DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/5/2025 has been entered.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3 and 5-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20120191010 A1 to Cabot.
Regarding Claim 1, Cabot discloses an apparatus, comprising inter alia:
an introducer (combination of flexible protective sheath 130, distal end 114, and female hub 108) coupleable to a peripheral intravenous line (placed catheter 104), the peripheral intravenous line being at least partially insertable into a vein of a patient (para. [0031] “…collection catheter should fit within the placed catheter and extend a distance beyond a distal end of the placed catheter... allows a fluid sample (e.g., blood) to be taken directly from the source…”), a proximal end of the introducer (proximal end 132 and female hub 108) comprising a locking mechanism (clips 142); and
a catheter (collection catheter 102) movable from a first position inside the introducer and outside the peripheral intravenous line (the catheter 102 can be seen in protective sheath 130 and outside the PIV line in FIG. 6A) to a second position at least partially outside the introducer and extending through the peripheral intravenous line (the catheter 102 can be seen at least partially outside the introducer and extending through the PIV in in FIG. 6B), a proximal end of the catheter (leading from middle half of collection catheter 102 to proximal end 106) disposed in the introducer when the catheter is in the first position and the second position (in both positions seen in FIG. 6A and 6B, middle half of collection catheter 102 to proximal end 106 is disposed within flexible protective sheath 130), wherein the introducer is configured to change in longitudinal length between a first configuration and a second configuration to move the catheter between the first position and the second position (see FIGS. 6A and 6B).
Regarding Claim 2, Cabot discloses the apparatus of claim 1, further comprising: an actuator (male Luer lock 112) coupled to the proximal end portion of the catheter (see FIGS. 6A and 6B) and movable along a fixed length of the introducer to move the catheter between the first position and the second position (lock 112 is capable of being manipulated to collapse the sheath 130, i.e., lock 112 is capable of being pushed forwardly/distally to advance the catheter 102 while collapsing the sheath 130).
Regarding Claim 3, Cabot discloses the apparatus of claim 2, wherein the introducer (combination of flexible protective sheath 130, distal end 114, and female hub 108) defines a slot (space within hub 108), the actuator (male Luer lock 112) being movable within the slot along the fixed length of the introducer (para. [0057] “…a female Luer lock hub 108 disposed thereon configured to couple to a male Luer lock 112…”).
Regarding Claim 5, Cabot discloses the apparatus of claim 1, wherein the introducer has a first length when in the first configuration and a second length less than the first length when in the second configuration (see FIGS. 6A and 6B).
Regarding Claim 6, Cabot discloses the apparatus of claim 1, wherein at least a portion of the introducer is collapsible from the first configuration to the second configuration (protective sheath 130 is collapsible from first to second configuration as seen in FIGS. 6A and 6B).
Regarding Claim 7, Cabot discloses the apparatus of claim 1, further comprising: an adapter (saline lock 122) coupleable between a lock at a distal end portion of the introducer (male Luer lock 117) and at least one of a first port (Luer lock 126) or a second port of the adpaper (branched off port extending downward and then distally from saline lock 122).
Regarding Claim 8, Cabot discloses the apparatus of claim 7, wherein the lock of the introducer (male Luer lock 117) is coupleable to the at least one port (male Luer lock 126) of the adapter (via needle 144), the catheter in the second position extendable through the adapter and the peripheral intravenous line such that a distal end of the catheter is distal to the peripheral intravenous line when the adapter is coupled between the lock of the introducer and the peripheral intravenous line (as best seen in FIG. 6B).
Regarding Claim 9, Cabot discloses an apparatus, comprising inter alia:
an introducer (combination of flexible protective sheath 130, distal end 114, and female hub 108) coupleable to a peripheral intravenous line (placed catheter 104), the peripheral intravenous line being at least partially insertable into a vein of a patient (para. [0031] “…collection catheter should fit within the placed catheter and extend a distance beyond a distal end of the placed catheter... allows a fluid sample (e.g., blood) to be taken directly from the source…”), a proximal end of the introducer (proximal end 132 and female hub 108) comprising a locking mechanism (clips 142); and
a catheter (collection catheter 102) movable between a first position inside the introducer and proximal to the peripheral intravenous line (the catheter 102 can be seen in protective sheath 130 and outside the PIV line in FIG. 6A) and a second position at least partially outside the introducer such that a distal end of the catheter is distal to the peripheral intravenous line (the catheter 102 can be seen at least partially outside the introducer and extending through the PIV in in FIG. 6B), a proximal-most end of the catheter disposed in the introducer (para. [0059] “The protective sheath 130 can have a length sufficient to substantially enclose the length of the catheter 102 in its expanded configuration.”) and proximal to the peripheral intravenous line when the catheter is in the second position (distal end 106 of catheter 102 can be seen proximal to the PIV line when the catheter is in the second position in FIG. 6B).
Regarding Claim 10, Cabot discloses the apparatus of claim 9, further comprising an actuator (male Luer lock 112) coupled to the proximal end portion of the catheter (see FIGS. 6A and 6B) and movable along a fixed length of the introducer to move the catheter between the first position and the second position (lock 112 is capable of being manipulated to collapse the sheath 130, i.e., lock 112 is capable of being pushed forwardly/distally to advance the catheter 102 while collapsing the sheath 130).
Regarding Claim 11, Cabot discloses the apparatus of claim 10, wherein the introducer (combination of flexible protective sheath 130, distal end 114, and female hub 108) defines a slot (space within hub 108), the actuator (male Luer lock 112) being movable within the slot along the fixed length of the introducer (para. [0057] “…a female Luer lock hub 108 disposed thereon configured to couple to a male Luer lock 112…”).
Regarding Claim 12, Cabot discloses the apparatus of claim 9, wherein a distal end portion of the introducer (combination of flexible protective sheath 130, distal end 114, and female hub 108) includes a lock (male Luer lock 117) that is coupleable to one of a first port (Luer lock 126) and a second port of an adapter (branched off port extending downward and then distally from saline lock 122) (via needle 144).
Regarding Claim 13, Cabot discloses the apparatus of claim 9, further comprising: an adapter (saline lock 122) coupleable between a lock (male Luer lock 117) at a distal end portion of the introducer and at least one of a first port (Luer lock 126) or a second port of the adapter (branched off port extending downward and then distally from saline lock 122).
Regarding Claim 14, Cabot discloses the apparatus of claim 13, wherein the catheter in the second position is extendable through the adapter and the peripheral intravenous line when the adapter is coupled between the lock of the introducer and the peripheral intravenous line such that (i) a distal end of the catheter is distal to the peripheral intravenous line and (ii) a proximal end of catheter is disposed in the introducer and proximal to the adapter (see FIG. 6B).
Regarding Claim 15, Cabot discloses an apparatus, comprising inter alia:
an introducer (combination of flexible protective sheath 130, distal end 114, and female hub 108) coupleable to an adapter (saline lock 122) (via needle 144) connected to a port (Luer lock 126) (fluidically) of a peripheral intravenous line (placed catheter 104) that is at least partially insertable into a vein of a patient (para. [0031] “…collection catheter should fit within the placed catheter and extend a distance beyond a distal end of the placed catheter... allows a fluid sample (e.g., blood) to be taken directly from the source…”), a proximal end of the introducer comprising a locking mechanism (Luer lock hub 108); and
a catheter (collection catheter 102) movable between a first position inside the introducer and proximal to the adapter (the catheter 102 can be seen in protective sheath 130 and outside the PIV line in FIG. 6A) and a second position partially outside the introducer (the catheter 102 can be seen at least partially outside the introducer and extending through the PIV in in FIG. 6B), a portion of the catheter (collection catheter 102) in the second position (FIG. 6B) extendable through the adapter (catheter 102 extends through saline lock 122 as best seen in FIG. 6B) and the peripheral intravenous line (catheter 102 extends through placed catheter 104 as best seen in FIG. 6B) to place a distal end of the catheter distal to the peripheral intravenous line (see distal placement of catheter 102 with respect to placed catheter 104 as best seen in FIG. 6B), a proximal-most end of the catheter in the second position disposed in the introducer and proximal to the adapter (para. [0059] “The protective sheath 130 can have a length sufficient to substantially enclose the length of the catheter 102 in its expanded configuration.”) (It is noted that the proximal-most end of the catheter and introducer position is static, meaning, the sheath covers and encloses the length of the catheter in the expanded configuration, and only exposes the distal most end of the catheter in the second position).
Regarding Claim 16, Cabot discloses the apparatus of claim 15, further comprising: an actuator (male Luer lock 112) coupled to the proximal end portion of the catheter (see FIGS. 6A and 6B) and movable along a fixed length of the introducer to move the catheter between the first position and the second position (lock 112 is capable of being manipulated to collapse the sheath 130, i.e., lock 112 is capable of being pushed forwardly/distally to advance the catheter 102 while collapsing the sheath 130).
Regarding Claim 17, Cabot discloses the apparatus of claim 16, wherein the introducer (combination of flexible protective sheath 130, distal end 114, and female hub 108) defines a slot (space within hub 108), the actuator being movable within the slot along the fixed length of the introducer (para. [0057] “…a female Luer lock hub 108 disposed thereon configured to couple to a male Luer lock 112…”).
Regarding Claim 18, Cabot discloses the apparatus of claim 15, wherein the introducer is configured to transition between a first configuration and a second configuration to move the catheter between the first position and the second position (see FIGS. 6A and 6B).
Regarding Claim 19, Cabot discloses the apparatus of claim 18, wherein the introducer has a first length when in the first configuration and a second length less than the first length when in the second configuration (see FIGS. 6A and 6B).
Regarding Claim 20, Cabot discloses the apparatus of claim 15, wherein the adapter having a first port (Luer lock 126) and a second port (branched off port extending downward and then distally from saline lock 122), the peripheral intravenous line being connectable to one of the first port and the second port (fluidically).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791