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 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) 1-6 and 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holt (US 2020/0147349 A1) in view of Franklin et al. (US 2020/0197682 A1), Al-Ali (US 2020/0188650 A1), and Dabbs (US 2008/0009793 A1).
With regard to claims 1, 2, 6, and 10, Holt teaches a rapidly insertable central catheter ("RICC") insertion assembly, comprising: a RICC including a primary lumen (Fig. 3 member 74); an introducer needle including a needle shaft having a longitudinal needle slot (Fig. 4 needle 30, slot 22); an access guidewire having a proximal portion disposed in the primary lumen of the RICC and a distal portion disposed in the needle shaft through the needle slot (Fig. 3 114); and a coupler coupling the RICC and the introducer needle together, the coupler including: a coupler housing including a sealing-module cavity of a sealing module (see Reference Figure 1 below, the coupler housing is the area generally outlined, the sealing-module cavity is the space within). Holt teaches sealing the guide wire via 110 (Fig. 3, which would include a partial length slit) but the seal is not within the coupler housing. Holt shows the needle to be sealed separately in the cavity via threads (Figs. 2-4 at 38 and 28) but does not teach an elastomeric seal. However, Franklin et al. teach a guidewire seal in a coupler housing (Fig. 11C seal 125). Further, Al-Ali teaches using an o-ring in conjunction with a fitting between components to prevent leakage ([0045]) and Dabs teaches equivalently using a threaded connection or a fitting with an o-ring ([0035]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to locate the seal of Holt such that it is within the coupler housing portion as in Franklin et al. as this would provide equivalent securement and yield the same predictable result. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include an o-ring as part of the elastic sealing module insert to seal around the needle in Holt as Al-Ali teach this is beneficial to prevent leakage and Dabs teach it would be an equivalent connection to threads and would yield the same predictable result. As combined the seals together form associated passageways around the guidewire and needle.
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With regard to claim 3, the o-ring forms has an interior which forms a passageway which seals around the introducer needle, from the center to the proximal end is the proximal portions that is sealing and the from center to the distal end is the distal end portion that is sealing.
With regard to claim 4, Holt teaches a seal for the guidewire with a passageway substantially as claimed but do not disclose an internal relief. However, Franklin et al. teach a dome shaped valve with a slit 125a and layers/material to prevent air and blood from entering channels ([0110], Fig. 12). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute a domed valve (providing an internal relief) in Holt as in Franklin et al. as Franklin et al. teach the valve to prevent air and blood from entering channels and such a valve would yield the same predictable result of sealing around the guidewire.
With regard to claim 5, in the area of 78 (Fig. 3) the distal end of the guidewire passage connects to a medical portion of the introducer needle passageway so the guidewire may be disposed in the needle.
With regard to claims 11 and 12, as combined the o-ring is compressed between the wall about 78 between 80 and where the hub of the needle (Fig. 3).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holt (US 2020/0147349 A1), Franklin et al. (US 2020/0197682 A1), Al-Ali (US 2020/0188650 A1), and Dabbs (US 2008/0009793 A1) as applied to claim 12 above, and further in view of Kurth (US 2009/0187147 A1).
With regard to claim 14, Holt teaches a device substantially as claimed. Holt does not disclose a sheath to seal the slot. However, Kurth teaches a needle (Fig. 4 and 5 member 16) including a slot sealed by a sheath (Figs. 4 and 5 slot 20 sheath 22) which allows the needle to be removed from the guidewire without pulling over the end of the guidewire to reduce tissue trauma (abstract, [0050]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a needle with a splittable sheath in Holt as in Kurth to allow the guidewire to be removed with reduced tissue trauma.
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holt (US 2020/0147349 A1), Franklin et al. (US 2020/0197682 A1), Al-Ali (US 2020/0188650 A1), Dabbs (US 2008/0009793 A1), and Kurth (US 20090187147 A1) as applied to claim 14 above, and further in view of Reavill (US 2008/0091137 A1).
With regard to claims 15-17, Holt as combined with Kurth teaches a splittable sheath but do not disclose a blade. However, Reavill teaches a blade within a coupling to cut a sheath from a needle shaft to provide reliable splitting and an equivalent mechanism to a pre-slit sheath (Fig. 7 blade 33, [0025]). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to place a blade within the coupler in Holt as in Reavill as this is equivalent to a pre-slit sheath and provides for reliable separation. The Examiner notes limitations to overmolding are product by process and the applicant is advised that patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process MPEP 2113. A combined the base of 33 is taken as the holder and the tip is the blade.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holt (US 2020/0147349 A1), Franklin et al. (US 2020/0197682 A1), Al-Ali (US 2020/0188650 A1), and Dabbs (US 2008/0009793 A1) as applied to claim 1 above, and further in view of Asai (US 2011/0071502 A1).
With regard to claim 18, Holt teaches a device substantially as claimed but does not disclose a loop or swivel arm. However, Franklin et al. teach an additional passage for the free end of the guide wire so it may be looped to prevent the free end from hanging loose (Fig. 11 passage 128, exemplary Figs. 6, [0112]). Further, Asai teaches using a portion which turns (i.e. swivels) to allow for better operability for the guidewire ([0010]-[0021], exemplary Fig. 9). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to use a loop and swivel arm in Holt as in Franklin et al. and Asai as this prevents the free end of the guidewire from hanging loose and enhances operability.
Allowable Subject Matter
Claims 7-9 and 13 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.
Claim 19 is allowed. The reasons for allowance are in the action dated August 22, 2025.
Response to Arguments
Applicant's arguments filed November 21, 2025 have been fully considered but they are not persuasive. Applicant argues the indicated slot 22 of Holt is a lumen, it is the Examiner’s position that a lumen is a slot without additional structure recited to the slot. Applicant argues the Examiner does not address the coupler. The coupler is recited as having a housing and a sealing module cavity. The rejection indicated the housing as shown in the Figure and that the cavity is the space within the module. Additional features of the coupler are addressed with the reference in combination with Holt. Applicant argues the indicated coupler does not connect 16 and 14. 16 is not relied upon to teach the RICC, 74 is. The coupler is between 74 and 34 indicated as the RICC and the needle. Franklin, Al-Ali, and Dabs are used to teach the sealing module insert. Applicant argues the sealing module insert is one element. There is nothing structurally recited that prevents the combination of sealing components relied upon from being considered together as the sealing module insert.
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 EMILY L SCHMIDT whose telephone number is (571)270-3648. The examiner can normally be reached Monday through Thursday 7:00 AM to 4:30 PM.
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/EMILY L SCHMIDT/Primary Examiner, Art Unit 3783