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 .
Status of Claims
This office action is responsive to the amendment filed 23 June 2026.
Claims 11-15 and 21 are withdrawn.
Claims 1-10 and 16-20 are presently pending in this application.
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 1-6 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Shultz (US Patent Publication No. 20140276651 A1) in view of Higgins et al. (US Patent Publication No. 20150258321 A1), hereinafter Higgins.
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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, proximal end N) and distal axial ends (Fig. 72, distal end M); a female, first Luer connector (Fig. 5A, female Luer-type connector 110) on the proximal end (N) of the housing (116), 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, distal end M) of the housing (116), a male Luer tip (Fig. 5A, male distal tip 104) thereof having a second lumen (Fig. 5A shown above, second lumen H) defined therein; a first passage (Fig. 5A shown above, first passage I) formed in the housing (116), in fluid communication with the first and second lumens (Fig. 5A shown above, passage I is in fluid communication with lumens G and H); 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) into the second lumen (H) of the housing's male, second Luer connector (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 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 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 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).
Regarding claim 2, Shultz in view of Higgins discloses the syringe above, where all of the Luer connectors (Shultz: 107, 110, and comprising 104 and 144) comprise threaded Luer connectors (Fig. 5A and 5B, all connectors are shown to be threaded; table 1), the syringe coupler (102) selectively removeable from the flush syringe (Fig. 3, device 102 can be removed from syringe) by unscrewing the female, first Luer connector (110) of the housing (116) from the male, barrel Luer connector (Fig. 2, all connectors are shown to be threaded, and device 102 can be removed from the syringe. Examiner interprets that the connector 110 must be unscrewed from threaded engagement with connector 107 in order to remove; table 1).
Regarding claim 3, Shultz in view of Higgins discloses the syringe above, the male, barrel Luer connector (Shultz: 107) and the male, second Luer connector (comprising 104 and 144) of the syringe coupler (102) further comprising threaded collars (table 1) circumscribing respective male Luer tips thereof (Fig. 5A and B, both the device 102 and the connector 107 are shown with threaded collars 116).
Regarding claim 4, Shultz in view of Higgins discloses the syringe above, the housing (Shultz: 116) further comprising a coupling sleeve (Fig. 72, shield 108) defining an internal coupling cavity (Fig. 72 shown above, internal coupling cavity J) on a proximal axial end (Fig. 72 shown above, proximal axial end K) thereof for slidable receipt of an exterior circumferential surface (Fig. 5B, cylindrical wall portion 154 is received within proximal end K) of a threaded outer collar (Fig. 5B, collar 116 of the connector 107) of the corresponding male, barrel Luer connector (107), and a distal axial end (Fig. 72 shown above, distal axial end L) of the coupling sleeve (108) coupled to the proximal, axial end (N) of the housing (116).
Regarding claim 5, Shultz in view of Higgins discloses the syringe above, further comprising the distal axial end (Shultz: L) of the coupling sleeve (108) and the proximal axial end (N) of the housing (116) selectively joined by a selectively engageable snap fitting (Fig. 72 shown above, distal axial end L joins with proximal axial end N via snap fitting; para. 0119), which when engaged, prevents axial separation of the coupling sleeve (108) and the corresponding male, barrel Luer connector (para. 0119).
Regarding claim 6, Shultz in view of Higgins discloses the syringe above, the snap fitting (L and N) comprising a circumferential flange (Fig. 72 shown above, circumferential flange P) oriented on the housing (116) and opposing, mating, biased hooks (Fig. 72, biasing hooks O) on the coupling sleeve that engage the circumferential flange (P) and prevent axial separation of the coupling sleeve (108) and the corresponding male, barrel Luer connector (107) when so engaged (para. 0119).
Regarding claim 16, Shultz discloses a syringe coupler (102) for intravenous fluid administration to a patient (para. 0029), comprising: a housing (Fig. 5A, collar 116 of the device 102) having proximal (N) and distal axial ends (M); a female, first Luer connector (Fig. 5A, female Luer-type connector 110) on the proximal end (N) of the housing (116), 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, distal end M) of the housing (116), a male Luer tip (Fig. 5A, male distal tip 104) thereof having a second lumen (Fig. 5A shown above, second lumen H) defined therein; a first passage (Fig. 5A shown above, first passage I) formed in the housing (116), in fluid communication with the first and second lumens (Fig. 5A shown above, passage I is in fluid communication with lumens G and H); the female first Luer connector (110) of the housing (116) adapted for coupled receipt of a male Luer tip (104) of a Luer connector (107) of a flush syringe (103); an outlet lumen (F) formed within the syringe’s male Luer tip (107); 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 of flushing solution (para. 0029) therefrom into the IV connector (engagement of needless IV port; table 1).
Shultz 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; whereby an outlet lumen receives the proximal axial end of the hollow sleeve therein for delivery of flushing solution from the flush syringe through the hollow sleeve.
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); whereby an outlet lumen (Fig. 3 and 5, tube 28 is inserted within a male luer connector 30; para. 0019) receives the proximal axial end (58) of the hollow sleeve (28) therein for delivery of flushing solution (flushing of connector assembly 24; para. 0021) through the hollow sleeve (28).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the coupler of Shultz such that 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; whereby an outlet lumen receives the proximal axial end of the hollow sleeve therein for delivery of flushing solution from the flush syringe through the hollow sleeve as taught by Higgins in order to form a seal between the connected device and the assembly (Higgins: para. 0019).
Regarding claim 17, Shultz in view of Higgins discloses the syringe coupler above, further comprising a threaded male, second Luer connector (Shultz: Fig. 5A, connector comprising 104 and 144 comprises threads on locking portion 144) on the distal end (M) of the housing (116).
Regarding claim 18, Shultz in view of Higgins discloses the syringe coupler above, the housing (Shultz: 116) further comprising a coupling sleeve (Fig. 72, shield 108) defining an internal coupling cavity (Fig. 72 shown above, internal coupling cavity J) on a proximal axial end (Fig. 72 shown above, proximal axial end K) thereof for slidable receipt of an exterior circumferential surface (Fig. 5B, cylindrical wall portion 154 is received within proximal end K) of an outer collar (Fig. 5B, collar 116 of the connector 107) of the corresponding male, Luer connector (107) of a flush syringe (103), and a distal axial end (Fig. 72 shown above, distal axial end L) of the coupling sleeve (108) coupled to the proximal, axial end (N) of the housing (116).
Regarding claim 19, Shultz in view of Higgins discloses the syringe coupler above, further comprising the distal axial end (Shultz: L) of the coupling sleeve (108) and the proximal axial end (N) of the housing (116) selectively joined by a selectively engageable snap fitting (Fig. 72 shown above, distal axial end L joins with proximal axial end N via snap fitting; para. 0119), which when engaged, prevents axial separation of the coupling sleeve (108) and the corresponding male, barrel Luer connector (para. 0119).
Regarding claim 20, Shultz in view of Higgins discloses the syringe coupler above, the snap fitting (L and N) comprising a radially projecting circumferential flange (Fig. 72 shown above, circumferential flange P) oriented on the housing (116) and opposing, mating, biased hooks (Fig. 72, biasing hooks O) on the coupling sleeve that engage the circumferential flange (P) and prevent axial separation of the coupling sleeve (108) and the corresponding male, barrel Luer connector (107) when so engaged (para. 0119).
Claims 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Shultz in view of Higgins, in further view of Mide et al. (US Patent Publication No. 20210268203 A1), hereinafter Mide.
Regarding claim 7, Shultz, in view of Higgins, discloses the syringe above.
Shultz in view of Higgins does not expressly disclose a selectively removeable storage cap coupled to the male, second Luer connector of the syringe coupler.
Mide teaches a selectively removeable storage cap (Mide: Fig. 24, disinfecting cap 1394) coupled to a male, Luer connector (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 device of Shultz in view of Higgins 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 8, Shultz, in view of Higgins, discloses the syringe above.
Shultz in view of Higgins does not expressly disclose the storage cap further comprising a scrubbing cap assembly that incorporates an antimicrobial agent therein for disinfecting a patient port prior to coupling the male, second Luer connector to the patient port.
Mide teaches a storage cap (Mide: 1394) comprising a scrubbing cap assembly (Fig. 24, chamber 1396) that incorporates an antimicrobial agent (chamber 1396 contains disinfectant solution; para. 0131) therein for disinfecting a patient port (the hub of a connected port is disinfected; para. 0131) prior to coupling a male, Luer connector (Fig. 25A, cap 1394 is shown coupled to separable collar 1412, which is a male luer shown in Fig. 25C) to the patient port (para. 0131).
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 Higgins such that the storage cap further comprising a scrubbing cap assembly that incorporates an antimicrobial agent therein for disinfecting a patient port prior to coupling the male, second Luer connector to the patient port as taught by Mide in order to seal the syringe and block ingress of pathogens and contaminants (Mide: para. 0131).
Regarding claim 9, Shultz, in view of Higgins discloses the syringe above.
Shultz in view of Higgins does not expressly disclose a selectively removeable storage cap coupled to the male, second Luer connector of the syringe coupler.
Mide teaches a selectively removeable storage cap (Mide: Fig. 24, disinfecting cap 1394) coupled to a male, Luer connector (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 device of Shultz in view of Higgins 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 10, Shultz, in view of Higgins discloses the syringe above.
Shultz in view of Higgins does not expressly disclose the storage cap further comprising a scrubbing cap assembly that incorporates an antimicrobial agent therein for disinfecting a patient port prior to coupling the male, second Luer connector to the patient port.
Mide teaches a storage cap (Mide: 1394) comprising a scrubbing cap assembly (Fig. 24, chamber 1396) that incorporates an antimicrobial agent (chamber 1396 contains disinfectant solution; para. 0131) therein for disinfecting a patient port (the hub of a connected port is disinfected; para. 0131) prior to coupling a male, Luer connector (Fig. 25A, cap 1394 is shown coupled to separable collar 1412, which is a male luer shown in Fig. 25C) to the patient port (para. 0131).
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 Higgins such that the storage cap further comprising a scrubbing cap assembly that incorporates an antimicrobial agent therein for disinfecting a patient port prior to coupling the male, second Luer connector to the patient port as taught by Mide in order to seal the syringe and block ingress of pathogens and contaminants (Mide: para. 0131).
Response to Arguments
Applicant's arguments filed 23 June 2026 have been fully considered but they are not persuasive.
Applicant argues that Shultz in view of Higgins fails to 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” as recited in claims 1 and 16.
Applicant fails to provide how Higgins, which is the prior art reference that was relied upon for the specified limitation, fails to teach the limitation. The rejection cited above for claims 1 and 16 clearly detail that the limitation is taught by Shultz in view of Higgins. Therefore, the rejections are maintained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LEI GONZALEZ/Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783
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