Researchers Submit Patent Application, “Secure Set-Up Of Genetic Related User Account”, for Approval (USPTO 20220157464): Patent Application

2022 JUN 06 (NewsRx) -- By a News Reporter-Staff News Editor at Insurance Daily News -- From Washington, D.C., NewsRx journalists report that a patent application by the inventors HON, Tsz-Kin (London, GB); TOUMAZOU, Christofer (London, GB), filed on March 16, 2020, was made available online on May 19, 2022.

No assignee for this patent application has been made.

News editors obtained the following quote from the background information supplied by the inventors: “Semiconductor nanotechnology and optical technologies have made significant contributions to people’s lifestyle, especially by facilitating hardware miniaturisation. Its application to the sequencing and genotyping industry has enabled so-called “lab-on-chip” systems. Depending on the biological questions/genes of interest, primer(s)/probe(s)-more generally referred to as “biomarkers”-can be designed accordingly. A biomarker is an oligonucleotide such as a DNA molecule and may target certain gene(s)/variation(s). A biomarker may alternatively, for example, be an antibody or an antigen. By applying/choosing different types of biomarkers on such systems, an individual can test his/her biological sample, DNA, RNA, protein etc, (extracted locally or remotely by a third party from e.g. saliva, blood, urine, tissue, stool, hair etc) for specific traits, possibly as dictated by certain lifestyle concerns or interest.

“Such “personal” genetic or biological information enables medical decisions to be made more effectively, for example, by selecting treatments or drug doses which are more likely to work for particular patients. Identifying individual differences at a molecular level also allows lifestyle and dietary/nutritional advice to be tailored according to the needs of individuals or particular classes of individuals. A number of private companies have been established in order to cater for the growing consumer genetics market and every day new genetic traits are being identified and described, generating a continuously expanding catalogue of biomarkers that have the potential to offer insight into the health, wellbeing, and, in the case of genetic variations, phenotype, of a great many people.

“Typically, when an individual that wants to gain access to information related to his/her genetics or health condition, whether for a specific purpose/concern or for general interest, he or she needs to go through a private clinic or professional body, provide sample to central labs (either in person or by post). Such a process is time consuming, inconvenient and may invade the individual’s privacy. For example, many tests are based on blood analysis, which requires the individual to attend a sample collection session with an expert. In the most convenient available approach, he/she needs to order a kit for collecting saliva sample and then post it to the lab having obtained the sample themselves.

“User privacy is of critical importance when it comes to offering personalised genetic-based services, not only because of the real threat of data leaking to unscrupulous parties, but also because of the need to ensure that users trust the services and are therefore willing to make use of them. Conventional personalised genetic-based services such as that offered by 23andme™ rely on users sending samples of their genetic material to a remote facility where analysis is performed and the results interpreted, before the results are returned to the users. Despite privacy safeguards, users are wary of such services as the results and analysis are to a large extent beyond their control.

“The majority of the currently available genetic services offer wide genome screening; e.g., using a predefined platform tagged with more than 100,000 biomarkers and screening irrespectively all client samples for all genetic biomarkers. This means that a high proportion of customers are being screened by default for genetic traits that they may not want to know about; for instance, an individual purchasing a test in order to determine his/her predisposition to detoxification will be also screened for serious neurodegenerative diseases such as Alzheimer’s and Parkinson’s disease. Giving a customer access to information related to concerns that the customer did not initially have, may have a detrimental effect on his or her socio/psychological balance.

“Confidentiality concerns may not be solely related to genetic results, i.e. what genetic variants the customer carries, but also relate to the personal concerns that motivated the customer to consider having a genetic test, for instance predisposition to impotence, baldness, drug addiction, alcoholism etc. If this information were to become available to health insurance providers, potential employers etc, an individual could be “genetically stigmatised” and “classified”. The impact of such disclosures on an individual’s life could be enormous.

“US2017/0323057A1 describes a wearable device for providing product recommendations, for example food and drink products, based on a user’s genetic data. The wearable device incorporates a laser scanner or barcode reader which the wearer of the device uses to identify a product he or she is interested in purchasing or consuming. The device then provides an indication whether or not the product is recommended for the wearer based on his or her genetics.

“US2017/0098268 describes a device for processing biological samples which is suitable for use in a non-technical environment such as a retail premise. A user provides a genetic sample, e.g. using a buccal swab, which is then applied to a test cartridge to identify whether a particular biomarker is present in the user’s genetic material, e.g. by carrying out Single Nucleotide Polymorphism (SNP) genotyping of the sample. As will be well known to the person of skill in the art, SNP genotyping involves detecting which of a number of genetic variations is present at each of one or more SNPs of a person or animal’s genome. These SNP variations can provide markers to a condition or trait of the person or animal whose genome is being analysed.

“Although there are considerable benefits with providing easy access for users to genetic or biological testing facilities, it is important that processes and systems are developed which ensure that user confidentiality is respected. In particular, performing personally sensitive tests in a busy, public place such as a retail environment may lead to mistakes or even malicious activities which deprive users of their right to privacy.”

As a supplement to the background information on this patent application, NewsRx correspondents also obtained the inventors’ summary information for this patent application: “The approach proposed here address confidentiality and user confidence concerns, vis-a-vis a wearable computer device that stores biologically/genetically derived data, by providing test cartridges with unique computer readable cartridge identifiers. This ID read by two separate means: firstly by a computer device that is used to set up a user account on some server system, and secondly by the wearable computer device itself. Prior to or during the test, the wearable computer device communicates the read ID to server system so that the test, and its results, can be unambiguously associated with the user account.

“According to a first aspect of the present invention there is provided a method of installing, into a memory of a wearable computer device, results obtained by analysing a biological sample of a user. The method comprises: providing a test cartridge for performing tests on said biological sample, the test cartridge being provided with a computer-readable test cartridge identifier. A computer device is used to: read said computer-readable identifier from the test cartridge; receive user account information, and communicate with a server or servers via a data communication network to set-up a user account at the server(s) associated with the test cartridge identifier. The method optionally further comprises using the wearable computer device to read the computer-readable identifier from the test cartridge. The method further comprises mechanically connecting the test cartridge to a test control system, optionally whilst coupling the wearable computer device to the test control system. The test control system sends the test cartridge identifier to the server(s) via the communication network. The test cartridge identifier is optionally received at the test control system from the wearable computer device. The method further comprises: operating the test control system to cause the test cartridge to perform the tests on the biological sample and to obtain test results from the test cartridge and installing a database of product codes into a memory of the wearable device. The test results are sent from the test control system to the server(s) via the communication network and at the server(s), the test results are processed to generate analysis results and, using the association between the user account and the test cartridge identifier, the analysis results are associated with the user account. The method also comprises: sending the analysis results to the wearable device and installing them into the memory of the wearable computer device, the analysis results comprising information which defines a product recommendation for benefitting the health of the user, or from which such a product recommendation can be derived, for each of the product codes.

“The steps of the method do not necessarily have to be carried out in the order given above. For example, the user account may be set-up either before or after operating the test control system to perform the tests on the biological sample.

“Examples of a wearable device include: a ring or keyring; a standalone unit suitable for example for carrying in a purse, bag or pocket; a module for attachment to a wristband of a watch; and a module integrated into a wristband.

“The product codes may correspond to machine readable codes such as 1D or 2D barcodes (e.g. UPC/EAN), QR, ISBN, PDF417, Data Matrix etc.

“The analysis results may be sent to the wearable device via the test control system.

“The analysis results may comprise a set of codes which identify genetic nutrition-traits of the user from which product recommendations can be derived. For example, the analysis results may comprise TPS codes associated with genotyping test results as described in WO2017/055867 (see e.g. the paragraph spanning pages 23 and 24).

“Operating the test control system to cause the test cartridge to perform the tests on the biological sample may be conditional upon the server(s) determining that the test cartridge identifier is associated with a user account.

“The database of product codes may be installed into the memory of the wearable device whilst the tests are being performed on the biological sample. Optionally, the wearable device may be coupled to the test control system whilst the database of product codes is installed.

“The server(s) may respond to the test control system sending the test cartridge identifier by sending a test identifier to the test control system via the communication network, the test identifier being associated with the test cartridge identifier and/or user account at the server(s).

“The method may further comprise at the server(s), using the test identifier to associate the received test results and/or analysis results with the test cartridge identifier and/or user account at the server(s).

“The method may comprise using the analysis results to generate product recommendations for each of a multiplicity of products having associated product codes. The method may comprise installing the product codes and respective product code recommendations into a product recommendation database of the wearable computer device. The product codes may be installed into the product recommendation database before the tests on the biological sample are completed.

“The computer-readable identifier may be a one-dimensional or two-dimensional barcode and the wearable computer device and the computer device may each comprise an optical component for reading the barcode.

“The biological sample of the user may be a DNA sample and the analysis results may comprise a genotype for the user.

“Processing the test results to generate analysis results may require the test cartridge identifier.

“The method may further comprise: generating a unique access key for the wearable computer device; and using the unique access key to protect the analysis results installed into the memory of the wearable computer device, wherein access to the analysis results requires the unique access key.

“The unique access key may comprise a unique customer identifier and a passcode, such as a password.

“The user account information may comprise information for contacting the user, such as an email address or a telephone number.

“The method may comprise using the user account information to send an activation code to the user, wherein the activation code allows a personal computing device of the user to retrieve the unique access key.

“The wearable device may be a wrist-worn wearable device or smartphone. The computer device may be a tablet computer device. The test control system may be a desktop system.

“According to a further aspect of the invention there is provided a method of operating a user computer device in order to provide product and/or service recommendations to a user of the user computer device. The method comprises identifying products available for purchase, applying a filter to these products, and displaying the filtered results to the user via a graphical user interface of the user computer device. The filter is derived from genetic information of the user and is made available to the user computer device upon the establishment of a wired or short-range wireless digital data communication link between the user computer device and a wearable computer device.

“The user computer device is a device which can be used for making online purchases, such as a desktop or laptop personal computer, a tablet, or a smartphone. It may have, for example, a user input device such as a touchscreen, keyboard and/or mouse which allows the user to select products for purchasing. In many cases, the wearable computer device may lack a graphical user interface and/or user input device which is suitable for making online purchases. The wearable computer device may be, for example, a module attachable to (or integrated into) a wristband, lanyard, keyring etc.

“Although the term “product” may include tangible products such as groceries, beverages, and cosmetics etc, it may also encompass “intangible” products, such as services. The products may be filtered in many different ways. For example, the products may be ranked, with only a certain number of the top-ranking products being included in the filtered results. Alternatively (or additionally) the filter may apply a criterion based on the user’s genetic information to each of the products, e.g. a criterion based on a maximum amount of a particular ingredient or type of ingredient, such as sugars or fats, which is acceptable for the user based on their genotype. In some cases, the filtering is based on genetic filter codes mapping to respective products or services or categories of products or services (but which may not explicitly identify a user’s biological information). In general, the genetic information is determined by genotyping (e.g. SNP genotyping) a biological sample provided by the user.

“The filter may be made available to the user computer device directly from the wearable computer device, e.g. the filter is transferred from the wearable computer device to the user computer device using the wired or short-range wireless digital data communication link. Alternatively, the wearable computer device may transfer an access key to the user computer device, which allows the user computer device to download the filter from a server. Optionally, the access key may be valid for only a predefined period, so that the user computer device has access to the filter for only a limited time. The access key may, for example, be generated by the wearable computer device for “one time” use by the user computer device.”

There is additional summary information. Please visit full patent to read further.”

The claims supplied by the inventors are:

“1. A method of obtaining and installing, into a memory of a wearable computer device, analysis results for a biological sample of a user, the method comprising: providing a test cartridge for performing tests on said biological sample, the test cartridge being provided with a computer-readable test cartridge identifier; using a computer device to: read said computer-readable identifier from the test cartridge; receive user account information, and communicate with a server or servers via a data communication network to set-up a user account, associated with said test cartridge identifier, at said server(s); mechanically connecting the test cartridge to a test control system; at the test control system, sending the test cartridge identifier to said server(s) via said communication network so that the server(s) can associate a test being run with said user account; operating the test control system to cause the test cartridge to perform said tests on the biological sample in order to obtain test results; sending the test results from the test control system to said server(s) via said communication network; at the server(s), processing the test results to generate analysis results; using the user account information to send an activation code to the user, wherein the activation code allows a personal computing device of the user to retrieve the analysis results; and sending the analysis results to the wearable device and installing them into said memory of the wearable computer device, the analysis results comprising information which defines a product recommendation for benefitting the health of the user, or from which such a product recommendation can be derived, for each of a multiplicity of product codes, the method further comprising installing a database containing said product codes into a memory of the wearable device either before, during or upon completion of said test.

“2. A method according to claim 1, further comprising: using the wearable computer device to read the computer-readable identifier from the test cartridge; coupling the wearable computer device to the test control system; and sending the test cartridge identifier from the wearable computer device to the test control system.

“3. A method according to claim 1, wherein the analysis results comprise a set of codes which identify genetic nutrition-traits of the user from which product recommendations can be derived.

“4. A method according to claim 1, wherein operating the test control system to cause the test cartridge to perform said tests on the biological sample is conditional upon said server or servers determining that the test cartridge identifier is associated with a user account.

“5. (canceled)

“6. A method according to claim 1, wherein the server(s) responds to the test control system sending the test cartridge identifier by sending a test identifier to the test control system via said communication network, the test identifier being associated with the test cartridge identifier and/or user account at the server(s).

“7. A method according to claim 6, further comprising at said server(s), using the test identifier to associate the received test results and/or the analysis results with said test cartridge identifier and/or user account at the server(s).

“8. A method according to claim 1 and comprising using the analysis results to generate product recommendations for each of a multiplicity of products having associated product codes.

“9. A method according to claim 8 and comprising installing the product codes and respective product code recommendations into a product recommendation database of the wearable computer device.

“10. A method according to claim 1, wherein the computer-readable identifier is a one-dimensional or two-dimensional barcode and the wearable computer device and the computer device each comprise an optical component for reading said barcode.

“11. A method according to claim 1, wherein the biological sample of the user is a DNA sample and the analysis results comprise a genotype for the user.

“12. A method according to claim 1, wherein processing the test results to generate the analysis results requires the test cartridge identifier.

“13. A method according to claim 1, further comprising: generating a unique access key for the wearable computer device; and using the unique access key to protect the analysis results installed into said memory of the wearable computer device, wherein access to the analysis results requires the unique access key.

“14. A method according to claim 13, wherein the unique access key comprises a unique customer identifier and a passcode, such as a password.

“15. A method according to claim 14, wherein the user account information comprises information for contacting the user, such as an email address or a telephone number.

“16. A method according to claim 15, wherein the activation code allows a personal computing device of the user to retrieve the unique access key.

“17. A method according to claim 1, wherein the wearable device is a wrist-worn device.

“18-19. (canceled)

“20. A method according to claim 1, wherein the wearable device is configured to fit within a wristband.

“21. A method according to claim 1, wherein the wearable device is a smartphone.

“22. A method according to claim 1, wherein the computer device is a tablet computer device.

“23. A method according to claim 1, wherein the test control system is a desktop system.”

For additional information on this patent application, see: HON, Tsz-Kin; TOUMAZOU, Christofer. Secure Set-Up Of Genetic Related User Account. Filed March 16, 2020 and posted May 19, 2022. Patent URL: https://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220220157464%22.PGNR.&OS=DN/20220157464&RS=DN/20220157464

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