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(s) (IDS) filed 12/10/2025 has/have been considered by the Examiner.
Status of the Claims
Claims 1-28 are currently pending. Claims 1-11, 15-23, and 26-28 are currently rejected. Claims 12-14 and 24-25 are objected to for being dependent upon rejected claims.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 lines 7-8 recite “a sheath over the needle shaft sealing the needle slot thereunder except for that under a sheath opening”. The “that” should be removed so this limitation reads “a sheath over the needle shaft sealing the needle slot thereunder except for under a sheath opening”.
Claim 4 lines 4-5 recite “a corresponding side of coupler housing”. A “the” should be added so this limitation reads “a corresponding side of the coupler housing”.
Claim 19 lines 6-7 “a sheath over the needle shaft sealing the needle slot thereunder except for that under a sheath opening”. The “that” should be removed so this limitation reads “a sheath over the needle shaft sealing the needle slot thereunder except for under a sheath opening”.
Appropriate correction is required.
Response to Arguments
Applicant's arguments filed 11/24/2025 have been fully considered but they are not persuasive.
Applicant argues that “that”, as discussed in the previous claim objections to claims 1 and 19, was appropriately used. Furthermore, Applicant argued that “of coupler housing”, in claim 4, is grammatically correct. Both of these objections are maintained as the current wording of the claims present an issue of clarity. In claims 1 and 19, “that” introduces confusion as “that” could refer back to the sheath, needle shaft, or needle slot. The phase “of coupler housing” does not appropriately link “coupler housing” back to the coupler housing already introduced, and requires “the” in front of it to properly show antecedent basis.
The objection to claim 1 lines 17-18 is withdrawn.
(Fact-finding Error 1) Applicant argues that Kurth does not appropriately teach a sheath opening being over the slot 20 of cannula 18.
However, Examiner already noted that the combination of Beirman and Kurth failed to point out the specific location of the sheath opening taught by Kurth. A rearrangement of parts rationale, supported by Kurth [0053], supports the placement of the sheath opening/slit of Kurth in the proximal portion of the sheath, and furthermore notes that the slit is meant to be the start of the tear, formed by the guidewire 8 as it cuts through the thin sleeve 22 which covers the slot 20 in cannula 18. The guidewire cannot push through the sleeve 22 at any point except where the thing sleeve 22 overlaps with the slot 20, since otherwise the guidewire would run into the inner wall of the cannula 18. Thus, if the slit is meant to be the start of the tear, and the tear must be formed in the slot 20, then the slit must be over the slot 20.
Although in some embodiments of Kurth, as noted by Applicant, the sleeve 22 may extend over more than just the cannula 18, the embodiment used by Examiner in the previous rejection references figures 4 and 5, and [0053], which respectively show and describe the sleeve covering only the cannula 18.
Additionally, the modification of Bierman with Kurth as described in the previous action places the sleeve 22 around only the cannula 18, as explained in the previous 103 rejections. Therefore, this argument is not persuasive.
(Fact-finding Error 2) Applicant argues that the asserted coupler has no extension arm. Examiner disagrees because the coupler includes both the coupler housing (dilator hub 38) and the extension arm (guidewire hub 46 and track 30) as noted in the previous rejection of claim 1. Thus, the coupler of Bierman includes all three noted elements (38, 46, 40) as previously presented, not just the coupler housing/dilator hub 38 as argued by Applicant.
As claimed, the coupler need not be monolithic as asserted by the Applicant, and thus Bierman’s coupler comprising the coupler housing (dilator hub 38) and extension arm (guidewire hub 46 and track 30) does satisfy the claim language. Thus, this argument is not persuasive, since the coupler of Bierman includes all three noted elements (38, 46, 40) as previously presented, and the claim language does not require a monolithic coupler, only “an extension arm connected to the coupler housing”. As previously noted, distal locking member 124 connects the track 30 to the dilator hub 38, see fig. 6a and [0140] of Bierman.
(Invalid Rationale 1) Applicant argues that modifying Bierman with Kurth renders Bierman unsatisfactory for its intended purpose, because the “sheath 26 must remain intact after removing the needle 22 and dilator 24 from Bierman’s access device 20”. Applicant points, in part, to Bierman [0131], which, contrary to Applicant’s arguments, states “[0131] Further, in some embodiments the sheath 26 can be a splittable sheath. For example, it may be advantageous to remove a portion or the entire sheath body 40 depending on the type of catheter or medical article that is to be inserted into the vessel after employing the access device 20.” Thus, Bierman [0131] provides support for having sheath 26 be splittable, and this argument is not persuasive.
(Invalid Rationale 2) Applicant argues that there would be no expectation of success in modifying the access guidewire and RICC of Bierman modified by Kurth to be in a loop as taught by DeMars. Applicant states “Whether the Examiner intends the dilator 24 or sheath 26 of Bierman’s access device 20 to be the claimed RICC, the dilator 24 and sheath 26 are over the needle 22,” which Bierman [0196] notes “preferably consists of ceramic, a rigid polymer, or a metal”.
However, as outlined in the previous rejection of claim 1, the dilator shaft 36 of Bierman is mapped to the claimed RICC. Additionally, Applicant seems to be interpreting the limitation “enforcing a loop in the access guidewire over which the RICC is disposed in at least the ready-to-deploy state of the RICC insertion assembly” means that both the guidewire and the RICC must have a loop. However, this can also be interpreted as there being a loop in the access guidewire, specifically the access guidewire that the RICC is disposed over in at least the ready-to-deploy state of the RICC insertion assembly. Therefore, the limitation only specifically notes a loop in the access guidewire, since the RICC is interpreted to be disposed over the access guidewire, not over the loop. Therefore, this argument is not persuasive as it depends upon a narrower interpretation of the claim limitation than the BRI.
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.
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(s) 1-11, 15-16, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bierman et al (US 20140081210 A1; hereafter Bierman) modified by Kurth et al (US 20090187147 A1; hereafter Kurth) and further in view of DeMars et al (US 20100305474 A1; hereafter DeMars).
Regarding claim 1, Bierman discloses a rapidly insertable central catheter ("RICC") insertion assembly (access device 20, fig. 1b, [0079]), comprising:
a RICC (dilator shaft 36, fig. 1a, [0080]);
an introducer needle (needle 22, fig. 2c, [0081] FIGS. 2A-2G illustrate the needle body 32 and needle hub 34 of the needle 22) including:
a needle shaft (needle body 32, fig. 2C, [0081]) extending from a proximal portion of the needle shaft (proximal portion 52, fig. 2c, [0081] the needle hub 34 lies at a proximal portion 52 of the needle 22) through a distal needle tip (bevel tip 54, fig. 2c; [0081] needle body 32 terminates at a distal end near a distal portion 50 of the needle 22; [0084] As best seen in FIGS. 2A and 2D, the needle body 32 can include a bevel tip 54 disposed on the distal portion 50);
a needle hub (needle hub 34, fig. 2c, [0081]) over the proximal portions of the needle shaft (32) ([0081] needle hub 34 is disposed on a proximal end of the needle body 32; see fig. 2c);
an access guidewire (guidewire 44, fig. 5a, [0080]) including:
a proximal portion including a proximal end (proximal end of the guidewire 44 noted in [0080]); and
a distal portion including a distal end (fig. 5a shows distal end) disposed in the introducer needle (22) just proximal of the needle tip (54) in at least a ready-to-deploy state of the RICC insertion assembly (fig. 1b shows that the guidewire 44 has not yet advanced past the end of the needle; fig. 9a shows that the guidewire 44 is advanced past the end of needle body 32); and
a coupler coupling the RICC (24), the introducer needle (22), and the access guidewire (44) together, the coupler including:
a coupler housing (dilator hub 38, fig. 3a, fig. 1a, [0080]) onto which a securing means (see 112f interpretation above; handling portions 58/59, figs. 2b and 2c, [0086]) for securing the needle hub (34) to the coupler housing (38) secures the needle hub (34) to the coupler housing (38) in at least the ready-to-deploy state of the RICC insertion assembly ([0094] locking structure includes a latch element 66 coupled to handling portion 58; [0095] latch element 66 releasably locks the needle hub 34 to the dilator hub 38).
an extension arm (guidewire hub 46 and track 30, fig. 7a/b, [0136]) connected to the coupler housing ([0140] distal locking member 124 that connects the track 30 to the dilator hub 38, see fig. 6a which shows distal locking member) to which extension arm (46 and 30) the proximal end of the access guidewire is attached ([0080] guidewire hub 46 is disposed on the proximal end of the guidewire 44; see fig. 7a/b which shows attachment of proximal end of guidewire 44 to hub 46 and through hub 46 to track 30), the RICC (36) disposed over the guidewire (44) in at least the ready-to-deploy state of the RICC insertion assembly (fig. 11a/b shows the RICC 36 disposed over the guidewire 44).
Bierman is silent to the needle shaft including a longitudinal needle slot extending from a proximal portion to a distal end and a sheath over the needle shaft sealing the needle slot.
Kurth, in the art of needles used for guidewire/catheter insertion, teaches a needle shaft (cannula 18, fig. 4, [0053]) including a longitudinal needle slot (slot 20, fig. 4, [0053]) extending from a proximal portion of the needle shaft through a distal needle tip ([0053] slot 20 is defined, machined or formed along the longitudinal length of the cannula 18, see fig. 4); and a sheath (shrink sleeve 22, fig. 4, [0053]) over the needle shaft sealing the needle slot thereunder (see fig. 4, [0053] slot is covered so it does not leak) except for that under a sheath opening (slit noted in [0053], not shown in figures) in a proximal portion of the sheath ([0053] needle 16 is pulled away from the distal portion 12 of the guidewire 8, guidewire 8 cuts through sheath 22, a slit can be provided in the sleeve 22 to ease the start of the tear; [0062] removal of needle allows the larger diameter portion of guidewire 8 to be advance).
Kurth also teaches a needle hub (hub 24, fig. 5, [0053]) over the proximal portions of the needle shaft (18) and the sheath (22) (see fig. 5, [0053] The proximal portion of the cannula 18 is molded with a slotted hub 24 shown in FIG. 5).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Bierman to have a slotted needle with a sheath as taught by Kurth since both references deal with needle insertion and guidewire introduced through needles. One would have been motivated to make the modification because the slotted needle with the tearable sheath of Kurth allow for easy needle removal once the guidewire has been introduced and the needle is no longer needed. This is beneficial because it removes the sharp bevel of the needle from the patient’s vicinity easily while leaving the guidewire for further use with less risk of accidental needle sticks.
Bierman modified by Kurth discloses the claimed invention except for the slit being located in a proximal portion of the sheath. Kurth is silent to the location of the slit, but notes that the tear starts at the slit [0053]. It would have been an obvious matter of rearrangement of parts to one of ordinary skill in the art before the effective filing date to arrange the slit at the proximal portion of the sheath. Furthermore, placing the slit in the proximal portion of the sheath would allow for better leverage while forcing the guidewire to break through the sheath than if the slit was at the opposite end of the sheath, and the user would have better control and visibility if the slit was located at the proximal end. MPEP 2144.04(VI)(C). Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation, and the device of Bierman modified by Kurth would still work effectively.
Bierman and Kurth are silent to the proximal and distal ends of the access guidewire enforcing a loop in the access guidewire.
DeMars, in the art of guidewire dispensers, teaches a coupler (apparatus 10, fig. 4, [0024]) including an extension arm (portion of apparatus 10 defining the three wire guide turns 30A/30B/30C ending at the wire guide opening 22, fig. 4, [0024]) connected to the coupler housing (guideway 36, spout 24, and finger grip 42; fig. 4; [0026]) to which extension arm the proximal end of the access guidewire is attached ([0029-0030] user advances the wire guide 50 out of the opening 22; Examiner notes that the proximal end of the guidewire resides in the three wire guide turns 30A/30B/30C as shown in fig. 6 as the wire guide distal end is advanced forward), the proximal and distal ends of the access guidewire enforcing a loop in the access guidewire (see fig. 4 which shows the three wire guide turns 30A/30B/30C).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the coupler of Bierman have the structure enforcing a loop as taught by DeMars since the apparatus of DeMars is meant to advance the guidewire for entrance into a needle bore [0028], and the coupler housing of Bierman is linked to the needle hub. One would have been motivated to make the modification because the extension arm of DeMars protects the guidewire prior to insertion and prevents contamination or kinking of the guidewire.
Regarding claim 2, Bierman modified by Kurth and DeMars discloses the RICC insertion assembly according to claim 1. Bierman further discloses wherein the securing means for securing the needle hub (34) to the coupler housing is a needle-hub clip (handling portions 58/59) ([0087] handling portions 58/59 can be formed integrally or separately from the remainder of needle hub 34), the needle-hub clip clipped onto the coupler housing in at least the ready-to-deploy state of the RICC insertion assembly (see fig. 1a).
Regarding claim 3, Bierman modified by Kurth and DeMars discloses the RICC insertion assembly according to claim 2, as described above, including wherein the needle-hub clip (handling portions 58/59, fig. 2c) is integral with the needle hub ([0087] handling portions 58/59 can be formed integrally or separately from the remainder of needle hub 34).
Regarding claim 4, Bierman modified by Kurth and DeMars discloses the RICC insertion assembly according to claim 2, as described above. Bierman further discloses wherein the needle-hub clip (handling portions 58/59, fig. 2c) includes a single levered clip arm (handling portion 58, fig. 2e) distally extending over the needle hub (34, fig. 2e) from a fulcrum (see annotated fig. 2e below) connecting the clip arm (58) to a remainder of the needle hub (needle hub 34 excluding clip arm 58, see annotated fig. 2e below), the clip arm including a protrusion (latch element 66, fig. 2e, [0094]) extending from a distal portion thereof ([0094] locking structure at distal portion 61 of needle hub 34 includes latch element 66 on clip arm/handling portion 58, see fig. 2e) configured to engage with a recess (annular groove 33, fig. 3e, [0095]) in a corresponding side of coupler housing (38, shown in fig. 3e, [0095] hub 38 includes an annular groove than can engage with latch element 66) when the clip arm (58) is clipped onto the coupler housing (see fig. 3e) and disengage from the recess (33) when a proximal portion of the clip arm is pressed in toward a centerline of the needle hub ([0096] the bias of latch element 66 can be overcome by applying pressure to handling element 58 to release latch element 66, see fig. 3e).
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Regarding claim 5, Bierman modified by Kurth and DeMars discloses the RICC insertion assembly according to claim 2, as described above. Bierman further discloses wherein the needle-hub clip includes a pair of levered clip arms (handling portion 58, fig. 2e) distally extending over opposite sides of the needle hub (34, fig. 2e) from a corresponding pair of fulcrums (see annotated fig. 2e above) connecting the clip arms to a remainder of the needle hub, each clip arm of the pair of clip arms including a protrusion (latch element 66, fig. 2e, [0094]) extending from a distal portion thereof ([0094] locking structure at distal portion 61 of needle hub 34 includes latch element 66 on clip arm/handling portion 58, see fig. 2e) configured to engage with a recess (annular groove 33, fig. 3e, [0095]) in a corresponding side of coupler housing (38, shown in fig. 3e, [0095] hub 38 includes an annular groove than can engage with latch element 66) to clip the needle hub (34) onto the coupler housing (hub 38) and disengage from the recess (33) when a proximal portion of the clip arm is pressed in toward a centerline of the needle hub ([0096] the bias of latch element 66 can be overcome by applying pressure to handling element 58 to release latch element 66, see fig. 3e).
Bierman modified by Kurth and DeMars discloses the claimed invention except for a pair of levered clip arms instead of a single levered clip arm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to duplicate the levered clip arm and its engagement with the hub 38, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See MPEP 2144.04 (VI-B). Additionally, Examiner notes that although the clip. Additionally, Bierman [0086] notes that “either or both of the handling portions 58, 59 can include one or more optional latch elements to couple the needle hub 34 to another component of access device 20”.
Regarding claim 6, Bierman modified by Kurth and DeMars discloses The RICC insertion assembly according to claim 2, including wherein the coupler housing (Bierman: hub 38, fig. 3b) includes a longitudinal coupler-housing slot (Bierman: fig. 3b shows the slot formed in the distal portion of the coupler housing) in a side of the coupler housing opposite the extension arm (Bierman: see fig. 1a, extension arm 30/46 is on the distal side of the coupler housing 38) opening in a same direction as the needle slot (Kurth, slot 20, fig. 4) of the needle shaft (Kurth: cannula 18, fig. 4) (Kurth: [0053] slot 20 is defined, machined or formed along the longitudinal length of the cannula 18, see fig. 4) (Bierman: see fig. 3b, distal end of coupler-housing slot is open), the coupler-housing slot configured to (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) allow the access guidewire (Bierman: 44) to escape from the coupler housing (Bierman: 38) during withdrawal of the introducer needle (Bierman: 16) from the coupler by the needle hub (Examiner notes that the guidewire could pass through the coupler-housing slot shown in fig. 3b and therefore meets the limitation.).
Regarding claim 7, Bierman modified by Kurth and DeMars discloses The RICC insertion assembly according to claim 6, as described above.
Bierman and Kurth are silent to the coupler housing having a thumb depression.
DeMars further teaches wherein the coupler housing (24/36/42, fig. 4, [0026]) includes a thumb depression (ribbed guideway 36, fig. 4, [0030] guide wire is threaded between the thumb of the user and the ribbed guideway 36) in the side of the coupler housing including the coupler-housing slot (spout 24 and dip between opening 23 and ribbed guideway 36, fig. 4) (Examiner interprets the top side of the coupler housing in fig. 4 to include the guideway 36 and the spout 24, the bottom side to include the finger grip 42), the thumb depression (ribbed guideway 36) configured for pressing the access guidewire (50, fig. 6) therein with a thumb to hold the access guidewire in place during at least a percutaneous puncture with the introducer needle or withdrawal of the introducer needle from the coupler by the needle hub (see fig. 6, [0030] guide wire is threaded between the thumb of the user and the ribbed guideway 36 during advancement or retraction of guide wire).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the coupler housing of Bierman further to have the thumb depression and finger grip as taught by DeMars since the coupler of Bierman is already modified by the coupler of DeMars (see 103 rejection of claim 1 above). One would have been motivated to make the modification because the ribbed guideway allows the user to easily advance the wire guide, as noted in [0030] of DeMars, and the opposed location of the thumb depression and the finger grip allow the user to easily exert force on the guidewire to advance or retract the guidewire as required.
Regarding claim 8, Bierman modified by Kurth and DeMars discloses the RICC insertion assembly according to claim 7, as described above, including wherein the coupler-housing slot partially extends into the thumb depression (36) (see DeMars fig. 4, lumen of spout 24 includes opening 23 and portion connected to guideway 36) such that the distal portion of the access guidewire (wire guide 50, fig. 6, [0029]) extends into the thumb depression (36) in at least the ready-to-deploy state of the state of the RICC insertion assembly (see fig. 6, [0029] During use of apparatus 10, an end of the wire guide 50 extends through opening 22, and further extends along the ribs of guideway 36 to opening 23).
Regarding claim 9, Bierman modified by Kurth and DeMars discloses the RICC insertion assembly according to claim 7, as described above, including wherein a surface of the thumb depression is textured (DeMars: see fig. 4, [0025] guideway 36 is provided with a gentle curvature, and a series of optional projections, such as ribs 38).
Regarding claim 10, Bierman modified by Kurth and DeMars discloses the RICC insertion assembly according to claim 7, as described above, including wherein the coupler housing (DeMars 24/36/42, fig. 4) includes a finger depression (finger grip 42, fig. 4) in a side of the coupler housing opposite the thumb depression (36) (thumb depression 36 is on top of the coupler housing and finger grip 42 is on the bottom as shown in fig 4), the finger depression configured for cradling the RICC insertion assembly thereby with a finger while pressing the access guidewire into the thumb depression with the thumb during at least the percutaneous puncture with the introducer needle or withdrawal of the introducer needle from the coupler by the needle hub (see DeMars fig. 4, [0030] thumb pressed guide wire into thumb depression/guideway 36 and finger cradling insertion assembly during advancement of the guidewire).
Regarding claim 11, Bierman modified by Kurth and DeMars discloses the RICC insertion assembly according to claim 2, as described above, including the extension arm (Bierman: fig. 1a parts 30/46; modified by DeMars fig. 4, portion of apparatus 10 including the three wire guide turns 30A/30B/30C ending at the wire guide opening 22) and the coupler housing (Bierman: fig. 1a part 38 modified by DeMars fig. 4, parts 24/36/36)
Bierman modified by Kurth and DeMars discloses the claimed invention except for wherein the extension arm is integral with the coupler housing. It would have been obvious to one having ordinary skill in the art at the time the invention was made to make the extension arm of Bierman modified by DeMars integral with the coupler housing of Bierman modified by DeMars, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. See MPEP 2144.04 (V-B). Additionally, Examiner notes that as seen in DeMars fig. 4, the extension arm and coupler housing of DeMars are already integral.
Regarding claim 15, Bierman modified by Kurth and DeMars discloses The RICC insertion assembly according to claim 2, as described above. Bierman further discloses wherein the coupler housing (38, see fig. 3b) includes a needle-hub receptacle (see annotated fig. 3b below) in a proximal portion of the coupler housing (38) into which needle-hub receptacle a distal portion (luer connection 64, fig. 2c, [0153]) of the needle hub (34, fig. 2c) is inserted in at least the ready-to-deploy state of the RICC insertion assembly ([0153] luer connection 64 can be configured to cooperate with the dilator hub 38 to form a substantially liquid tight seal, see fig. 3e).
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Regarding claim 16, Bierman modified by Kurth and DeMars discloses the RICC insertion assembly according to claim 2, as described above.
Bierman and DeMars are silent to a valve module.
Kurth further teaches a valve module (hemostatic valve membrane 36, fig. 12, [0056]) disposed in a valve-module compartment (cap 38, fig. 11, note [0056] bifurcated hub 24 in FIGS. 10 and 11 includes a hemostatic valve membrane 36 and a cap 38 for holding the membrane 36) sealing around the distal portion of the access guidewire (guidewire 8, noted in [0056] as extending through the hub) that extends through the sheath opening in at least the ready-to-deploy state of the RICC insertion assembly ([0062] slotted needle 16 with an attached tightly fitted thin wall coaxial sleeve 22. The guidewire 8 is placed through the needle 16), thereby enabling leak-free aspiration through the introducer needle (Examiner notes that this limitation is functional and the prior art must only be capable of performing the recited function. See [0056] this prevents blood from leaking out of the system or air from entering).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Bierman modified by Kurth and DeMars to include the valve module of Kurth since all deal with guidewire advancement through needles interfacing with the human body. One would have been motivated to make the modification because, as Kurth notes: [0056] this prevents blood from leaking out of the system or air from entering.
Bierman modified by Kurth and DeMars discloses the claimed invention except for the valve compartment located in the coupler housing and thus sealing around the proximal portion of the sheath as well as the distal portion of the guidewire. It would have been an obvious matter of rearrangement of parts to one of ordinary skill in the art before the effective filing date to rearrange the valve and valve compartment taught by Kurth to be in the coupler housing of Bierman modified by Kurth and DeMars since the guidewire enters through the coupler housing, thereby yielding predictable results without change to inventive function. Furthermore, placing the valve in the coupler housing would be obvious to try by beneficially locating the valve at the point where the guidewire enters the sheath. MPEP 2144.04(VI)(C). Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation, and the device of Bierman modified by Kurth and DeMars would still work effectively.
Regarding claim 18, Bierman modified by Kurth and DeMars discloses the RICC insertion assembly according to claim 2, as described above. Bierman further discloses further comprising a syringe (syringe noted in [0093]) fluidly coupled to the introducer needle (needle 22, fig. 2b shows needle 22 attached to needle hub 34) in at least the ready-to-deploy state of the RICC insertion assembly ([0093] a physician or healthcare provider may attach a syringe or monitoring equipment to the locking structure on the proximal end of the needle hub 34 to perform procedures).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bierman modified by Kurth and DeMars as applied to claim 16 above, and further in view of Reavill (US 20080091137 A1; hereafter Reavill).
Regarding claim 17, Bierman modified by Kurth and DeMars discloses the RICC insertion assembly according to claim 16, as described above, including the valve module (Kurth: hemostatic valve membrane 36, fig. 12; see rejection of claim 16), the needle slot (Kurth: slot 20, fig. 4; see rejection of claim 1), and allowing the access guidewire (Kurth: guidewire 8, fig. 1) to escape from the needle shaft (Kurth: cannula 18, fig. 4) by way of the needle slot (20) (Kurth: [0053] guidewire 8 cuts through sheath 22 which covers slot 20 to escape needle 16).
Bierman, Kurth, and DeMars are silent to an integrated blade.
Reavill, in the art of catheter introduction systems, teaches wherein the valve module (flexible air fluid seals noted in [0015] and the internal space of Y-shaped housing 19 disposed between the seals, see fig. 8 for housing 19) includes an integrated blade (knife edge or blade 33, [0025], fig. 8 shows that blade 33 is disposed in the internal space of housing 19 and thus within the valve module), the blade including a distal-facing blade edge (see fig. 33) configured to (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) cut the sheath off the needle shaft during withdrawal of the introducer needle from the coupler by the needle hub ([0025] sheath/coating 10 is split and separated by the blade 33 during withdrawal of the tube which the sheath coats; Examiner further notes that as modified by Kurth in claim 1, the sheath is separated from the needle shaft during withdrawal of the needle.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Bierman, Kurth, and DeMars to include the blade taught by Reavill since Reavill also deals with inserting infusion catheters, and specifically it would have been obvious to have the blade (Reavill 33) disposed in the needle slot (Kurth 20) under a distal end of the sheath opening (slit noted in Kurth [0053]), since the blade is meant to cut the sheath and not the needle. One would have been motivated to make the modification because, as noted in Kurth [0053], deformation or kinking of the guidewire may occur when the needle is removed since the guidewire itself is tearing through the sheath. By adding in the blade of Reavill, strain can be removed from the guidewire, further helping to prevent damage to the guidewire during needle/sheath removal.
Claim(s) 19-21 and 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bierman in view of Kurth.
Regarding claim 19, Bierman discloses a coupler assembly for a rapidly insertable central catheter ("RICC") insertion assembly, comprising:
an introducer needle (needle 22, fig. 2c, [0081] FIGS. 2A-2G illustrate the needle body 32 and needle hub 34 of the needle 22) including:
a needle shaft (needle body 32, fig. 2C, [0081]) extending from a proximal portion of the needle shaft (proximal portion 52, fig. 2c, [0081] the needle hub 34 lies at a proximal portion 52 of the needle 22) through a distal needle tip (bevel tip 54, fig. 2c; [0081] needle body 32 terminates at a distal end near a distal portion 50 of the needle 22; [0084] As best seen in FIGS. 2A and 2D, the needle body 32 can include a bevel tip 54 disposed on the distal portion 50);
a needle shaft (needle body 32, fig. 2C, [0081]) extending from a proximal portion of the needle shaft (proximal portion 52, fig. 2c, [0081] the needle hub 34 lies at a proximal portion 52 of the needle 22) through a distal needle tip (bevel tip 54, fig. 2c; [0081] needle body 32 terminates at a distal end near a distal portion 50 of the needle 22; [0084] As best seen in FIGS. 2A and 2D, the needle body 32 can include a bevel tip 54 disposed on the distal portion 50);
a needle hub (needle hub 34, fig. 2c, [0081]) over the proximal portions of the needle shaft (32), the needle hub (34, fig. 2e shows the needle hub including the needle clip 58/59) including a needle-hub clip (handling portions 58/59, figs. 2b and 2c, [0086]); and
a coupler coupled together with the introducer needle (22), the coupler including:
a coupler housing (dilator hub 38, fig. 3a, fig. 1a, [0080]) onto which the needle-hub clip (58/59) is clipped in at least the ready-to-deploy state of the coupler assembly (([0094] locking structure includes a latch element 66 coupled to handling portion 58; [0095] latch element 66 releasably locks the needle hub 34 to the dilator hub 38); and
an extension arm (guidewire hub 46 and track 30, fig. 7a/b, [0136]) connected to the coupler housing ([0140] distal locking member 124 that connects the track 30 to the dilator hub 38, see fig. 6a which shows distal locking member), which extension arm is configured for attaching a proximal end of an access guidewire thereto ([0080] guidewire hub 46 is disposed on the proximal end of the guidewire 44; see fig. 7a/b which shows attachment of proximal end of guidewire 44 to hub 46 and through hub 46 to track 30).
Bierman is silent to the needle shaft including a longitudinal needle slot extending from a proximal portion to a distal end and a sheath over the needle shaft sealing the needle slot.
Kurth, in the art of needles used for guidewire/catheter insertion, teaches a needle shaft (cannula 18, fig. 4, [0053]) including a longitudinal needle slot (slot 20, fig. 4, [0053]) extending from a proximal portion of the needle shaft through a distal needle tip ([0053] slot 20 is defined, machined or formed along the longitudinal length of the cannula 18, see fig. 4); and a sheath (shrink sleeve 22, fig. 4, [0053]) over the needle shaft sealing the needle slot thereunder (see fig. 4, [0053] slot is covered so it does not leak) except for that under a sheath opening (slit noted in [0053], not shown in figures) in a proximal portion of the sheath ([0053] needle 16 is pulled away from the distal portion 12 of the guidewire 8, guidewire 8 cuts through sheath 22, a slit can be provided in the sleeve 22 to ease the start of the tear; [0062] removal of needle allows the larger diameter portion of guidewire 8 to be advance).
Kurth also teaches a needle hub (hub 24, fig. 5, [0053]) over the proximal portions of the needle shaft (18) and the sheath (22) (see fig. 5, [0053] The proximal portion of the cannula 18 is molded with a slotted hub 24 shown in FIG. 5).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Bierman to have a slotted needle with a sheath as taught by Kurth since both references deal with needle insertion and guidewire introduced through needles. One would have been motivated to make the modification because the slotted needle with the tearable sheath of Kurth allow for easy needle removal once the guidewire has been introduced and the needle is no longer needed. This is beneficial because it removes the sharp bevel of the needle from the patient’s vicinity easily while leaving the guidewire for further use with less risk of accidental needle sticks.
Bierman modified by Kurth discloses the claimed invention except for the slit being located in a proximal portion of the sheath. Kurth is silent to the location of the slit, but notes that the tear starts at the slit [0053]. It would have been an obvious matter of rearrangement of parts to one of ordinary skill in the art before the effective filing date to arrange the slit at the proximal portion of the sheath. Furthermore, placing the slit in the proximal portion of the sheath would allow for better leverage while forcing the guidewire to break through the sheath than if the slit was at the opposite end of the sheath, and the user would have better control and visibility if the slit was located at the proximal end. MPEP 2144.04(VI)(C). Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation, and the device of Bierman modified by Kurth would still work effectively.
Regarding claim 20, Bierman modified by Kurth discloses the coupler assembly according to claim 19, as described above. Bierman further discloses wherein the needle-hub clip includes a pair of levered clip arms (handling portion 58, fig. 2e) distally extending over opposite sides of the needle hub (34, fig. 2e) from a corresponding pair of fulcrums (see annotated fig. 2e above) connecting the clip arms to a remainder of the needle hub, each clip arm of the pair of clip arms including a protrusion (latch element 66, fig. 2e, [0094]) extending from a distal portion thereof ([0094] locking structure at distal portion 61 of needle hub 34 includes latch element 66 on clip arm/handling portion 58, see fig. 2e) configured to engage with a recess (annular groove 33, fig. 3e, [0095]) in a corresponding side of coupler housing (38, shown in fig. 3e, [0095] hub 38 includes an annular groove than can engage with latch element 66) to clip the needle hub (34) onto the coupler housing (hub 38) and disengage from the recess (33) when a proximal portion of the clip arm is pressed in toward a centerline of the needle hub ([0096] the bias of latch element 66 can be overcome by applying pressure to handling element 58 to release latch element 66, see fig. 3e).
Bierman modified by Kurth discloses the claimed invention except for a pair of levered clip arms instead of a single levered clip arm. It would have been obvious to one having ordinary skill in the art at the time the invention was made to duplicate the levered clip arm and its engagement with the hub 38, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. See MPEP 2144.04 (VI-B). Additionally, Examiner notes that although the clip. Additionally, Bierman [0086] notes that “either or both of the handling portions 58, 59 can include one or more optional latch elements to couple the needle hub 34 to another component of access device 20”.
Regarding claim 21, Bierman modified by Kurth discloses the coupler assembly according to claim 19, as described above, including wherein the coupler housing (Bierman: hub 38, fig. 3b) includes a longitudinal coupler-housing slot (Bierman: fig. 3b shows the slot formed in the distal portion of the coupler housing) in a side of the coupler housing opposite the extension arm (Bierman: see fig. 1a, extension arm 30/46 is on the distal side of the coupler housing 38) opening in a same direction as the needle slot (Kurth, slot 20, fig. 4) of the needle shaft (Kurth: cannula 18, fig. 4) (Kurth: [0053] slot 20 is defined, machined or formed along the longitudinal length of the cannula 18, see fig. 4) (Bierman: see fig. 3b, distal end of coupler-housing slot is open), the coupler-housing slot configured to (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) allow the access guidewire (Bierman: 44) to escape from the coupler housing (Bierman: 38) when the access guidewire is disposed therein (Examiner notes that the guidewire could pass through the coupler-housing slot shown in fig. 3b and therefore meets the limitation.
Regarding claim 26, Bierman modified by Kurth discloses the coupler assembly according to claim 19, as described above. Bierman further discloses wherein the coupler housing (38, see fig. 3b) includes a needle-hub receptacle in a proximal portion of the coupler housing (see annotated fig. 3b above) into which a distal portion (luer connection 64, fig. 2c, [0153]) of the needle hub (34, fig. 2c) is inserted in at least the ready-to-deploy state of the coupler assembly ([0153] luer connection 64 can be configured to cooperate with the dilator hub 38 to form a substantially liquid tight seal, see fig. 3e).
Regarding claim 27, Bierman modified by Kurth discloses the coupler assembly according to claim 19, as described above.
Bierman is silent to a valve module.
Kurth further teaches a valve module (hemostatic valve membrane 36, fig. 12, [0056]) disposed in a valve-module compartment (cap 38, fig. 11, note [0056] bifurcated hub 24 in FIGS. 10 and 11 includes a hemostatic valve membrane 36 and a cap 38 for holding the membrane 36) sealing around the access guidewire (guidewire 8, noted in [0056] as extending through the hub) when the access guidewire extends through the sheath opening ([0062] slotted needle 16 with an attached tightly fitted thin wall coaxial sleeve 22. The guidewire 8 is placed through the needle 16), thereby enabling leak-free aspiration through the introducer needle (Examiner notes that this limitation is functional and the prior art must only be capable of performing the recited function. See [0056] this prevents blood from leaking out of the system or air from entering).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Bierman modified by Kurth to include the valve module of Kurth since both deal with guidewire advancement through needles interfacing with the human body. One would have been motivated to make the modification because, as Kurth notes: [0056] this prevents blood from leaking out of the system or air from entering.
Bierman modified by Kurth discloses the claimed invention except for the valve compartment located in the coupler housing and thus sealing around the proximal portion of the sheath as well as the guidewire. It would have been an obvious matter of rearrangement of parts to one of ordinary skill in the art before the effective filing date to rearrange the valve and valve compartment taught by Kurth to be in the coupler housing of Bierman modified by Kurth since the guidewire enters through the coupler housing, thereby yielding predictable results without change to inventive function. Furthermore, placing the valve in the coupler housing would be obvious to try by beneficially locating the valve at the point where the guidewire enters the sheath. MPEP 2144.04(VI)(C). Please note that in the instant application, the Applicant has not disclosed any criticality for the claimed limitation, and the device of Bierman modified by Kurth would still work effectively.
Claim(s) 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bierman modified by Kurth as applied to claim 19 above, and further in view of DeMars.
Regarding claim 22, Bierman modified by Kurth discloses the coupler assembly according to claim 21, as described above.
Bierman and Kurth are silent to the coupler housing having a thumb depression.
DeMars in the art of guidewire dispensers, teaches a coupler (apparatus 10, fig. 4, [0024]) wherein the coupler housing (guideway 36, spout 24, and finger grip 42; fig. 4; [0026]) includes a thumb depression (ribbed guideway 36, fig. 4, [0030] guide wire is threaded between the thumb of the user and the ribbed guideway 36) in the side of the coupler housing including the coupler-housing slot (spout 24 and dip between opening 23 and ribbed guideway 36, fig. 4) (Examiner interprets the top side of the coupler housing in fig. 4 to include the guideway 36 and the spout 24, the bottom side to include the finger grip 42) such that the coupler-housing slot partially extends into the thumb depression (see DeMars fig. 4, lumen of spout 24 includes opening 23 and portion connected to guideway 36), the thumb depression (ribbed guideway 36) configured for pressing the access guidewire (50, fig. 6) therein with a thumb to hold the access guidewire in place when the access guidewire is disposed in the coupler housing (see fig. 6, [0030] guide wire is threaded between the thumb of the user and the ribbed guideway 36 during advancement or retraction of guide wire).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the coupler of Bierman have the thumb depression and finger grip as taught by DeMars since the apparatus of DeMars is meant to advance the guidewire for entrance into a needle bore [0028], and the coupler housing of Bierman is linked to the needle hub. One would have been motivated to make the modification because the ribbed guideway allows the user to easily advance the wire guide, as noted in [0030] of DeMars, and the opposed location of the thumb depression and the finger grip allow the user to easily exert force on the guidewire to advance or retract the guidewire as required.
Regarding claim 23, Bierman modified by Kurth and DeMars discloses the coupler assembly according to claim 22, as described above, including wherein the coupler housing (DeMars 24/36/42, fig. 4) includes a finger depression (finger grip 42, fig. 4) in a side of the coupler housing opposite the thumb depression (36) (thumb depression 36 is on top of the coupler housing and finger grip 42 is on the bottom as shown in fig 4), the finger depression configured for cradling the coupler assembly thereby with a finger while pressing the access guidewire into the thumb depression with the thumb when the access guidewire is disposed in the coupler housing (see DeMars fig. 4, [0030] thumb pressed guide wire into thumb depression/guideway 36 and finger cradling insertion assembly during advancement of the guidewire).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bierman modified by Kurth as applied to claim 27 above, and further in view of Reavill.
Regarding claim 28, Bierman modified by Kurth discloses the coupler assembly according to claim 27, as described above, including the valve module (Kurth: hemostatic valve membrane 36, fig. 12; see rejection of claim 16), the needle slot (Kurth: slot 20, fig. 4; see rejection of claim 1), and allowing the access guidewire (Kurth: guidewire 8, fig. 1) to escape from the needle shaft (Kurth: cannula 18, fig. 4) by way of the needle slot (20) (Kurth: [0053] guidewire 8 cuts through sheath 22 which covers slot 20 to escape needle 16).
Bierman and Kurth are silent to an integrated blade.
Reavill, in the art of catheter introduction systems, teaches wherein the valve module (flexible air fluid seals noted in [0015] and the internal space of Y-shaped housing 19 disposed between the seals, see fig. 8 for housing 19) includes an integrated blade (knife edge or blade 33, [0025], fig. 8 shows that blade 33 is disposed in the internal space of housing 19 and thus within the valve module), the blade including a distal-facing blade edge (see fig. 33) configured to (Claim language of “configured to” implies functional language and the prior art must only be capable of performing the recited function.) cut the sheath off the needle shaft during withdrawal of the introducer needle from the coupler by the needle hub ([0025] sheath/coating 10 is split and separated by the blade 33 during withdrawal of the tube which the sheath coats; Examiner further notes that as modified by Kurth in claim 1, the sheath is separated from the needle shaft during withdrawal of the needle.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of Bierman, Kurth, and DeMars to include the blade taught by Reavill since Reavill also deals with inserting infusion catheters, and specifically it would have been obvious to have the blade (Reavill 33) disposed in the needle slot (Kurth 20) under a distal end of the sheath opening (slit noted in Kurth [0053]), since the blade is meant to cut the sheath and not the needle. One would have been motivated to make the modification because, as noted in Kurth [0053], deformation or kinking of the guidewire may occur when the needle is removed since the guidewire itself is tearing through the sheath. By adding in the blade of Reavill, strain can be removed from the guidewire, further helping to prevent damage to the guidewire during needle/sheath removal.
Allowable Subject Matter
Claims 12-14 and 24-25 are 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: the prior art of record does not disclose, alone or in combination, the assembly of claim 12, specifically the extension-arm clip clipped onto a Luer connector of the RICC and the guidewire extending through the extension-arm clip.
Bierman as modified by Kurth and DeMars discloses the assembly of claim 2, on which claim 14 depends. However, none of these references disclose a guidewire extending through a Luer connector of a RICC and an extension-arm clip clipped onto a Luer connector. While clips and Luer connectors do appear in related art, it would not have been obvious to further modify the device of Bierman modified by Kurth and DeMars to arrive at the claimed limitations.
Claims 13 and 14 are dependent on claim 12 and thus incorporate the allowable subject matter of claim 12.
Likewise, the prior art of record does not disclose, alone or in combination, the assembly of claim 24, specifically the extension-arm clip connected to a Luer connector of a RICC and the guidewire extending through the extension-arm clip. For similar reasons to those above, it would not have been obvious to arrive at the claimed limitation.
Claims 25 is dependent on claim 24 and thus incorporates the allowable subject matter of claim 24.
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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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 02/06/2026