DETAILED ACTION
This office action is responsive to the response filed 11/13/2025. Claims 1 and 3-20 remain pending and under prosecution.
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 § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 13-14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Burkholz et al (US Pub No. 20200170559).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Burkholz et al disclose an extension set comprising:
a distal connector 34, 60 configured to connect the extension set to a vascular access device 32 – “a distal connector 34, which may be configured to couple to a proximal end of the catheter adapter 32. In some embodiments, the distal connector 34 may include a luer adapter, such as a slip or thread male or female luer adapter, or another suitable connector” (0065, 0088), best seen in Figure 1A and 4A;
an extension tube 12 attached to and extending from a proximal portion of the distal connector, a fluid pathway being formed through the distal connector and the extension tube, best seen in Figure 1A – “ in response to depression of the plunger 16, the liquid 38 may exit the distal opening 46 of the syringe 12. In some embodiments, a diameter of the distal opening 46 of the syringe 12 may be greater than an outer diameter of the instrument 22. In some embodiments, in response to depression of the plunger 16, the liquid 38 may flow around the instrument 22 and into and/or through the catheter assembly 30” (0078);
a probe 22 (i.e. instrument) having a proximal end 28 and a distal end 25, best seen in Figure 1B and 4A (0064); and
a handle 16 that slides along the extension tube to cause the distal end of the probe to be extended from a position initially within the distal connector, best seen in Figure 1B,
to a position distally from the distal connector, best seen in Figure 1G – “a first end 25 of the instrument 22 may be advanced in the distal direction beyond a distal opening 46 of the syringe 12 in response to the plunger 16 being partially and/or fully depressed within the barrel 14 in the distal direction” (0064),
wherein the proximal end of the probe is secured to the proximal portion of the distal connector, best seen in Figure 1 and 4 – “a second end 28 of the instrument 22 may be fixed. In some embodiments, the second end 28 of the instrument 22 may be fixed within the barrel 14 or the distal connector 34” (0064), “the second end 28 of the instrument 22 may be fixed within an interface adapter 60” (0088), wherein the distal connector is defined to include the portion where the probe 22 is fixed, which is a proximal portion of the distal connector, best seen in Figure 1A and 4A,
such that the proximal end of the probe does not move – is fixed – with respect to the distal connector when the distal end of the probe is extended (0064, 0088),
wherein the handle defines a channel 20 therein, and wherein the probe is looped through the channel, best seen in Figure 1A, B – “the instrument 22 may move through the channel 20, and a first end 25 of the instrument 22 may be advanced in the distal direction a second distance… due to the U-shape of the channel 20” (0060, 0074, 0077).
13. Burkholz et al disclose the distal end 25 of the probe 22 comprises a sensor – “In some embodiments, the instrument 22 may include a probe (which may include a sensor)” (0062).
14. Burkholz et al disclose the distal connector 60 includes one or more seals, the probe 22 extending through the one or more seals, best seen in Figure 4 (0089, 0091).
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, 5-6, 10-11, 14, and 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon (US 8366685 B2) in view of Burkholz et al (US Pub No. 20200170559).
Regarding claims 1 and 2, Devgon disclose an extension set (Abstract) comprising:
a distal connector 8131 (stated as a “lock mechanism”), best seen in Fig. 23 (Column 2 Lines 20-22 “locking mechanism is coupled to the distal end of the introducer and is configured to couple the introducer to a peripheral intravenous line“) configured to connect the extension set to a vascular access device, i.e. can be put in a catheter;
an extension tube 8150 (stated as a “first member”) coupled to the distal connector, best seen in Figure 23,
a fluid pathway is formed through the distal connector and the extension tube, best seen in Figure 23-24 ( (8131) lock mechanism, (8223) sheath, (8230) distal end of catheter, (8150) first member; Column 21 Lines 42-48 “method 100 includes coupling a container to a proximal end of the introducer sheath such that the container is fluidically coupled to the catheter…the catheter is placed in fluid communication with the fluid container”);
a probe 8200 (stated as a “catheter”) having a proximal end 8220 and a distal end 8230 (Column 18 Lines 17-18 “catheter 8200 includes the proximal end…and a distal end”), best seen in Figure 23; and
a handle 8170 (stated as a “third member”) that slides along the extension tube 8150, best seen in Figure 23 (Column 18 Lines 52-58 “a user…can engage the introducer 8100 and apply a given force, as indicated by the arrow JJ in FIG. 24…the applied force can be such that the third member 8170 moves in the distal direction relative to the second member 8160…the second member 8160 is moved in the distal direction relative to the first member 8150”) to cause the distal end 8230 of the probe to be extended distally from the distal connector 8131, best seen in Figure 24 (Column 19 Lines 10-13 “motion of the introducer 8100 is such that the catheter 8200 disposed within the introducer 8200 is advanced through the lock mechanism 8131”), the probe 8200 routed through the handle 8170, best seen in Figure 23.
However, Devgon does not expressly disclose the proximal end of the probe is secured to the proximal portion of the distal connector such that the proximal end of the probe does not move with respect to the distal connector when the distal end of the probe is extended,
wherein the handle defines a channel therein, and wherein the probe is looped through the channel.
Burkholz et al disclose an extension set comprising:
a distal connector 34, 60 configured to connect the extension set to a vascular access device 32 – “a distal connector 34, which may be configured to couple to a proximal end of the catheter adapter 32. In some embodiments, the distal connector 34 may include a luer adapter, such as a slip or thread male or female luer adapter, or another suitable connector” (0065, 0088), best seen in Figure 1A and 4A;
an extension tube 12 attached to and extending from a proximal portion of the distal connector, a fluid pathway being formed through the distal connector and the extension tube, best seen in Figure 1A – “ in response to depression of the plunger 16, the liquid 38 may exit the distal opening 46 of the syringe 12. In some embodiments, a diameter of the distal opening 46 of the syringe 12 may be greater than an outer diameter of the instrument 22. In some embodiments, in response to depression of the plunger 16, the liquid 38 may flow around the instrument 22 and into and/or through the catheter assembly 30” (0078);
a probe 22 (i.e. instrument) having a proximal end 28 and a distal end 25, best seen in Figure 1B and 4A (0064); and
a handle 16 that slides along the extension tube to cause the distal end of the probe to be extended from a position initially within the distal connector, best seen in Figure 1B,
to a position distally from the distal connector, best seen in Figure 1G – “a first end 25 of the instrument 22 may be advanced in the distal direction beyond a distal opening 46 of the syringe 12 in response to the plunger 16 being partially and/or fully depressed within the barrel 14 in the distal direction” (0064),
wherein the proximal end of the probe is secured to the proximal portion of the distal connector, best seen in Figure 1 and 4 – “a second end 28 of the instrument 22 may be fixed. In some embodiments, the second end 28 of the instrument 22 may be fixed within the barrel 14 or the distal connector 34” (0064), “the second end 28 of the instrument 22 may be fixed within an interface adapter 60” (0088), wherein the distal connector is defined to include the portion where the probe 22 is fixed, which is a proximal portion of the distal connector, best seen in Figure 1A and 4A,
such that the proximal end of the probe does not move – is fixed – with respect to the distal connector when the distal end of the probe is extended (0064, 0088),
wherein the handle defines a channel 20 therein, and wherein the probe is looped through the channel, best seen in Figure 1A, B – “the instrument 22 may move through the channel 20, and a first end 25 of the instrument 22 may be advanced in the distal direction a second distance… due to the U-shape of the channel 20” (0060, 0074, 0077).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Devgon such that the proximal end of the probe is secured to the proximal portion of the distal connector such that the proximal end of the probe does not move with respect to the distal connector when the distal end of the probe is extended and wherein the handle defines a channel therein, and wherein the probe is looped through the channel as taught by Burkholz et al as an equally effective configuration for the probe to be moved by the handle to provide the functions already taught by Devgon.
Regarding claim 3, Devgon teaches a sleeve 8160 (stated as a “second member”) that extends between the distal connector 8131 and the handle 8170, the probe 8200 being contained within the sleeve, best seen in Figure 23.
Regarding claim 5, Devgon teaches wherein the sleeve 8160 compresses as the handle 8170 slides towards the distal connector 8131, best seen in Figure 23-24 (Column 18 Lines 61-63 “the introducer 8100 is moved to the second configuration in which the introducer 8100 is substantially collapsed or compressed”).
Regarding claim 6, Devgon teaches wherein the handle 8170 surrounds the extension tube 8150, best seen in Figure 24.
Regarding claim 10, Devgon teaches wherein the probe 8200 includes a fluid permeable distal portion 2231, best seen in Figure 3 (Column 6 Lines 41-47 “the distal end 2230 of the catheter 2200 includes a set of openings 2231 such that when in the second configuration…the openings 2231 act to transport a bodily fluid (e.g., blood) to a volume outside the catheter 2200.”).
Regarding claim 11, Devgon teaches wherein the fluid permeable distal portion 2231 comprises a coil surrounding the probe (Column 8 Lines 55-64). Also see Deckard et al as modified above, best seen in Figure 1-2 and 5 (0039).
Regarding claim 14, Devgon teaches wherein the distal connector 8131 includes one or more seals, the probe 8200 extending through the one or more seals (Column 11 Lines 40-49).
Regarding claims 16 and 17, Devgon teaches an extension set (Abstract) comprising:
a distal connector 8131 (stated as a “lock mechanism”), best seen in Figure 23 (Column 2 Lines 20-22 “locking mechanism is coupled to the distal end of the introducer and is configured to couple the introducer to a peripheral intravenous line“) configured to connect the extension set to a vascular access device, i.e. can be put in a catheter;
a proximal connector 8222 (stated as a “needle”), best seen in Figure 23 (Column 6 Lines 64-66 “needle…can extend through the sheath…when engaged with a conventional phlebotomy fluid container”), best seen in Figure 23;
an extension tube 8150 (stated as a “first member”) extending between the proximal connector 8222 and the distal connector 8131, best seen in Figure 23,
a fluid pathway is formed through the distal connector, the extension tube, and the proximal connector, best seen in Figure 24 (Column 21 Lines 42-48 “method 100 includes coupling a container to a proximal end of the introducer sheath such that the container is fluidically coupled to the catheter…the catheter is placed in fluid communication with the fluid container”);
a handle 8170 (stated as a “third member”) that is positioned between the distal connector 8131 and the proximal connector 8222, best seen in Figure 23,
the handle is configured to slide along the extension tube 8150 (Column 18 Lines 52-58 “a user…can engage the introducer 8100 and apply a given force, as indicated by the arrow JJ in FIG. 24…the applied force can be such that the third member 8170 moves in the distal direction relative to the second member 8160…the second member 8160 is moved in the distal direction relative to the first member 8150”);
a sleeve 8160 (stated as a “second member”) that extends between the distal connector 8131 and the handle 8170, best seen in Figure 23; and
a probe 8200 (stated as a “catheter”) that is interfaced with the handle 8170 such that a distal end 8230 of the probe is extended distally from the distal connector 8131 when the handle slides towards the distal connector, best seen in Figure 24 (Column 18 Lines 52-58 as quoted above; Column 19 Lines 10-13 “motion of the introducer 8100 is such that the catheter 8200 disposed within the introducer 8200 is advanced through the lock mechanism 8131”), the probe 8200 routed through the handle 8170, best seen in Figure 23.
However, Devgon does not expressly disclose a proximal end of the probe is attached to a proximal portion of the distal connector such that the proximal end of the probe does not move with respect to the distal connector when the distal end of the probe is extended,
wherein the handle defines a channel therein, and wherein the probe is routed through the channel.
Burkholz et al disclose an extension set comprising:
a distal connector 34, 60 configured to connect the extension set to a vascular access device 32 – “a distal connector 34, which may be configured to couple to a proximal end of the catheter adapter 32. In some embodiments, the distal connector 34 may include a luer adapter, such as a slip or thread male or female luer adapter, or another suitable connector” (0065, 0088), best seen in Figure 1A and 4A;
an extension tube 12 attached to and extending from a proximal portion of the distal connector, a fluid pathway being formed through the distal connector and the extension tube, best seen in Figure 1A – “ in response to depression of the plunger 16, the liquid 38 may exit the distal opening 46 of the syringe 12. In some embodiments, a diameter of the distal opening 46 of the syringe 12 may be greater than an outer diameter of the instrument 22. In some embodiments, in response to depression of the plunger 16, the liquid 38 may flow around the instrument 22 and into and/or through the catheter assembly 30” (0078);
a probe 22 (i.e. instrument) having a proximal end 28 and a distal end 25, best seen in Figure 1B and 4A (0064); and
a handle 16 that slides along the extension tube to cause the distal end of the probe to be extended from a position initially within the distal connector, best seen in Figure 1B,
to a position distally from the distal connector, best seen in Figure 1G – “a first end 25 of the instrument 22 may be advanced in the distal direction beyond a distal opening 46 of the syringe 12 in response to the plunger 16 being partially and/or fully depressed within the barrel 14 in the distal direction” (0064),
wherein the proximal end of the probe is secured to the proximal portion of the distal connector, best seen in Figure 1 and 4 – “a second end 28 of the instrument 22 may be fixed. In some embodiments, the second end 28 of the instrument 22 may be fixed within the barrel 14 or the distal connector 34” (0064), “the second end 28 of the instrument 22 may be fixed within an interface adapter 60” (0088), wherein the distal connector is defined to include the portion where the probe 22 is fixed, which is a proximal portion of the distal connector, best seen in Figure 1A and 4A,
such that the proximal end of the probe does not move – is fixed – with respect to the distal connector when the distal end of the probe is extended (0064, 0088),
wherein the handle defines a channel 20 therein, and wherein the probe is routed through the channel, best seen in Figure 1A, B – “the instrument 22 may move through the channel 20, and a first end 25 of the instrument 22 may be advanced in the distal direction a second distance… due to the U-shape of the channel 20” (0060, 0074, 0077).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Devgon such that the proximal end of the probe is secured to the proximal portion of the distal connector such that the proximal end of the probe does not move with respect to the distal connector when the distal end of the probe is extended and wherein the handle defines a channel therein, and wherein the probe is routed through the channel as taught by Burkholz et al as an equally effective configuration for the probe to be moved by the handle to provide the functions already taught by Devgon.
Regarding claim 18, Devgon teaches wherein the sleeve 8150 (“second member”) surrounds the extension tube 8150, best seen in Figure 23-24, and a portion of the probe 8200 that is positioned between the distal connector 8131 and the handle 8170, best seen in Figure 23-24.
Regarding claim 19, Devgon teaches wherein the probe 8200 includes a coil (Column 8 Lines 55-64) and a fluid permeable distal portion 2231 of the probe, best seen in Figure 3 (Column 6 Lines 41-47 “the distal end 2230 of the catheter 2200 includes a set of openings 2231 such that when in the second configuration…the openings 2231 act to transport a bodily fluid (e.g., blood) to a volume outside the catheter 2200”). Also see Deckard et al as modified above, best seen in Figure 1-2 and 5 (0039).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Devgon (US 8366685 B2) in view of Burkholz et al as applied in claim 3 above, further in view of Devgon (US 20170216564 A1 – cited by Applicant) herein after referred to as “Ehrenreich” for the sake of clarity.
Devgon in combination with Burkholz et al teach in the invention above but do not teach the movement between the sleeve and the handle is alternatively facilitated via one or more rails positioned within the sleeve, the one or more rails extending proximally from the distal connector.
Devgon teaches wherein the movement between the sleeve and the handle is facilitated via a series of grooves and protrusions (Devgon Column 18 Lines 39-51).
The invention described in Ehrenreich is drawn to an apparatus including a “catheter, an introducer, and an actuator” wherein the catheter moves “between a first position, in which the catheter is disposed within the introducer, and a second position, in which at least a portion of the catheter is disposed within the peripheral intravenous line (Ehrenreich Abstract).” Ehrenreich teaches wherein “a distal end portion of the introducer is configured to be coupled to a peripheral intravenous line (Ehrenreich Abstract).” Ehrenreich teaches wherein “the actuator extends through a slot defined by the introducer” and “the actuator is moved relative to the introducer to advance the catheter from a first position…toward a second position (Ehrenreich ¶[0037]).” Ehrenreich teaches wherein the actuator can be moved by a user (Ehrenreich ¶[0054]).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the grooves/protrusions sliding mechanism set forth by Devgon as modified by Burkholz et al to include the rail/slot sliding mechanism set forth by Ehrenreich because both inventions are drawn to catheter delivery devices of similar configuration, while Ehrenreich teaches the use of a rail/slot sliding mechanism to facilitate movement between the main body/sleeve and actuator/handle to drive the movement of the catheter. The combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of the invention.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Devgon (US 8366685 B2) in view of Burkholz et al as applied in claim 1 above, further in view of Devgon (US 9744344 B1).
Devgon in combination with Burkholz et al disclose the invention above but do not expressly teach a proximal connector or integrated device coupled to the extension tube opposite the distal connector.
Devgon (’44) teach that it is well-known in the art an analogous extension set comprising:
Regarding claims 7 and 8, Devgon (’44) teaches a proximal connector or integrated device 379 (stated as a “coupler”) coupled to the extension tube 410 opposite the distal connector 450 (Fig. 13 as annotated above, see Claim 20 above), the fluid pathway extending through the proximal connector or integrated device (Column 17 Lines 18-20 “volume of blood is transferred to, for example, a fluid reservoir...coupled to the coupler 379”).
Regarding claim 9, Devgon (’44) teaches wherein the integrated device 379 is a vacuum tube receiver (Column 16 Lines 43-44 “fluid reservoir can be an evacuated reservoir such as a Vacutainer® tube, which can exert a suction force”).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Devgon as modified by Burkholz et al such that there is a proximal connector or integrated device coupled to the extension tube opposite the distal connector that is a vacuum tube receiver as taught by Devgon (’44) to effectively enable collection of blood for storage by providing a suction force through the vacuum tube receiver.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Devgon (US 8366685 B2) in view of Burkholz et al as applied in claim 11 above, further in view of Yang (US 20200205845 A1).
Devgon in combination with Burkholz et al disclose the invention above but do not teach the coil has a distal portion that extends distally beyond the distal end of the probe.
The invention described in Yang is drawn to a catheter comprising “an elongate tubular body…extending between a proximal end…and a distal functional end (Yang ¶[0099]).” Yang further teaches wherein the distal functional end further comprises a portion that extends distally beyond the distal end of the probe stated as a “distal flared tip (Yang Fig. 4F-4G; ¶[0120]).” Yang teaches wherein “the distal flared tip may comprise embedded elastic elements…e.g., a coil” in order to enable the distal functional end to engage with and remove a clot (Yang ¶[0120]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter described in Devgon as modified by Burkholz et al to include a coil having a distal portion that extends distally beyond the distal end of the probe as described in Yang because both inventions are drawn to catheter systems, while Yang further teaches the use of a distal coil end in order to engage with and remove a clot (Yang ¶[0120]). The combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of the claimed invention.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Devgon (US 8366685 B2) in view of Burkholz et al as applied in claim 1 above, further in view of Rioux (US 20040167385 A1).
Devgon in combination with Burkholz et al disclose the invention above but do not expressly teach the distal end of the probe comprises a sensor.
The invention described in Rioux is drawn to a system comprising “a catheter with a lumen extending therethrough from a proximal opening to a distal opening (Rioux ¶[0005]).” Rioux teaches wherein the system comprises “at least one sensor coupled proximate to the distal end of the catheter to generate signals relating to a physiological condition” of a subject (Rioux Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the catheter set forth in Devgon as modified by Burkholz et al to include a sensor as described in Rioux because both inventions are drawn to catheter systems, while Rioux teaches wherein the distal end of the catheter comprises a sensor in order to “generate signals relating to a physiological condition” of a subject (Rioux Abstract). The combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of the invention.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Devgon (US 8366685 B2) in view of Burkholz et al as applied in claim 14 above, further in view of Skutnik (US 9782536 B2).
Devgon in combination with Burkholz et al disclose the invention above including Devgon teaches the distal connector includes one or more of a primary/secondary seal, the probe extending through the primary/secondary seals (Column 11 Lines 40-49), but do not teach wherein the secondary seal comprises a distally-facing pocket.
The invention described in Skutnik is drawn to a system comprising a catheter and a hub/housing (Skutnik Fig. 1 (12) hub, (14) catheter). Skutnik teaches wherein “the junction between the catheter…and the hub…can be sealed to prevent leakage…by one or more sealing elements (Skutnik Column 19 Lines 1-4).” Skutnik teaches wherein one of the plurality of seals could comprise a cup shaped seal “or other type of wipe seal (Skutnik Column 19 Lines 6-10).”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the catheter seals described in Devgon as modified by Burkholz et al to include the cup shaped wiping seal as described in Skutnik because both inventions are drawn to a catheter system coupled to a housing and seal disposed therebetween, while Skutnik further teaches wherein the seal could comprise a cup shaped wiping seal. The combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of the claimed invention as one of ordinary skill in the art would understand a cup shaped wiping seal to be a usable seal type in catheter applications.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Devgon (US 9744344 B1) in view of Burkholz et al (US Pub No. 20200170559).
Devgon teaches a method for collecting blood (Column 5 Line 4 “a blood draw catheter”) comprising:
attaching an extension set to a vascular access device PIV (Column 12 Lines 57-60 “lock 350 can be a Luer Lok™ or the like configured to couple the introducer 310 to the adapter 375 and/or an indwelling PIV”) that is inserted into a patient's vasculature (Column 5 Lines 4-11), the extension set comprising:
a distal connector 450 (stated as a “lock”) by which the extension set is attached to the vascular access device (Column 18 Lines 29-31 “distal end portion of the introducer 410 includes and/or is coupled to a lock 450 configured to physically and fluidically couple the introducer 410 to the PIV”);
an extension tube 410 (stated as an “introducer”) coupled to the distal connector, best seen in Figure 13 (Column 18 Lines 29-31 “distal end portion of the introducer 410 includes and/or is coupled to a lock 450”);
a vacuum tube receiver 379 (stated as a “coupler”) coupled to the extension tube opposite the distal connector (Fig. 13 as annotated below (379) coupler, (410) introducer, (450) lock),
a vacuum tube (fluid reservoir) is inserted into the vacuum tube receiver (Column 17 Lines 18-20 “volume of blood is transferred to, for example, a fluid reservoir…coupled to the coupler 379;” Column 16 Lines 43-44 “fluid reservoir can be an evacuated reservoir such as a Vacutainer® tube, which can exert a suction force”),
a fluid pathway being formed through the distal connector 450, the extension tube 410 and the vacuum tube receiver (Fig. 13 as annotated below; Column 10 Lines 49-50 “catheter 260 in fluid communication with a portion of the vein”; Column 17 Lines 18-20 “volume of blood is transferred to, for example, a fluid reservoir…coupled to the coupler 379”);
a probe (stated as a “catheter”) having a proximal end and a distal end (Column 3 Lines 31-32 “catheter has a proximal end portion and a distal end portion”); and
a handle 470 (stated as an “actuator”) that slides along the extension tube 410, best seen in Figure 13 (Column 18 Lines 45-46 “a user moves the actuator 470 relative to the introducer 410”) to cause the distal end of the probe to be extended distally from the distal connector 450 when the handle is moved toward the distal connector (Column 19 Lines 30-31 “the catheter 460 can be moved (e.g., via movement of the actuator 470) between a first position and a second position”) and therefore through the vascular access device and into the patient’s vasculature,
this action can result in removing an occlusion that is preventing blood from flowing through the fluid pathway into the vacuum tube (Column 34 Lines 49-55 “advancing the catheter to a position such that the distal end of the catheter is distal to the distal tip of the PIV can, for example, remove debris such as fibrin, clots, etc. from the distal tip of the PIV, which in turn, may be sufficient to allow for successful blood draw through the catheter”).
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However, Devgon does not expressly disclose a proximal end of the probe is attached to a proximal portion of the distal connector.
Burkholz et al teach that it is well-known in the art to provide an analogous extension set comprising:
a distal connector 34, 60 configured to connect the extension set to a vascular access device 32 – “a distal connector 34, which may be configured to couple to a proximal end of the catheter adapter 32. In some embodiments, the distal connector 34 may include a luer adapter, such as a slip or thread male or female luer adapter, or another suitable connector” (0065, 0088), best seen in Figure 1A and 4A;
an extension tube 12 attached to and extending from a proximal portion of the distal connector, a fluid pathway being formed through the distal connector and the extension tube, best seen in Figure 1A – “ in response to depression of the plunger 16, the liquid 38 may exit the distal opening 46 of the syringe 12. In some embodiments, a diameter of the distal opening 46 of the syringe 12 may be greater than an outer diameter of the instrument 22. In some embodiments, in response to depression of the plunger 16, the liquid 38 may flow around the instrument 22 and into and/or through the catheter assembly 30” (0078);
a probe 22 (i.e. instrument) having a proximal end 28 and a distal end 25, best seen in Figure 1B and 4A (0064); and
a handle 16 that slides along the extension tube to cause the distal end of the probe to be extended from a position initially within the distal connector, best seen in Figure 1B,
to a position distally from the distal connector, best seen in Figure 1G – “a first end 25 of the instrument 22 may be advanced in the distal direction beyond a distal opening 46 of the syringe 12 in response to the plunger 16 being partially and/or fully depressed within the barrel 14 in the distal direction” (0064),
wherein the proximal end of the probe is secured to the proximal portion of the distal connector, best seen in Figure 1 and 4 – “a second end 28 of the instrument 22 may be fixed. In some embodiments, the second end 28 of the instrument 22 may be fixed within the barrel 14 or the distal connector 34” (0064), “the second end 28 of the instrument 22 may be fixed within an interface adapter 60” (0088), wherein the distal connector is defined to include the portion where the probe 22 is fixed, which is a proximal portion of the distal connector, best seen in Figure 1A and 4A.
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify Devgon such that the device includes a probe with the proximal end of the probe attached to a proximal portion of the distal connector, as taught by Burkholz et al in the manner above as an equally effective configuration for the probe to provide the desired function of Devgon including to effectively remove an occlusion that is preventing blood from flowing through the fluid pathway when the distal end of the probe is extended distally from the distal connector as claimed.
Response to Arguments
Applicant’s arguments with respect to claim(s) above have been considered and are fully persuasive given the statement invoking 102(b)(2)(c) for commonly owned Burkholz et al (US Pub No. 20200016374). Therefore, said art rejection is withdrawn.
However, Burkholz et al (US Pub No. 20200170559) is set forth above.
It is also noted that other similar commonly owned references may be applied, all of which may benefit from an addition statement invoking 102(b)(2)(c):
Burkholz et al (US Pub No. 20200316346)
Burkholz et al (US Pat No. 12491342).
Conclusion
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/H.Q.N/Examiner, Art Unit 3791 /JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791