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 new listing of the Claims filed 02/13/2026 has been entered.
No claims have been amended, added, or canceled.
Claims 1-13, 15, 17-18 and 22-24 are being examined in this office action.
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.
Claims 8-10, 13 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fedor (US 20180078751).
Regarding claim 8, Fedor discloses a port (Figs. 26A-D: port 810) configured for subdermal implantation (para. [0041] sentence 1), comprising: a silicone body (para. [0094], sentence 2; body 836 made of silicone); a port hub disposed in the silicone body (see annotated Fig. 26C below, hub parts 814+812A+832+834 disposed within silicone 836), the port hub having an access funnel (Fig. 26A: 814) and a septum (see annotated Fig. 26C: the septum dividing 836 and separating the lumens) defining a pair of port-hub lumens (see annotated Fig. 26C: the septum separating and defining the lumens); and a catheter tube having a septum defining a pair of catheter-tube lumens fluidly coupled to the pair of port-hub lumens (para. [0089], sentence 1: indwelling dual-lumen catheter has a septum to define the two lumens, coupled to 824A to fluidly couple to 812A).
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Annotated Fig. 26C, Fedor
Regarding claim 9, Fedor discloses the port of claim 8, as described above, the port hub having a pair of valves (Fig. 27C: 834) in a distal-end portion of the access funnel (Fig. 25D: displays where the valves 834 within set 822 sit at the distal end of the funnels forming lumens 812A) configured to open when a pair of cannulas of a single-use access device is inserted into the pair of valves (para. [0091], sentence 2: slits 834A of valves 834 open a passage allowing the catheter/insertion instrument to pass through).
Regarding claim 10, Fedor discloses the port of claim 8, as described above, the port hub having a bifurcated stem (see annotated Fig. 26C above, bifurcated stem 812B+824) extending from the port hub (Fig. 26A: 812B+824 extends distally from body 836 containing port hub elements) configured to insert into the pair of catheter-tube lumens (para. [0089], sentence 1).
Regarding claim 13, Fedor discloses the port of claim 8, as described above, wherein the access funnel is titanium or an alloy thereof (para. [0086], sentence 3), the access funnel configured for a relatively low-angle approach by a single-use access device (Fig. 26B: low/shallow angle between 814+812A and 812B).
Regarding claim 23, Fedor discloses the port of claim 8, as described above, wherein the septum of the port hub is transversely oriented to the pair of port-hub lumens defined thereby (see annotated Fig. 26C: the septum defines a “y-plane” and the pair of port-hub lumens defines an “x-plane” transverse to the “y-plane”).
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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Fedor (US 20180078751) in view of Goode (US 20100121313).
Regarding claim 11, Fedor discloses the port of claim 10, as described above, but fails to teach a catheter lock over the port.
Goode teaches a catheter lock (Fig. 6: 20 and 40) over the catheter tube (see annotated Fig. 10 below) over the bifurcated stem (see annotated Fig. 10 below), the catheter lock configured to lock the catheter tube onto the bifurcated stem (para. [0038], last sentence) for an analogous vascular access device and system. 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 Fedor port assembly by incorporating the catheter lock taught by Goode in order to increase the secured connection of the catheter to the port for long-term usage without accidental disconnection (Goode: para. [0010], sentence 1).
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Annotated Fig. 10, Goode
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Fedor (US 20180078751) in view of Wilson (US 20020099326).
Regarding claim 12, Fedor discloses the port of claim 8, as described above, but fails to disclose the catheter tube being a radiopaque polyurethane catheter tube.
Wilson teaches an analogous implanted dual-lumen catheter being made from radiopaque silicone (page 3, paragraph [0039]). 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 combined the Fedor port with the Wilson catheter, as described above, in order to have an implanted vascular access catheter and port for long-term continued use, as well as to use a catheter with radiopaque material to facilitate image guided placement of the catheter (page 3, paragraph [0039]). The instant invention claims a radiopaque polyurethane material for the catheter, while Wilson teaches a radiopaque silicone material for the catheter. The substitution of polyurethane in place of silicone for the catheter would have been an obvious substitution of one known element for another to obtain predictable results to one of ordinary skill in the art (see MPEP 2143 B), as silicone and polyurethane extremely similar material properties including strength, elasticity, and biocompatibility, and are often used for the same applications in the art.
Claims 1, 3-5, 7, 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Fedor (US 20180078751) in view of Wilson (US 20020099326) in further view of Finch (US 6120492).
Regarding claim 1, Fedor discloses a vascular access system, comprising: a port (Figs. 26A-D: port 810) configured for subdermal implantation (para. [0041] sentence 1), comprising: a silicone body (para. [0094], sentence 2; body 836 made of silicone); a port hub disposed in the silicone body (see annotated Fig. 26C above, hub parts 814+812A+832+834 disposed within silicone 836), the port hub having an access funnel (Fig. 26A: 814) and a septum defining a pair of port-hub lumens (see annotated Fig. 26C: the septum dividing 836 and separating the lumens); and a catheter tube having a septum defining a pair of catheter-tube lumens fluidly coupled to the pair of port-hub lumens (para. [0089], sentence 1: indwelling dual-lumen catheter has a septum to define the two lumens, coupled to 824A to fluidly couple to 812A). However, Fedor discloses the access device as a catheter disposed on a needle (Fig. 2: 40 on 42 for port access), and fails to disclose the access device as a bifurcated hub.
Wilson teaches an analogous vascular access system comprising an analogous implanted dual lumen catheter (12), accessed by a single-use access device (see annotated Fig. 1 below), the access device including: a bifurcated hub (Fig. 1: hub 20, bifurcating from single output at 20a to two extension tubes 26 and 28) including a pair of bifurcated-hub lumens (Fig. 2: lumens extending through 24a+24b+28a+28b and 22a+22b+26a+26b); and a pair of cannulas (Fig. 2: cannulas 22 and 24; para. [0015], sentence 2) defining a pair of cannula lumens fluidly coupled to the pair of bifurcated-hub lumens (Fig. 3: lumens through each 22 and 24 connecting upward through the hub), the pair of cannulas simultaneously inserted (Fig. 2: cannulas 22 and 24 are fixed to one another by hub 20, thereby moving together as a single unit for simultaneous insertion). 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 Fedor vascular access system by incorporating the bifurcated-hub access device taught by Wilson in order to provide an access device in which the cannulas are simultaneously inserted into the port to reduce the amount of funnel locating and insertion, reducing the time and risk associated with placing separate catheters and separate access cannulas (Wilson: para. [0005]). However, this Fedor-Wilson vascular access system fails to explicitly teach the pair of cannulas piercing the skin of the patient for insertion into the port.
Finch teaches an analogous vascular access system with an implanted port (Fig. 4A: P) and an access device (Fig. 4A: 32+30+20; Fig. 3) having a cannula (20), the cannulas configured to pierce skin of a patient (Fig. 4B: 20 pierces S; col. 9, lines 33-35), insert into the port (Fig. 4B: 20 inserted into port P via A), and fluidly couple the pair of cannula lumens to the catheter-tube when the pair of cannulas is fully seated in the port hub (Fig. 4B: 12 fluidly coupled to implanted catheter C via access device and cannula 20 seated in port P; col. 9, lines 44-47). 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 Fedor-Wilson vascular access system described above by incorporating the teachings of the cannula of the access device taught by Finch, such that upon the combination the pair of cannulas (taught by Wilson) simultaneously pierce skin of a patient, insert into the access funnel of the port (taught by Fedor), and fluidly couple the pair of cannula lumens to the pair of catheter-tube lumens, in order to simplify the access of the port by reducing the amount of additional access needles and incisions (such as that taught by Fedor), and allow simple and direct connection of the access device to the implanted port via the piercing cannulas.
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Annotated Fig. 1, Wilson
Regarding claim 3, Fedor in view of Wilson in further view of Finch teaches the vascular access system of claim 1, as described above, the single-use access device including a pair of extension legs (Wilson: Fig. 1: 26 and 28) defining a pair of extension-leg lumens fluidly coupled to the pair of bifurcated-hub lumens (Wilson: Fig. 3: dashed lines showing lumens in hub coupled to lumens of 26 and 28).
Regarding claim 4, Fedor in view of Wilson in further view of Finch teaches the vascular access system of claim 1, as described above, the port hub having a pair of valves (Fedor: Fig. 27C: 834) in a distal-end portion of the access funnel (Fedor: Fig. 25D: displays where the valves 834 within set 822 sit at the distal end of the funnels forming lumens 812A) configured to open when the pair of cannulas is inserted into the pair of valves (Fedor: para. [0091], sentence 2: slits 834A of valves 834 open a passage allowing the catheter/insertion instrument to pass through).
Regarding claim 5, Fedor in view of Wilson in further view of Finch teaches the vascular access system of claim 1, as described above, the port hub having a bifurcated stem extending from the port hub (Fig. 26C: bifurcated stem 812B+824+824A, extending from 836) configured to insert into the pair of catheter-tube lumens (Fedor: para. [0089], sentence 1).
Regarding claim 7, Fedor in view of Wilson in further view of Finch teaches the vascular access system of claim 1, as described above, the vascular access system configured for continuous flow at a flow rate of at least 300 to 500 mL/min (Fedor: para. [0042], sentence 3; 5 mL/second equaling 300 mL/minute).
Regarding claim 22, Fedor in view of Wilson in further view of Finch teaches the vascular access system of claim 1, as described above, wherein the septum of the port hub is perpendicular to the pair of port-hub lumens defined thereby (Fedor: Fig. 26C: septums 832 perpendicular to lumens 812A).
Regarding claim 24, Fedor in view of Wilson in further view of Finch teaches the vascular access system of claim 1, as described above, wherein each cannula of the pair of cannulas has a beveled tip (Finch: Fig. 3: beveled tip of 20, to create a sharp tip for easily piercing the patient’s skin).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Fedor (US 20180078751) in view of Wilson (US 20020099326) in further view of Finch (US 6120492) in further view of Prosl (US20140024998).
Regarding claim 2, Fedor in view of Wilson in further view of Finch teaches the vascular access system of claim 1, as described above, but fails to explicitly teach that the pair of cannulas simultaneously pierces the skin of the patient to insert into the port.
Prosl teaches an analogous implantable port system wherein the pair of cannulas configured to pierce skin of a patient before inserting the pair of cannulas into the access funnel of the port when implanted under the skin (Figs. 1 and 6; para. [0168]). 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 Fedor-Wilson-Finch combination assembly by incorporating the simultaneous cannula insertion into the skin as taught by Prosl in order to facilitate an obvious means for the Wilson hub and cannulas to access the Fedor port when it is located under the skin of the patient, without the need of an extra surgical step required to open the skin first.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Fedor (US 20180078751) in view of Wilson (US 20020099326) in further view of Finch (US 6120492) in further view of Goode (US 20100121313).
Regarding claim 6, Fedor in view of Wilson in further view of Finch teaches the vascular access system of claim 5, as described above, but fails to teach a catheter lock over the port.
Goode teaches a catheter lock (Fig. 6: 20 and 40) over the catheter tube (see annotated Fig. 10 above) over the bifurcated stem (see annotated Fig. 10 above), the catheter lock configured to lock the catheter tube onto the bifurcated stem (para. [0038], last sentence) for an analogous vascular access device and system. 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 Fedor-Wilson-Finch system by incorporating the catheter lock taught by Goode in order to increase the secured connection of the catheter to the port for long-term usage without accidental disconnection (Goode: para. [0010], sentence 1).
Claims 15 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Prosl (US 20140024998) in view of Wilson (US 20020099326).
Regarding claim 15, Prosl discloses a single-use access device, comprising: a hub including a pair of hub lumens (Fig. 2: 23, connected needle assembly); and a pair of cannulas defining a pair of cannula lumens fluidly coupled to the pair of hub lumens (Figs. 1-2: needles 5), each cannula of the pair of cannulas having a beveled tip (Fig. 6: tips of 5; para. [0177], sentence 2), the pair of cannulas thereby configured to simultaneously pierce skin of a patient (Figs. 1 and 6; para. [0168]), insert into an access funnel of an implantable port (Figs. 5-6), and fluidly couple the pair of cannula lumens to a pair of catheter-tube lumens when the pair of cannulas is fully seated in the implantable port (Figs. 5-6: 5 fluidly coupled to 11 when fully inserted). However, Prosl fails to explicitly disclose the hub with the pair of cannulas being a bifurcated hub with a pair of bifurcated-hub lumens.
Wilson teaches an analogous hub for insertion into an implanted catheter, having a bifurcated hub including a pair of bifurcated-hub lumens (Fig. 2: bifurcated hub 20 with lumens 22b and 24b). 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 hub of the Prosl device to have a bifurcated hub structure as taught by Wilson, in order to be able to have a more compact, neater hub assembly that for easier handling and easier insertion that the attached needles into the port.
Regarding claim 17, Prosl in view of Wilson teaches the access device of claim 15, as described above, further comprising a pair of extension legs (Wilson: Fig. 1: 26 and 28) defining a pair of extension-leg lumens fluidly coupled to the pair of bifurcated-hub lumens (Wilson: Fig. 3: dashed lines showing lumens in hub coupled to lumens of 26 and 28).
Regarding claim 18, Prosl in view of Wilson teaches the access device of claim 17, as described above, further comprising a pair of Luer connectors (Wilson: Fig. 1: 30 and 32; para. [0017], sentence 2), each Luer connector connected to an extension leg of the pair of extension legs (Wilson: Fig. 1: 32 connected to leg 28 and 30 connected to leg 26).
Response to Arguments
Applicant’s arguments, filed 06/24/2026, with respect to the prior art rejection(s) of independent claim(s) 1, 8 and 15 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in further view of Prosl.
Regarding independent claim 8, the rejection has been updated with a new interpretation of the septum disclosed by Fedor. Because the claims to not specifically claim the exact structure of the septum and do not explicitly define axes/planes for their transverse orientation, given the broadest reasonable interpretation of the claims as they are currently written, Examiner maintains that Fedor reads on the septum which separates the two lumens, and that the plane on which that septum lies is transverse to the plane on which the two lumens lie side-by-side on.
Regarding claims 1 and 15, the rejections of the claims now rely upon Prosl to teach the simultaneous insertion of the pair of beveled cannulas into a port implanted under the skin of a patient.
For these reasons, claims 1-13, 15, 17-18 and 22-24 stand rejected as recited above.
Conclusion
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
