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 November 24, 2025. As directed by the amendment: no claims have been amended, added, or canceled. Thus claims 1-8, 21, 24-25, 28, 36-42, 44-45, 63, and 67 are presently pending in this application, and claims 3-4, 8, and 43 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Species 1, sub-species b, and sub-species ii in the reply filed on November 24, 2025 is acknowledged.
Claims 3-4, 8, and 43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 24, 2025. The examiner notes that claim 43 is drawn to nonelected species 2: second arm removably coupled to the hub (Figs. 7-9), and is therefore also withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 7, 2020 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. The information disclosure statement (IDS) submitted on February 25, 2025 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. The information disclosure statement (IDS) submitted on November 20, 2025 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 37-38, 42, 44-45, 63, and 67 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Sauer et al. (US 20210178142), hereinafter Sauer.
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).
Regarding claim 2, Sauer 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, Sauer 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, Sauer 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, Sauer 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, Sauer 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, Sauer 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, Sauer 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, Sauer 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(s) 21 and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schock et al. (US 5254097), hereinafter Schock.
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).
Regarding claim 36, Schock 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 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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Sauer (US 20210178142), in view of Kaczorowski (US 20170120033).
Regarding claim 5, Sauer discloses ---the hub according to claim 1.
Sauer fails to disclose a plug configured to be removably inserted into a proximal end of the first lumen. However, Kaczorowski discloses a plug configured to be removably inserted into a proximal end of the first lumen (Fig. 8 and 11, occlusive cap for insertion in 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 Sauer to incorporate the disclosures of Kaczorowski and modify the hub to comprise a plug configured to be removably inserted into a proximal end of the first lumen. Doing so would a provide a cap for when endovascular access is not needed, blocking laminar blood flow from said port thus preventing thrombus formation in long-term use systems (Kaczorowski, [0071, 0077]).
Claim 6 and 39-41 is rejected under 35 U.S.C. 103 as being unpatentable over Sauer (US 20210178142), in view of Schock (US 5254097).
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 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 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 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 Schock, discloses ---the hub according to claim 39, as explained above. As noted above Sauer 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 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 discloses ---the hub according to claim 38.
Sauer 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 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 Valley et al. (US 20010016725), hereinafter Valley.
Regarding claim 7, Sauer discloses ---the hub according to claim 1.
Sauer 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 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]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Schock (US 5254097), in view of Valley (US 20010016725).
Regarding claim 24, Schock discloses ---the hub according to claim 21.
Schock 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 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 25 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Schock (US 5254097), in view of Kaczorowski (US 20170120033).
Regarding claim 25, Schock discloses ---the hub according to claim 21.
Schock fails to disclose a plug configured to be inserted into the first lumen, wherein the plug includes a slit through which a medical device may be inserted into the first lumen. However, Kaczorowski discloses a plug configured to be inserted into the first lumen (Fig. 9-10, adaptor 30d, which is at least partially inserted into lumen of arm 25), wherein the plug includes a slit through which a medical device may be inserted into the first lumen (Fig. 9-10 and [0059], adaptor 30d comprises a membrane 36 with a perforating slit(s), through which devices 60 may be inserted into 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 to incorporate the disclosures of Kaczorowski and modify the hub to comprise a plug configured to be inserted into the first lumen, wherein the plug includes a slit through which a medical device may be inserted into the first lumen. Doing so would allow access to the hub lumen(s) while maintaining hemostatic conditions and preventing back bleeding (Kaczorowski, [0059]).
Regarding claim 28, Schock discloses ---the hub according to claim 21.
Schock fails to disclose a third lumen operably connected to the first lumen, the second lumen, or both. However, Kaczorowski 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 to 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]).
Conclusion
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
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783