DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on May 18, 2026. As directed by the amendment: claims 1 and have been amended, no claims have been added, claims 5 and 25 have been canceled. Thus claims 1-4, 6-8, 21, 24, 28, 36-45, 63, and 67 are presently pending in this application, and claims 3-4, 8, and 43 are withdrawn.
Response to Arguments
Applicant’s arguments, see Remarks, filed May 18, 2026, with respect to the rejection(s) of independent claim(s) 1 and 21 under 35 U.S.C. 102 have been fully considered and are persuasive.
With regards to independent claim 1, pg. 6-7 of the Remarks, the examiner agrees that none of Sauer, Kaczorowski, or Valley disclose all limitations of amended claim 1, namely the added limitation of a plug disposed at a proximal end of the first lumen, distally from a hemostatic valve. Therefore, the rejection has been withdrawn, and the rejections of all claims dependent on claim 1 (claims 2, 6-7, 37-42, 44-45, 63, and 67) are withdrawn for similar reasons. However, upon further consideration, in light of the amendments, a new ground(s) of rejection is made below.
With regards to independent claim 21, pg. 7-8 of the Remarks, the examiner agrees that none of Schock, Kaczorowski, or Valley disclose all limitations of amended claim 1, namely the added limitation of the plug includes a slit through which a medical device may be inserted into the first lumen, the slit extending through the first arm to a joint lumen. Therefore, the rejection has been withdrawn, and the rejections of all claims dependent on claim 21 (claims 24, 28, and 36) are withdrawn for similar reasons. However, upon further consideration, in light of the amendments, a new ground(s) of rejection is made below.
Applicant's arguments regarding dependent claim 6, pg. 8 of the Remarks, have been fully considered but they are not persuasive. Applicant argues that insertion of a dilator like device 56 of Schock into the arm 14/12 of Sauer would destroy the functionality of the device of Sauer, as the arm 14/12 of Sauer requires fluid flow through, and the device 56 of shock would function as a plug which prevent that fluid flow. The examiner respectfully disagrees. As seen in Fig. 4 and disclosed in [0034] of Sauer, an inner cannula 54 is inserted through arm 14/12 to provide fluid flow through the device. As seen in Fig. 4 of Schock, the device 56 is provided with a lumen through which a medical tool, such as guidewire 58, may extend through and out the distal end of for further insertion through leg 12 of the device. Therefore, in the modified device od Sauer, the dilator device of Schock, inserted into the lumen of arm 12/14, may receive the inner cannula 54 within its lumen, in order to allow for fluid flow through arm 14/12. Thus, Schock does not destroy the functionality of the device of Sauer and meets the claimed limitation.
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) 1-2, 37-38, 42, 44-45, 63, and 67 are rejected under 35 U.S.C. 103 as being unpatentable over Sauer et al. (US 20210178142), hereinafter Sauer, in view of Trainer et al. (US 20130237925), hereinafter Trainer, and Liu et al. (US 20230149690), hereinafter Liu.
Regarding claim 1, Sauer discloses a hub for an access device (Fig. 1, coupler 10), comprising a first arm (Fig. 1, arm 12/14) with a first lumen extending from a proximal end to a distal end (Fig. 4, internal lumen of arm 12/14), the distal end being configured to be operably coupled to a cannula (Fig. 4, distal end of arm 12/14 is coupled to cannula 52), wherein a central axis of the first lumen at the distal end forms an angle with the central axis of the first lumen at the proximal end (Fig. 4, central axis of lumen at distal end (12) of arm 12/14 is angled relative to central axis of lumen at proximal end (14)); and wherein the first arm being configured to be operably coupled to a second arm (Fig. 1 and 4, arm 12/14 is coupled to arm 16), the second arm comprising a second lumen extending therethrough (Fig. 4, internal lumen of arm 16).
Sauer fails to disclose a plug disposed at a proximal end of the first lumen. However, Trainer discloses a plug disposed at a proximal end of the first lumen (Fig. 1 and [0026], closable septum 22 formed in lumen at proximal end of a hub arm).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Sauer to incorporate the teachings of Trainer and modify the first lumen to comprise a plug disposed at the proximal end. Doing so would prevent in/outflow of fluid during insertion/removal of a medical tool through the lumen and allows for sealing of lumen when medical tool is removed (Trainer, [0026]).
Sauer, in view of Trainer, fails to disclose the plug disposed distally from a hemostatic valve. However, Liu discloses distally from a hemostatic valve (Fig. 3 and 5 and [0048], plug 120 is provided within proximal end lumen 106 of introducer device 100, and is distal to the hemostasis valve provided in end hub 60 located at proximal opening 107 of introducer device).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Sauer, in view of Trainer, to incorporate the teachings of Liu and modify the first lumen to comprise a hemostasis valve, wherein the plug is distal to hemostasis valve. Doing so would further provide fluid tight seals around inserted medical devices to inhibit fluid/blood from traveling proximally within the lumen during movement of the medical devices, thus preventing any leakage of fluid/blood during use of device (Liu, [0048,0052-0053]).
Regarding claim 2 and Sauer, in view of Trainer and Liu, Sauer further discloses the hub according to claim 1, wherein the second arm is coupled to the hub (Fig. 1-4, arm 16 is coupled to/ apart of hub 10).
Regarding claim 37 and Sauer, in view of Trainer and Liu, Sauer further discloses the hub according to claim 1, wherein the central axis of the first lumen at the distal end forms a second arm angle with a central axis of the second lumen at the proximal end (Fig. 4, the central axis of arm 12/14 at the distal end forms a second arm angle with a central axis of the lumen of arm 16 at the proximal end), where the angle is 15-30 degrees ([0045], where the angle between the branches of the connector arms is 25 degrees).
Regarding claim 38 and Sauer, in view of Trainer and Liu, Sauer further discloses the hub according to claim 1, further comprising a cap coupled to the proximal end of the first arm (Fig. 1 and 4, cap 22).
Regarding claim 42 and Sauer, in view of Trainer and Liu, Sauer further discloses an access device comprising: a cannula (Fig. 4, cannula 52) having a proximal end (Fig. 4, end of cannula 52 coupled to hub 10) and a distal end (Fig. 5, distal end 52D), the cannula having a joint lumen therethrough (Fig. 4, lumen of cannula 52, which is a joint lumen as proximal end of lumen is coupled to distal end of hub and may be in communication with both the lumen of arm 12/14 and arm 16); and a hub according to claim 1, configured to be operably coupled to a proximal end of the cannula (Fig. 4, hub 10 coupled to proximal end of cannula 52).
Regarding claim 44 and Sauer, in view of Trainer and Liu, Sauer further discloses the access device according to claim 42, further comprising a tubular extension capable of being removably coupled to the proximal end of the cannula and to the hub (Fig. 4, tubular extension 82, removably coupled to hub 10 and to proximal end of cannula 52 (via hub 10)).
Regarding claim 45 and Sauer, in view of Trainer and Liu, Sauer further discloses the access device according to claim 44, wherein the tubular extension is also configured to be capable of being removably coupled to a proximal end of a second arm (Fig. 4, tubular extension 82 is removably coupled to arm 16).
Regarding claim 63 and Sauer, in view of Trainer and Liu, Sauer further discloses a method for using an access device, comprising: providing an access device according to claim 42; inserting the cannula of the access device into a patient (Fig. 5 and [0035], cannula 52 is inserted into patient); and inserting a medical device through a hub of the access device and into the patient (Fig. 4-5 and [0035], inner cannula 54 is delivered through arm 12/14 of hub 10 to patient), and/or oxygenating blood with an extracorporeal membrane oxygenation (ECMO) device operably coupled to the cannula through a second arm, an alternate connector subsystem, or both (Fig. 4-6 and [0035], Oxygenating blood using ECMO device 80 coupled to arm 16).
Regarding claim 67 and Sauer, in view of Trainer and Liu, Sauer further discloses a kit comprising: an access device according to claim 42; an extracorporeal membrane oxygenation (ECMO) device configured to be operably coupled to a cannula of the access device (Fig. 6, ECMO device 80 operably coupled to cannula 52); and a medical device configured to be inserted through a hemostatic valve, a first lumen, and a joint lumen of the access device (Fig. 4 and [0039], inner cannula 54 which is configured to be inserted through a bushing/O-ring for a hemostatic seal, arm 12/14 lumen, and cannula 52 lumen).
Claim 6 and 39-41 is rejected under 35 U.S.C. 103 as being unpatentable over Sauer (US 20210178142), in view of Trainer (US 20130237925) and Liu (US 20230149690), as applied to claim 1 and 38 above, and further in view of Schock et al. (US 5254097), hereinafter Schock.
Regarding claim 6, Sauer discloses ---the hub according to claim 1.
Sauer fails to disclose one or more dilators that are configured to extend from the proximal end of the first lumen less than an entire length of the first lumen. However, Schock discloses one or more dilators that are configured to extend from the proximal end of the first lumen less than an entire length of the first lumen (Fig. 4 and Col. 8:8-31, device 56, which expands the seals of the lumen 42 for insertion of other devices through hub 10, thus functioning as a dilator. Device 56 extends from proximal of lumen 42, but not through the entire length of the common lumen 38).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sauer to incorporate the disclosures of Schock and modify the hub to comprise one or more dilators that are configured to extend from the proximal end of the first lumen less than an entire length of the first lumen. Doing so would aid in facilitating the advancement of other device through the hub system, such as a guide wire (Schock, Col. 8:8-31).
Regarding claim 39, Sauer, in view of Trainer and Liu, discloses ---the hub according to claim 38, further comprising an O-ring (Fig. 4, O-ring 40) positioned between a portion of the cap and a portion of the first arm (fig. 4, O-ring positioned between cap and arm 12/14). .
Sauer, in view of Trainer and Liu, fails to disclose a silicone valve positioned between a portion of the cap and a portion of the first arm. However, Schock discloses a silicone valve positioned between a portion of the cap and a portion of the first arm (Fig. 8 and Col. 10:15-30, elastomeric diaphragm valve 144 provided between arm 116 and cap 162).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sauer, in view of Trainer and Liu, to incorporate the disclosures of Schock and modify hub to comprise a silicone valve positioned between a portion of the cap and a portion of the first arm. Doing so would provide the arm of the hub with a hemostatic valve which allows for fluid-tight passage of secondary medical devices into the hub (Schock, Col. 10:15-30; 49-52).
Regarding claim 40, Sauer, in view of Trainer, Liu, and Schock, discloses ---the hub according to claim 39, as explained above. As noted above Sauer, in view of Trainer and Liu, fails to disclose a silicone valve, and is thus silent to a second O-ring disposed between the silicone valve and the cap. However, Schock further discloses a second O-ring disposed between the silicone valve and the cap (Fig. 8, annular seal ring 180 is seated between conical diaphragm 144 and port hub 134, which is connected to cap 162).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sauer, in view Trainer, Liu, and Schock, to further incorporate the disclosures of Schock and modify the hub to comprise a second O-ring disposed between the silicone valve and the cap. Doing so would ensure a fluid tight seal of the valve/access port/cap in the arm of the hub (Schock, Col. 10:31-40).
Regarding claim 41, Sauer, in view of Trainer and Liu, discloses ---the hub according to claim 38.
Sauer, in view of Trainer and Liu, fails to disclose wherein the cap is a Touhy Borst valve. However, Schock discloses wherein the cap is a Touhy Borst valve (Fig. 8 and Col. 11: 14-32, access port/cap may comprise various types of valves including a Touhy Borst valve).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sauer, in view of Trainer and Liu, to incorporate the disclosures of Schock and modify cap to comprise a Touhy Borst valve. Doing so would provide the user with an active valve which is able to provide a seal under changing conditions (Schock, Col. 2:62-66).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Sauer (US 20210178142), in view of Trainer (US 20130237925) and Liu (US 20230149690), as applied to claim 1 above, and further in view of Valley et al. (US 20010016725), hereinafter Valley.
Regarding claim 7, Sauer, in view of Trainer and Liu, discloses ---the hub according to claim 1.
Sauer, in view of Trainer and Liu, fails to disclose a plug configured to be removably inserted into a proximal end of the second lumen. However, Valley discloses a plug configured to be removably inserted into a proximal end of the second lumen (Fig. 31, connector plug 871 for removably placing over barbed connection 859 of hub arm (similar to barbs 24 of arm 16 of Sauer (see Fig. 1)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Sauer, in view of Trainer and Liu, to incorporate the disclosures of Valley and modify the hub to comprise a plug configured to be removably inserted into a proximal end of the second lumen. Doing so would provide the arm of the hub with a hemostatic seal (Valley, [0200]).
Claims 21, 28, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Schock (US 5254097), in view of Kaczorowski (US 20170120033) and Trainer (US 20130237925).
Regarding claim 21, Schock discloses a hub for an access device (Fig. 1, hub 10), comprising: a first arm (Fig. 1, arm 16) with a first lumen extending from a proximal end to a distal end (Fig. 2 and 4, lumen 42/38 (proximal end/distal end)), the distal end being configured to be operably coupled to a cannula (Fig. 2, distal end 38 of lumen 42/39 is coupled to cannula sheath 18); a second arm operably coupled to the first arm (Fig. 1, arm 14), the second arm comprising a second lumen extending therethrough (Fig. 2, lumen 40); and one or more dilators extending from the proximal end less than an entire length of the first lumen (Fig. 2 and 4 and Col. 8:8-31, device 56, which expands the seals of the lumen 42/38 for insertion of other devices through hub 10, thus functioning as a dilator. Device 56 extends from proximal end 42 of lumen 42/39, but not through the entire length of the distal potion 38 of lumen 42/38 ), wherein the one or more dilators is configured to fill at least a portion of space in the first lumen at or near the proximal end of the first lumen (Fig. 2 and 4 and Col. 8:8-31, device 56 fills at least a portion of the space in lumen 42/39 at and near proximal end 42).
Schock fails to disclose a plug configured to be inserted into the first lumen, the plug extending through the first arm to a joint lumen. However, Kaczorowski discloses a plug configured to be inserted into the first lumen, the plug extending through the first arm to a joint lumen (Fig. 11 and [0072], occluding member 42, inserted into lumen 28 of arm 25 and extending through lumen 28 up to/into the joint lumen 27).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schock to incorporate the teachings of Kaczorowski and modify the first arm to comprise a plug configured to be inserted into the first lumen, the plug extending through the first arm to a joint lumen. Doing so would provide a member which allows for fully blocking off the arm channel when not need, thus preventing blood from entering, thus preventing blood stagnation and potential thrombus formation within the lumen of the arm (Kaczorowski, [0072])
Schock, in view of Kaczorowski, fails to disclose wherein the plug includes a slit through which a medical device may be inserted into the first lumen, the slit extending through the first arm to a joint lumen. However, Trainer discloses wherein the plug includes a slit through which a medical device may be inserted into the first lumen (Fig. 1 and [0026], closable septum 22 is formed with a slit opening through which a medical device needle 20 may be inserted through), the slit extending through the first arm to a joint lumen (Fig. 1, slit in septum 22 extends the entire length of septum, therefore when the slit is applied to member 42 of Kaczorowski, the slit would extend to the joint lumen 27 since the occluding member 42 extends to the lumen 27).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schock, in view of Kaczorowski, to incorporate the teachings of Trainer and modify the plug to comprise a slit through which a medical device may be inserted into the first lumen, the slit extending through the first arm to a joint lumen. Doing so would allow for insertion of the medical tool through the slit of the plug, while preventing in/outflow of fluid during insertion/removal of a medical tool through the lumen and also allowing for the closing of plug slit and re-sealing of lumen to prevent fluid from passing through plug when medical tool is removed (Trainer, [0026]).
Regarding claim 28, Schock, in view of Kaczorowski and Trainer, discloses ---the hub according to claim 21, as explained above. Schock is silent to a third lumen operably connected to the first lumen, the second lumen, or both. However, Kaczorowski further discloses a third lumen operably connected to the first lumen, the second lumen, or both (Fig. 9-10, hub 200d may comprise an adaptor 30d which comprises a third lumen 48 that is operably coupled to the lumen of arm 25).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schock, in view of Kaczorowski and Trainer, to further incorporate the disclosures of Kaczorowski and modify the hub to comprise a third lumen operably connected to the first lumen, the second lumen, or both. Doing so would provide a lumen for venting any air which may be present in the lumens of the hub and/or cannula of the ECMO system (Kaczorowski, [0057]).
Regarding claim 36 and Schock, in view of Kaczorowski and Trainer, Schock further discloses the hub according to claim 21, wherein a longitudinal axis of the first arm is laterally offset from a longitudinal axis of the second arm (Fig. 1, longitudinal axes of arm 16 and arm 14 are laterally offset).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Schock (US 5254097), in view of Kaczorowski (US 20170120033) and Trainer (US 20130237925), as applied to claim 21 above, and further in view of Valley (US 20010016725).
Regarding claim 24, Schock, in view of Kaczorowski and Trainer, discloses ---the hub according to claim 21.
Schock, in view of Kaczorowski and Trainer, fails to disclose a plug configured to be removably inserted into a proximal end of the second lumen. However, Valley discloses a plug configured to be removably inserted into a proximal end of the second lumen (Fig. 31, connector plug 871 for removably placing over barbed connection 859 of hub arm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Schock, in view of Kaczorowski and Trainer, to incorporate the disclosures of Valley and modify the hub to comprise a plug configured to be removably inserted into a proximal end of the second lumen. Doing so would provide the arm of the hub with a hemostatic seal (Valley, [0200]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH D GRASMEDER whose telephone number is (571)272-0258. The examiner can normally be reached M-F 8 am-5 pm EST.
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/SARAH DYMPNA GRASMEDER/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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