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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the three channels of the valve assembly comprise two channels operable for biological fluid sample collection and one channel operable for system flushing as described in the specification. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 3-7, 9-14, and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over CN 112618819 A to Chen et al. (“Chen”) in view of US 2020/0355605 A1 to Causey.
As to claim 1, Chen discloses a system for collecting a biological fluid sample (see Abstract), the system comprising:
a sampling assembly configured to collect a biological fluid sample (see Abstract);
a valve assembly having one or more actuators and a corresponding number of channels configured to transport the biological fluid sample to a sample collection device (see four-way rotary valves, 4, 9; pinch valves, 13-1, 13-2, 13-3, reversing valves 10, 11; each valve is controlled by controller – see p. 8 (all references herein are directed to the Google Patents machine translation) “The control unit is capable of communicating with a computer provided outside the casing 1, for example, receiving a command signal from the computer and controlling the syringe pumps 3-1 and 3-2, the four-way valves 4 and 9, the fluid detectors 5 and 8, the peristaltic pump 7, and the tube pressure valves 13-1 to 13-3 according to the command signal, thereby performing various operations to be described later to achieve the drawing and storage of blood and the like.”); and
a controller in signal communication with the sampling assembly and the valve assembly, the controller with one or more processors and a memory having computer-readable instructions that, when executed by the processor, cause the processor to transmit a plurality of signals to:
initiate collection of a predetermined volume of the biological fluid sample by the sampling assembly (see p. 9 – “As shown in FIGS. 1 and 8, during the third stage of sample collection and testing, pure blood is drawn. Specifically, the position of the four-way rotary valve 9 is adjusted to connect the two channels of the A channel 9-1 and the B channel 9-4, the tube pressing valve 13-1 is opened, the tube pressing valve 13-2 is opened, the tube pressing valve 13-3 is closed, the injection pump 3-2 is used for starting blood drawing, and pure blood is led to pass through the pipeline formed by the conduits 12-3, 12-4 and 12-7.”);
extract the biological fluid sample using the sampling assembly (see p. 9 – “A set volume of blood is withdrawn, for example, if a target volume to be withdrawn is set to 200ul, 205ul of blood is withdrawn and the target volume of blood is deposited in the catheter 12-7.”); and
transport the biological fluid sample to the sample collection device using the corresponding channel of the valve assembly (see pp. 9-10 – “Then, the blood is sent to the blood reservoir 6, specifically, the position of the four-way rotary valve 9 is adjusted, the two channels of the A channel 9-1 and the B channel 9-4 are connected, the pinch valve 13-1 is closed, the pinch valve 13-2 is closed, the pinch valve 13-3 is opened to connect the conduit 12-5 and the conduit 12-7, and the injection pump 3-2 starts to push out the air, and starts to push out some air from the beginning of the detection of the air by the fluid detector 8, and then continues to push out some air, so as to ensure that all the pure blood in the conduit 12-7 is pushed into the blood reservoir 6.”).
Chen fails to disclose the sampling assembly in fluid connection with an intravenous (IV) catheter. However, this was well-known as shown by Causey (see, e.g,, [0065] and Fig 3). It would have been obvious to one of ordinary skill in the art to combine the sampling assembly of Chen with the intravenous catheter of Causey in order to provide the predictable result of making the device easier to use in a clinical setting.
As to claim 3, Chen further discloses wherein the computer readable instructions further cause the processor to transmit a signal to flush and reset the sampling assembly and the valve assembly for initiation of a collection of a second biological fluid sample (see pp. 9-10 where the purging/flushing process is described as occurring in three stages).
As to claim 4, Chen further discloses wherein the valve assembly comprises a rotatable multichannel valve (see Fig 1, element 4 described in specification while the four positions (4-1, 4-2, 4-3, and 4-4 are explicitly shown).
As to claim 5, Chen further discloses wherein the one or more actuators of the valve assembly are individually selected from a rotary actuator, a linear actuator or a combination thereof (see treatment of claims 1 and 4).
As to claim 6, Chen further discloses wherein each of the actuators of the valve assembly are in individual signal communication with the controller (see p. 8 – “The control unit is capable of communicating with a computer provided outside the casing 1, for example, receiving a command signal from the computer and controlling the syringe pumps 3-1 and 3-2, the four-way valves 4 and 9, the fluid detectors 5 and 8, the peristaltic pump 7, and the tube pressure valves 13-1 to 13-3 according to the command signal, thereby performing various operations to be described later to achieve the drawing and storage of blood and the like.”).
As to claim 7, Chen further discloses wherein the valve assembly contains three actuators and three channels (see p. 8 – “The control unit is capable of communicating with a computer provided outside the casing 1, for example, receiving a command signal from the computer and controlling the syringe pumps 3-1 and 3-2, the four-way valves 4 and 9, the fluid detectors 5 and 8, the peristaltic pump 7, and the tube pressure valves 13-1 to 13-3 according to the command signal, thereby performing various operations to be described later to achieve the drawing and storage of blood and the like.”).
As to claim 9, Chen further discloses wherein the biological fluid sample is blood or cerebrospinal fluid (see Abstract).
As to claim 10, Chen further discloses wherein the biological fluid sample consists essentially of blood (see Abstract).
As to claim 11, Chen fails to disclose wherein biological fluid sample collection is performed under sterile conditions. However, Causey discloses such conditions (see [0258]). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the automatic blood sampler of Chen in order to make it under sterile conditions as taught by Causey in order to achieve the predictable result of preventing infection.
As to claim 12, Chen further discloses wherein the predetermined volume is in a range of about 1 ul to about 20 ml (see treatment of claim 1).
As to claim 13, Chen further discloses wherein the biological fluid sample is collected over a predetermined time period ranging from about 30 seconds to about 12 hours (see p. 11 – “Moreover, the automatic blood drawing instrument supports the networking operation of a plurality of machines, and is convenient for independently drawing blood for a plurality of animals at regular time and quantity.”).
As to claim 14, Chen discloses a method for collecting a biological fluid sample from a subject, the method comprising:
propagating a signal from a controller to a sampling assembly and a valve assembly for initiating collection of a biological fluid sample (see p. 8 -- “The control unit is capable of communicating with a computer provided outside the casing 1, for example, receiving a command signal from the computer and controlling the syringe pumps 3-1 and 3-2, the four-way valves 4 and 9, the fluid detectors 5 and 8, the peristaltic pump 7, and the tube pressure valves 13-1 to 13-3 according to the command signal, thereby performing various operations to be described later to achieve the drawing and storage of blood and the like.”);
extracting the biological fluid sample from the subject using the sampling assembly (see Abstract);
transporting the biological fluid sample from the sampling assembly using the valve assembly having one or more actuators in individual signal communication with the controller (see pp. 9-10 and treatment of claim 1); and
depositing the biological fluid sample in a sample collection device (see pp. 9-10 – “Then, the blood is sent to the blood reservoir 6, specifically, the position of the four-way rotary valve 9 is adjusted, the two channels of the A channel 9-1 and the B channel 9-4 are connected, the pinch valve 13-1 is closed, the pinch valve 13-2 is closed, the pinch valve 13-3 is opened to connect the conduit 12-5 and the conduit 12-7, and the injection pump 3-2 starts to push out the air, and starts to push out some air from the beginning of the detection of the air by the fluid detector 8, and then continues to push out some air, so as to ensure that all the pure blood in the conduit 12-7 is pushed into the blood reservoir 6.”).
Chen fails to disclose the method using an intravenous catheter attached to the subject. However, this is shown by Causey (see, e.g,, [0065] and Fig 3). It would have been obvious to one of ordinary skill in the art to combine the sampling assembly of Chen with the intravenous catheter of Causey in order to provide the predictable result of making the device easier to use in a clinical setting.
As to claim 16, Chen further discloses further comprising the step of flushing and resetting the sampling assembly and the valve assembly (see pp. 9-10 where the purging/flushing process is described as occurring in three stages).
As to claim 17, Chen further discloses wherein the biological fluid sample is blood or cerebrospinal fluid (see Abstract).
As to claim 18, Chen further discloses wherein the biological fluid sample consists essentially of blood (see Abstract).
As to claim 19, Chen is silent as to whether the extracting and transporting of the biological fluid sample collection occurs under sterile conditions. However, Causey discloses such conditions (see [0258]). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the automatic blood sampler of Chen in order to make it under sterile conditions as taught by Causey in order to achieve the predictable result of preventing infection.
As to claim 20, Chen further discloses wherein the biological fluid sample is extracted at a predetermined volume ranging from about 1 ul to about 20 ml (see treatment of claim 1).
Claim(s) 2 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Causey as applied to claim 1 above, and further in view of US 4,127,111 A to Drolet.
As to claim 2, while Chen teaches that a controller sends signals to perform each of several steps, there does not appear to be disclosure of wherein the computer readable instructions further cause the processor to transmit a signal to a user device in signal communication with the controller to indicate completion of collection of the biological fluid sample.
However, Drolet teaches this (see Abstract). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the automatic sampler of Chen/Causey with the instructions that cause the processor to a signal to a user device in signal communication with the controller to indicate completion of collection of the biological fluid sample as done by Drolet in order to provide the predictable result of informing the user when a sample is ready.
As to claim 15, neither Chen nor Causey disclose the step of transmitting a signal from the controller to a user device in signal communication with the controller to indicate completion of collection of the biological fluid sample. However, this is shown by Drolet (see Abstract). It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to combine the automatic sampler of Chen/Causey with completion indication of Drolet in order to provide the predictable result of informing the user when a sample is ready.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Causey as applied to claim 7 above, and further in view of US 5,785,662 A to Alexander.
As to claim 8, Chen discloses where one channel is operable for system flushing (see Fig 1, element 11), but only shows a single channel given that the sample collection is done using a rotating sample containment device and thus does not disclose wherein three channels of the valve assembly comprise two channels operable for biological fluid sample. However, Alexander shows that multiple samples can be obtained at a time using a manifold (see Fig 1A, element 306), which comprises multiple channels. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to modify the rotating sample collection device with the manifold that comprises multiple channels as done by Alexander in order to achieve the predictable result of obtaining multiple samples at once.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric Messersmith whose telephone number is (571)270-7081. The examiner can normally be reached M-F, 830am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791