DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/3/2025 has been entered.
Response to Arguments
Applicant's arguments filed 12/3/2025 have been fully considered. The Applicant’s arguments with respect to Moorehead are found persuasive, however, Applicant’s arguments with respect to Cabot are not found persuasive in light of the new interpretation of the reference against newly amended Claims 1-17.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/3/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claims 1 and 12, the limitation “the introducer having a proximal end and a distal end” and “a catheter defining a lumen between a proximal end and a distal end” render the claim indefinite. It is unclear if the “a proximal end” and “a distal end” recites after the catheter are proximal and distal ends of the introducer or catheter. All instances of “distal end” and proximal end” in the claims not specifically coupled with their particular part are thereby indefinite. The claims should be amended to specifically address which proximal and distal ends are being referenced.
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) 1-6 and 9-17 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 introducer having a proximal end (proximal end 132 and female hub 108) and a distal end (distal end 134 and distal end 114), wherein the distal end of the introducer includes a locking mechanism (male Luer lock 116) (para. [0059] “The distal end 134 of the protective sheath 130 can be substantially fixedly attached to a proximal end 150 of the male lock 116…”) to couple the introducer to the peripheral intravenous line ((para. [0058] “In the illustrated embodiment, a male Luer lock 116 is disposed on the distal end 114 of the collection catheter system 100 and is configured to couple to a corresponding female Luer lock hub 118 disposed on a proximal end 120 of a saline lock 122 disposed within the placed catheter 104.”),
a catheter (collection catheter 102) defining a lumen between a proximal end and a distal end (para. [0056] “The collection catheter 102 can generally be elongate and tubular, and can have a proximal end 106 and a distal end 136.”), the catheter movable from a first position where the distal end of the catheter is positioned within the introducer (distal end of the catheter can be seen within the introducer in FIG. 6A) to a second position where the distal end of the catheter is positioned outside of the introducer (distal end of the catheter can be seen outside of the introducer in FIG. 6B); and
an actuator (male lock 112) coupled to the catheter (male lock 112 is coupled to the collection catheter 102 because it is a proximal hub fixed to the proximal end of the catheter via female hub 108 and serves as a structural interface for advancing the catheter tube through 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 forward/distally to advance the catheter 102 while collapsing the sheath), wherein the actuator moves relative to the introducer in a direction extending parallel to a longitudinal axis of the introducer when the catheter moves from the first position to the second position (parallel movement shown in the movement of the sheath and catheter between FIG. 6A and 6B).
Regarding Claim 2, Cabot discloses the apparatus of claim 1, wherein a portion of the actuator (male lock 112) is positioned outside of the introducer (as shown in FIGS. 6A and 6B, at least a proximal portion of male lock 112 is positioned outside of sheath 130)
Regarding Claim 3, Cabot discloses the apparatus of claim 1, wherein the introducer includes a sheath defining a lumen configured to receive at least a portion of the catheter (para. [0059] “The protective sheath 130 can have a length sufficient to substantially enclose the length of the catheter 102 in its expanded configuration. The protective sheath 130 can generally be flexible so that it is collapsible and/or contractible, and it can be formed from any suitable material known in the art, including, but not limited to polymeric materials and fabrics that are biocompatible and used in a variety of medical procedures.”).
Regarding Claim 4, Cabot discloses the apparatus of claim 1, wherein the proximal end (proximal end 132 and female hub 108) of the introducer (flexible protective sheath 130) includes a port (clips 142), and wherein the catheter is received by the port (proximal end 132 includes clips 142, where the proximal end is received in/between the clips).
Regarding Claim 6, Cabot discloses the apparatus of claim 1, wherein the locking mechanism is a luer lock (male Luer lock 116) (para. [0059] “The distal end 134 of the protective sheath 130 can be substantially fixedly attached to a proximal end 150 of the male lock 116…”).
Regarding Claim 9, Cabot discloses the apparatus of claim 1, wherein a portion of the actuator (male lock 112) extends through an opening (female hub 108) of the introducer (male lock 112 extends through female hub 108 as seen in FIGS. 6A and 6B, therefore, a portion of the actuator extends through an opening of the introducer, as female hub 108 is being interpreted as part of the introducer above in Claim 1).
Regarding Claim 10, Cabot discloses the apparatus of claim 9, wherein the opening of the introducer comprises a slot (the opening of the introducer, i.e., the space within female hub 108, especially as broadly claimed, is “slot” shaped).
Regarding Claim 11, Cabot discloses the apparatus of claim 1, wherein the proximal end (proximal end 106) of the catheter (collection catheter 102) is positioned outside of the introducer in the first position and the second position of the catheter (shown in FIGS. 6A and 6B).
Regarding Claim 12, 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 introducer having a proximal end (proximal end 132 and female hub 108) and a distal end (distal end 134 and distal end 114);
a catheter (collection catheter 102) defining a lumen between a proximal end and a distal end (para. [0056] “The collection catheter 102 can generally be elongate and tubular, and can have a proximal end 106 and a distal end 136.”), the catheter movable from a first position where the distal end of the catheter is positioned within the introducer (distal end of the catheter can be seen within the introducer in FIG. 6A) to a second position where the distal end of the catheter is positioned outside of the introducer (distal end of the catheter can be seen outside of the introducer in FIG. 6B), the catheter being provided separate from the peripheral intravenous line (placed catheter 104 is separate from collection catheter 102); and
a locking mechanism on a distal end of the introducer (male Luer lock 116) (para. [0059] “The distal end 134 of the protective sheath 130 can be substantially fixedly attached to a proximal end 150 of the male lock 116…”) and configured to fluidically couple the peripheral intravenous line to the introducer and place the catheter into fluid communication with the peripheral intravenous line (para. [0058] “In the illustrated embodiment, a male Luer lock 116 is disposed on the distal end 114 of the collection catheter system 100 and is configured to couple to a corresponding female Luer lock hub 118 disposed on a proximal end 120 of a saline lock 122 disposed within the placed catheter 104.”),
wherein a protruding portion of the catheter extends from the proximal end of the introducer (portion of collection catheter 102 that resides within distal end 114), the protruding portion having a first length when the catheter is in the first position and a second length when the catheter is in the second position, and wherein the second length is smaller than the first length (first and second lengths demonstrated below in annotated Figs 6A-B).
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Regarding Claim 13, Cabot discloses the apparatus of claim 12, further comprising an actuator (male lock 112) coupled to the catheter (male lock 112 is coupled to the collection catheter 102 because it is a proximal hub fixed to the proximal end of the catheter via female hub 108 and serves as a structural interface for advancing the catheter tube through the introducer) and configured 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 forward/distally to advance the catheter 102 while collapsing the sheath), wherein the actuator moves relative to the introducer in a direction extending parallel to a longitudinal axis of the introducer when the catheter moves from the first position to the second position (parallel movement shown in the movement of the sheath and catheter between FIG. 6A and 6B).
Regarding Claim 14, Cabot discloses the apparatus of claim 12, wherein the introducer includes a sheath defining a lumen configured to receive at least a portion of the catheter (para. [0059] “The protective sheath 130 can have a length sufficient to substantially enclose the length of the catheter 102 in its expanded configuration. The protective sheath 130 can generally be flexible so that it is collapsible and/or contractible, and it can be formed from any suitable material known in the art, including, but not limited to polymeric materials and fabrics that are biocompatible and used in a variety of medical procedures.”).
Regarding Claim 15, Cabot discloses the apparatus of claim 12, wherein the proximal end (proximal end 132 and female hub 108) of the introducer (combination of flexible protective sheath 130, distal end 114, and female hub 108) includes a port (clips 142), and wherein the catheter is received by the port (proximal end 132 includes clips 142, where the proximal end is received in/between the clips).
Regarding Claim 16, Cabot discloses the apparatus of claim 12, wherein the locking mechanism is a luer lock (male Luer lock 116).
Regarding Claim 17, Cabot discloses the apparatus of claim 13, wherein a portion of the actuator (male lock 112) extends through an opening (female hub 108) of the introducer (male lock 112 extends through female hub 108 as seen in FIGS. 6A and 6B, therefore, a portion of the actuator extends through an opening of the introducer, as female hub 108 is being interpreted as part of the introducer above in Claim 12).
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.
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.
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cabot in view of US 2012/0277630 A1 to Devgon.
Cabot discloses the claimed invention as set forth and cited above in Claim 1, except for expressly disclosing where the catheter is between 16 gauge and a 26 gauge and wherein the catheter has a Shore durometer of 20 Shore A to 50 Shore D. However, Devgon teaches at paragraph [0028] that a catheter between a 16 to 26 gauge with a Shore durometer of 20 Shore A to 50 Shore D would be sufficiently stiff to be advanced through a peripheral intravenous line. Therefore, a skilled artisan would have found the modification of the catheter of Cabot to have the Shore durometer of Devgon, as Devgon teaches that stiffness of a catheter for the successful advancement through a peripheral intravenous line.
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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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791