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 .
Election/Restrictions
Applicant’s election without traverse of species G, corresponding to fig. 30-34, in the reply filed on 08/27/2025 is acknowledged.
Information Disclosure Statement
The information disclosure statement filed 05/11/2022 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Specifically, Cite No. 484 is not legible.
The IDS of 05/11/2022 has been placed in the application file, and the references listed therein have been considered by Examiner except where lined through. Examiner thanks Applicant for indicating those references considered to be especially relevant.
Status of the Claims
Claims 59-80 are currently pending. Claims 59-80 are currently rejected.
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 61, 65-66, and 75 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.
Claim 61 recites the limitation "the distal tip" in lines 1-2 and 3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the instance of “the distal tip” on lines 1-2 has been interpreted to read “a distal tip”.
Claim 61 recites the limitation “the position that is at or proximally recessed from a proximal end of the valve” in lines 3-4. Claim 61 depends from claim 59 which introduces “a position that is at or proximally recessed from a proximal end of the valve” on lines 6-7. It is unclear from the phrasing of the limitation in claim 61 whether the “proximal end of the valve” is meant to refer to the same “proximal end of the valve” previously introduced or a different “proximal end” since both instances are introduced as “a proximal end of the valve”. Thus, it is also unclear whether the “position” in claim 61 is meant to refer back to the “position” introduced in claim 59 line 6 or a different position in relation to a different valve or different valve end. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
Claim 65 recites the limitation "the sealable region" in line 4. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, this limitation has been interpreted to read “a sealable region”.
Claim 66 recites the limitation "the distal tip" in line 2. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the distal tip” on line 2 has been interpreted to read “a distal tip”.
Claim 75 recites the limitation “a portion of the catheter tube” in line 1. Claim 59, from which claim 75 depends, recites the limitation “a portion of the catheter tube” in line 10. Although the claims provide some context for where “a portion” is located in each case, it is unclear whether the “portion” in claim 75 is meant to be the same portion referred to in claim 59 or a different portion of the catheter tube. For the purposes of examination, any of the situations described has been interpreted to meet the claim limitation.
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)(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.
(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) 59, 62, 65, and 69-78 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Devgon et al (US 20200100716 A1; hereafter Devgon).
Regarding claim 59, Devgon discloses a method comprising:
coupling an access system (fluid transfer device 210, fig. 5, [0068]) that comprises a reinforcement member (proboscis 242, fig. 5, [0077]) and a movable cannula (catheter 230, fig. 7, [0070] catheter 230 is movable within the introducer 215 of fluid transfer device 210) with
a preplaced closed catheter system (access device 270, fig. 3/4, [0066] access device 270 and the insertion device 290 can collectively form the closed system access device 200) that comprises a valve (seal 274, fig. 4, [0060] seal 274 is disposed in the hub 271 and can be a valve) and a catheter tube (catheter 272, fig. 4, [0066]) that is positioned within a blood vessel of a patient ([0066] insertion device 290 can be retracted and/or removed from the access device 270 leaving the relatively flexible catheter 272 in the vein),
said coupling ([0068] the fluid transfer device 210 can be used with (e.g., coupled to) the access device 270) comprising securing the access system (210, fig. 7) to the preplaced closed catheter system (270, fig. 7) such that the reinforcement member (242, see fig. 5 and [0077]) is fixed at a position that is at or proximally recessed from a proximal end of the valve (274, fig. 7) ([0077] when the lock 240 couples to the proximal port 273, the proboscis 242 can be inserted into the proximal port 273 and in contact with and/or at least partially through the seal 274 disposed in the proximal port 273; Examiner interprets the proboscis 242 being in contact with or partially through the seal 274 as the reinforcement member/proboscis 242 being “at” the valve/seal 274); and
advancing the cannula (230, fig. 7) of the access system from a position (see fig. 6, note [0081] fig. 6 shows a first actuator position in which catheter 230 can be disposed within the introducer 215 and/or a portion of the lock 240 and proximal to the access device 270; note that proboscis 242 is a part of the lock 240) inside the reinforcement member (242, fig. 7) to a position in which the cannula (230, fig. 7) extends through the valve (274, fig. 7) of the closed catheter system (270, fig. 7) and through at least a portion of the catheter tube (272, fig. 7) (see fig. 7, note [0081] catheter 230 extends through the proboscis 242, the lumen 275 of the access device 270, and the catheter 272 to place a distal end portion of the catheter 230 of the transfer device 210 in a distal position relative to the distal end portion of the catheter 272 of the access device 270) (note [0081] describes advancement of catheter 230 from the reinforcement member 242 through the catheter tube 272 and as seen in fig. 7 the cannula/catheter 272 must pass through the reinforcement member/proboscis 242 prior to entering the catheter tube 272).
Regarding claim 62, Devgon discloses the method of claim 59, as described above. Devgon further discloses wherein the reinforcement member (242, fig. 5) comprises a tube (see fig. 5 which shows that proboscis 242 is a tube, note [0081] catheter 230 extends through the proboscis 242 and [0078] proboscis 242 defines a lumen, thus the reinforcement member/proboscis 242 must comprise a tube since fluid and catheter 230 may move through the proboscis 242).
Regarding claim 65, Devgon discloses the method of claim 59, as described above. Devgon further discloses wherein the valve (274, fig. 4) of the closed catheter system (270, fig. 4) comprises a closable opening ([0064] when the insertion device 290 is removed from the access device 270, the seal 274 can be configured to transition from the open state to a closed or sealed state; Examiner notes that the seal 274 as described comprises a closable opening.) that is configured to permit a piercing element (insertion member 292, fig. 3, [0064] insertion member 292 such as a rigid needle, trocar, or the like) to extend therethrough (see fig. 3) during insertion ([0064] insertion member 292 extends through the seal 274, thereby placing the seal 274 in the open state and/or configuration) of the catheter tube (272, fig. 3) into the blood vessel of the patient,
wherein the sealable region (see 112b interpretation above) is in a self-sealed state with the piercing element (292) having been removed therefrom during said coupling ([0064] seal 274 closes to a fluid tight seal when the piercing element/insertion member 292 is removed), and
wherein said advancing the cannula (230, fig. 7) comprises advancing the cannula through the closable opening of the valve (274, fig. 7) ([0081] describes advancement of cannula/catheter 230 from the reinforcement member 242 through the catheter tube 272 and as seen in fig. 7 the cannula 230 extends through the opening in valve 274).
Regarding claim 69, Devgon discloses the method of claim 59, as described above. Devgon further discloses wherein the closed catheter system (270, fig. 3) further comprises a hub (hub 271, fig. 4, [0059] The access device 270 includes a hub 271 and a catheter 272) coupled with the catheter tube (272, fig. 4 shows catheter tube coupled to hub 271) at a first port of the hub (see annotated fig. 1 below, catheter tube 272 couples to the hub 271 at a first port), wherein an extension tube (see annotated fig. 4 below which shows extension tube coupled to second port of hub) is coupled with a second port (side port 276, fig. 4, [0059] hub 271 of the access device 270 can include a side port 276) of the hub, and wherein a third port (proximal port 273, fig. 4, [0059] hub 271 of the access device 270 can include a proximal port 273) of the hub comprises the valve (274, fig. 4) ([0059] proximal port 273 includes a seal 274).
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Regarding claim 70, Devgon discloses the method of claim 69, as described above. Devgon further discloses wherein said coupling the access system (210, fig. 5) with the preplaced closed catheter system (270, fig. 4) comprises coupling a connector (set of arms 241, fig. 5, [0076]) of the access system (210, fig. 5) with the third port (273, fig. 4) of the hub (271, fig. 4) ([0076] set of arms 241 can be configured to engage an outer surface of the proximal port 273 of the access device 270 when the lock 240 is coupled thereto; fig. 7 shows coupled state).
Regarding claim 71, Devgon discloses the method of claim 69, as described above. Devgon further discloses wherein said advancing the cannula (230, fig. 7) comprises advancing a distal portion of the cannula through the third port (273, fig. 4) of the hub (271, fig. 4) then through the first port (see annotated fig. 4 above) of the hub (271, fig. 4) and into the catheter tube (272, fig. 4) (see fig. 6, before extension of cannula 230, and fig. 7, after extension of cannula 230; note [0081] describes advancement of catheter 230 from the reinforcement member 242 through the catheter tube 272 and as seen in fig. 7 the cannula/catheter 272 must pass through the third port 273 and the first port as shown in fig. 4/7 prior to entering the catheter tube 272).
Regarding claim 72, Devgon discloses the method of claim 69, as described above. Devgon further discloses wherein the hub of the preplaced closed catheter system (access device 270, fig. 4) is secured directly to the skin of the patient ([0125] Although not shown in FIGS. 1-17, any of the embodiments described herein can be used with any suitable dressing configured to secure an access device to the skin of a patient; [0127] dressing 1301 can be applied to and/or can cover the hub 1371 of the access device 1370, see fig. 18; [0125] access device 1370 can be substantially similar to any of the access devices 170, 270, and/or 370 described in detail above).
Regarding claim 73, Devgon discloses the method of claim 72, as described above. Devgon further discloses wherein said coupling ([0129] describes coupling to the third port 273/1373 after the dressing 1301 has been applied to cover the hub 271/1371) and said advancing (see [0081] and fig. 6 and 7 which describe advancement of cannula 230 by moving actuator 220 which as shown in fig. 6/7 is part of the access system/transfer device 210) are achieved without moving the hub of the preplaced catheter system (access device 270, fig. 6/7) relative to the skin of the patient ([0125] notes that the dressing secures the preplaced catheter system/access device 270 to the skin of the patient; [0129] notes that the third port may be engaged after the dressing is applied; [0081] and fig. 6/7 show that the coupling occurs at the third port 273, and the cannula 230 is advanced without moving the preplaced catheter system 270, but instead from moving the actuator 220 relative to the preplaced catheter system 270).
Regarding claim 74, Devgon discloses the method of claim 72, as described above. Devgon further discloses wherein the hub (271 in fig. 4, 1371 in fig. 18) of the preplaced closed catheter system (270/1370; [0125] access device 1370 can be substantially similar to any of the access devices 170, 270, and/or 370 described in detail above) is positioned flat against the skin of the patient without any other element being present between the hub and the skin of the patient (see fig. 18, [0127] dressing 1301 can cover the hub 1371 of the access device 1370 and the insertion site 1302 of the patient).
Regarding claim 75, Devgon discloses the method of claim 72, as described above. Devgon further discloses wherein a portion (see 112b interpretation above) of the catheter tube (272, fig. 4) is positioned within an insertion site that extends through the skin of the patient ([0066] catheter tube/catheter 272 is inserted into the vein of the patient), and wherein said coupling ([0129] describes coupling to the third port 273/1373 after the dressing 1301 has been applied to cover the hub 271/1371) and said advancing (see [0081] and fig. 6 and 7 which describe advancement of cannula 230 by moving actuator 220 which as shown in fig. 6/7 is part of the access system/transfer device 210) are achieved without contacting an external surface of one or more of the hub (271, fig. 4) or the catheter tube (272, fig. 4) to adjust a position of the portion of the catheter tube that extends through the insertion site ([0066] catheter tube 272 is left in the vein of the patient after retraction of insertion device 290; [0125] any of the embodiments described herein can be used with any suitable dressing configured to secure an access device to the skin of a patient; [0127] dressing 1301 can cover the hub 1371 of the access device 1370 and the insertion site 1302 of the patient) (Examiner notes that since the coupling and advancing occur after placement and securing of the catheter tube 272 at the insertion site, both steps are accomplished without moving the catheter tube 272 relative to the insertion site.).
Regarding claim 76, Devgon discloses the method of claim 59, as described above. Devgon further discloses wherein the access system (210, fig. 5) further comprises
an additional connector (coupler 246, fig. 5, [0074]) at a proximal end of the cannula (230, fig. 7) ([0074] a proximal end portion of the catheter 230 can be coupled to a fluid reservoir, fluid source, syringe, and/or the like via a coupler 246), and wherein the method further comprises:
coupling a fluid collection device ([0068] the fluid transfer device 210 can be used with (e.g., coupled to) the access device 270 and manipulated to withdraw a volume of blood from the vein of the patient into one or more fluid collection devices, reservoirs, containers, etc.) to the additional connector ([0074] a proximal end portion of the catheter 230 can be coupled to a fluid reservoir, fluid source, syringe, and/or the like via a coupler 246); and
after said advancing the cannula (catheter 230, fig. 7) of the access system (fluid transfer device 210, fig. 5), drawing blood through the cannula into the fluid collection device (note [0068], see also [0196]-[0197] which describe the steps of inserting the closed catheter system 270 into the vein of a patient, attaching a transfer device, advancing a catheter of the transfer device into the vein, and withdrawing blood through the catheter into a syringe).
Regarding claim 77, Devgon discloses the method of claim 76, as described above. Devgon further discloses further comprising, after said drawing blood, retracting the cannula (230, fig. 7) of the access system (210, fig. 7) from the catheter tube (272, fig. 7) ([0198] once the sample volume of blood is collected, the transfer device can be transitioned from the second configuration (see fig. 7) to the first configuration (see fig. 6); [0015] figs. 6 and 7 are top view illustrations of the fluid transfer device of fig. 5 coupled to the PIV of fig. 3 and disposed in a first configuration and a second configuration, respectively).
Regarding claim 78, Devgon discloses the method of claim 77, as described above. Devgon further discloses further comprising, after said retracting the cannula (230, fig. 7), decoupling the access system (210, fig. 7) from the preplaced closed catheter system (270, fig. 4) ([0198] the transfer device can be transitioned from the second configuration toward the first configuration and/or a third configuration (e.g., a “used” configuration). The transfer device can then be decoupled from the PIV, extension set, and/or adapter and safely discarded; [0013] figs. 3 and 4 are schematic illustrations of a closed system access device (“PIV”)).
Claim(s) 59, 63-64, and 66-68 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by an alternative interpretation of Devgon et al (US 20200100716 A1; hereafter Devgon2).
Alternatively, regarding claim 59, Devgon2 discloses a method comprising:
coupling an access system (fluid transfer device 210, fig. 5, [0068]) that comprises a reinforcement member (introducer 215, fig. 5, [0081]) and a movable cannula (catheter 230, fig. 7, [0070] catheter 230 is movable within the introducer 215 of fluid transfer device 210) with
a preplaced closed catheter system (access device 270, fig. 3/4, [0066] access device 270 and the insertion device 290 can collectively form the closed system access device 200) that comprises a valve (seal 274, fig. 4, [0060] seal 274 is disposed in the hub 271 and can be a valve) and a catheter tube (catheter 272, fig. 4, [0066]) that is positioned within a blood vessel of a patient ([0066] insertion device 290 can be retracted and/or removed from the access device 270 leaving the relatively flexible catheter 272 in the vein),
said coupling ([0068] the fluid transfer device 210 can be used with (e.g., coupled to) the access device 270) comprising securing the access system (210, fig. 7) to the preplaced closed catheter system (270, fig. 7) such that the reinforcement member (215, see fig. 5 and [0081]) is fixed at a position that is at or proximally recessed from a proximal end of the valve (274, fig. 7 shows reinforcement member/introducer 215 located proximally of the valve/seal 274); and
advancing the cannula (230, fig. 7) of the access system from a position (see fig. 6, note [0081] fig. 6 shows a first actuator position in which catheter 230 can be disposed within the introducer 215 and/or a portion of the lock 240 and proximal to the access device 270) inside the reinforcement member (215, fig. 7) to a position in which the cannula (230, fig. 7) extends through the valve (274, fig. 7) of the closed catheter system (270, fig. 7) and through at least a portion of the catheter tube (272, fig. 7) (see fig. 7, note [0081] catheter 230 extends through the proboscis 242, the lumen 275 of the access device 270, and the catheter 272 to place a distal end portion of the catheter 230 of the transfer device 210 in a distal position relative to the distal end portion of the catheter 272 of the access device 270) (note [0081] describes advancement of catheter 230 from the reinforcement member 215 through the catheter tube 272 and as seen in fig. 7 the cannula/catheter 272 must pass through the reinforcement member 215 prior to entering the catheter tube 272).
Regarding claim 63, Devgon2 discloses the method of claim 59, as described above. Devgon2 further discloses wherein said coupling is achieved without making any contact between the reinforcement member (215, fig. 7) and the valve (274, fig. 7) (see fig. 6/7 which shows the coupled position, note there is no contact between reinforcement member 215 and valve 274).
Regarding claim 64, Devgon2 discloses the method of claim 59, as described above. Devgon2 further discloses wherein said coupling is achieved without advancing any portion of the reinforcement member (215, fig. 7) into or through the valve (274, fig. 7) (see fig. 6/7 which shows the coupled position, note there is no contact between reinforcement member 215 and valve 274).
Regarding claim 66, Devgon2 discloses the method of claim 59, as described above. Devgon2 further discloses wherein said advancing (advancement shown between fig. 6 and 7, see [0081]) the cannula (230, fig. 7) is achieved without advancing the distal tip (see 112b interpretation above) of the reinforcement member (215, fig. 7) distally past the proximal end of the valve (274, fig. 7) (see fig. 6/7 which show the arrangement before and after advancing the cannula 230, note there is no contact between reinforcement member 215 and valve 274 in either figure).
Regarding claim 67, Devgon2 discloses the method of claim 59, as described above. Devgon2 further discloses wherein said advancing (advancement shown between fig. 6 and 7, see [0081]) the cannula (230, fig. 7) is achieved without contacting the reinforcement member (215, fig. 7) to the valve (274, fig. 7) (see fig. 6/7 which show the arrangement before and after advancing the cannula 230, note there is no contact between reinforcement member 215 and valve 274 in either figure).
Regarding claim 68, Devgon2 discloses the method of claim 59, as described above. Devgon2 further discloses wherein said advancing (advancement shown between fig. 6 and 7, see [0081]) the cannula (230, fig. 7) is achieved without extending the reinforcement member (215, fig. 7) through any portion of the valve (274, fig. 7) (see fig. 6/7 which show the arrangement before and after advancing the cannula 230, note there is no contact between reinforcement member 215 and valve 274 in either figure).
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) 60-61 are rejected under 35 U.S.C. 103 as being unpatentable over Devgon as applied to claim 59 above and further in view of Agrawal et al (US 20180256872 A1; hereafter Agrawal).
Regarding claim 60, Devgon discloses the method of claim 59, as described above, including wherein the closed catheter system (access device 270, fig. 3) comprises a valve assembly that includes the valve (seal 274, fig. 4, [0060] seal 274 is disposed in the hub 271 and can be a valve).
Devgon is silent to a valve assembly that further includes a septum positioned proximal to the valve.
Agrawal, in the art of hemostasis valves, teaches a valve assembly (main body 12 including first and second seal members 24/26, fig. 5b, [0041] and [0047]) that further includes a septum (first seal member 24, fig. 5b, [0047]) positioned proximal to the valve (second seal member 26, [0047], fig. 5b shows septum 24 positioned proximal to the valve 26).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the valve assembly of Devgon to include a septum in addition to a valve as taught by Agrawal since both references deal with inserting a blood collection device into a valve for withdrawing blood, and thus both make use of hemostasis valves. One would have been motivated to make the modification because adding an additional seal member as taught by Agrawal, instead of a single seal as found in Devgon, would better ensure that no fluid escapes through the valve except through an appropriately attached collection device. Additionally, by having the tubular region 46 of Agrawal, similar to the reinforcement member 242 of Devgon, extend only through the first seal member, a tighter seal could be established around the catheter 230 of Devgon which may be advanced through the reinforcement member 242, thus decreasing the likelihood of blood leaking out when the cannula/catheter 230 of Devgon is withdrawn through the reinforcement member 242.
Regarding claim 61, Devgon modified by Agrawal discloses the method of claim 60, as disclosed above, including wherein said coupling comprises advancing the distal tip (see 112b interpretation above) of the reinforcement member (Devgon: 242, fig. 5; Agrawal: tubular region 46, fig. 5a, [0047] tubular region 46 of the plunger 18 may extend through (and open) the first seal member 24) of the access system (Devgon: 210, fig. 5; Agrawal: plunger 18) through the septum (Agrawal: 24, fig. 5a) before the distal tip is fixed at the position that is at or proximally recessed from a proximal end (see 112b interpretation above) of the valve (Devgon: seal 274, fig. 7; Agrawal: second seal member 26, fig. 5a).
Claim(s) 79 is rejected under 35 U.S.C. 103 as being unpatentable over Devgon as applied to claim 78 above and further in view of Ma et al (WO 2020150486 A1; hereafter Ma).
Regarding claim 79, Devgon discloses the method of claim 78, as described above. Devgon further discloses further comprising, after retracting a piercing member (insertion member 292 of insertion device 290, fig. 3), power injecting fluid into the patient via the preplaced closed catheter system (270, fig. 4) ([0061] after removal of the insertion device 290, high-power infusion may be used to deliver fluid to the patient through the closed catheter system 270).
Devgon is silent to the method further comprising, after said retracting the cannula, power injecting fluid into the patient via the preplaced closed catheter system.
Ma, directed to a blood collection system, teaches after detaching a blood collection tube (130, fig. 9, [0075]), power injecting fluid into the patient ([0080] saline flush tube 200 may flush 945 a saline through the IV catheter 920 and into the blood stream of the patient 905 so that the IV catheter 920 may be cleared for subsequent injections or blood draws, note this occurs after blood collection tube 130 is detached as shown in fig. 9) via the preplaced closed catheter system (IV catheter 920, fig. 9, [0075]).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the method of Devgon to include a power injecting fluid step after detaching the blood collection system from the catheter system as taught by Ma, especially since Devgon [0061] already teaches power injection through the catheter system after the insertion device has been removed. One would have been motivated to make the modification because, as noted by Ma [0080], flushing fluid through the catheter system into the patient after a blood draw clears the catheter system for subsequent injections or blood draws. This prevents stagnant blood from collecting in the catheter system, thereby improving the quality of subsequent blood draws.
Claim(s) 80 is rejected under 35 U.S.C. 103 as being unpatentable over Devgon as applied to claim 59 above and further in view of Devgon et al (US 20180028800 A1; hereafter Devgon800).
Regarding claim 80, Devgon discloses the method of claim 59, as described above, including the catheter tube (272, fig. 4) of the preplaced closed catheter system (270, fig. 4) is inserted into a vein of the patient ([0066] insertion device 290 can be retracted and/or removed from the access device 270 leaving the relatively flexible catheter 272 in the vein).
Devgon is silent to the preplaced closed catheter system being inserted into a vein of the patient at any one of a dorsal arch of a hand, a forearm, or an antecubital fossa position.
Devgon800, directed to devices and methods for catheter placement within a vein, teaches wherein the catheter tube (peripheral intravenous catheter 180, fig. 2, [0037]) of the preplaced closed catheter system ([0042] peripheral intravenous catheter 180 (also referred to herein as “peripheral intravenous line” or simply “PIV”) can be any suitable peripheral intravenous catheter such as any suitable known PIV. The PIV 180 can have any suitable length between a hub (not shown) and a distal surface of the PIV catheter) is inserted into a vein (vein 40, fig. 2, [0037]) of the patient at any one of a dorsal arch of a hand, a forearm, or an antecubital fossa position ([0037] vein 40 can be any suitable vein such as those included in the forearm or hand of a patient as described above with reference to fig. 1.).
It would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the method of Devgon to attach the PIV 270 of Devgon ([0013] figs. 3 and 4 are schematic illustrations of a closed system access device (“PIV”) to a vein in the forearm as taught by Devgon800 since both references deal with catheter placement for blood draws. One would have been motivated to make the modification because, as noted in Devgon800 [0034] “the cutaneous veins of the antecubital arm region, forearm, and hand are the most accessed sites for intravenous catheterization”. Thus, medical practitioners are already familiar with the method of inserting the catheter tube into veins in the hand/forearm, and placing the catheter system in these areas would likely be efficient since a practitioner would already be familiar with locating appropriate veins for the placement of the catheter device of Devgon in the areas of the hand/forearm.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISABELLA NORTH whose telephone number is (703)756-5942. The examiner can normally be reached M-F 7:30-5:00.
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/I.S.N./Examiner, Art Unit 3783
/JASON E FLICK/Primary Examiner, Art Unit 3783 10/28/2025