DETAILED ACTION
This action is responsive to the claim amendments and remarks filed 14 November 2025. The Examiner acknowledges the amendments to claims 1, 4-5, 14, and 18, the cancelation of claims 7-11, and the addition of new claims 21-25. Claims 1-6 and 12-25 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).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-6 and 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon (US-20200100716-A1, previously presented) in view of Bullington (US-20190175087-A1, previously presented) and Hayakawa (US-20150045771-A1).
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 diversion portion [any of the closed system access devices described herein can include and/or can be coupled to a flash chamber or the like configured to receive, for example, a first volume of blood (e.g., a pre-sample of blood) resulting from the initial venipuncture event… In such embodiments, the first volume of blood can flow through, for example, a one-way seal such as a sponge seal or the like and into the flash chamber. The arrangement of the seal can be such that once the seal is wetted (e.g., with blood), the flow of the first volume of blood stops (Devgon ¶0194)].
However, Devgon fails to explicitly disclose a dual port adapter coupled to a proximal end of the extension tube, wherein the dual port adapter comprises a Y-adapter or a T-adapter including a first port and a second port; a vented flashback and diversion chamber coupled to one of the first port and the second port, wherein the vented flashback and diversion chamber is configured to receive and hold an initial volume of blood drawn through the extension tube by the blood draw device; and a secondary extension tube, wherein a distal end of the secondary extension tube is coupled to one of the first port and the second port and a proximal end of the secondary extension tube is coupled to a connector, with the vented flashback and diversion chamber coupled to the connector.
Bullington discloses blood draw systems, wherein Bullington discloses a dual port adapter coupled to a proximal end of an extension tube extending from a blood draw device, wherein the dual port adapter comprises a Y-adapter including a first port and a second port [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… in the embodiment shown in FIGS. 5-7, the housing 330 forms a Y-connector and/or the like (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)], 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 [As such, a first amount or initial amount of bodily fluid can be transferred into the lumen 339 of the first outlet tubing 338 (Bullington ¶0110, Fig. 7)]; and a secondary extension tube, wherein a distal end of the secondary extension tube is coupled to one of the first port and the second port [first outlet tubing 338 (Bullington ¶0105, Figs. 5, 7)], with the vented flashback and diversion chamber coupled toa proximal end of the secondary extension tube [Bullington Fig. 7]; and wherein Bullington generally discloses that the vented flashback and diversion chamber may be coupled to the secondary extension tube via a connector [Although not shown, any of the devices described herein can include an opening, port, coupler, septum, Luer-Lok, gasket, valve, threaded connecter, standard fluidic interface, etc. (referred to for simplicity as a “port”) in fluid communication with the sequestration chamber. In some such embodiments, the port can be configured to couple to any suitable device, reservoir, pressure source, etc. For example, in some embodiments, the port can be configured to couple to a reservoir, which in turn, can allow a greater volume of bodily fluid to be diverted and/or transferred into the sequestration chamber (Bullington ¶0187)].
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 Devgon to employ a dual port adapter coupled to a proximal end of the extension tube, wherein the dual port adapter comprises a Y-adapter or a T-adapter including a first port and a second port; a vented flashback and diversion chamber coupled to one of the first port and the second port, wherein the vented flashback and diversion chamber is configured to receive and hold an initial volume of blood drawn through the extension tube by the blood draw device; and a secondary extension tube, wherein a distal end of the secondary extension tube is coupled to one of the first port and the second port and a proximal end of the secondary extension tube is coupled to a connector, with the vented flashback and diversion chamber coupled to the connector, 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)].
However, Devgon in view of Bullington fails to explicitly disclose a fluid occlusion device positioned in-line with the secondary extension tube, wherein the fluid occlusion device is configured to be selectively clamped to occlude a flow of the initial volume of blood back out from the vented flashback and diversion chamber.
Bullington suggests the use of a clamp for manipulating fluid flow [the actuator 250 can be a switch, a valve, a port, a membrane, a movable channel, a clamp, and/or the like configured to manipulate fluid flow (either directly or indirectly) through the housing 230 (Bullington ¶0089); As described above, the actuator 250 can be switched between the first and second configuration and/or position using a mechanically activated mechanism (e.g. button-press, turn-control activated, lever activated, clamp activated, or a switch activated) or any other suitable mechanisms (e.g. pressure dependent, volume dependent, and/or time dependent, etc.) (Bullington ¶0099); As previously described with respect to actuators 150, and/or 250 associated with devices 100 and/or 200, respectively, the actuator 350 can be a switch, a valve, a port, and/or the like, that can directly manipulate and/or establish one or more fluid flow paths, or that can indirectly manipulate and/or establish one or more fluid flow paths (Bullington ¶0107)].
Hayakawa discloses blood draw systems, wherein Hayakawa discloses drawing an initial volume of blood into a first collection system through an extension tube, wherein a fluid occlusion device positioned in-line with the extension tube is configured to be selectively clamped to occlude a flow of the initial volume of blood back out from the first collection system [Also, the clamp 111a is not closed and the branch tube 106f is kept opened. A blood collection is started in this condition with the needle tube 51 puncturing a blood vessel of a blood donor. Here, the initial flow blood is collected into the test blood bag 110 through the tube 53 and the branch tube 106f (Hayakawa ¶0093); After a prescribed amount of the initial flow blood is collected into the test blood bag 110, the clamp 111a is closed and the branch tube 106f is occluded (Hayakawa ¶0094, Fig. 12), wherein the Examiner notes that “occluding” the branch tube 106f is considered to prevent fluid flow in either direction (flow into and out of branch tube 106f) based on the plain definition of “occluding” referring to close up or block off : obstruct (https://www.merriam-webster.com/dictionary/occlude)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Devgon in view of Bullington to employ a fluid occlusion device positioned in-line with the secondary extension tube, wherein the fluid occlusion device is configured to be selectively clamped to occlude a flow of the initial volume of blood back out from the vented flashback and diversion chamber, to prevent any possible contaminants included in the diverted initial volume of blood from contaminating any subsequent samples.
Regarding claim 2, Devgon in view of Bullington and Hayakawa teaches
The system of claim 1, wherein the vented flashback and diversion chamber further comprises a venting portion [Bullington ¶0105].
Regarding claim 3, Devgon in view of Bullington and Hayakawa teaches
The system of claim 2, wherein the venting portion is configured to vent air when the blood draw device is coupled to the vascular access device and the blood draw tube of the blood draw device is advanced into a patient's vasculature to draw the initial volume of blood into the vented flashback and diversion chamber [the access device 270 (e.g., PIV) can be at least partially disposed within a vein of a patient via a venipuncture event or the like (Devgon ¶0058), wherein as depicted in Devgon Fig. 7, the blood draw device (catheter 230) extends past the catheter 272 of access device 270, such that the blood draw device is considered to be in fluid communication with the patient’s vein; Bullington ¶0105].
Regarding claim 4, Devgon in view of Bullington and Hayakawa teaches
The system of claim 3, wherein the venting portion is configured to vent air automatically when the blood draw device is coupled to the vascular access device and the blood draw tube of the blood draw device is advanced into the patient's vasculature [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 and Hayakawa teaches
The system of claim 3, wherein the venting portion is manually vented when the blood draw device is coupled to the vascular access device and the blood draw tube of the blood draw device is advanced into the patient's vasculature [Bullington ¶0112].
Regarding claim 6, Devgon in view of Bullington and Hayakawa teaches
The system of claim 3, wherein the venting portion is formed of at least one of a membrane, paper, porous material, film, or mechanical feature that allows air to pass therethrough but prevents fluid to pass therethrough when wetted [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 12, Devgon in view of Bullington and Hayakawa teaches
The system of claim 1, wherein the blood draw device further includes an introducer body [introducer 215 (Devgon Figs. 5-7)], and wherein the actuator is configured to move linearly along the introducer body to advance and retract the blood draw tube from the distal end portion of the blood draw device [Devgon ¶¶0074-0075, wherein as depicted in Devgon Figs. 6-7, the actuator 220 moves linearly along the introducer 215].
Regarding claim 13, Devgon in view of Bullington and Hayakawa teaches
The system of claim 1.
However, while Devgon discloses collecting a pre-sample volume of blood of about 1-3 mL or up to 8-10 mL [the volume of blood extracted from the patient can be a first volume of blood that can be discarded and/or at least temporarily stored apart from a subsequent sample volume of blood (e.g., typically a volume of about 1-3 milliliters (mL) but up to 8-10 mL of blood can be a “waste” or “pre-sample” volume) (Devgon ¶0198)], Devgon in view of Bullington and Hayakawa as presently modified to explicitly disclose wherein have a combined internal volume of at least 0.15 mL.
Bullington does disclose that the initial volume of blood drawn into the vented flashback and diversion chamber may be at least 0.15 mL [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.
Claim(s) 14-20 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 14, Devgon teaches
A method of using a blood sample collection system, comprising:
providing the blood sample collection system, the system comprising:
a blood draw device having a distal end portion and a proximal end portion [fluid transfer device 210 includes at least an introducer 215 (Devgon ¶0069, Figs. 5-7); The introducer 215 includes a proximal end portion 216 and a distal end portion 217 (Devgon ¶0071, Fig. 5)], wherein the blood draw device comprises an actuator and a blood draw tube operably coupled to the actuator [the catheter 230 of the transfer device 210 is movably disposed within the inner volume defined by the introducer 215 and is coupled to the actuator 220. In some embodiments, the catheter 230 can be moved (e.g., via movement of the actuator 220) between a first position and a second position to transition the transfer device 210 between the first configuration and the second configuration, respectively (Devgon ¶0072, Figs. 5-7)],
an extension tube extending from the proximal end portion of the blood draw device, wherein the proximal extension tube is in fluid communication with the blood draw tube of the blood draw device [secondary catheter 245; The first portion of the actuator 220 can also be coupled to an outlet or secondary catheter 245 such that the catheter 230 and the outlet or secondary catheter 245 are in fluid communication (Devgon ¶0074, Figs. 5-7)];
a flashback and diversion chamber [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
allowing the initial volume of blood to flow through the blood draw tube and the extension tube [Devgon ¶0074].
However, Devgon fails to explicitly disclose the blood sample collection system comprising a dual port adapter coupled to the 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, such that the initial volume of blood flows 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.
Bullington discloses blood draw systems, wherein Bullington discloses a dual port adapter, wherein the dual port adapter comprises a first port and a second port [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)], 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 [As such, a first amount or initial amount of bodily fluid can be transferred into the lumen 339 of the first outlet tubing 338 (Bullington ¶0110, Fig. 7)]. Bullington further discloses a step of isolating the initial volume of blood in the vented flashback and diversion chamber to prevent outflow thereof back into the dual port adapter during collection of a subsequent blood sample [the actuator 350 that can be configured 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, as described in further detail below (Bullington ¶0105); the user can engage the actuator 350 to transition the actuator 350 to the second state once the user confirms (e.g., visually) that the desired initial volume is disposed in the first outlet tubing 338. As described above, transitioning the actuator 350 from the first state to the second state can be such that (1) the first outlet tubing 338 is sequestered (e.g., blocked or sealed by a portion of the actuator 350) and (2) the lumen 358 defined by the actuator 350 establishes fluid communication between the second outlet 337 and the inlet 332 (Bullington ¶0113), wherein blocking/sealing the first outlet tubing 338 is considered to prevent fluid flow into or out of first outlet tubing 338].
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 blood draw system used in the method of Devgon to employ a dual port adapter coupled to the 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, such that the initial volume of blood flows through the blood draw tube and the extension tube and into the vented flashback and diversion chamber of the blood sample collection system, and further 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, 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 15, Devgon in view of Bullington teaches
The method of claim 14, further comprising venting the vented flashback and diversion chamber prior to allowing the initial volume of blood to flow therein [Bullington ¶0105, wherein the vented flashback and diversion chamber being gas permeable is considered to read on the claimed limitation].
Regarding claim 16, Devgon in view of Bullington teaches
The method of claim 15, wherein venting the vented flashback and diversion chamber comprises manual venting [Bullington ¶0112].
Regarding claim 17, Devgon in view of Bullington teaches
The method of claim 15, wherein venting the vented flashback and diversion chamber comprises automatic venting [Bullington ¶0112].
Regarding claim 18, Devgon in view of Bullington teaches
The method of claim 14.
However, Devgon in view of Bullington as presently modified fails to explicitly disclose coupling a blood collection interface to the other one of the first port and the second port of the dual port adapter that is not coupled to the vented flashback and diversion chamber.
Bullington discloses coupling a blood collection interface to the other one of the first port and the second port of the dual port adapter [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); 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 coupling a blood collection interface to the other one of the first port and the second port of the dual port adapter that is not coupled to the vented flashback and diversion chamber, so as to allow for collection of blood free of contaminants that may have been contained in an initial volume of blood contained in the vented flashback and diversion chamber [Bullington ¶0026].
Regarding claim 19, Devgon in view of Bullington teaches
The method of claim 18, further comprising:
coupling a first blood collection container to the blood collection interface after the initial volume of blood is collected in the vented flashback and diversion chamber [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 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) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon in view of Bullington, as applied to claim 14, in further view of Breindel (US-20190374145-A1, previously presented).
Regarding claim 21, Devgon in view of Bullington teaches
The method of claim 14,
wherein isolating the initial volume of blood in the vented flashback and diversion chamber comprises actuating a check valve provided at an entrance of the vented flashback and diversion chamber [the actuator 350 can be a switch, a valve, a port, and/or the like, that can directly manipulate and/or establish one or more fluid flow paths, or that can indirectly manipulate and/or establish one or more fluid flow paths (Bullington ¶0107), wherein the actuator 350 being configured to block/seal the initial volume of blood is considered to define a type of check valve].
However, Devgon in view of Bullington fails to explicitly disclose wherein the vented flashback and diversion chamber is coupled directly to the one of the first port and the second port.
Breindel discloses blood draw systems, wherein Breindel discloses a dual port adapter comprising a first port and a second port, and a vented flashback and diversion chamber directly coupled to one of the first port and the second port [a body member 102 having an interior wall 104 defining a generally “Y” shaped fluid conduit 106. The fluid conduit 106 can include a distal portion 108, a first proximal portion 110, and a second proximal portion 112 (Breindel ¶0038, Fig. 1A); The first proximal portion 110 can include a vent path 126 configured to enable the escape of the gas initially trapped within the sequestration chamber 124 (Breindel ¶0042, Fig. 1B)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Devgon in view of Bullington to employ wherein the vented flashback and diversion chamber is coupled directly to the one of the first port and the second port, as this modification would amount to mere simple substitution of one known element [connection between a port and the vented flashback and diversion chamber] for another with similar expected results [MPEP § 2143(I)(B)].
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon in view of Bullington, as applied to claim 14 above, in further view of Hayakawa.
Regarding claim 22, Devgon in view of Bullington teaches
The method of claim 14.
However, Devgon in view of Bullington as presently modified fails to explicitly disclose wherein the blood sample collection system further comprises: a secondary extension tube, wherein a distal end of the secondary extension tube is coupled to the one of the first port and the second port and a proximal end of the secondary extension tube is coupled to a connector, with the vented flashback and diversion chamber coupled to the connector.
Bullington discloses blood draw systems, wherein Bullington discloses that the vented flashback and diversion chamber is coupled to a proximal end of the secondary extension tube, wherein a distal end of the secondary extension tube is coupled to a port of the dual port adapter; and wherein Bullington generally discloses that the vented flashback and diversion chamber may be coupled to the secondary extension tube via a connector [Bullington ¶¶0102, 0104-0105, 0110, 0187, 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 Devgon in view of Bullington to employ wherein the blood sample collection system further comprises: a secondary extension tube, wherein a distal end of the secondary extension tube is coupled to the one of the first port and the second port and a proximal end of the secondary extension tube is coupled to a connector, with the vented flashback and diversion chamber coupled to the connector, 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)].
However, Devgon in view of Bullington fails to explicitly disclose a fluid occlusion device positioned in-line with the secondary extension tube; and wherein isolating the initial volume of blood in the vented flashback and diversion chamber comprises clamping the fluid occlusion device to occlude a flow of the initial volume of blood back out from the vented flashback and diversion chamber.
Bullington suggests the use of a clamp for manipulating fluid flow [the actuator 250 can be a switch, a valve, a port, a membrane, a movable channel, a clamp, and/or the like configured to manipulate fluid flow (either directly or indirectly) through the housing 230 (Bullington ¶0089); As described above, the actuator 250 can be switched between the first and second configuration and/or position using a mechanically activated mechanism (e.g. button-press, turn-control activated, lever activated, clamp activated, or a switch activated) or any other suitable mechanisms (e.g. pressure dependent, volume dependent, and/or time dependent, etc.) (Bullington ¶0099); As previously described with respect to actuators 150, and/or 250 associated with devices 100 and/or 200, respectively, the actuator 350 can be a switch, a valve, a port, and/or the like, that can directly manipulate and/or establish one or more fluid flow paths, or that can indirectly manipulate and/or establish one or more fluid flow paths (Bullington ¶0107)].
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 a fluid occlusion device positioned in-line with the secondary extension tube; and wherein isolating the initial volume of blood in the vented flashback and diversion chamber comprises clamping the fluid occlusion device to occlude a flow of the initial volume of blood back out from the vented flashback and diversion chamber, to prevent any possible contaminants included in the diverted initial volume of blood from contaminating any subsequent samples.
Claim(s) 23 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon (US-20200100716-A1, previously presented) in view of Bullington (US-20190175087-A1, previously presented) and Breindel (US-20190374145-A1, previously presented).
Regarding claim 23, Devgon teaches
A blood draw system, comprising:
a blood draw device having a distal end portion and a proximal end portion [fluid transfer device 210 includes at least an introducer 215 (Devgon ¶0069, Figs. 5-7); The introducer 215 includes a proximal end portion 216 and a distal end portion 217 (Devgon ¶0071, Fig. 5)], wherein the blood draw device comprises an actuator and a blood draw tube operably coupled to the actuator [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 diversion portion [any of the closed system access devices described herein can include and/or can be coupled to a flash chamber or the like configured to receive, for example, a first volume of blood (e.g., a pre-sample of blood) resulting from the initial venipuncture event… In such embodiments, the first volume of blood can flow through, for example, a one-way seal such as a sponge seal or the like and into the flash chamber. The arrangement of the seal can be such that once the seal is wetted (e.g., with blood), the flow of the first volume of blood stops (Devgon ¶0194)].
However, Devgon fails to explicitly disclose a dual port adapter coupled to a proximal end of the extension tube, wherein the dual port adapter comprises a Y-adapter or a T-adapter including a first port and a second port; and a vented flashback and diversion chamber coupled to one of the first port and the second port, wherein the vented flashback and diversion chamber is configured to receive and hold an initial volume of blood drawn through the extension tube by the blood draw device.
Bullington discloses blood draw systems, wherein Bullington discloses a dual port adapter, wherein the dual port adapter comprises a first port and a second port [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)], 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 [As such, a first amount or initial amount of bodily fluid can be transferred into the lumen 339 of the first outlet tubing 338 (Bullington ¶0110, Fig. 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 blood draw system of Devgon to employ a dual port adapter, 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, 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)].
However, while Bullington discloses that the other one of the first port and the second port may be coupled to one or more fluid collection devices [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, Fig. 7)], Devgon in view of Bullington fails to explicitly disclose wherein the other one of the first port and the second port to which the vented flashback and diversion chamber is not coupled comprises a luer connection to which a luer lock access device may be directly coupled.
Breindel discloses blood draw systems, wherein Breindel discloses a dual port adapter comprising a first port and a second port, and a vented flashback and diversion chamber coupled to one of the first port and the second port [a body member 102 having an interior wall 104 defining a generally “Y” shaped fluid conduit 106. The fluid conduit 106 can include a distal portion 108, a first proximal portion 110, and a second proximal portion 112 (Breindel ¶0038, Fig. 1A); The first proximal portion 110 can include a vent path 126 configured to enable the escape of the gas initially trapped within the sequestration chamber 124 (Breindel ¶0042)], wherein the other one of the first port and the second port is coupled to a luer lock access device [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. For example, in one embodiment, the outlet port 132 can define a Luer connector configured to accept a portion of the blood collection device 134 (Breindel ¶0046)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Devgon in view of Bullington to employ further comprising a luer lock access device coupled to the other one of the first port and the second port, as this modification would amount to mere simple substitution of one known element [coupling as disclosed in Bullington] for another [luer lock access device] with similar expected results [MPEP § 2143(I)(B)].
Regarding claim 25, Devgon in view of Bullington and Breindel teaches
The system of claim 23, further comprising a luer lock access device coupled to the luer connection of the other one of the first port and the second port [Breindel ¶0046].
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Devgon in view of Bullington and Breindel, as applied to claim 23 above, in further view of Kater (US-5046509-A, previously presented).
Regarding claim 24, Devgon in view of Bullington and Breindel teaches
The system of claim 23.
However, Devgon in view of Bullington and Breindel fails to explicitly disclose further comprising a removable end cap positionable on the other one of the first port and the second port.
Kater discloses blood draw systems, wherein Kater discloses a dual port adapter, wherein the dual port adapter comprises a first port and a second port [coupling 126 (dual port adapter) comprises adapter sleeve 138 (first port) and port 140 (second port) (Kater Fig. 1)]; a vent coupled to one of the first port and the second port [The coupling 126 also includes a plug 142 positioned within the shaft 136 intermediate the adapter sleeve 138 and the port 140. The plug 142 comprises a liquid flow control device such as, for example, a porous plug, for venting air trapped within the connector members 106, 114, tubing 122, shaft 136, and port 140 during the initial stages of the blood sampling operation (Kater Col 4:11-17, Fig. 1)]; and a removable end cap positionable on the other one of the first port and the second port [the port 140 is adapted for receiving a first blood storage device 130. A cap 144 is matably engageable with the port 140 to seal the port from inadvertent blood loss at times when the first blood storage device 130 is not connected to the coupling 126. In normal operation, however, the cap 144 will be removed from the port 140 and the first blood storage device 130 coupled thereto (Kater Col 4:27-34, Fig. 1)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Devgon in view of Bullington and Breindel to employ a removable end cap positionable on the other one of the first port and the second port, so as to prevent leakage prior to coupling a blood collection device to the other one of the first port and the second port [Kater Col 4:27-34].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 8, filed 14 November 2025, with respect to the previously presented claim objections have been fully considered and are persuasive. The objections to claims 4-5, 11, and 18 have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 8-9, with respect to the previously presented provisional nonstatutory double patenting rejections have been fully considered and are persuasive. The provisional nonstatutory double patenting rejections of claims 1-2 and 14-15 have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 9-13, with respect to the rejection(s) of claim(s) 1 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-20190175087-A1, previously presented) and Hayakawa (US-20150045771-A1).
Regarding claim 1, the Applicant asserts with respect to the subject matter of “a fluid occlusion device positioned in-line with the secondary extension tube, wherein the fluid occlusion device is configured to be selectively clamped to occlude flow of the initial volume of blood back out from the vented flashback and diversion chamber” [as previously taught by Devgon in view of Bullington and Bischof in the § 103 rejection of previously presented claim 11], fails to be rendered obvious by the combination of Bischof with Devgon and Bullington, as the Applicant argues that the disclosure of Bischof merely describes clamping off tubing to divert blood from one path to a different path to change/alter collection from one container to a different container, as opposed to the claimed functionality to occlude a flow of the initial volume of blood back out from the vented flashback and diversion chamber. Applicant’s arguments with respect to claim(s) 1 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 is modified by Bullington and Hayakawa to teach the argued subject matter regarding “a fluid occlusion device positioned in-line with the secondary extension tube, wherein the fluid occlusion device is configured to be selectively clamped to occlude flow of the initial volume of blood back out from the vented flashback and diversion chamber”, as the Examiner notes that Bullington suggests the use of a clamp for manipulating fluid flow [the actuator 250 can be a switch, a valve, a port, a membrane, a movable channel, a clamp, and/or the like configured to manipulate fluid flow (either directly or indirectly) through the housing 230 (Bullington ¶0089); As described above, the actuator 250 can be switched between the first and second configuration and/or position using a mechanically activated mechanism (e.g. button-press, turn-control activated, lever activated, clamp activated, or a switch activated) or any other suitable mechanisms (e.g. pressure dependent, volume dependent, and/or time dependent, etc.) (Bullington ¶0099); As previously described with respect to actuators 150, and/or 250 associated with devices 100 and/or 200, respectively, the actuator 350 can be a switch, a valve, a port, and/or the like, that can directly manipulate and/or establish one or more fluid flow paths, or that can indirectly manipulate and/or establish one or more fluid flow paths (Bullington ¶0107)] and 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)].
Applicant's arguments, see Applicant’s Remarks p. 9-13, with respect to the previously applied rejections of claims 14 and those dependent therefrom have been fully considered but they are not persuasive.
Regarding claim 14, the Applicant asserts there is no teaching provided in Devgon or Bullington of isolating the initial volume of blood in the vented flashback and diversion chamber to prevent outflow thereof back into the dual port adapter during collection of a subsequent blood sample. However, the Examiner disagrees with the Applicant’s argument and notes that Bullington does disclose a step of isolating the initial volume of blood in the vented flashback and diversion chamber to prevent outflow thereof back into the dual port adapter during collection of a subsequent blood sample [the actuator 350 that can be configured 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, as described in further detail below (Bullington ¶0105); the user can engage the actuator 350 to transition the actuator 350 to the second state once the user confirms (e.g., visually) that the desired initial volume is disposed in the first outlet tubing 338. As described above, transitioning the actuator 350 from the first state to the second state can be such that (1) the first outlet tubing 338 is sequestered (e.g., blocked or sealed by a portion of the actuator 350) and (2) the lumen 358 defined by the actuator 350 establishes fluid communication between the second outlet 337 and the inlet 332 (Bullington ¶0113), wherein blocking/sealing the first outlet tubing 338 is considered to prevent fluid flow into or out of first outlet tubing 338].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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