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 Interpretation
Claims 1 and 8 recite the phrase “septum defining a pair of port-hub lumens.” Here, “defining” is broad, and the structural limitations it imposes is not clearly defined. For example, it is unclear if the septum “defining” the pair of lumens requires the septum to divide the space, thereby forming the two lumens, or if the septum must merely “define” the space or shape of each of the lumens. For the purposes of examination, Examiner interprets this limitation broadly as the septum “defining” any structure/shape of the lumens.
Claims 1 and 15 recite the phrase “the pair of cannulas configured to simultaneously pierce the skin of the patient, insert into the access funnel….” Here, the sentence structure leaves it broad and unclear if the “simultaneous” piercing refers to the two cannulas in the pair piercing the skin at the same time as each other, or as the cannulas piercing the skin at the same time as they are inserted into the port and fluidly coupled to the catheter tube. For the purposes of examination, Examiner interprets this limitation as the two cannulas in the pair piercing the skin at the same time as each other.
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 (Fig. 26C: septums 832) defining a pair of port-hub lumens (Fig. 26C: 832 is disposed within and defines shape/space of lumen 812A); 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 (Fig. 26C: septums 832 transverses lumens 812A).
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 1-5, 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 (Fig. 26C: septums 832) defining a pair of port-hub lumens (Fig. 26C: 832 is disposed within and defines shape/space of lumen 812A); 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.
Regarding claim 2, Fedor in view of Wilson in further view of Finch teaches the vascular access system of claim 1, as described above, 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 (Finch: Figs. 4A-B: 20 must pierce S before reaching A of port P).
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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 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 Wilson (US 20020099326) in view of Finch (US 6120492).
Regarding claim 15, Wilson discloses a single-use access device, comprising: 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). However, Wilson fails to explicitly teach the pair of cannulas having beveled ends and piercing the skin of the patient for insertion into the port.
Finch teaches an analogous vascular access device with a cannula (20), each cannula having a beveled tip (Fig. 3: beveled tip of 20, to create a sharp tip for easily piercing the patient’s skin), 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 Wilson vascular access device 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, 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 or attachment mechanisms (such as 34 of Wilson; para. [0026]), and allow simple and direct connection of the access device to the implanted port via the piercing cannulas.
Regarding claim 17, Wilson in view of Finch 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, Wilson in view of Finch 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 02/13/2026 have been fully considered but they are not persuasive.
Regarding the prior art rejection of independent claims 1 and 8, Applicant argues that Fedor fails to disclose the limitation of “a septum defining a pair of port-hub lumens.” Applicant argues that the cited Fedor septum (dual septum 832) fails to read on the claim because the Fedor septum structure is disclosed as two separate septum pieces, one for each of the lumens. Applicant argues that “the claimed septum defines two port-hub lumens in a 1-to-2 relationship of the septum to the lumens defined thereby.” However, the claim langue itself, as it is currently written, no where specifies this ratio. Rather, the claim states that the septum must define the pair of port hub lumens. As such, given the broadest reasonable interpretation of the claim language, Examiner maintains that the Fedor septum structure reads on all limitations of the septum as claimed in independent claims 1 and 8, as both pieces of 832 were cited as the septum in the previous office action. Furthermore, it is unclear how only one septum piece, as implied by “a 1-to-2 relationship of the septum to the lumens,” can define two port hub lumens as the claim calls for. As such, the prior art rejection of independent claims 1 and 8, as well as their depending claims, are maintained as recited above, Fedor reading on all noted limitations of the septum and its structures.
Regarding independent claim 15, Applicant argues that it would not have been obvious for one of ordinary skill in the art to modify Wilson by incorporating the beveled tips taught by Finch. The basis of Applicant’s argument is that Wilson and Finch do not teach analogous devices for this combination due to the nature that Wilson does not explicitly teach an implantable port, and would change the subcutaneously tunneled nature of the catheter of Wilson. However, Examiner maintains that regardless of differences in Wilson and Finch possessing implantable ports as stated, Wilson and Finch remain analogous as teachings vascular access devices. As such, the teaching of the beveled cannula tips taught by Finch would be an obvious structure to integrate into the Wilson device, as to render the device of Wilson to be better utilized for using with an implantable port, as stated in the rejection description above, and as routinely used in the art.
For these reasons, Examiner maintains the prior art rejections of independent claims 1, 8 and 15, as recited above, as well as their depending claims.
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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/K.A.W./Examiner, Art Unit 3783
/NATHAN R PRICE/Primary Examiner, Art Unit 3783