Prosecution Insights
Last updated: April 19, 2026
Application No. 17/953,959

Insertion Assemblies of Rapidly Insertable Central Catheters and Methods Thereof

Non-Final OA §103§112
Filed
Sep 27, 2022
Examiner
BOSWORTH, KAMI A
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Bard Access Systems Inc.
OA Round
1 (Non-Final)
68%
Grant Probability
Favorable
1-2
OA Rounds
3y 8m
To Grant
98%
With Interview

Examiner Intelligence

Grants 68% — above average
68%
Career Allow Rate
667 granted / 974 resolved
-1.5% vs TC avg
Strong +30% interview lift
Without
With
+29.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
76 currently pending
Career history
1050
Total Applications
across all art units

Statute-Specific Performance

§101
0.8%
-39.2% vs TC avg
§103
42.1%
+2.1% vs TC avg
§102
26.4%
-13.6% vs TC avg
§112
25.6%
-14.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 974 resolved cases

Office Action

§103 §112
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. Election/Restrictions Applicant’s election without traverse of Group I in the reply filed on 12/19/2025 is acknowledged. Accordingly, claims 19-29 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claim Objections Claim 5 is objected to because of the following informalities: The term “thereof” on line 6 is unnecessary and should be removed . Appropriate correction is required. Claim 7 is objected to because of the following informalities: The term “a” on line 4 should be replaced with the term “the” because a “ready-to-deploy state” has already been introduced in claim 1 . Appropriate correction is required. Claim 14 is objected to because of the following informalities: The term “thereof” on line 4 is unnecessary and should be removed. The term “a” on line 4 should be replaced with the term “the” because a “ready-to-deploy state” has already been introduced in claim 1 . Appropriate correction is required. Claim 17 is objected to because of the following informalities: The term “being” should be inserted between the terms “RICC” and “a” on line 2 in order to be grammatically correct . Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.— The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claim s 1-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 recites “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” on lines 6-7. This text renders the claim indefinite because is unclear as to what previously-recited feature the term “that” is intended to refer to. For the sake of examination, the term “that” is interpreted as referring to “a portion of the needle slot”; accordingly, it is suggested to amend claim 1 to replace the term “that” with the phrase “a portion of the needle slot”. Claim 1 recites “a needle hub, over the proximal portions of the needle shaft and the sheath, the needle hub;” on lines 8-9. This text renders the claim indefinite since it is unclear if line 9 is incomplete or if the text of line 9 was provided in error. For the sake of examination, the text of line 9 is interpreted as being provided in error; accordingly, it is suggested to replace the comma on line 8 with a semi-colon and to delete line 9. Claims 2-18 are rejected due to their dependence on claim 1. Claim 3 recites “the valve module including an introducer-needle passageway and an access-guidewire passageway connected thereto” on lines 3-4. This text renders the claim indefinite because it is unclear as to which previously recited feature that the term “thereto” is intended to refer to. For the sake of examination, the term “thereto” is interpreted as referring to the introducer-needle passageway; accordingly, it is suggested to and claim 3 to replace the term “thereto” with the phrase “to the introducer-needle passageway”. C laims 4 and 5 are rejected due to their dependence on claim 3. Claim 4 recites “the sheath opening of the sheath opens toward an opposite side of the coupler assembly than that including the extension arm” on lines 1-3. This text renders the claim indefinite because it is unclear as to which previously recited feature that the term “that” is intended to refer to. For the sake of examination, the term “that” is interpreted as referring to a side of the coupler assembly; accordingly, it is suggested to amend claim 4 to replace the term “that” with the phrase “a side of the coupler assembly”. Claim 8 recites “the needle-hub extension tube including an arcuate extension-tube protrusion in a distal portion thereof” on lines 2-3. This text renders the claim indefinite because it is unclear as to which previously recited feature that the term “thereof” is intended to refer to. For the sake of examination, the term “thereof” is interpreted as referring to the needle-hub extension tube; accordingly, it is suggested to amend claim 8 to replace the term “thereof” with the phrase “of the needle-hub extension tube”. Claim 10 recites “the lock-ring protrusion positioned on the lock ring to create a tortured guidewire passageway therearound” on lines 2-3. This text renders the claim indefinite because it is unclear as to which previously recited feature that the term “therearound” is intended to refer to. For the sake of examination, the term “therearound” is interpreted as meaning “around the lock ring”; accordingly, it is suggested to amend claim 10 to replace the term “therearound” with the phrase “around the lock ring”. Claim 10 recites “when a lock-ring tab extending away from the centerline of the lock ring is to a side of a tab slot of the nose-piece housing through which tab slot the lock-ring tab extends” on lines 4-6. This text renders the claim indefinite since it appears that line 6 includes a typographic error and it is unclear what line 6 is intended to say. For the sake of examination, line 6 is interpreted with the phrase “tab slot” removed; accordingly, it is suggested to remove the phrase “tab slot” from line 6. Claims 11 and 12 are rejected due to their dependence on claim 10. 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. Claim s 1 , 2, 13 and 18 a re rejected under 35 U.S.C. 103 as being unpatentable over Murphy (PG PUB 2022/0203075) in view of Kurth et al. (PG PUB 2009/0187147). Re claim 1, Murphy discloses a rapidly insertable central catheter ("RICC") insertion assembly 110 (Fig 5; it is noted that all reference characters cited below refer to Fig 5 unless otherwise noted) , comprising: a RICC 100 (best seen in Fig 6J) ; an introducer needle 132+150+64 including: a needle shaft 132 including a distal needle tip 133 ; and a needle hub 150+64 over the proximal portion of the needle shaft (as seen in Fig 6F, wherein portion 64 is labeled as 164) ; an access guidewire 24 including: a proximal portio n (extending through arm 31 in Fig 5) including a proximal end 28 ; and a distal portion (extending through needle shaft 132 in Fig 5) including a distal end 26 disposed in the introducer needle just proximal of the needle tip in at least a ready-to-deploy state of the RICC insertion assembly ( Para 57, “the proximal end of the wire may be right at the tip 33 or rearwardly of the tip as it is passed into the tissue 82” ); and a coupler assembly 18+112 coupling the RICC, the introducer needle, and the access guidewire together ( as seen in Fig 5 ) , the coupler assembly including: a nose piece 112 ; and a tail piece 18 coupled to the nose piece (as seen in Fig 5) , the tail piece of the coupler assembly including an extension arm 30 by which the proximal end of the access guidewire is held ( as seen in Fig 5 , Para 59 ) , the proximal and distal ends of the access guidewire 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 ( as seen in Fig 5 ) . Murphy does not disclose that the needle shaft includes a longitudinal needle slot extending from a proximal portion of the needle shaft through the distal needle tip or that the introducer needle includes 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 , wherein the proximal portion of the sheath is under the needle hub. Kurth , however, teaches a needle shaft 16 (Fig 4,5) comprising a needle slot 20 (Fig 4) that extends from a proximal portion of the needle shaft through a distal needle tip (Para 53) and a sheath 22 (Fig 4) over the needle shaft that seals the needle slot thereunder (Para 53, “the slot 20 is filled and/or coated so that it does not leak”) except for under a sheath opening in a proximal portion of the sheath (Para 53, “a slit (not shown) can be provided in the sleeve 22 to ease the start of the tear”), wherein the proximal portion of the sheath and a proximal portion or the needle shaft are under a needle hub 24 (Fig 5, Para 53). Kurth teaches that providing the needle shaft with a slot and a sheath over the shaft allows for the needle shaft to be removed from a guidewire while the guidewire is still in use (Para 50). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Murphy to include the needle shaft with a needle slot and a sheath that seals the needle slot except for under a sheath opening, as taught by Kurth , for the purpose of allowing for the needle shaft to be removed from the guidewire while the guidewire is still in use (Para 50). Re claim 2, Murphy discloses that the nose piece of the coupler assembly includes a nose-piece housing (the body that forms the nose piece 112 itself) defining a valve-module compartment ( the slot within the distal mount section 180 in Fig 5 ; it is noted that the phrase “a valve-module compartment” does not require a valve-module be in the compartment, but rather only requires the compartment be capable of receiving a valve-module) and a lock-ring compartment ( the lumen within mount section 176, the lumen within mount section 178, or the slot 181 within the proximal mount section 180 in Fig 5 ; it is note that the phrase “a lock-ring compartment” does not require a lock-ring be in the compartment, but rather only requires the compartment be capable of receiving a lock-ring) proximal of the valve-module compartment (as seen in Fig 5 ). Re claim 13, Murphy discloses that the nose-piece housing of the nose piece includes a longitudinal nose piece-housing slot 181 on a same side of the coupler assembly as the extension arm of the tail piece (as seen in Fig 5 , both the slot and the extension arm are on the side of the coupler that faces out of the page ), the nose piece-housing slot configured to allow the access guidewire to escape from the nose piece during separation of the nose piece from the access guidewire ( since the guidewire can be withdrawn through the RICC 100 within the slot 181 ). Re claim 18, Murphy discloses a syringe 14 fluidly coupled to the introducer needle in at least the ready-to-deploy state of the RICC insertion assembly (as seen in Fig 1) . Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Murphy (PG PUB 2022/0203075)/ Kurth et al. (PG PUB 2009/0187147) in view of Fleming III (US Pat 5,718,678) . Re claim 16, Murphy discloses that the extension arm terminates with an extension-arm connector 33+35 (Para 66) connected to a connector 104 of the RICC in at least the ready-to-deploy state of the RICC insertion assembly (as seen in Fig 5, all components of assembly 110 are connected to each other either directly or indirectly; in this instance the connection is indirect). Murphy does not disclose that connector 104 is a Luer connector. Fleming , however, teaches providing a RICC 10 (Fig 1 ) with Luer connector 86 (Fig 1 ; Col 9, Lines 51-53) for the purpose of connecting the RICC to fluid supply devices, for coupling with dialysis equipment, or for similar applications (Col 9, Lines 51-57) . Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify Murphy/ Kurth to include the connector of the RICC as a Luer connector, as taught by Fleming , for the purpose of connecting the RICC to fluid supply devices, for coupling with dialysis equipment, or for similar applications (Col 9, Lines 51-57). Allowable Subject Matter Claims 3 - 12 and 14, 15, and 17 would be allowable if rewritten to overcome the objections and the rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), 2nd paragraph, set forth in this Office action and to include 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 subject matter of dependent claim s 3 (upon which claims 4 and 5 depend), 6 (upon which claims 7-12 depend), 14 (upon which claim 15 depends), and 17 could not be found nor were suggested in the prior art of record in combination with the subject matter of independent claim 1. Dependent claim 3 requires the nose piece to include “a valve module disposed in the valve-module compartment”, the valve module including “an introducer-needle passageway and an access-guidewire passageway” that correspondingly seal the introducer needle and the access guidewire in the ready-to-deploy state of the RICC insertion assembly to enable leak-free aspiration through the introducer needle . Murphy does not disclose a valve module in the nose piece as claimed. Additionally, it would not have been obvious to one of ordinary skill in the art at the time the invention was made to modify Murphy to include a valve module as claimed in the slot of the distal mount section 180 (which, as set forth in the rejection of claim 2 above, reads on the claimed “valve-module compartment”) since this compartment already receives dilator 102 therein (as seen in Fig 5). Additionally, a RICC insertion assembly requiring all of the features of claim 3 (in combination with the features of claims 1 and 2) could not be found nor was suggested elsewhere in the prior art of record. Dependent claim 6 requires the nose piece to include “a lock ring captively but rotatably disposed in the lock-ring compartment” . Murphy does not disclose a lock ring as claimed. Additionally, it would not have been obvious to one of ordinary skill in the art at the time the invention was made to modify Murphy to include a lock - ring as claimed in either the lumen of mount sections 176 or 178 or slot 181 of the proximal mount section 180 (which, as set forth in the rejection of claim 2 above, read on the claimed “lock-ring compartment”) since th ese compartment s already receive either the guide 170 (which is not disclosed as being able to rotate in either mount section) or the RICC 100 therein . Additionally, a RICC insertion assembly requiring all of the features of claim 6 (in combination with the features of claims 1 and 2) could not be found nor was suggested elsewhere in the prior art of record. Dependent claim 14 requires the needle hub of the introducer needle to include “a pair of clip arms distally extending from opposite sides of the needle hub, the clip arms configured to extend completely over corresponding sides of the tail piece of the coupler assembly to at least the nose piece in at least the ready-to-deploy state of the RICC insertion assembly”. Murphy does not disclose that the needle hub 150+64 includes a pair of clip arms as claimed. Additionally, it would not have been obvious to one of ordinary skill in the art at the time the invention was made to modify Murphy to include the needle hub with a pair of clip arms as there is no motivation to. Additionally, a RICC insertion assembly requiring all of the features of claim 14 (in combination with the features of claim 1) could not be found nor was suggested elsewhere in the prior art of record. Dependent claim 17 requires the extension-arm connector to include “a male Luer connector” and the Luer connector of the RICC to be “a female counterpart to the male Luer connector of the extension- arm connector”. Although Fleming , as cited in the rejection of claim 16 above, discloses the Luer connector of the RICC as a female Luer connector ( as seen in Fig 1 ), the extension-arm connector 30 of Murphy is not a Luer connector. Additionally, since the extension-arm connector 30 of Murphy is a clamp to frictionally grip or clamp the guidewire (Para 66), it would not have been obvious to one of ordinary skill in the art at the time the invention was made to replace the extension-arm connector 30 with a male Luer connector as doing so would render the extension-arm connector of Murphy inoperable for its intended purpose. Additionally, a RICC insertion assembly requiring all of the features of claim 17 (in combination with the features of claims 1 and 16) could not be found nor was suggested elsewhere in the prior art of record. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT KAMI A BOSWORTH whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-5414 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Thursday 8 am - 4 pm . 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, FILLIN "SPE Name?" \* MERGEFORMAT Kevin Sirmons can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (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. /KAMI A BOSWORTH/ Primary Examiner, Art Unit 3783
Read full office action

Prosecution Timeline

Sep 27, 2022
Application Filed
Mar 25, 2026
Non-Final Rejection — §103, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
68%
Grant Probability
98%
With Interview (+29.8%)
3y 8m
Median Time to Grant
Low
PTA Risk
Based on 974 resolved cases by this examiner. Grant probability derived from career allow rate.

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