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 .
Response to Amendment
This office action is responsive to the amendment filed 18 September 2025. As directed by the amendment claims 1-20 are presently pending in this application. The amendments to claims 1-12 have overcome the previous 112(b) rejections.
Response to Arguments
Applicant's arguments filed 18 September 2025 have been fully considered but they are not persuasive.
Applicant argues that Burkholz does not show an “annular protrusion” in claims 1, 11 and 13, however, the updated rejection that has been clarified due to amendment points out the annular protrusions on the device that help in sealing the tubing of the assembly. Specifically, the protrusions shown in the annotated figure 1b in the rejection of claim 1 below. Furthermore, the device of Burkholz teaches that sealing is present for the tube in the device (¶[0067]). Although his points to the septum slit, it still teaches that sealing is a necessary component of the device as a whole and that the design of said tubing and delivery device has features such as those shown in figure 1b that contribute to sealing purposes.
Regarding claim 14 , the device of Burkholz shows a portion of both the catheter as well as the tubing that has at least a portion of the tubing with increased diameter. The arguments presented regarding claim 14 pertain to functional limitations. Additionally, paragraph [0063] of Burkholz states portions of the structure may be approximately equal to the inner diameter of extension tubing 66. The updated rejection of claim 14 reflects this as shown in figure 1B.
Regarding claim 15, as best described in paragraph 67 of the Burkholz reference, the device does a have a sealing feature that relates to advancing or retracting the catheter which includes the septum 39. This advancing will also include in part the movement of the tubing in the Burkholz device and not exclusively the catheter portion.
Regarding claim 7, the O-Rings that are used in Fischer do form a sealing portion and when combined with the device of Burkholz can be used on the interior of the adapter lumen and would be able to be placed between the proximal end of the tube and the hub side port. The disclosure of Fischer is used to teach the use of O-rings in the device for sealing purposes as that is their purpose in Fischer as well.
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.
Claim 13 recites the limitation "the second end of the instrument" in lines 8-9. There is insufficient antecedent basis for this limitation in the claim. Additionally is unclear how to interpret “the second end” of an instrument being moved as the original orientation of the device is not defined.
Claim 14 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. Specifically, “the tube” in line 24 is not defined as to refer to either the tube of the instrument advancement device or the extension tube of the catheter assembly.
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, 11-18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burkholz et al. (US 2019/0321590).
Regarding claim 1, Burkholz discloses a catheter assembly (Fig. 1A-5A), comprising:
an adapter (Fig. 5A; 10 & 72) comprising a distal end (see annotated figure below), a proximal end (see annotated figure below) aligned with the distal end of the adapter (where the two ends form a lumen and are continuous), a side port disposed between the distal end of the adapter and the proximal end of the adapter (see annotated figure below), and an adapter lumen (see annotated figure below) extending through the distal end of the adapter, proximal end of the adapter, and the side port, wherein a portion of the adapter lumen between the distal end of the adapter and the side port comprises an annular protrusion configured to form a fluidic seal around a tube of an instrument advancement device (¶[0067], where there is a slit to maintain a seal, Fig. 1b, where the portions inside 20 as shown in annotated figure 1b below are protrusions that help to maintain a seal)(see annotated figure below, where the tube is secured inside the lumen of the adapter in a portion that can form a seal to ensure liquid is properly delivered from the adapter to the hub);
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a catheter hub (Fig. 5A, 54), comprising a distal end (56), a proximal end (58), a catheter hub lumen (60) extending through the distal end of the catheter hub and the proximal end of the catheter hub (lumen 60 extends through the ends of the device), and a hub side port (62) disposed in fluid communication with the catheter hub lumen (where the tubing runs from the adapter through the side port); and
an extension tube (Fig. 5A, 66), comprising a distal end (68) and a proximal end (70), wherein the distal end of the extension tube is coupled to the hub side port (62), wherein the distal end of the adapter is coupled to the proximal end of the extension tube(where proximal end 70 of tube 66 is coupled to the distal end of the adapter in the annotated figure above).
Regarding claim 2, Burkholz discloses the catheter assembly of claim 1, wherein the adapter comprises a Y-connector (Fig. 5A, 72 where the connector is shaped as a Y-connector).
Regarding claim 3, Burkholz discloses he catheter assembly of claim 1, wherein the extension tube comprises a first extension tube (Fig. 5A, 66) , and wherein the catheter assembly further comprises a second extension tube (see annotated figure below), wherein the side port is coupled to the second extension tube (where the tube runs into the side port of the adapter).
Regarding claim 4, Burkholz discloses the catheter assembly of claim 1, wherein the portion of the adapter lumen between the distal end of the adapter and the side port comprises a cylindrical uniform diameter portion proximate the proximal end of the extension tube and proximate an outward taper, wherein the annular protrusion is proximal to the outward taper. (see annotated figure below).
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Regarding claim 5, Burkholz discloses the catheter assembly of claim 1, wherein the annular protrusion is proximate the proximal end of the extension tube (see annotated figure above, where the protrusion is proximate to the proximal end of the extension tube 66).
Regarding claim 6, Burkholz discloses the catheter assembly of claim 5, wherein an edge of the annular protrusion proximate the proximal end of the extension tube is disposed an equal or greater distance from a longitudinal axis of the adapter than an inner surface of the extension tube proximate the annular protrusion (where the annular protrusion is a disposed at least an equal distance away from the longitudinal axis as the proximal end of the tube does not extend fully in the adapter).
Regarding claim 11, Burkholz discloses catheter assembly (Fig. 5A, 10), comprising:
an adapter (Fig. 5A, 72) comprising a distal end (see annotated figure below), a proximal end (see annotated figure below) aligned with the distal end of the adapter (where the two ends form a lumen and are continuous), a side port disposed between the distal end of the adapter and the proximal end of the adapter (see annotated figure below), and an adapter lumen (see annotated figure below) extending through the distal end of the adapter, proximal end of the adapter, and the side port;
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a catheter hub (Fig. 5A, 54), comprising a distal end (56), a proximal end (58), a catheter hub lumen (60) extending through the distal end of the catheter hub and the proximal end of the catheter hub (lumen 60 extends through the ends of the device), and a hub side port (62) disposed in fluid communication with the catheter hub lumen (where the tubing runs from the adapter through the side port);
an extension tube (Fig. 5A, 66), comprising a distal end (68) and a proximal end (70), wherein the distal end of the extension tube is coupled to the hub side port (62), wherein an inner surface of the extension tube comprises an annular protrusion configured to form a fluidic seal around a tube of an instrument advancement device (where the tube is extended around the outer area to form a tight seal with the lumen of the device with a smaller interior diameter than exterior diameter that couples with the portions proximal and distal to it to form a seal), wherein the distal end of the adapter is coupled to the proximal end of the extension tube (Fig. 5A, where the distal end of the adapter receives the proximal end of the tube).
Regarding claim 12, Burkholz discloses he catheter assembly of claim 11, wherein the annular protrusion comprises a first annular protrusion, and wherein the inner surface of the extension tube comprises a second annular protrusion (where the extension tubing 66 has varying diameters between the inner and outer portion of the tubing meaning more than one part protrudes).
Regarding claim 13, Burkholz discloses an instrument advancement device (Fig. 1A, 10), comprising:
a housing (Fig. 1A, 14), comprising a proximal end (Fig. 1A, 18), a distal end (Fig. 1A, 16), a lumen disposed between the proximal end and a distal end (Fig. 1B, 28 & 30, where between them lumens run through the device), and a slot disposed between the proximal end and the distal end (Fig. 1A, 20, where this is a slot that runs the length of the device);
an advancement element extending through the slot and configured to move linearly along the slot between a retracted position and an advanced position (Fig. 1A, 44);
a tube comprising a distal end and a proximal end (Fig. 1A-2B, 12), wherein when the advancement element is moved linearly along the slot from the retracted position to the advanced position (¶[0050]), the second end of the instrument is advanced beyond the distal end of the housing (Fig. 2B, where 12 is advanced out the distal end of the housing), wherein the distal end of the tube comprises an annular protrusion or an outward flare (Fig. 2B, where 24 shows a non-uniform tubing design), wherein the annular protrusion and the outward flare are configured to form a fluidic seal within an adapter of a catheter assembly (where the non-uniform configuration helps to keep a fluidic seal with the adapter of the device, where 51 is a septum; ¶[0053]).
Regarding claim 14, Burkholz discloses an arrangement of an instrument advancement device and catheter assembly (Fig. 1A-5A, comprising:
an instrument advancement device (Fig. 1A, 10) comprising:
a housing (Fig. 1A, 14), comprising a proximal end (Fig. 1A, 18), a distal end (Fig. 1A, 16), a lumen disposed between the proximal end and a distal end (Fig. 1B, 28 & 30, where between them lumens run through the device), and a slot disposed between the proximal end and the distal end (Fig. 1A, 20, where this is a slot that runs the length of the device);
an advancement element extending through the slot and configured to move linearly along the slot between a retracted position and an advanced position (Fig. 1A, 44); and
a tube comprising a distal end and a proximal end (Fig. 1A-2B, 12), wherein when the advancement element is moved linearly along the slot from the retracted position to the advanced position (¶[0050]), the second end of the tube is advanced beyond the distal end of the housing (Fig. 2B, where 12 is advanced out the distal end of the housing), and
a catheter assembly, comprising:
an adapter (Fig. 5A, 72 & 10) comprising a distal end (see annotated figure below), a proximal end (see annotated figure below) aligned with the distal end of the adapter (where the two ends form a lumen and are continuous), a side port disposed between the distal end of the adapter and the proximal end of the adapter (see annotated figure below), and an adapter lumen (see annotated figure below) extending through the distal end of the adapter, proximal end of the adapter, and the side port,
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a catheter hub (Fig. 5A, 54), comprising a distal end (56), a proximal end (58), a catheter hub lumen (60) extending through the distal end of the catheter hub and the proximal end of the catheter hub (lumen 60 extends through the ends of the device), and a hub side port (62) disposed in fluid communication with the catheter hub lumen (where the tubing runs from the adapter through the side port);
an extension tube (Fig. 5A, 66), comprising a distal end (68) and a proximal end (70), wherein the distal end of the extension tube is coupled to the hub side port (62), wherein the distal end of the adapter is coupled to the proximal end of the extension tube(where proximal end 70 of tube 66 is coupled to the distal end of the adapter in the annotated figure above)
wherein the tube comprises an increased diameter portion configured to form a fluidic seal within the adapter of the catheter assembly (¶[0063], Fig. 1B, where at least a portion of the inner tubing has a larger diameter portion as well as the catheter having and increase diameter portion).
Regarding claim 15, Burkholz discloses a method of blood collection (¶[0056]), comprising:
providing a catheter assembly, comprising:
an adapter (Fig. 5A, 72) comprising a distal end (see annotated figure below), a proximal end (see annotated figure below) aligned with the distal end of the adapter (where the two ends form a lumen and are continuous), a side port disposed between the distal end of the adapter and the proximal end of the adapter (see annotated figure below), and an adapter lumen (see annotated figure below) extending through the distal end of the adapter, proximal end of the adapter, and the side port,
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a catheter hub (Fig. 5A, 54), comprising a distal end (56), a proximal end (58), a catheter hub lumen (60) extending through the distal end of the catheter hub and the proximal end of the catheter hub (lumen 60 extends through the ends of the device), and a hub side port (62) disposed in fluid communication with the catheter hub lumen (where the tubing runs from the adapter through the side port); and
an extension tube (Fig. 5A, 66), comprising a distal end (68) and a proximal end (70), wherein the distal end of the extension tube is coupled to the hub side port (62), wherein the distal end of the adapter is coupled to the proximal end of the extension tube(where proximal end 70 of tube 66 is coupled to the distal end of the adapter in the annotated figure above);and
advancing a tube distally within the adapter of the catheter assembly (Fig. 3A-3B, where the tubing 34 is extended distally), wherein in response to advancing the tube distally within the adapter of the catheter assembly, a fluidic seal is formed around the tube within the adapter, distal to the side port ( Fig. 5A, where a fluidic seal is formed by septum 51, ¶[0056], [0060], [0063], [0064], [0067]).
Regarding claim 16, Burkholz discloses the method of claim 15, wherein a distal end of the adapter comprises an opening, wherein the fluidic seal is formed proximal to the opening (¶[0053], [0056], [0060], where the septum along with the non-uniform diameter tubing forms a fluidic seal at the distal end of the device).
Regarding claim 17, Burkholz discloses the method of claim 16, wherein the tube comprises an annular protrusion (Fig. 1B, 32), wherein in response to advancing the tube distally within the adapter of the catheter assembly, the fluidic seal is formed at the annular protrusion ( where 51 is a fluidic seal and the protrusions at 32 form a fluidic seal with 51 ¶[0053], [0056], [0060], where the septum along with the non-uniform diameter tubing forms a fluidic seal at the distal end of the device).
Regarding claim 18, Burkholz discloses the method of claim 15, wherein the adapter (Fig. 5A, 72) comprises a distal end (see annotated figure below), a proximal end (see annotated figure below) aligned with the distal end of the adapter (where the two ends form a lumen and are continuous), the side port disposed between the distal end of the adapter and the proximal end of the adapter (see annotated figure below), and an adapter lumen (see annotated figure below) extending through the distal end of the adapter, proximal end of the adapter, and the side port, wherein a portion of the adapter lumen between the distal end of the adapter and the side port comprises an annular protrusion configured to form the fluidic seal in response to advancing the tube distally within the adapter of the catheter assembly (where the housing 14 of the adapter 14 & 72 has an inward projection at the proximal end shown in the annotated figure below that is an annular protrusion).
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Regarding claim 20, Burkholz discloses he method of claim 15, wherein the adapter (Fig. 5A, 72) comprises a distal end (see annotated figure below), a proximal end (see annotated figure below) aligned with the distal end of the adapter (see annotated figure below), the side port disposed between the distal end of the adapter and the proximal end of the adapter (see annotated figure below), and an adapter lumen extending through the distal end of the adapter, the proximal end of the adapter, and the side port (see annotated figure below), wherein an extension tube extends from the distal end of the adapter to a catheter adapter (Fig. 1A, 12, 5A, 66), wherein an inner surface of the extension tube comprises an annular protrusion (where the tube is extended around the outer area to form a tight seal with the lumen of the device with a smaller interior diameter than exterior diameter that couples with the portions proximal and distal to it to form a seal) that forms the fluidic seal around the tube of an instrument advancement device in response to advancing the tube distally within the adapter of the catheter assembly (see annotated figure below, where the tube is secured inside the lumen of the adapter in a portion that can form a seal to ensure liquid is properly delivered from the adapter to the hub).
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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) 7-10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Burkholz et al. (US 2019/0321590) in view of Fischer Jr. et al. (hereinafter “Fischer”, US 2017/0189644).
Regarding claim 7, Burkholz discloses a catheter assembly comprising an adapter comprising an adapter (Fig. 5A, 72) comprising a distal end (see annotated figure below), a proximal end (see annotated figure below) aligned with the distal end of the adapter (where the two ends form a lumen and are continuous), a side port disposed between the distal end of the adapter and the proximal end of the adapter (see annotated figure below), and an adapter lumen (see annotated figure below) extending through the distal end of the adapter, proximal end of the adapter, and the side port,
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a catheter hub (Fig. 5A, 54), comprising a distal end (56), a proximal end (58), a catheter hub lumen (60) extending through the distal end of the catheter hub and the proximal end of the catheter hub (lumen 60 extends through the ends of the device), and a hub side port (62) disposed in fluid communication with the catheter hub lumen (where the tubing runs from the adapter through the side port);
an extension tube (Fig. 5A, 66), comprising a distal end (68) and a proximal end (70), wherein the distal end of the extension tube is coupled to the hub side port (62), wherein the distal end of the adapter is coupled to the proximal end of the extension tube(where proximal end 70 of tube 66 is coupled to the distal end of the adapter in the annotated figure above).
Burkholz does not specifically teach an annular elastomeric seal disposed within the adapter lumen between the proximal end of the extension tube and the side port, wherein the annular elastomeric seal is configured to form a fluidic seal around a tube of an instrument advancement device.
Fischer teaches a catheter device that includes a side port for infusing fluid with a tube and sealing properties. Fischer teaches wherein an inner surface of the adapter forming the adapter lumen comprises an annular groove, wherein the annular elastomeric seal is seated within the annular groove (Fig. 9, where the O-rings in the sealing area sit inside a groove). By modifying the device of Burkholz to include an elastomeric seal that sits in an annular groove it would secure the sealing function of the device and keep the sealing features in place to have a reliable seal (¶[0073]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Burkholz to include and elastomeric seal to form a fluidic seal around a tube of an instrument device within the adapter lumen (¶[0073] from Fischer).
Regarding claim 8, Burkholz and Fischer disclose the catheter assembly of claim 7, Fischer further teaches wherein an inner surface of the adapter forming the adapter lumen comprises an annular groove, wherein the annular elastomeric seal is seated within the annular groove (Fig. 9, where there is a groove in which O-rings sit to keep them secure).
Regarding claim 9, Burkholz and Fischer teach he catheter assembly of claim 8, Fischer further teaches wherein the annular elastomeric seal comprises an O-ring (Fig. 9, 96C).
Regarding claim 10, Burkholz and Fischer teach the catheter assembly of claim 7, Burkholz further teaches wherein a portion of the adapter lumen between the distal end of the adapter and the side port comprises a cylindrical uniform diameter portion proximate an outward taper, wherein the annular elastomeric seal is proximal to the outward taper (see annotated figure below).
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Regarding claim 19, Burkholz discloses the method of claim 15, wherein the adapter (Fig. 5A, 72) comprises (see annotated figure below), a proximal end (see annotated figure below) aligned with the distal end of the adapter (where the two ends form a lumen and are continuous), the side port disposed between the distal end of the adapter and the proximal end of the adapter (see annotated figure below), and an adapter lumen (see annotated figure below) extending through the distal end of the adapter, proximal end of the adapter, and the side port,
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Burkholz does not specifically wherein an elastomeric O-ring is disposed within adapter lumen between the proximal end of the extension tube and the side port, wherein the elastomeric O-ring forms the fluidic seal in response to advancing the tube distally within the adapter of the catheter assembly.
Fischer teaches a catheter device that includes a side port for infusing fluid with a tube and sealing properties. Fischer teaches wherein an inner surface of the adapter forming the adapter lumen comprises an annular groove, wherein the annular elastomeric seal is seated within the annular groove (Fig. 9, where the O-rings in the sealing area sit inside a groove). By modifying the device of Burkholz to include an elastomeric seal that sits in an annular groove it would secure the sealing function of the device and keep the sealing features in place to have a reliable seal (¶[0073]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Burkholz to include and elastomeric seal to form a fluidic seal around a tube of an instrument device within the adapter lumen (¶[0073] from Fischer).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HADEN M RITCHIE whose telephone number is (703)756-1699. The examiner can normally be reached M-F 8am-5:30pm.
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/HADEN MATTHEW RITCHIE/Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 02/02/2026