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 .
Response to Amendment
This is an office action in response to Applicant’s arguments and remarks filed on 4 September 2026. Claims 1-17 are currently pending. Claims 11-12 have been previously withdrawn from consideration. Claims 1-10 and 13-17 are being examined herein.
Status of Objections and Rejections
The objection to claim 3 is withdrawn in view of amendments.
The rejections to claims 1 and 8-10 under 35 U.S.C. § 102(a)(1) in view of Liu, et. al. (CN 207717625 U) are maintained.
The rejections to claims 2-3 and 17 under 35 U.S.C. § 103 in view of Liu, et. al. (CN 207717625 U) in view of Wilkinson (US 20060091669 A1) are maintained.
The rejection to claim 5 under 35 U.S.C. § 103 in view of Liu, et. al. (CN 207717625 U) in view of Wilkinson (US 20060091669 A1) and Motadel, et. al. (US 20180333717 A1) are maintained.
The rejection to claim 6 under 35 U.S.C. § 103 in view of Liu, et. al. (CN 207717625 U) in view of Blaszcak, et. al. (US 20190015830 A1) are maintained.
The rejections to claims 13-16 under 35 U.S.C. § 103 in view of Liu, et. al. (CN 207717625 U) in view of Kato, et. al. (US 20220065882 A1) are maintained.
Response to Arguments
Applicant's arguments filed 4 September 2026 have been fully considered but they are not persuasive.
Applicant first argues Liu does not teach “the analyzer control volume having a preconfigured volume” as recited in claim 1 (Remarks, pg. 8, par.02-06).
Examiner respectfully disagrees. Under broadest reasonable interpretation, a "preconfigured volume" can be any volume, including a maximum volume. Further, the specification provides no details as to how to interpret "preconfigured volume" and can mean anywhere from 0.1 mL to 1.5 mL (or more or less), which the cup as taught by Liu is fully capable of holding. Finally, "having a preconfigured volume" is drawn to a functional limitation of the device. Because the cup is more than capable of holding a volume of fluid and "preconfigured volume" is a broad phrase, one of ordinary skill in the art will conclude that analyzer control fluid in the cup has a volume, wherein the upper limit of the volume is the volume of the cup body.
Applicant then argues Liu does not teach “a sealing member… to seal the control fluid void” as recited in claim 1 (Remarks, pg. 8, par. 07 – pg. 9, par. 01).
Examiner respectfully disagrees. Under broadest reasonable interpretation, "seal" does not necessarily mean that the seal must be airtight (as suggested by the argument). The cup lid as taught by Liu sufficiently closes off the inner volume of the cup when installed on the cup. Liu teaches "the cup lid is tightly connected to the cup body through the inner lid, and the end of the cup body is located in an annular groove between the outer lid and inner lid" (par. 0008). Further, the exterior walls of the cup 3 reach the interior surface of the lid between the outer 4 and inner 5 lid, as seen in Figure 3 providing a liquid-tight seal. This is further supported because vent 5 is located on inner lid 5, and the upper edge of the cup 3 and the area of the inner surface of the lid encompasses the vent 6 and inner lid 5.
Applicant further argues Liu does not teach “an inner void configured to receive the ridge to seal the control fluid void” as recited in claim 8 (Remarks, pg. 9, par. 02)
Examiner respectfully disagrees. As seen in Figure 3, the inner 5 and outer 4 lid form a void (see outline) that void houses the ridge (see horizontal arrow) and the upper end of the cup is seal by the interior surface of the lid (see vertical arrow). Liu teaches when putting the lid on the cup, the combination is "tightly connected" (par. 0008). Ultimately, the lid and cup come together to form a seal to protect the fluid inside the cup/void, and when combined together, the top end of the side wall has a ridge that is held within the void created by the inner and outer lids.
PNG
media_image1.png
486
368
media_image1.png
Greyscale
Applicant additionally argues Liu does not teach “the peripheral edge is in contact with the sidewall at the top portion to seal the control fluid void” as recited in claim 9 (Remarks, pg. 9, par.03).
Examiner respectfully disagrees. The top surface of the lid is clearly shared by both the inner and out lid portions. However, the bottom surface of the lid is split with both the outer lid having a bottom surface and the inner lid having a bottom surface. Modified Figure 2 is provided below where the arrows on the left side indicate the inner and outer lid bottom surface. A third arrow on the right indicates the peripheral edge of the inner lid. Just as the inner and outer lid each have a respective bottom surface, each has a peripheral edge. The peripheral edge of the inner lid forms the seal, as Liu teaches "the cup lid is tightly connected to the cup body through the inner lid" (par. 0008).
PNG
media_image2.png
200
261
media_image2.png
Greyscale
Applicant then argues against the combination of Liu in view of Wilkinson to teach a threshold indicator on the exterior of the cup sidewall (claims 2-3 and 17) (Remarks, pg. 10, par. 03 – pg. 11, par. 05).
Examiner respectfully disagrees. The addition of a label with a threshold indicator to show a minimum volume as taught by Wilkinson in fact further adds to the benefits of Liu (as recited by in the argument) because the threshold indicator allows the operator to quickly glance at the cup to ensure sufficient volume is present. Automated analyzers are well known in the art and are capable of aspirating and dispensing a plurality of times from the same vial/tube/cup/etc. Ultimately, Liu teaches an apparatus that improves the use and storage of a calibration fluid, with one aspect being through minimizing manual operation (Liu, par. 0012). Wilkinson teaches the label with threshold indicator improves allows for a quick glance to be made at a container to determine if it contains a sufficient volume (Wilkinson, par. 0021). In busy labs day to day work can be performed by multiple operators on a single instrument. In the instance of a shift change, if a cup is mistakenly left in the instrument, for example, the threshold indictor label of Wilkinson allows the next shift operator to know how much volume remains in the cup without having to open or aspirate and measure the volume. Ultimately, Liu and Wilkinson both teach a cup for holding a fluid with the goals of minimizing errors associated with human operation error.
Regarding the freeze-dried reagent, the reagents are only freeze-dried for storage. The cup as taught by Liu holds a reagent for calibration wherein Liu teaches the reagent does not need to be manually dispensed from the cup for use (Liu, par. 0022), implying during use, the reagent is a liquid.
Applicant finally argues the combination of Liu in view of Motadel does not teach “wherein the bottom surface of the sealing member is adhered to the top of the top portion of the seal to control the fluid void” as recited in claim 7 (Remarks, pg. 11, par. 06 – pg. 12, par. 04).
Examiner respectfully disagrees. Under broadest reasonable interpretation, the verb adhere does not necessarily imply a permanent connection. Motadel teaches an embodiment of a lid wherein the bottom surface of the lid is engaged with/stuck to the top of the top portion of the tube and remain stuck to together until a certain force applied to the lid actuates the openings. Under the broadest reasonable interpretation, the term "adhered" can mean a configuration wherein two parts are stuck together (adhered together) until actuated by an outside force.
The arguments against the rejection of Lui in view of Kato for claims 13-16 are the same as the arguments against Liu for claim 1 (Remarks, pg. 12, par. 05 – pg. 13). Examiner presents the same rebuttal as above in claim 1 regarding the "preconfigured volume" and "seal" for claim 13.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu, et. al. (CN 207717625 U; citations made with respect to attached English machine translation and original document provided with IDS dated 25 September 2023).
Regarding claim 1, Liu teaches a cup for holding a calibration product for an analytical instrument (Abstract). Liu teaches the cup comprises a cup body 3 (a rack tube, comprising) with a bottom (see bottommost arrow in provided Fig. 3 below) (a base portion), a top as defined by a ledge on the cup body (see outlined portion in provided Fig. 3 below) (a top portion), and a sidewalls defined below the ledge of the top to the bottom (see near arrow 3 in provided Fig. 3 below) (a sidewall extending from the base portion to the top portion). Liu teaches the sidewalls have an inner surface (defining cup interior) and an outer surface (defining cup exterior) that extend the length of the cup to join the top and bottom parts and ultimately define a volume for holding a liquid (Fig. 1, 3) (the sidewall having an inner peripheral surface and an outer peripheral surface, at least one of the inner peripheral surface and the outer peripheral surface in contact with the base portion to form a control fluid void). Liu further teaches a cup lid 2 to seal the interior volume of the cup by attaching to the top portion of the cup body (Fig. 1-2) (a sealing member attached to the top portion to seal the control void). Liu teaches the cup is for holding calibration standards for quality control and instrument calibration (0006) at a volume predefined by cup dimensions (par. 0010) (an analyzer control fluid within the control fluid void, the analyzer control fluid having a preconfigured volume).
PNG
media_image3.png
310
224
media_image3.png
Greyscale
Regarding claim 8, Liu teaches the top portion of the cup is defined by a ledge (see the outlined portion in provided Fig. 3 above) with a sidewall connecting the ledge to an upper surface of the top portion (Fig. 3) (wherein the top portion further includes a ridge formed circumferentially along the sidewall of the top portion). Liu teaches cup lid 2 is defined by an outside surface (see ribbed surface in Fig. 2) and an inside surface (see smooth surface opposite ribbed surface in Fig. 2) (and wherein the sealing member further includes an inside surface and an outside surface). The inside surface of the cup lid 2 defines an open area that is configured to receive the top part of the cup body 3 to seal the inner volume of the cup body 3 (see outlined area of provided Fig. 3 above to see how cup lid 2 receives the cup body 3) (the inside surface forming an inner void configured to receive the ridge of the top portion to seal the control fluid void).
Regarding claim 9, Liu teaches cup lid 2 has a top surface (see uppermost arrow in provided Fig. 1 below) (wherein the sealing member has a top surface) and a bottom surface (see near arrow for label 4 for outer lid and corresponding part for inner lid in Fig. 2) (a bottom surface) and an inner lid 5 that engages with the sidewalls of the top portion of the cup body 3 to seal the inner volume of the cup (Fig. 2, 3) (and a peripheral edge wherein the sealing member is sized such that the peripheral edge is in contact with the sidewall of the top portion to seal the control fluid void).
PNG
media_image4.png
279
304
media_image4.png
Greyscale
Regarding claim 10, Liu teaches cup lid 2 has a ribbed outer surface and a smooth inner surface that includes inner lid 5 (Fig. 2) (wherein the sealing member further includes an inside surface and an outside surface). Liu teaches the inner surface of cup lid 2 (including inner lid 5) engage with the sidewalls of the top portion of cup body 3 to seal the inner volume (Fig. 3; par. 0021) (the inside surface configured to engage the sidewall of the top portion to seal the control fluid void).
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.
Claims 2-3 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Liu, et. al. (CN 207717625 U; citations made with respect to attached English machine translation and original document provided with IDS dated 25 September 2023) in view of Wilkinson (US 20060091669 A1).
Regarding claim 2, Liu teaches the limitation as applied to claim 1 (see above).
Liu is silent to wherein the rack tube further includes a threshold indicator disposed adjacent the outer peripheral surface, the threshold indicator configured to indicate a minimum volume of the analyzer control fluid.
Wilkinson teaches a label system for containers to provide visual indication for fill volume and identification information (Abstract). Wilkinson teaches a container 10 with a label 20 affixed to an outer surface of the container sidewall (Fig. 1-2; par. 0021). Wilkinson teaches label 20 comprises a gap 35 to indicate the desired fill volume (Fig. 1; par. 0021, 0033) (wherein the rack tube further includes a threshold indicator disposed adjacent the outer peripheral surface, the threshold indicator configured to indicate a minimum volume of the analyzer control fluid). Wilkinson teaches the gap in the label allows for an operator to quickly and easily confirm sufficient fluid is in the container (par. 0021).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to combine the cup of Liu with the label system of Wilkinson. One would be motivated to make this combination because the gap in the label allows for an operator to quickly and easily assess if the container/cup is holding a sufficient volume of fluid as taught by Wilkinson (Wilkinson, par. 0021) wherein the combination of the cup and label system will yield predictable results. MPEP 2143(I)(A).
Regarding claim 3, Liu teaches the limitation as applied to claim 1 (see above).
Liu is silent to wherein rack tube further includes an identifier disposed adjacent the outer peripheral surface, the identifier configured to indicate one or more of a lot number, an expiration date, and an expected range.
Wilkinson teaches a label system for containers to provide visual indication for fill volume and identification information (Abstract). Wilkinson teaches a container 10 with a label 20 affixed to an outer surface of the container sidewall (Fig. 1-2; par. 0021). Wilkinson teaches label 20 comprises identification information such as lot number for fluids in container 10 (par. 0023) with other variations (seen in Fig. 4a-c) additionally including expiration dates of fluid in the container (par. 0029) (wherein rack tube further includes an identifier disposed adjacent the outer peripheral surface, the identifier configured to indicate one or more of a lot number, an expiration date). Wilkinson teaches adding identification information to the label allows for an operator to quickly and easily identify relevant information about the fluid the container is holding (par. 0009).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to combine the cup of Liu with the label system of Wilkinson. One would be motivated to make this combination because the identifying information on the label allows for an operator to quickly and easily assess the container/cup contents as taught by Wilkinson (Wilkinson, par. 0009) wherein the combination of the cup and label system will yield predictable results. MPEP 2143(I)(A).
Regarding claim 17, Liu teaches a cup for holding a calibration product for an analytical instrument (Abstract). Liu teaches the cup comprises a cup body 3 (a rack tube, comprising) with a bottom (see bottommost arrow in provided Fig. 3 below) (a base portion), a top as defined by a ledge on the cup body (see outlined portion in provided Fig. 3 below) (a top portion), and a sidewalls defined below the ledge of the top to the bottom (see near arrow 3 in provided Fig. 3 below) (a sidewall extending from the base portion to the top portion). Liu teaches the sidewalls have an inner surface (defining cup interior) and an outer surface (defining cup exterior) that extend the length of the cup to join the top and bottom parts and ultimately define a volume for holding a liquid (Fig. 1, 3) (the sidewall having an inner peripheral surface and an outer peripheral surface, at least one of the inner peripheral surface and the outer peripheral surface in contact with the base portion to form a control fluid void). Liu teaches the cup is for holding calibration standards for quality control and instrument calibration (0006) (at least one of a sample and an analyzer control fluid).
PNG
media_image3.png
310
224
media_image3.png
Greyscale
Liu is silent to a threshold indicator disposed adjacent the outer peripheral surface, the threshold indicator configured to indicate a minimum volume of at least one of a sample and an analyzer control fluid.
Wilkinson teaches a label system for containers to provide visual indication for fill volume and identification information (Abstract). Wilkinson teaches a container 10 with a label 20 affixed to an outer surface of the container sidewall (Fig. 1-2; par. 0021). Wilkinson teaches label 20 comprises a gap 35 to indicate the desired fill volume (Fig. 1; par. 0021, 0033) (a threshold indicator disposed adjacent the outer peripheral surface, the threshold indicator configured to indicate a minimum volume of at least one of a sample and an analyzer control fluid). Wilkinson teaches the gap in the label allows for an operator to quickly and easily confirm sufficient fluid is in the container (par. 0021).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to combine the cup of Liu with the label system of Wilkinson. One would be motivated to make this combination because the gap in the label allows for an operator to quickly and easily assess if the container/cup is holding a sufficient volume of fluid as taught by Wilkinson (Wilkinson, par. 0021) wherein the combination of the cup and label system will yield predictable results. MPEP 2143(I)(A).
Examiner notes the instant Claim 17 contains functional language (ex: "configured to "). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims. In this instance, if cup is capable of holding an analyzer control fluid, it is capable of holding a (fluid) sample.
Claims 4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Liu, et. al. (CN 207717625 U; citations made with respect to attached English machine translation and original document provided with IDS dated 25 September 2023) in view of Motadel, et. al. (US 20180333717 A1).
Regarding claim 4, Liu teaches the limitation as applied to claim 1 (see above).
Liu is silent to wherein the rack tube further includes a threshold indicator disposed adjacent the inner peripheral surface, the threshold indicator configured to indicate a minimum volume of the analyzer control fluid.
Motadel teaches a tube for holding fluids comprising a cap (Abstract) and volumetric graduation lines (Fig. 1). Motadel teaches wherein the tube body comprises volumetric graduation marks or volume indicators on a tube body surface, the tube body surface in some embodiments being an interior surface (Fig. 1; par. 0092) (wherein the rack tube further includes a threshold indicator disposed adjacent the inner peripheral surface, the threshold indicator configured to indicate a minimum volume of the analyzer control fluid). The addition of volume indicators to the tube body allow the operator to determine how much fluid in the container.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to combine the cup of Liu with the interior volume indicators of Motadel. One would be motivated to make this combination because the volume indicators allow for an operator asses if the tube/cup is holding a sufficient volume of fluid, wherein the combination of the cup and volumetric indicators will yield predictable results. MPEP 2143(I)(A).
Regarding claim 7, Liu teaches cup lid 2 has a top surface (see uppermost arrow in provided Fig. 1 below) (wherein the sealing member has a top surface) and a bottom surface (see near arrow for label 4 in Fig. 2) (a bottom surface) and an inner lid 5 that engages with the sidewalls of the top portion of the cup body 3 to seal the inner volume of the cup (Fig. 2, 3) (and a peripheral edge).
Liu is silent to wherein the bottom surface of the sealing member is adhered to the top of the top portion to seal the control fluid void.
Motadel teaches a tube for holding fluids comprising a cap (Abstract). Motadel teaches tube 700 comprises a tube body 705 and is used with a cap 800. Motadel teaches wherein the cap comprises a proximal surface 805, a distal surface 815, and an engagement surface 825 (Fig. 50-55, Table 1) (wherein the sealing member includes a top surface, a bottom surface and a peripheral edge). Motadel teaches tube body 705 comprises a rim 707 at a top portion of the tube wherein the rim 707 further comprises a rim proximal surface 710 (Fig. 50-55, Table 1) (the top of the top portion). As seen in Figures 51 and 52, when the cap 800 is engaged with the tube body 705, the distal surface 815 of the cap is flush with the rim proximal surface 710 of the tube body (and wherein the bottom surface of the sealing member is adhered to the top of the top portion to seal the control fluid void). Motadel teaches this embodiment of a tube and cap attachment minimizes the force needed to engage and disengage the cap from the tube body to ultimately reduce negative conditions linked to repetitive motion (par. 0005).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the cap and cup combination of Liu to more closely resemble the cap and tube combination of Motadel because doing so would make the cap insertion and removal process more ergonomically friendly as suggested by Motadel (Motadel, par. 0005) wherein the modification will have a reasonable expectation of success. MPEP 2143(I)(G).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Liu, et. al. (CN 207717625 U; citations made with respect to attached English machine translation and original document provided with IDS dated 25 September 2023) in view of Wilkinson (US 20060091669 A1) and Motadel, et. al. (US 20180333717 A1).
Regarding claim 5, Liu teaches the limitation as applied to claim 1 (see above).
Liu is silent to wherein rack tube further includes an identifier disposed adjacent the outer peripheral surface, the identifier configured to indicate one or more of a lot number, an expiration date, and an expected range.
Wilkinson teaches a label system for containers to provide visual indication for fill volume and identification information (Abstract). Wilkinson teaches a container 10 with a label 20 affixed to an outer surface of the container sidewall (Fig. 1-2; par. 0021). Wilkinson teaches label 20 comprises identification information such as lot number for fluids in container 10 (par. 0023) with other variations (seen in Fig. 4a-c) additionally including expiration dates of fluid in the container (par. 0029) (wherein rack tube further includes an identifier… the identifier configured to indicate one or more of a lot number, an expiration date). Wilkinson teaches adding identification information to the label allows for an operator to quickly and easily identify relevant information about the fluid the container is holding (par. 0009).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to combine the cup of Liu with the label system of Wilkinson. One would be motivated to make this combination because the identifying information on the label allows for an operator to quickly and easily assess the container/cup contents as taught by Wilkinson (Wilkinson, par. 0009) wherein the combination of the cup and label system will yield predictable results. MPEP 2143(I)(A).
Modified Liu is silent to the identifier being disposed adjacent the inner peripheral surface.
Motadel teaches a tube for holding fluids comprising a cap (Abstract). Motadel teaches wherein the tube body comprises indicators on a tube body surface, the tube body surface in some embodiments being an interior surface (Fig. 1; par. 0092) (disposed adjacent the inner peripheral surface). Including indica and markings on an interior surface will prevent the fading of markings from operator handling.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the identification information of modified Lui to be adjacent to an interior surface as taught by Motadel because doing so would prevent the marked information from fading and wearing off from operator handling with reasonable expectation of success. MPEP 2143(I)(G).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Liu, et. al. (CN 207717625 U; citations made with respect to attached English machine translation and original document provided with IDS dated 25 September 2023) in view of Blaszcak, et. al. (US 20190015830 A1).
Regarding claim 6, Liu teaches the limitations as applied to claim 1 (see above).
Liu is silent to wherein the rack tube sealing member is threadably engaged with the rack tube.
Blaszcak teaches a cap and tube combination for ergonomic engagement (Abstract). Blaszcak teaches a tube 600 with annular projections 640, 645 on the interior surface of top part of the tube 600 (Fig. 33A-C, 35, 36; Table 1) and cap 700 with first insert region projection 734, 735, and second insert region projection 739, 740 (Fig. 40-44; Table 1). Blaszcak teaches cap 700 is engageable with tube 600 through the annular projections and insert region projections (par. 0040-0041) (wherein the rack tube sealing member is threadably engaged with the rack tube). Blaszcak teaches the projections provide a way of engaging the cap and tube to enhance the ergonomics of the device (par. 0020).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to modify the cap and cup combination of Liu to more closely resemble the cap and tube combination of Blaszcak because doing so would make the cap insertion and removal process more ergonomically friendly as suggested by Blaszcak (Blaszcak, par. 0020) wherein the modification will have a reasonable expectation of success. MPEP 2143(I)(G).
Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Liu, et. al. (CN 207717625 U; citations made with respect to attached English machine translation and original document provided with IDS dated 25 September 2023) in view of Kato, et. al. (US 20220065882 A1; claiming a foreign priority date of 31 August 2020).
Regarding claim 13, Liu teaches a cup for holding a calibration product for an analytical instrument (Abstract) (the analyzer control product, comprising). Liu teaches the cup comprises a cup body 3 (a rack tube, comprising) with a bottom (see bottommost arrow in provided Fig. 3 below) (a base portion), a top as defined by a ledge on the cup body (see outlined portion in provided Fig. 3 below) (a top portion), and a sidewalls defined below the ledge of the top to the bottom (see near arrow 3 in provided Fig. 3 below) (a sidewall extending from the base portion to the top portion). Liu teaches the sidewalls have an inner surface (defining cup interior) and an outer surface (defining cup exterior) that extend the length of the cup to join the top and bottom parts and ultimately define a volume for holding a liquid (Fig. 1, 3) (the sidewall having an inner peripheral surface and an outer peripheral surface, at least one of the inner peripheral surface and the outer peripheral surface in contact with the base portion to form a control fluid void). Liu further teaches a cup lid 2 to seal the interior volume of the cup by attaching to the top portion of the cup body (Fig. 1-2) (a sealing member attached to the top portion to seal the control void). Liu teaches the cup is for holding calibration standards for quality control and instrument calibration (0006) at a volume predefined by cup dimensions (par. 0010) (an analyzer control fluid within the control fluid void, the analyzer control fluid having a preconfigured volume).
While not explicitly stated, Liu suggests the calibration cup disclosed is part of a larger set wherein multiple calibration standards or quality control samples of a known values are measured to generate instrument calibration data (par. 0004, pg. 4) (an analyzer control kit).
PNG
media_image3.png
310
224
media_image3.png
Greyscale
Liu is silent to the analyzer control product being received by a sample rack.
Kato teaches a method for an automatic analyzer system for generating calibration data and testing standard samples of a known value (Abstract). Kato teaches a measurement unit 2 and transport unit 3. Transport unit 3 comprises a specimen rack 15 for holding a plurality of specimen containers 14 to be transported to the measurement unit for processing and analysis (Fig. 2; par. 0040-0046). Kato teaches when conducting the calibration process, a container holding the standard sample is added to rack 15 where the calibration standard is then transferred to the measurement unit 2 for processing and analysis (Fig. 8, 11; par. 0080-0085) (a sample rack configured to receive an analyzer control product). Kato teaches the standard sample and calibrations standard(s) undergo the same processing as the specimen sample (including loading onto racks and being transferred) (par. 0085) and this is because using the same processing and measurement steps as the specimen samples ensures the validity of the calibration (par. 0006). Further, adding standard containers to a sample rack allows for further automation of the processing and transport steps.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to combine the analyzer control product of Liu with the sample rack of Kato. One would be motivated to make this combination because it allows for all containers holding unknown samples, calibration and quality control standards to be treated the same way to extend the validity of the calibration data of the instrument (Kato, par. 0006) and further allow for the automation of an analysis system as a whole, wherein this combination would yield predictable results. MPEP 2143(I)(A).
Regarding claim 14, modified Liu in view of Kato teaches sample rack 15 can hold a plurality of containers 14 (Kato, Fig. 2) (wherein the sample rack is configured to receive more than one analyzer control product). It is understood through claim 13 each container (analyzer control product) will have a cup body, a cup lid, and hold a volume of calibration fluid (Liu, Fig. 3; par. 0006) (the analyzer control product being a first analyzer control product, the rack tube being a first rack tube, the sealing member being a first sealing member, and the analyzer control fluid being a first analyzer control fluid, and further comprising a second analyzer control product comprising a second rack tube, a second analyzer control fluid, and a second sealing member).
Regarding claim 15, modified Liu in view of Kato teaches in order to validate the calibration data, a confirmation quality control process is performed (Kato, par. 0095-0096). Kato teaches to perform the quality control operation quality control standards of a known concentration are used to test the validity of the calibration curve by adding containers 14 of a known concentration to the sample rack 15 for processing and analysis (Kato, par. 0095, 0100-0101). Kato teaches wherein multiple quality control measurements 921 are taken (Kato, Fig. 16; par. 0107), and while not explicitly disclosed, it is suggested that because multiple quality control measurements 192 are needed, multiple containers 14 can hold the same quality control standard (wherein the first analyzer control fluid and the second analyzer control fluid are the same).
Examiner notes the instant claim 15 contains functional language drawn to the type of fluid held by the analyzer control product. However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims. In this instance, changing the type of analyzer control fluid to be the same is not patentably distinguishable over the prior art as an operator is able to control what fluid is filled in analyzer control product or able to select what pre-filled analyzer control products will be loaded onto a sample rack depending on the calibration or quality control method being conducted.
Regarding claim 16, modified Liu in view of Kato teaches a container 14 containing a calibration standard is placed on rack 15 (Kato, par. 0080). One of ordinary skill in the art understands to create calibration standards a minimum of three concentrations are needed (Kato, Fig. 7; par. 0088) meaning each container 14 will hold calibration standards of different concentrations (wherein the first analyzer control fluid and the second analyzer control fluid are different).
Examiner notes the instant claim 16 contains functional language drawn to the type of fluid held by the analyzer control product. However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims. In this instance, merely changing the type of analyzer control fluid to be different is not patentably distinguishable over the prior art as an operator is able to control what fluid is filled in analyzer control product or able to select what pre-filled analyzer control products will be loaded onto a sample rack depending on the calibration or quality control method being conducted.
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 MADISON T HERBERT whose telephone number is (571)270-1448. The examiner can normally be reached Monday-Friday 8:30a-5:00p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.T.H./Examiner, Art Unit 1758
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
Prosecution Insights