FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENT RULES, 2003
COMPLETE SPECIFICATION
(See Section 10 and Rule 13)
Title of invention:
A MAGNETIC THERMOSHAKER ASSEMBLY FOR A DIAGNOSTIC SYSTEM
APPLICANT:
MYLAB DISCOVERY SOLUTIONS PRIVATE LIMITED
An Indian entity having address as:
PLOT NO 99-B, LONAVALA INDUSTRIAL CO-OPERATIVE ESTATE LTD,
NANGARGAON, LONAVALA, PUNE – 410401
MAHARASHTRA, INDIA
The following specification describes the invention and the manner in which it is to be performed.2

CROSS-REFERENCE TO RELATED APPLICATIONS AND PRIORITY
The present application does not claim priority from any other patent application.
TECHNICAL FIELD
The present subject matter described herein, in general, relates to a field of a 5 diagnostic system. More particularly, the present subject matter relates to a diagnostic system having a thermo-shaker and a magnetic assembly extraction of nucleic acid and performing RT-PCR.
BACKGROUND 10
Nucleic acids (NA) are the main information-carrying molecules of the cell, and by directing the process of protein synthesis, they determine the inherited characteristics of every living thing. The two main classes of nucleic acids are a deoxyribonucleic acid (DNA) and a ribonucleic acid (RNA). The DNA is the master blueprint for life and constitutes the genetic material in all free-living organisms 15 and most viruses. The RNA is the genetic material of certain viruses, but it is also found in all living cells, where it plays an important role in certain processes such as the making of proteins - and thus nucleic acid is the basic object of molecular biology research, and the extraction of the nucleic acid is the most important criteria for the detection of disease and research. 20
A variety of methods to extract NA (DNA or RNA) from biological sample are available such as traditional organic solvent extraction method, column adsorption method, magnetic bead partition method and the charge method etc. for isolating nucleic acid (NA) from complex starting materials like whole blood, tissues, 25 sputum, blood serum, urine or faeces, or any biological materials, extraction of NA from any of these samples usually involve lysis of biological material by a solvent or detergent in the presence of protein degrading enzymes, followed by several extractions with organic solvents, e.g., phenol and/or chloroform, ethanol precipitation etc. 30 3

These known methods of isolating NA from biological samples are very laborious and time-consuming. The relatively large number of steps required to purify NA from such starting materials increase the risk of transmission of NA from sample to sample in the simultaneous processing of several clinical samples. When the NA is isolated for the subsequent detection of the presence of NA of, e.g., a pathogen (e.g., 5 a virus or a bacterium) by means of a nucleic acid amplification method using the utmost sensitive Real Time polymerase-chain-reaction (RTPCR), the increased risk of such a transmission of NA between different samples which causes false positive results is a serious drawback. To reduce such mishaps automating the entire manual process is a must. 10
Automated analysers are well-known in the field of molecular biology, clinical laboratories, immunochemistry, and biological research. Extraction from human or environmental sample is a complicated process that may be required to eliminate the presence of proteins, polysaccharides, and small molecules that inhibit the PCR 15 assay at the heart of most molecular assays. Therefore, laboratory staff must isolate the DNA and/or RNA content of the sample prior to molecular analysis.
Several commercial products for DNA extraction exist. However, these products require users to process samples through several steps of cell lysis, inhibitor 20 adsorption, and protein digestion before collecting and cleaning the final NA isolate using a microcentrifuge spin column or other methods employed.
The resulting NA is then suitable for most applications, also most commercially available products for extraction process takes too long a time to complete the entire 25 process, is complicated, and many a times also increases the risk of sample cross-contamination as there are manual intervention in the process increasing time and chances of error.
Also, these commercially available instruments require substantial capital 30 investment and additional pre-processing steps for use. Till date very few available 4

instruments are available for processing the sample after the extraction process is complete. Most of the available instruments the extracted NA is the final product, which is then manually processed for further analysis. Manual intervention always possesses the risk of errors.
5
Thus, there is a long-standing need of a thermoshaker with magnetic assembly for a diagnostic system which solves above mentioned problems. To eliminate any errors and to diminish all manual interventions the proposed system is designed to execute NA extraction and reagent preparation for further RTPCR analysis.
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SUMMARY
This summary is provided to introduce the concepts related to a thermoshaker and magnetic assembly for a diagnostic system and the concepts are further described in the detail description. This summary is not intended to identify essential features of the claimed subject matter, nor it is intended to use in determining or limiting the 15 scope of claimed subject matter.
In one implementation, the thermoshaker and magnetic assembly for a diagnostic system is disclosed. Further, the thermoshaker and the magnetic assembly comprises a base plate, a heating block, a reaction tube, a magnetic strip, a nylon plate and temperature sensors. This assembly serves to facilitate and regulate 20 rotational movement for sample mixing and separation. The Magnetic assembly moves horizontally and vertically with respect to the shaking module thereby brings out magnetism influenced shaking process.
In another implementation, a method of a magnetic thermoshaker assembly for a diagnostic system for Automated Nucleic acid extractor and Real Time PCR 25 (RTPCR) reagent preparator for is disclosed. The method comprises first step of passing, programmable commands to PLC going to Motor drives, wherein the Motor Shaft Transfers the Motion to an eccentric shaft via coupler and grub screw mechanism then the Eccentric shaft provides Vortex motion to Teflon spring through bearing housing, wherein the Vortex motion is transferred to heating block 30 through a Teflon plate. Further the second step involves rotation of a set of motors, 5

with respect to commands provided, wherein motor (1) is configured to rotate the magnetic plate in the reverse forward motion and motor (2) is configured to rotate the Magnetic plate in and down motion. Furthermore, the third step involves setting, of the magnetic plate at a programmable height by motor (2) once the shaking action completed by shaker mechanism and an inbuilt heater reaches at a desired 5 temperature. Fourth step involves approaching of the magnetic plate, towards the Heating Block with forward- Reverse commands of Motor (1), wherein the Magnetic plate remains attached with the heating Block for a programmable time. The fifth step of this invention involves leaving of the magnetic plate from the heating block and moving backward with Motor (1) in the reverse direction. 10
BRIEF DESCRIPTION OF DRAWINGS
The detailed description is described with reference to the accompanying figures. In the Figures, the left-most digit(s) of a reference number identifies the Figure in 15 which the reference number first appears. The same numbers are used throughout the drawings to refer like features and components.
Figure 1 illustrates a thermoshaker assembly (100) for a diagnostic system, in accordance with an embodiment of a present subject matter. 20
Figure 2(a) and 2(b), illustrates another embodiment of a diagnostic system 100, in accordance with the present disclosure.
Figure 3, illustrates another exemplary embodiment of a magnetic assembly, in 25 accordance with the present disclosure.
Figure 4 illustrates an exemplary method for RTPCR, in accordance with the present disclosure.
30 6

DETAILED DESCRIPTION
Reference throughout the specification to “various embodiments,” “some embodiments,” “one embodiment,” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, appearances of the phrases “in various 5 embodiments,” “in some embodiments,” “in one embodiment,” or “in an embodiment” in places throughout the specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner in one or more embodiments. 10
The present disclosure relates to a diagnostic system. The exemplary embodiment of the diagnostic system may comprise a thermoshaker assembly and a magnetic assembly. The thermoshaker assembly and magnetic assembly are configured to work in conjugation. In accordance with the exemplary embodiment a specimen of 15 Nucleic Acid (NA) in a test tube is first heated and then Shaked to separate the strands of DNA or RNA. Further metallic beads may be placed in the test tube while the shaking process so as to retain some of the nucleic acid on the surface of the beads. Further the magnetic assembly comprising a magnetic strip or magnetic bar may be positioned or moved closer to the test tube on in thermoshaker. Further with 20 the movement of the magnets the beads may be separated from the solution in the test tube.
The thermoshaker assembly as disclosed in the exemplary embodiment may comprise a platform/base. The platform as disclosed may be integrally mounted on 25 two or more pillars. The two or more pillars may have a hollow internal structure. Further the hollow internal structure of the each of the pillar may be configured to accommodate at least one motor. The at least one motor may have a motor/rotor shaft. The motor shaft may further be coupled to an eccentric shaft via a coupler and a grub screw. The eccentric shaft may be configured to convert the rotational 30 7

motion of the rotor shaft into an oblique or an elliptical motion or a vortex motion. Further the vortex motion of the eccentric shaft may be transferred to a spring.
The spring in accordance with the exemplary embodiment may be a leaf spring or a circular spring fabricated from Teflon or Nylon. Further the spring may be 5 configured to transfer the motion the vortex motion to a receptacle. The spring may also act as damper to dampening to the receptacle once the vortex motion cesses. Further the receptacle may comprise a plurality of wells or plurality of cavities. The plurality of wells may be configured to hold, receive, or accommodate testing tubes.
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Further a heating element may be placed or positioned adjacent to the plurality of receptacles such that the heating elements runs along the height of the receptable and width of the plurality of receptacles. Further only one side of the plurality of receptacles may be exposed or in contact with the heating element. The heating element may be mounted on the platform/base. Further the other side of the plurality 15 of receptacles, i.e., the side opposite to the side exposed to the heating elements, may be exposed to the magnetic assembly.
The magnetic assembly in accordance with an exemplary embodiment may be mounted on the platform/base, or in another exemplary embodiment the magnetic 20 assembly may be independently mounted on a module or carriage. The module or the carriage may be configured to travel in a horizontal direction and vertical direction with respect to the thermoshaker assembly. The magnet in the magnetic assembly may be a bar magnet or strip of magnets mounted on a block.
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The exemplary embodiment disclosing the mounting of the magnetic assembly on the platform may further comprise a bar magnet or a block strip of magnet configured to move towards or away from the plurality of receptacles. The motion of the magnet may be controlled by same BLDC motor providing shaking motion to the thermoshaker, or by a separate BLDC motor. 30 8

Further in accordance with the other exemplary embodiment wherein the magnetic assembly is mounted on the independent module or carriage, the module or carriage may have independent BLDC motors. Further the carriage may be moved in vertical direction and horizontal direction using the independent BLDC Motor. The magnet along with the carriage may be moved towards or away from the plurality of 5 receptacles to separate the nucleotides on attached on the magnetic beads.
In accordance with Figure 1 illustrates a diagnostic system 100 in accordance with the with an exemplary embodiment of the present disclosure. The exemplary embodiment of the diagnostic system 100 may comprise a platform/base 102. The 10 platform/base 102 may further comprise a top surface 104 and a bottom surface 106. The platform 102 may be integrally mounted on at least two pillar 108. The at least two pillar 108 may have hollow internal structure and configured to accommodate at least one motor 110 in each of the pillar 108. In an exemplary embodiment the at least one motor 110 may be a Brushless DC Motor (BLDC). 15 Further the at least one motor 110 may have a motor/rotor shaft. The motor shaft may further be coupled to an eccentric shaft via a coupler and a grub screw. The eccentric shaft may be configured to convert the rotational motion of the rotor shaft into an oblique or an elliptical motion or a vortex motion. The vortex motion of the eccentric shaft may further be transferred to a spring 112. 20
The spring 112 may be a leaf spring fabricated from Teflon or Nylon. Further the spring 112 may in turn transfer the vortex motion to a receptacle 114. The receptacle 114 in accordance with the exemplary embodiment may comprise a plurality of wells 116. The plurality of wells 116 may be configured to hold, receive, or 25 accommodate testing tubes. The receptacle 114 may be mounted on the spring 112, or an intermediary plate 118. In accordance with the exemplary embodiment,
The diagnostic system 100 may further comprise mounting elements 120. The mounting elements 120 may be positioned or mounted on the platform/base 102. 30 9

Further the mounting elements 120 may be configured to engage with tracks for enabling motion.
Referring to Figure 2(a) and 2(b), illustrates another embodiment of a diagnostic system 100, in accordance with the present disclosure. The diagnostic assembly 100 5 as illustrated may comprise at least one receptable 204 mounted on a platform/base 102, wherein the at least one receptable 204 may comprise a plurality of wells 212 for holding a tube. In another exemplary embodiment the at least one receptable may comprise a single well mounted on the platform 102.
10
The platform 102 may further comprise a first motor 202 mounted on a top surface 208 of the platform 102. The first motor 202 may further be coupled to a magnetic strip 206 in an exemplary embodiment. The first motor 202 and the magnetic strip may be coupled in a such a way that the rotation of spindle of the motor 202 may move the magnetic strip 206 towards or away from the at least one receptable 204. 15
In accordance with an exemplary embodiment a thermoshaker assembly 200 may comprise the at least one receptable 204 mounted on a leaf spring 210, which in turn may be mounted on the platform 102. The receptacle 204, comprising the plurality of wells 212 may be configured to receive the testing samples. Further the 20 receptacle 204, may be shaked in eccentric motion. The eccentric motion may be provided by a second motor 214, wherein the second motor 214, may be positioned below the platform 102. The second motor 214, may be coupled to the leaf spring 210. Further the receptacle 204, may have a heating element 216 integrated within it and temperature sensor 218. 25
Referring to Figure 3, illustrates another exemplary embodiment of a magnetic assembly, in accordance with the present disclosure. The magnetic assembly 300 may comprise a magnetic strip 302. Further the magnetic 302, may be mounted on a carriage 304. Further the carriage 304, may be configured to have horizontal and 30 10

vertical motion. The carriage 304 may be moved adjacent to the thermoshaker assembly during a diagnostic cycle.
Now referring to Figure 4, a method (300) of a magnetic thermoshaker assembly (100) for a diagnostic system for Automated Nucleic acid extractor and Real Time 5 PCR (RTPCR) reagent preparator is illustrated, in accordance with the embodiment of the present subject matter.
At step (302), the system may be configured for passing, programmable commands to PLC going to Motor drives, wherein the Motor Shaft Transfers the 10 Motion to an eccentric shaft via coupler and grub screw mechanism then the Eccentric shaft provides Vortex motion to Teflon spring through bearing housing, wherein the Vortex motion is transferred to heating block through a Teflon plate.
15
At step (304), the system may be configured for rotation of a set of motors, with respect to commands provided, wherein motor (1) may be configured to rotate the magnetic plate in the reverse forward motion and motor (2) is configured to rotate the Magnetic plate in and down motion.
20
At step (306), the system may be configured for setting, of the magnetic plate at a programmable height by motor (2) once the shaking action completed by shaker mechanism and an inbuilt heater reaches at a desired temperature.
At step (308), the system may be configured for approaching of the magnetic plate, 25 towards the Heating Block with forward- Reverse commands of Motor (1), wherein the Magnetic plate remains attached with the heating Block for a programmable time. 11

At step (310), the system may be configured for leaving of the magnetic plate from the heating block and moving backward with Motor (1) in the reverse direction.
The embodiments illustrated above, especially related to the magnetic thermoshaker assembly for a diagnostic system provide following advantages:
• • The system for magnetic thermoshaker assembly for a diagnostic system 5 requires less time for Automated Nucleic acid extractor and Real Time PCR (RTPCR) reagent preparator.
• • The system for magnetic thermoshaker assembly for a diagnostic system decrease the risk of false positive results.
• • The system for magnetic thermoshaker assembly for a diagnostic system is 10 maintain accurate defined temperature ranges that increases the accuracy of process.

Various modifications to the embodiment will be readily apparent to those skilled in the art and the generic principles herein may be applied to other embodiments. 15 However, one of ordinary skill in the art will readily recognize that the present disclosure is not intended to be limited to the embodiments illustrated but is to be accorded the widest scope consistent with the principles and features described herein.
20
The foregoing description shall be interpreted as illustrative and not in any limiting sense. A person of ordinary skill in the art would understand that certain modifications could come within the scope of this disclosure.
The embodiments, examples and alternatives of the preceding paragraphs or the 25 description and drawings, including any of their various aspects or respective individual features, may be taken independently or in any combination. Features described in connection with one embodiment are applicable to all embodiments, unless such features are incompatible. 12

WE CLAIM:
1. A diagnostic system (100), comprising:

a base platform 102;
a thermoshaker module 200, wherein the thermoshaker module is mounted a top surface of the base platform 102: 5
a magnetic module 300, 206, communicably connected to the thermoshaker 200; and
characterized therein, the thermoshaker module 200 further comprises a plurality of springs mounted on the platform 102, a plurality of receptable mounted on the plurality of springs, and heating element 10 integrated within the plurality of receptable.
2. The magnetic thermoshaker assembly (100) as claimed in claim 1, the thermoshaker module comprises of a set of magnetic strip, a set of two BLDC motors, a block holder for a sample processing tubes, a nylon base 15 plate, a heating block, a temperature sensors.

3. The magnetic thermoshaker assembly (100) as claimed in claim 1, the thermoshaker assembly comprises the block holder for the sample processing tubes, wherein the block is placed in such a way that a wells 20 are housing at the edge of the block, which facilitates a magnetic beads present in the sample processing tube along with the substrate to get attracted to the magnetic module.

4. The magnetic thermoshaker assembly (100) as claimed in claim 1, the 25 magnetic assembly comprises two magnetic strips (2) and each strip comprises8 individual magnets which also can be designed using a bar magnet or an electromagnet.
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5. The magnetic thermoshaker assembly as claimed in claim 1, the magnetic module configured to moves horizontally and vertically with respect to the thermoshaker module, Wherein the magnetic module configured to receive power from the set of two BLDC motors, wherein the first BLDC motor configured to give for upward and downward 5 movement to the magnetic module and the second BLDC motor configure to give forward and reverse movement to the magnetic module.

6. The magnetic thermoshaker assembly as claimed in claim 1, the thermoshaker module comprises a temperature and a RPM regulator, 10 wherein the shaking speed of the motor varies from 200 rpm to 1500 rpm and the heating block temperature ranges from room temperature 200 C to 1000 C.

7. The magnetic thermoshaker assembly as claimed in claim 1, the accuracy 15 of the Thermoshaker module position is controlled in range of 100 micron, wherein the thermoshaker module is specified for 16 positions at a time with single magnetic assembly.

8. The magnetic thermoshaker assembly as claimed in claim 1, the 20 temperature of a heating block of the thermoshaker module ranges from room temperature 20º C to 100º C; wherein the block is placed in such a way that the wells (9) have housing at the edge of the block, facilitating the magnetic beads present in the tube along with the substrate to get attracted to the magnetic assembly. 25

9. The magnetic thermoshaker assembly as claimed in claim 1, is manufactured with Aluminium HE30 and SS 316 material to prevent rusting and used as medical instrument. 30
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10. A method of a magnetic thermoshaker assembly for a diagnostic system for automated Nucleic acid (NA) extraction and Real Time PCR (RTPCR) reagent preparation comprising steps of:

5
Passing, programmable commands to PLC going to Motor drives, wherein the Motor Shaft Transfers the Motion to an eccentric shaft via coupler and grub screw mechanism then the Eccentric shaft provides Vortex motion to Teflon spring through bearing housing, wherein the Vortex motion is transferred to heating block through a Teflon plate, 10
Rotation of a set of motors, with respect to commands provided, wherein motor (1) is configured to rotate the magnetic plate in the reverse forward motion and motor (2) is configured to rotate the Magnetic plate in and down motion,
Setting, the magnetic plate at a programmable height by motor (2) 15 once the shaking action completed by shaker mechanism and an inbuilt heater reaches at a desired temperature,
Approaching of the magnetic plate, towards the Heating Block with forward- Reverse commands of Motor (1), wherein the Magnetic plate remains attached with the heating Block for a programmable time, 20
Leaving, the magnetic plate from the heating block and moving backward with Motor (1) in the reverse direction.