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 .
Applicant’s arguments filed in the reply on June 3, 2026 were received and fully considered. Please see below for more detail.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The term “wherein the measured gas pressure decreases as the blood flows into the collection vessel” fails to further limit the claim as Applicant seems to be reciting a detail of Boyle’s Law equation, a property inherent to gas pressure (see Specification [0046]). Thus this language does not further limit the claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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) 1-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feijen et al (WO 2021/023773) (“Feijen”) as noted in Applicant IDS dated 2/22/204 in view of Delnevo (US 2004/0231414).
Regarding Claim 1, while Feijen teaches a method for determining an accurate target fill volume of blood in a collection vessel (Abstract, Fig. 1, [0007]-[0013], [0045]), the method comprising:
providing a blood metering device (Fig. 1, [0045] blood metering device / blood metering device 130) comprising:
a housing comprising an inlet and an outlet (Fig. 1, [0045], [0054] blood metering device 130 shown with a housing / adaptor unit 150 with an inlet connecting to tubing 120 and an outlet connecting to collection bottle 160); and
a blood flow conduit disposed in the housing, the blood flow conduit providing a continuous conduit from the inlet to the outlet ([0052]-[0053] blood flow conduit / blood flow path 162);
connecting the blood metering device to the collection vessel such that the blood metering device is in fluid communication with the collection vessel ([0054] blood metering device / blood metering device 130 connected to collection vessel / culture bottle 160);
inputting the target fill volume to the blood metering device ([0059] where a preset step, and thus a preliminary step of the process, includes selecting a target fill volume);
determining a target sensor value ([0026] sensor signals are associated with blood volume, enabling a determination of a target sensor value corresponding to predetermined volume of blood);
collecting a blood sample from a patient by venipuncture, thereby causing blood to flow through the blood metering device to the collection vessel ([0026], [0045]-[0046]);
repeatedly measuring a sensor value as blood flows into the collection vessel ([0026], [0045]-[0046], [0054]);
repeatedly comparing the measured sensor value with the target sensor value ([0026], [0045]-[0046], [0054]); and
stopping the blood from flowing into the collection vessel when the measured sensor value is equal to the target sensor value ([0026], [0045]-[0046], [0054]),
where a wide variety of sensor values can be used for the system ([0014] a paddle wheel flow detector is mainly described, but it is noted as an optional modality with multiple others envisioned).
Feijen fails to teach the method comprising the sensor value being a gas pressure, necessitating the method steps to be
determining a target gas pressure in the collection vessel;
repeatedly measuring a gas pressure in the collection vessel as blood flows into the collection vessel;
repeatedly comparing the measured gas pressure with the target gas pressure; and
stopping the blood from flowing into the collection vessel when the measured gas pressure is equal to the target gas pressure.
However Delnevo teaches a method for identifying a collected blood volume (Abstract, [0017]-[0025]) based on a container of set volume, the container comprising a volume of air and a volume of blood and the volume of blood determined based on detected gas pressure ([0017]-[0025] relationship of detected gas pressure, detected flow rate, temperature, volume of air, and volume of container used to measure of volume of blood in system, [0026]-[0045] two different techniques outlined).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to perform the blood volume monitoring by gas pressure of Delnevo for the blood volume monitoring of Feijen as an example sensing modality used to accomplish the system control desired in Feijen ([0014]).
Regarding Claim 2, Feijen and Delnevo teach the method of claim 1, wherein the target gas pressure indicates that the target fill volume of blood has entered the collection vessel (See Claim 1 Rejection).
Regarding Claim 3, Feijen and Delnevo teach the method of claim 1, and Delnevo teaches the method further comprising, before determining a target gas pressure in the collection vessel, determining an initial gas pressure in the collection vessel and initial gas volume in the collection vessel ([0038]-[0045] initial gas pressure determined, [0040]-[0041] with initial gas volume determined from a disturbance step).
Regarding Claim 4, Feijen and Delnevo teach the method of claim 3, wherein the initial gas pressure is a pressure in the collection vessel before collecting the blood sample from the patient (See Claim 3 Rejection).
Regarding Claim 5, Feijen and Delnevo teach the method of claim 3, wherein the initial gas volume is a gas volume in the collection vessel before collecting the blood sample from the patient (See Claim 3 Rejection).
Regarding Claim 6, Feijen and Delnevo teach the method of claim 3, wherein the target gas pressure is determined based on the target fill volume, initial gas pressure, and initial gas volume (See Claim 3 Rejection, when Feijen’s sensor values are gas pressure of the collection vessel and Delnevo’s steps are utilized, the initial gas pressure and the initial gas volume are used to identify initial blood volume, which is then used to identify how much gas pressure target value to use as a comparison point for the blood collection).
Regarding Claim 7, Feijen and Delnevo teach the method of claim 1, wherein the target fill volume is a desired amount of blood to be filled within the collection vessel.
Regarding Claim 8, Feijen and Delnevo teach the method of claim 1, wherein the measured gas pressure decreases as the blood flows into the collection vessel (See Claim 1 Rejection, an inherent outcome of a reduction in gas pressure as noted by Boyle’s law and confirmed in paragraph [0046] of Applicant’s Specification dated 2/22/2024).
Regarding Claim 9, while Feijen teaches a blood metering device for determining an accurate target fill volume of blood in a collection vessel (Abstract, Fig. 1, [0007]-[0013], [0045] blood metering device / blood metering device 130), the blood metering device comprising:
a housing comprising an inlet and an outlet (Fig. 1, [0045], [0054] blood metering device 130 shown with a housing / adaptor unit 150 with an inlet connecting to tubing 120 and an outlet connecting to collection bottle 160); and
a blood flow conduit defined in the housing, the blood flow conduit providing a continuous conduit from the inlet to the outlet ([0052]-[0053] blood flow conduit / blood flow path 162);
a valve disposed in the blood flow conduit wherein a valve operation is controlled by a valve actuator for moving the valve from an open position to a closed position, wherein the valve actuator is responsive to a measured sensor value in a collection vessel in fluid communication with the outlet of the housing where the valve is moved to the closed position when the measured sensor value is approximately equal to a target sensor value ([0026] sensor signals are associated with blood volume, enabling a determination of a target sensor value corresponding to predetermined volume of blood, [0045]-[0048], [0054] valve actuator 188 and valve 189 controlled by sensor values to reach predetermined fill volume);
where a wide variety of sensor values can be used for the system ([0014] a paddle wheel flow detector is mainly described, but it is noted as an optional modality with multiple others envisioned).
Feijen fails to teach the method comprising the sensor value being a gas pressure.
However Delnevo teaches a method for identifying a collected blood volume (Abstract, [0017]-[0025]) based on a container of set volume, the container comprising a volume of air and a volume of blood and the volume of blood determined based on detected gas pressure ([0017]-[0025] relationship of detected gas pressure, detected flow rate, temperature, volume of air, and volume of container used to measure of volume of blood in system, [0026]-[0045] two different techniques outlined).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to perform the blood volume monitoring by gas pressure of Delnevo for the blood volume monitoring of Feijen as an example sensing modality used to accomplish the system control desired in Feijen ([0014]).
Regarding Claim 10, Feijen and Delnevo teach the blood metering device of claim 9, wherein the target gas pressure in the collection vessel indicates that the target fill volume of blood has entered the collection vessel (See Claim 9 Rejection).
Regarding Claim 11, Feijen and Delnevo teach the blood metering device of claim 9, wherein the target gas pressure is determined based on the target fill volume, initial gas pressure, and initial gas volume (See Claim 9 Rejection, when Feijen’s sensor values are gas pressure of the collection vessel and Delnevo’s steps are utilized, the initial gas pressure and the initial gas volume are used to identify initial blood volume, which is then used to identify how much gas pressure target value to use as a comparison point for the blood collection).
Regarding Claim 12, Feijen and Delnevo teach the blood metering device of claim 11, wherein the target fill volume, initial gas pressure, and initial gas volume are a desired amount of blood to be filled within the collection vessel, a pressure in the collection vessel before collecting a blood sample from a patient, and a gas volume in the collection vessel before collecting the blood sample from the patient, respectively (See Claim 9 Rejection, based on how the term ‘initial’ is understood).
Regarding Claim 13, Feijen and Delnevo teach the blood metering device of claim 9, wherein the blood flow conduit includes a first portion with a first inner diameter, a second portion with a second inner diameter, and a transition portion from the first inner diameter to the second inner diameter (See Claim 13 Rejection, the diameters are not noted as different in size and thus the length of the conduit can be considered a first portion, a second portion, and a transition portion).
Claim(s) 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feijen in view of Delnevo and further in view of Ono et al (US 2021/0387180) (“Ono”).
Regarding Claim 14, Feijen and Delnevo teach the blood metering device of claim 13, their combined efforts fail to teach wherein the first inner diameter is larger than the second inner diameter.
However Ono teaches a blood collection system (Abstract) where fluid flow may be controlled by a valve interacting with a frustum-shaped fluid path (Abstract, Figs. 11-13, [0100]-[0111] inner space 64, showing a first inner diameter larger than a second inner diameter and a valve member 63 and rod member 82 selectively block off the fluid passage based on the valve member 63 interfacing with an inner diameter that blocks forward movement).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to replace the valve of Feijen with the valve of Ono as a simple substitution of valve structure in a fluid directing system (Feijen Figs. 2B-2C where actuation of valve actuator 189 downward will block passage into outlet channel 166) for another (Feijen Figs. 11-13 where actuation of valve of sealing instrument 60 includes downward actuation so valve member 63 will block passage back out of the sealing instrument) to obtain predictable results of controlled flow of fluid. Furthermore, it would be obvious that these valves can be substituted as they both work on a downward actuation to block a passage. Finally, if the valve of Ono replaces the valve of Feijen, then Fig. 2C’s valve structure would have the outlet channel 66 connect to channel 169 by a frustrum shape, with a first inner diameter is larger than a second inner diameter for controlled fluid flow.
Regarding Claim 15, while Feijen and Delnevo teach the blood metering device of claim 13, their combined efforts fail to teach wherein the valve comprises a sealing portion and a rod portion operable from the open position to the closed position.
However Ono teaches a blood collection system (Abstract) where fluid flow may be controlled by a valve interacting with a frustum-shaped fluid path (Abstract, Figs. 11-13, [0100]-[0111] inner space 64, showing a first inner diameter larger than a second inner diameter and a valve member 63 and rod member 82 selectively block off the fluid passage based on the valve member 63 interfacing with an inner diameter that blocks forward movement).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to replace the valve of Feijen with the valve of Ono as a simple substitution of valve structure in a fluid directing system (Feijen Figs. 2B-2C where actuation of valve actuator 189 downward will block passage into outlet channel 166) for another (Feijen Figs. 11-13 where actuation of valve of sealing instrument 60 includes downward actuation so valve member 63 will block passage back out of the sealing instrument) to obtain predictable results of controlled flow of fluid. Furthermore, it would be obvious that these valves can be substituted as they both work on a downward actuation to block a passage. Finally, if the valve of Ono replaces the valve of Feijen, then Fig. 2C’s valve structure would have the outlet channel 66 connect to channel 169 by a frustrum shape, with a sealed portion and rod portion controlling the opening and closing position of the location.
Regarding Claim 16, Feijen, Delnevo, and Ono teach the blood metering device of claim 15, wherein the valve blocks flow of blood in the blood flow conduit in the closed position by drawing the sealing portion into the transition portion, thereby sealing the first portion off from the second portion (See Claim 15 Rejection).
Regarding Claim 17, while Feijen and Delnevo teach the blood metering device of claim 13, their combined efforts fail to teach wherein the transition portion is frustrum-shaped and connects the first portion at one end and the second portion at the other end.
However Ono teaches a blood collection system (Abstract) where fluid flow may be controlled by a valve interacting with a frustum-shaped fluid path (Abstract, Figs. 11-13, [0100]-[0111] inner space 64, showing a first inner diameter larger than a second inner diameter and a valve member 63 and rod member 82 selectively block off the fluid passage based on the valve member 63 interfacing with an inner diameter that blocks forward movement).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to replace the valve of Feijen with the valve of Ono as a simple substitution of valve structure in a fluid directing system (Feijen Figs. 2B-2C where actuation of valve actuator 189 downward will block passage into outlet channel 166) for another (Feijen Figs. 11-13 where actuation of valve of sealing instrument 60 includes downward actuation so valve member 63 will block passage back out of the sealing instrument) to obtain predictable results of controlled flow of fluid. Furthermore, it would be obvious that these valves can be substituted as they both work on a downward actuation to block a passage. Finally, if the valve of Ono replaces the valve of Feijen, then Fig. 2C’s valve structure would have the outlet channel 66 connect to channel 169 by a frustrum shape, with a first inner diameter is larger than a second inner diameter for controlled fluid flow.
Regarding Claim 18, Feijen, Delnevo, and Ono teach the blood metering device of claim 15, wherein the rod portion connects the valve and valve actuator and extends through a hole defined on the second portion of the blood flow conduit (See Claim 15 Rejection, the rod portion would connect the valve actuator 189 at the top of Feijen with the sealing valve component at the entrance of the outlet channel 166).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Feijen in view of Delnevo and further in view of Sundström et al (WO 2010/112555) (“Sundstrom”).
Regarding Claim 19, while Feijen and Delnevo teach the blood metering device of claim 9, further comprising a first needle for filling blood in the collection vessel and measures gas pressure in the collection vessel at a similar location (See Claim 9 Rejection, first needle is needle 152, where Delnevo teaches a gas pressure sensor placed near the entrance of the collection bottle), their combined efforts fail to teach a second needle for measuring gas pressure in the collection vessel.
However Sundstrom teaches a needle system performing pressure sensing and fluid delivery (Abstract, Fig. 3, p6, L. 37 – p7, L. 15) where both function mays be performed by a double needles (p7, L. 27 - p8, L. 9).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the needle interface of Feijen and Delnevo be two needles that measures gas pressure and provides blood filling as Sundstrom teaches that such a needle structure can be advantageous by performing both functionalities at a singular location and without system movement (p8, L. 16-19).
Regarding Claim 20, while Feijen and Delnevo teach the blood metering device of claim 9, further comprising a single needle for filling blood in the collection vessel and measures gas pressure in the collection vessel at a similar location (See Claim 9 Rejection, first needle is needle 152, where Delnevo teaches a gas pressure sensor placed near the entrance of the collection bottle), their combined efforts fail to teach the device further comprising a double lumen needle for filling blood in the collection vessel and measuring gas pressure in the collection vessel.
However Sundstrom teaches a needle system performing pressure sensing and fluid delivery (Abstract, Fig. 3, p6, L. 37 – p7, L. 15) where both function mays be performed by a double lumen needle (p7, L. 27 - p8, L. 9).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the needle interface of Feijen and Delnevo be a dual lumen needle that measures gas pressure and provides blood filling as Sundstrom teaches that such a needle structure can be advantageous by performing both functionalities at a singular location and without system movement (p8, L. 16-19).
Response to Arguments
Applicant’s amendments and arguments filed 6/03/2026 with respect to the 35 USC 112(d) rejections have been fully considered, but are not persuasive. Applicant states that Boyle’s Law states that ‘the pressure of a given quantity of gas varies inversely with its volume.’ Applicant also states that the ‘pressure decreases as the fill volume increases (and the gas volume decreases)’ and thus the relationship between the measured gas pressure and the increasing fill volume in the collection is narrowed. Examiner respectfully disagrees. If Boyle’s Law states that ‘the pressure of a given quantity of gas varies inversely with its volume’ and Applicant’s invention includes a fill volume of a container increasing, displacing gas which reduces the gas volume, then logically the pressure of the of the gas will also decreases as the gas volume decrease. The rejection stands.
Applicant’s amendments and arguments filed 6/03/2026 with respect to the 35 USC 103 rejections have been fully considered, but are not persuasive.
Applicant argues on pages 7-8 that Delnevo teaches a dialysis machine with a container having a determined shape and known volume, with hardware such as temperature sensors and pressure sensors, to hermetically seal a container for both supplying and returning blood as opposed to the present application which intends to just store the blood sample for further use. Thus Delnevo’s objective is to maintain a level of blood in a container and does not disclose or suggest stopping the blood from flowing into the collection vessel when the measured gas pressure is equal to the target gas pressure. Examiner respectfully notes that the rejection is based on the combination of Feijen and Delnevo. Feijen teaches stopping the blood from flowing into the collection vessel when a measured value is equal to a target value. Delnevo is simply referred to teach that gas pressure measurements can be used for controlling the amount of blood in a vessel, within a similar field of art.
Applicant argues on pages 8-12 of the Remarks that Delnevo describes a method based on the principle of disturbance of the overall mass contained in container 5. Specifically, the volume is determined from the changes of mass of blood in the container, calculating an integral of the balance of the blood inflow rate and outflow rate, measuring gas pressures, and assuming the volume of the container and temperature are constant. This reflects a requirement for a flow rate measurement, not seen in the Present Application. This is distinct from the monitoring specifics of the Present Application outlined in pages 9-12. Examiner respectfully notes that the claim language does not prevent the addition of flow rate as a dataset to accomplish the claim language. Further, Feijen is the reference being modified and Feijen positively teaches the various method steps. Whether either reference teaches exact claim language is immaterial as their combination renders the claim language obvious.
Applicant argues on pages 12-13 that Ono’s valve member 13 prevents filtered diluent from flowing back into a flow channel and is not responding to measured gas pressure. Thus it would not render obvious the language of claim 14. Examiner respectfully disagrees. Control of a valve is taught by Feijin. Ono is simply providing an alternate example structure for the valve in Feijen, that still accomplishes the desired control of blood collection.
Applicant argues on page 14 of the Remarks that Sundstrom is directed to a postoperative CSF dynamical examination, used to improve regulation of cerebrospinal fluid circulation. This is a fundamentally different problem than the one Applicant is trying to solve. Further, Sundstrom does not remedy the previous deficiencies of Feijen. Examiner respectfully disagrees. The addition of Sundstrom does not necessitate that the references of Feijen and Sundstrom are attempting to solve the same problem. Rather, the question is whether they are in similar art, and would the teachings of Sundstrom render certain modifications in Feijen obvious. And Examiner considers the references to be in similar art as they are directed to fluid managements systems for a human patient. Further, as Feijen and Delnovo already teach the control of blood delivery and gas pressure measurements, identifying a paired structure for fluid delivery and gas pressure measurements as seen in Sundstrom would motivate one of ordinary skill in the art to consider the applicability of such structure for their own invention. Examiner maintains that the combination is obvious. The rejection(s) stand.
Consequently, claims 2-8 and 10-20 remain rejected due to their dependency on rejected independent claims 1 and 9.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
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