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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 17 April 2026 has been entered.
The Examiner acknowledges the amendments to claims 1, 14, and 23. Claims 1-6 and 12-25 are pending.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1, 14, and 23 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 11 and 18 of copending Application No. 18/198,557 (conflicting reference application, hereinafter Burkholz) in view of Bullington (US-20180353117-A1).
Conflicting claim 11 of Burkholz is considered to anticipate almost each and every limitation of instant claim 1 [see comparison below], except for the instant limitations directed towards the particularity of the structural incorporation of the initial blood volume diversion device of “a dual port adapter coupled to a proximal end of the extension tube, wherein the dual port adapter comprises a Y-adapter or a T-adapter including a first port and a second port”, wherein the vented flashback and diversion chamber is “coupled to one of the first port and the second port”, and “a secondary extension tube, wherein a distal end of the secondary extension tube is coupled to one of the first port and the second port and a proximal end of the secondary extension tube is coupled to a connector, with the vented flashback and diversion chamber coupled to the connector”; as well as the limitations directed towards the additional structures and functionality of “a vacuumed collection container coupleable to the other of the first port and the second port; wherein during blood collection, upon the initial volume of blood being received and held in the vented flashback and diversion chamber, a flow of blood is caused to automatically flow through the other of the first port and the second port and into the vacuumed collection container upon connection thereof to the other of the first port and the second port”.
Bullington discloses Bullington discloses blood draw systems, wherein Bullington discloses a dual port adapter coupled to a proximal end of the extension tube in fluid communication with a blood draw device, wherein the dual port adapter comprises a Y-adapter or a T-adapter including a first port and a second port [a housing 730 in fluid communication with and/or configured to be placed in fluid communication with the inlet device 710. The inlet device 710 can be any suitable device(s) such as, for example, an IV catheter, a sharpened catheter or sharpened needle, and/or any other suitable lumen-containing device (Bullington ¶0147, Figs. 17, 19-20); The housing 730 includes a body 731 having and/or forming an inlet 732, a first outlet 736, and a second outlet 737. In addition, the housing 730 defines a fluid flow path 733 configured to selectively place the inlet 732 in fluid communication with the first outlet 736 or the second outlet 737 (see e.g., FIG. 20). The body 731 of the housing 730 can be any suitable shape, size, and/or configuration. For example, in the embodiment shown in FIGS. 17-20, the body 731 forms a T-connector or Y-connector (Bullington ¶0148, Figs. 17, 19-20)]; a vented flashback and diversion chamber coupled to one of the first port and the second port, wherein the vented flashback and diversion chamber is configured to receive and hold an initial volume of blood drawn through the extension tube by the blood draw device [The first outlet 736 is coupled to a first flexible outlet tubing 738 (also referred to herein as “first outlet tubing”), which defines a lumen 739 configured to receive a first or initial volume of bodily fluid flowing through the housing 730. The first outlet tubing 738 is also coupled to a vent 735 having a vent material 742 that can selectively vent the lumen 739 of the first outlet tubing 738. As such, at least a portion of the lumen 739 can form, for example, a sequestration and/or diversion portion and/or the like, as described in further detail herein (Bullington ¶0149, Figs. 17, 19-20)]. Bullington further generally discloses that the vented flashback and diversion chamber may be coupled to the dual port adapter via a secondary extension tube, wherein a distal end of the secondary extension tube is coupled to one of the first port and the second port and a proximal end of the secondary extension tube is coupled to a connector, with the vented flashback and diversion chamber coupled to the connector [Although not shown, any of the devices described herein can include an opening, port, coupler, septum, Luer-Lok, gasket, valve, threaded connecter, standard fluidic interface, etc. (referred to for simplicity as a “port”) in fluid communication with the sequestration portion (e.g., chamber). In some such embodiments, the port can be configured to couple to any suitable device, reservoir, pressure source, etc. For example, in some embodiments, the port can be configured to couple to a reservoir, which in turn, can allow a greater volume of bodily fluid to be diverted and/or transferred into the sequestration portion (Bullington ¶0287)]. Bullington also discloses wherein a vacuumed collection container is coupled to the other of the first port and the second port; wherein during blood collection, upon the initial volume of blood being received and held in the vented flashback and diversion chamber, a flow of blood is caused to automatically flow through the other of the first port and the second port and into the vacuumed collection container upon connection thereof to the other of the first port and the second port [The second outlet is in fluid communication with a second flexible outlet tubing 747 (also referred to herein as “second outlet tubing”), which defines a lumen 748 configured to place the second outlet 747 in fluid communication with one or more fluid collection devices (not shown) (Bullington ¶0149, Figs. 17, 19-20); a pressure differential (e.g., a negative pressure differential) between the lumen 739 of the first outlet tubing 738 and, for example, the lumen 721 of the flexible tubing 720 can be greater than a pressure differential between the lumen 748 of the second outlet tubing 747 and the lumen 721 of the flexible tubing 720. Thus, as bodily fluid flows into the fluid flow path 733, the bodily fluid will flow into the first outlet 736 in response to the greater pressure differential (e.g., based at least in part on the venting of the first outlet tubing 738). That is to say, when the housing 730 is in the first or initial state, the housing 730 diverts and/or directs the flow of bodily fluid from the inlet 732 to the first outlet 736 (Bullington ¶0153); fully filling the lumen 739 of the first outlet tubing 738 and/or saturating the vent material 742 can place the housing 730 and/or the device 700 in a second state or configuration, in which any subsequent volume of bodily fluid flows through the fluid flow path 733 and into the second outlet 737, as indicated by the arrow CC in FIG. 20 (Bullington ¶0156); the second outlet 737 is in fluid communication with one or more fluid collection devices (e.g., via the second outlet tubing 747) such that the subsequent volume(s) of the bodily fluid can flow from the inlet 732, through the fluid flow path 733, the second outlet 736, and the second outlet tubing 747, and into the fluid collection device (not shown) (Bullington ¶0157); In some embodiments, a fluid collection device can include, can define, and/or can be actuated to generate a negative pressure condition inside the fluid collection device, which in turn, can facilitate withdrawal of bodily fluid from the bodily fluid source (e.g., the patient) into the fluid collection device via a vacuum or suction force. In embodiments in which the fluid collection device is an evacuated container or the like, the container can include a vacuum seal or the like that can be transitioned from a sealed state to an unsealed state. In some instances, a user can couple an evacuated container to an outlet of a fluid control device such as those described herein after an initial portion of the bodily fluid is diverted and/or sequestered, which in turn, can limit and/or substantially prevent an initial portion of the bodily fluid (potentially containing contaminants) from being transferred into the container (e.g., fluid collection device) (Bullington ¶0040); In embodiments in which the fluid collection device is an evacuated container or the like, the user can couple the fluid collection device to the outlet 136 after the initial portion of the bodily fluid is transferred into and/or sequestered by the sequestration portion 134, which in turn, can limit and/or substantially prevent an initial portion of the bodily fluid (potentially containing contaminants) from being transferred into the fluid collection device, as described in further detail herein (Bullington ¶0071), wherein the Examiner notes that as disclosed in Bullington ¶¶0156-0157, upon filling the first outlet tubing 738 (vented flashback and diversion chamber) the bodily fluid flow is automatically redirected towards second outlet 737, which is understood to be coupleable with a vacuumed collection container (Bullington ¶¶0040, 0071, 0157)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Burkholz to employ the particularity of the structural incorporation of the initial blood volume diversion device of “a dual port adapter coupled to a proximal end of the extension tube, wherein the dual port adapter comprises a Y-adapter or a T-adapter including a first port and a second port”, wherein the vented flashback and diversion chamber is “coupled to one of the first port and the second port”, and “a secondary extension tube, wherein a distal end of the secondary extension tube is coupled to one of the first port and the second port and a proximal end of the secondary extension tube is coupled to a connector, with the vented flashback and diversion chamber coupled to the connector”; as well as the limitations directed towards the additional structures and functionality of “a vacuumed collection container coupleable to the other of the first port and the second port; wherein during blood collection, upon the initial volume of blood being received and held in the vented flashback and diversion chamber, a flow of blood is caused to automatically flow through the other of the first port and the second port and into the vacuumed collection container upon connection thereof to the other of the first port and the second port”, so as to divert and sequester an initial volume of blood to prevent any contaminants in the initial volume of blood from affecting subsequently drawn volumes of blood [Once the initial amount is sequestered, any subsequent amount of the bodily fluid flow can be diverted, channeled, directed, flow controlled (e.g., manually, automatically, and/or semi-automatically) to a second reservoir, second portion of the device, and/or any additional flow path(s). Thus, with the initial amount sequestered, any additional and/or subsequent amount(s) of bodily fluid are substantially free from contaminants that may otherwise produce inaccurate, distorted, adulterated, falsely positive, falsely negative, etc., results in some diagnostics and/or testing (Bullington ¶0035)], and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [vent and divert/sequester an initial blood volume to prevent contamination of subsequent samples] [MPEP § 2143(I)(D)].
Conflicting claim 11 of Burkholz as modified by Bullington is further considered to render instant claim 23 obvious, due to the similar subject matter of instant claim 23 with respect to claim 1 mutatis mutandis.
Claim 1 of the Instant Application
Claim 11 of Conflicting Patent 18/198,557 [Burkholz]
A blood draw system, comprising:
A blood draw system, comprising: [Burkholz claim 1, line 1]
a blood draw device having a distal end portion and a proximal end portion, wherein the blood draw device comprises an actuator and a blood draw tube operably coupled to the actuator, wherein the actuator is configured to selectively advance the blood draw tube through a catheter of a vascular access device when the blood draw device is coupled to the vascular access device;
a blood draw device having a distal end portion and a proximal end portion, wherein the blood draw device comprises an actuator and a blood draw tube operably coupled to the actuator, wherein the actuator is configured to selectively advance the blood draw tube through a catheter of a vascular access device when the blood draw device is coupled to the vascular access device; [Burkholz claim 1, lines 2-6]
an extension tube extending from the proximal end portion of the blood draw device, wherein the extension tube is in fluid communication with the blood draw tube of the blood draw device;
an extension tube extending from the proximal end portion of the blood draw device, with the extension tube including a distal portion and a proximal portion, wherein the extension tube is in fluid communication with the blood draw tube of the blood draw device; [Burkholz claim 1, lines 7-9]
a vented flashback and diversion chamber, wherein the vented flashback and diversion chamber is configured to receive and hold an initial volume of blood drawn through the extension tube by the blood draw device;
an initial blood volume diversion device, wherein the initial blood volume diversion device comprises a diversion and isolation chamber configured to receive and hold an initial volume of blood drawn through the extension tube by the blood draw device [Burkholz claim 1, lines 12-16]
a fluid occlusion device positioned in-line with the secondary extension tube, wherein the fluid occlusion device is configured to be selectively clamped to occlude a flow of the initial volume of blood back out from the vented flashback and diversion chamber; and
a fluid occlusion device positioned at a distal portion of the diversion and isolation chamber, and wherein upon collection of the initial volume of blood in the diversion and isolation chamber, the fluid occlusion device is operable to selectively occlude a flow of blood back out from the diversion and isolation chamber, thereby isolating the initial volume of blood therein [Burkholz claim 11, lines 1-6]
Conflicting claim 18 of Burkholz is considered to anticipate almost each and every limitation of instant claim 14 [see comparison below], except for the instant limitations directed towards the particularity of the structural incorporation of the initial blood volume diversion device of “a dual port adapter coupled to a proximal end of the extension tube, wherein the dual port adapter comprises a first port and a second port”, wherein the vented flashback and diversion chamber is “coupled to one of the first port and the second port”; as well as the limitations directed towards the steps of “coupling a vacuumed collection container to the other of the first port and the second port; and collecting a blood sample in the vacuumed collection container, with a flow of blood caused to automatically flow through the other of the first port and the second port and into the vacuumed collection container upon coupling thereof to the other of the first port and the second port”.
Bullington discloses blood draw systems and methods of using thereof, wherein Bullington discloses a blood sample collection system comprising a dual port adapter coupled to a proximal end of the extension tube in fluid communication with a blood draw device, wherein the dual port adapter comprises a first port and a second port [Bullington ¶¶0147-0148, Figs. 17, 19-20]; and a vented flashback and diversion chamber coupled to one of the first port and the second port [Bullington ¶0149, Figs. 17, 19-20]. Bullington further discloses steps of coupling a vacuumed collection container to the other of the first port and the second port; and collecting a blood sample in the vacuumed collection container, with a flow of blood caused to automatically flow through the other of the first port and the second port and into the vacuumed collection container upon coupling thereof to the other of the first port and the second port [Bullington ¶¶0040, 0071, 0149, 0153, 0156-0157, Figs. 17, 19-20, wherein the Examiner notes that as disclosed in Bullington ¶¶0156-0157, upon filling the first outlet tubing 738 (vented flashback and diversion chamber) the bodily fluid flow is automatically redirected towards second outlet 737, which is understood to be coupleable with a vacuumed collection container (Bullington ¶¶0040, 0071, 0157)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Devgon to employ the particularity of the structural incorporation of the initial blood volume diversion device of “a dual port adapter coupled to a proximal end of the extension tube, wherein the dual port adapter comprises a first port and a second port”, wherein the vented flashback and diversion chamber is “coupled to one of the first port and the second port”; as well as the limitations directed towards the steps of “coupling a vacuumed collection container to the other of the first port and the second port; and collecting a blood sample in the vacuumed collection container, with a flow of blood caused to automatically flow through the other of the first port and the second port and into the vacuumed collection container upon coupling thereof to the other of the first port and the second port”, so as to divert and sequester an initial volume of blood to prevent any contaminants in the initial volume of blood from affecting subsequently drawn volumes of blood [Bullington ¶0035], and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [vent and divert/sequester an initial blood volume to prevent contamination of subsequent samples] [MPEP § 2143(I)(D)].
Claim 14 of the Instant Application
Claim 18 of Conflicting Patent 18/198,557 [Burkholz]
A method of using a blood sample collection system, comprising:
A method of using a blood sample collection system, comprising: [Burkholz claim 16, lines 1-2]
providing the blood sample collection system, the system comprising:
providing the blood sample collection system, the system comprising: [Burkholz claim 16, line 3]
a blood draw device having a distal end portion and a proximal end portion, wherein the blood draw device comprises an actuator and a blood draw tube operably coupled to the actuator,
a blood draw device having a distal end portion and a proximal end portion, wherein the blood draw device comprises an actuator and a blood draw tube operably coupled to the actuator, wherein the actuator is configured to selectively advance the blood draw tube, [Burkholz claim 16, lines 4-6]
an extension tube extending from the proximal end portion of the blood draw device, wherein the proximal extension tube is in fluid communication with the blood draw tube of the blood draw device;
an extension tube extending from the proximal end portion of the blood draw device, with the extension tube including a distal portion and a proximal portion, wherein the extension tube is in fluid communication with the blood draw tube of the blood draw device, [Burkholz claim 16, lines 7-9]
a vented flashback and diversion chamber
an initial blood volume diversion device… wherein the initial blood volume diversion device comprises a diversion and isolation chamber configured to receive and hold an initial volume of blood drawn through the extension tube [Burkholz claim 16, lines 12-17]
coupling the blood draw device to a vascular access device having an indwelling catheter;
coupling the blood draw device to a vascular access device having an indwelling catheter; [Burkholz claim 16, lines 18-19]
advancing the blood draw tube of the blood draw device through the vascular access device and beyond a distal tip of the indwelling catheter;
advancing the blood draw tube of the blood draw device through the vascular access device and beyond a distal tip of the indwelling catheter; [Burkholz claim 16, lines 20-21]
allowing the initial volume of blood to flow through the blood draw tube and the extension tube and into the vented flashback and diversion chamber of the blood sample collection system;
drawing the initial volume of blood through the blood draw tube and the extension tube and into the diversion and isolation chamber of the initial blood volume diversion device [Burkholz claim 16, lines 22-23]
isolating the initial volume of blood in the vented flashback and diversion chamber, to prevent outflow thereof back into the dual port adapter during collection of a subsequent blood sample;
clamping a distal portion of the diversion and isolation chamber after the initial volume of blood is collected in the diversion and isolation chamber, thereby isolating the initial volume of blood therein [Burkholz claim 18, lines 1-4]
This is a provisional nonstatutory double patenting rejection.
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) 1-6 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon (US-20200100716-A1, previously presented) in view of Bullington (US-20180353117-A1) [not the same as the previously cited Bullington ‘087] and Hayakawa (US-20150045771-A1, previously presented).
Regarding claim 1, Devgon teaches
A blood draw system, comprising:
a blood draw device having a distal end portion and a proximal end portion [fluid transfer device 210 includes at least an introducer 215 (Devgon ¶0069, Figs. 5-7); The introducer 215 includes a proximal end portion 216 and a distal end portion 217 (Devgon ¶0071, Fig. 5)], wherein the blood draw device comprises an actuator and a blood draw tube operably coupled to the actuator, wherein the actuator is configured to selectively advance the blood draw tube through a catheter of a vascular access device when the blood draw device is coupled to the vascular access device [the catheter 230 of the transfer device 210 is movably disposed within the inner volume defined by the introducer 215 and is coupled to the actuator 220. In some embodiments, the catheter 230 can be moved (e.g., via movement of the actuator 220) between a first position and a second position to transition the transfer device 210 between the first configuration and the second configuration, respectively (Devgon ¶0072, Figs. 5-7)];
an extension tube extending from the proximal end portion of the blood draw device, wherein the extension tube is in fluid communication with the blood draw tube of the blood draw device [secondary catheter 245; The first portion of the actuator 220 can also be coupled to an outlet or secondary catheter 245 such that the catheter 230 and the outlet or secondary catheter 245 are in fluid communication (Devgon ¶0074, Figs. 5-7)].
However, while Devgon discloses employing a diversion portion [any of the closed system access devices described herein can include and/or can be coupled to a flash chamber or the like configured to receive, for example, a first volume of blood (e.g., a pre-sample of blood) resulting from the initial venipuncture event… In such embodiments, the first volume of blood can flow through, for example, a one-way seal such as a sponge seal or the like and into the flash chamber. The arrangement of the seal can be such that once the seal is wetted (e.g., with blood), the flow of the first volume of blood stops (Devgon ¶0194)], Devgon fails to explicitly disclose a dual port adapter coupled to a proximal end of the extension tube, wherein the dual port adapter comprises a Y-adapter or a T-adapter including a first port and a second port; a vented flashback and diversion chamber coupled to one of the first port and the second port, wherein the vented flashback and diversion chamber is configured to receive and hold an initial volume of blood drawn through the extension tube by the blood draw device; a secondary extension tube, wherein a distal end of the secondary extension tube is coupled to one of the first port and the second port and a proximal end of the secondary extension tube is coupled to a connector, with the vented flashback and diversion chamber coupled to the connector; a fluid occlusion device positioned in-line with the secondary extension tube, wherein the fluid occlusion device is configured to be selectively clamped to occlude a flow of the initial volume of blood back out from the vented flashback and diversion chamber; and a vacuumed collection container coupleable to the other of the first port and the second port; wherein during blood collection, upon the initial volume of blood being received and held in the vented flashback and diversion chamber, a flow of blood is caused to automatically flow through the other of the first port and the second port and into the vacuumed collection container upon connection thereof to the other of the first port and the second port.
Bullington discloses blood draw systems, wherein Bullington discloses a dual port adapter coupled to a proximal end of the extension tube in fluid communication with a blood draw device, wherein the dual port adapter comprises a Y-adapter or a T-adapter including a first port and a second port [a housing 730 in fluid communication with and/or configured to be placed in fluid communication with the inlet device 710. The inlet device 710 can be any suitable device(s) such as, for example, an IV catheter, a sharpened catheter or sharpened needle, and/or any other suitable lumen-containing device (Bullington ¶0147, Figs. 17, 19-20); The housing 730 includes a body 731 having and/or forming an inlet 732, a first outlet 736, and a second outlet 737. In addition, the housing 730 defines a fluid flow path 733 configured to selectively place the inlet 732 in fluid communication with the first outlet 736 or the second outlet 737 (see e.g., FIG. 20). The body 731 of the housing 730 can be any suitable shape, size, and/or configuration. For example, in the embodiment shown in FIGS. 17-20, the body 731 forms a T-connector or Y-connector (Bullington ¶0148, Figs. 17, 19-20)]; a vented flashback and diversion chamber coupled to one of the first port and the second port, wherein the vented flashback and diversion chamber is configured to receive and hold an initial volume of blood drawn through the extension tube by the blood draw device [The first outlet 736 is coupled to a first flexible outlet tubing 738 (also referred to herein as “first outlet tubing”), which defines a lumen 739 configured to receive a first or initial volume of bodily fluid flowing through the housing 730. The first outlet tubing 738 is also coupled to a vent 735 having a vent material 742 that can selectively vent the lumen 739 of the first outlet tubing 738. As such, at least a portion of the lumen 739 can form, for example, a sequestration and/or diversion portion and/or the like, as described in further detail herein (Bullington ¶0149, Figs. 17, 19-20)]. Bullington further generally discloses that the vented flashback and diversion chamber may be coupled to the dual port adapter via a secondary extension tube, wherein a distal end of the secondary extension tube is coupled to one of the first port and the second port and a proximal end of the secondary extension tube is coupled to a connector, with the vented flashback and diversion chamber coupled to the connector [Although not shown, any of the devices described herein can include an opening, port, coupler, septum, Luer-Lok, gasket, valve, threaded connecter, standard fluidic interface, etc. (referred to for simplicity as a “port”) in fluid communication with the sequestration portion (e.g., chamber). In some such embodiments, the port can be configured to couple to any suitable device, reservoir, pressure source, etc. For example, in some embodiments, the port can be configured to couple to a reservoir, which in turn, can allow a greater volume of bodily fluid to be diverted and/or transferred into the sequestration portion (Bullington ¶0287)]. Bullington also discloses wherein a vacuumed collection container is coupled to the other of the first port and the second port; wherein during blood collection, upon the initial volume of blood being received and held in the vented flashback and diversion chamber, a flow of blood is caused to automatically flow through the other of the first port and the second port and into the vacuumed collection container upon connection thereof to the other of the first port and the second port [The second outlet is in fluid communication with a second flexible outlet tubing 747 (also referred to herein as “second outlet tubing”), which defines a lumen 748 configured to place the second outlet 747 in fluid communication with one or more fluid collection devices (not shown) (Bullington ¶0149, Figs. 17, 19-20); a pressure differential (e.g., a negative pressure differential) between the lumen 739 of the first outlet tubing 738 and, for example, the lumen 721 of the flexible tubing 720 can be greater than a pressure differential between the lumen 748 of the second outlet tubing 747 and the lumen 721 of the flexible tubing 720. Thus, as bodily fluid flows into the fluid flow path 733, the bodily fluid will flow into the first outlet 736 in response to the greater pressure differential (e.g., based at least in part on the venting of the first outlet tubing 738). That is to say, when the housing 730 is in the first or initial state, the housing 730 diverts and/or directs the flow of bodily fluid from the inlet 732 to the first outlet 736 (Bullington ¶0153); fully filling the lumen 739 of the first outlet tubing 738 and/or saturating the vent material 742 can place the housing 730 and/or the device 700 in a second state or configuration, in which any subsequent volume of bodily fluid flows through the fluid flow path 733 and into the second outlet 737, as indicated by the arrow CC in FIG. 20 (Bullington ¶0156); the second outlet 737 is in fluid communication with one or more fluid collection devices (e.g., via the second outlet tubing 747) such that the subsequent volume(s) of the bodily fluid can flow from the inlet 732, through the fluid flow path 733, the second outlet 736, and the second outlet tubing 747, and into the fluid collection device (not shown) (Bullington ¶0157); In some embodiments, a fluid collection device can include, can define, and/or can be actuated to generate a negative pressure condition inside the fluid collection device, which in turn, can facilitate withdrawal of bodily fluid from the bodily fluid source (e.g., the patient) into the fluid collection device via a vacuum or suction force. In embodiments in which the fluid collection device is an evacuated container or the like, the container can include a vacuum seal or the like that can be transitioned from a sealed state to an unsealed state. In some instances, a user can couple an evacuated container to an outlet of a fluid control device such as those described herein after an initial portion of the bodily fluid is diverted and/or sequestered, which in turn, can limit and/or substantially prevent an initial portion of the bodily fluid (potentially containing contaminants) from being transferred into the container (e.g., fluid collection device) (Bullington ¶0040); In embodiments in which the fluid collection device is an evacuated container or the like, the user can couple the fluid collection device to the outlet 136 after the initial portion of the bodily fluid is transferred into and/or sequestered by the sequestration portion 134, which in turn, can limit and/or substantially prevent an initial portion of the bodily fluid (potentially containing contaminants) from being transferred into the fluid collection device, as described in further detail herein (Bullington ¶0071), wherein the Examiner notes that as disclosed in Bullington ¶¶0156-0157, upon filling the first outlet tubing 738 (vented flashback and diversion chamber) the bodily fluid flow is automatically redirected towards second outlet 737, which is understood to be coupleable with a vacuumed collection container (Bullington ¶¶0040, 0071, 0157)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Devgon to employ a dual port adapter coupled to a proximal end of the extension tube, wherein the dual port adapter comprises a Y-adapter or a T-adapter including a first port and a second port; a vented flashback and diversion chamber coupled to one of the first port and the second port, wherein the vented flashback and diversion chamber is configured to receive and hold an initial volume of blood drawn through the extension tube by the blood draw device; a secondary extension tube, wherein a distal end of the secondary extension tube is coupled to one of the first port and the second port and a proximal end of the secondary extension tube is coupled to a connector, with the vented flashback and diversion chamber coupled to the connector; and a vacuumed collection container coupleable to the other of the first port and the second port; wherein during blood collection, upon the initial volume of blood being received and held in the vented flashback and diversion chamber, a flow of blood is caused to automatically flow through the other of the first port and the second port and into the vacuumed collection container upon connection thereof to the other of the first port and the second port, so as to divert and sequester an initial volume of blood to prevent any contaminants in the initial volume of blood from affecting subsequently drawn volumes of blood [Once the initial amount is sequestered, any subsequent amount of the bodily fluid flow can be diverted, channeled, directed, flow controlled (e.g., manually, automatically, and/or semi-automatically) to a second reservoir, second portion of the device, and/or any additional flow path(s). Thus, with the initial amount sequestered, any additional and/or subsequent amount(s) of bodily fluid are substantially free from contaminants that may otherwise produce inaccurate, distorted, adulterated, falsely positive, falsely negative, etc., results in some diagnostics and/or testing (Bullington ¶0035)], and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [vent and divert/sequester an initial blood volume to prevent contamination of subsequent samples] [MPEP § 2143(I)(D)].
However, Devgon in view of Bullington fails to explicitly disclose a fluid occlusion device positioned in-line with the secondary extension tube, wherein the fluid occlusion device is configured to be selectively clamped to occlude a flow of the initial volume of blood back out from the vented flashback and diversion chamber.
Bullington suggests fully sequestering the initial amount of bodily fluid flow [A first reservoir, channel, flow path, or portion of the device can receive an initial amount of the bodily fluid flow, which then can be substantially or fully sequestered (e.g., contained or retained, circumvented, isolated, segregated, vapor-locked, separated, and/or the like) in or by the first reservoir or first portion of the device (Bullington ¶0035)].
Hayakawa discloses blood draw systems, wherein Hayakawa discloses drawing an initial volume of blood into a first collection system through an extension tube, wherein a fluid occlusion device positioned in-line with the extension tube is configured to be selectively clamped to occlude a flow of the initial volume of blood back out from the first collection system [Also, the clamp 111a is not closed and the branch tube 106f is kept opened. A blood collection is started in this condition with the needle tube 51 puncturing a blood vessel of a blood donor. Here, the initial flow blood is collected into the test blood bag 110 through the tube 53 and the branch tube 106f (Hayakawa ¶0093); After a prescribed amount of the initial flow blood is collected into the test blood bag 110, the clamp 111a is closed and the branch tube 106f is occluded (Hayakawa ¶0094, Fig. 12), wherein the Examiner notes that “occluding” the branch tube 106f is considered to prevent fluid flow in either direction (flow into and out of branch tube 106f) based on the plain definition of “occluding” referring to close up or block off : obstruct (https://www.merriam-webster.com/dictionary/occlude)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Devgon in view of Bullington to employ a fluid occlusion device positioned in-line with the secondary extension tube, wherein the fluid occlusion device is configured to be selectively clamped to occlude a flow of the initial volume of blood back out from the vented flashback and diversion chamber, to prevent any possible contaminants included in the diverted initial volume of blood from contaminating any subsequent samples.
Regarding claim 2, Devgon in view of Bullington and Hayakawa teaches
The system of claim 1, wherein the vented flashback and diversion chamber further comprises a venting portion [Bullington ¶0149, Fig. 19].
Regarding claim 3, Devgon in view of Bullington and Hayakawa teaches
The system of claim 2, wherein the venting portion is configured to vent air when the blood draw device is coupled to the vascular access device and the blood draw tube of the blood draw device is advanced into a patient's vasculature to draw the initial volume of blood into the vented flashback and diversion chamber [the access device 270 (e.g., PIV) can be at least partially disposed within a vein of a patient via a venipuncture event or the like (Devgon ¶0058), wherein as depicted in Devgon Fig. 7, the blood draw device (catheter 230) extends past the catheter 272 of access device 270, such that the blood draw device is considered to be in fluid communication with the patient’s vein; Bullington ¶0149].
Regarding claim 4, Devgon in view of Bullington and Hayakawa teaches
The system of claim 3, wherein the venting portion is configured to vent air automatically when the blood draw device is coupled to the vascular access device and the blood draw tube of the blood draw device is advanced into the patient's vasculature [a pressure differential (e.g., a negative pressure differential) between the lumen 739 of the first outlet tubing 738 and, for example, the lumen 721 of the flexible tubing 720 can be greater than a pressure differential between the lumen 748 of the second outlet tubing 747 and the lumen 721 of the flexible tubing 720. Thus, as bodily fluid flows into the fluid flow path 733, the bodily fluid will flow into the first outlet 736 in response to the greater pressure differential (e.g., based at least in part on the venting of the first outlet tubing 738) (Bullington ¶0153)].
Regarding claim 5, Devgon in view of Bullington and Hayakawa teaches
The system of claim 3, wherein the venting portion is manually vented when the blood draw device is coupled to the vascular access device and the blood draw tube of the blood draw device is advanced into the patient's vasculature [the first outlet tubing 738 can include, for example, a valve or selectively permeable membrane configured to limit and/or substantially prevent an outflow of the bodily fluid from the first outlet tubing 738. In some embodiments, such a valve or membrane can be automatically activated, user activated, and/or a combination thereof (Bullington ¶0155)].
Regarding claim 6, Devgon in view of Bullington and Hayakawa teaches
The system of claim 3, wherein the venting portion is formed of at least one of a membrane, paper, porous material, film, or mechanical feature that allows air to pass therethrough but prevents fluid to pass therethrough when wetted [the vent material 242 is described as being an absorbent material and/or a selectively permeable member or membrane (Bullington ¶0100); As described above with reference to the vent material 242 included in the housing 230, the vent material 742 (e.g., flow controller) can be configured to transition from an open or venting state or configuration to a closed or sealed configuration in response to being wetted or saturated (e.g., fully saturated) (Bullington ¶0155)].
Regarding claim 12, Devgon in view of Bullington and Hayakawa teaches
The system of claim 1, wherein the blood draw device further includes an introducer body [introducer 215 (Devgon Figs. 5-7)], and wherein the actuator is configured to move linearly along the introducer body to advance and retract the blood draw tube from the distal end portion of the blood draw device [Devgon ¶¶0074-0075, wherein as depicted in Devgon Figs. 6-7, the actuator 220 moves linearly along the introducer 215].
Regarding claim 13, Devgon in view of Bullington and Hayakawa teaches
The system of claim 1.
However, while Devgon discloses collecting a pre-sample volume of blood of about 1-3 mL or up to 8-10 mL [the volume of blood extracted from the patient can be a first volume of blood that can be discarded and/or at least temporarily stored apart from a subsequent sample volume of blood (e.g., typically a volume of about 1-3 milliliters (mL) but up to 8-10 mL of blood can be a “waste” or “pre-sample” volume) (Devgon ¶0198)], Devgon in view of Bullington as presently modified fails to explicitly disclose wherein the vented flashback and diversion chamber and the second port have a combined internal volume of at least 0.15 mL.
Bullington does disclose that the initial volume of blood drawn into the vented flashback and diversion chamber may be at least 0.15 mL [As described in further detail herein, any of the devices and methods can be used to procure bodily fluid samples with reduced contamination by, for example, diverting a “pre-sample” volume of bodily fluid prior to collecting a “sample” volume of bodily fluid. Each of the terms “pre-sample,” “first,” and/or “initial,” can be used interchangeably to describe and/or refer to an amount, portion, or volume of bodily fluid that is transferred, diverted, and/or sequestered prior to procuring the “sample” volume. In some embodiments, the terms “pre-sample,” “first,” and/or “initial” can refer to a predetermined, defined, desired, or given volume, portion, or amount of bodily fluid. For example, in some embodiments, a predetermined and/or desired pre-sample volume of bodily fluid can be about 0.01 milliliter (mL), about 0.1 mL, about 0.2 mL, about 0.3 mL, about 0.4 mL, about 0.5 mL, about 1.0 mL, about 2.0 mL, about 3.0 mL, about 4.0 mL, about 5.0 mL, about 10.0 mL, about 20 mL, about 50 mL, and/or any volume or fraction of a volume therebetween (Bullington ¶0046)]. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454 456, 105 USPQ 233 235 (CCPA 1955); MPEP § 2144.05(II). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize the internal volume of the vented flashback and diversion chamber and the second port to divert a predetermined initial volume of blood.
“The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims… [I]n such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range.” In re Woodruff, 919 F.2d 1575 1578 (Fed. Cir. 1990). Criticality is shown by some noticeable difference in the qualities. In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933). Nothing in the specification leads one of ordinary skill in the art to understand that the range(s) claim 15 is/are somehow ‘critical’ or lead to unexpected results.
Claim(s) 14-20, 23, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon (US-20200100716-A1, previously presented) in view of Bullington (US-20180353117-A1) [not the same as the previously cited Bullington ‘087].
Regarding claim 14, Devgon teaches
A method of using a blood sample collection system, comprising:
providing the blood sample collection system, the system comprising:
a blood draw device having a distal end portion and a proximal end portion [fluid transfer device 210 includes at least an introducer 215 (Devgon ¶0069, Figs. 5-7); The introducer 215 includes a proximal end portion 216 and a distal end portion 217 (Devgon ¶0071, Fig. 5)], wherein the blood draw device comprises an actuator and a blood draw tube operably coupled to the actuator [the catheter 230 of the transfer device 210 is movably disposed within the inner volume defined by the introducer 215 and is coupled to the actuator 220. In some embodiments, the catheter 230 can be moved (e.g., via movement of the actuator 220) between a first position and a second position to transition the transfer device 210 between the first configuration and the second configuration, respectively (Devgon ¶0072, Figs. 5-7)],
an extension tube extending from the proximal end portion of the blood draw device, wherein the proximal extension tube is in fluid communication with the blood draw tube of the blood draw device [secondary catheter 245; The first portion of the actuator 220 can also be coupled to an outlet or secondary catheter 245 such that the catheter 230 and the outlet or secondary catheter 245 are in fluid communication (Devgon ¶0074, Figs. 5-7)];
coupling the blood draw device to a vascular access device having an indwelling catheter [Devgon ¶0072, Figs. 6-7; such an arrangement can allow the catheter 272 to be disposed in a portion of a patient (e.g., a vein of the patient) for an extended period of time while reducing a likelihood of injury to the patient (Devgon ¶0063), such that the catheter 272 is considered to define an “indwelling” catheter];
advancing the blood draw tube of the blood draw device through the vascular access device and beyond a distal tip of the indwelling catheter [the access device 270 (e.g., PIV) can be at least partially disposed within a vein of a patient via a venipuncture event or the like (Devgon ¶0058), wherein as depicted in Devgon Fig. 7, the blood draw device (catheter 230) extends past the catheter 272 of access device 270, such that the blood draw device is considered to be in fluid communication with the patient’s vein];
allowing the initial volume of blood to flow through the blood draw tube and the extension tube and into the vented flashback and diversion chamber of the blood sample collection system [Devgon ¶0074].
However, while Devgon discloses employing a diversion portion [any of the closed system access devices described herein can include and/or can be coupled to a flash chamber or the like configured to receive, for example, a first volume of blood (e.g., a pre-sample of blood) resulting from the initial venipuncture event… In such embodiments, the first volume of blood can flow through, for example, a one-way seal such as a sponge seal or the like and into the flash chamber. The arrangement of the seal can be such that once the seal is wetted (e.g., with blood), the flow of the first volume of blood stops (Devgon ¶0194)] and coupling a vacuumed collection container to a proximal end of the extension tube [coupling the fluid reservoir to the coupler 246 can place the catheter 230 in fluid communication with the fluid reservoir, which in turn can allow bodily fluid to flow from the patient, through the catheter 230 and the secondary or outlet catheter 245 and into the fluid reservoir. In some embodiments, the bodily fluid can flow from the patient to the fluid reservoir in response to a negative pressure produced and/or introduced by coupling the fluid reservoir to the coupler 246 (e.g., the fluid reservoir is evacuated and/or is manipulated to create a negative pressure as with a syringe). Thus, the transfer device 210 can be used to transfer a volume of bodily fluid from the patient to the fluid reservoir coupled thereto (Devgon ¶0082)], Devgon fails to explicitly disclose the blood sample collection system comprising a dual port adapter coupled to a proximal end of the extension tube, wherein the dual port adapter comprises a first port and a second port; and a vented flashback and diversion chamber coupled to one of the first port and the second port; and further steps of isolating the initial volume of blood in the vented flashback and diversion chamber, to prevent outflow thereof back into the dual port adapter during collection of a subsequent blood sample; coupling a vacuumed collection container to the other of the first port and the second port; and collecting a blood sample in the vacuumed collection container, with a flow of blood caused to automatically flow through the other of the first port and the second port and into the vacuumed collection container upon coupling thereof to the other of the first port and the second port.
Bullington discloses blood draw systems and methods of using thereof, wherein Bullington discloses a blood sample collection system comprising a dual port adapter coupled to a proximal end of the extension tube in fluid communication with a blood draw device, wherein the dual port adapter comprises a first port and a second port [a housing 730 in fluid communication with and/or configured to be placed in fluid communication with the inlet device 710. The inlet device 710 can be any suitable device(s) such as, for example, an IV catheter, a sharpened catheter or sharpened needle, and/or any other suitable lumen-containing device (Bullington ¶0147, Figs. 17, 19-20); The housing 730 includes a body 731 having and/or forming an inlet 732, a first outlet 736, and a second outlet 737. In addition, the housing 730 defines a fluid flow path 733 configured to selectively place the inlet 732 in fluid communication with the first outlet 736 or the second outlet 737 (see e.g., FIG. 20). The body 731 of the housing 730 can be any suitable shape, size, and/or configuration. For example, in the embodiment shown in FIGS. 17-20, the body 731 forms a T-connector or Y-connector (Bullington ¶0148, Figs. 17, 19-20)]; and a vented flashback and diversion chamber coupled to one of the first port and the second port [The first outlet 736 is coupled to a first flexible outlet tubing 738 (also referred to herein as “first outlet tubing”), which defines a lumen 739 configured to receive a first or initial volume of bodily fluid flowing through the housing 730. The first outlet tubing 738 is also coupled to a vent 735 having a vent material 742 that can selectively vent the lumen 739 of the first outlet tubing 738. As such, at least a portion of the lumen 739 can form, for example, a sequestration and/or diversion portion and/or the like, as described in further detail herein (Bullington ¶0149, Figs. 17, 19-20)]. Bullington further discloses steps of isolating the initial volume of blood in the vented flashback and diversion chamber, to prevent outflow thereof back into the dual port adapter during collection of a subsequent blood sample [The arrangement of the first outlet tubing 738 (e.g., the sequestration chamber) is such that the lumen retains and/or sequesters the initial volume or amount of bodily fluid therein. As described in detail above, contaminants such as, for example, dermally residing microbes or the like dislodged during the venipuncture event, can be entrained and/or included in the initial volume of the bodily fluid and thus, can also be sequestered in the first outlet tubing 738 (Bullington ¶0156)]; coupling a vacuumed collection container to the other of the first port and the second port; and collecting a blood sample in the vacuumed collection container, with a flow of blood caused to automatically flow through the other of the first port and the second port and into the vacuumed collection container upon coupling thereof to the other of the first port and the second port [The second outlet is in fluid communication with a second flexible outlet tubing 747 (also referred to herein as “second outlet tubing”), which defines a lumen 748 configured to place the second outlet 747 in fluid communication with one or more fluid collection devices (not shown) (Bullington ¶0149, Figs. 17, 19-20); a pressure differential (e.g., a negative pressure differential) between the lumen 739 of the first outlet tubing 738 and, for example, the lumen 721 of the flexible tubing 720 can be greater than a pressure differential between the lumen 748 of the second outlet tubing 747 and the lumen 721 of the flexible tubing 720. Thus, as bodily fluid flows into the fluid flow path 733, the bodily fluid will flow into the first outlet 736 in response to the greater pressure differential (e.g., based at least in part on the venting of the first outlet tubing 738). That is to say, when the housing 730 is in the first or initial state, the housing 730 diverts and/or directs the flow of bodily fluid from the inlet 732 to the first outlet 736 (Bullington ¶0153); fully filling the lumen 739 of the first outlet tubing 738 and/or saturating the vent material 742 can place the housing 730 and/or the device 700 in a second state or configuration, in which any subsequent volume of bodily fluid flows through the fluid flow path 733 and into the second outlet 737, as indicated by the arrow CC in FIG. 20 (Bullington ¶0156); the second outlet 737 is in fluid communication with one or more fluid collection devices (e.g., via the second outlet tubing 747) such that the subsequent volume(s) of the bodily fluid can flow from the inlet 732, through the fluid flow path 733, the second outlet 736, and the second outlet tubing 747, and into the fluid collection device (not shown) (Bullington ¶0157); In some embodiments, a fluid collection device can include, can define, and/or can be actuated to generate a negative pressure condition inside the fluid collection device, which in turn, can facilitate withdrawal of bodily fluid from the bodily fluid source (e.g., the patient) into the fluid collection device via a vacuum or suction force. In embodiments in which the fluid collection device is an evacuated container or the like, the container can include a vacuum seal or the like that can be transitioned from a sealed state to an unsealed state. In some instances, a user can couple an evacuated container to an outlet of a fluid control device such as those described herein after an initial portion of the bodily fluid is diverted and/or sequestered, which in turn, can limit and/or substantially prevent an initial portion of the bodily fluid (potentially containing contaminants) from being transferred into the container (e.g., fluid collection device) (Bullington ¶0040); In embodiments in which the fluid collection device is an evacuated container or the like, the user can couple the fluid collection device to the outlet 136 after the initial portion of the bodily fluid is transferred into and/or sequestered by the sequestration portion 134, which in turn, can limit and/or substantially prevent an initial portion of the bodily fluid (potentially containing contaminants) from being transferred into the fluid collection device, as described in further detail herein (Bullington ¶0071), wherein the Examiner notes that as disclosed in Bullington ¶¶0156-0157, upon filling the first outlet tubing 738 (vented flashback and diversion chamber) the bodily fluid flow is automatically redirected towards second outlet 737, which is understood to be coupleable with a vacuumed collection container (Bullington ¶¶0040, 0071, 0157)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Devgon to employ the blood sample collection system comprising a dual port adapter coupled to a proximal end of the extension tube, wherein the dual port adapter comprises a first port and a second port; and a vented flashback and diversion chamber coupled to one of the first port and the second port; and further steps of isolating the initial volume of blood in the vented flashback and diversion chamber, to prevent outflow thereof back into the dual port adapter during collection of a subsequent blood sample; coupling a vacuumed collection container to the other of the first port and the second port; and collecting a blood sample in the vacuumed collection container, with a flow of blood caused to automatically flow through the other of the first port and the second port and into the vacuumed collection container upon coupling thereof to the other of the first port and the second port, so as to divert and sequester an initial volume of blood to prevent any contaminants in the initial volume of blood from affecting subsequently drawn volumes of blood [Once the initial amount is sequestered, any subsequent amount of the bodily fluid flow can be diverted, channeled, directed, flow controlled (e.g., manually, automatically, and/or semi-automatically) to a second reservoir, second portion of the device, and/or any additional flow path(s). Thus, with the initial amount sequestered, any additional and/or subsequent amount(s) of bodily fluid are substantially free from contaminants that may otherwise produce inaccurate, distorted, adulterated, falsely positive, falsely negative, etc., results in some diagnostics and/or testing (Bullington ¶0035)], and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [vent and divert/sequester an initial blood volume to prevent contamination of subsequent samples] [MPEP § 2143(I)(D)].
Regarding claim 15, Devgon in view of Bullington teaches
The method of claim 14, further comprising venting the vented flashback and diversion chamber prior to allowing the initial volume of blood to flow therein [Bullington ¶¶0148-0149, 0153].
Regarding claim 16, Devgon in view of Bullington teaches
The method of claim 15, wherein venting the vented flashback and diversion chamber comprises manual venting [Bullington ¶0155].
Regarding claim 17, Devgon in view of Bullington teaches
The method of claim 15, wherein venting the vented flashback and diversion chamber comprises automatic venting [Bullington ¶0153].
Regarding claim 18, Devgon in view of Bullington teaches
The method of claim 14, further comprising:
coupling a blood collection interface to the other one of the first port and the second port of the dual port adapter that is not coupled to the vented flashback and diversion chamber [The second outlet is in fluid communication with a second flexible outlet tubing 747 (also referred to herein as “second outlet tubing”), which defines a lumen 748 configured to place the second outlet 747 in fluid communication with one or more fluid collection devices (not shown) (Bullington ¶0149, Figs. 17, 19-20); the second outlet 737 is in fluid communication with one or more fluid collection devices (e.g., via the second outlet tubing 747) such that the subsequent volume(s) of the bodily fluid can flow from the inlet 732, through the fluid flow path 733, the second outlet 736, and the second outlet tubing 747, and into the fluid collection device (not shown) (Bullington ¶0157)].
Regarding claim 19, Devgon in view of Bullington teaches
The method of claim 18, further comprising:
coupling a first blood collection container to the blood collection interface after the initial volume of blood is collected in the vented flashback and diversion chamber, and
collecting a first blood sample within the first blood collection container [Bullington ¶¶0149, 0157].
Regarding claim 20, Devgon in view of Bullington teaches
The method of claim 19.
However, Devgon in view of Bullington as presently modified fails to explicitly disclose the method further comprising: removing the first blood collection container from the blood collection interface, coupling a second blood collection container to the blood collection interface, and collecting a second blood sample within the second blood collection container.
Bullington is considered to suggest the use of a plurality of blood collection containers to collect a plurality of blood samples within respective blood collection containers [The second outlet is in fluid communication with a second flexible outlet tubing 747 (also referred to herein as “second outlet tubing”), which defines a lumen 748 configured to place the second outlet 747 in fluid communication with one or more fluid collection devices (not shown) (Bullington ¶0149); The fluid collection device can be any suitable device for receiving and/or at least temporarily containing a bodily fluid, such as, for example, any of those described above. In some embodiments, the fluid collection device can be a single-use disposable collection tube(s), a vacuum-based collection tube(s), and/or the like. For example, in some embodiments, the fluid collection device can be substantially similar to or the same as known sample containers such as, for example, a Vacutainer® (manufactured by BD), a BacT/ALERT® SN or BacT/ALERT® FA (manufactured by Biomerieux, Inc.), and/or any suitable reservoir, vial, microvial, microliter vial, nanoliter vial, container, microcontainer, nanocontainer, and/or the like (Bullington ¶0071)], wherein Bullington is further considered to refer to selective coupling of each blood collection container to the blood collection interface [Bullington ¶¶0071, 0149].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Devgon in view of Bullington to employ further comprising: from the blood collection interface, coupling a second blood collection container to the blood collection interface, and collecting a second blood sample within the second blood collection container, as this modification would amount to merely applying a known technique [selective coupling/removal of a blood collection container to the blood interface] to a known method ready for improvement to yield predictable results [define a fluid flow path for bodily fluid collection] [MPEP § 2143(I)(D)].
Regarding claim 23, Devgon teaches
A blood draw system, comprising:
a blood draw device having a distal end portion and a proximal end portion [fluid transfer device 210 includes at least an introducer 215 (Devgon ¶0069, Figs. 5-7); The introducer 215 includes a proximal end portion 216 and a distal end portion 217 (Devgon ¶0071, Fig. 5)], wherein the blood draw device comprises an actuator and a blood draw tube operably coupled to the actuator, wherein the actuator is configured to selectively advance the blood draw tube through a catheter of a vascular access device when the blood draw device is coupled to the vascular access device [the catheter 230 of the transfer device 210 is movably disposed within the inner volume defined by the introducer 215 and is coupled to the actuator 220. In some embodiments, the catheter 230 can be moved (e.g., via movement of the actuator 220) between a first position and a second position to transition the transfer device 210 between the first configuration and the second configuration, respectively (Devgon ¶0072, Figs. 5-7)];
an extension tube extending from the proximal end portion of the blood draw device, wherein the extension tube is in fluid communication with the blood draw tube of the blood draw device [secondary catheter 245; The first portion of the actuator 220 can also be coupled to an outlet or secondary catheter 245 such that the catheter 230 and the outlet or secondary catheter 245 are in fluid communication (Devgon ¶0074, Figs. 5-7)].
However, while Devgon discloses employing a diversion portion [any of the closed system access devices described herein can include and/or can be coupled to a flash chamber or the like configured to receive, for example, a first volume of blood (e.g., a pre-sample of blood) resulting from the initial venipuncture event… In such embodiments, the first volume of blood can flow through, for example, a one-way seal such as a sponge seal or the like and into the flash chamber. The arrangement of the seal can be such that once the seal is wetted (e.g., with blood), the flow of the first volume of blood stops (Devgon ¶0194)], Devgon fails to explicitly disclose a dual port adapter coupled to a proximal end of the extension tube, wherein the dual port adapter comprises a Y-adapter or a T-adapter including a first port and a second port; and a vented flashback and diversion chamber coupled to one of the first port and the second port, wherein the vented flashback and diversion chamber is configured to receive and hold an initial volume of blood drawn through the extension tube by the blood draw device; a luer lock access device coupled to the other one of the first port and the second port to which the vented flashback and diversion chamber is not coupled, the other one of the first port and the second port comprising a luer connection; and a vacuumed collection container coupleable to the luer lock access device; wherein during blood collection, upon the initial volume of blood being received and held in the vented flashback and diversion chamber, a flow of blood is caused to automatically flow through the other of the first port and the second port and into the vacuumed collection container upon connection thereof to the luer lock access device.
Bullington discloses blood draw systems, wherein Bullington discloses a dual port adapter coupled to a proximal end of the extension tube in fluid communication with a blood draw device, wherein the dual port adapter comprises a Y-adapter or a T-adapter including a first port and a second port [a housing 730 in fluid communication with and/or configured to be placed in fluid communication with the inlet device 710. The inlet device 710 can be any suitable device(s) such as, for example, an IV catheter, a sharpened catheter or sharpened needle, and/or any other suitable lumen-containing device (Bullington ¶0147, Figs. 17, 19-20); The housing 730 includes a body 731 having and/or forming an inlet 732, a first outlet 736, and a second outlet 737. In addition, the housing 730 defines a fluid flow path 733 configured to selectively place the inlet 732 in fluid communication with the first outlet 736 or the second outlet 737 (see e.g., FIG. 20). The body 731 of the housing 730 can be any suitable shape, size, and/or configuration. For example, in the embodiment shown in FIGS. 17-20, the body 731 forms a T-connector or Y-connector (Bullington ¶0148, Figs. 17, 19-20)]; and a vented flashback and diversion chamber coupled to one of the first port and the second port, wherein the vented flashback and diversion chamber is configured to receive and hold an initial volume of blood drawn through the extension tube by the blood draw device [The first outlet 736 is coupled to a first flexible outlet tubing 738 (also referred to herein as “first outlet tubing”), which defines a lumen 739 configured to receive a first or initial volume of bodily fluid flowing through the housing 730. The first outlet tubing 738 is also coupled to a vent 735 having a vent material 742 that can selectively vent the lumen 739 of the first outlet tubing 738. As such, at least a portion of the lumen 739 can form, for example, a sequestration and/or diversion portion and/or the like, as described in further detail herein (Bullington ¶0149, Figs. 17, 19-20)]; a luer lock access device coupled to the other one of the first port and the second port to which the vented flashback and diversion chamber is not coupled, the other one of the first port and the second port comprising a luer connection [Although not shown, any of the devices described herein can include an opening, port, coupler, septum, Luer-Lok, gasket, valve, threaded connecter, standard fluidic interface, etc. (referred to for simplicity as a “port”) in fluid communication with the sequestration portion (e.g., chamber). In some such embodiments, the port can be configured to couple to any suitable device, reservoir, pressure source, etc. For example, in some embodiments, the port can be configured to couple to a reservoir, which in turn, can allow a greater volume of bodily fluid to be diverted and/or transferred into the sequestration portion (Bullington ¶0287)]; and a vacuumed collection container coupleable to the luer lock access device; wherein during blood collection, upon the initial volume of blood being received and held in the vented flashback and diversion chamber, a flow of blood is caused to automatically flow through the other of the first port and the second port and into the vacuumed collection container upon connection thereof to the luer lock access device [The second outlet is in fluid communication with a second flexible outlet tubing 747 (also referred to herein as “second outlet tubing”), which defines a lumen 748 configured to place the second outlet 747 in fluid communication with one or more fluid collection devices (not shown) (Bullington ¶0149, Figs. 17, 19-20); a pressure differential (e.g., a negative pressure differential) between the lumen 739 of the first outlet tubing 738 and, for example, the lumen 721 of the flexible tubing 720 can be greater than a pressure differential between the lumen 748 of the second outlet tubing 747 and the lumen 721 of the flexible tubing 720. Thus, as bodily fluid flows into the fluid flow path 733, the bodily fluid will flow into the first outlet 736 in response to the greater pressure differential (e.g., based at least in part on the venting of the first outlet tubing 738). That is to say, when the housing 730 is in the first or initial state, the housing 730 diverts and/or directs the flow of bodily fluid from the inlet 732 to the first outlet 736 (Bullington ¶0153); fully filling the lumen 739 of the first outlet tubing 738 and/or saturating the vent material 742 can place the housing 730 and/or the device 700 in a second state or configuration, in which any subsequent volume of bodily fluid flows through the fluid flow path 733 and into the second outlet 737, as indicated by the arrow CC in FIG. 20 (Bullington ¶0156); the second outlet 737 is in fluid communication with one or more fluid collection devices (e.g., via the second outlet tubing 747) such that the subsequent volume(s) of the bodily fluid can flow from the inlet 732, through the fluid flow path 733, the second outlet 736, and the second outlet tubing 747, and into the fluid collection device (not shown) (Bullington ¶0157); In some embodiments, a fluid collection device can include, can define, and/or can be actuated to generate a negative pressure condition inside the fluid collection device, which in turn, can facilitate withdrawal of bodily fluid from the bodily fluid source (e.g., the patient) into the fluid collection device via a vacuum or suction force. In embodiments in which the fluid collection device is an evacuated container or the like, the container can include a vacuum seal or the like that can be transitioned from a sealed state to an unsealed state. In some instances, a user can couple an evacuated container to an outlet of a fluid control device such as those described herein after an initial portion of the bodily fluid is diverted and/or sequestered, which in turn, can limit and/or substantially prevent an initial portion of the bodily fluid (potentially containing contaminants) from being transferred into the container (e.g., fluid collection device) (Bullington ¶0040); In embodiments in which the fluid collection device is an evacuated container or the like, the user can couple the fluid collection device to the outlet 136 after the initial portion of the bodily fluid is transferred into and/or sequestered by the sequestration portion 134, which in turn, can limit and/or substantially prevent an initial portion of the bodily fluid (potentially containing contaminants) from being transferred into the fluid collection device, as described in further detail herein (Bullington ¶0071), wherein the Examiner notes that as disclosed in Bullington ¶¶0156-0157, upon filling the first outlet tubing 738 (vented flashback and diversion chamber) the bodily fluid flow is automatically redirected towards second outlet 737, which is understood to be coupleable with a vacuumed collection container (Bullington ¶¶0040, 0071, 0157)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Devgon to employ a dual port adapter coupled to a proximal end of the extension tube, wherein the dual port adapter comprises a Y-adapter or a T-adapter including a first port and a second port; and a vented flashback and diversion chamber coupled to one of the first port and the second port, wherein the vented flashback and diversion chamber is configured to receive and hold an initial volume of blood drawn through the extension tube by the blood draw device; a luer lock access device coupled to the other one of the first port and the second port to which the vented flashback and diversion chamber is not coupled, the other one of the first port and the second port comprising a luer connection; and a vacuumed collection container coupleable to the luer lock access device; wherein during blood collection, upon the initial volume of blood being received and held in the vented flashback and diversion chamber, a flow of blood is caused to automatically flow through the other of the first port and the second port and into the vacuumed collection container upon connection thereof to the luer lock access device, so as to divert and sequester an initial volume of blood to prevent any contaminants in the initial volume of blood from affecting subsequently drawn volumes of blood [Once the initial amount is sequestered, any subsequent amount of the bodily fluid flow can be diverted, channeled, directed, flow controlled (e.g., manually, automatically, and/or semi-automatically) to a second reservoir, second portion of the device, and/or any additional flow path(s). Thus, with the initial amount sequestered, any additional and/or subsequent amount(s) of bodily fluid are substantially free from contaminants that may otherwise produce inaccurate, distorted, adulterated, falsely positive, falsely negative, etc., results in some diagnostics and/or testing (Bullington ¶0035)], and as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [vent and divert/sequester an initial blood volume to prevent contamination of subsequent samples] [MPEP § 2143(I)(D)].
Regarding claim 25, Devgon in view of Bullington teaches
The system of claim 23, further comprising a luer lock access device coupled to the luer connection of the other one of the first port and the second port [Bullington ¶0287].
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon in view of Bullington, as applied to claim 14, in further view of Breindel (US-20190374145-A1, previously presented).
Regarding claim 21, Devgon in view of Bullington teaches
The method of claim 14,
wherein isolating the initial volume of blood in the vented flashback and diversion chamber comprises actuating a check valve provided at an entrance of the vented flashback and diversion chamber [the first outlet tubing 738 can include, for example, a valve or selectively permeable membrane configured to limit and/or substantially prevent an outflow of the bodily fluid from the first outlet tubing 738. In some embodiments, such a valve or membrane can be automatically activated, user activated, and/or a combination thereof (Bullington ¶0155), wherein the valve being configured to selectively limit or prevent outflow therethrough is considered to define a type of check valve].
However, Devgon in view of Bullington fails to explicitly disclose wherein the vented flashback and diversion chamber is coupled directly to the one of the first port and the second port.
Breindel discloses blood draw systems, wherein Breindel discloses a dual port adapter comprising a first port and a second port, and a vented flashback and diversion chamber directly coupled to one of the first port and the second port [a body member 102 having an interior wall 104 defining a generally “Y” shaped fluid conduit 106. The fluid conduit 106 can include a distal portion 108, a first proximal portion 110, and a second proximal portion 112 (Breindel ¶0038, Fig. 1A); The first proximal portion 110 can include a vent path 126 configured to enable the escape of the gas initially trapped within the sequestration chamber 124 (Breindel ¶0042, Fig. 1B)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Devgon in view of Bullington to employ wherein the vented flashback and diversion chamber is coupled directly to the one of the first port and the second port, as this modification would amount to mere simple substitution of one known element [connection between a port and the vented flashback and diversion chamber] for another with similar expected results [define a fluid flow path for bodily fluid collection] [MPEP § 2143(I)(B)].
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon in view of Bullington, as applied to claim 14 above, in further view of Hayakawa (US-20150045771-A1, previously presented).
Regarding claim 22, Devgon in view of Bullington teaches
The method of claim 14.
However, Devgon in view of Bullington as presently modified fails to explicitly disclose wherein the blood sample collection system further comprises: a secondary extension tube, wherein a distal end of the secondary extension tube is coupled to the one of the first port and the second port and a proximal end of the secondary extension tube is coupled to a connector, with the vented flashback and diversion chamber coupled to the connector; and a fluid occlusion device positioned in-line with the secondary extension tube; and wherein isolating the initial volume of blood in the vented flashback and diversion chamber comprises clamping the fluid occlusion device to occlude a flow of the initial volume of blood back out from the vented flashback and diversion chamber.
Bullington discloses that the blood sample collection system may comprise a secondary extension tube, wherein a distal end of the secondary extension tube is coupled to the one of the first port and the second port and a proximal end of the secondary extension tube is coupled to a connector, with the vented flashback and diversion chamber coupled to the connector [Bullington ¶0287].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Devgon in view of Bullington to employ the blood sample collection system to further comprise: a secondary extension tube, wherein a distal end of the secondary extension tube is coupled to the one of the first port and the second port and a proximal end of the secondary extension tube is coupled to a connector, with the vented flashback and diversion chamber coupled to the connector; and a fluid occlusion device positioned in-line with the secondary extension tube, as this modification would amount to mere application of a known technique to a known device (method, or product) ready for improvement to yield predictable results [define a fluid flow path for bodily fluid collection] [MPEP § 2143(I)(D)].
However, Devgon in view of Bullington fails to explicitly disclose wherein the blood sample collection system further comprises: a fluid occlusion device positioned in-line with the secondary extension tube; and wherein isolating the initial volume of blood in the vented flashback and diversion chamber comprises clamping the fluid occlusion device to occlude a flow of the initial volume of blood back out from the vented flashback and diversion chamber.
Bullington suggests fully sequestering the initial amount of bodily fluid flow [A first reservoir, channel, flow path, or portion of the device can receive an initial amount of the bodily fluid flow, which then can be substantially or fully sequestered (e.g., contained or retained, circumvented, isolated, segregated, vapor-locked, separated, and/or the like) in or by the first reservoir or first portion of the device (Bullington ¶0035)].
Hayakawa discloses blood draw systems, wherein Hayakawa discloses drawing an initial volume of blood into a first collection system through an extension tube, wherein a fluid occlusion device positioned in-line with the extension tube is configured to be selectively clamped to occlude a flow of the initial volume of blood back out from the first collection system [Hayakawa ¶¶0093-0094, Fig. 12, wherein the Examiner notes that “occluding” the branch tube 106f is considered to prevent fluid flow in either direction (flow into and out of branch tube 106f) based on the plain definition of “occluding” referring to close up or block off : obstruct (https://www.merriam-webster.com/dictionary/occlude)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Devgon in view of Bullington to employ the blood sample collection system to further comprise: a fluid occlusion device positioned in-line with the secondary extension tube; and wherein isolating the initial volume of blood in the vented flashback and diversion chamber comprises clamping the fluid occlusion device to occlude a flow of the initial volume of blood back out from the vented flashback and diversion chamber, to prevent any possible contaminants included in the diverted initial volume of blood from contaminating any subsequent samples.
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon in view of Bullington, as applied to claim 23 above, in further view of Kater (US-5046509-A, previously presented).
Regarding claim 24, Devgon in view of Bullington teaches
The system of claim 23.
However, Devgon in view of Bullington and Breindel fails to explicitly disclose further comprising a removable end cap positionable on the other one of the first port and the second port.
Kater discloses blood draw systems, wherein Kater discloses a dual port adapter, wherein the dual port adapter comprises a first port and a second port [coupling 126 (dual port adapter) comprises adapter sleeve 138 (first port) and port 140 (second port) (Kater Fig. 1)]; a vent coupled to one of the first port and the second port [The coupling 126 also includes a plug 142 positioned within the shaft 136 intermediate the adapter sleeve 138 and the port 140. The plug 142 comprises a liquid flow control device such as, for example, a porous plug, for venting air trapped within the connector members 106, 114, tubing 122, shaft 136, and port 140 during the initial stages of the blood sampling operation (Kater Col 4:11-17, Fig. 1)]; and a removable end cap positionable on the other one of the first port and the second port [the port 140 is adapted for receiving a first blood storage device 130. A cap 144 is matably engageable with the port 140 to seal the port from inadvertent blood loss at times when the first blood storage device 130 is not connected to the coupling 126. In normal operation, however, the cap 144 will be removed from the port 140 and the first blood storage device 130 coupled thereto (Kater Col 4:27-34, Fig. 1)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Devgon in view of Bullington to employ further comprising a removable end cap positionable on the other one of the first port and the second port, so as to prevent leakage prior to coupling a blood collection device to the other one of the first port and the second port [Kater Col 4:27-34].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 8-12, filed 17 April 2026, with respect to the rejection(s) of claim(s) 1, 14, 23, and those dependent therefrom under § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Devgon (US-20200100716-A1, previously presented) in view of Bullington (US-20180353117-A1) [not the same as the previously cited Bullington ‘087] and Hayakawa (US-20150045771-A1, previously presented) with respect to claim 1, and in view of Devgon (US-20200100716-A1, previously presented) in view of Bullington (US-20180353117-A1) [not the same as the previously cited Bullington ‘087] with respect to claims 14 and 23.
Regarding claims 1 and 23, the Applicant asserts that there is no teaching provided in Bullington [previously presented US-20190175087-A1, hereinafter Bullington ‘087] that fluid control device 300 is operable such that during blood collection, upon the initial volume of blood being received and held in the vented flashback and diversion chamber, a flow of blood is caused to automatically flow through the other of the first port and the second port and into the vacuumed collection container upon connection thereof to the other of the first port and the second port or connection thereof to the luer lock access device, as now recited in amended claims 1 and 23, wherein the Applicant notes that Bullington specifically discloses an actuator 350 that functions to switch between a first configuration and a second configuration to selectively control fluid communication between each outlet. The Applicant further asserts that neither Devgon or Hayakawa teach or suggest a blood draw system as argued above, such that the combination of Devgon, Bullington ‘087, and Hayakawa fails to render obvious that which is called for in claims 1 and 23. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1 and 23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Devgon (US-20200100716-A1, previously presented) is presently modified in view of Bullington (US-20180353117-A1) [not the same as the previously cited Bullington ‘087] and Hayakawa (US-20150045771-A1, previously presented), wherein the Examiner notes that Bullington is considered to teach the argued subject matter regarding upon the initial volume of blood being received and held in the vented flashback and diversion chamber, a flow of blood is caused to automatically flow through the other of the first port and the second port and into the vacuumed collection container upon connection thereof to the other of the first port and the second port or connection thereof to the luer lock access device [Bullington ¶¶0040, 0071, 0149, 0153, 0156-0157, Figs. 17, 19-20, wherein the Examiner notes that as disclosed in Bullington ¶¶0156-0157, upon filling the first outlet tubing 738 (vented flashback and diversion chamber) the bodily fluid flow is automatically redirected towards second outlet 737, which is understood to be coupleable with a vacuumed collection container (Bullington ¶¶0040, 0071, 0157)].
Regarding claim 14, the Applicant asserts that the housing 330 of Bullington ‘087 does not provide for collecting a blood sample in a vacuumed collection container, with a flow of blood caused to automatically flow through the other port (i.e., the port to which a vented flashback and diversion chamber is not coupled) and into the vacuumed collection container upon coupling thereof to the other port, without any actuation of the dual port adapter, similar to the Applicant’s arguments with respect to the disclosure of Bullington regarding the amended subject matter of claims 1 and 23 presented above. The Applicant further notes that Devgon provides no teaching of a blood collection system that includes a dual port adapter coupled to a proximal end of the extension tube, wherein the dual port adapter comprises a first port and a second port, such that Devgon cannot teach the argued subject matter of claim 14, and such that the combination of Devgon and Bullington ‘087 would fail to render obvious that which is called for in claim 14. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1 and 23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Devgon (US-20200100716-A1, previously presented) is presently modified in view of Bullington (US-20180353117-A1) [not the same as the previously cited Bullington ‘087], wherein the Examiner notes that Bullington is considered to teach the argued subject matter regarding upon the initial volume of blood being received and held in the vented flashback and diversion chamber, a flow of blood is caused to automatically flow through the other of the first port and the second port and into the vacuumed collection container upon connection thereof to the other of the first port and the second port or connection thereof to the luer lock access device [Bullington ¶¶0040, 0071, 0149, 0153, 0156-0157, Figs. 17, 19-20; see Examiner’s analysis above]. The Examiner further notes that while considered moot due to the new grounds of rejection, the argument wherein “a flow of blood caused to automatically flow through the other port (i.e., the port to which a vented flashback and diversion chamber is not coupled) and into the vacuumed collection container upon coupling thereof to the other port, without any actuation of the dual port adapter” [emphasis applied], is considered a feature(s) upon which applicant relies that is/are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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