DETAILED ACTION
This action is responsive to the amendments and Applicant’s Remarks filed 17 February 2026. The Examiner acknowledges the amendments to claims 1, 4-5, 24, 27, and 30. Claims 1-2, 4-8, 10-11, 13-17, and 21-30 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 Objections
Claim(s) 25 and 30 objected to because of the following informalities:
Claim 25 should read “based on a signal from the processor” [line 3].
Claim 30 should read “wherein the adapter unit has disposed therein [[is]] a paddle wheel” [line 5].
Appropriate correction is required.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4-8, 10, 13-17, 25, and 27-30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bullington (US-20140155782-A1, previously presented) in view of Franano (US-20140296615-A1) and Sharma (US-20200138301-A1, EFD of 2 November 2018, previously presented).
Regarding claim 1, Bullington teaches
A blood metering device comprising:
an adapter unit [diversion mechanism 520 (Bullington ¶0123, Fig. 29)] comprising a housing [housing 501 (Bullington ¶0123, Fig. 29)] that defines a blood flow pathway that is adapted to be connected to a blood collection set [The housing 501 is physically and fluidically coupled to the distribution member 529, and provides and/or defines a set of fluid flow pathways for collecting bodily-fluids from the patient (Bullington ¶0123); an inlet port 521 that can be fluidically coupled to a medical device (either directly or indirectly via an adapter 504) that defines a fluid flow pathway for withdrawing and/or conveying bodily-fluid from a patient to the collection device 500 (Bullington ¶0128)], wherein the adapter unit has disposed therein a paddle wheel [flow metering mechanism 567 (Bullington ¶126, Fig. 31)] that measures a volume of blood flowing through the blood flow pathway [bodily-fluid can enter the inlet port 553 of the movable member 550 and flow past the flow metering device 567, which in turn, can result in a rotation of the flow metering device 567 relative to the movable member 550. Thus, characteristics of the rotation of the flow metering device 567 can be operable in determining a volume of bodily-fluid transferred to the inner volume 552 of the movable member 550, a volumetric flow rate, and/or the like (Bullington ¶0126)], wherein the paddle wheel rotates freely in the housing [The flow metering mechanism 567 can be, for example, a wheel or the like that can include a set of spokes or fins (e.g., a turbine or the like). In this manner, bodily-fluid can enter the inlet port 553 of the movable member 550 and flow past the flow metering device 567, which in turn, can result in a rotation of the flow metering device 567 relative to the movable member 550 (Bullington ¶0126, Fig. 31), wherein the paddle wheel allowing for rotation in response to flow is considered to read on being freely rotatable];
a sensor unit that is responsive to a determination that a predetermined volume of blood has passed through the adapter unit [the flow metering mechanism included therein can send a signal or the like to the display that is operable in lighting the first light, the second light, and/or the third light according to a volume of bodily-fluid that is transferred through the movable member 550 (Bullington ¶0136), wherein any electronics not specifically depicted by Bullington may read on the specific function of controlling the response of the sensor unit in response to a determination by the sensor unit that a predetermined volume of blood has passed through the adapter unit in light of the cited portion of Bullington].
However, Bullington is silent regarding how the paddle wheel may be mounted within the housing, such that Bullington fails to explicitly disclose that the paddle wheel rotates on an integrated pin that defines an axis of rotation of the paddle wheel and is supported by the housing, the integrated pin being a part of the blood flow pathway.
Franano discloses systems for defining a flow rate of blood through the system, wherein Franano discloses a housing comprising an impeller disposed therein, wherein the impeller rotates freely in the housing on an integrated pin that defines an axis of rotation of the paddle wheel and is supported by the housing [As shown in FIGS. 3A-4B, the pivot axis for the impeller 140, magnets 150, and enclosure 155 is the impeller pivot 145. As depicted in FIGS. 5A-B, the impeller pivot 145 is pivotally supported (i.e. restrained in all degrees of freedom except rotation about a single axis) via a top bearing pin 130 and a bottom bearing pin 160. The top bearing pin 130 is received and fixed in a cylindrical recess 240 in the inlet cap 125, while the bottom bearing pin 160 is received and fixed in a cylindrical recess 245 in the bottom impeller casing 165. The impeller pivot 145 extends through and is fixed to a center cylindrical opening 250 in the impeller 140 (Franano ¶0079); the impeller assembly may freely rotate in the impeller chamber 205 on the impeller pivot 145, which is supported end to end with the bearing pins 130 and 160, in a configuration commonly known as a "double pin bearing." (Franano ¶0084); the impeller assembly is a composite of the impeller shaft 145, top bearing pin 130, and bottom bearing pin 160 (Franano ¶0085)], the integrated pin being a part of the blood flow pathway [wherein as depicted n Franano Fig. 3A, at least pin 130 (understood to be integrated with the impeller based on Franano ¶0085) is in line with the blood flow pathway defined inlet 180].
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 device of Bullington to employ wherein the paddle wheel rotates on an integrated pin that defines an axis of rotation of the paddle wheel and is supported by the housing, the integrated pin being a part of the blood flow pathway, as this modification would amount to mere simple substitution of one known element for another with similar expected results [allow a rotating element to rotate within a housing] [MPEP § 2143(I)(B)].
However, while Bullington does disclose that the volume of blood flowing through the blood flow pathway is measured [Bullington ¶0126] and that the device is responsive to a comparison between the measured volume of blood and a predetermined volume of blood [the housing 501 and/or the movable member 550a can include a detent, lock, catch, protrusion, recess, and/or the like that can temporarily retain the movable member 550a in the second position until a predetermined volume of sample has been transferred to the sample reservoir. Moreover, once placed in the second position, the display can be configured to illuminate, for example, a light or the like associated with the predetermined volume to indicate to the user the volume of bodily-fluid to be transferred to the sample reservoir. Once the desired volume of bodily fluid is transferred to and fluidically isolated in the sample reservoir, the diversion mechanism 520 can be configured to automatically return the movable member 550a back to its first position. In this manner, the diversion mechanism 520 and the flow controller 540 can be physically and fluidically coupled to any number of sample reservoirs and used to transferred a precise volume of bodily-fluid to each sample reservoir (Bullington ¶0136)], Bullington in view of Franano fails to explicitly disclose that the sensor unit comprises: i) a sensor that is configured to detect the rotation of the paddle wheel in response to blood flowing through the blood flow pathway with the paddle wheel therein in the adapter unit; and ii) a processor that is configured to associate the rotation of the paddle wheel detected by the sensor with a blood volume and is further configured to control the response of the sensor unit in response to a determination by the processor that a predetermined volume of blood has passed through the adapter unit.
Sharma discloses a blood metering device, wherein Sharma further discloses a sensor unit [The blood flow meter 100 further includes a control unit 110 (Sharma ¶0048)] that is engaged with an adapter unit comprising a volume indicator [a tube 202 partially enclosing a sensing chamber 204. A rotor 206 is disposed within the sensing chamber 204 (Sharma ¶0056, Fig. 2); the blood flow meter 200 may be, be similar to, include, or be included in, the blood flow meter 100 depicted in FIG. 1 (Sharma ¶0056)]; the sensor unit comprising: i) a sensor that is configured to detect the rotation of the paddle wheel in response to blood flowing through the blood flow pathway with the paddle wheel therein in the adapter unit [The blood flow meter 100 includes a rotation sensor 104 configured to sense the rotation of the rotor 102. The rotation sensor 104 may be any type of sensing device capable of sensing a rotation of a rotor. The control unit 110 (described below) may be configured to determine, based on the rotation signal, a blood flow rate. In embodiments, the rotation sensor 104 may include a magnetic encoder disposed outside of the flow of blood… The rotation signal may include, for example, a series of magnetic impulse measurements representative of an alteration of a magnetic field caused by the passing of each blade of an impeller through the field (Sharma ¶0046)]; and ii) a processor [the control unit 110 may include a processing unit configured to communicate with memory to execute computer-executable instructions stored in the memory (Sharma ¶0048)] that associates the sensor signals with a blood volume [Sharma ¶0046] and is further configured to control the response of the sensor unit [The control unit 110 may execute instructions and perform desired tasks as specified by computer-executable instructions stored in the memory (Sharma ¶0049)].
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 device of Bullington to modify the sensor unit to employ: i) a sensor that is configured to detect the rotation of the paddle wheel in response to blood flowing through the blood flow pathway with the paddle wheel therein in the adapter unit; and ii) a processor that is configured to associate the rotation of the paddle wheel detected by the sensor with a blood volume and is further configured to control the response of the sensor unit in response to a determination by the processor that a predetermined volume of blood has passed through the adapter unit, as this modification would amount to mere simple substitution of one known element [defined signal pathway of the blood metering device of Bullington of the flow metering mechanism 567 for outputting signals for the display to display calculated information including volume (see Bullington ¶0126); undisclosed signal pathway for controlling the response of the sensor unit of Bullington in response to a determination by the sensor unit that a predetermined volume of blood has passed through the adapter unit (see Bullington ¶0136)] for another [rotation sensor 104 of Sharma (Sharma ¶0046); processor of Sharma configured to execute functions (Sharma ¶¶0048-0049)] to obtain predictable results [allow for measuring of volumetric blood flow through the paddle wheel] [MPEP § 2143(I)(B)].
Regarding claim 2, Bullington in view of Franano and Sharma teaches
The blood metering device of claim 1.
However, Bullington in view of Franano and Sharma as presently modified fails to explicitly disclose wherein the sensor unit is configured to be one of: detachably engaged with the adapter unit or monolithically integrated with the adapter unit.
Sharma does disclose that the sensor may be integrated into the housing of the volume indicator [the rotation sensor 104 may include a magnetic encoder disposed outside of the flow of blood, a sensor integrated into the rotor housing and/or bearing, a sensor integrated into a housing of the motor 112 (discussed below), and/or the like (Sharma ¶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 device of Bullington to employ the sensor unit and the adapter unit as being monolithically integrated as a matter of making parts integral [MPEP § 2144.04(V)(B)].
Regarding claim 4, Bullington in view of Franano and Sharma teaches
The blood metering device of claim 1, wherein the axis of rotation of the paddle wheel is orthogonal to a blood flow direction in the blood flow pathway [Bullington Fig. 31].
Regarding claim 5, Bullington in view of Franano and Sharma teaches
The blood metering device of claim 1.
However, Bullington in view of Franano and Sharma as presently modified fails to explicitly disclose wherein the axis of rotation of the paddle wheel is in line with a blood flow direction in the blood flow pathway.
Franano depicts a housing defining a blood flow pathway that is in line with the axis of rotation of the integrated pin [See Fig. 3B of Franano, wherein the blood flow pathway defined from the inlet fluid channel 180 towards impeller 140 (understood to be fixed to impeller pivot 140, which forms a composite with pins 130, 160, see Franano ¶0085) passes along at least pin 130 and pivot 145 to define a blood flow direction in line with the integrated pin].
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 device of Bullington in view of Franano and Sharma, as this modification would amount to mere simple substitution of one known element for another with similar expected results [defining a blood flow pathway along the paddle wheel] [MPEP § 2143(I)(B)].
Regarding claim 6, Bullington in view of Franano and Sharma teaches
The blood metering device of claim 1, wherein the processor controls the response of the sensor unit in response to the determination by the processor that the predetermined volume of blood has passed through the paddle wheel disposed in the adapter unit [see § 103 modification of claim 1 above].
Regarding claim 7, Bullington in view of Franano and Sharma teaches
The blood metering device of claim 1, wherein the adapter unit is configured to be attachable to a collection vessel, wherein the collection vessel is selected from the group consisting of blood culture bottles and sample collection tubes [In this manner, the inlet port 521 can be configured to selectively place the pre-sample reservoir 570, the first sample reservoir 580, the second sample reservoir 580', the third sample reservoir 590, and the fourth sample reservoir 590' in fluid communication with the patient (Bullington ¶0128, Fig. 28)].
Regarding claim 8, Bullington in view of Franano and Sharma teaches
The blood metering device of claim 6, wherein the processor is configured to compare a measured blood volume with the predetermined volume of blood [Bullington ¶0126; Sharma ¶¶0048-0049; see § 103 modification of claim 1] and, when the measured blood volume is equal to the predetermined volume, the processor is configured to send a signal to close a blood flow valve that shuts off the flow of blood to the blood metering device [the housing 501 and/or the movable member 550a can include a detent, lock, catch, protrusion, recess, and/or the like that can temporarily retain the movable member 550a in the second position until a predetermined volume of sample has been transferred to the sample reservoir. Moreover, once placed in the second position, the display can be configured to illuminate, for example, a light or the like associated with the predetermined volume to indicate to the user the volume of bodily-fluid to be transferred to the sample reservoir. Once the desired volume of bodily fluid is transferred to and fluidically isolated in the sample reservoir, the diversion mechanism 520 can be configured to automatically return the movable member 550a back to its first position. In this manner, the diversion mechanism 520 and the flow controller 540 can be physically and fluidically coupled to any number of sample reservoirs and used to transferred a precise volume of bodily-fluid to each sample reservoir (Bullington ¶0136); wherein under the § 103 modification of claim 1 above, the modified processor is considered to send the claimed signal].
Regarding claim 10, Bullington in view of Franano and Sharma teaches
The blood metering device of claim 1, wherein the sensor is one of an axial rotor sensor, a peristaltic pump sensor, a magnetic field sensor [Sharma ¶0046], and rotating sensors [Sharma ¶0046].
Regarding claim 13, Bullington in view of Franano and Sharma teaches
The blood metering device of claim 1, wherein the blood flow pathway defined by the housing has an outlet [the bodily-fluid to flow from the first flow channel 535a, into the inner cavity 552 of the movable member 550, and out of the piercing member 555 into the first sample reservoir 580 (Bullington ¶0133)].
Regarding claim 14, Bullington in view of Franano and Sharma teaches
The blood metering device of claim 1, wherein the adapter unit comprises an activation element that activates the processor when the adapter unit is attached to a blood culture bottle [the movable members 550a, 550b, 550c, and 550d can be actuated (e.g., moved) by the user from a first position and a second position relative to the housing 501 and distribution member 529 to direct fluid flow into the first sample reservoir 580, the second fluid reservoir 580', the third fluid reservoir 590, and the fourth sample reservoir 590', respectively (Bullington ¶0125), wherein the moveable members 550a-d may be considered to read on the activation element; In this manner, bodily-fluid can enter the inlet port 553 of the movable member 550 and flow past the flow metering device 567, which in turn, can result in a rotation of the flow metering device 567 relative to the movable member 550. Thus, characteristics of the rotation of the flow metering device 567 can be operable in determining a volume of bodily-fluid transferred to the inner volume 552 of the movable member 550, a volumetric flow rate, and/or the like… Thus, as bodily-fluid is transferred, for example, to the sample reservoirs 580, 580', 590, and/or 590', volumetric information associated with the flow of bodily-fluid can be presented on the displays 575' (Bullington ¶0126), wherein based on the § 103 modification of claim 1 above, the flow metering of the volume indicator is processed by the modified processor, which is considered to read on the broadest reasonable interpretation to “activate the processor”, wherein as disclosed in ¶0125 of Bullington, the blood metering device exists in a conditional state in which a blood culture bottle is attached to the adapter unit].
However, Bullington in view of Franano and Sharma as presently modified fails to explicitly disclose that the activation element is an activation lever.
Bullington separately discloses known types of actuators, wherein Bullington does disclose a lever-based actuator [The actuator can include any suitable mechanism for actuating the flow of bodily-fluid into the collection device 100, such as, for example, a rotating disc, a plunger, a slide, a dial, a button, a handle, a lever, and/or any other suitable mechanism or combination thereof (Bullington ¶0069)].
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 device of Bullington in view of Franano and Sharma to employ an activation lever, based on the disclosure of Bullington [Bullington ¶0069], as this modification would amount to mere simple substitution of one known element [movable members 550a-d (Bullington ¶0125)] for another [actuation lever (Bullington ¶0069)] to obtain predictable results [provide a means for actuation/activation] [MPEP § 2143(I)(B)].
Regarding claim 15, Bullington in view of Franano and Sharma teaches
The blood metering device of claim 1, wherein the sensor unit comprises a battery [wherein since Bullington discloses the use of electronic signals and a light up display (a display can include a set of three lights (Bullington ¶0136), the device of Bullington is considered to comprise a form of a battery].
Regarding claim 16, Bullington in view of Franano and Sharma teaches
The blood metering device of claim 1, wherein the device comprises a valve actuator [the movable members 550a, 550b, 550c, and 550d can be moved from a first position to a second, third, or fourth position, relative to the housing 501. In such embodiments, the positions can be associated with, for example, an intended volume of bodily-fluid to be transferred to a sample reservoir. For example, in some embodiments, a user can actuate (e.g., move) the movable member 550a from its first position to its second position. In such embodiments, the second position can be associated with, for example, a low volume of bodily-fluid (e.g., 10 mL) to be transferred to a sample reservoir. In some embodiments, the housing 501 and/or the movable member 550a can include a detent, lock, catch, protrusion, recess, and/or the like that can temporarily retain the movable member 550a in the second position until a predetermined volume of sample has been transferred to the sample reservoir (Bullington ¶0136, Figure 29)].
However, Bullington in view of Franano and Sharma as presently modified fails to explicitly disclose that the sensor unit comprises the valve actuator.
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 device of Bullington in view of Franano and Sharma to employ the sensor unit comprising the valve actuator as this modification would amount to mere rearrangement of parts [MPEP § 2144.04(VI)(C)] [wherein the Examiner notes that the claimed adapter unit and sensor unit are very broadly defined in terms of structure].
Regarding claim 17, Bullington in view of Franano and Sharma teaches
The blood metering device of claim 16, wherein the valve actuator is one of a moving magnet actuator, a micro actuator [wherein the disclosure of Bullington ¶0136 may be considered to read on the broadest reasonable interpretation of a “micro actuator” due to the lack of additional structural language to further define the structure of the claimed “micro actuator”], a solenoid, or a paired magnet actuator.
Regarding claim 25, Bullington in view of Franano and Sharma teaches
The blood metering device of claim 1, wherein the sensor unit has an indicator light that is configured to indicate that the predetermined volume of blood has passed through the adapter unit based on signal from the processor [a display can include a set of three lights with a first light with low volume (e.g., 10 mL), a second light associated with medium volume (e.g., 20 mL), and a third light associated with high volume (e.g., 30 mL)].
Regarding claim 27, Bullington teaches
A blood metering device comprising:
an adapter unit [diversion mechanism 520 (Bullington ¶0123, Figure 29)] comprising a housing [housing 501 (Bullington ¶0123, Figure 29)] that defines a blood flow pathway [The housing 501 is physically and fluidically coupled to the distribution member 529, and provides and/or defines a set of fluid flow pathways for collecting bodily-fluids from the patient (Bullington ¶0123)] that is adapted to be connected to a blood collection set [an inlet port 521 that can be fluidically coupled to a medical device (either directly or indirectly via an adapter 504) that defines a fluid flow pathway for withdrawing and/or conveying bodily-fluid from a patient to the collection device 500 (Bullington ¶0128)], wherein the adapter unit has disposed therein a paddle wheel that is disposed in the blood flow pathway but freely rotatable within the housing [flow metering mechanism 567… The flow metering mechanism 567 can be, for example, a wheel or the like that can include a set of spokes or fins (e.g., a turbine or the like)… bodily-fluid can enter the inlet port 553 of the movable member 550 and flow past the flow metering device 567, which in turn, can result in a rotation of the flow metering device 567 relative to the movable member 550. Thus, characteristics of the rotation of the flow metering device 567 can be operable in determining a volume of bodily-fluid transferred to the inner volume 552 of the movable member 550, a volumetric flow rate, and/or the like (Bullington ¶126, Figure 31)];
a sensor unit that is engaged with the adapter unit, wherein the sensor unit is configured to be responsive to a determination by the sensor unit that a predetermined volume of blood has passed through the adapter unit [the flow metering mechanism included therein can send a signal or the like to the display that is operable in lighting the first light, the second light, and/or the third light according to a volume of bodily-fluid that is transferred through the movable member 550 (Bullington ¶0136), wherein any electronics not specifically depicted by Bullington may read on the specific function of controlling the response of the sensor unit in response to a determination by the sensor unit that a predetermined volume of blood has passed through the adapter unit in light of the cited portion of Bullington]; and
a valve actuator [the movable members 550a, 550b, 550c, and 550d can be moved from a first position to a second, third, or fourth position, relative to the housing 501. In such embodiments, the positions can be associated with, for example, an intended volume of bodily-fluid to be transferred to a sample reservoir. For example, in some embodiments, a user can actuate (e.g., move) the movable member 550a from its first position to its second position. In such embodiments, the second position can be associated with, for example, a low volume of bodily-fluid (e.g., 10 mL) to be transferred to a sample reservoir. In some embodiments, the housing 501 and/or the movable member 550a can include a detent, lock, catch, protrusion, recess, and/or the like that can temporarily retain the movable member 550a in the second position until a predetermined volume of sample has been transferred to the sample reservoir (Bullington ¶0136, Figure 29)].
However, Bullington is silent regarding how the paddle wheel may be mounted within the housing, such that Bullington fails to explicitly disclose that the paddle wheel rotates on an integrated pin that defines an axis of rotation of the paddle wheel and is supported by the housing, the integrated pin being a part of the blood flow pathway.
Franano discloses systems for defining a flow rate of blood through the system, wherein Franano discloses a housing comprising an impeller disposed therein, wherein the impeller rotates freely in the housing on an integrated pin that defines an axis of rotation of the paddle wheel and is supported by the housing [As shown in FIGS. 3A-4B, the pivot axis for the impeller 140, magnets 150, and enclosure 155 is the impeller pivot 145. As depicted in FIGS. 5A-B, the impeller pivot 145 is pivotally supported (i.e. restrained in all degrees of freedom except rotation about a single axis) via a top bearing pin 130 and a bottom bearing pin 160. The top bearing pin 130 is received and fixed in a cylindrical recess 240 in the inlet cap 125, while the bottom bearing pin 160 is received and fixed in a cylindrical recess 245 in the bottom impeller casing 165. The impeller pivot 145 extends through and is fixed to a center cylindrical opening 250 in the impeller 140 (Franano ¶0079); the impeller assembly may freely rotate in the impeller chamber 205 on the impeller pivot 145, which is supported end to end with the bearing pins 130 and 160, in a configuration commonly known as a "double pin bearing." (Franano ¶0084); the impeller assembly is a composite of the impeller shaft 145, top bearing pin 130, and bottom bearing pin 160 (Franano ¶0085)], the integrated pin being a part of the blood flow pathway [wherein as depicted n Franano Fig. 3A, at least pin 130 (understood to be integrated with the impeller based on Franano ¶0085) is in line with the blood flow pathway defined inlet 180].
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 device of Bullington to employ wherein the paddle wheel rotates on an integrated pin that defines an axis of rotation of the paddle wheel and is supported by the housing, the integrated pin being a part of the blood flow pathway, as this modification would amount to mere simple substitution of one known element for another with similar expected results [allow a rotating element to rotate within a housing] [MPEP § 2143(I)(B)].
However, while Bullington does disclose that the volume of blood flowing through the blood flow pathway is measured [Bullington ¶0126] and that the device is responsive to a comparison between the measured volume of blood and a predetermined volume of blood [the housing 501 and/or the movable member 550a can include a detent, lock, catch, protrusion, recess, and/or the like that can temporarily retain the movable member 550a in the second position until a predetermined volume of sample has been transferred to the sample reservoir. Moreover, once placed in the second position, the display can be configured to illuminate, for example, a light or the like associated with the predetermined volume to indicate to the user the volume of bodily-fluid to be transferred to the sample reservoir. Once the desired volume of bodily fluid is transferred to and fluidically isolated in the sample reservoir, the diversion mechanism 520 can be configured to automatically return the movable member 550a back to its first position. In this manner, the diversion mechanism 520 and the flow controller 540 can be physically and fluidically coupled to any number of sample reservoirs and used to transferred a precise volume of bodily-fluid to each sample reservoir (Bullington ¶0136)], Bullington in view of Franano fails to explicitly disclose that the sensor unit comprises: i) a sensor that is configured to detect a rotation of the paddle wheel in response to blood flowing through the blood flow pathway in the adapter unit, ii) a processor that is configured to associate the rotation of the paddle wheel with a blood volume and is further configured to control the response of the sensor unit in response to the determination by the processor that a predetermined volume of blood has passed through the adapter unit, and iii) the valve actuator, wherein the valve actuator is configured to be in signal communication with and is further configured to be controlled by the processor.
Sharma discloses a blood metering device, wherein Sharma further discloses a sensor unit [The blood flow meter 100 further includes a control unit 110 (Sharma ¶0048)] that is engaged with an adapter unit comprising a volume indicator [a tube 202 partially enclosing a sensing chamber 204. A rotor 206 is disposed within the sensing chamber 204 (Sharma ¶0056, Fig. 2); the blood flow meter 200 may be, be similar to, include, or be included in, the blood flow meter 100 depicted in FIG. 1 (Sharma ¶0056)]; the sensor unit comprising: i) a sensor that is configured to detect the rotation of the paddle wheel in response to blood flowing through the blood flow pathway with the paddle wheel therein in the adapter unit [The blood flow meter 100 includes a rotation sensor 104 configured to sense the rotation of the rotor 102. The rotation sensor 104 may be any type of sensing device capable of sensing a rotation of a rotor. The control unit 110 (described below) may be configured to determine, based on the rotation signal, a blood flow rate. In embodiments, the rotation sensor 104 may include a magnetic encoder disposed outside of the flow of blood… The rotation signal may include, for example, a series of magnetic impulse measurements representative of an alteration of a magnetic field caused by the passing of each blade of an impeller through the field (Sharma ¶0046)]; and ii) a processor [the control unit 110 may include a processing unit configured to communicate with memory to execute computer-executable instructions stored in the memory (Sharma ¶0048)] that associates the sensor signals with a blood volume [Sharma ¶0046] and is further configured to control the response of the sensor unit [The control unit 110 may execute instructions and perform desired tasks as specified by computer-executable instructions stored in the memory (Sharma ¶0049)].
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 device of Bullington in view of Franano to modify the sensor unit to employ: i) a sensor that is configured to detect a rotation of the paddle wheel in response to blood flowing through the blood flow pathway in the adapter unit, ii) a processor that is configured to associate the rotation of the paddle wheel with a blood volume and is further configured to control the response of the sensor unit in response to the determination by the processor that a predetermined volume of blood has passed through the adapter unit, as this modification would amount to mere simple substitution of one known element [defined signal pathway of the blood metering device of Bullington of the flow metering mechanism 567 for outputting signals for the display to display calculated information including volume (see Bullington ¶0126); undisclosed signal pathway for controlling the response of the sensor unit of Bullington in response to a determination by the sensor unit that a predetermined volume of blood has passed through the adapter unit (see Bullington ¶0136)] for another [rotation sensor 104 of Sharma (Sharma ¶0046); processor of Sharma configured to execute functions (Sharma ¶¶0048-0049)] to obtain predictable results [allow for measuring of volumetric blood flow through the paddle wheel] [MPEP § 2143(I)(B)].
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 device of Bullington in view of Franano and Sharma to employ the sensor unit to comprise: iii) the valve actuator, as this modification would amount to mere rearrangement of parts [MPEP § 2144.04(VI)(C)] [wherein the Examiner notes that the claimed adapter unit and sensor unit are very broadly defined in terms of structure]; and to have modified the sensor unit to employ the valve actuator to be in signal communication with and be controlled by the processor, as Bullington suggests a signal pathway between the paddle wheel [flow metering mechanism 567] and the valve actuator [Once the desired volume of bodily fluid is transferred to and fluidically isolated in the sample reservoir, the diversion mechanism 520 can be configured to automatically return the movable member 550a back to its first position. In this manner, the diversion mechanism 520 and the flow controller 540 can be physically and fluidically coupled to any number of sample reservoirs and used to transferred a precise volume of bodily-fluid to each sample reservoir (Bullington ¶0136)], and as mere matter of merely automating a manual activity [MPEP § 2144.04(III)].
Regarding claim 28, Bullington in view of Franano and Sharma teaches
The blood metering device of claim 27, wherein the adapter unit comprises an activation element that is configured to activate the processor when the adapter unit is attached to a blood culture bottle [Bullington ¶0125, wherein the moveable members 550a-d may be considered to read on the activation element; Bullington ¶0126, wherein based on the § 103 modification of claim 27 above, the flow metering of the volume indicator is processed by the modified processor, which is considered to read on the broadest reasonable interpretation to “activate the processor”, wherein as disclosed in ¶0125 of Bullington, the blood metering device exists in a conditional state in which a blood culture bottle is attached to the adapter unit].
However, Bullington fails to explicitly disclose that the activation element is an activation lever.
Bullington separately discloses known types of actuators, wherein Bullington does disclose a lever-based actuator [Bullington ¶0069].
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 device of Bullington in view of Franano and Sharma to employ an activation lever, based on the disclosure of Bullington [Bullington ¶0069], as this modification would amount to mere simple substitution of one known element [movable members 550a-d (Bullington ¶0125)] for another [actuation lever (Bullington ¶0069)] to obtain predictable results [provide a means for actuation/activation] [MPEP § 2143(I)(B)].
Regarding claim 29, Bullington in view of Franano and Sharma teaches
The blood metering device of claim 28, wherein the processor is configured to associate the rotation of the paddle wheel with the blood volume to determine a measured blood volume that has flowed through the blood metering device [Sharma ¶0046; see also § 103 modification of claim 27 above] and wherein the processor is further configured to control the response of the sensor unit in response to the determination by the processor that the predetermined volume blood has passed through the paddle wheel disposed in the adapter unit [see § 103 modification of claim 27 above].
Regarding claim 30, Bullington teaches
A method for determining a volume of blood flowing from a patient to a collection bottle the method comprising:
providing an assembly of an adapter unit [diversion mechanism 520 (Bullington ¶0123, Figure 29)] and a sensor unit, the adapter unit comprising a housing [housing 501 (Bullington ¶0123, Figure 29)] that defines a blood flow pathway [The housing 501 is physically and fluidically coupled to the distribution member 529, and provides and/or defines a set of fluid flow pathways for collecting bodily-fluids from the patient (Bullington ¶0123)] that is adapted to be connected to a blood collection set [an inlet port 521 that can be fluidically coupled to a medical device (either directly or indirectly via an adapter 504) that defines a fluid flow pathway for withdrawing and/or conveying bodily-fluid from a patient to the collection device 500 (Bullington ¶0128)], wherein the adapter unit has disposed therein is a paddle wheel that is disposed in the blood flow pathway but freely rotatable within the housing [flow metering mechanism 567… The flow metering mechanism 567 can be, for example, a wheel or the like that can include a set of spokes or fins (e.g., a turbine or the like)… bodily-fluid can enter the inlet port 553 of the movable member 550 and flow past the flow metering device 567, which in turn, can result in a rotation of the flow metering device 567 relative to the movable member 550. Thus, characteristics of the rotation of the flow metering device 567 can be operable in determining a volume of bodily-fluid transferred to the inner volume 552 of the movable member 550, a volumetric flow rate, and/or the like (Bullington ¶126, Figure 31)];
wherein the sensor unit is configured to control the response of the sensor unit in response to a determination by the sensor unit that a predetermined volume of blood has passed through the adapter unit [the flow metering mechanism included therein can send a signal or the like to the display that is operable in lighting the first light, the second light, and/or the third light according to a volume of bodily-fluid that is transferred through the movable member 550 (Bullington ¶0136), wherein any electronics not specifically depicted by Bullington may read on the specific function of controlling the response of the sensor unit in response to a determination by the sensor unit that a predetermined volume of blood has passed through the adapter unit in light of the cited portion of Bullington];
providing a valve actuator [the movable members 550a, 550b, 550c, and 550d can be moved from a first position to a second, third, or fourth position, relative to the housing 501. In such embodiments, the positions can be associated with, for example, an intended volume of bodily-fluid to be transferred to a sample reservoir. For example, in some embodiments, a user can actuate (e.g., move) the movable member 550a from its first position to its second position. In such embodiments, the second position can be associated with, for example, a low volume of bodily-fluid (e.g., 10 mL) to be transferred to a sample reservoir. In some embodiments, the housing 501 and/or the movable member 550a can include a detent, lock, catch, protrusion, recess, and/or the like that can temporarily retain the movable member 550a in the second position until a predetermined volume of sample has been transferred to the sample reservoir (Bullington ¶0136, Figure 29)].
connecting the assembly to the blood collection set, the blood collection set comprising a needle and tubing such that the blood collection set is in fluid communication with the blood flow pathway, wherein the needle is configured for venipuncture [In this manner, the inlet port 521 can be configured to selectively place the pre-sample reservoir 570, the first sample reservoir 580, the second sample reservoir 580', the third sample reservoir 590, and the fourth sample reservoir 590' in fluid communication with the patient (Bullington ¶0128, Figure 28); For example, the inlet port 521 of the collection device 500 can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing). Following venipuncture (or other method of accessing bodily-fluid) (Bullington ¶0130)];
connecting the adapter unit to a blood collection vessel such that the blood flow pathway in the adapter unit is in fluid communication with the blood collection vessel [Thus, as bodily-fluid is transferred, for example, to the sample reservoirs 580, 580', 590, and/or 590', volumetric information associated with the flow of bodily-fluid can be presented on the displays 575' (Bullington ¶0126)], wherein a pressure in the blood collection vessel is less than atmospheric pressure [As described above, the sample reservoir can include a negative pressure or the like that can, for example, initiate a flow of bodily-fluid from the patient to the sample reservoir (Bullington ¶0140)];
collecting a blood sample from the patient by venipuncture of the patient with the needle, thereby causing blood to flow through the blood flow pathway to the blood collection vessel [Bullington ¶0128];
flowing the blood through the paddle wheel [Bullington ¶0126];
measuring the rotation of the paddle wheel [Bullington ¶0126];
measuring a volume of blood flowing into the blood collection vessel from the blood flow pathway [Bullington ¶0126]; and
comparing the measured volume of blood with the predetermined volume of blood [Bullington ¶0126],
wherein, when the measured volume of blood equals the predetermined volume of blood, the valve actuator is actuated to stop the blood from flowing into the collection vessel [Bullington ¶0136].
However, Bullington is silent regarding how the paddle wheel may be mounted within the housing, such that Bullington fails to explicitly disclose that the paddle wheel rotates on an integrated pin that defines an axis of rotation of the paddle wheel and is supported by the housing.
Franano discloses systems for defining a flow rate of blood through the system, wherein Franano discloses a housing comprising an impeller disposed therein, wherein the impeller rotates freely in the housing on an integrated pin that defines an axis of rotation of the paddle wheel and is supported by the housing [As shown in FIGS. 3A-4B, the pivot axis for the impeller 140, magnets 150, and enclosure 155 is the impeller pivot 145. As depicted in FIGS. 5A-B, the impeller pivot 145 is pivotally supported (i.e. restrained in all degrees of freedom except rotation about a single axis) via a top bearing pin 130 and a bottom bearing pin 160. The top bearing pin 130 is received and fixed in a cylindrical recess 240 in the inlet cap 125, while the bottom bearing pin 160 is received and fixed in a cylindrical recess 245 in the bottom impeller casing 165. The impeller pivot 145 extends through and is fixed to a center cylindrical opening 250 in the impeller 140 (Franano ¶0079); the impeller assembly may freely rotate in the impeller chamber 205 on the impeller pivot 145, which is supported end to end with the bearing pins 130 and 160, in a configuration commonly known as a "double pin bearing." (Franano ¶0084); the impeller assembly is a composite of the impeller shaft 145, top bearing pin 130, and bottom bearing pin 160 (Franano ¶0085)].
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 device of Bullington to employ wherein the paddle wheel rotates on an integrated pin that defines an axis of rotation of the paddle wheel and is supported by the housing, as this modification would amount to mere simple substitution of one known element for another with similar expected results [allow a rotating element to rotate within a housing] [MPEP § 2143(I)(B)].
However, while Bullington does disclose that the volume of blood flowing through the blood flow pathway is measured [Bullington ¶0126] and that the device is responsive to a comparison between the measured volume of blood and a predetermined volume of blood [the housing 501 and/or the movable member 550a can include a detent, lock, catch, protrusion, recess, and/or the like that can temporarily retain the movable member 550a in the second position until a predetermined volume of sample has been transferred to the sample reservoir. Moreover, once placed in the second position, the display can be configured to illuminate, for example, a light or the like associated with the predetermined volume to indicate to the user the volume of bodily-fluid to be transferred to the sample reservoir. Once the desired volume of bodily fluid is transferred to and fluidically isolated in the sample reservoir, the diversion mechanism 520 can be configured to automatically return the movable member 550a back to its first position. In this manner, the diversion mechanism 520 and the flow controller 540 can be physically and fluidically coupled to any number of sample reservoirs and used to transferred a precise volume of bodily-fluid to each sample reservoir (Bullington ¶0136)], Bullington in view of Franano further fails to explicitly disclose that sensor unit comprises: i) a sensor that is configured to detect a rotation of the paddle wheel in response to blood flowing through the blood flow pathway in the adapter unit, ii) a processor that is configured to associate the rotation of the paddle wheel with a blood volume and control the response of the sensor unit in response to the determination by the processor that a predetermined volume of blood has passed through the adapter unit, and iii) the valve actuator, wherein the valve actuator is configured to be in signal communication with and is further configured to be controlled by the processor.
Sharma discloses a sensor unit [The blood flow meter 100 further includes a control unit 110 (Sharma ¶0048)] that is engaged with an adapter unit comprising a volume indicator [a tube 202 partially enclosing a sensing chamber 204. A rotor 206 is disposed within the sensing chamber 204 (Sharma ¶0056, Figure 2); the blood flow meter 200 may be, be similar to, include, or be included in, the blood flow meter 100 depicted in FIG. 1 (Sharma ¶0056)]; the sensor unit comprising: i) a sensor that is configured to detect the rotation of a rotor in response to blood flowing through the blood flow pathway in the adapter unit [The blood flow meter 100 includes a rotation sensor 104 configured to sense the rotation of the rotor 102. The rotation sensor 104 may be any type of sensing device capable of sensing a rotation of a rotor. The control unit 110 (described below) may be configured to determine, based on the rotation signal, a blood flow rate. In embodiments, the rotation sensor 104 may include a magnetic encoder disposed outside of the flow of blood… The rotation signal may include, for example, a series of magnetic impulse measurements representative of an alteration of a magnetic field caused by the passing of each blade of an impeller through the field (Sharma ¶0046)]; and ii) a processor [the control unit 110 may include a processing unit configured to communicate with memory to execute computer-executable instructions stored in the memory (Sharma ¶0048)] that is configured to associate the rotation of the rotor with a blood volume [Sharma ¶0046] and is further configured to control the response of the sensor unit [The control unit 110 may execute instructions and perform desired tasks as specified by computer-executable instructions stored in the memory (Sharma ¶0049)].
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 Bullington to employ the sensor unit to comprise: i) a sensor that is configured to detect a rotation of the paddle wheel in response to blood flowing through the blood flow pathway in the adapter unit; ii) a processor that is configured to associate the rotation of the paddle wheel with a blood volume and is further configured to control the response of the sensor unit in response to a determination by the sensor unit that a predetermined volume of blood has passed through the adapter unit, as this modification would amount to mere simple substitution of one known element [defined signal pathway of the blood metering device of Bullington of the flow metering mechanism 567 for outputting signals for the display to display calculated information including volume (Bullington ¶0126); undisclosed signal pathway for controlling the response of the sensor unit of Bullington in response to a determination by the sensor unit that a predetermined volume of blood has passed through the adapter unit (Bullington ¶0136)] for another [rotation sensor 104 of Sharma (Sharma ¶0046); processor of Sharma configured to execute functions (Sharma ¶¶0048-0049)] to obtain predictable results [MPEP § 2143(I)(B)].
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 Bullington in view of Sharma to employ the sensor unit to comprise: iii) the valve actuator as this modification would amount to mere rearrangement of parts [MPEP § 2144.04(VI)(C)] [wherein the Examiner notes that the claimed adapter unit and sensor unit are very broadly defined in terms of structure]; and to have modified the sensor unit to employ the valve actuator to be in signal communication with and be controlled by the processor, such that the processor sends a signal to the valve actuator to stop the blood from flowing into the collection vessel, as Bullington suggests a signal pathway between the paddle wheel [flow metering mechanism 567] and the valve actuator [Once the desired volume of bodily fluid is transferred to and fluidically isolated in the sample reservoir, the diversion mechanism 520 can be configured to automatically return the movable member 550a back to its first position. In this manner, the diversion mechanism 520 and the flow controller 540 can be physically and fluidically coupled to any number of sample reservoirs and used to transferred a precise volume of bodily-fluid to each sample reservoir (Bullington ¶0136)], and as mere matter of merely automating a manual activity [MPEP § 2144.04(III)].
Claim(s) 11 and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bullington in view of Franano and Sharma, as applied to claim 1 above, and in further view of Sweeney (US-20140099615-A1, previously applied).
Regarding claim 11, Bullington in view of Franano and Sharma teaches
The blood metering device of claim 1.
However, Bullington in view of Franano and Sharma fails to explicitly disclose wherein the sensor that is configured to detect the rotation of the paddle wheel is a hall effect sensor, wherein the paddle wheel is configured to carry a magnet and the housing has the hall effect sensor disposed thereon that is actuated as the magnet passes by the hall effect sensor.
Sharma does disclose wherein a volume indicator defined as a paddle wheel [Sharma Fig. 2] carries a magnet [The control unit 110 (described below) may be configured to determine, based on the rotation signal, a blood flow rate. In embodiments, the rotation sensor 104 may include a magnetic encoder disposed outside of the flow of blood… The rotation signal may include, for example, a series of magnetic impulse measurements representative of an alteration of a magnetic field caused by the passing of each blade of an impeller through the field (Sharma ¶0046)], wherein Sharma further discloses a magnetic sensor that is actuated as the magnet passes by the magnetic sensor [Sharma ¶0046].
Sweeney discloses a flow meter for measuring fluid flow rate through a fluid flow pathway, wherein Sweeney discloses the use of a hall effect sensor for measuring a speed of rotation of a turbine that has magnets attached to the turbine blades [the flow meter 14 includes one or more magnets 24 attached to the turbine blades and a hall-effect sensor 26 to produce an electronic pulse from the magnetic field passing by the sensor 26 (Sweeney ¶0038)].
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 device of Bullington in view of Sharma to employ wherein the sensor that is configured to detect the rotation of the paddle wheel is a hall effect sensor, wherein the paddle wheel is configured to carry a magnet and the housing has the hall effect sensor disposed thereon that is actuated as the magnet passes by the hall effect sensor, as this modification would amount to mere application of a known technique to a device (method, or product) ready for improvement to yield predictable results [measure flow rate of liquid passing through a paddle wheel] [MPEP § 2143(I)(B)].
Regarding claim 21, Bullington in view of Franano, Sharma, and Sweeney teaches
The blood metering device of claim 11, wherein the hall effect sensor is configured to measure a speed of rotation of the paddle wheel [Bullington ¶0126; see § 103 modification of claim 11 above with respect to the hall effect sensor].
Regarding claim 22, Bullington in view of Franano, Sharma, and Sweeney teaches
The blood metering device of claim 21, wherein the processor determines the volume of blood flowing through the pump based on the speed of rotation of the motor [Sharma ¶0046; see § 103 modification of claims 11 and 21 above].
Regarding claim 23, Bullington in view of Franano, Sharma, and Sweeney teaches
The blood metering device of claim 22, wherein the blood collection set comprises a needle and tubing adapted for venipuncture [the inlet port 521 of the collection device 500 can be fluidically coupled to a needle or other lumen-defining device (e.g., flexible sterile tubing) (Bullington ¶0130)].
Claim(s) 24 and 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bullington in view of Franano, Sharma and Sweeney, as applied to claim 23 above, and in further view of Gilcher (US-4385630-A, previously presented).
Regarding claim 24, Bullington in view of Franano, Sharma, and Sweeney teaches
The blood metering device of claim 23, further comprising a flowmeter [Bullington ¶0147].
However, Bullington in view of Franano, Sharma, and Sweeney as presently modified fails to explicitly disclose wherein the device further comprises a pump in addition to the flowmeter, wherein the pump comprises a motor, the motor comprising a rotor and wherein the housing forms a stator for the pump, wherein the rotor comprises one or more magnets and a hall effect sensor that measure a speed of rotation of the rotor, wherein, in operation, when the speed of rotation of the motor falls below a predetermined speed of rotation, the processor is configured to indicate a vein collapse.
Sharma discloses the use of a combined flowmeter and pump in a blood metering device [a motor 222 that is operatively coupled to the rotor 206 (Sharma ¶0058, Figure 2), see corresponding claim rejection and interpretation under § 112(b) above], wherein the pump comprises a motor, the motor comprising a rotor and wherein the housing forms a stator for the pump [Sharma ¶0045, ¶0058, Figure 2].
It would have been 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 device of Bullington in view of Sharma and Sweeney to employ a flowmeter and a pump, wherein the pump comprises a motor, the motor comprising a rotor and wherein the housing forms a stator for the pump, so as to allow for control over the flow rate of blood through the blood flow pathway to prevent slip in the blood flow pathway, which may cause damage to blood cells [According to embodiments, the control unit 110 is configured to control the motor 112 so as to maintain a differential pressure of zero, or at least approximately zero. In this manner, the control unit 110 can control the motor 112 to maintain a zero slip condition based on the differential pressure. During operation of the blood flow meter 100, as the rotor 102 begins turning due to blood flow, drag forces, friction in the bearing and the inside of the meter, and turbulence around the rotor 102 leads to slip, which can cause damage to blood cells, as well as reduce the accuracy of blood flow rate measurements (Sharma ¶0053)].
Based on the prior modification by the disclosures of Sharma and Sweeney regarding the paddle wheel comprising a magnet and a hall effect sensor that measures a speed of rotation of the paddle wheel, it would amount to mere duplication of parts to employ wherein the rotor comprises one of more magnets and a hall effect sensor that measure a speed of rotation of the rotor [MPEP § 2144.04(VI)(B)].
Gilcher discloses systems for withdrawing blood, wherein Gilcher further discloses using an electronic processing system to indicate vein collapse when the measure blood withdrawal flow rate falls below a predetermined threshold [Furthermore, in order to avoid collapsing of the vein in the event the vacuum is such that more blood is withdrawn from the donor than the vein can accomodate, sensing means are provided in the apparatus of the present invention which will automatically slow or stop the pump when the pressure goes below a certain level or when the rate of flow drops below a certain level (Gilcher Col 3:44-50); There is also provided in accordance with the invention apparatus for preventing the collapse of a vein in the event that more blood is being pulled through the system than the vein can accommodate. Thus, in the event the flow of blood tends to decrease, as would occur when the vein starts to collapse, the pressure bag 28 will also tend to collapse causing relay arm 34 to move inwardly (away from the viewer in FIG. 1) deactivating relay switch 32 which turns off pump 24 and simultaneously lights the "no flow" light 36b alerting the operator to the fact that the flow of blood has ceased (Gilcher Col 6:7-18)].
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 device of Bullington in view of Franano, Sharma, and Sweeney to employ the processor indicates a vein collapse when the speed of rotation of the motor falls below a predetermined speed of rotation, so as to provide an alert that the vein is collapsed or about to collapse [Gilcher Col 3:44-50; Col 6:7-18].
Regarding claim 26, Bullington in view of Franano, Sharma, Sweeney, and Gilcher teaches
The blood metering device of claim 24.
However, Bullington in view of Franano, Sharma, Sweeney, and Gilcher as presently modified fails to explicitly disclose wherein the sensor unit has an indicator light that is configured to indicate that the vein collapse has occurred based on a signal from the processor.
Gilcher discloses an indicator light that indicates that a vein collapse has occurred based on a signal from an electronic processing system [Furthermore, in order to avoid collapsing of the vein in the event the vacuum is such that more blood is withdrawn from the donor than the vein can accomodate, sensing means are provided in the apparatus of the present invention which will automatically slow or stop the pump when the pressure goes below a certain level or when the rate of flow drops below a certain level (Gilcher Col 3, lines 44-50); There is also provided in accordance with the invention apparatus for preventing the collapse of a vein in the event that more blood is being pulled through the system than the vein can accommodate. Thus, in the event the flow of blood tends to decrease, as would occur when the vein starts to collapse, the pressure bag 28 will also tend to collapse causing relay arm 34 to move inwardly (away from the viewer in FIG. 1) deactivating relay switch 32 which turns off pump 24 and simultaneously lights the "no flow" light 36b alerting the operator to the fact that the flow of blood has ceased (Gilcher Col 6, lines 7-18)].
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 device of Bullington in view of Sharma to employ the sensor unit to comprise an indicator light that indicates that a vein collapse has occurred based on a signal from the processor, so as to provide an alert that the vein is collapsed or about to collapse [Gilcher Col 3, lines 44-50; Col 6, lines 7-18].
Response to Arguments
Applicant’s arguments, see Applicant’s Remarks p. 8, filed 17 February 2026, with respect to the previously presented drawing objections have been fully considered and are persuasive. The drawing objections for reference character(s) not mentioned in the description have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 8-9, with respect to the previously presented claim objections have been fully considered and are persuasive. The objections to claims 5 and 27 have been withdrawn.
Applicant’s arguments, see Applicant’s Remarks p. 9-20, with respect to the rejection(s) of claim(s) 1, 27, 30, 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 Bullington (US-20140155782-A1, previously presented) in view of Franano (US-20140296615-A1) and Sharma (US-20200138301-A1, EFD of 2 November 2018, previously presented).
The Applicant asserts that Sharma is silent regarding the means by which rotor 206 is mounted within tube 202 [Sharma ¶0045, Fig. 2], wherein the Applicant further notes that bearing 208 supports the rotor 206, not an integrated pin. The Applicant further argues that the axis of the rotor-bearing-shaft assembly of Sharma is parallel to the axis of the sensing chamber 204 within tube 202, and notes that the Office Action has not explained how the rotor 206 might be supported by the claimed integrated pin, which defines the axis of rotation of the paddle wheel; and further notes how Sharma fails to describe how the rotor-shaft-bearing assembly is supported within sensing chamber 204. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1, 27, and 30 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. Bullington is presently modified by Franano (US-20140296615-A1) and Sharma, wherein Franano is applied to teach the argued amended limitations regarding wherein the paddle wheel rotates freely in the housing on an integrated pin that defines an axis of rotation of the paddle wheel and is supported by the housing, the integrated pin being a part of the blood flow pathway, as Franano discloses a housing comprising an impeller disposed therein, wherein the impeller rotates freely in the housing on an integrated pin that defines an axis of rotation of the paddle wheel and is supported by the housing [As shown in FIGS. 3A-4B, the pivot axis for the impeller 140, magnets 150, and enclosure 155 is the impeller pivot 145. As depicted in FIGS. 5A-B, the impeller pivot 145 is pivotally supported (i.e. restrained in all degrees of freedom except rotation about a single axis) via a top bearing pin 130 and a bottom bearing pin 160. The top bearing pin 130 is received and fixed in a cylindrical recess 240 in the inlet cap 125, while the bottom bearing pin 160 is received and fixed in a cylindrical recess 245 in the bottom impeller casing 165. The impeller pivot 145 extends through and is fixed to a center cylindrical opening 250 in the impeller 140 (Franano ¶0079); the impeller assembly may freely rotate in the impeller chamber 205 on the impeller pivot 145, which is supported end to end with the bearing pins 130 and 160, in a configuration commonly known as a "double pin bearing." (Franano ¶0084); the impeller assembly is a composite of the impeller shaft 145, top bearing pin 130, and bottom bearing pin 160 (Franano ¶0085)], the integrated pin being a part of the blood flow pathway [wherein as depicted n Franano Fig. 3A, at least pin 130 (understood to be integrated with the impeller based on Franano ¶0085) is in line with the blood flow pathway defined inlet 180].
The Applicant also argues that the Examiner has conflated two separate embodiments of Sharma [Figs. 1, 2] to identify support for mounting the flow metering mechanism on a pin supported by the housing, and that neither embodiment alone or in combination suggests a freely rotatable paddle wheel with an integrated pin that defines the axis of rotation of the paddle wheel and is supported by the housing. The Applicant notes that the embodiment of Fig. 1 of Sharma discloses a system that causes an alteration of the rotor based on a measured differential pressure via a motor to maintain a zero slip condition; and further notes that the embodiment of Fig. 2 of Sharma discloses similar functionality, such that Sharma does not teach a “freely rotatable” paddle wheel that is supported by a pin that defines an axis of rotation and is supported by the housing as alleged by the Office Action, such that the proposed substitution is impermissible hindsight. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1, 27, and 30 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. Bullington is presently modified by Franano (US-20140296615-A1) and Sharma, wherein the Examiner notes that at least both Bullington and Franano are considered to disclose a freely rotatable paddle wheel/rotor [Bullington ¶0126, wherein the paddle wheel allowing for rotation in response to flow is considered to read on being freely rotatable; Franano ¶0084] and wherein Franano is considered to disclose particular structure regarding how the integrated pin is supported by the housing [Franano ¶¶0079, 0084].
Regarding claim 4, the Applicant notes that while the Office Action relies on Bullington Fig. 31 to teach that the axis of rotation is orthogonal to the blood flow pathway, the Office Action does not state how Sharma informs modification of Bullington Fig. 31 to render claim 4 obvious. Further based on the Applicant’s arguments as presented above, as the Applicant notes that Sharma fails to describe any sort of integrated pin supported by a housing, Sharma provides no suggestions to provide a paddle wheel rotatably supported by an integrated pin that forms an axis of rotation orthogonal to the flow of blood past the paddle wheel. However, the Examiner notes that Applicant’s arguments with respect to claim(s) 1, 27, and 30 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. Bullington is presently modified by Franano (US-20140296615-A1) and Sharma, wherein the Examiner notes that based on the modification of claim 1 by Franano is considered to render the subject matter of claim 4 obvious, due to the similar structures depicted between Bullington and Franano to define blood flow pathways.
The Applicant further asserts that the additionally cited references of Sweeney and Gilcher fail to remedy the argued deficiencies of Bullington and Sharma. However, based on the Examiner’s responses to the Applicant’s arguments above, the Examiner notes that Sweeney and Gilcher are not required to remedy any alleged deficiencies of the presently applied modification Bullington in view of Franano and Sharma.
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 SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791
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