DETAILED ACTION
This action is responsive to the claim amendments and Applicant’s Remarks filed 5 November 2025. The Examiner acknowledges the amendments to claims 1-2, 4-5, 11, and 16. Claims 1-20 are pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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) 16 and 19-20 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 18-20 of copending Application No. 18/198,584 (reference application, hereinafter Burkholz). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 18 of Burkholz is considered to anticipate each and every limitation of instant claim 16 [see comparison below]. Claims 19-20 of Burkholz are further considered to anticipate instant claims 19-20.
Instant Claim 16 of the Instant Application
Claim 18 of Conflicting Patent Application 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, lines 3-4]
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 5-8]
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, wherein the proximal extension tube is in fluid communication with the blood draw tube of the blood draw device; [claim 14, lines 9-12]
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 positioned in-line with the extension tube between the blood draw device and the blood collection interface, 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 15-19]
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. [claim 14, lines 25-28]
[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 20-21]
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 22-24]
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. [claim 14, lines 25-28]
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) 1-6, and 13 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-6, and 13 of copending Application No. 18/198,584 (reference application, hereinafter Burkholz) in view of Bullington (US-20190175087-A1, previously presented). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 of Burkholz is considered to anticipate almost each and every limitation of instant claim 1 [see comparison below], except for the limitations of “a proximal connector positioned at a proximal end of the extension tube” and wherein the initial blood volume diversion device is positioned “between the blood draw device and the proximal connector”. Bullington discloses blood draw systems, wherein Bullington discloses a proximal connector positioned at a proximal end of an extension tube defining a fluid flow path [the fluid collection device can be fluidically connected to the second outlet 337 via the second outlet tubing 347 after the actuator 350 and/or the device 300 is in the second state (e.g., after the initial volume of bodily fluid has been sequestered in the sequestration portion 334) (Bullington ¶0114)], wherein an initial blood volume diversion device is positioned in-line with the extension tube between the blood draw device and the proximal connector [a housing 330 in fluid communication with and/or configured to be placed in fluid communication with the inlet device 310 (Bullington ¶0102, Figs. 5, 7); the housing 330 includes an inlet 332, a first outlet 336, and a second outlet 337 (Bullington ¶0104), wherein the first outlet 336 and second outlet 337 may read on the first port and second port]; and a vented flashback and diversion chamber coupled to one of the first port and the second port [a flow of bodily fluid is diverted or directed from the inlet 332 to the first outlet 336 and into the sequestration portion 334 (defined or formed by the first outlet tubing 338) (Bullington ¶0110, Fig. 7); The first outlet tubing 338 is also coupled to a vent 335 having a vent material 342 that can selectively vent the lumen 339 of the first outlet tubing 338. As such, at least a portion of the lumen 339 can form, for example, a sequestration portion 334 (also referred to herein as “sequestration portion”) and/or the like, as described in further detail herein (Bullington ¶0105, Figs. 5, 7)].
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 extension tube and to position the initial blood volume diversion device between the blood draw device and the proximal connector, in order to allow for collection of a blood sample after sequestration of an initial volume of blood to prevent contaminants from being collected with the blood sample [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 flow 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 ¶0026)].
Claims 2-6, and 13 of Burkholz as modified by Bullington are further considered to anticipate instant claims 2-6, and 13.
Instant Claim 1 of the Instant Application
Claim 1 of Conflicting Patent Application 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 2-9]
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, wherein the extension tube is in fluid communication with the blood draw tube of the blood draw device; [claim 1, lines 10-13]
an initial blood volume diversion device positioned in-line with 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 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]
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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) 1-10, 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-20190175087-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 [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, 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)];
a proximal connector 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)];
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 the initial blood volume diversion device being positioned in-line with the extension tube between the blood draw device and the proximal connector.
Bullington discloses blood draw systems, wherein Bullington discloses an extension tube defining a fluid flow path from a blood draw device [the flexible tubing 320 defines a lumen 321 extending through the flexible tubing 320… Likewise, the flexible tubing 320 is coupled to, for example, a proximal end portion of the body 311 such that the lumen 321 of the flexible tubing 320 is in fluid communication with the lumen 312 of the body 311. Thus, the lumen 315 of the needle 314, the lumen 312 of the body 311, and the lumen 321 of the flexible tubing 320 collectively define a fluid flow path extending through the inlet device 310 (Bullington ¶0103, Figs. 5, 7)], an initial blood volume diversion device positioned in-line with the extension tube between the blood draw device and a proximal connector [The housing 330 can be any suitable device or set of devices configured to (1) receive a flow of bodily fluid, (2) store and sequester a first volume or initial volume of the bodily fluid, and (3) direct or divert a subsequent flow of the bodily fluid to a fluid collection device, as described in further detail herein. In the embodiment shown in FIGS. 5-7, the housing 330 includes an inlet 332, a first outlet 336, and a second outlet 337, and defines a fluid flow path 333 and a sequestration portion 334 (Bullington ¶0104, Fig. 7); The second outlet 337 is in fluid communication with a second flexible outlet tubing 347 (also referred to herein as “second outlet tubing”), which defines a lumen 348 configured to place the second outlet tubing 347 in fluid communication with one or more fluid collection devices (not shown) (Bullington ¶0105)], 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 [The first outlet 336 is coupled to a first flexible outlet tubing 338 (also referred to herein as “first outlet tubing”), which defines a lumen 339 configured to receive a first or initial volume of bodily fluid flowing through the housing 330. The first outlet tubing 338 is also coupled to a vent 335 having a vent material 342 that can selectively vent the lumen 339 of the first outlet tubing 338 (Bullington ¶0105, Figs. 5, 7)].
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 the initial blood volume diversion device to be positioned in-line with the extension tube between the blood draw device and the proximal connector, 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 flow 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 ¶0026)].
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 ¶0105].
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 ¶0105].
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 [In such embodiments, the first outlet tubing 338 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 338. In some embodiments, such a valve or membrane can be automatically activated, user activated, and/or a combination thereof (Bullington ¶0112)].
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 [Bullington ¶0112].
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 [a semi-permeable member or membrane disposed in or about the vent to selectively allow a flow of air or gas through the vent while limiting or substantially preventing a flow of fluid (e.g., bodily fluid such as blood) through the vent (Bullington ¶0055); the vent material 342 can be a gas permeable and fluid impermeable barrier or the like (Bullington ¶0111); the first or initial amount of bodily fluid is a volume sufficient to wet or saturate the vent material 342. As described above with reference to the control device 100, the vent material 342 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). In this manner, transferring the first or initial volume of bodily fluid into the lumen 339 of the first outlet tubing 338 (e.g., the sequestration portion 334) seals the vent material 342 (Bullington ¶0112)].
Regarding claim 7, Devgon in view of Bullington teaches
The system of claim 1.
However, Devgon in view of Bullington as presently modified fails to explicitly disclose wherein the initial blood volume diversion device further comprises a flashback visualization and blood sample fluid path arm, and wherein the flashback visualization and blood sample fluid path arm is in fluid communication with the extension tube and the proximal connector.
Bullington discloses a flashback visualization and blood sample fluid path arm, and wherein the flashback visualization and blood sample fluid path arm is in fluid communication with the extension tube and the proximal connector [the second outlet 337 is in fluid communication with one or more fluid collection device(s) (e.g., via the second outlet tubing 347) such that subsequent volume(s) of the bodily fluid can flow from the inlet 332, through the fluid flow path 333, the lumen 358 of the actuator 350, the second outlet 336, and the second outlet tubing 347, and into the fluid collection device(s) (not shown) (Bullington ¶0114, Figs. 5, 7), wherein the second outlet tubing 347 being coupled to a fluid collection device to allow for fluid collection is considered to read on allowing for flashback visualization as fluid is collected].
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 flashback visualization and blood sample fluid path arm, and wherein the flashback visualization and blood sample fluid path arm is in fluid communication with the extension tube and the proximal connector, so as to allow for blood sampling free of any contaminants contained within the diverted initial volume of blood [Bullington ¶0026].
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 ¶¶0104-0105; wherein the Examiner notes that as depicted in Fig. 7 of Bullington, the vent 335 being wider than the first outlet tubing 338 (considered to define the 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 ¶0105, Fig. 7].
Regarding claim 10, Devgon in view of Bullington teaches
The system of claim 8.
However, Devgon in view of Bullington as presently modified fails to explicitly disclose 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.
Bullington discloses 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 [the second outlet 337 is in fluid communication with one or more fluid collection device(s) (e.g., via the second outlet tubing 347) such that subsequent volume(s) of the bodily fluid can flow from the inlet 332, through the fluid flow path 333, the lumen 358 of the actuator 350, the second outlet 336, and the second outlet tubing 347, and into the fluid collection device(s) (not shown) (Bullington ¶0114, Figs. 5, 7), wherein the second outlet tubing 347 being coupled to a fluid collection device to allow for fluid collection is considered to read on allowing for flashback visualization as fluid is collected].
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 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, so as to allow for blood sampling free of any contaminants contained within the diverted initial volume of blood [Bullington ¶0026].
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 fails to explicitly disclose 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 [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 0.1 milliliter (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 ¶0036)]. “[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 13 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, 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)],
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 [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 that the initial blood volume diversion device is positioned in-line with the extension tube between the blood draw device and the blood collection interface, 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 an extension tube defining a fluid flow path from a blood draw device [the flexible tubing 320 defines a lumen 321 extending through the flexible tubing 320… Likewise, the flexible tubing 320 is coupled to, for example, a proximal end portion of the body 311 such that the lumen 321 of the flexible tubing 320 is in fluid communication with the lumen 312 of the body 311. Thus, the lumen 315 of the needle 314, the lumen 312 of the body 311, and the lumen 321 of the flexible tubing 320 collectively define a fluid flow path extending through the inlet device 310 (Bullington ¶0103, Figs. 5, 7)], an initial blood volume diversion device positioned in-line with the extension tube between the blood draw device and a blood collection interface [The housing 330 can be any suitable device or set of devices configured to (1) receive a flow of bodily fluid, (2) store and sequester a first volume or initial volume of the bodily fluid, and (3) direct or divert a subsequent flow of the bodily fluid to a fluid collection device, as described in further detail herein. In the embodiment shown in FIGS. 5-7, the housing 330 includes an inlet 332, a first outlet 336, and a second outlet 337, and defines a fluid flow path 333 and a sequestration portion 334 (Bullington ¶0104, Fig. 7); The second outlet 337 is in fluid communication with a second flexible outlet tubing 347 (also referred to herein as “second outlet tubing”), which defines a lumen 348 configured to place the second outlet tubing 347 in fluid communication with one or more fluid collection devices (not shown) (Bullington ¶0105)], 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 [The first outlet 336 is coupled to a first flexible outlet tubing 338 (also referred to herein as “first outlet tubing”), which defines a lumen 339 configured to receive a first or initial volume of bodily fluid flowing through the housing 330. The first outlet tubing 338 is also coupled to a vent 335 having a vent material 342 that can selectively vent the lumen 339 of the first outlet tubing 338 (Bullington ¶0105, Figs. 5, 7)].
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 initial blood volume diversion device to be positioned in-line with the extension tube between the blood draw device and the blood collection interface, 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 [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 flow 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 ¶0026)].
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 ¶0105, wherein the vented flashback and diversion chamber being gas permeable is considered to read on the claimed limitation].
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 ¶0114], and
collecting a first blood sample within the first blood collection container [Bullington ¶0114].
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 [As described in detail above, the second outlet 337 is in fluid communication with one or more fluid collection device(s) (e.g., via the second outlet tubing 347) such that subsequent volume(s) of the bodily fluid can flow from the inlet 332, through the fluid flow path 333, the lumen 358 of the actuator 350, the second outlet 336, and the second outlet tubing 347, and into the fluid collection device(s) (not shown). In some embodiments, the fluid collection device(s) can be any suitable device such as a reservoir, syringe, container, etc. For example, in some embodiments, the fluid collection device can be a reservoir or device that includes and/or defines a negative pressure such as, for example, a single-use disposable collection tube(s), a vacuum-based collection tube(s), a syringe(s), a blood culture bottle(s), and/or the like (Bullington ¶0114), wherein the Examiner places emphasis on the reference to a plurality of fluid collection devices and a plurality of subsequent volumes of blood to be collected], wherein Bullington is further considered to refer to selective coupling of each blood collection container to the blood collection interface [In some instances, the fluid collection device can be fluidically connected to the second outlet 337 via the second outlet tubing 347 after the actuator 350 and/or the device 300 is in the second state (e.g., after the initial volume of bodily fluid has been sequestered in the sequestration portion 334) (Bullington ¶0114)].
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 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 [MPEP § 2143(I)(D)].
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 Bischof (US-6126618-A, previously presented).
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 to selectively occlude a flow of blood from the diversion and isolation chamber.
Bischof discloses blood draw systems, wherein Bischof discloses the use of a fluid occlusion device to selectively occlude a first fluid path to divert blood flow into a second fluid path [The illustrated disposable set 10 may include a needle such as venipuncture needle 12, and a length of plastic tubing 14 extending from needle 12 to a collection container such as a flexible plastic bag 16 (Bischof Col 4:3-6, Fig. 1); Referring first to FIG. 3, sampling vial 20 is inserted into the interior 42 of receptacle 40 so that cap 48 of vial 20 is pierced by the second piercing end 38 of piercing member 34, as shown in FIG. 4. Next, the entire vial with receptacle is moved forward by adjusting the length of sleeve 32. As shown, for example, in FIGS. 4 and 5, vial 20 with receptacle 40 is moved forward by compressing length adjustable sleeve 32. As length adjustable sleeve 32 is compressed, end 36 of piercing member 34 penetrates access site 23 as substantially shown in FIG. 4... In any event, continued translational movement of the vial and receptacle toward the access site 23 causes further penetration of the piercing member through the barrier and into the flow path 22 of the housing 18 (Bischof Col 5:61-6:10, Figs. 3-5); During collection of the blood sample, it may be desirable to clamp off tubing 14 near container 16 and divert the blood as described above (Bischof Col 6:15-17)].
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 at a distal portion of the diversion and isolation chamber to selectively occlude a flow of blood from the diversion and isolation chamber, so as to facilitate fluid flow away from the vented flashback and diversion chamber after drawing the initial volume of blood [Bischof Col 6:15-17].
Regarding claim 18, Devgon in view of Bullington teaches
The method of claim 16.
However, Devgon in view of Bullington fails to explicitly disclose the method 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.
Bischof discloses blood draw systems, wherein Bischof discloses the use of a fluid occlusion device to selectively occlude a first fluid path to divert blood flow into a second fluid path [Bischof Col 4:3-6, Fig. 1, Col 5:61-6:10, Figs. 3-5, Col 6:15-17].
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 clamping a distal portion of the diversion and isolation chamber after the initial volume of blood is collected in the diversion and isolation chamber, so as to facilitate fluid flow away from the vented flashback and diversion chamber after drawing the initial volume of blood [Bischof Col 6:15-17].
Claim(s) 12-13 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 Breindel (US-20190374145-A1, previously presented).
Regarding claim 12, Devgon in view of Bullington teaches
The system of claim 1.
However, Devgon in view of Bullington as presently modified fails to explicitly disclose wherein the proximal connector is configured to be removably coupled to a luer lock access device.
Breindel discloses a blood draw system comprising an initial blood volume diversion device [the blood sequestration device 100 can include 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, Figs. 1A-C); 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, while inhibiting the escape of blood (Breindel ¶0042)], wherein a proximal connector for fluid collection [outlet port 132; The second proximal portion 112 can define a fluid path and an outlet port 132 configured to be fluidly coupled to a blood collection device 134 (Breindel ¶0046)] is configured to be removably coupled to a luer lock access device [the outlet port 132 can define a Luer connector configured to accept a portion of the blood collection device 134. In other embodiments, the outlet port 132 can define a threaded portion configured to be threadably coupled to a portion of the blood collection device 134 (Breindel ¶0046, Fig. 1C)].
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 proximal connector is configured to be removably coupled to a luer lock access device, as this modification would amount to mere simple substitution of one known element for another [luer coupling] with similar expected results [MPEP § 2143(I)(B)].
Regarding claim 13, Devgon in view of Bullington teaches
The system of claim 1.
However, Devgon in view of Bullington fails to explicitly disclose wherein the proximal connector is integrated with a luer lock access device.
Breindel discloses a blood draw system comprising an initial blood volume diversion device [Breindel ¶¶0038, 0042, Figs. 1A-C], wherein a proximal connector for fluid collection is integrated with a luer lock access device [Breindel ¶0046, Fig. 1C, wherein the outlet 132 defining a luer connector is considered read on being integrated with a luer lock access device].
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 proximal connector is integrated with a luer lock access device, as this modification would amount to mere simple substitution of one known element for another [luer coupling] with similar expected results [MPEP § 2143(I)(B)].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 7, filed 5 November 2025, with respect to the previously presented claim objections have been fully considered and are persuasive. The claim objections of claims 1, 4-5, 11, and 16 have been withdrawn.
Applicant's arguments, see Applicant’s Remarks p. 7-8, with respect to the previously applied claim rejections under Double Patenting have been fully considered but they are not persuasive.
The Applicant that the claim language of Burkholz regarding “a dual port adapter coupled to a proximal end of the extension tube” [Burkholz claims 1, 14] does not anticipate or render obvious a blood draw system that includes an initial blood volume diversion device that is positioned in-line with an extension tube between the blood draw device and the proximal connector, as recited in claims 1 and 16. However, the Examiner disagrees with the Applicant’s argument, as based on the broadest reasonable interpretation of “in-line” [having the parts or units arranged in a straight line (https://www.merriam-webster.com/dictionary/in-line)], the dual port adapter being coupled to the proximal end of the extension tube and wherein one of the first and second port is connected to a blood collection interface is considered to define the extension tube, dual port adapter, and blood collection being arranged in a line. As such, Burkholz is considered to anticipate an initial blood volume diversion device positioned in-line with the extension tube between the extension tube and the blood collection interface.
The Applicant further argues that Bullington does not teach or suggest such inclusion of an “in-line” initial blood volume diversion device between an extension tube and a proximal connector [wherein the Applicant presents that particular argument against Bullington in the Remarks regarding the prior art rejection of the claims]. However, the Examiner disagrees with the Applicant’s arguments against Bullington as explained in further detail below in the Examiner’s Response to the Applicant’s arguments against the prior art rejections.
Applicant's arguments, see Applicant’s Remarks p. 8-12, with respect to the previously applied claim rejections under § 103 have been fully considered but they are not persuasive.
The Applicant asserts that Bullington fails to teach or suggest an initial blood volume diversion device positioned in-line with the extension tube between the blood draw device and the proximal connector, such that the combination of Devgon in view of Bullington would fail to render obvious claims 1 and 16, wherein the Applicant argues that one skilled in the art would not consider the sequestration portion 334 in first outlet tubing 338 to be positioned “in-line” with an extension tube having a proximal connector that provides for connection to/with a fluid/blood collection device – as the sequestration portion in first outlet tubing 338 is instead provided on a separate or parallel path/location from the second outlet tubing 347 that is in fluid communication with or more fluid collection devices [Applicant cites Bullington ¶0105, Fig. 7]. However, the Examiner notes that in response to applicant’s argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a sequestration portion positioned in-line with the extension tube between the blood draw device and the proximal connector [narrow]) 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). The Examiner notes that all claims 1 and 16 requires is “an initial blood volume diversion device positioned in-line with the extension tube between the blood draw device and the proximal connector” [broad], which is considered to be disclosed in Bullington ¶0105 and depicted in Bullington Fig. 7 [as the control device 300 (initial blood volume diversion device) is depicted as being in-line with flexible tubing 230 (extension tube) between inlet device 310 (blood draw device) and second outlet tubing 347 (proximal connector, as outlet tubing 347 is configured to be connected to one or more fluid collection devices as disclosed in Bullington ¶0105)]. As such, the modification of Devgon in view of Bullington is considered to render obvious the argued limitation of “an initial blood volume diversion device positioned in-line with the extension tube between the blood draw device and the proximal connector”.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/S.P.L./Examiner, Art Unit 3791