DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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) 1-4, 6-8, 10, 12-14, and 30-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers et al (US 2018/0177445) (“Rogers 445”) as evidenced by Thomas et al (US 4,349,035) (“Thomas”) in view of Bullington et al (US 2019/0365303) (“Bullington 303”) and further in view of Davis et al (US 2011/0009717).
Regarding Claim 1, while Rogers 445 teaches a diversion device for collecting a biological sample (Abstract, Figs. 20 and 23A-23B, [0131]-[0132], [0135]-[0137] general diversion device / blood sequestration device 2008 with a specific example given by Fig. 23), the diversion device comprising:
an inlet for receiving a biological sample collected from a patient (Figs. 20 and 23A-23B, [0131]-[0132] “FIG. 20 shows a blood sample optimization system 2000 that includes a patient needle 2002 for vascular access to a patient's bloodstream,” inlet of blood sequestration device 2008 connects to biological sample collector);
an outlet for delivering the collected biological sample to a collection vessel, the collection vessel being under sub-atmospheric pressure (Figs. 20 and 23A-23B, [0131]-[0132] “a blood sample collection device 2004 to facilitate the collecting of one or more blood samples, and a conduit 2006 providing a fluid connection between the patient needle 2002 and the blood sample collection device 2004. In some implementations, the blood sample collection device 2004 includes a protective shield that includes a sealed collection needle on which a sealed vacuum-loaded container is placed, which, once pierced by the collection needle, draws in a blood sample under vacuum pressure or force through the conduit 2006 from the patient needle 2002.” outlet of blood sequestration device 2008 may be deliver the collected biological sample to a collection vessel / vacuum-loaded container through the conduit 2006 and the blood sample collection device 2004 where a vacuum-loaded / evacuated container would be understood to be under sub-atmospheric pressure as noted in Thomas, Col. 4, L. 39 – Col. 5, L. 4);
a first channel into which a first portion of the collected biological sample flows upon commencement of sample collection, the first channel comprising a first valve such that air in the first channel exits the first channel through the valve as the collected sample fills the first channel (Figs. 20 and 23A-23B, [0131]-[0132], [0135]-[0137] first channel 2306 into which a first portion of the collected biological sample flows upon commencement of a sample collection, the first channel comprising a first valve / hydrophobic plug 2312 such that air in the first channel exits the first through the valve as the collected sample fills the first channel);
a second channel into which a second portion of the collected sample flows after the first channel is substantially filled with collected sample, the second channel in fluid communication with the first channel through a second valve (Figs. 20 and 23A-23B, [0131]-[0132], [0135]-[0137] second channel / sampling channel 2308 and outlet port 2304 into which a second portion of the collected sample flows after the first channel is substantially filled with collected sample, the second channel in fluid communication with the first channel through a second valve / valve 2310. Examiner notes that there appears to be a typographical error where the valve is marked as 2308, but in consideration of the “sampling channel” being previously marked as 2308 and Fig. 23A showing a well-known valve 2310 on the sampling channel 2308, one can conclude the appropriate meaning);
wherein the outlet is adapted for attachment to a needle with a lumen, the needle adapted to pierce a seal on the collection vessel, such that the sub-atmospheric pressure of the collection vessel draws the biological sample from the diversion device to the collection vessel (Figs. 20 and 23A-23B, [0131], outlet of blood sequestration device is adapted for attachment to a needle / a sealed collection needle of blood sample collection device 2004 with a lumen / conduit 2006, “In some implementations, the blood sample collection device 2004 includes a protective shield that includes a sealed collection needle on which a sealed vacuum-loaded container is placed, which, once pierced by the collection needle, draws in a blood sample under vacuum pressure or force through the conduit 2006 from the patient needle 2002.” the needle adapted to pierce a seal on the collection vessel, such that the sub-atmospheric pressure of the collection vessel draws the biological sample from the diversion device to the collection vessel); and
wherein the first valve is a first hydrophobic flow restrictor comprising a barrier ([0135]-[0136]) and the second valve is a second hydrophobic flow restrictor comprising a barrier that impedes a flow of liquid ([0135]-[0136] valve 2310 “can also be formed as a flap, door or closable window or barrier within the sampling channel 2308.”),
and Rogers 445 further teaches that the first valve may alternatively be a filter with multiple layers ([0137] as a modification of the first valve in Figs. 23A-23B, [0154] where a more detailed example includes filters with blood reactive materials)
Rogers 445 fails to teach wherein the first valve is a first hydrophobic flow restrictor comprising two barriers each comprising an orifice and an air-gap therebetween and is configured as a barrier to a flow of liquid therethrough during collection of the biological sample and the second valve is a second hydrophobic flow restrictor comprising a barrier with a pore that is configured as a barrier that that impedes a flow of liquid therethrough during collection of the biological sample.
However Bullington 303 teaches a diversion device for collecting a biological sample (Abstract, Fig. 4, [0113]-[0122]), the diversion device comprising:
an inlet for receiving a biological sample collected from a patient (Fig. 4, inlet 412);
an outlet for delivering the collected biological sample to a collection vessel (Fig. 4, outlet 416),
a first channel into which a first portion of the collected biological sample flows upon commencement of sample collection, the first channel comprising a first valve such that air in the first channel exits the first channel through the valve as the collected sample fills the first channel (Fig. 4, [0118]-[0122] first channel / second portion 425 that collects a first portion of the collected biological sample upon commencement of sample collection, the flow controller 415 and flow restrictor 432 acting as the first valve together);
a second channel into which a second portion of the collected sample flows after the first channel is substantially filled with collected sample, the second channel in fluid communication with the first channel through a second valve ([0118]-[0122] second channel / first portion 424 that collects a subsequent portion of the collected sample after sequestration chamber 414 fills up, fluid communication between the channels occurs through a second valve / flow restrictor 431);
wherein the valves are hydrophobic flow restrictor with orifices/pores ([0079] “In some embodiments, the flow controller 215 can be formed of a porous material having any suitable pore size to, for example, permit a flow of air therethrough while limiting and/or substantially preventing a flow of liquid therethrough.”, [0049] fluid flow control mechanisms can be separately and/or used together, [0101] flow control mechanisms such as a porous material and hydrophobic material, [0133] “In such embodiments, a porosity and/or permeability of the porous material 436 can be adjusted to adjust a magnitude of a pressure differential sufficient to induce and/or result in a flow of fluid (e.g., bodily fluid) through the orifice or channel.” controlling for pore size and desired pressure differential enables a barrier of porous material to act as a flow restrictor).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the barriers of Rogers 445 can be configured as hydrophobic, porous material-based barriers as taught by Bullington 303 as a more specific teaching on how the hydrophobic plug first valve and the barrier second valve can accomplish their tasks. Specifically, Bullington 303’s porous material can be combined with hydrophobic material ([0049] synergizing with Rogers 445), act as Rogers 445’ first valve ([0079] “In some embodiments, the flow controller 215 can be formed of a porous material having any suitable pore size to, for example, permit a flow of air therethrough while limiting and/or substantially preventing a flow of liquid therethrough.”), and act as Rogers 445’ second valve (Bullington 303: [0133] “In such embodiments, a porosity and/or permeability of the porous material 436 can be adjusted to adjust a magnitude of a pressure differential sufficient to induce and/or result in a flow of fluid (e.g., bodily fluid) through the orifice or channel.”).
Yet their combined efforts fail to teach wherein the first valve is a first hydrophobic flow restrictor comprising two barriers each comprising an orifice and an air-gap therebetween,
Where the hydrophobic flow restrictor of this structure is configured as a barrier to a flow of liquid therethrough during collection of the biological sample.
However Davis teaches a blood sampling device (Abstract, Figs. 4-5, 10, 12A-14B, [0045]-[0046], [0051], [0060]-[0061], [0064]-[0067]) comprising a first channel where a biological sample collection occurs (Figs. 4-5, 10, 12A-14B, [0045]-[0046], [0051], [0060]-[0061], [0064] first channel comprises a blood sampling devices with a reservoir connected to the extravascular system), the first channel comprising a first valve such that air in the first channel exits the first channel through the valve as the collected sample fills the first channel ([0045]-[0046], [0051], [0060]-[0061], [0064] combination of mechanisms recognized as first valve include the gas permeable vent 604, the flow restrictor 620, and hole 706, these mechanisms enabling the collection of blood within the blood sampling device while allowing air in the first channel to exit through the gas permeable vent 604 as the collected sample fills the first channel),
wherein the first valve is a first hydrophobic flow restrictor comprising two barriers each comprising an orifice and an air-gap therebetween and is configured as a barrier to a flow of liquid therethrough during collection of the biological sample (Figs. 10, 12A-14B, [0060]-[0061], [0064] the combination of mechanisms recognized as first valve include the gas permeable vent 604 / barrier and barrier 704 with hole 706 / barrier with the collection space within the blood collection device considered an air gap, stopping blood flow collection through the first channel as the hole 706 / barrier’s size prevents flow outside of the internal reservoir, absent external pressure), and
where the vent can be hydrophobic ([0051]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the first hydrophobic flow restrictor / first barrier allowing the venting of air of Rogers 445 and Bullington 303 further include a second barrier spaced apart from the first barrier by an air gap as taught by Davis as additional structure that supports the goal of both Rogers 445 and Davis. Specifically, both blood sampling devices use a hydrophobic vent to enable the drawing of a fluid into a collection volume with the intention of isolating the fluid within this collection volume (Rogers 445: [0135] the sequestration chamber and Davis: [0051], [0064] the reservoir). The addition of Davis’ barrier 704 maintaining fluid within the volume will heighten the level of sequestration for Rogers 445. Further, the porosity / orifice characteristic of a hydrophobic vent that stops fluid flow was outlined above in the teachings of Bullington, rendering this characteristic obvious in view of the combined teachings of Rogers 445, Bullington 303, and Davis.
Regarding Claim 2, Rogers 445, Thomas, Bullington 303, and Davis teach the diversion device of claim 1, and Rogers 445 teaches wherein the inlet is adapted for connection to a line set for collecting a biological sample from a patient (Fig. 20, [0131]).
Regarding Claim 3, Rogers 445, Thomas, Bullington 303, and Davis teach the diversion device of claim 2, wherein the line set comprises a sample collection needle and a collection tube (See Claim 2 Rejection, Fig. 20, [0131] sample collection needle / patient needle 2002 and a collection tube being the tubing between the needle and the blood sequestration device 2008).
Regarding Claim 4, Rogers 445, Thomas, Bullington 303, and Davis teach the diversion device of claim 3, wherein the sample collection needle is a butterfly needle selected from the group consisting of a single-winged butterfly needle or a dual wing butterfly needle (See Claim 3 Rejection, [0013] system meant to function with butterfly needle systems and Fig. 20 shows a dual wing butterfly needle).
Regarding Claim 6, Rogers 445, Thomas, Bullington 303, and Davis teach the diversion device of claim 1, and Rogers 445 teaches wherein the diversion device is adapted to be coupled to an adapter that couples to a collection vessel (Fig. 5, patient needle 1 at input end and sample needle 5 at output end, [0072] connected by a luer lock connector to a connector to the sequestration system).
Regarding Claim 7, Rogers 445, Thomas, Bullington 303, and Davis teach the diversion device of claim 6, wherein the adapter is coupled to the diversion device by a threaded connection (See Claim 6 Rejection, luer lock connector).
Regarding Claim 8, Rogers 445, Thomas, Bullington 303, and Davis teach the diversion device of claim 7, wherein the adapter is coupled to the diversion device by a luer connector (See Claim 7 Rejection).
Regarding Claim 10, Rogers 445, Thomas, Bullington 303, and Davis teach the diversion device of claim 1, and Bullington 303 teaches wherein each orifice of 2 mm or less therein (See Claim 1 Rejection, [0079] membranes / porous material preventing fluid flow but allowing air flow may have pores / orifices of 0.45 micrometers (μm)).
Regarding Claim 12, Rogers 445, Thomas, Bullington 303, and Davis teach the diversion device of claim 1, and Bullington 303 teaches wherein the first channel is a serpentine channel (Fig. 4, Examiner considers the path comprising the second portion 425, the flow path 413, the sequestration chamber 414, the flow controller 415, and the flow restrictor 432 a serpentine channel).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that first channel of Rogers 445 be substituted with a serpentine channel as taught by Bullington 303 as a simple substitution of one form of a sequestration area (Rogers 445 Fig. 20 shows a straight line) for another (Bullington 303 Fig. 4 show a serpentine path) to obtain predictable results of initial sequestered blood sample.
Regarding Claim 13, Rogers 445, Thomas, Bullington 303, and Davis teach the diversion device of claim 12, and Bullington 303 teaches wherein the first channel has diameter of 3 mm to 4 mm ([0079] flow controller 215 shown to be flush with a second portion 225 / first channel, the flow controller having a diameter of 3 mm to 4 mm, [0113] teachings from the different embodiments may be freely adapted across each other).
Regarding Claim 14, Rogers 445, Thomas, Bullington 303, and Davis teach the diversion device of claim 1, and Bullington 303 teaches wherein the pore has a diameter of 0.5 µm or less (See Claim 1 Rejection, [0079] 0.45 µm or less).
Regarding Claim 30, Rogers 445, Thomas, Bullington 303, and Davis teach the diversion device of claim 1, wherein an outlet of the first valve is connected to the second channel (See Claim 1 Rejection, Rogers 445: outlet of the first valve 2312 through which air escapes is connected to second channel by connecting to output port 2304).
Regarding Claim 31, Rogers 445, Thomas, Bullington 303, and Davis teach the diversion device of claim 30, wherein the first valve comprises a passage configured to permit the flow of air therethrough but as a barrier to the flow of the collected biological sample therethrough (See Claim 30 Rejection, in view of the incorporated teachings of Davis).
Claim(s) 5, 19, 21, 23-25, and 32-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers 445 as evidenced by Thomas in view of Bullington 303 in view of Davis and further in view of Bullington et al (US 2019/0175087) (“Bullington 087”).
Regarding Claim 5, while Rogers 445, Thomas, Bullington 303, and Davis teach the diversion device of claim 4, their combined efforts fail to teach wherein the butterfly needle is a dual winged butterfly and the diversion device is integrated into one wing of the butterfly.
However Bullington 087 teaches a fluid sequestration device (Abstract) comprising a fluid control device configured like a dual winged butterfly needle with sequestration portions housed within the wings of the butterfly needle ([0119]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the sequestration chamber of Rogers 445 and Bullington 303 be placed in the wings of the butterfly needle as taught by Bullington 087 as a positive recitation of how the coupling of the inlet in Rogers 445 and Bullington 303 is accomplished. Furthermore, it would be obvious that one can limit the sequestration device of the butterfly wings of Bullington 087 to a single butterfly wing as an obvious rearrangement of parts that does not modify the operation of the device [In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice)].
Regarding Claim 19, while Rogers 445 teaches a diversion device assembly for collecting a biological sample (Abstract, Figs. 20 and 23A-23B, [0131]-[0132], [0135]-[0137] general diversion device / blood sequestration device 2008 with a specific example given by Fig. 23), the diversion device comprising:
A butterfly needle (Fig. 20, [0013], [0131] patient needle 2002 shown as a butterfly needle);
an inlet for receiving a biological sample collected from a patient (Figs. 20 and 23A-23B, [0131]-[0132] “FIG. 20 shows a blood sample optimization system 2000 that includes a patient needle 2002 for vascular access to a patient's bloodstream,” inlet of blood sequestration device 2008 connects to biological sample collector);
an outlet for delivering the collected biological sample to a collection vessel, the collection vessel being under sub-atmospheric pressure (Figs. 20 and 23A-23B, [0131]-[0132] “a blood sample collection device 2004 to facilitate the collecting of one or more blood samples, and a conduit 2006 providing a fluid connection between the patient needle 2002 and the blood sample collection device 2004. In some implementations, the blood sample collection device 2004 includes a protective shield that includes a sealed collection needle on which a sealed vacuum-loaded container is placed, which, once pierced by the collection needle, draws in a blood sample under vacuum pressure or force through the conduit 2006 from the patient needle 2002.” outlet of blood sequestration device 2008 may be deliver the collected biological sample to a collection vessel / vacuum-loaded container through the conduit 2006 and the blood sample collection device 2004 where a vacuum-loaded / evacuated container would be understood to be under sub-atmospheric pressure as noted in Thomas, Col. 4, L. 39 – Col. 5, L. 4);
a first channel into which a first portion of the collected biological sample flows upon commencement of sample collection, the first channel comprising a first valve such that air in the first channel exits the first channel through the valve as the collected sample fills the first channel (Figs. 20 and 23A-23B, [0131]-[0132], [0135]-[0137] first channel 2306 into which a first portion of the collected biological sample flows upon commencement of a sample collection, the first channel comprising a first valve / hydrophobic plug 2312 such that air in the first channel exits the first through the valve as the collected sample fills the first channel);
a second channel into which a second portion of the collected sample flows after the first channel is substantially filled with collected sample, the second channel in fluid communication with the first channel through a second valve (Figs. 20 and 23A-23B, [0131]-[0132], [0135]-[0137] second channel / sampling channel 2308 and outlet port 2304 into which a second portion of the collected sample flows after the first channel is substantially filled with collected sample, the second channel in fluid communication with the first channel through a second valve / valve 2310. Examiner notes that there appears to be a typographical error where the valve is marked as 2308, but in consideration of the “sampling channel” being previously marked as 2308 and Fig. 23A showing a well-known valve 2310 on the sampling channel 2308, one can conclude the appropriate meaning);
wherein the second channel is in fluid communication with an adapter wherein the adapter receives the collected biological sample from the second channel and wherein an adapter outlet is adapted for attachment to a needle with a lumen, the needle adapter to pierce a seal on a collection vessel, such that the sub-atmospheric pressure of the collection vessel draws the biological sample from the diversion device to the collection vessel (Figs. 20 and 23A-23B, [0131], outlet of blood sequestration device is adapted for attachment to a needle / a sealed collection needle of blood sample collection device 2004 with a lumen / conduit 2006, “In some implementations, the blood sample collection device 2004 includes a protective shield that includes a sealed collection needle on which a sealed vacuum-loaded container is placed, which, once pierced by the collection needle, draws in a blood sample under vacuum pressure or force through the conduit 2006 from the patient needle 2002.” the needle adapted to pierce a seal on the collection vessel, such that the sub-atmospheric pressure of the collection vessel draws the biological sample from the diversion device to the collection vessel. Further, regarding the adapter, in Fig. 5, [0072] patient needle 1 at input end and sample needle 5 at output end and both identified as connected by a luer lock connector / adapter to a connector / adapter to the sequestration system); and
wherein the first valve is a first hydrophobic flow restrictor comprising a barrier ([0135]-[0136]) and the second valve is a second hydrophobic flow restrictor comprising a barrier that impedes a flow of liquid ([0135]-[0136] valve 2310 “can also be formed as a flap, door or closable window or barrier within the sampling channel 2308.”),
and Rogers 445 further teaches that the first valve may alternatively be a filter with multiple layers ([0137] as a modification of the first valve in Figs. 23A-23B, [0154] where a more detailed example includes filters with blood reactive materials)
Rogers 445 fails to teach wherein the first valve is a first hydrophobic flow restrictor comprising two barriers each comprising an orifice and an air-gap therebetween and the second valve is a second hydrophobic flow restrictor comprising a barrier with a pore that impedes a flow of liquid.
However Bullington 303 teaches a diversion device for collecting a biological sample (Abstract, Fig. 4, [0113]-[0122]), the diversion device comprising:
an inlet for receiving a biological sample collected from a patient (Fig. 4, inlet 412);
an outlet for delivering the collected biological sample to a collection vessel (Fig. 4, outlet 416),
a first channel into which a first portion of the collected biological sample flows upon commencement of sample collection, the first channel comprising a first valve such that air in the first channel exits the first channel through the valve as the collected sample fills the first channel (Fig. 4, [0118]-[0122] first channel / second portion 425 that collects a first portion of the collected biological sample upon commencement of sample collection, the flow controller 415 and flow restrictor 432 acting as the first valve together);
a second channel into which a second portion of the collected sample flows after the first channel is substantially filled with collected sample, the second channel in fluid communication with the first channel through a second valve ([0118]-[0122] second channel / first portion 424 that collects a subsequent portion of the collected sample after sequestration chamber 414 fills up, fluid communication between the channels occurs through a second valve / flow restrictor 431);
wherein the valves are hydrophobic flow restrictor with orifices/pores ([0079] “In some embodiments, the flow controller 215 can be formed of a porous material having any suitable pore size to, for example, permit a flow of air therethrough while limiting and/or substantially preventing a flow of liquid therethrough.”, [0049] fluid flow control mechanisms can be separately and/or used together, [0101] flow control mechanisms such as a porous material and hydrophobic material, [0133] “In such embodiments, a porosity and/or permeability of the porous material 436 can be adjusted to adjust a magnitude of a pressure differential sufficient to induce and/or result in a flow of fluid (e.g., bodily fluid) through the orifice or channel.” controlling for pore size and desired pressure differential enables a barrier of porous material to act as a flow restrictor)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the barriers of Rogers 445 can be configured as hydrophobic, porous material-based barriers as taught by Bullington 303 as a more specific teaching on how the hydrophobic plug first valve and the barrier second valve can accomplish their tasks. Specifically, Bullington 303’s porous material can be combined with hydrophobic material ([0049] synergizing with Rogers 445), act as Rogers 445’ first valve ([0079] “In some embodiments, the flow controller 215 can be formed of a porous material having any suitable pore size to, for example, permit a flow of air therethrough while limiting and/or substantially preventing a flow of liquid therethrough.”), and act as Rogers 445’ second valve (Bullington 303: [0133] “In such embodiments, a porosity and/or permeability of the porous material 436 can be adjusted to adjust a magnitude of a pressure differential sufficient to induce and/or result in a flow of fluid (e.g., bodily fluid) through the orifice or channel.”).
Yet their combined efforts fail to teach wherein the first valve is a first hydrophobic flow restrictor comprising two barriers each comprising an orifice and an air-gap therebetween,
Where the hydrophobic flow restrictor of this structure is configured as a barrier to a flow of liquid therethrough during collection of the biological sample.
However Davis teaches a blood sampling device (Abstract, Figs. 4-5, 10, 12A-14B, [0045]-[0046], [0051], [0060]-[0061], [0064]-[0067]) comprising a first channel where a biological sample collection occurs (Figs. 4-5, 10, 12A-14B, [0045]-[0046], [0051], [0060]-[0061], [0064] first channel comprises a blood sampling devices with a reservoir connected to the extravascular system), the first channel comprising a first valve such that air in the first channel exits the first channel through the valve as the collected sample fills the first channel ([0045]-[0046], [0051], [0060]-[0061], [0064] combination of mechanisms recognized as first valve include the gas permeable vent 604, the flow restrictor 620, and hole 706, these mechanisms enabling the collection of blood within the blood sampling device while allowing air in the first channel to exit through the gas permeable vent 604 as the collected sample fills the first channel),
wherein the first valve is a first hydrophobic flow restrictor comprising two barriers each comprising an orifice and an air-gap therebetween and is configured as a barrier to a flow of liquid therethrough during collection of the biological sample (Figs. 10, 12A-14B, [0060]-[0061], [0064] the combination of mechanisms recognized as first valve include the gas permeable vent 604 / barrier and barrier 704 with hole 706 / barrier with the collection space within the blood collection device considered an air gap, stopping blood flow collection through the first channel as the hole 706 / barrier’s size prevents flow outside of the internal reservoir, absent external pressure), and
where the vent can be hydrophobic ([0051]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the first hydrophobic flow restrictor / first barrier allowing the venting of air of Rogers 445 and Bullington 303 further include a second barrier spaced apart from the first barrier by an air gap as taught by Davis as additional structure that supports the goal of both Rogers 445 and Davis. Specifically, both blood sampling devices use a hydrophobic vent to enable the drawing of a fluid into a collection volume with the intention of isolating the fluid within this collection volume (Rogers 445: [0135] the sequestration chamber and Davis: [0051], [0064] the reservoir). The addition of Davis’ barrier 704 maintaining fluid within the volume will heighten the level of sequestration for Rogers 445. Further, the porosity / orifice characteristic of a hydrophobic vent that stops fluid flow was outlined above in the teachings of Bullington, rendering this characteristic obvious in view of the combined teachings of Rogers 445, Bullington 303, and Davis.
Yer their combined efforts fail to teach a diversion device integrated on the butterfly needle.
However Bullington 087 teaches a fluid sequestration device (Abstract) comprising a fluid control device configured like a dual winged butterfly needle with sequestration portions housed within the wings of the butterfly needle ([0119]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that the sequestration chamber of Rogers 445 and Bullington 303 be placed in the wings of the butterfly needle as taught by Bullington 087 as a positive recitation of how the coupling of the inlet in Rogers 445 and Bullington 303 is accomplished. Furthermore, it would be obvious that one can limit the sequestration device of the butterfly wings of Bullington 087 to a single butterfly wing as an obvious rearrangement of parts that does not modify the operation of the device [In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice)].
Regarding Claim 21, Rogers 445, Thomas, Bullington 303, Davis, and Bullington 087 teach the diversion device of claim 19, and Bullington 303 teaches wherein orifice has a diameter of 2 mm or less therein (See Claim 19 Rejection, [0079] orifices / pores having a size of about 0.45 micrometers (µm)).
Regarding Claim 23, Rogers 445, Thomas, Bullington 303, Davis, and Bullington 087 teach the diversion device of claim 19, and Bullington 303 wherein the first channel is a serpentine channel (See Claim 19 Rejection, Fig. 4, Examiner considers the path comprising the second portion 425, the flow path 413, the sequestration chamber 414, the flow controller 415, and the flow restrictor 432 a serpentine channel).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, that first channel of Rogers 445 be substituted with a serpentine channel as taught by Bullington 303 as a simple substitution of one form of a sequestration area (Rogers 445 Fig. 20 shows a straight line) for another (Bullington 303 Fig. 4 show a serpentine path) to obtain predictable results of initial sequestered blood sample.
Regarding Claim 24, Rogers 445, Thomas, Bullington 303, Davis, and Bullington 087 teach the diversion device of claim 23, and Bullington 303 teaches wherein the first channel has a diameter ranging from 3 mm to 4 mm ([0079] flow controller 215 shown to be flush with a second portion 225 / first channel, the flow controller having a diameter of 3 mm to 4 mm, [0113] teachings from the different embodiments may be freely adapted across each other).
Regarding Claim 25, Rogers 445, Thomas, Bullington 303, Davis, and Bullington 087 teach the diversion device of claim 21, and Bullington 303 teaches wherein the pore has a diameter of 0.5 µm or less (See Claim 21 Rejection, [0079] 0.45 µm or less).
Regarding Claim 32, Rogers 445, Thomas, Bullington 303, Davis, and Bullington 087 teach the diversion device of claim 19, wherein an outlet of the first valve connected to the second channel (See Claim 19 Rejection, Rogers 445: outlet of the first valve 2312 through which air escapes is connected to second channel by connecting to output port 2304).
Regarding Claim 33, Rogers 445, Thomas, Bullington 303, Davis, and Bullington 087 teach the diversion device of claim 32, wherein the first valve comprises a passage configured to permit the flow of air therethrough but as a barrier to the flow of the collected biological sample therethrough (See Claim 32 Rejection, in view of the incorporated teachings of Davis).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers 445 as evidenced by Thomas in view of Bullington 303 in view of Davis and further in view of Rogers et al (US 2020/0305780) (“Rogers 780”).
Regarding Claim 18, while Rogers 445, Thomas, Bullington 303, and Davis teach the diversion device of claim 1, their combined efforts fail to teach wherein the hydrophobic flow restrictor is made of one of polytetrafluoroethylene (PTFE) or polypropylene.
However Rogers 780 teaches a blood sequestration system (Abstract) wherein a hydrophobic coating is made of one of polytetrafluoroethylene (PTFE) or polypropylene ([0066]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to create the hydrophobic flow restrictor of Rogers 445 and Bullington 303 with the material of polytetrafluoroethylene (PTFE) as taught by Rogers 780 as a way to standardize the construction of the diversion device and increase consistency between results across applications of the invention.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rogers 445 as evidenced by Thomas in view of Bullington 303 and further in view of Davis and further in view of Bullington 087 and further in view of Rogers 780.
Regarding Claim 29, while Rogers 445, Thomas, Bullington 303, Davis, and Bullington 087 teach the diversion device of claim 19, their combined efforts fail to teach wherein the hydrophobic flow restrictor is made of one of polytetrafluoroethylene (PTFE) or polypropylene.
However Rogers 780 teaches a blood sequestration system (Abstract) wherein a hydrophobic coating is made of one of polytetrafluoroethylene (PTFE) or polypropylene ([0066]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to create the hydrophobic flow restrictor of Rogers 445 and Bullington 303 with the material of polytetrafluoroethylene (PTFE) as taught by Rogers 780 as a way to standardize the construction of the diversion device and increase consistency between results across applications of the invention.
Response to Arguments
Applicant’s amendments and arguments filed 2/25/2026 with respect to the 35 USC 103 rejections 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
Rogers 445, Thomas, Bullington 303, and Davis for Claim 1,
Rogers 445, Thomas, Bullington 303, Davis, and Bullington 870 for Claim 19,
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791