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
The Amendments filed 03/17/2026 have been entered.
Claim 1 has thereby been amended.
Claim 4 has been cancelled.
Claims 1-3 and 5-20 are being examined in this office action.
Claim Interpretation
The meaning of the limitation “provides concentricity” recited in claim 14 is not abundantly clear in light of the claimed language, drawings, or specification. Examiner interprets this limitation as meaning that the catheter and secondary catheter become linearly aligned.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5-10 and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Naing (US 20180256857) in view of Burkholz (US 20190321599).
Regarding claim 1, Naing discloses a catheter system comprising: a catheter (34) having a catheter distal end and a catheter proximal end (see annotated Fig. 3 below); a catheter hub (12) configured to receive a portion of the catheter therein (Fig. 3: proximal end of catheter 34 in 12), the catheter hub comprising: a hub body (see annotated Fig. 3 below) having a hub distal end and a hub proximal end (see annotated Fig. 3 below), the hub body having a cavity formed therein extending between the hub distal end and the hub proximal end (see annotated Fig. 3 below); a hub port positioned at the hub proximal end (see annotated Fig. 3 below); and a wedge (32) positioned within the cavity adjacent the hub distal end (Fig. 3: 32 in cavity distal to septum 42), the wedge coupled to the catheter proximal end to retain the catheter to the catheter hub (para. [0026]); and a connector (20) coupled to the catheter hub (Fig. 3: 20 connected to 12), the connector having a connector distal end and a connector proximal end (see annotated Fig. 3 below), with the connector comprising: a distal coupler (see annotated Fig. 3 below) positioned at the connector distal end and configured to mate with the hub port (Fig. 3: connection of 20 to 12 formed); a proximal coupler (see annotated Fig. 3 below) positioned at the connector proximal end; and a primary lumen extending between the distal coupler and the proximal coupler (located at dashed line 30 in Fig. 3, through extension 36), the primary lumen being in fluid communication with a catheter lumen defined by the catheter when the distal coupler is coupled to the hub port (see annotated Fig. 3 below); wherein the distal coupler comprises: a collar portion configured to mate with the hub port (see annotated Fig. 3 below, collar portion being the outside portion of the distal end of 20); and an extension tip (Fig. 3: 50+36) extending distally out past the collar portion and extending into the cavity, to the wedge of the catheter hub (Fig. 4: 36 reaching wedge 32; para. [0031], sentence 1). However, Naing fails to explicitly disclose the hub port and distal coupler as luer connections.
Burkholz teaches an analogous catheter system wherein the hub port comprises a female luer port and the distal coupler comprises a male luer connection (Fig. 1B and para. [0041], sentences 3-5: the distal end of hub 12 and connector 34 are connected via luer connection, with Fig. 1B showing the hub port having the female luer and the distal coupler having the male luer), with the collar portion threadingly engaging the female luer port (para. [0041], sentences 5-6) and the extension tip extending through the female luer port (see annotated Fig. 1B below). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Naing catheter system by incorporating the luer connections taught by Burkholz in order to create fluid-tight connections that can be coupled to any standard luer medical device. In order to preserve the movement and purpose of the sliding Naing hub and connector, it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have performed a rearrangement of the orientation of the female and male luers taught by Burkholz (see MPEP 2144.04 VI. C), such that the female luer tapers inward at the present locking protrusion (Naing: 28) and tapers in the proximal direction. Additionally, the male luer tapers in the proximal direction as well, aligning with the inward tapering portion of 50 seen in Fig. 3 of Naing below, to align with 28. As such, the luers will form a sealed connection with one another as 20 is pulled proximally into the locking position with 12, aligned with the current usage and/or locking of Naing (para. [0035]), however, with the added benefit of having a more fluid-tight seal provided by the luer connection as opposed to a snap connection.
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Annotated Fig. 3, Naing
Regarding claim 2, Naing in view of Burkholz teaches the catheter system of claim 1, as described above, wherein a distal end of the extension tip abuts the wedge (Naing: Fig. 4: 36 distal end within and abutting wedge 32), such that a distal end of the primary lumen is directly adjacent a proximal end of the catheter lumen (Naing: Figs. 3 and 4: primary lumen extending through 36 directly adjacent proximal end of 34).
Regarding claim 3, Naing in view of Burkholz teaches the catheter system of claim 2, as described above, wherein the wedge includes a wedge lumen formed therein (Naing: seen in Fig. 4), and abutting of the distal end of the extension tip with the wedge directly aligns the primary lumen with the wedge lumen (Naing: Fig. 4: primary lumen through 36 directly aligns with lumen through 32).
Regarding claim 5, Naing in view of Burkholz teaches the catheter system of claim 1, as described above, wherein the connector (Burkholz: Fig. 1B: 34+24+30) further comprises a side port arranged in the connector between the proximal coupler and the distal coupler (Burkholz: Fig. 1B: side port off of 30 between the distal end of 34 and the proximal end of 30 at 38), the side port configured to be in fluid communication with the primary lumen (Burkholz: Fig. 1B: side port lumen directly connecting to primary lumen). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also modified the Naing catheter system by incorporating the side port of the connector taught by Burkholz in order to allow for dual-device coupling to the catheter hub (Burkholz: Fig. 1C).
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Annotated Fig. 1B, Burkholz
Regarding claim 6, Naing in view of Burkholz teaches the catheter system of claim 5, as described above, wherein the connector comprises a Y-connector (Burkholz: Fig. 1B: 30 being Y-connector), with the side port extending from the connector at an angle relative to the primary lumen of between 15-165 degrees (Burkholz: Fig. 1B: side port of 30 at approximately 45 degrees).
Regarding claim 7, Naing in view of Burkholz teaches the catheter system of claim 5, as described above, further comprising a needle-free access connector coupled to the side port (Burkholz: Fig. 1D: 53; para. [0056], second-to-last sentence).
Regarding claim 8, Naing in view of Burkholz teaches the catheter system of claim 5, as described above, further comprising an IV tube coupled to the side port and fluidly connected to the primary lumen (Burkholz: Fig. 1B: IV tube 44), to deliver fluid to the primary lumen and onto the catheter.
Regarding claim 9, Naing in view of Burkholz teaches the catheter system of claim 1, as described above, wherein the proximal coupler comprises: a proximal access port (Burkholz: see annotated Fig. 1B above); and a split septum connector (Burkholz: Fig. 1B: split septum 38) coupled to the proximal access port (Burkholz: see annotated Fig. 1B above, 30 connected to proximal access port), the split septum connector comprising a first ring and a second ring spaced apart laterally from the first ring (see annotated Fig. 1B above). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also modified the Naing catheter system by incorporating the septum/septum connector taught by Burkholz in order to prevent blood or other fluids from leaking from the connector (Burkholz: para. [0042], sentence 3).
Regarding claim 10, Naing in view of Burkholz teaches the catheter system of any of claim 9, as described above, wherein the catheter system further comprises a blood draw device (Burkholz: Fig. 1C: blood draw device connected to end of 50; para. [0050], last sentence), the blood draw device coupled to the proximal coupler of the connector (Burkholz: Fig. 1C: connected to 30 via 48).
Regarding claim 15, Naing in view of Burkholz teaches the catheter system of claim 1, as described above, wherein the catheter hub comprises an open peripheral intravenous catheter (PIVC) catheter hub (Burkholz: para. [0039], last sentence).
Regarding claim 16, Naing discloses a catheter system comprising: a catheter (34) having a catheter distal end and a catheter proximal end (see annotated Fig. 3 above); a catheter hub (12) configured to receive a portion of the catheter therein (Fig. 3: proximal end of catheter 34 in 12), the catheter hub comprising: a hub body (see annotated Fig. 3 above) having a hub distal end and a hub proximal end (see annotated Fig. 3 above), the hub body having a cavity formed therein extending between the hub distal end and the hub proximal end (see annotated Fig. 3 above); a hub port positioned at the hub proximal end (see annotated Fig. 3 above); and a wedge (32) positioned within the cavity adjacent the hub distal end (Fig. 3: 32 in cavity distal to septum 42), the wedge coupled to the catheter proximal end to retain the catheter to the catheter hub (para. [0026]); and a connector (20) coupled to the catheter hub (Fig. 3: 20 connected to 12), the connector having a connector distal end and a connector proximal end (see annotated Fig. 3 above), an extension tip (Fig. 3: 50+36) that extends into the cavity and substantially therethrough, to abut the wedge (Fig. 4: 36 reaching wedge 32; para. [0031], sentence 1). However, Naing fails to explicitly disclose the hub port and distal coupler as luer connections.
Burkholz teaches an analogous catheter system wherein the hub port comprising a female luer connection and the connector comprising a male luer connection at the connector distal end configured to mate with the female luer connection (Fig. 1B and para. [0041], sentences 3-6: the distal end of hub 12 and connector 34 are connected via luer connection, with Fig. 1B showing the hub port having the female luer and the distal coupler having the male luer). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Naing catheter system by incorporating the luer connections taught by Burkholz in order to create fluid-tight connections that can be coupled to any standard luer medical device.
Regarding claim 17, Naing in view of Burkholz teaches the catheter system of claim 16, wherein the male luer connection comprises a collar positioned about a portion of the extension tip (see annotated Fig. 3 above, collar portion being the outside portion of the distal end of 20, surrounding extension tip), the collar having a threaded inner surface configured to engage a threaded outer surface of the female luer connection (Burkholz: para. [0041], sentences 5-6).
Regarding claim 18, Naing in view of Burkholz teaches the catheter system of claim 16, wherein the connector further comprises a proximal coupler (see annotated Fig. 3 above) positioned at the connector proximal end, the proximal coupler comprising: a proximal access port (see annotated Fig. 1B above); and a split septum connector (Fig. 1B: split septum 38) coupled to the proximal access port (see annotated Fig. 1B above, 30 connected to proximal access port), the split septum connector comprising a first ring and a second ring spaced apart laterally from the first ring (see annotated Fig. 1B above).
Claims 11-14, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Naing (US 20180256857) in view of Burkholz (US 20190321599) in further view of Burkholz’ (US 20210402152).
Regarding claim 11, Naing in view of Burkholz teaches the catheter system of claim 10, as described above, wherein the blood draw device comprises: a secondary catheter (Burkholz: Fig. 1C: 50); an introducer (Burkholz: Fig. 1C: 48) having a proximal end and a distal end (Burkholz: Fig. 1C: distal end of 48 connected to 30, proximal end of 48 connected to 50), and a top surface and a bottom surface (Burkholz: Fig. 1C: top surface of 48 facing up, bottom surface of 48 facing down), that define an inner volume configured to movably receive the secondary catheter (para. [0050], sentence 4); to move a distal end of the secondary catheter from a position within the introducer to a position outside the introducer housing and past the catheter distal end of the catheter (Burkholz: para. [0050], sentences 3-4); and a lock positioned at the distal end of the introducer that is coupled to the proximal coupler of the connector (Burkholz: Fig. 1C: lock with levered arms connecting 48 to 30). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also incorporated the blood draw device taught by Burkholz into the Naing-Burkholz catheter system in order to allow for a second catheter to be advanced into the patient and for blood to be drawn from the patient without removing and replacing the whole catheter system within the patient. However, this Naing-Burkholz combination does not explicitly teach an actuator movably coupled to the introducer.
Burkholz’ teaches an analogous catheter system to both Naing and Burkholz, having an actuator (Fig. 1A: tab 38) movably coupled to the introducer (Fig. 1A: introducer 32), the actuator configured to move relative to the introducer (para. [0049]) to advance the secondary catheter. It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the actuator of the introducer taught by Burkholz’ into the introducer of the Naing-Burkholz system, so that the secondary catheter (50) of Naing-Burkholz could be advanced without contacting the catheter itself, lowering risk of infection.
Regarding claim 12, Naing in view of Burkholz in further view of Burkholz’ teaches the catheter system of claim 11, as described above, wherein the lock comprises a pair of locking arms (Burkholz: Fig. 1C: levered arms of lock connecting 48 to 30), and wherein the pair of locking arms engage the split septum connector (Burkholz: Fig. 1C: locking arms engaged at split septum connector). Burkholz does not teach, however, the locking arms snapping in between the first and second rings, as seen in Burkholz Fig. 1C. Burkholz’, however, does teach a configuration of rings in which the arms fit/snap in between then (see annotated Fig. 1A below). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also incorporated the placement of the first and second rings taught by Burkholz’, such that the arms of the lock fit by snapping in between the first ring and the second ring of the split septum connector of the Naing-Burkholz-Burkholz’ system, in order to create a deeper depression for the arms to sit/snap into, creating a more secure lock.
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Annotated Fig. 1A, Burkholz’
Regarding claim 13, Naing in view of Burkholz in further view of Burkholz’ teaches the catheter system of claim 12, as described above, wherein the primary lumen has a linear shape such that the secondary catheter may be advanced through the primary lumen in a straight line when the blood draw device is coupled to the proximal coupler of the connector (Naing and Burkholz annotated figures above, primary lumens are linear).
Regarding claim 14, Naing in view of Burkholz in further view of Burkholz’ teaches the catheter system of claim 11, as described above, wherein extension of the extension tip distally to the wedge of the catheter hub provides concentricity between the secondary catheter and the catheter (Burkholz: para. [0050], sentences 3-4; Fig. 1C: when advanced, 50 is linearly aligned and therefore concentric with catheter 20).
Regarding claim 19, Naing in view of Burkholz teaches the catheter system of claim 18, wherein the catheter system further comprises a blood draw device (Burkholz: Fig. 1C: blood draw device connected to end of 50; para. [0050], last sentence) coupleable to the proximal coupler of the connector (Burkholz: Fig. 1C: connected to 30 via 48), the blood draw device comprising: a secondary catheter (Burkholz: Fig. 1C: 50); an introducer (Burkholz: Fig. 1C: 48) having a proximal end and a distal end (Burkholz: Fig. 1C: distal end of 48 connected to 30, proximal end of 48 connected to 50), and a top surface and a bottom surface (Burkholz: Fig. 1C: top surface of 48 facing up, bottom surface of 48 facing down), that define an inner volume configured to movably receive the secondary catheter (para. [0050], sentence 4); to move a distal end of the secondary catheter from a position within the introducer to a position outside the introducer housing and past the catheter distal end of the catheter (Burkholz: para. [0050], sentences 3-4); and a lock positioned at the distal end of the introducer that is coupled to the proximal coupler of the connector (Burkholz: Fig. 1C: lock with levered arms connecting 48 to 30). However, this Naing-Burkholz combination does not explicitly teach an actuator movably coupled to the introducer.
Burkholz’ teaches an analogous catheter system to both Naing and Burkholz, having an actuator (Fig. 1A: tab 38) movably coupled to the introducer (Fig. 1A: introducer 32), the actuator configured to move relative to the introducer (para. [0049]) to advance the secondary catheter. It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the actuator of the introducer taught by Burkholz’ into the introducer of the Naing-Burkholz system, so that the secondary catheter (50) of Naing-Burkholz could be advanced without contacting the catheter itself, lowering risk of infection.
Regarding claim 20, Naing in view of Burkholz in further view of Burkholz’ teaches the catheter system of claim 19, wherein the lock comprises a pair of locking arms (Burkholz: Fig. 1C: levered arms of lock connecting 48 to 30), and wherein the pair of locking arms engage the split septum connector (Burkholz: Fig. 1C: locking arms engaged at split septum connector). Burkholz does not teach, however, the locking arms snapping in between the first and second rings, as seen in Burkholz Fig. 1C. Burkholz’, however, does teach a configuration of rings in which the arms fit/snap in between then (see annotated Fig. 1A below). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have also incorporated the placement of the first and second rings taught by Burkholz’, such that the arms of the lock fit by snapping in between the first ring and the second ring of the split septum connector of the Naing-Burkholz-Burkholz’ system, in order to create a deeper depression for the arms to sit/snap into, creating a more secure lock.
Response to Arguments
Applicant's arguments filed 03/17/2026 regarding the prior art rejections have been fully considered and are considered moot in light of the updated rejection above in response to the amendments filed 03/17/2026 which changed the scope of independent claim 1. Examiner maintains it would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified Naing with Burkholz, as described in the rejections above, particularly with a rearrangement of the luer connector parts of Burkholz in order to maintain the sliding motion/usage of the Naing device while improving the seal, as taught by Burkholz.
For these reasons, claims 1-3 and 5-20 stand rejected as recited above.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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