Prosecution Insights
Last updated: April 19, 2026
Application No. 17/954,132

Couplers and Assemblies Thereof for Rapidly Insertable Central Catheters

Final Rejection §103
Filed
Sep 27, 2022
Examiner
MARRISON, SAMUEL JOSEPH
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Bard Access Systems Inc.
OA Round
2 (Final)
66%
Grant Probability
Favorable
3-4
OA Rounds
3y 11m
To Grant
99%
With Interview

Examiner Intelligence

Grants 66% — above average
66%
Career Allow Rate
23 granted / 35 resolved
-4.3% vs TC avg
Strong +59% interview lift
Without
With
+59.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 11m
Avg Prosecution
57 currently pending
Career history
92
Total Applications
across all art units

Statute-Specific Performance

§101
1.4%
-38.6% vs TC avg
§103
51.0%
+11.0% vs TC avg
§102
24.7%
-15.3% vs TC avg
§112
18.6%
-21.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 35 resolved cases

Office Action

§103
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 Claim 1 was previously objected to for improper wording and was not amended; the previous objection remains. Claims 1-13 and 16-20 were previously rejected and remain objected to as no amendments were made, and claims 14-15 were objected to as allowable if rewritten as independent claims and remain objected to. Claim Objections Claim 1 objected to because of the following informalities: Claim 1 is objected to for improper wording where it recites “sealing the needle slot thereunder except for that under a sheath opening in a proximal portion of the sheath” which should instead likely recite “sealing the needle slot thereunder except for under a sheath opening in a proximal portion of the sheath” to more clearly define the claim limitation. Appropriate correction is required. 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. Claim(s) 1-13 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Blanchard et al. (US 20150231364, henceforth Blanchard) in view of Barker et al. (US 20020045843, henceforth Barker) and Reavill (US 20080091137, henceforth Reavill). Regarding claim 1, Blanchard discloses a rapidly insertable central catheter (RICC) insertion assembly (assembly of figs. 48-65), comprising: a RICC (catheter 42, fig. 49); an introducer needle (needle 16, fig. 49) including: a needle shaft (the length of needle 16 shown in fig. 49 is its shaft) having a proximal portion of the needle shaft (the proximal portion of needle 16 is the portion closest to valve 52, fig. 49) and a distal needle tip (the distal tip of needle 16 is shown as distal end 16B, fig. 49); a needle hub (the combination of needle hub 1214, clip arms 1300, head portion 1222 make up the claimed needle hub, see fig. 49) over the proximal portions of the needle shaft (see fig. 52 and [0177]), the needle hub including a distally extending needle-hub extension arm (head portion 1222, which extends distally relative to actuation block 1258 as shown in fig. 52, excluding wings 1280); and a needle-hub portion of a RICC clip (arms 1248, fig. 50) configured to hold a portion of the RICC therein (see fig. 50, catheter 40 is held radially between arms 1248) in at least a ready-to-deploy state of the RICC insertion assembly (see the state of fig. 50A, this is the claimed state); an access guidewire (guidewire 22, fig. 52) including: a proximal portion (the portion of guidewire 22 extends proximally of catheter 42 within housing 12 is a proximal portion as claimed) including a proximal end (the end of guidewire 22 which is mounted into top housing portion as detailed in [0174] is the claimed proximal end); and a distal portion (the portion of guidewire 22 which is inserted into catheter 42 is a distal portion as claimed) including a distal end (the end of guidewire 22 which extends distally to the distal tip of the needle 16B is the claimed distal end) disposed in the introducer needle (see [0174], guidewire 22 is initially disposed within the lumen of needle 16) just proximal of the needle tip in at least the ready-to-deploy state of the RICC insertion assembly (see [0174], the distal end of guidewire 22 is considered to be just proximal of tip 16B since it can be translated manually through tip 16B to protrude through needle 16); and a coupler (handle assembly 1220, fig. 48A) coupling the RICC, the introducer needle, and the access guidewire together (see fig. 50A), the coupler including: a coupler housing (handle assembly 1220 including bottom housing portion 12B and safety housing 54 but excluding tail portion 1224 and valve 52, fig. 49); and a coupler portion of the RICC clip connected to the coupler housing (tail portion 1224, fig. 49, which is connected to the called out housing where it is disposed about safety housing 54 as in [0180]), the proximal and distal ends of the access guidewire enforcing a loop in the access guidewire (see fig. 53A, guidewire 22 is shown as being looped over guide surfaces 980 because of the arrangement of the ends of the guidewire 22) over which the RICC is disposed in at least the ready-to- deploy state of the RICC insertion assembly (see state of figs. 48A and 50A, catheter 42 is arranged over guidewire 22 since it is arranged over needle 16 which guidewire 22 is inside of). Blanchard additionally discloses an alternative embodiment where the introducer needle (needle 216, fig. 17A) includes a longitudinal needle slot (slot 226, fig. 17A) extending from the proximal portion of the needle shaft through the distal needle tip (see [0110], needle slot 226 can extend for the entire length of the needle). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the needle slot of the alternative embodiment of Blanchard to the elected embodiment of Blanchard for allowing the guidewire to be inserted into, slide relative to, and removed from the needle during use such as to accommodate for leaving the guidewire in the catheter during use after removal of the needle as desired (see [0110]-[0111]) and further since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. Blanchard as modified does not disclose the assembly comprising a sheath over the needle shaft sealing the needle slot thereunder except for that under a sheath opening in a proximal portion of the sheath. Barker teaches an assembly comprising an introducer needle (needle 365, fig. 14) having a shaft (the length of needle 365 extends over its shaft) and a sheath (sheath 330, fig. 14) arranged over the needle shaft (see fig. 14) sealing the needle thereunder (see [0075], sheath 330 has the same internal bore as the external diameter of needle 365, meaning that it seals it) except for that under a sheath opening in a proximal portion of the sheath (the proximal end of the sheath is considered to be an opening at which point the sheath no longer seals the needle within itself, see fig. 13). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the sheath of Barker to the modified assembly of Blanchard in the claimed configuration for the benefit of sealing the introducer needle such as to allow for aspiration of blood through the needle to check for proper placement as was taught as beneficial in Barker ([0008], the needle is aspirated through; this would not be possible in the modified device of Blanchard due to the needle slot, and thus a sealing component would be necessary to achieve aspiration). Such a modified device would then include that the needle hub was arranged over the proximal portion of the sheath as claimed where since the needle hub would include sealing of the sheath in the modified device such as to not allow blood flow into other components of the handle assembly in Blanchard as modified. In order to make such a device usable and maintain the benefit of the added needle slot in the modified device, the sheath would have to be arranged to be separable from the needle to provide the possible guidewire removal from the needle arrangement as desired. In order to make the sheath separable, it would have to be cut such as to allow the guidewire to move through it similarly to the slot of the introducer needle; such a cutting piece is not disclosed in the modified device. Reavill teaches a RICC insertion assembly (see [0014]) including an integrated blade disposed under a distal end of a sheath opening (Y-shaped housing 19 including blade 33 disposed under a distal end of coating 10, see [0025] & see figs. 2 and 7-8), the blade including a distal facing blade edge configured to cut the sheath off of a needle shaft as an introducer needle is withdrawn from a coupler (blade 33 having an edge configured to slit coating 10, removing it from catheter 12, as it passes through housing 19, [0025] & Fig. 7-9). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the blade and arrangement thereof of Reavill to the modified device of Blanchard for the benefit of providing a reliable means of splitting the sheath from the needle such as to be able to remove the guidewire as desired in the modified device and further because such an addition would have yielded predictable results pertaining to sheath splitting (see [0025] of Reavill). Such an addition could be added where the clave 52 of Blanchard is shown as this is a location where sealing is meant to occur in Blanchard to prevent unwanted leakage. Regarding claim 2, Blanchard as modified discloses the assembly of claim 1 wherein the coupler housing includes a proximally extending coupler-housing support (safety housing 54, fig. 49) over which at least the needle- hub extension arm is slidably disposed in at least the ready-to-deploy state of the RICC insertion assembly (head portion 1222 is slidably disposed as is disclosed in [0192], and this is considered to be a disposal over safety housing 54 because the head portion 1222 can be arranged to be above safety housing 54 and thus it would be over the safety housing 54). Regarding claim 3, Blanchard as modified discloses the assembly of claim 2 wherein the coupler portion of the RICC clip is a first 'C'-shaped portion of the RICC clip (tail portion 1224, fig. 56C, is C shaped where it has 2 portions which are each curved with a hollowed out center to resemble a C as claimed) suspended from a proximal portion of the coupler-housing support (tail portion 1224 is suspended from a proximal portion of safety housing 54 as shown in fig. 59 where the elements are separable from each other), the needle-hub portion of the RICC clip is a second 'C'- shaped portion of the RICC clip (arms 1248 are C shaped when they are in their opened configuration as shown in fig. 57A and create an angle between two elongated portions with a hollowed out center to create a C shape as claimed) suspended from a proximal portion of the needle hub (a proximal portion of the called out needle hub is needle hub 1214; arms 1248 are suspended from needle hub 1214 where there is a space between them longitudinally), and the first and second 'C'-shaped portions of the RICC clip open toward each other (see fig. 59; in this state, the tail portion 1224 is open where the hollowed out C-shaped sections are not filled with anything and the arms 1248 which form the second C-shaped section when opened are not clamped onto catheter 42; the openings thus face each other in this state) such that the RICC clip is completed in at least the ready-to-deploy state of the RICC insertion assembly (the clip is considered to be completed in the state of fig. 48 when the device is fully assembled; note that the claim does not recite that the C-shaped portions are opened in the claimed read-to-deploy state of the assembly, nor does the claim require that the portions always open toward each other or open toward each other in the ready-to-deploy state). Regarding claim 4, Blanchard as modified discloses the assembly of claim 2 wherein the RICC clip is configured to hold one or more extension legs of the RICC therein such that the RICC is suspended from the RICC insertion assembly in at least the ready-to-deploy state of the RICC insertion assembly (catheter hub 46 is an extension leg of catheter 42; the clip holds catheter hub 46 within itself where hub 46 is longitudinally between arms 1248 and tail portion 1224 in the ready-to-deploy state as claimed; the assemblies are suspended from each other where they are detachable from one another as shown in fig. 59). Regarding claim 5, Blanchard as modified discloses the assembly of claim 4 wherein the RICC clip is configured to release the one-or-more extension legs of the RICC therefrom when the introducer needle is withdrawn from the coupler (this is a disassembly of the assembly as shown in fig. 59; catheter hub 46 is released longitudinally from the called out RICC clip elements in this state). Regarding claim 6, Blanchard as modified discloses the assembly of claim 1 wherein the coupler housing includes a needle-hub receptacle (bottom housing portion 12B, fig. 59) in a proximal portion of the coupler housing (bottom housing portion 12B exists in the proximal most portion of the called out coupler housing which is handle assembly 1220 including bottom housing portion 12B and safety housing 54 but excluding tail portion 1224, fig. 49) into which needle-hub receptacle a distal portion of the needle hub including the needle-hub extension arm is disposed in at least the ready-to-deploy state of the RICC insertion assembly (since bottom housing portion 12B longitudinally extends around head portion 1222 which is a distal portion of the needle hub in the state of fig. 48, the claim requirement is met). Regarding claim 7, Blanchard as modified discloses the assembly of claim 6 the coupler further including a valve module (valve 52, fig. 49, and the added blade component of Reavill make up the claimed valve module in the modified device) disposed in a valve-module compartment of the coupler housing (see figs. 52 and 54, the added blade and valve 52 are considered to be in a compartment of the called out coupler housing) distal of the needle-hub receptacle (valve 52 is located distal to the proximal end of bottom housing portion 12B, see figs. 52 and 54), the valve module sealing around the proximal portion of the sheath and the distal portion of the access guidewire that extends through the sheath opening in at least the ready-to-deploy state of the RICC insertion assembly (see fig. 52 and see the modification to claim 1 above), thereby enabling leak-free aspiration through the introducer needle (see fig. 52 and see the modification to claim 1 above, the added sheath and sealing of valve 52 means that the introducer needle is functionally capable of leak-free aspiration since it is sealed within the sheath). Regarding claim 8, Blanchard as modified discloses the assembly of claim 7 wherein the valve module includes an integrated blade disposed in the needle slot under a distal end of the sheath opening (see rejection of claim 1 above regarding the addition of Reavill), the blade including a distal-facing blade edge configured to cut the sheath off the needle shaft when 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 thereof (see rejection of claim 1 above regarding the addition of Reavill). Regarding claim 9, Blanchard as modified discloses the assembly of claim 1 wherein the coupler includes a pair of lock buttons (pair of wings 1280, fig. 52) extending through opposite sides of the coupler housing (see figs. 48 and 52, wings 1280 extend through opposite sides of the coupler housing on either side of catheter 42 as shown), the pair of lock buttons respectively mounted on a pair of axles (wings 1280 are mounted onto the top surfaces of gaps 1250 on either side of the coupler housing where each of the wings 1280 slide on these top surfaces) captively held in the coupler housing (the top surfaces are considered to be held in the coupler housing as claimed where they exist within the exterior boundaries of bottom housing portion 12B which is a part of the coupler housing) such that each lock button of the pair of lock buttons pivots on a corresponding axle (wings 1280 are considered to be pivoting about their respective axles where they are pushed upwards from a more downwards position as the wings 1280 are translated distally, see [0193]). Regarding claim 10, Blanchard as modified discloses the assembly of claim 9 wherein each lock button of the pair of lock buttons has a protrusion (ridges 1282 are protrusions, see fig. 50B) extending from a crossarm (posts 1286, fig. 57B; ridges 1282 extend radially away from posts 1286) connecting the protrusion to an external, pressable portion of the lock button (the external, pressable portion of wings 1280 is the flattened exterior portions of the wings 1280 which the ridges 1282 protrude from) and a gap (the space between the ridges 1282 and the flattened exterior portions of the wings 1280 which the ridges 1282 protrude from is the claimed gap) opposite the crossarm (the gap is opposite posts 1286 where it is on the opposite side of wings 1280 as compared to posts 1286 relative to the radial interior most parts of wings 1280) between the protrusion and the external, pressable portion of the lock button (the gaps are found between the edges of ridges 1282 and the flattened portions of wings 1280 which they protrude from). Regarding claim 11, Blanchard as modified discloses the assembly of claim 10 wherein the pair of lock buttons are biased away from a centerline of the coupler (wings 1280 are biased away from the center line of handle assembly 1220 due to the rigid nature of the material which they are made from; the wings 1280 are understood to be rigid since they impinge on housing 12A without flexing) such that the protrusion of each lock button of the pair of lock buttons is disposed in a notch of a pair of notches (the space between ridges 1282 on wings 1280 and head portion 1222 is considered to be a notch which exists for each of the wings as claimed) in a wall of the needle- hub extension arm (the called out notches are spaces defined by emptiness of head portion 1222 and are thus notches of head portion 1222 as claimed) on opposite sides of the needle-hub extension arm (the notches are found on both sides of the head portion 1222 as shown in fig. 60) in a default state of the pair of lock buttons (this is the state of fig. 48A). Regarding claim 12, Blanchard as modified discloses the assembly of claim 11 wherein the wall of the needle-hub extension arm on both sides of the needle-hub extension arm passes through the gap between the protrusion and the external, pressable portion of each lock button of the pair of lock buttons when the pair of lock buttons are pressed in toward the centerline of the coupler (the exterior surface of head portion 1222, which is the wall of the extension arm as claimed, passes through the gap at all times where a portion of the exterior surface exists at the same location transverse to the centerline as the claimed gap). Regarding claim 13, Blanchard as modified discloses the assembly of claim 1 wherein the needle hub includes a proximally extending needle-hub cradle (clips arms 1300 make up a cradle where there is a space between the arms cradling head portion 1222, see fig. 60) with grip pads on opposite sides of the needle-hub cradle (the walls of clip arms 1300 which face the exterior are grip pads as they can be gripped by a user, see fig. 60) to facilitate holding the RICC insertion assembly thereby (since the clip arms 1300 are used to hold components together as in [0196], this is considered to be true) when the introducer needle is withdrawn from the coupler (in the disassembled configuration of fig. 59, clip arms 1300 are exposed, and thus a user could at this time grab the clip arms 1300 for gripping as claimed). Regarding claim 16, Blanchard as modified discloses the assembly of claim 1 wherein the needle hub includes an access-guidewire channel (the opening in the middle of needle hub 1214 is an access-guidewire channel as claimed, see fig. 53A) defined by a notch (the claimed notch is the exterior wall of the called out opening, see fig. 53) in a distally extending needle-hub extension tube (the claimed extension tube is the cylindrical opening which extends over the longitudinal length of needle hub 1214, and it extends distally relative to guide surfaces 980 as shown in fig. 53A) over the proximal portions of the needle shaft and the sheath (see fig. 53A and see the modifications made to the assembly in claim 1 regarding Barker). Regarding claim 17, Blanchard as modified discloses the assembly of claim 16 wherein the needle hub includes a transverse bar (spring arm 1260, fig. 53A, which extends transversely relative to wings 1280) and a needle-hub pad (posts 1264, fig. 53A) between the bar and the access-guidewire channel (see fig. 53A, posts 1264 extend in the space between spring arm 1260 and the opening in needle hub 1214 as shown), the bar and the needle-hub pad configured for pressing and holding the access guidewire in place thereagainst when establishing a needle tract from an area of skin to a blood-vessel lumen of a patient (see at least [0177] and [0183], the structures are used to lock guidewire 22 in place). Regarding claim 18, Blanchard as modified discloses the assembly of claim 1 wherein the coupler housing includes a longitudinal coupler-housing slot (the space occupied by and in the middle of valve 52 is considered to be a longitudinal space, and thus since valve 52 is not included in the coupler housing, the coupler housing makes this space via a longitudinal slot as claimed) on a same side of the coupler housing as the coupler portion of the RICC clip (both the called out longitudinal slot and the tail portion 1224 are on the same side of the housing, the proximal side, relative to support structure 47), the coupler-housing slot thereby opening in a direction opposite that of the needle slot of needle shaft (while the needle slot of the needle shaft opens in the distal direction, relative to support structure 47, the longitudinal slot opens in the proximal direction, which is opposite to the distal direction as claimed), the coupler-housing slot configured to allow the access guidewire to escape from the coupler housing when the introducer needle is withdrawn from the coupler (when the device is disassembled into the state of fig. 59, the slot allows the guidewire 22 to be separated with needle 16 from handle assembly 1220). Regarding claim 19, Blanchard as modified discloses the assembly of claim 18 wherein the coupler-housing slot has a narrower portion and a wider portion proximal of the narrower portion (the distal portion of valve 52 is narrower than the proximal portion of valve 52, and thus the slot is considered to take up this same space which meets the claim limitations), the wider portion of the coupler-housing slot configured for at least aligning a needle-hub alignment rail of the needle hub while assembling the RICC insertion assembly (see figs. 52 and 53A, the called out slot and proximal ending thereof is configured for the claimed alignment where it must be coaxial with guidewire lever 24 as shown to allow for proper alignment and movement of guidewire 22 and needle 16). Regarding claim 20, Blanchard as modified discloses the assembly of claim 1 wherein the access guidewire includes an access-guidewire hub (actuation block 1258, fig. 52) over the distal end of the access guidewire (the assembly can be arranged such that action block is held by a user above, or over, the distal end of guidewire 22 relative to the ground which the user is standing on), the access- guidewire hub configured to prevent over advancement of the access guidewire (see [0188], actuation block 1258 is used for locking at the end of the movement of guidewire 22 which meets the claim requirement). Allowable Subject Matter Claims 14 and 15 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 14 particularly comprising a syringe fluidly coupled to the introducer needle where a barrel of the syringe is disposed within a needle-hub cradle with grip pads of the needle-hub cradle flanking the barrel of the syringe. Blanchard as modified discloses the assembly of claim 13 which claim 14 is dependent on. However, Blanchard does not disclose a syringe as claimed, nor does Blanchard as modified appear to be obviously combinable with other prior art to render the claimed invention. While there are assemblies similar to the claimed invention which have syringes fluidly coupled to introducer needles as claimed (see the cited art below in the Conclusion section calling out additional relevant prior art references), these assemblies do not disclose the claimed needle-hub cradle which is a part of the needle hub which is over portions of a needle shaft and a needle sheath which also has a needle-hub extension arm as claimed. Claim 15 is dependent on claim 14 and thus requires all limitations of claim 14 including the called out allowable subject matter. Response to Arguments Applicant's arguments filed 11/19/2025 have been fully considered but they are not persuasive. Regarding the outstanding claim objection to claim 1, the use of the term “that” in the claim appears to be referring to a portion of the needle slot under a sheath opening, and thus Applicant’s argument that the “that” is demonstratively referring to “the needle shaft” and is clear and does not require amending is not persuasive as simply replacing the “that” with “the needle shaft” would change the requirements of the claim. The interpretation of “a sheath over the needle shaft sealing the needle slot thereunder except for Applicant additionally argues that the interpretation of claim 1 regarding the objection overly broadens the claim and thus that the rejection is improper regarding the over/under directions relied on in the interpretation above. Examiner respectfully disagrees, as the claim as written does not require the specific directions as argued by Applicant since it only requires the elements to be over/under each other, but does not explicitly require a consistent radial direction. Applicant has also argued that the rationales relied upon for the modifications made to the device of claim 1 conflict as the ability to slide the guide wire into, relative to, and be removed from the needle during use as in Blanchard and the sealing of the introducer needle of Barker are allegedly contradictory. Examiner respectfully disagrees. The functions rendered capable due to the modified device (possible guidewire movements during use and possible blood aspiration during use) are not required to be done at the same time, and different practitioners will have different uses/methods of using the device. For instance, the guidewire could be inserted into, moved relative to, and then removed from the needle, and then the needle could separately be used for aspiration to confirm location using the modified device since it has the functional capability for these actions due to the modifications made. Both of these actions are considered to be during use, but not necessarily simultaneously. Applicant has additionally argued that Examiner has improperly argued the directions for the claim limitation “a sheath over the needle shaft sealing the needle slot thereunder except for [that] under a sheath opening in a proximal portion of the sheath”. This is also found unpersuasive; the claim requires (1) the sheath to be over the needle shaft, (2) structurally capable of sealing the needle slot underneath itself [note especially that this is a functional limitation and not a positively recited method step of sealing], (3) the sheath to have an opening in a proximal portion, and (4) the opening to be structurally configured to not seal a portion of the needle shaft under it. Examiner notes that the claim does not specify what directions over/under are meant to be or provide any further relative directions (under being within or arranged separately such that the needle shaft lays under the sheath, for example). In the modified device, these limitations are each respectively met where: (1) the added sheath of Barker is arranged radially around the shaft of Blanchard similar to the arrangement of Barker, or radially over the needle shaft, (2) the sheath is configured for sealing to allow blood aspiration as in Barker, which means it seals the needle within, or under, itself where it covers the needle, (3) the sheath has an opening at its proximal end where the sealing with the needle shaft ends, and (4) the opening is configured to not seal the needle underneath, or within itself, as the sheath must be arranged to be separable from the needle shaft to allow for the possible guidewire removal as desired and as indicated above (see the paragraph prior to the teachings of Reavill in particular). The claim does not specify any further structural features of the proximal end opening which preclude this interpretation and there are no limitations in the claim which are not met, and thus this argument is also respectfully found unpersuasive. 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL J MARRISON whose telephone number is (703)756-1927. The examiner can normally be reached M-F 7:00a-3:30p ET. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /SAMUEL J MARRISON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
Read full office action

Prosecution Timeline

Sep 27, 2022
Application Filed
Aug 19, 2025
Non-Final Rejection — §103
Nov 19, 2025
Response Filed
Feb 26, 2026
Final Rejection — §103 (current)

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Prosecution Projections

3-4
Expected OA Rounds
66%
Grant Probability
99%
With Interview (+59.2%)
3y 11m
Median Time to Grant
Moderate
PTA Risk
Based on 35 resolved cases by this examiner. Grant probability derived from career allow rate.

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