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 .
Claim Objections
Claim 9 is objected to because of the following informalities: Since the “tail piece” is a component of the “coupler assembly”, lines 4-5 should be amended to recite “separation of the tail piece from the rest of the coupler assembly” or “separation of the tail piece from the nose piece of the coupler assembly”. Appropriate correction is required.
Claim 14 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 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.
Claims 1, 2, 13 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Murphy (PG PUB 2022/0203075)1 in view of Bierman et al. (PG PUB 2011/0009827) and Blanchard et al. (PG PUB 2011/0282285).
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 portion (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 end2 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 a portion of the needle slot under a sheath opening in a proximal portion of the sheath that does not include a proximal end of the sheath; because Murphy does not disclose a sheath, it does not disclose that the proximal portion of the sheath is under the needle hub.
Bierman, however, teaches an assembly (Fig 8C; it is noted that all reference characters cited below refer to Fig 8C,8D unless otherwise noted) comprising a needle shaft 32 comprising a needle slot 56 that extends distally from a proximal portion of the needle shaft (as seen in FIG 8C, wherein the “proximal portion” extends proximally from the cross-section line 8D), a sheath 36+38 (Fig 3B) comprising a sheath opening 74 in a proximal portion of the sheath (as seen in Fig 8C, wherein the “proximal portion” extends proximally from the cross-section line 8D) that does not include a proximal end (to the right in Fig 8C) of the sheath (as seen in Fig 8C), an outer cover 40, and a needle hub 34 (Fig 2E) that is over the proximal portions of the needle shaft and the sheath (Para 144 discloses that “the needle hub 34 may have a luer connection 64 that locks to the luer connector 78 of the dilator hub 38” and Para 98 discloses that “the male-female luer slip connectors on the dilator hub [38] and the needle hub 34 can also be reversed”; therefore, although not shown in a drawing, Para 98 supports the needle hub 34 being over portion 38 of the sheath 36+38), wherein the sheath is located over the needle shaft such that it seals the needle slot thereunder except for a portion of the needle slot that is under the sheath opening (as seen in Fig 8D, Para 133) for the purpose of providing a means of flashback to indicate to a user that a distal tip 54 of the needle has punctured a vessel (Para 136). 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 to include a sheath with a sheath opening and an outer cover, as taught by Bierman, for the purpose of providing of flashback to indicate to a user that the needle tip has punctured a vessel (Para 136). Although Bierman teaches that the needle slot extends in the distal direction, it does not explicitly disclose that the needle slot extends through the distal needle tip.
Blanchard, however, teaches that a needle 216 (Fig 15B) having a slot 226 (Fig 15B) that extends through a distal needle tip (as seen in Fig 15B, Para 76) can also be used to provide flashback to confirm proper positioning of the needle tip with a vessel (Para 108 discloses that slot 816A provides flashback and Para 104 discloses that slot 816A is the same as slot 226). Since Blanchard’s slot 226, which extends through the distal needle tip, provides the same result as slot 56 of Bierman (which does not extend through the distal needle tip), these configuration were art-recognized equivalents at the time the invention was made. Since it has been held that substituting art-recognized equivalents of an invention involves only routine skill in the art, it would have been obvious to one of ordinary skill in the art to substitute Blanchard’s slot in place of Bierman’s slot.
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)/Bierman et al. (PG PUB 2011/0009827)/Blanchard et al. (PG PUB 2011/0282285) 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/Bierman/Blanchard 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, 14, 15, and 17 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. As these claims were indicated as containing allowable subject matter in the last Office Action, please see the 3/30/2026 Office Action for a detailed statement of reasons for allowability.
Response to Arguments
Applicant’s arguments filed 6/30/2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The arguments only pertain to the Kurth reference that is no longer utilized in the present rejections.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAMI A BOSWORTH whose telephone number is (571)270-5414. The examiner can normally be reached 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, 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.
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
1 Effective filing date 12/15/2020.
2 It is noted that the term “proximal” in the Murphy reference is the same as the term “distal” in the present application and vice versa.
