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 .
Claim Rejections - 35 USC § 112
Claims 16-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Specifically, claim 16 recites “heating the cartridge from the first temperature to the second temperature…”, and it is unclear which cartridges are heated.
In addition, claim 16 recites a seventh device and a ninth device but it is unclear what the structure and function of both the seventh and ninth device is.
Therefore, claim 16 is considered indefinite, and dependent claims 17-18 are also indefinite based upon their dependence from claim 16.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-12 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al (WO 2021/138963, with references taken from US PGPub 2022/0397583) in view of Stein et al (US PGPub 2019/0277869) and Hunt et al (US PGPub 2012/0060541, as cited on the IDS).
Regarding Claims 1-2, 4-5, 7, and 19-21, Xu et al teaches an automatic analysis system for analyzing a sample (see abstract), comprising:
a first device for storing cartridges (referred to as a reaction vessel loading module 2 which stores reaction cups, see [0095], and Figures 28 and 32);
a second device for receiving a transport box (referred to as a robotic arm sampling module 3 which receives sampling device 301 and 302) (see [0306] and Figure 9);
a third device for storing cartridges (reaction cups) at a second temperature (referred to as a magnetic separation cleaning module 6) (see [0095] and Figure 3);
a fifth device for pipetting at least one liquid (referred to as a pipette tip assembly 30201, having a pipetting needle (see [0121]- [0125], [0131] and Figures 15 and 18);
a sixth device for incubating at least one cartridge (i.e. reaction cup) (referred to as incubation module 4) (see [0095] and [0136]).
Furthermore, Xu et al teaches that the at least one cartridge (i.e. reaction cup) can be delivered throughout the analysis system by the manipulator and transfer module (5), and wherein manipulators (501, 502) and multiple transfer devices (503) can be arranged as required to fit independent module functional components (see abstract, [0099] and [0102]). Furthermore, Xu et al teaches that a measurement of a test preparation can take place by means of a seventh device (referred to as detection module 7), wherein reaction vessel (9) located in the incubation module (4) is transferred to the magnetic separation cleaning module (6) for magnetic attachment cleaning. The cleaned reaction vessel (9) is transferred by the manipulator and transfer module (5) to the test module (7) for testing (see [0095] and Figure 3).
In addition, Xu et al teaches that robotic arm sampling module 3 is equipped with a sample tube compartment assembly 307 (which serves as a third compartment) and a reagent box compartment 308 (which serves as a first compartment) (see [0128]- [0131]).
Xu et al does not explicitly disclose a fourth device for heating the cartridges from one temperature to another, and wherein the cartridges also comprise a second compartment with at least one control.
However, in the analogous art of automated clinical analyzer, Stein et al teaches control storage, where control and calibrator storage is a refrigerated module designed to cool quality control (QC) material while, at the same time, minimizing evaporation of QC material and light exposure. In some embodiments, the control storage module is located in the sample handler, and wherein control storage can be accessed by the sample handler robot arm (see [0058]). Furthermore, Stein et al teaches that the control storage module is generally designed to store control and calibrator vials. Vials/tubes fit into a thermally conductive tube base subassembly (e.g., a thermally conductive plate having recesses to receive tubes), which is cooled using thermoelectric devices attached to the refrigerated storage subassembly, and wherein refrigerated storage for controls and calibrators provides long-term storage of multiple days for controls and calibrators in sample tubes (see [0058] and [0175]). In addition, Stein et al teaches modules including a Peltier device, and also teaches that in-line fluid heaters are used in conjunction with control of the air temperature in compartments of a clinical analyzer module through which the fluidics tubing is routed. This allows the fluid heaters to be mounted at some distance away from the point at which the fluid is dispensed (see [0177] and [0287]).
It would have been obvious to one of ordinary skill in the art to modify the automatic analysis system of Xu et al by further incorporating in-line heaters (as a fourth device) for the benefit of bringing fluids used in the immunoassay to a constant temperature. Furthermore, it would have been obvious to one of ordinary skill in the art to modify the cartridges of Xu et al by further including a second compartment having a control (as taught by Stein et al) for the benefit of providing long term storage of multiple days for controls and calibrators in sample tubes, such that the samples in the sample may be compared with the control/calibrators.
In addition, the combination of Xu et al and Stein et al teaches that a first and third temperature used is less than 268.15 kelvin (specifically 245.15 – 255.15 K, and less than 263.15), that a second temperature used is more than 273.15 (specifically 293.15 – 315.15 Kelvin, such as 308.15-312.15) or a fourth temperature used is ranging from 233.15 to 323.15 kelvin (specifically 288.15 -298.15 K).
However, in the analogous art of automated storage and retrieval system, Hunt et al teaches a system 10 including a horizontal freezer 12 for storing biological or chemical samples typically in SBS format tube storage racks and/or storage plates. Typically, the freezer chest 12 will be located within a refrigerated enclosure that is maintained at a low temperature of approximately -15 to -30 degrees Celsius (which is 243.15 to 258.15 Kelvin) (see [0021]). Furthermore, Hunt et al teaches that the cassettes (which contain samples stored in racks) are transferred to moved from 20°C to 36°C (i.e. 293.15K to 309.15K) (see [0032]). It would have been obvious to have first and third temperatures be less 268.15 kelvin, have a second temperature used be more than 273.15 and a fourth temperature used range from 233.15 to 323.15 kelvin (as taught by Hunt et al) for the benefit of first storing the samples at less 268.15 kelvin so the biological samples remain stable, and move the samples to higher temperatures (such as between 20°C to 36°C) (as taught by Hunt et al) for the benefit of enabling additional reactions to occur, while the samples remain stable and transferring the samples via a fourth temperature (of 288.15 – 298.15K), as this temperature is known to be able to maintain the samples in the cartridges/test tubes while also enabling the appropriate reactions.
Regarding Claim 3, Xu et al teaches that the third device (magnetic-separation cleaning module 6) at least partially includes the fifth and sixth devices (i.e. the pipetting assembly 5 and incubation module 4) (see Figures 3 and 34).
Regarding Claim 6, the combination of Xu et al, Stein et al and Hunt et al teaches that liquid comprises a sample liquid (see [0003] of Stein et al and [0122] and [0154] of Xu et al).
Regarding Claim 8, the combination of Xu et al, Stein et al and Hunt et al teaches a recess, the recess being configured to receive at least one transport box (see [0079] of Stein et al).
Regarding Claim 9, the combination of Xu et al, Stein et al and Hunt et al teaches that the analysis system comprises an eighth device for controlling the first, second, third or fourth temperature (i.e. a temperature controller or temperature control system) (see [0177] and [0308]-[0310] of Stein et al).
Regarding Claims 10-12, the combination of Xu et al, Stein et al and Hunt et al teaches ninth to eleventh devices for automatically bringing at least one cartridge out of the first, second and third devices (where Xu et al teaches “a plurality of manipulators and a plurality of transit devices may be disposed as required, to link the mutually independent functional parts of the modules.”, see abstract and [0043] of Xu et al).
Claim(s) 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al, Stein et al and Hunt et al as applied to claim 1 above, and further in view of Viola et al (US PGPub 2012/0329082, as cited in the IDS).
Regarding Claims 13-14, the combination of Xu et al and Hunt et al teaches that robotic arm sampling module 3 (which constitutes and includes a cartridge and the transport box for transporting the cartridges) is equipped with a sample tube compartment assembly 307 (which serves as a third compartment) and a reagent box compartment 308 (which serves as a first compartment) (see [0128]-[0131]).
The combination of Xu et al and Hunt et al does not explicitly disclose that the cartridges also comprise a second compartment with at least one control.
However, in the analogous art of automated clinical analyzer, Stein et al teaches control storage, where control and calibrator storage is a refrigerated module designed to cool quality control (QC) material while, at the same time, minimizing evaporation of QC material and light exposure. In some embodiments, the control storage module is located in the sample handler, and wherein control storage can be accessed by the sample handler robot arm (see [0058]). Furthermore, Stein et al teaches that the control storage module is generally designed to store control and calibrator vials. Vials/tubes fit into a thermally conductive tube base subassembly (e.g., a thermally conductive plate having recesses to receive tubes), which is cooled using thermoelectric devices attached to the refrigerated storage subassembly, and wherein refrigerated storage for controls and calibrators provides long-term storage of multiple days for controls and calibrators in sample tubes (see [0058] and [0175]). In addition, Stein et al teaches modules including a Peltier device, and also teaches that in-line fluid heaters are used in conjunction with control of the air temperature in compartments of a clinical analyzer module through which the fluidics tubing is routed. This allows the fluid heaters to be mounted at some distance away from the point at which the fluid is dispensed (see [0177] and [0287]).
It would have been obvious to one of ordinary skill in the art to modify the cartridges of Xu et al by further including a second compartment having a control (as taught by Stein et al) for the benefit of providing long term storage of multiple days for controls and calibrators in sample tubes, such that the samples in the sample may be compared with the control/calibrators.
Furthermore, the combination of Xu et al, Stein et al and Hunt et al does not explicitly disclose that the first compartment comprises a frozen reagent.
However, in the analogous art of devices, systems and methods for evaluation of hemostasis, Viola et al teaches that the reagent used in the device for a given test chamber can be frozen to solidify all of its water molecules. Once frozen, the product is placed in a vacuum and gradually heated without melting the product. This process, called sublimation, transforms the ice directly into water vapor, without first passing through the liquid state. The water vapor given off by the product in the sublimation phase condenses as ice on a collection trap, known as a condenser, within the lyophilizer's vacuum chamber. The lyophilized product, which may be a pellet, can then be positioned in each test chamber. Once placed in a test chamber, the test chamber can be sealed to prevent unwanted rehydration of the product (see [0061]).
It would have been obvious to one of ordinary skill in the art to utilize a frozen reagent in the first compartment for the benefit of producing lyophilized reagent that can be sealed in the compartment to prevent unwanted rehydration of the product.
Allowable Subject Matter
Claims 16-18 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Regarding Claims 16-18, the prior art neither teaches nor fairly suggests a method for analyzing a sample by means of an automatic analysis system, comprising: removing the cartridge from the first device and delivering it into a third device with a tenth device, the third device for storing cartridges at a second temperature, the second temperature higher than 273.15 kelvin, and wherein the tenth device for automatically bringing at least one cartridge out of the first device and into the third device,
measuring the test preparation using a seventh device in the measurement cuvette of a third compartment of the cartridge, and
evaluating the measurement of the test preparation by using at least one calibration curve, which has been transmitted electronically to the analysis system.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER WECKER whose telephone number is (571)270-1109. The examiner can normally be reached 9:30AM - 6 PM EST M-F.
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/JENNIFER WECKER/ Primary Examiner, Art Unit 1797
