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 09/13/2026 have been entered.
Claim 1 has thereby been amended.
Claims 1 and 3-13 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, 3-10 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Erskine (US 5356390) in view of Neilsen (US 9199057) in further view of Mirigian (US 20140277085) in further view of Milner (US 20180333560).
Regarding claim 1, Erskine discloses a vascular access device, comprising: an advancement element (Fig. 2: 68); a housing extending through the advancement element (Fig. 2: 16), wherein the housing comprises a lumen extending therethrough (Fig. 2: 50); a pair of opposing pinch members configured to pinch the housing (Fig. 2: 70, 72 and 74, 76), wherein the pair of opposing pinch members are disposed within the advancement element (Fig. 2: 70, 72 and 74, 76 disposed within 68) and configured to move along the housing with the advancement element (col. 3, lines 13-16); and an instrument (Fig. 2: 32) comprising a distal end and a proximal end, wherein the proximal end of the instrument comprises a wedge (Fig. 5: proximal end of 32 is bead 38), wherein the instrument is disposed within the lumen (Fig. 2: 32 within lumen 50), wherein in response to moving the advancement element along the housing, the pair of opposing pinch members move the wedge and the instrument is moved axially (col. 3, lines 13-16), and wherein the pair of opposing pinch members comprise rounded surfaces (Fig. 4: rounded surfaces at the 40-degree slant). However, Erskine discloses that the opposing pinch members (70, 72 and 74, 76) are configured to allow only proximal advancement of the advancement element to retract the instrument/wedge (col. 3, lines 19-25: Fig. 4; col. 3, lines 30-33), and fails to disclose the distal advancement of the advancement element to advance the instrument/wedge distally. Erskine also fails to explicitly disclose that the opposing pinch members rotate with the advancement, and that the wedge is monolithically formed with the instrument.
Neilsen teaches an analogous catheter access device with an advancement element comprising opposing pinch members (Figs. 4a-b: 16, 17) configured to axially advance the proximal wedge of an instrument in both the proximal and distal directions (Figs. 4a-b: arrows A and B), wherein in response to moving the advancement element (15) distally along the housing, the pair of opposing pinch members (16 and 17) move the wedge (9) distally and the instrument (4) is advanced distally (col. 7, lines 16-30). The both distal and proximal advancement is permitted by the angled edges of the opposing pinch members (Neilsen: col. 7, lines 22-24; Fig. 1, angles 19 and 20). 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 single direction of the angled edges of the opposing pinch members disclosed by Erskine (Erskine: Fig. 4; col. 3, lines 30-33) with the dual direction of the angled edges of the opposing pinch members taught by Neilsen (shown in annotated figure below) in order to permit contact-free advancement and retraction of the instrument (Neilsen: col. 7, lines 22-24; Fig. 1, angles 19 and 20).), allowing for adjustment and increased precision of the placement.
Although the Erskine-Neilsen device teaches the wedge being formed to be a single unit with the distal end of the instrument, it does not explicitly disclose that they are monolithically formed from one piece of material. However, it would have been obvious for one of ordinary skill in the art to make the Erskine-Neilsen wedge and instrument monolithically or integrally formed together as an obvious design choice to increase the strength between the wedge and instrument (see MPEP 2144.04 V.B.). Additionally, Mirigian teaches an analogous wire instrument with a wedge end portion, wherein the wedge is monolithically formed as a single unit with the distal end of the instrument (Mirigian: 144 coiled from one wire 112; para. [0080], monolithically formed). 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 proximal wedge of the Erskine-Neilsen device with the wire coiling technique/end taught by Mirigian, in order to simplify the manufacturing of the proximal wedge of the instrument without requiring additional materials or attachment means, and merely requiring the coiling of the wire around itself, thereby reducing the risk of the wedge being disconnected from the instrument.
However, this Erskine-Neilsen-Mirigian device fails still to teach the opposing pinch members rotating upon their advancement. Milner teaches an analogous vascular access device with opposing pinch members (Figs. 7 and 8: pinch members 30 and 32) for advancing an instrument (Figs. 7 and 8: advancement of 14), and, in response to the advancement, the opposing pinch members rotate with respect to the advancement element and the housing (Figs. 7 and 8: rotation 40 of the pinch member(s) with respect to advancement element 16 and housing 48; para. [0038], sentences 1-2). 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 Erskine-Neilsen-Mirigian device pinch members, by incorporating the rotational wheel configuration of the pinching portions as taught by Milner, in order to accommodate a smoother movement of the advancement element and pinch members along the housing, and reduce the chance of snags or possible tears occurring.
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Regarding claim 3, Erskine in view of Neilsen in further view of Mirigian in further view of Milner teaches the vascular access device of claim 1, as described above, wherein the wedge is cylindrical (Mirigian: Fig. 1: 144 Neilsen: Fig. 2, cylindrical wedge 21).
Regarding claim 4, Erskine in view of Neilsen in further view of Mirigian in further view of Milner teaches the vascular access device of claim 1, as described above, wherein an outer surface of the wedge comprises a plurality of grooves (Erskine: Figs. 5-6: grooves 39, 41, 43, 45; also Mirigian: Fig. 1: 144, grooves from the coiling) configured to allow fluid to pass the wedge (Erskine: col. 2, line 68 – col. 3, line 3).
Regarding claim 5, Erskine in view of Neilsen in further view of Mirigian in further view of Milner teaches the vascular access device of claim 1, as described above, wherein the wedge comprises a plurality of fins (Erskine: Fig. 6: four fins disposed between grooves 39, 41, 43, 45). 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 fin configuration taught by Erskine into the coiled wedge in order to create a configuration that more fluid can easily pass by.
Regarding claim 6, Erskine in view of Neilsen in further view of Mirigian in further view of Milner teaches the vascular access device of claim 1, as described above, wherein the wedge is spherical (Erskine: Fig. 4: bead 38 is spherical). 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 spherical configuration taught by Erskine into the coiled wedge, such that the wire is coiled into a spherical shape, in order to create a smoother exterior for grasping, as taught by the Erskine beads.
Regarding claim 7, Erskine in view of Neilsen in further view of Mirigian in further view of Milner teaches the vascular access device of claim 1, as described above, wherein the wedge is constructed of metal (Mirigian: para. [0080], formed from metal wire).
Regarding claim 8, Erskine in view of Neilsen in further view of Mirigian in further view of Milner teaches the vascular access device of claim 1, as described above, wherein the pair of opposing pinch members are disposed within the advancement element proximal to the wedge (Erskine: Fig. 4: opposing pinch members 72 and 74 proximal to wedge 38), further comprising another pair of opposing pinch members configured to pinch the housing, wherein the other pair of opposing pinch members are disposed within the advancement element distal to the wedge (Erskine: Fig. 4: opposing pinch members 70 and 76 distal to wedge 38) and configured to move along the housing with the advancement element, wherein in response to moving the advancement element proximally along the housing, the pair of opposing pinch members move the wedge (Erskine: general movement described in col. 3, lines 13-16) proximally and the instrument is retracted proximally (Erskine: proximal advancement specifically, described in col. 3, lines 34-37).
Regarding claim 9, Erskine in view of Neilsen in further view of Mirigian in further view of Milner teaches the vascular access device of claim 1, as described above, wherein an inner surface of the advancement element comprises a plurality of bumps in contact with the pair of opposing pinch members (Erskine: Fig. 7: bumps 73).
Regarding claim 10, Erskine in view of Neilsen in further view of Mirigian in further view of Milner teaches the vascular access device of claim 1, as described above, further comprising a distal adapter (Erskine: Fig. 1: 14 and 14) configured to couple to a catheter assembly Erskine: Fig. 1: 12, coupled to 14 and 14, wherein a distal end of the housing is coupled to the distal adapter (Erskine: Fig. 1: 14 and 14 coupled to distal end of housing 17, housing 16 comprising distal end 17; col. 2, lines 48-50).
Regarding claim 13, Erskine in view of Neilsen in further view of Mirigian in further view of Milner teaches the vascular access device of claim 1, as described above, wherein the instrument (Mirigian: 112) is coiled to form the wedge (Mirigian: Fig. 1: 144).
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Erskine (US 5356390) in view of Neilsen (US 9199057) in further view of Mirigian (US 20140277085) in further view of Milner (US 20180333560) in further view of Devgon (US 20170216564).
Regarding claim 11, Erskine in view of Neilsen in further view of Mirigian in further view of Milner teaches the vascular access device of claim 10, as described above, but fails to teach the distal adapter comprising a shaft and lever locks.
Devgon teaches an analogous vascular access device with instrument advancement, wherein the distal adapter comprises a shaft and opposing lever locks (Fig. 4: shaft 242 and opposing lever locks 240 and 243, 250). 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 distal adapter of the Erskine-Neilsen-Mirigian-Milner device with the distal shaft and lever locks taught by Devgon in order to increase the selectivity by which the distal connector is coupled to the catheter assembly, increase the ease by which it is coupled and removed, and securely lock the catheter assembly in position (Devgon: page 9. Para. [0078], sentences 1-2 and last two sentences).
Regarding claim 12, Erskine in view of Neilsen in further view of Mirigian in further view of Milner teaches the vascular access device of claim 1, as described above, further comprising a proximal connector coupled to a proximal end of the housing (Erskine: Fig. 1: proximal connector 58 connected at 52), but fails to explicitly teach the proximal connector for coupling to a blood collection device.
Devgon teaches an analogous vascular access device with instrument advancement, wherein the proximal connector (269) is configured to couple to a blood collection device (page 10, para. [0085], sentences 2 and 5-7). 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 proximal luer connector of the Erskine-Neilsen-Mirigian-Milner device with the coupling to the blood collection device taught by Devgon in order to allow for blood to be collected from the patient and other fluids to be administered to the patient (Devgon: page 14, para. [0107], sentence 1).
Response to Arguments
Applicant’s arguments filed 03/19/2026, with respect to the rejection of independent claim 1 have been fully considered but are moot in light of the amendments to claim 1 altering the scope of the independent claim and all its depending claims. The new ground of rejection no longer solely relies on the Erskine-Neilsen-Mirigian combination of references to teach all the limitations of the independent claim, specifically challenged in the argument regarding the rotation of the opposing pinch members. As a result of this change in scope of the claim limitations, independent claim 1, as well as its respective dependent claims, now relies upon the Milner reference to teach the rotation of the opposing pinch members upon advancement, and the claims are rejected in view of the Erskine-Neilsen-Mirigian combination in further view of Milner.
The combination of Milner to the Erskine-Neilsen-Mirigian device thereby teaches all claimed limitations of independent claim 1. Therefore, Independent claim 1 and its depending claims 3-13 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