DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7 May 2026 has been entered.
The Examiner acknowledges the amendments to claims 1, 7, 11, and 18, the cancelation of claims 12-13, and the addition of new claims 21-22. Claims 1-11 and 14-22 are pending.
Claim Objections
Claim(s) 21 is/are objected to because of the following informalities:
Claim 21 should read “the diversion and isolation chamber[[,]];” [line 3].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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) 1-6, 16, and 19-20 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-6, 16, and 18-20 of copending Application No. 18/198,584 (reference application, hereinafter Burkholz) in view of Bullington (US-20180353117-A1) [not the same as the previously cited Bullington ‘087]. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Conflicting claim 1 of Burkholz is considered to anticipate almost each and every limitation of instant claim 1 [see comparison below], except for the instant limitations “a proximal connector positioned at a proximal end of the proximal portion of the extension tube” and wherein the initial blood volume diversion device is “positioned on and in-line with the extension tube between the blood draw device and the proximal connector, to separate the distal portion of the extension tube from the proximal portion of the extension tube”.
Bullington discloses blood draw systems, wherein Bullington discloses a distal extension tube defining a fluid flow path from a blood draw device [the control device 700 includes an inlet device 710 and 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. For example, in the embodiment shown in FIGS. 17-20, the inlet device 710 is a butterfly needle or other suitable access device having a body 711, a needle 714, and a flexible tubing 720 (Bullington ¶0147, Figs. 19-20)], an initial blood volume diversion device positioned on and in-line with the distal extension tube between the blood draw device and on and in-line with a connected proximal fluid collection device [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) (Bullington ¶0148, Figs. 19-20); As shown, the inlet 732 is coupled to the flexible tubing 720 (e.g., the flexible tubing 720 is a flexible inlet tubing for the housing 730), which defines a lumen configured to place the inlet 732 in fluid communication with the inlet device 710. 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. 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 second outlet tubing 747 can include a port or the like that can be in a closed configuration prior to coupling to the fluid collection device such that the second outlet tubing 747 is substantially sealed (Bullington ¶0153), wherein the housing 730 including first flexible outlet tubing 738 and second flexible outlet tubing 747 is disclosed as being positioned on and in-line with flexible tubing 720 (defining a distal extension tube) and on and in-line with a proximal fluid collection device(s)], 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 distal extension tube by the blood draw device [such an arrangement can result in a desired and/or predetermined flow of bodily fluid through the first outlet 736 and into the first outlet tubing 738 (e.g., the sequestration portion) prior to a flow of bodily fluid through the second outlet 737 and toward the second outlet tubing 747 (Bullington ¶0151)].
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 a proximal connector positioned at a proximal end of the proximal portion of the extension tube and wherein the initial blood volume diversion device is positioned on and in-line with the extension tube between the blood draw device and the proximal connector, to separate the distal portion of the extension tube from the proximal portion of the extension tube, 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 [the fluid control device has a first state in which an initial volume of bodily fluid can flow from the inlet to a sequestration and/or diversion portion of the fluid control device (which can be formed by or in the fluid control device or coupled thereto) and a second state in which (1) the initial volume is sequestered in the sequestration and/or diversion portion of the fluid control device, and (2) a subsequent volume of bodily fluid, being substantially free of contaminants, can flow from the bodily fluid source, through at least a portion of the fluid control device, and into the fluid collection device (Bullington ¶0039)].
Conflicting claims 2-6 of Burkholz in view of Bullington are further considered to render obvious instant claims 2-6.
Claim 1 of the Instant Application
Claim 1 of Conflicting Patent 18/198,584
A blood draw system, comprising:
A blood draw system, comprising: [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; [claim 1, lines 2-5]
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;
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; [claim 1, lines 6-8]
[wherein the Examiner notes that based on the plain definition of tube referring to “any of various usually cylindrical structures or devices: such as a: a hollow elongated cylinder” (https://www.merriam-webster.com/dictionary/tube), the extension tube of Burkholz is considered to define a distal portion and a proximal portion]
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.
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, 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. [claim 1, lines 14-21]
Conflicting claim 18 of Burkholz is considered to anticipate almost each and every limitation of instant claim 16 [see comparison below], except for the instant limitation wherein the initial blood volume diversion device is “positioned on and in-line with the extension tube between the blood draw device and the blood collection interface, to separate the distal portion of the extension tube from the proximal portion of the extension tube”.
Bullington discloses blood draw systems, wherein Bullington discloses a distal extension tube defining a fluid flow path from a blood draw device [Bullington ¶0147, Figs. 19-20], an initial blood volume diversion device positioned on and in-line with the distal extension tube between the blood draw device and on and in-line with a proximal fluid collection device [Bullington ¶0148-0149, 0158, Figs. 19-20, wherein the housing 730 including first flexible outlet tubing 738 and second flexible outlet tubing 747 is disclosed as being positioned on and in-line with flexible tubing 720 (defining a distal extension tube) and on and in-line with a connected proximal fluid collection device(s)], 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 distal extension tube by the blood draw device [Bullington ¶0151].
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 Burkholz to employ wherein the initial blood volume diversion device is positioned on and in-line with the extension tube between the blood draw device and the proximal connector, to separate the distal portion of the extension tube from the proximal portion of the extension tube, 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 ¶0039].
Conflicting claims 19-20 of Burkholz in view of Bullington are further considered to render obvious instant claims 19-20.
Claim 16 of the Instant Application
Claim 18 of Conflicting Patent 18/198,584
A method of using a blood sample collection system, comprising:
A method of using a blood sample collection system, comprising: [claim 14, lines 1-2]
providing the blood sample collection system, the system comprising:
providing the blood sample collection system, the system comprising: [claim 14, 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, wherein the actuator is configured to selectively advance the blood draw tube,
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, [claim 14, lines 5 4-6]
advancing the blood draw tube of the blood draw device through the vascular access device and beyond a distal tip of the indwelling catheter; and [claim 14, lines 16-17]
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,
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; [claim 14, lines 7-9]
[wherein the Examiner notes that based on the plain definition of tube referring to “any of various usually cylindrical structures or devices: such as a: a hollow elongated cylinder” (https://www.merriam-webster.com/dictionary/tube), the extension tube of Burkholz is considered to define a distal portion and a proximal portion]
a blood collection interface positioned at a proximal end of the extension tube, and
coupling a blood collection interface to the other one of the first port and the second port of the dual port adapter [claim 18]
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;
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; [claim 14, lines 10-13]
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; and 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. [claim 14, lines 18-23]
[The Examiner notes that the vented flashback and diversion chamber of Burkholz is considered to read on the instantly claimed diversion and isolation chamber]
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; [claim 14, lines 14-15]
advancing the blood draw tube of the blood draw device through the vascular access device and beyond a distal tip of the indwelling catheter; and
advancing the blood draw tube of the blood draw device through the vascular access device and beyond a distal tip of the indwelling catheter; and [claim 14, lines 16-17]
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.
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; and 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. [claim 14, lines 18-23]
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, 8-10, 14-17, and 19-20 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 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 [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)], 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 [Devgon ¶0072, Figs. 6-7];
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 [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), wherein the Examiner notes that as at least Devgon Figs. 5-7 depict the secondary catheter 245 (extension tube) as being elongated, the secondary catheter 245 is considered to be defined by a distal portion and a proximal portion];
a proximal connector positioned at a proximal end of the proximal portion of the extension tube [coupler 246; 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 (Devgon ¶0082, Figs. 5-7)]; and
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 [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)].
However, Devgon fails to explicitly disclose wherein the initial blood volume diversion device is positioned on and in-line with the extension tube between the blood draw device and the proximal connector, to separate the distal portion of the extension tube from the proximal portion of the extension tube.
Bullington discloses blood draw systems, wherein Bullington discloses a distal extension tube defining a fluid flow path from a blood draw device [the control device 700 includes an inlet device 710 and 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. For example, in the embodiment shown in FIGS. 17-20, the inlet device 710 is a butterfly needle or other suitable access device having a body 711, a needle 714, and a flexible tubing 720 (Bullington ¶0147, Figs. 19-20)], an initial blood volume diversion device positioned on and in-line with the distal extension tube between the blood draw device and on and in-line with a proximal fluid collection device [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) (Bullington ¶0148, Figs. 19-20); As shown, the inlet 732 is coupled to the flexible tubing 720 (e.g., the flexible tubing 720 is a flexible inlet tubing for the housing 730), which defines a lumen configured to place the inlet 732 in fluid communication with the inlet device 710. 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. 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 second outlet tubing 747 can include a port or the like that can be in a closed configuration prior to coupling to the fluid collection device such that the second outlet tubing 747 is substantially sealed (Bullington ¶0153), wherein the housing 730 including first flexible outlet tubing 738 and second flexible outlet tubing 747 is disclosed as being positioned on and in-line with flexible tubing 720 (defining a distal extension tube) and on and in-line with a proximal fluid collection device(s)], 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 distal extension tube by the blood draw device [such an arrangement can result in a desired and/or predetermined flow of bodily fluid through the first outlet 736 and into the first outlet tubing 738 (e.g., the sequestration portion) prior to a flow of bodily fluid through the second outlet 737 and toward the second outlet tubing 747 (Bullington ¶0151)].
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 wherein the initial blood volume diversion device is positioned on and in-line with the extension tube between the blood draw device and the proximal connector, to separate the distal portion of the extension tube from the proximal portion of the extension tube, 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 [the fluid control device has a first state in which an initial volume of bodily fluid can flow from the inlet to a sequestration and/or diversion portion of the fluid control device (which can be formed by or in the fluid control device or coupled thereto) and a second state in which (1) the initial volume is sequestered in the sequestration and/or diversion portion of the fluid control device, and (2) a subsequent volume of bodily fluid, being substantially free of contaminants, can flow from the bodily fluid source, through at least a portion of the fluid control device, and into the fluid collection device (Bullington ¶0039)].
Regarding claim 2, Devgon in view of Bullington teaches
The system of claim 1, wherein the initial blood volume diversion device further comprises a venting portion in fluid communication with the diversion and isolation chamber [Bullington ¶0149, Fig. 19].
Regarding claim 3, Devgon in view of Bullington 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 diversion and isolation 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 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 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 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 8, Devgon in view of Bullington teaches
The system of claim 1, wherein the initial blood volume diversion device further comprises a distal fluid path diversion adapter and a proximal vented collar adapter, and wherein the diversion and isolation chamber extends between the distal fluid path diversion adapter and the proximal vented collar adapter [Bullington ¶0149; wherein the Examiner notes that as depicted in Fig. 19 of Bullington, the vent 735 being wider than the first flexible outlet tubing 738 (diversion and isolation chamber) is considered to read on a proximal vented collar adapter].
Regarding claim 9, Devgon in view of Bullington teaches
The system of claim 8, wherein the proximal vented collar adapter includes a vented portion, and wherein a proximal end of the diversion and isolation chamber terminates at the vented portion [Bullington ¶0149, Fig. 19].
Regarding claim 10, Devgon in view of Bullington teaches
The system of claim 8, wherein the initial blood volume diversion device further comprises a primary flow tube extending between the distal fluid path diversion adapter and the proximal vented collar adapter and positioned parallel to the diversion and isolation chamber, wherein the primary flow tube is in fluid communication with the extension tube and the proximal connector [See modification of claim 1 above; 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), wherein the second flexible outlet tubing 747 of the housing 730 of Bullington is considered to define a primary flow tube extending between the distal fluid path diversion adapter and the proximal vented collar adapter and positioned parallel to the first flexible outlet tubing 738 (diversion and isolation chamber) (see Bullington Fig. 19), and as depicted in Bullington Figs. 19-20 and disclosed in ¶0149, the second flexible outlet tubing 747 is in fluid communication with the distal portion of secondary catheter 245 of Devgon/flexible tubing 720 of Bullington (distal portion of the extension tube as modified) and a proximal portion of secondary catheter 245 (proximal portion of extension tube as modified)].
Regarding claim 14, Devgon in view of Bullington 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 15, Devgon in view of Bullington 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 wherein the diversion and isolation chamber has an 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.
Regarding claim 16, 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, wherein the actuator is configured to selectively advance the blood draw tube [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, 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 [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), wherein the Examiner notes that as at least Devgon Figs. 5-7 depict the secondary catheter 245 (extension tube) as being elongated, the secondary catheter 245 is considered to be defined by a distal portion and a proximal portion],
a blood collection interface positioned at a proximal end of the extension tube [coupler 246; 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 (Devgon ¶0082, Figs. 5-7)], and
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 [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)];
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]; and
drawing the initial volume of blood through the blood draw tube and the extension tube [Devgon ¶0074].
However, Devgon fails to explicitly disclose wherein the initial blood volume diversion device is positioned on and in-line with the extension tube between the blood draw device and the blood collection interface, to separate the distal portion of the extension tube from the proximal portion of the extension tube, such that the initial volume of blood is drawn through the extension tube by the blood draw device and into the diversion and isolation chamber of the initial blood volume diversion device.
Bullington discloses blood draw systems, wherein Bullington discloses a distal extension tube defining a fluid flow path from a blood draw device [the control device 700 includes an inlet device 710 and 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. For example, in the embodiment shown in FIGS. 17-20, the inlet device 710 is a butterfly needle or other suitable access device having a body 711, a needle 714, and a flexible tubing 720 (Bullington ¶0147, Figs. 19-20)], an initial blood volume diversion device positioned on and in-line with the distal extension tube between the blood draw device and on and in-line with a proximal fluid collection device [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) (Bullington ¶0148, Figs. 19-20); As shown, the inlet 732 is coupled to the flexible tubing 720 (e.g., the flexible tubing 720 is a flexible inlet tubing for the housing 730), which defines a lumen configured to place the inlet 732 in fluid communication with the inlet device 710. 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. 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 second outlet tubing 747 can include a port or the like that can be in a closed configuration prior to coupling to the fluid collection device such that the second outlet tubing 747 is substantially sealed (Bullington ¶0153), wherein the housing 730 including first flexible outlet tubing 738 and second flexible outlet tubing 747 is disclosed as being positioned on and in-line with flexible tubing 720 (defining a distal extension tube) and on and in-line with a proximal fluid collection device(s)], 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 distal extension tube by the blood draw device [such an arrangement can result in a desired and/or predetermined flow of bodily fluid through the first outlet 736 and into the first outlet tubing 738 (e.g., the sequestration portion) prior to a flow of bodily fluid through the second outlet 737 and toward the second outlet tubing 747 (Bullington ¶0151)].
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 wherein the initial blood volume diversion device is positioned on and in-line with the extension tube between the blood draw device and the blood collection interface, to separate the distal portion of the extension tube from the proximal portion of the extension tube, such that the initial volume of blood is drawn through the extension tube by the blood draw device and into the diversion and isolation chamber of the initial blood volume diversion 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 [the fluid control device has a first state in which an initial volume of bodily fluid can flow from the inlet to a sequestration and/or diversion portion of the fluid control device (which can be formed by or in the fluid control device or coupled thereto) and a second state in which (1) the initial volume is sequestered in the sequestration and/or diversion portion of the fluid control device, and (2) a subsequent volume of bodily fluid, being substantially free of contaminants, can flow from the bodily fluid source, through at least a portion of the fluid control device, and into the fluid collection device (Bullington ¶0039)].
Regarding claim 17, Devgon in view of Bullington teaches
The method of claim 16, further comprising venting the diversion and isolation chamber prior to drawing the initial volume of blood therein [Bullington ¶¶0148-0149, 0153].
Regarding claim 19, Devgon in view of Bullington teaches
The method of claim 16, further comprising:
coupling a first blood collection container to the blood collection interface after the initial volume of blood is collected in the diversion and isolation chamber [Bullington ¶0149], and
collecting a first blood sample within the first blood collection container [Bullington ¶0149].
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: 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, 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)].
Claim(s) 7 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon in view of Bullington, as applied to claims 3 and 17 above, in further view of Chelak (US-20090088617-A1).
Regarding claim 7, Devgon in view of Bullington teaches
The system of claim 3, wherein the initial blood volume diversion device further comprises a blood sample fluid path arm arranged in parallel with the diversion and isolation chamber, and wherein the blood sample fluid path arm is in fluid communication with the distal and proximal portions of the extension tube and with the proximal connector [See modification of claim 1 above; 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), wherein the second flexible outlet tubing 747 of the housing 730 of Bullington is considered to define a flashback visualization and blood sample fluid path arm arranged in parallel with the first flexible outlet tubing 738 (diversion and isolation chamber) (see Bullington Fig. 19), and as depicted in Bullington Figs. 19-20 and disclosed in ¶0149, the second flexible outlet tubing 747 is in fluid communication with the distal portion of secondary catheter 245 of Devgon/flexible tubing 720 of Bullington (distal portion of the extension tube as modified) and a proximal portion of secondary catheter 245 (proximal portion of extension tube as modified); and wherein as the second outlet tubing 747 is configured to define a fluid flow path for a subsequent volume of bodily fluid];
wherein the diversion and isolation chamber and the blood sample fluid path arm are simultaneously in fluid communication with the distal portion of the extension tube [Bullington ¶0148, Fig. 20]; and
wherein with the blood draw tube advanced into the patient's vasculature and the initial volume of blood being drawn into and filling the diversion and isolation chamber, an additional portion of blood moves into the blood sample fluid path arm, to prime the system for connection and filling of a blood collection container to be connected to the proximal connector [Devgon ¶¶0072, 0082, Figs. 5-7; Bullington ¶¶0148-0149, Fig. 19; wherein the second outlet tubing 747 accepting a subsequent volume of bodily fluid for subsequent collection in a fluid collection device located proximal to the second outlet tubing 747 is considered to read on the claimed limitation].
However, Devgon in view of Bullington fails to explicitly disclose wherein the blood sample fluid path arm is further defined as a flashback visualization and blood sample fluid path arm.
Chelak discloses blood collection systems, wherein Chelak discloses that it is known in the art to form blood sample fluid tubing of a transparent material to allow medical personnel to visualize blood flow, i.e., flashback through the tubing [Chelak ¶0006].
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 wherein the blood sample fluid path arm as a flashback visualization and blood sample fluid path arm, so as to allow for confirmation of flashback and blood flow through the blood sample fluid path arm to enable collection of blood samples.
Regarding claim 21, Devgon in view of Bullington teaches
The method of claim 17, wherein the initial blood volume diversion device further comprises a blood sample fluid path arm arranged in parallel with the diversion and isolation chamber [See modification of claim 1 above; Bullington ¶0157, wherein the second flexible outlet tubing 747 of the housing 730 of Bullington is considered to define a flashback visualization and blood sample fluid path arm arranged in parallel with the first flexible outlet tubing 738 (diversion and isolation chamber) (see Bullington Fig. 19), and as depicted in Bullington Figs. 19-20 and disclosed in ¶0149, the second flexible outlet tubing 747 is in fluid communication with the distal portion of secondary catheter 245 of Devgon/flexible tubing 720 of Bullington (distal portion of the extension tube as modified) and a proximal portion of secondary catheter 245 (proximal portion of extension tube as modified); and wherein as the second outlet tubing 747 is configured to define a fluid flow path for a subsequent volume of bodily fluid],;
wherein the diversion and isolation chamber and the blood sample fluid path arm are simultaneously in fluid communication with the distal portion of extension tube [Bullington ¶0148, Fig. 20]; and
wherein with the blood draw tube advanced into the patient's vasculature and the initial volume of blood being drawn into and filling the diversion and isolation chamber, an additional portion of blood moves into the blood sample fluid path arm, to prime the blood sample collection system for connection and filling of a blood collection container to be connected to the proximal connector [Devgon ¶¶0072, 0082, Figs. 5-7; Bullington ¶¶0148-0149, Fig. 19; wherein the second outlet tubing 747 accepting a subsequent volume of bodily fluid for subsequent collection in a fluid collection device located proximal to the second outlet tubing 747 is considered to read on the claimed limitation].
However, Devgon in view of Bullington fails to explicitly disclose wherein the blood sample fluid path arm is further defined as a flashback visualization and blood sample fluid path arm.
Chelak discloses blood collection systems, wherein Chelak discloses that it is known in the art to form blood sample fluid tubing of a transparent material to allow medical personnel to visualize blood flow, i.e., flashback through the tubing [Chelak ¶0006].
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 blood sample fluid path arm is further defined as a flashback visualization and blood sample fluid path arm, so as to allow for confirmation of flashback and blood flow through the blood sample fluid path arm to enable collection of blood samples.
Claim(s) 11 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon in view of Bullington, as applied to claims 1 and 16 above, in further view of Hayakawa (US-20150045771-A1).
Regarding claim 11, Devgon in view of Bullington teaches
The system of claim 1.
However, Devgon in view of Bullington fails to explicitly disclose wherein the initial blood volume diversion device further comprises 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.
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 wherein the initial blood volume diversion device further comprises 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, to prevent any possible contaminants included in the diverted initial volume of blood from contaminating any subsequent samples.
Regarding claim 18, Devgon in view of Bullington teaches
The method of claim 16.
However, Devgon in view of Bullington fails to explicitly disclose further comprising 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.
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 further comprising 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, to prevent any possible contaminants included in the diverted initial volume of blood from contaminating any subsequent samples.
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 1 above, in further view of Rogers (US-20200281514-A1).
Regarding claim 22, Devgon in view of Bullington teaches
The system of claim 1.
However, Devgon in view of Bullington fails to explicitly disclose wherein the initial blood volume diversion device further comprises a body within which the diversion and isolation chamber and the venting portion are positioned.
Rogers discloses blood collection systems, wherein Rogers discloses an initial blood volume diversion device that comprises a body within which a diversion and isolation chamber, venting portion, and blood sample fluid path are positioned [In some implementations, the sampling channel 3106 and the sequestration chamber 3108 are formed by grooves, channels, locks or other pathways formed in housing 3101, such as by corresponding grooves, channels, locks or other pathways formed in either or both the top member 3120 or bottom member 3122 of the housing 3101. The housing 3101 can be made of rubber, plastic, metal or any other suitable material. The housing 3101 can be formed of a clear or translucent material, or of an opaque or non-translucent material. In other implementations, the housing 3101 can be mostly opaque or non-translucent, while the housing surface directly adjacent to the sampling channel 3106 and/or the sequestration chamber 3108 may be clear or translucent, giving a practitioner a visual cue or sign that the sequestration chamber 3108 is first filled to the extent necessary or desired, and/or then a visual cue or sign that the sequestered blood remains sequestered while a clean sample of blood is drawn through the sampling channel 3106 (Rogers ¶0187); The sequestration chamber 3108 is preferably maintained at atmospheric or near-atmospheric pressure, and includes a venting mechanism 3110 at or near a distal end of the sequestration chamber 3108 (Rogers ¶0188)].
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 wherein the initial blood volume diversion device further comprises a body within which the diversion and isolation chamber and the venting portion are positioned, 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 [form and contain a diversion and isolation chamber and venting portion of an initial blood volume diversion device] [MPEP § 2143(I)(D)].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 8-9, filed 7 May 2026, with respect to the provisional rejection(s) of claim(s) 1, 16, and those dependent therefrom under Non-Statutory Double Patenting 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 Application No. 18/198,584 (reference application, hereinafter Burkholz) in view of Bullington (US-20180353117-A1) [not the same as the previously cited Bullington ‘087].
The Applicant asserts the claims of Burkholz and Bullington ‘087 do not teach or suggest such inclusion of an initial blood volume diversion device that is positioned on and in-line with the extension tube between the blood draw device and the blood collection interface, to separate the distal portion of the extension tube from the proximal portion of the extension tube, for reasons similar to the arguments presented in the Applicant’s Remarks with respect to the previously applied rejections of claims 1 and 16 under § 103. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1 and 16 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) in view of Bullington (US-20180353117-A1) [not the same as the previously cited Bullington (US-20190175087-A1), hereinafter Bullington ‘087] is presently applied to teach the argued subject matter regarding an initial blood volume diversion device positioned on an in-line with the extension tube between the blood draw device and the proximal connector, to separate the distal portion of the extension tube from the proximal portion of the extension tube, as Bullington is considered to teach an initial blood volume diversion device positioned on and in-line with the distal extension tube between the blood draw device and on and in-line with a proximal fluid collection device [Bullington ¶¶0148-0149, 0153, Figs. 19-20, wherein the housing 730 including first flexible outlet tubing 738 and second flexible outlet tubing 747 is disclosed as being positioned on and in-line with flexible tubing 720 (defining a distal extension tube) and on and in-line with a proximal fluid collection device(s)].
Applicant’s arguments, see Applicant’s Remarks p. 9-14, with respect to the rejection(s) of claim(s) 1, 16, 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].
Regarding claims 1 and 16, the Applicant asserts that Bullington fails to teach or suggest an initial blood volume diversion device positioned on an in-line with the extension tube between the blood draw device and the proximal connector, to separate the distal portion of the extension tube from the proximal portion of the extension tube, wherein the initial blood volume diversion device comprises a diversion and isolation chamber configured to receive and hold an initial volume of blood drawn the extension tube by the blood draw device; wherein the Applicant notes that one skilled in the art would not consider the “initial blood volume diversion device of Bullington to separate a distal portion of an extension tube from a proximal portion of the extension tube – i.e., the housing 330 and sequestration portion 334 would not be considered to separate distal and proximal portions of an extension tube. However, the Examiner disagrees with the Applicant’s argument and notes that Applicant’s arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. The Examiner further notes that Applicant’s arguments with respect to claim(s) 1 and 16 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) in view of Bullington (US-20180353117-A1) [not the same as the previously cited Bullington (US-20190175087-A1), hereinafter Bullington ‘087] is presently applied to teach the argued subject matter regarding an initial blood volume diversion device positioned on an in-line with the extension tube between the blood draw device and the proximal connector, to separate the distal portion of the extension tube from the proximal portion of the extension tube, as Bullington is considered to teach an initial blood volume diversion device positioned on and in-line with the distal extension tube between the blood draw device and on and in-line with a proximal fluid collection device [Bullington ¶¶0148-0149, 0153, Figs. 19-20, wherein the housing 730 including first flexible outlet tubing 738 and second flexible outlet tubing 747 is disclosed as being positioned on and in-line with flexible tubing 720 (defining a distal extension tube) and on and in-line with a proximal fluid collection device(s)].
Regarding claim 7, the Applicant asserts that neither Devgon or Bullington ‘087 discloses a flashback visualization and blood sample fluid path arm as now called for in claim 7 – where the diversion and isolation chamber and the flashback visualization and blood sample fluid path are simultaneously in fluid communication with the distal portion of the extension tube and wherein the blood draw tube advanced into the patient’s vasculature and the initial volume of blood being drawn into and filling the diversion and isolation chamber, an additional portion of blood moves into the flashback visualization and blood sample fluid path arm, to prime the system for connection and filling of a blood collection container to be connected to the proximal connector; wherein the Applicant notes that the actuator 350 of Bullington is included therein to switch between a first configuration in which the actuator 350 establishes fluid communication between the inlet 332 and the first outlet 336, and a second configuration in which the actuator 350 establishes fluid communication between the inlet 332 and the second outlet 337, such that it is not possible for both first outlet tubing 338 and second outlet tubing 347 to be simultaneously in fluid communication with the flexible tube 320, nor is it possible for an additional portion of blood to move into the second outlet tubing 347 to prime the system for connection and filling of a blood collection container to be connected to the proximal connector. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 7 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 in view of Bullington and Chelak (US-20090088617-A1) is considered to teach the argued limitation wherein the diversion and isolation chamber and the blood sample fluid path arm are simultaneously in fluid communication with the distal portion of the extension tube [Bullington ¶0148, Fig. 20] and wherein the blood sample fluid path arm is further defined as a flashback visualization and blood sample fluid path arm [Chelak ¶0006].
Regarding claim 11, the Applicant asserts that none of Devgon, Bullington ‘087, or Bischof discloses 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 isolated 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 back out from the diversion and isolation chamber, thereby isolating the initial volume of blood therein; wherein the Applicant notes that Bischof cannot be said to teach or suggest what is called for in claim 11, as any teaching in Bischof of a clamp used to occlude tubing 14 is not for purposes of “isolating” an initial volume of blood already collected (in a diversion and isolation chamber) and preventing mixing of that initial volume with subsequently collected blood. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 11 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 in view of Bullington and Hayakawa is presently applied to render claim 11 obvious, as 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)].
Regarding claims 21-22, the Applicant asserts that new claim 21 recites similar language to claim 7, such that the corresponding arguments with respect to claim 7 are applicable to claim 21; and regarding new claim 22, the Applicant asserts that Bullington ‘087, alone or in combination with Devgon, fails to teach, disclose, or suggest wherein the initial blood volume diversion device to further comprise a body within which the diversion and isolation chamber and the venting portion are positioned, as no “body” is provided as part of the initial blood volume diversion device within which the sequestration portion 334 (formed by first outlet tubing 338) and vent 335 are positioned. However with respect to claim 21, the Examiner notes that claim 21 is rendered obvious for similar reasons as explained in the Examiner’s response to the arguments regarding claim 7 above; and with respect to claim 22, Devgon in view of Bullington is further modified in view of Rogers (US-20200281514-A1), wherein Rogers discloses an initial blood volume diversion device that comprises a body within which a diversion and isolation chamber, venting portion, and blood sample fluid path are positioned [Rogers ¶¶0187-0188].
Conclusion
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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