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 statements filed 03/25/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
The information disclosure statement (IDS) submitted on 07/11/2024, 10/09/2024, 04/17/2025, 07/16/2025, 10/16/2025 and 01/23/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Makower et al (US 5380290 A) in view of Devgon et al (US 20140364766 A1).
Regarding claim 1, Makower et al disclose a method for inserting a rapidly insertable central catheter (“RICC) (fig 13) into a blood-vessel lumen (22) of a patient (fig 1), comprising: obtaining a RICC assembly (fig 17-22) including the RICC (54), an introducer including a syringe (12) coupled to an introducer needle (14), and a coupling system (see figs 18-21, said RICC and introducer are coupled together) that couples the RICC and the introducer together by distal-end portions thereof in at least a ready-to-deploy state of the RICC assembly; establishing a needle tract from an area of skin (20) to the blood-vessel lumen (22) of the patient with a cannula (14) of the introducer needle while holding a distal-end portion of a barrel of the syringe (col 1, lines 13-18 and col 6, lines 28-33, examiner notes: while holding a distal-end portion of a barrel of the syringe is an intended use that the device is capable of), through a side aperture in a distal-end portion of a catheter tube (54) of the RICC, along an introducing lumen (56) of the catheter tube, and out a distal end of the RICC for establishing the needle tract (figs 16-20, col 8, lines 17-27); advancing a distal-end portion of the catheter tube into the blood-vessel lumen over the cannula (figs 20-21); and withdrawing the cannula from the introducing lumen by way of the side aperture of the catheter tube (figs 22-23, col 9, lines 1-11).
Makower et al fail to teach a coupling system including a distal coupler that couples the RICC and the introducer together by distal-end portions and said cannula of the introducer extending through a longitudinal through hole of the distal coupler.
However, Devgon et al disclose a rapidly insertable central catheter (6300), an introducer (6100) with a cannula (6200) and a distal coupler (6400) wherein the distal coupler couples the RICC and the introducer together by distal-end portions and said cannula (6200) of the introducer extending through a longitudinal through hole of the distal coupler (fig 10 and 13, para 0116).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the coupling system of Makower et al to include a distal coupler that couples the RICC and the introducer together by distal-end portions and said cannula of the introducer extending through a longitudinal through hole of the distal coupler as taught by Devgon et al. This would provide the benefit of securely lock the RICC and the introducer together by preventing a flow of bodily fluid in the proximal direction prior to advancing the cannula of the introducer (para 0107).
Regarding claim 2, Makower et al in view of Devgon et al disclose the method of claim 1,
Makower et al disclose said method further comprising aspirating blood with the syringe before withdrawing the cannula from the introducing lumen, thereby confirming the cannula is disposed in the blood-vessel lumen of the patient (col 1, lines 38-47 and col 10, lines 32-47).
Regarding claim 3, Makower et al in view of Devgon et al disclose the method of claim 1,
Makower et al disclose wherein establishing the needle tract includes ensuring blood flashes back into a needle hub (15) of the introducer needle, a side arm of the needle hub, or a fluid-pressure indicator extending from the side arm of the needle hub (col 1, lines 38-47 and col 10, lines 32-56).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Makower et al (US 5380290 A) in view of Devgon et al (US 20140364766 A1) and further in view of Orlenas et al (US 20170296792 A1).
Regarding claim 4, Makower et al in view of Devgon et al disclose the limitations of claim 1 but fail to teach wherein establishing the needle tract while holding the distal-end portion of the barrel of the syringe includes holding the barrel by a syringe clip around the distal-end portion of the barrel, the syringe clip part of a proximal coupler of the coupling system.
Makower et al disclose establishing the needle tract while holding the distal-end portion of the barrel of the syringe includes holding the barrel (col 6, lines 25-33).
Orlenas et al disclose an apparatus (10) for accessing a blood vessel comprising a catheter (71), a syringe with a barrel (50) with a cannula (40) and coupling system (70) wherein establishing the needle tract while holding the distal-end portion of the barrel of the syringe includes holding the barrel by a syringe clip (73) around the distal-end portion of the barrel, the syringe clip part of a proximal coupler of the coupling system (fig 4).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the coupling system of Makower et al to have a syringe clip around the distal-end portion of the barrel, the syringe clip part of a proximal coupler of the coupling system as taught by Orlenas et al. This would provide the benefit of easier gripping of said barrel which would result in the exposure of said cannula to establish needle tract (para 0052).
Allowable Subject Matter
Claims 5-11 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.
Regarding claim 5, Makower et al in view of Devgon et al and Orlenas et al fail to teach or render obvious “the distal coupler including a tab configured for advancing the catheter tube into the blood-vessel lumen with the single finger” in addition to other limitations.
Regarding claim 6, Makower et al in view of Devgon et al and Orlenas et al fail to teach or render obvious “wherein advancing the distal-end portion of the catheter tube into the blood-vessel lumen includes advancing a catheter hub of the RICC from a catheter-hub clip of the proximal coupler and, thereafter, one or more extension legs of the RICC within the catheter-hub clip, the RICC configured to suspend from the coupling system until at least withdrawing the cannula from both the introducing lumen and the longitudinal through hole of the distal coupler” in addition to other limitations.
Regarding claim 7, Makower et al in view of Devgon et al fail to teach or render obvious said method “further comprising advancing an access guidewire disposed in an access-guidewire lumen formed of at least a plunger lumen of a plunger of the syringe and a needle lumen of the introducer needle into the blood-vessel lumen beyond a distal end of the cannula before advancing the distal-end portion of the catheter tube into the blood-vessel lumen over the cannula” in addition to other limitations.
Claims 8-11 are objected to for incorporating the above limitations of claims 7 due to their respective dependencies on claim 7.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FATIMATA S DIOP whose telephone number is (571)272-3299. The examiner can normally be reached Monday- Friday, 9am to 6pm ET.
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/FATIMATA SAHRA DIOP/Examiner, Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783
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