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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/20/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
This office action is responsive to the amendment filed on 06/23/2026. As directed by the amendment: claims 1 & 18 have been amended. Claims 38-51 have been cancelled.
Thus, claims 1-37 are pending in this application with claims 3, 4, 6, 7, 9, 10, 12-14, 18, 20, 21, 23, 24, 26, 27 and 29-31 being withdrawn from consideration.
Applicant’s amendments to the drawings and specification have overcome each and every objection previously set forth in the Non-final Office Action mailed on 03/23/2026.
Claim Objections
Claims 1 and 18 are objected to because of the following informalities:
Claim 1, line 22, “a proximal portion of the sheath” should read “the proximal portion of the sheath”.
Claim 18, line 26, “a proximal portion of the sheath” should read “the proximal portion of the sheath”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1, 2, 5, 8, 11, 15, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Makower et al (US 5380290 A) in view of Kruth et al (US 20090187147 A1).
Regarding claim 1, Makower et al disclose an introducer needle ((14), fig 1), comprising: a needle shaft (14) including a needle slot (26) extending from a proximal portion of the needle shaft through a distal needle tip (16) having a bevel with a tip bevel (18) and a heel (fig 2), the needle shaft including one or more features selected from a group of features consisting of: a) opposite needle-slot walls face each other and are parallel to each other consistent with the needle slot being cut into the needle shaft (fig 9); b) the opposite needle-slot walls face each other but are oblique to each other consistent with the needle shaft being stamped or rolled to form the needle slot; c) the opposite needle-slot walls face away from a bottom of the needle slot consistent with the needle slot being ground into the needle shaft; d) the opposite needle-slot walls face toward the bottom of the needle slot consistent with opposite needle-slot walls being bent in toward the bottom of the needle slot; and e) the opposite needle-shaft walls are parallel to each other consistent with the needle shaft being stamped or rolled to form the needle slot;
a sheath (28) over the needle shaft (14) sealing the needle slot thereunder (fig 1) but for a portion of the needle slot under a sheath opening (32) of the sheath (fig 5), the sheath opening (32) in a proximal portion of the sheath that does not include a proximal end of the sheath (figs 3 and 7); and a needle hub (15) but fail to teach said hub is around both the proximal portion of the needle shaft and a proximal portion of the sheath.
Kruth et al disclose an introducer needle (16) comprising a needle shaft (18), a sheath (22) and a needle hub (24) wherein the hub is around both the proximal portion of the needle shaft and a proximal portion of the sheath (fig 5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the introducer needle of Makower et al to have the hub around both the proximal portion of the needle shaft and a proximal portion of the sheath as taught by Kruth et al. This would provide the benefit of a having both said needle shaft and sheath molded in said hub that is held with a single handle to manipulate said introducer needle into a subject (para 0053).
Regarding claim 2, Makower et al in view of Kruth et al disclose the introducer needle of claim 1,
Makower et al further disclose wherein the needle slot (26) extends along at least a portion of a top of the needle shaft, the top of the needle shaft including the heel of the bevel (fig 9).
Regarding claim 5, Makower et al in view of Kruth et al disclose the introducer needle of claim 1,
Makower et al further disclose wherein the needle slot (26) bisects the heel of the bevel (fig 9).
Regarding claim 8, Makower et al in view of Kruth et al disclose the introducer needle of claim 1,
Makower et al further disclose wherein the needle slot (26') is linear from the proximal portion of the needle shaft through the needle tip (fig 10).
Regarding claim 11, Makower et al in view of Kruth et al disclose the introducer needle of claim 1,
Makower et al further disclose wherein the needle slot (26') has a constant needle-slot width (fig 10).
Regarding claim 15, Makower et al in view of Kruth et al disclose the introducer needle of claim 1,
Makower et al further disclose wherein the needle slot is short (36) of a proximal end of the needle shaft (fig 9).
Regarding claim 16, Makower et al in view of Kruth et al disclose the introducer needle of claim 1,
Kruth et al further disclose a needle slot (30, fig 7) wherein the needle slot extends through a proximal end of the needle shaft (para 0060).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the introducer needle of Makower et al to have the needle slot that extends through a proximal end of the needle shaft as taught by Kruth et al. This would provide the benefit of having a slot so that a guidewire or other elongate element extending through said needle shaft and hub can be readily pulled through said slot (para 0060).
Regarding claim 17, Makower et al in view of Kruth et al disclose the introducer needle of claim 1,
Makower et al further disclose the introducer needle of claim 1, wherein edges of the needle-slot walls are finished, thereby minimizing or eliminating sharp, access guidewire-fraying edges of the needle slot (see fig 9, edges of slot 26 is machined and finished).
Claims 18, 19, 22, 25, 28, 32, 33, 34 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Makower et al (US 5380290 A) in view of Kruth et al (US 20090187147 A1) and further in view of Dong (US 20220168548 A1).
Regarding claim 18, Makower et al disclose a rapidly insertable central catheter ("RICC") insertion assembly (fig 11), comprising: a RICC (fig 11) including a catheter tube (38) and a primary lumen (lumen of 38) therethrough; an introducer needle (14) including: a needle shaft (shaft of 14) including a needle slot (26’) extending from a proximal portion of the needle shaft through a distal needle tip (16) having a bevel with a tip bevel (18) and a heel (fig 10), the needle shaft including one or more features selected from a group of features consisting of: a) opposite needle-slot walls face each other and are parallel to each other consistent with the needle slot being cut into the needle shaft (fig 10); b) the opposite needle-slot walls face each other but are oblique to each other consistent with the needle shaft being stamped or rolled to form the needle slot; c) the opposite needle-slot walls face away from a bottom of the needle slot consistent with the needle slot being ground into the needle shaft; d) the opposite needle-slot walls face toward the bottom of the needle slot consistent with opposite needle-slot walls being bent in toward the bottom of the needle slot; and e) the opposite needle-shaft walls are parallel to each other consistent with the needle shaft being stamped or rolled to form the needle slot;
a sheath (28) over the needle shaft sealing the needle slot thereunder but for a portion of the needle slot under a sheath opening of the sheath, the sheath opening in a proximal portion of the sheath that does not include a proximal end of the sheath (figs 10-11, sheath 28 has an opening when catheter 38 is inserted); and a needle hub (15); an access guidewire (24) including a proximal portion disposed in the primary lumen of the RICC and a distal portion disposed in the needle shaft through both the sheath opening and needle slot (fig 11, guidewire 24 is through lumen of 36, through an opening of catheter 38 and though slot 30 of needle shaft).
Makower et al fail to teach said hub is around both the proximal portion of the needle shaft and a proximal portion of the sheath.
However, Kruth et al disclose an introducer needle (16) comprising a needle shaft (18), a sheath (22) and a needle hub (24) wherein the hub is around both the proximal portion of the needle shaft and a proximal portion of the sheath (fig 5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the introducer needle of Makower et al to have the hub around both the proximal portion of the needle shaft and a proximal portion of the sheath as taught by Kruth et al. This would provide the benefit of a having both said needle shaft and sheath molded in said hub that is held with a single handle to manipulate said introducer needle into a subject (para 0053).
Makower et al fail to teach a coupler coupling the RICC and the introducer needle together.
However, Dong discloses a rapidly insertable central catheter (fig 3A), comprising an introducer needle (1+2), a catheter tube (4) and a coupler (23) wherein the coupler couples the RICC and the introducer together (figs 3A-B, para 0088).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the coupling system of Makower et al to include a coupler that couples the RICC and the introducer together as taught by Dong. This would provide the benefit of securely locking the RICC and the introducer together and to seal said guidewire from the external environment once they are passed through said hub (para 0078).
Regarding claim 19, Makower et al in view of Kruth et al and Dong disclose the RICC insertion assembly of claim 18,
Makower et al further disclose wherein the needle slot extends along at least a portion of a top of the needle shaft, the top of the needle shaft including the heel of the bevel (fig 10).
Regarding claim 22, Makower et al in view of Kruth et al and Dong disclose the RICC insertion assembly of claim 18,
Makower et al further disclose wherein the needle slot bisects the heel of the bevel (fig 10).
Regarding claim 25, Makower et al in view of Kruth et al and Dong disclose the RICC insertion assembly of claim 18,
Makower et al further disclose wherein the needle slot is linear from the proximal portion of the needle shaft through the needle tip (fig 10).
Regarding claim 28, Makower et al in view of Kruth et al and Dong disclose the RICC insertion assembly of claim 18,
Makower et al further disclose wherein the needle slot has a constant needle-slot width (fig 10).
Regarding claim 32, Makower et al in view of Kruth et al and Dong disclose the RICC insertion assembly of claim 18,
Makower et al further disclose wherein the needle slot (26) is short (36) of a proximal end of the needle shaft (fig 9).
Regarding claim 33, Makower et al in view of Kruth et al and Dong disclose the RICC insertion assembly of claim 18,
Kruth et al further disclose a needle slot (30, fig 7) wherein the needle slot extends through a proximal end of the needle shaft (para 0060).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the introducer needle of Makower et al to have the needle slot that extends through a proximal end of the needle shaft as taught by Kruth et al. This would provide the benefit of having a slot so that a guidewire or other elongate element extending through said needle shaft and hub can be readily pulled through said slot (para 0060).
Regarding claim 34, Makower et al in view of Kruth et al and Dong disclose the RICC insertion assembly of claim 18,
Makower et al further disclose wherein edges of the needle-slot walls are finished, thereby minimizing or eliminating sharp, access guidewire-fraying edges of the needle slot (see fig 10, edges of slot 26’ is machined and finished).
Regarding claim 35, Makower et al in view of Kruth et al and Dong disclose the RICC insertion assembly of claim 18,
Dong further discloses wherein the coupler (23) including a coupler housing (body of 23) including a sealing-module cavity (interior, see in Fig. 3B), and a sealing-module insert (25) disposed in the sealing-module cavity (Fig. 3B), the sealing-module cavity and the sealing-module insert forming a sealing module of the RICC insertion assembly configured to separately seal around a proximal portion of the introducer needle including the sheath opening (as needle is inserted distally into position shown in Fig. 3B, the sheath opening of Makower et al will be sealed) and the distal portion of the access guidewire (31, Fig. 3A) when compressed in the sealing-module cavity ([0078]).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Makower et al (US 5380290 A) in view of Kruth et al (US 20090187147 A1) and further in view of Dong (US 20220168548 A1) and Walker (US 5261887 A).
Regarding claim 37, Makower et al in view of Kruth et al and Dong disclose the limitations of claims 18 and 35 as discussed above but fail to teach the coupler includes a blade extending into the sealing module such that the blade is disposed in the needle slot under a distal end of the sheath opening, the blade including a distal-facing blade edge configured to cut the sheath away from the needle shaft as the introducer needle is withdrawn from the coupler, thereby allowing the access guidewire to escape from the needle shaft by way of the needle slot.
Walker relates to sealed catheter hubs used with guidewires and is therefore from an art which is the same as, or very closely analogous to, those of Applicant's claims. Walker teaches that, in order to strip a covering (here, the catheter 12) off of the outer surface of a guidewire (14) while the guidewire is still within the patient (col. 8, lines 31- 39), the coupler includes a blade (52 in Fig. 2) extending into the sealing module (blade 52 would be positioned in Dong's sealing module in order to have access to the exterior of its needle, while still sterile) such that the blade is disposed in the needle slot under a distal end of the sheath opening (same), the blade including a distal-facing blade edge configured to cut the sheath away from the needle shaft as the introducer needle is withdrawn from the coupler (Walker Fig. 2), thereby allowing the access guidewire to escape from the needle shaft by way of the needle slot (Walker col. 8, lines 31-39).
It 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, to further include, in a Makower et al in view of Kruth et al and Dong device, the additional subject matter of Claim 37 (noted above), because Walker teaches doing so in closely related catheter guidewire proximal hub, in order to more easily strip off the covering of a vascular-indwelling medical device without the need to remove that medical device.
Allowable Subject Matter
Claim 36 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 36, Makower et al in view of Kruth et al and Dong disclose the limitations of claims 18 and 35 but fail to each or render obvious “wherein the coupler housing includes a longitudinal coupler-housing slot configured to allow the access guidewire to escape from the coupler housing after a distal portion of the sealing-module insert is removed from the sealing-module cavity with withdrawal of the introducer needle from the coupler” in addition to other limitations.
Response to Arguments
Applicant’s arguments, see Remarks, filed 06/23/2026, with respect to the rejection(s) of claim(s) 1, 2, 5, 8, 11, 15-19, 22, 25, 28 and 32-37 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 view of Makower et al (US 5380290 A) in view of Kruth et al (US 20090187147 A1) and further in view of Dong (US 20220168548 A1).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 FATIMATA S DIOP whose telephone number is (571)272-3299. The examiner can normally be reached Monday- Friday, 9am to 6pm ET.
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/FATIMATA SAHRA DIOP/ Examiner, Art Unit 3783
/JASON E FLICK/ Primary Examiner, Art Unit 3783 09/17/2026
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