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«2 United States Patent Dau et al. (US011344257B2 IS 11,344,257 B2 May 31, 2022 20) Patent No.: 4s) Date of Patent: os) om m™ @) (6) 1) (2) TRONIC CONTAINMENT SYS FOR STORING AND CHARGING AN INSTRUMENTED INTRA-ORAL APPLIANCE, AND TRANSMITTING DATA THEREFROM. Applicant: Biomechanics Consulting and Research, LIC, Charlortesville, VA (us) Inventors: Nathan Dau, Palmyra, VA (US); Jeff (Ceandall, Charlonesville, VA (US) Assignee: BIOCORE LLC, Charlottesville, VA (us) Notice: Subject any disclaimer, the term ofthis patent is extended or adjusted under 35, USC. 154(b) by 731 days Appl. No. 16M158,778 Filed: Oct. 12, 2018 Prior Publication Data US 2019011074641 Ape 18, 2019 Related US Data Applic Provisional application No. 62/571 410, filed on Oct. 12, 2017. Int. Cl AGIB 5/00 (2006.01) ‘AGIB 5/145 (2006.01), (Continued) us. cl. Pe AGIB §/682 (2013.01); AGIB 50022 (2013.01); A6IB 02055 (2013.01): A61B 502438 (2013.01); AOIB S/14542 (201301), AGIB 5/746 (2013.01); AGIF 5/566 (2013.01), AGLL. 2/10 (2013.01); AB3B 71/085 (2013.01) AGIB 2560/0214 (2013.01); A6IB 2560006 (2013.01); 467B 2562/0219 (2013.01), A618 362/24 (2013.01); 61B 2562/242 (2013.01), A6IC 7/08 (2013.01); AOIC 19°02 (2013.01) (Continued) (58) Field of Classification Search None Se application fle for complete search history. 66) References Cited US, PATENT DOCUMENTS 6417761 BI* 72002 Ellon Aste 700 Las3859 ‘9980799 82* S2018 Wilson Ale 708 (Continued) Primary Examiner — Shirley X Jian (74) Attorney, Agent, or Firm — Woods Rogers PLC; Nathan A. Evans on ABSTRACT Te present invention isa holding case for an instrumented intra-oral appliance containing recorded dat, which charges the intra-oral appliance while not in use’ and transmits recorded data to slorage for review and analysis, The tans ferred data may be subjected to downloading, validation, storage, analysis, measuring, database fusion (with for example data from other devices), data output, and data recording. Output may be father transferred to computer, processor, phone, tablet computer, of other hardware for review by a user or technical, esearch, medical, or other ‘oversight personnel. The holding case can also send data to the appliance including firmware or other onboard operating, instictons. The holding ease ean include addtional fea tures such as custom dentition of the user, UV light, or a visual user interface. 1s, 4 Drawing Sheets ‘An electronic “suant” ease with a battery (1010) electronics including memory and a microprocessor (1020), and the geometry of the wearer’s dentition fit into the bottom half of case (1030). The instrumented mouthguard (1040) is also show, US 11,344,257 B2 Page 2 (51) Im. ch, AGIB S024 (2006.01) AGB 7108 (2006.01), AGIE 5/56 (2006.01), AGI 210 (2006.01), ‘AGIB 5/0205 (2006.01), AGI 7/08 (2006.01), AGIC 19104 (2006.01), AGIC 1902 (2006.01), (2) US.CL cee AGIC 19/04 (2013.01); A6IL 2202/24 (2013.01), 4638 223006 2013.01), 4638 2230020 (2013.01), (56) References Cited US. PATENT DOCUMENTS: 10,470847 B2* 11/2019 Shanon Hose 510086 10888728 B* 32020 Wilson BSD 48163, log72 714 BI* 92020 Chapman To,888'396 B2® 1/2021. Shania 200710277836 AL® 122007 Longley 200910823370 AL* 122009 Koo 20 2OLT6TT AL® 72012 Logan 20140156 AL® S204 Smith 201si0190537 AL Kerr 2o16io1a0924 Al Wilon 20170086760 AL 2ou7o16s04 AL 10000863 AL* 2o1s0181795 a 2or00083571 Al * cited by examiner Hoaw 4029 A610 71002 ABIES 566, ass ASIB 110676 362573 AaB 21/0088 600'301 ASIBS 51468 4336 os 70057 Ba 90215010 206685 AGIBG 145 ‘Gok 9100805 AGIB S682 ASIC 17224 Hoag 900 US. Patent May 31,2022 Sheet 1 of 4 US 11,344,257 B2 Figure L: An electronic “sma ha battery (1010), electronics including memory and a microprocessor (1020), and the geometry of the wearer's dentition fit into the bottom half of a case (1030). The instrumented mouthguard (1040) is also shown. US. Patent May 31,2022 Sheet 2 of 4 US 11,344,257 B2 Figure 2: A hollow model of a wearer’s dentition from the occlusal surface (2010) and the underside (2020), depicting an. inductive coil to charge the intra-oral appliance. US. Patent May 31,2022 Sheet 3 of 4 US 11,344,257 B2 3030 Figure 3: A standard case with electronics in one end depicted in yellow (3010) and a portion of the wearer's dentition with an intra-oral appliance (3020) depicting the three degrees of freedom (3030) used to align the inductive coil in the case with inductive coil in the intra-oral appliance. US. Patent May 31,2022 Sheet 4 of 4 US 11,344,257 B2 Each appliance is paired to its own specific case/container | in a plurality of cases/containers Each case/container has a processor which receives data from 0 “its specific paired appliance and sends that data to a remote electronic device, such as a server, computer, processor, | controller, phone, tablet, or any other remote electronic device Figure 4 US 11,344,257 B2 1 ELECTRONIC CONTAINMENT SYSTEM FOR STORING AND CHARGING AN INSTRUMENTED INTRA-ORAL APPLIANCE, "AND TRANSMITTING DATA THEREFROM. (CROSS.REFERENCE TO RELATED APPLICATION ‘The preseat application relies on the disclosures of and claims priority to and the benefit ofthe filing date of US. Provisional Applicaton No, 62/571,$10, fled Oct. 12,2017. ‘The disclosures of that application are hereby incorporated by reference herein in their entireties BACKGROUND Field of the Invention ‘The present invention is directed to a holding ease for an instrumented intra-oral appliance containing ovorded dat, Which charges the intra-oral appliance while aot in use and ‘transmits reconled data to storage andlor for processing, The transfered data may be subjected to downloading, valde tion, storage analysis, measuring, database fusion (with for 2 ‘example data trom other devices), data output, and data recording, Output may be tansfered to a cloud server, ‘computer, processor, phone, or other hardware for review by none aspect, the case includes a portion of the intra-oral appliance wearer's 3D dental geometry which matches or ‘mirrors the particular custom-shaped intra-oral appliance's ‘geometry. In another aspect, the invention comprises an apparats for performing an intra-oral appliance intogrity check within the holding case. Ina prefered embodimeat of the present invention, the case includes a meckanism for transfering of data from the case andor intra-oral appliance to a cloud server or other physical or viwal storage media ‘where the data can be processed, reviewed, andlor analyzed by the appliance wearer andior technical, esearch, medical, ‘or other oversight personnel. In a relate aspoct, the data is ‘wansferred trom the case andlor inta-oral appliance t0 a central data hub such as a computer, processor, phone, serve, or storage unit, which then transmits the data to a cloud server or other storage medium where the data can be reviewed by the appliance wearer andlor, technical, research, medical or oer oversight personnel. ln an aspect ‘of tis embodiment, the data may be processed or analyzed before or after iti reviewed. In another embodiment, the case includes a UV light source within, near, or affixed to the holding case to com- pletely or partially sterilize the intra-oral appliance. none embodiment, the case has a visual andor graphical user interface such as a touchscreen, a series of LEDS or a single LED, a series of multicolor LEDs or single multicolor LED, andor physical buttons or switches In. another embodiment, a system of holding cases matched with instrumented intra-oral appliances containing recorded data, changes the intra-oral appliances while not in use and transmits recorded data from each individual appli ance labeled by appliance or appliance user to a storage andlor processing device, such as an internal or remote storage andior processing device, for review, processing, and/or analysis. In yet another embodiment, the case includes a mecha- nism to identify its unique intra-oral appliance sehen in proximity tothe ease using a wireless protocol suc as radon 4s 2 frequency identification (RFID), near field communication (NEC), Bluetooth low energy (BILE), or other low energy comanication protocol DESCRIPTION OF THE RELATED ART All references disclosed herein are incorporated by ref US. Pat, No. 3,938,018 describes a device that changes a DC battery without physical connection between the changer ‘and the hater. US. Pat. No. 4873,677 describes a device that includes indvetive coils to charge a DC battery including a mechani- cal yoke inthe charger case that aligns the induetive cols. Inspects, the curent invention uses the wearer's anatomy as the alignment between the appliance and the charging US. Patent Application Publication No. 20160250517 escribes a system for monitoring @ team sport activity 20 including plurality of training devices and a. singular docking tation to transfer data from the plurality of training devices 10 the singular docking station and charge the ‘aumerous training devices, The system teaches sending data within service broadcasting pockets. The current invention embodies 1 unique, custom case for one specific intra-oral appliance that is associated with the case, whereby the case not only charges the matched appliance, bu also, in some aspects, transmits data recorded on the appliance, sanitizes, the device, et. One ease per appliance eliminates the need of the system administrator t handle individual devices which are exposed to and possibly covered in the weater's bodily fluids, such as saliva or sweat. The addition of individual cases for each appliance reduces the risk of contaniation of the wearer's device by third party han ling, cross contamination by the handling of rnultiple devices, or contamination ofthe system administrator. US, Pat, No, 8,092,251 describes an ative packaging for electronic media device which provides power tothe device ‘while in packaging, The intent of the current invention sto charge the appliance for continved use and download the data from the appliance. These increase the functionality of the appliance by limiting the interaction with individual devices and increases the time between charges. USS. Patent Application Publication No. 201510097700 describes a plurality of athlete monitoring systems which connect to a plurality of docking stations for charging, However, the curreat invention stores data on the monitor- ing/measurement device, while the teachings of Application No. 201510097700 describe streaming data live to @ base station. The invention described herein allows for both individual charging and data transmission from the plurality of appliances t0 a unigue matched case. SUMMARY ‘The present invention is @ holding case for an insteu- ‘mented intra-oral appliance containing recorded data. The holding case downloads data for transfer to, in one embodi- ment, @ central data location and charges the instrumented intra-oral appliance, among other things. The holding case may also include 3D dental geometry of the wearer to receive the appliance and can perform alditional tasks such asadevice integrity check, sterilization, and provide a visual user interface for the user. The invention includes the implementation of a single holding case o a group of holding cases as part of a system of eases 10 monitor 3 specie population, US 11,344,257 B2 3 In prefered embodiment, the preset invention is holding ese for an instrumented intra-oral aplince on- tnining recorded at. The boling case wanes data blt- erally with the appliance flowing forthe data from the appliance to be processed, analyze, validated, compile, andlor stored on the ease or ination, an da, inp. information isitions,orsommands can beset ‘the case to modify the operation of the appliance. The case Imiy also include pressor to process information from the appliance, The ce may also include storage medi to sore information fom the appliance. The case aay also incide an antenna o send information from he epics, tere or after rocescing, fo remote eletoie device, soch as server computer processor, phone, oF elevsion, ty way of example In another embodiment, the ease may compris the apa ratus for holding the intra-oral appliance, electronics for ctarging the eleewonc intra-oral appliance, electronics fr downloading andor transfering dt, and in some aspects stom dentition. The electronics may be ged. pote, snap-fitted, adhered, taped, press-fitted, or otherwise attached 10 the case. The custom dentin maybe 3D-printd, thermoformed, pressure formes, ijstion inolded or otherwise manufactured. The cusiom dentition may be glued, snap-fited, pressure fited, adhered, sonic > welded, or otherwise stached to the ease andlor eletronics. In one aspect, the holding ease includes 3D dental goom- try of the wearer to receive the appliance. This would facilitate the accurate placement of inductive cols and radio antennae for charging and data transfer: Accurate receipt of the appliance, as defined by a field detect in the inductive coil ofthe case, may aso initiate reading of data, transfer of data, charging, integrity checks, or other functions per- formed by the case “The holding case, in some aspects, performs additonal tasks, such as device and data integrity checks. These tasks are performed using sensors on or inthe appliance, and/or ‘unigue sensors within, in, or onthe bolding case, or using a ‘processor within, near, or on the appliance that, in aspects, ‘may ave superior computing power to that coatined within the appliance, or may be the same processor. Alternatively, ‘processor i, on, or near the holding conaineecase may be used In another aspect, a device integrity check inclodes the measurement of Frequency data measured by sensors in the appliance when the appliance is inserted into the ease. The ‘action of inserting the device into the case, in aspects, initiates data recording on the appliance, which also initiates the appliance o the appliance case performing an integrity check on the data. In other cases, a user may: manually contro when data is sent or received, or integrity checks performed ‘A device integrity check may include sensors in the appliance case to measure interscton between the appliance ‘and the 3D dental geomety in the ease including, but not limited to, surface area, force, pressure, or strain. Changes in surface contact would indicate the appliance has heen mechanically deformed. Inne aspect of this invention, the case comprises a UV light source within the holding case that sterlizes the intra-oral appliance. The UV light source is designed to inradiate most or all surfaces ofthe appliance for sufficient, duration to sterilize the appliance andl is timed to occur before, during or after transmission of data “The holding case, in certain aspects, includes visual user imterface. The visual user interface provides the user infor- ‘mation regarding the eppliance ineluding thatthe corect ” 4s 4 appliance is in proximity to the case, that the appliance reeds to be serviced or replaced, thatthe appliance isnot properly placed in the case, ofthe status of its data dovsn- Toad, the status ofthe charge, that data should be reviewed by the user on another deviee, that the user should contact ‘wehnical, research, medical, or other oversight personnel, and other funetions relating tothe appliance, the user, andor data on the appliance. The visual user interface may be provide on a separate device such as a tablet, smartphone, ‘computer, server, or other electronics display. another embodiment, the visual user interface provides third party such as a parent, coach, practioner, or tech nical, research, medical, or other oversight personnel, infor. ‘mation regarding the case andor the appliance, including if it needs to be serviced or replaced, the status of is data download, the status ofthe charge, the amount of time the appliance has been in use ifthe device memory is fll, that data should be reviewed on another device etc, Such visual user interface provided to a thind party may also act as an alert of the state ofthe user othe appliance, for example a visual indicator may be provided to communicate & trat- vatic head impact event experienced by the person wearing the appliance. “The invention comprises the implementation of a single holding case or a group of holding eases which re part of 1 system (0 record and transmit data related toa specific populatioa. An implementation ofa group of holding cases as a system, in one aspect, also includes a central hut that charges the holding eases or slores, analyzes, or processes information. The charging of the eases could be accom plished either wired of wirelessly In one embodiment, firmware updates for cases or appli- tances are transfered from the central hub, a server, of a computer to the eases andior appliances ofa singular ease tandior appliance. This fle transfer can be performed over the air via wireless protocol, theough an inductive coil used for changing and transferring data, through a direct wired connection, or any other means. Such firmware updates may be for the appliances, in Which case the firmware would be transferred from the central hub, a compute, or a server directly to the appli- ‘ances, of through the case as connected to the appliance. ‘This file wansfer can be performed over the air via wireless protocol, through an indvctive coil used for charging and transferring dat, through a direct wired connection, of any other means. In another aspect, data from an appliance or a plurality of| appliances are reviewed on a local central storage device, ‘The local storage device may include, but isnot limited to, a phone, tablet, computer or other electronic device with a user display. In yot another aspect of this invention, the data fom an appliance or a plurality of appliances are reviewed remotely aller data has been sent wo a cloud server location, another computer, a phone, or other remote electronic device. The data can be reviewed as a whole, ora subset of data can be reviewod that is selected manually, randomly, based on specific criteria, or hased on data integrity evaluations conducted by the appliance, the appliance case, the central data hub, computer software, or clowd-based software. In one embodiment, the only data observed from an ‘appliance ora plurality of appliances locally is their charge are! download! status to protect the data privacy of the appliance’s wearer from the local system administrator ne embodiment ofthe present invention, a case for an electronic intra-oral appliance is provided that charges the intra-oral appliance, and downloads andor transfer data US 11,344,257 B2 5 from the intrs-oral appliance. Charging may be accom- plished by wired or wireless means of providing electricity to the case andlor the intra-oral appliance coupled to the Tn another embodiment of the present invention, the ease transfers data to a computer, smartphone, tablet computer, processor, a server, or the cloud for storage and analysis. Such analysis may include, but is not limited to, human performance data or health metics, blood oxygen level, heat rate, head kinematics (eg, experienced during impact ‘events, with an emphasis on avoiding recording false po tives), ee In another embodiment, data transferred from the intra- ‘oral appliance and the results of the analysis are sent for review by a user, such as on 8 computer, television, smart- phone, tablet, or other hardware. The analysis of the data ‘may occur on a processor, a computer, a smartphone, 2 tablet, or any other software located on hardware, a server, ‘on the cloud, or otherwise. The data may be transmitted to > ‘8 central repository either wirelessly or by wired commu nicatioa/connection I other embodiments, the analysis and ‘output may be perfomed by electronics andlor processor(s) located on, in, oF nea the ease. Data may als be stored on a storage device on, in, or near the case. In another embodiment, the data analysis feedback to 3 user may comprise biostatistics, indication of possible ta matic event, injury, or condition, possible diagnoses of & ‘traumatic event, injury, or condition, along with possible treatment of such event, injury, oF condition, including Whether to consult with a physician. In another embodiment, the data analysis feedback to technical, research, medical, or other oversight personnel -may comprise biostatistics, indication of possible traumatic ‘even, injury, or condition, possible diagnoses ofa traumatic event, injury, or condition, along with possible treatment of such event, injury, or condition, inchiding whether to consult, with a physician, In another embodiment, the data analysis feedback to technical, esearch, medical or other oversight personnel ‘may comprise biostatistics, indication of elevated risk of possible traumatic event, injury. or condition, or possible prescriptive reetmens of alcrations in taining to mitigate the elevated risk of possible traumatic event, iniury, o condition. In another embodiment, the case and associated software! firmware may perform electronics, structural, data, and other integrity checks on the inta-oral appliance. Feedback is provided to a user if, for example, the electronics, structure, data, or other componeat ofthe intra-oral appliance and/or recording system has been compromised, In the case of ‘group of cases as part ofa system, feedback is provided to the system administrator, In another embodiment, the results of electronics, struc~ ‘ural, and data integrity checks are seat to reseaeh, techni= cel, medical, or other oversight personnel. If the device requires replacement or service, notification is sent for a replacement appliance to be manufactured or shipped to replace the damaged or compromised device. BRIEF DESCRIPTION OF THE DRAWINGS ‘The accompanying drawings illustrate certain aspects of some of the embodiments of the present invention, and should not be used to limit or define the invention, Together with the written description the drawings serve to explain ceritn principles of the invention, ” 4s © 6 FIG. 1 shows a photo of a possible embodiment of an lectronicints-oral appliance case according to the present invention with a rechargeable batery; electronics. circuit board including @ microprocessor, memory, antenna for Wireless communication, and circuitry for battery charging; a porion of the wearer's dentition (the geometry of the ‘wearer's dentition fit into the bottom half of the cae); to receive the instrumented appliance. FIG. 2 shows a portion ofthe dentition according to one Possible embodiment ofthe present invention, which was Included in the intra-oral appliance case. The occlusal sur- face is shown to depict the surface area that interacts with the intra-oral appliance. The underside is also shown to depict how an inductive coil ean be placed to align with an indvetive cil in the appliance. FIG. 3 shows an appliance container according to one possible embodiment of the present invention FIG. 4 shows one possible embodiment of the invention ‘aught herein DETAILED DESCRIPTION “The present invention has been described with reference to particular embodiments having various features. I will be apparent to those skilled in the ar that various mosiications ‘and variations can be made in the practice of the present invention without departing from the scope or sprit ofthe favention. One skilled inthe att will recognize that these ‘eatures may be used singularly or in ay combination based ‘onthe requirements and specifications ofa given application or design. Embodiments comprising various features may also consist of or consist esteatilly of those various fea- tures. Other embodiments ofthe invention will be apparent tw those skilled in the art fom consideration of the speci= fication and practice of the iavention. The description of the invention provided is merely exemplary in nature and, thus, variations that do not depart from the essence of the inven tion are intended to be within the scope ofthe invention. All references cited inthis specification are hereby incorporated by reference in their entireties, ‘Embodiments of the invention also include a computer readable medium comprising one of more computer fies comprising a set of computer-exccutable instructions for performing one or more of the calculations steps, processes And operations described and/or depicted herein. In exemt- plary embodiments the files may be stored contiguously or ron-contiguously on the computer-eadable medium, Embodiments may iachude @ computer program product comprising the computer fils, either in the fom of the computer-readable medium comprising the computer files and, optionally, made available to a consumer through pockaging, or altematively made available to a consumer through electronic distribution. As used inthe context of this, specification, a “computerteadable medium” isa non-iran~ silory computerreadable medium and includes any kind of computer memory such as foppy disks, conventional hard disks, CD-ROM, Flash ROM, non-volatile ROM, electri- cally erasable programmable read-only memory (EE PROM), and RAM. In exemplary embodiments, the com- puter readable medium has a set of instructions stored thereon which, when executed by a processor, cause the processor to perform tasks, based on data stored in the electronic database or memory described herein. The pro- cessor may implement this process through any of the procedures discussed in this disclosure or through any ‘equivalent procedure US 11,344,257 B2 7 In other embodiments ofthe invention, files comprising the set of computer-executable instructions may be stored in ‘computerreadable memory on a single computer or disrib- uted across multiple computers. skilled artisan wil further appreciate, in light of this disclosure, how the invention can ‘be implemented, in addition to software, using hardware or firmware, As such, as used herein, the operations of the invention can be implemented in a system comprising a ‘combination of software, hardware, or firmware. Embodiments of this disclosure include one or more ‘computers or devices loaded with a set of the computer: ‘executable instructions desribed herein. The computers or devices may be a general purpose computer, a speci ‘purpose computer, or other programmable dats processing ‘apparatus to produce particular machine, such thatthe one ‘oF more computers or devices are instructed and configured to carry out the calculations, processes, steps, operations, algorithms, statistical methods, formulas, or computational routines of this disclosure. The computer or device perform- ing the specified calculations, processes, steps, operations, algorithms, statistical methods, formulas, or computational routines ofthis disclosure may comprise atleast one pro- cessing clement such as a central processing unit (ie. processor) and a form of computerreadable memory which ray inclnde random-aecess memory (RAM) of readonly. > memory (ROM). The computer-executable instructions can be embedded in computer hardware of stored in the com= pputer-readable memory such that the computer of device -may be directed to perform one or more ofthe calculations, steps, processes and operations depicted andlor described here. Additional embodiments of this disclosure comprise a ‘computer system for carrying out the computeriample- ‘mented method ofthis disclosure, The computer system may ‘comprise a processor for executing the computer executable instructions, one or more electronic databases contzining the data or information described herein, an inpuvoutpt inter- face or user interface, and a set of instructions (eg, software) for carrying out the method. The computer system can include a stand-alone computer, such a a desktop computer, 4 portable computer, such as a tablet, laptop, PDA, or smariphone, of a set of computers connected through 2 ‘network including a cliea-sever configuration and one or more database servers. The network may use any suitable network protocol, including IP, UDP, or ICMP. and may be any suitable wired or wiceless network inchuding any local area network, wide area network, Intemet network, telecom ‘munications network, Wi-Fi enabled network, or Bluetooth ‘enabled network. In one embodiment, the computer system ‘comprises a central computer connocid tothe intemet that has the computer-executable instructions stored in memory that is operably connected to an internal electronic database. ‘The central computer may perform the computer-imple- ‘mented method based on input aux commands received from remote computers through the intemet. The central com- puter may effectively serve as a server and the remote computers may serve as client computers such that the serverclent relationship is established, and the client come puters issue queries or receive output from the server over & network, ‘The inpuvoutput interfaces may include a graphical user interface (GUT) which may be used in conjunction with the ccomputerexecutable code and electronic databases. ‘The ‘raphical user interface may allow a user to perform these tasks through the use of text field, check boxes, pull-downs, ‘command Butons, andthe like. A skilled artisan will appre= ciate how such graphical features may be implemented for 4s © 8 performing the tasks of this disclosure. The user interface ‘may optionally be acessible through a computer connected to the interme. In one embodiment, the user interface is ‘accessible by typing in an internet address through an industry standard web browser and logging intoa web page. ‘The user interface may then be operated through a remote computer (client computer) accessing the web page and transmitting queries or receiving output from a server through a network connection, Before explaining at least one embodiment of the inven- tion in detail, itis w be understood thatthe invention is not Timited in its application tothe details of construction and the arrangement ofthe componeats set forth in the following

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