Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 32 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 5,976,896 (“Kumar”) in view of US 20070207450 (hereinafter "Rodgers").
Claim 1 recites a cartridge comprising a first well configured to receive the biological sample, and a second well that stores a cartridge reagent for conducting an assay to detect the analyte, wherein the cartridge comprises an identifier encoding information corresponding to the cartridge;
a reader assembly for conducting the assay to detect the analyte, wherein the reader assembly comprises a detection assembly configured to detect a signal indicative of a presence of the analyte in an assay unit,
an identifier reader configured to read the identifier on the cartridge; and
a computer system configured to receive the information from the identifier reader,
associate the information with a protocol of the plurality of protocols based at least in part on the identity of the analyte to be detected; and
transmit the protocol to the reader assembly,
wherein the reader assembly conducts the assay by moving the assay unit relative to the cartridge based on the protocol received from the computer system.
The following disclosure by Kumar is considered relevant to Applicant’s claims.
“A fluorescent immunoassay employing the interior surface of a capillary tube is provided. Devices to permit immunoassays using one or more capillary tubes, an apparatus for use with the devices, and a process for screening for analyte in a sample using the devices and apparatus are also provided. Samples suspected of containing analyte are added to a disposable self-contained sample tray containing one or more sample wells, mixed with a reagent, drawn into one or more spaced-apart capillary tubes held within a disposable cartridge connected to an analytical apparatus, reacted with a binding member on the surface of the capillary tube, washed to stop the reaction, and dried by the apparatus. The capillary tube is then exposed to a signal generation device to create a fluorescence signal that is detected using a signal detector. The apparatus determines the presence of the analyte and optionally determines the amount of analyte present in the sample, and presents the results to the operator.” Abstract (emphasis added).
Kumar further teaches an assay system that can be automated.
More specifically, Kumar in column 17, line 2 to column 18, line 10 discloses the following.
“Capillary tubes prepared by the methods described above can be used individually or in combination for an immunoassay in accordance with the method discussed above. The assay can be performed manually or automatically, as discussed hereinafter. One end of a single capillary tube can be introduced into a sample and sample drawn up by any convenient means, e.g. capillary action or active pumping, to provide an appropriately sized sample in the capillary tube. Alternatively, a plurality of capillary tubes coated with appropriate binding members can be used to permit a plurality of immunoassays on one sample or a single immunoassay on multiple samples to screen for one or multiple analytes. The capillary tubes can be held in a cartridge that permits sequential or simultaneous use and/or that permits interaction with other devices and/or apparatus to effectuate an immunoassay of this invention.” Column 17, line 2 to column 18, line 10. (Emphasis added.)
Moreover, column 18, lines 41-46 of Kumar discloses the following.
“Capillary tubes as prepared above can be used with commercially available containers suitable for independently housing the reagents and waste of immunoassays, such as microtiter wells or plates. Alternatively, the capillary tubes can be used with a sample tray designed to contain a reagent and means to mix fluid held within the wells.” Column 18, lines 41-46. (Emphasis added).
Thus Kumar teaches that reagents can be provided in wells of a microtiter plate or wells of a sample tray. Moreover, Kumar teaches that the reagents can be provided in the wells or plates, as an alternative to reagents being contained and mixed in a sample tray. [The microtiter plate or the sample tray is equivalent to Applicant’s cartridge. The wells of the microtiter wells or sample tray are equivalent to Applicant’s cartridge comprising wells.]
Kumar teaches capillary tubes used individually or in combination for an immunoassay. One end of the capillary tube can be introduced into a sample. The capillary tubes are coated with binding members to permit a plurality of immunoassay on one sample or multiple samples to screen for one or multiple analytes. The capillary tubes can be held in a cartridge that permits sequential or simultaneous use and/or that permits interaction with other devices and/or apparatus to effectuate an immunoassay (col. 17, lines 62 to col. 18, line 10.)
The capillary tubes can be used with a sample tray designed to contain a reagent and means to mix the fluid within the wells [of the sample tray.] Column 18, lines 41-46.
The apparatus has the ability to manipulate one or more capillary tubes and a sample tray, to control the flow of and house fluids, to carry out a substantial portion of the steps of a plurality of immunoassays for efficiency, including the step of detecting and analyzing the signal. Column 19,lines 6-19.
In figure 12 there is shown an apparatus 200 that comprises prep station 201, capillary tubes 2, and detection station 203. Column 29, lines 55-67. The prep station 201 comprises syringe 210, a first section for containing the cartridge 1 (which holds capillaries, see for example col. 21, lines 19-22), and a second section comprising a tray holder 212 for holding the sample tray 3. See column 30, lines 1-10.
The capillary tubes are spaced apart along the outside of the longitudinal side of a cylinder or by a disc or plurality of discs, containing openings to hold a plurality of spaced apart capillary tubes in a circular manner. The cylinder can rotate to present a particular tube to a sample source or to a fluid source for washing, adding reagent, or other desired fluid to each tube. The cylinder can also rotate to present a capillary tube to a signal generation and detection means. Column 35, line 66-column 36, line 16.
[Examiner notes that the Kumar system is not configured such that the capillaries, which are held by the cylinder, are coupled to a fluid transfer device [such as a syringe] while being detected by the detector. New claim 32 however does not require this. Rather, claim 32 only requires that the reader assembly comprises a detection assembly configured to detect a signal indicative of a presence of the analyte in an assay unit. This is different from claim 1 in which the reader assembly comprises a stage on which the cartridge is received, a fluid transfer device coupled to an assay unit, and a detection assembly configured to detect a signal indicative of a presence of the analyte in the assay unit [that is, in the assay unit coupled to the fluid transfer device].
See also figure 1, disclosing cartridge (1), capillary tube 92) where reaction takes place, sample tray (3) for containing sample, reagents, and other fluids.
The microtiter plate or the sample tray is equivalent to Applicant’s cartridge. The wells of the microtiter wells or sample tray are equivalent to Applicant’s sample well and reagent well wherein the capillary is used to transfer the sample and reagents from the wells.
See also column 18, lines 44-46, disclosing that the sample tray is designed to contain a reagent and means to mix fluid held within the wells, and column 19, lines 35-36 disclosing that the sample is added to one or more wells in the sample tray). Examiner emphasizes that since Applicant’s claims are directed to a device, rather than a method, the prior art meets the claims if it is capable of performing the intended use, in this case the intended use of containing a reagent in one well and a sample in a separate well for sequentially being introduced into the capillary separately from the sample.
See also column 18, lines 41-46 disclosing another example in which the capillary tubes can be used with commercially available containers suitable for independently housing the reagents and waste of immunoassays, such as microtiter wells or plates, or alternatively a sample tray can contain a reagent and means to mix fluid held within the wells.” Column 18, lines 41-46. Thus Kumar teaches microtiter well plates as alternatives to a sample tray. Microtiter well plates are thus alternatively considered equivalent to Applicant’s cartridge comprising a sample well and a reagent well since the wells of microtiter plates are capable of containing a sample in one well and a reagent in another well.
Moreover, Kumar discloses a method for use with the disclosed system, wherein the sample is added to the capillary with free antibody and an enzyme linked antibody, and free antibody is washed away before enzyme substrate is added to the complex, following with detection. Column 33, line 63 to column 34, line 8.
Thus, Kumar shows an example of use of the disclosed capillary wherein sample is added to the capillary, and then subsequently another reagent (e.g., enzyme substrate) is added to the capillary. While Kumar does not give details as to the container holding the sample and reagent in the disclosure of this assay format, it is understood that the sample and reagent can be provided in a container generally disclosed elsewhere by Kumar in the patent, that is, commercially available microtiter well plates or a sample tray (col. 18, lines 41-46.) See also disclosure of wells in the sample tray (column 19, lines 35-36; and col. 32, lines 20-24 and see figures 4 and 9). [Examiner advises that, as an alternative grounds for rejection, providing the sample and reagents in separate wells in the same microtiter well plate or the same sample well plate requires only ordinary skills in the art since it leads to a predictable outcome of providing the materials necessary for performing the assay.]
Kumar also discloses that the apparatus positions the sample tray under the cartridge located thereon and draws the mixture into one or more capillary tubes, e.g., via suction. Column 19, lines 42-56. See also column 30, lines 47-49 disclosing a motor for moving the sample tray under the cartridge [which holds the capillary, equivalent to Applicant’s assay unit.]
A syringe or suctioning means (column 30, lines 1-10) is equivalent to the claimed fluid transfer device configured to direct transfer of the sample and the cartridge reagents from the cartridge into the assay unit such that a reaction occurs within the assay unit.
Kumar also teaches that the sample tray holder, and thereby the sample tray, is lifted by a lift motor to contact the mixture in wells 57 (col. 32, lines 20-24 and see figures 4 and 9).
The Kumar sample tray holder is equivalent to Applicant’s claimed cartridge.
Regarding the limitations in claim reciting a computer system that stores protocols to be transmitted to the reader assembly, column 31, lines 40-44 of Kumar discloses that "[t]he automated non-operator dependent portion of the apparatus 200 system software is provided by an erasable programmable read only memory (EPROM) module 348 connected to the control PCA 300 via a 30 position edge connector 349." (Emphasis added).
Moreover, column 36, lines 50-67 of Kumar discloses the following: "An important aspect of an alternative embodiment of the apparatus for use with a preferred embodiment of the cartridge and sample tray is that embodiments of the apparatus are able to communicate with the cartridge and sample tray, that the apparatus is equipped with appropriate electronics and/or optics for a given, immunoassay, and that the apparatus is capable of performing or interfaced with an instrument capable of performing an automated immunoassay and of computing qualitative, semi-quantitative, and/or quantitative results. Another aspect of the apparatus for use with a preferred embodiment of the cartridge and sample tray combination is that the apparatus house or control a suitably substantial portion of the means to move fluid in and out of the wells, capillary tubes, and chambers." (Emphasis added.)
Column 37, lines 56-67 discloses the following: "Alternative embodiments of the apparatus of the present invention can also include various levels of automation. One embodiment of the apparatus of the present invention can be designed such that only instrument control is possible with the stand alone apparatus and all data reduction and analysis is performed by a computer connected or networked to the apparatus via a port, such as RS-232, IEEE-488 (HP-IB), contact closure, and the like. Similarly, control of the apparatus can be automated by a connection to a computer as previously described where all control inputs are directed by the computer and initiated by an operator or alternatively by a computer program." (Emphasis added).
Moreover, Kumar in column 3, lines 1-18: "Additionally, a preferred embodiment of the apparatus of the present invention or variations of it can be interfaced with laboratory robots, such as cylindrical, cartesian, and articulated robots and the like; to enable complete automation of the immunoassay. The robotics device can be programmed to remove sample from a central container and add it to each well and alternatively to perform any pre-assay sample processing and preparation necessary, such as filtration, extraction, dilution, removal of certain components, and other manipulations depending on the sample. The robotics device can also place the sample tray and cartridge on the apparatus and subsequently move the cartridge to the centrifuge or other device and dispose of the sample tray. The robotics device can be integrated into an alternative embodiment of the apparatus of the present invention or it can be a commercially available robot for use in the laboratory and known to those of ordinary skill in the art of the present invention." Thus Kumar discloses use of laboratory robots to enable complete automation of an immunoassay, including adding a sample to a container and performing dilution [which Examiner notes is addition of a reagent].
In summary, Kumar teaches the disclosed system can be automated and programed for automating an assay (column 31, lines 40-44), including controlling the means to move fluid in and out of wells of a sample tray (column 36, lines 50-67), and that the control inputs can be directed by the computer or initiated by an operator (column 37, lines 56-67). Again, a syringe or suctioning means as disclosed by Kumar (column 30, lines 1-10) is equivalent to the claimed fluid transfer device configured to direct transfer of the sample and the cartridge reagents from the cartridge into the assay unit such that a reaction occurs within the assay unit. Thus, the Kumar system is configured to transmit a protocol to the reader assembly [i.e., capillary, tray, and detector system] to perform a protocol (via a program or control initiated by an operator).
Applicant’s claim 1 also recites “wherein the reader assembly conducts the assay by moving the assay unit relative to the cartridge based on the protocol received from the computer system.”
The following by Kumar shows that the capillaries are moved relative to the cartridge [tray of wells].
Kumar discloses that in one embodiment, the capillary tubes are spaced apart along the outside of the longitudinal side of a cylinder or by a disc or plurality of discs, containing openings to hold a plurality of spaced apart capillary tubes in a circular manner. The cylinder can rotate to present a particular tube to a sample source or to a fluid source for washing, adding reagent, or other desired fluid to each tube. Column 35, line 66-column 36, line 16.
Examiner notes that translating (as recited in claim 1) encompasses rotation, and the tubes are rotated (translated) relative to the cartridge (tray of wells) when the tubes are rotated to present the tubes to the wells/fluid source, which thus meets Applicant’s limitation.
Kumar teaches the disclosed system can be automated and programed for automating an assay (column 31, lines 40-44), including controlling the means to move fluid in and out of wells of a sample tray (column 36, lines 50-67), and that the control inputs can be directed by the computer or initiated by an operator (column 37, lines 56-67). A syringe or suctioning means as disclosed by Kumar (column 30, lines 1-10) is equivalent to the claimed fluid transfer device configured to direct transfer of the sample and the cartridge reagents from the cartridge into the assay unit such that a reaction occurs within the assay unit. Thus, the Kumar system is configured to transmit a protocol to the reader assembly [i.e., capillary, tray, and detector system] to perform a protocol (via a program or control initiated by an operator).
A detection assembly to detect a signal in the assay unit is disclosed as a detection means (see for example col. 36, lines 7-8).
Regarding an identifier on the cartridge, as recited by Applicant in claim 1, see Kumar in column 31, line 47 to column 32, line 44, which discloses the following.
“…In a typical immunoassay using a preferred embodiment of the present invention, the cartridge 1 and sample tray 3 are placed on the prep station 201 by the operator as shown in FIG. 12, then 100 microliters of a sample possibly containing an analyte of interest, such as milk suspected of containing .beta.-lactam antibiotics, is added to one or more wells 57 located in the sample tray 3 which contain a dried stabilized reagent comprising an antibody to the analyte of interest, which antibody is conjugated with a highly fluorescent label… A barcode, provided with the cartridge 1 and sample tray 3 combination kit, is then scanned using a standard commercially available barcode wand associated with the barcode wand input connector 338 to provide calibration information to the apparatus 200. For example, the barcode can contain the pass/fail threshold level of fluorescence for a particular immunoassay. The operator then inputs additional information via the alphanumeric keypad controller 204 and subsequently starts the apparatus 200. The sample and fluorescently-labeled conjugate reagent are then mixed while in the well 57…” (Emphasis added.)
The Kumar barcode is equivalent to Applicant’s identifier in claim 1.
While Kumar discloses a barcode provided with the cartridge and sample tray, Kumar is silent as to the barcode being configured to provide information related to a protocol such that the reader assembly conducts the assay based on the protocol received from the computer system.
However, Rodgers in paragraph 0065 discloses that the module is able to read an identification tag associated with a substrate or chamber such as a bar code or serial number. Rodgers discloses that the identifier provides the advantage of using it to track the movement or position of the chamber within the device, and react in an appropriate manner such as by performing an assay on it, or transmit data identified using the identification system to a processor for further analysis. Rodgers also teaches providing assay modules and/or handling apparatuses that may be controlled by a control panel or a computer, and may be automated and/or programmable.
It would have been obvious to one skilled in the art to combine the teachings of Rodgers with Kumar such that the identifier [the same barcode disclosed by Kumar, or a separate identifier] on the Kumar cartridge or sample tray provides for tracking movement or positioning of the cartridge or sample tray, or to perform a reaction by performing an assay [any of which are equivalent to a protocol], as taught by Rodgers.
Allowable Subject Matter
Claims 1-2, 4-17, 28-29 and 31 are allowed for the reasons set forth in the previous Office action.
Response to Arguments
Applicant has added new claim 32, which is rejected for the reasons set forth above.
Examiner notes that the Kumar system is not configured such that the capillaries, which are held by the cylinder, are coupled to a fluid transfer device [such as a syringe] while being detected by the detector. New claim 32 however does not require this. Rather, claim 32 only requires that the reader assembly comprises a detection assembly configured to detect a signal indicative of a presence of the analyte in an assay unit. This is different from claim 1 in which the reader assembly comprises a stage on which the cartridge is received, a fluid transfer device coupled to an assay unit, and a detection assembly configured to detect a signal indicative of a presence of the analyte in the assay unit [that is, in the assay unit coupled to the fluid transfer device].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Montgomery whose telephone number is (571)272-0894. The examiner can normally be reached Mon-Fri, 9-5:30 PM PST.
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/Ann Montgomery/ Primary Examiner, Art Unit 1678
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