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 03/23/2026 have been entered.
Claim 1 has thereby been amended.
Claims 1-6 and 14-20 are being examined in this office action.
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 1-6, 15-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20190321599) in view of Funk (US 20190160275).
Regarding claim 1, Burkholz discloses a catheter system, comprising: a catheter adapter (12), comprising a distal end and a proximal end aligned with the distal end (Fig. 1D: proximal end of 12 aligned with 14); a catheter extending from the distal end of the catheter adapter (Fig. 1D: catheter 20 extends from 14, the distal end of 12); an extension set, comprising: a distal end, comprising a first connector (34) coupled to the proximal end of the catheter adapter (Fig. 1D: 34 connected to proximal end of 12); a second connector (30); an extension tube (24) disposed between the first connector and the second connector (Fig. 1D: 24 between 34 and 30), wherein the catheter, the catheter adapter, the first connector, the extension tube, and the second connector are in fluid communication (Fig. 1D: connected fluid path from 30 through 20; para. [0049], last sentence); a stabilization platform (55 and 54a of general stabilization feature 54, or 72) disposed below the first connector (Figs. 1D-E: 55 below 34); and a proximal extension (see annotated Fig. 1D+1A below, a portion of Fig. 1A used only to more clearly show the proximal extension in Fig. 1D) positioned proximate the first connector, wherein the proximal extension is located between the first connector and the extension tube (see annotated Fig. 1D+1A below). However, Burkholz fails to disclose that the proximal extension is angled from the longitudinal axis of the first connector.
Funk teaches an analogous catheter and connector system, having a first connector (Fig. 3: 220) with a proximal extension proximate the first connector (Fig. 3: 210) and a second connector without an extension tube between the proximal extension and the second connector, wherein the proximal extension is angled from a longitudinal axis of the first connector (Fig. 3: axis of proximal extension 210 is angled from the longitudinal axis of 220, more clearly depicted in Fig. 7). 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 Burkholz catheter extension set by incorporating the angle between the first connector and its proximal extension taught by Funk, in order to provide a more optimal angle of the connected catheter adapter and catheter into the patient to improve the both success of insertion and comfort to the patient (Funk: para. [0070]).
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Annotated Fig. 1D+1A, Burkholz
Regarding claim 2, Burkholz in view of Funk teaches the catheter system of claim 1, as described above, wherein the first connector comprises a luer-lock connector (Burkholz: 34 having luer connector with locking feature; para. [0041], last three sentences).
Regarding claim 3, Burkholz in view of Funk teaches the catheter system of claim 2, as described above, wherein the stabilization platform comprises a first wing and a second wing opposing the first wing (Burkholz: Figs. 1D-E: laterally extending wings of 55; para. [0052], sentences 2-3).
Regarding claim 4, Burkholz in view of Funk teaches the catheter system of claim 2, as described above, wherein an upper surface of the stabilization platform is coupled to the luer-lock connector (Burkholz: para. [055], second-to-last sentence, stabilization platform coupled to 34; Figs. 1D-E: 55/54a coupled to luer connector 34).
Regarding claim 5, Burkholz in view of Funk teaches the catheter system of claim 2, as described above, wherein a bottom surface of the stabilization platform is arc-shaped (Funk: Fig. 5: bottom surface 231 of stabilization platform 230 has arc/curved shape). 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 Burkholz stabilization platform of the Burkholz-Funk system by also incorporating the arc/curved shape of the stabilization platform taught by Funk in order to better fit the contour of the patient’s limb or body part it is in contact with, to provide increased contact and therefore increased stabilization.
Regarding claim 6, Burkholz in view of Funk teaches the catheter system of claim 2, as described above, wherein the catheter, the catheter adapter, the luer-lock connector, the second connector, and the extension tube are configured to be arranged in a straight line (Burkholz: para. [0049], last sentence; Fig. 1D: 20, 12, 34, 24, and 30 all arranged in a straight line).
Regarding claim 15, Burkholz in view of Funk teaches the catheter system of claim 1, as described above, wherein the extension tube is angled downwardly with respect to a longitudinal axis of the first connector (Burkholz: para. [0065], sentence 1; wedge-shaped stabilization platform, seen in Fig. 2D, creates downward angle of 24 relative to the insertion angle of 34 and 12).
Regarding claim 16, Burkholz in view of Funk teaches the catheter system of claim 15, as described above, wherein an angle between the longitudinal axis of the first connector and a longitudinal axis of the extension tube is between 135° and 180° (Burkholz: para. [0065], last two sentences; Fig. 2D: the wedge angle of 30°, or 0°-40°, creates and angle of 150°, or 180°-140°, between 24 and 34, complementing the wedge angle).
Regarding claim 17, Burkholz in view of Funk teaches the catheter system of claim 1, as described above, wherein the extension set further comprises an anti-reflux valve disposed within the second connector (Burkholz: septum 65 of connector 30 of the extension set prevents reflux/proximal leakage; para. [0069], sentence 2).
Regarding claim 18, Burkholz in view of Funk teaches the catheter system of claim 1, as described above, wherein the second connector is configured to couple to an instrument advancement device (Burkholz: para. [0040], sentences 3-4; instrument delivery/advancement device is coupled via 30).
Regarding claim 20, Burkholz in view of Funk teaches the catheter system of claim 19, as described above, wherein the first connector further comprises a plurality of snap features (Burkholz: para. [0055]], second-to-last sentence, 54 snapping onto 34 meaning that some form of snapping features are present on 34 for this snap-coupling).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20190321599) in view of Funk (US 20190160275) in further view of Frey (US 20090069792).
Regarding claim 14, Burkholz in view of Funk teaches the catheter system of claim 1, as described above, but fails to explicitly disclose that the stabilization platform is over molded over the extension tube.
Frey teaches an analogous catheter assembly, wherein the stabilization platform (Fig. 3: platform/extensions 42) is over molded over the extension tube (Fig. 3: extension tube 3; overmolding: para. [0034], sentence 1). 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 coupling of the stabilization platform to the first connector and extension tube of the Burkholz-Funk assembly by incorporating the method of overmolding the platform over the tube as taught by Frey, in order to ensure a more secure physical connection and ensure a tight fluid seal between the extension tube and the connector (Frey: para. [0034], sentence 1).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Burkholz (US 20190321599) in view of Funk (US 20190160275) in further view of Scherich (US 20200078565).
Regarding claim 19, Burkholz in view of Funk teaches the catheter system of claim 1, as described above, but fails to explicitly disclose a blunt cannula as part of the first connector.
Scherich teaches an analogous catheter assembly with a first connector (30) that couples to a catheter adapter (16), wherein the first connector comprises a blunt cannula (Fig. 1A: first connector 30 includes blunt cannula 38). 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 first connector of Burkholz-Funk by incorporating the blunt cannula taught by Scherich in order to provide an additional coupling element for securely connecting the first connector to the catheter adapter, and to allow for an additional valve/septum for reflux prevention to be disposed in the catheter adapter, through which the cannula would be inserted in order to establish fluid connection (Sherich: para. [0040]).
Response to Arguments
Applicant's arguments filed 03/23/2026, with respect to the rejection of independent claim 1 and its depending claims, has been fully considered but are moot in light of the amendments to independent claim 1. The new ground of rejection no longer solely relies on Burkholz to teach all limitations of claim 1, but now relies on the Funk reference to teach the angle between the first connector and proximal extension, as Applicant argues that Burkholz fails to disclose.
Therefore, Burkholz in view of Funk reads on all limitations of independent claim 1 as currently amended, and the rejections of claims 1-6 and 14-20 are maintained 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
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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