in further view of Becker (US Patent Publication No. 20200155737 A1) and Capitaine.
Regarding claim 10, Shultz in view of Mide and Capitaine disclose the syringe above.
Shultz in view of Mide and Capitaine does not expressly disclose a hollow coupler sleeve having a proximal end with an inner surface thereof receiving rigidly therein an exterior circumferential surface of the male, barrel Luer connector, and a distal end with an outer surface thereof received.
Becker teaches a hollow coupler sleeve (Becker: Fig. 2, second end section 14) having a proximal end (Fig. 2, proximal end of section 14) with an inner surface thereof (Fig. 2, inner surface of section 14) receiving rigidly therein an exterior circumferential surface of the male, barrel Luer connector (Fig. 2 and 3, section 14 receives exterior surface of male Luer fitting 42; para. 0038-0039), and a distal end (Fig. 2, distal end of section 14) with an outer surface thereof received (para. 0038-0039)
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Shultz in view of Mide and Capitaine such that it comprised a hollow coupler sleeve having a proximal end with an inner surface thereof receiving rigidly therein an exterior circumferential surface of the male, barrel Luer connector, and a distal end with an outer surface thereof received as taught by Becker in order to allow for threaded attachment of the male to the female Luer (Becker: para. 0038).
Shultz in view of Mide and Becker does not expressly disclose the twist-lock mechanism further comprising: the housing defining a housing skirt intermediate the respective first, female and second, male Luer connectors, the housing skirt circumscribing the housing and the first, female Luer connector about the central axis and extending axially toward the proximal end of the housing; a skirt pin extending radially inwardly toward the central axis; a camming slot formed in the outer surface of the distal end of the coupler sleeve, receiving and capturing the skirt pin therein, with the skirt pin oriented in the first position within the camming slot when the first, female Luer connector and the barrel Luer connector are fully tightened in fluid-sealed engagement, and with the skirt pin oriented in the second position in the camming slot when the first, female Luer connector and the barrel Luer connector are disconnected from each other.
Capitaine teaches a housing (Capitaine: Fig. 3, exterior of luer connector 11) defining a housing skirt (Fig. 3, collar 19) intermediate a respective first, female (Fig. 3, female conical connection 15) and second, male Luer connectors (Fig. 3, conical end 21 is male), the housing skirt (19) circumscribing the housing (exterior of 11) and the first, female Luer connector (15) about a central axis and extending axially toward the proximal end of the housing (Fig. 3, collar 19 extends proximally); a skirt pin (Fig. 3, lugs 17 and 18) extending radially inwardly toward the central axis (Fig. 3, lugs 17 and 18 extend inwardly); a camming slot (Fig. 3, threading 13) formed in the outer surface of the distal end of a coupler sleeve (Fig. 3, collar 12), receiving and capturing the skirt pin (17 and 18) therein (lugs 17 and 18 engage exterior threading 13; para. 0070), with the skirt pin (17 and 18) oriented in the first position (when connectors 10 and 11 are connected; para. 0070) within the camming slot (13) when the first, female Luer connector (15) and the barrel Luer connector (Fig. 3, male conical portion 14) are fully tightened in fluid-sealed engagement (when tightened, lugs 17 and 18 are engaged with the threading 13; para. 0070 and 0072), and with the skirt pin (17 and 18) oriented in the second position (prior to connecting; para. 0070) in the camming slot (13) when the first, female Luer connector (15) and the barrel Luer connector (14) are disconnected from each other.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Shultz in view of Mide and Becker such that the twist-lock mechanism further comprising: the housing defining a housing skirt intermediate the respective first, female and second, male Luer connectors, the housing skirt circumscribing the housing and the first, female Luer connector about the central axis and extending axially toward the proximal end of the housing; a skirt pin extending radially inwardly toward the central axis; a camming slot formed in the outer surface of the distal end of the coupler sleeve, receiving and capturing the skirt pin therein, with the skirt pin oriented in the first position within the camming slot when the first, female Luer connector and the barrel Luer connector are fully tightened in fluid-sealed engagement, and with the skirt pin oriented in the second position in the camming slot when the first, female Luer connector and the barrel Luer connector are disconnected from each other as taught by Capitaine in order to provide an error-proof element that prohibits assembly of luer connectors without an unlocking body (Capitaine: para. 0033).
Regarding claim 11, Shultz in view of Mide, Becker, and Capitaine discloses the syringe above.
Shultz in view of Mide and Capitaine does not expressly disclose a threaded barrel, first, female and second, male Luer connectors; the male, barrel Luer connector and the male, second Luer connector respectively having threaded collars circumscribing respective male Luer tips thereof; the hollow coupler sleeve receiving rigidly therein an exterior circumferential surface of the outer threaded collar of the corresponding male, barrel Luer connector, or formed integrally with the male, Barrel Luer connector.
Becker teaches a threaded barrel, first, female (Becker: Fig. 2, section 14 is a female Luer connector) and second, male Luer connectors (Fig. 2, male Luer fitting 42); the male Luer connector (42) having a threaded collar circumscribing male Luer tip thereof (Fig. 2, fitting 42 has threads circumscribing the tip); the hollow coupler sleeve (14) receiving rigidly therein an exterior circumferential surface of the outer threaded collar (Fig. 2, fitting 42 has threads circumscribing the tip) of the corresponding male, Luer connector (42), or formed integrally with the male, Luer connector (42).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Shultz in view of Mide and Capitaine such that it comprised a threaded barrel, first, female and second, male Luer connectors; the male, barrel Luer connector and the male, second Luer connector respectively having threaded collars circumscribing respective male Luer tips thereof; the hollow coupler sleeve receiving rigidly therein an exterior circumferential surface of the outer threaded collar of the corresponding male, barrel Luer connector, or formed integrally with the male, barrel Luer connector as taught by Becker in order to allow for threaded attachment of the male to the female Luer (Becker: para. 0038).
Shultz in view of Mide and Becker does not expressly disclose the skirt pin oriented in the first position within the camming slot when the first, female Luer connector and the barrel Luer connector are fully screwed together and the skirt pin oriented in the second position when first, female Luer connector and the barrel Luer connector are fully screwed from each other; and a pawl oriented within the camming slot intermediate the first and second positions, for inhibiting inadvertent movement of the pin to the second position.
Capitaine teaches a skirt pin (Capitaine: 17 and 18) oriented in a first position (connected; para. 0070) within a camming slot (13) when a first, female Luer connector (15) and a barrel Luer connector (14) are fully screwed together (para. 0070) and the skirt pin (17 and 18) oriented in the second position (disconnected; para. 0070) when first, female Luer connector (15) and the barrel Luer connector (14) are fully screwed from each other (para. 0070); and a pawl (Fig. 3, crown 16) oriented within the camming slot (13) intermediate the first and second positions (Fig. 3, crown 16 must be accessed in order for the lugs 17 and 18 to thread with threads 13), for inhibiting inadvertent movement of the pin to the second position (para. 0070).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Shultz in view of Mide and Becker such that the skirt pin oriented in the first position within the camming slot when the first, female Luer connector and the barrel Luer connector are fully screwed together and the skirt pin oriented in the second position when first, female Luer connector and the barrel Luer connector are fully screwed from each other; and a pawl oriented within the camming slot intermediate the first and second positions, for inhibiting inadvertent movement of the pin to the second position as taught by Capitaine in order to provide an error-proof element that prohibits assembly of luer connectors without an unlocking body (Capitaine: para. 0033).
Regarding claim 23, Shultz in view of Mide, Becker, and Capitaine disclose the syringe above.
Shultz in view of Mide and Capitaine does not expressly disclose a hollow coupler sleeve having a proximal end with an inner surface thereof receiving rigidly therein an exterior circumferential surface of the male, barrel Luer connector, and a distal end with an outer surface thereof received.
Becker teaches a hollow coupler sleeve (Becker: Fig. 2, second end section 14) having a proximal end (Fig. 2, proximal end of section 14) with an inner surface thereof (Fig. 2, inner surface of section 14) receiving rigidly therein an exterior circumferential surface of the male, barrel Luer connector (Fig. 2 and 3, section 14 receives exterior surface of male Luer fitting 42; para. 0038-0039), and a distal end (Fig. 2, distal end of section 14) with an outer surface thereof received (para. 0038-0039)
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Shultz in view of Mide and Capitaine such that it comprised a hollow coupler sleeve having a proximal end with an inner surface thereof receiving rigidly therein an exterior circumferential surface of the male, barrel Luer connector, and a distal end with an outer surface thereof received as taught by Becker in order to allow for threaded attachment of the male to the female Luer (Becker: para. 0038).
Shultz in view of Mide and Becker does not expressly disclose the twist-lock mechanism further comprising: the housing defining a housing skirt intermediate the respective first, female and second, male Luer connectors, the housing skirt circumscribing the housing and the first, female Luer connector about the central axis and extending axially toward the proximal end of the housing; a skirt pin extending radially inwardly toward the central axis; a camming slot formed in the outer surface of the distal end of the coupler sleeve, receiving and capturing the skirt pin therein, with the skirt pin oriented in the first position within the camming slot when the first, female Luer connector and the barrel Luer connector are fully tightened in fluid-sealed engagement, and with the skirt pin oriented in the second position in the camming slot when the first, female Luer connector and the barrel Luer connector are disconnected from each other.
Capitaine teaches a housing (Capitaine: Fig. 3, exterior of luer connector 11) defining a housing skirt (Fig. 3, collar 19) intermediate a respective first, female (Fig. 3, female conical connection 15) and second, male Luer connectors (Fig. 3, conical end 21 is male), the housing skirt (19) circumscribing the housing (exterior of 11) and the first, female Luer connector (15) about a central axis and extending axially toward the proximal end of the housing (Fig. 3, collar 19 extends proximally); a skirt pin (Fig. 3, lugs 17 and 18) extending radially inwardly toward the central axis (Fig. 3, lugs 17 and 18 extend inwardly); a camming slot (Fig. 3, threading 13) formed in the outer surface of the distal end of a coupler sleeve (Fig. 3, collar 12), receiving and capturing the skirt pin (17 and 18) therein (lugs 17 and 18 engage exterior threading 13; para. 0070), with the skirt pin (17 and 18) oriented in the first position (when connectors 10 and 11 are connected; para. 0070) within the camming slot (13) when the first, female Luer connector (15) and the barrel Luer connector (Fig. 3, male conical portion 14) are fully tightened in fluid-sealed engagement (when tightened, lugs 17 and 18 are engaged with the threading 13; para. 0070 and 0072), and with the skirt pin (17 and 18) oriented in the second position (prior to connecting; para. 0070) in the camming slot (13) when the first, female Luer connector (15) and the barrel Luer connector (14) are disconnected from each other.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Shultz in view of Mide and Becker such that the twist-lock mechanism further comprising: the housing defining a housing skirt intermediate the respective first, female and second, male Luer connectors, the housing skirt circumscribing the housing and the first, female Luer connector about the central axis and extending axially toward the proximal end of the housing; a skirt pin extending radially inwardly toward the central axis; a camming slot formed in the outer surface of the distal end of the coupler sleeve, receiving and capturing the skirt pin therein, with the skirt pin oriented in the first position within the camming slot when the first, female Luer connector and the barrel Luer connector are fully tightened in fluid-sealed engagement, and with the skirt pin oriented in the second position in the camming slot when the first, female Luer connector and the barrel Luer connector are disconnected from each other as taught by Capitaine in order to provide an error-proof element that prohibits assembly of luer connectors without an unlocking body (Capitaine: para. 0033).
Regarding claim 24, Shultz in view of Mide, Becker, and Capitaine disclose the syringe above.
Shultz in view of Mide and Capitaine does not expressly disclose a pawl oriented within the camming slot intermediate the first and second positions, for inhibiting inadvertent movement of the pin to the second position.
Capitaine teaches a pawl (Fig. 3, crown 16) oriented within the camming slot (13) intermediate the first and second positions (Fig. 3, crown 16 must be accessed in order for the lugs 17 and 18 to thread with threads 13), for inhibiting inadvertent movement of the pin to the second position (para. 0070).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the syringe of Shultz in view of Mide and Becker such that it comprised a pawl oriented within the camming slot intermediate the first and second positions, for inhibiting inadvertent movement of the pin to the second position as taught by Capitaine in order to provide an error-proof element that prohibits assembly of luer connectors without an unlocking body (Capitaine: para. 0033).
Conclusion
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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
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