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 (IDS) is submitted is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant's arguments filed on 07/21/2026 have been fully considered but they are not persuasive.
Applicant respectfully submits that Devgon cannot support the rejection, and that the articulated basis for combining Devgon with Makower lacks rational underpinning for the reasons below.
In response to the arguments that “The proposed motivation is drawn from a structure and a purpose that are not relevant to the feature being imported”, examiner respectfully disagrees.
Devgon discloses a coupling system that couple a PIV and an introducer together (fig 10) and that coupling system can include a seal member which is still part of the coupling system to ensure that said PIV and introducer together are well coupled together during usage. In para 107, Devgon discloses in use, the seal member (part of the coupling system ) can be configured to receive a portion of the cannula 6200 to allow the cannula 6200 to advance, in the distal direction, beyond the seal member 6132. In this manner, the seal member 6132 can form a substantially fluid tight seal around the cannula 6200 such that the seal member 6132 substantially prevents a backflow into the introducer 6100. Thus, the tight seal enhances the coupling between said introducer and PIV.
Applicant is reminded that a standard peripheral intravenous line (PIV) can be converted into a RICC using a guidewire exchange technique, thus the coupling system of Devgon can be used to couple a RICC and an introducer.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to the arguments that “Devgon is not a catheter-insertion reference but is instead a system for drawing blood through an intravenous line that the patient already has in place”, examiner respectfully disagrees. Examiner acknowledges that the disclosure mainly focuses that apparatus 6000 is used for phlebotomy through a peripheral intravenous line, however, Devgon discloses that the y-adapter (coupling system) includes a dedicated port for the blood collection device and another standard port for conventional medicine and fluid infusion (para 0094). Thus, this peripheral intravenous line (PIV) can be converted into a RICC to introduce fluid into a patient. In other words, said coupling system of Devgon is capable of coupling a RICC and an introducer together.
In response to the arguments that “Devgon's operating principle is the opposite of the claimed over-the-needle insertion, SO the references cannot be combined as proposed without redesigning Makower”, examiner respectfully disagrees.
Examiner does not rely on the operation function of the device of Devgon to establish a prima facie case of obviousness but rather the coupling of said RICC and introducer. Since the adapter of Devgon is capable of coupling said RICC and introducer, thus it would be obvious to use the coupling system of Devgon to couple the RICC and introducer of Makower.
The rejections of claims 1-4 are maintained.
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.
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
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FATIMATA SAHRA DIOP/ Examiner, Art Unit 3783
/JASON E FLICK/ Primary Examiner, Art Unit 3783 09/28/2026
