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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4-5, 7-9, 12-14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Fung et al. (US 20220369953 A1), hereinafter Fung.
Regarding claim 1, Fung teaches A self-sampling management electronic device comprising: (Para. 9 see "The contemplated subject matter includes a system for a person to provide biological data using a self-administered method and kit with verification that the biological data was obtained from the intended person in a way that does not require in-person, professional administration." Para. 10 see "the method includes establishing a video communication between the person and a verification program through a computer or smartphone."). a memory storing instructions; and at least one processor, (Para. 10 see "the method includes establishing a video communication between the person and a verification program through a computer or smartphone." Para. 32 see "direct the user to go to a webpage on their smartphone or any computer device with a camera and internet connection, to initiate an internet communication." and "a software application program that is programmed to instruct the user step-wise through the components of the kit for the specimen and biological data collection." (Software application means there is memory storing instructions and a processor.)). wherein the processor is configured, by executing the instructions, to: track a sampling action of a specimen provider by using images of the specimen provider handling a specimen sampling kit; (Para. 10 see "the inventive subject matter provides methods and kits for collecting a specimen and/or biological information from a person" and "the method includes obtaining one or more specimens from the person or one or more types of biological information of the person, wherein the obtaining the one or more specimens of the person includes at least one of: i) videoing the person while obtaining the one or more specimens and videoing the obtained one or more specimens being placed into a coded tamper-evident sample container; ii) before the obtaining, electronically communicating/videoing a code on a collection device and/or videoing the removal of a collection device from a coded tamper-evident container or iii) videoing the one or more obtained specimens being placed in a coded tamper-evident sample container, and wherein obtaining at least one type of biological information of the person includes videoing the person while obtaining at least one type of biological information of the person."). and verify whether or not the specimen provider is the same person as a person who has requested the specimen sampling kit, by using at least one of the images used for the tracking. (Para. 10 see "the inventive subject matter provides methods and kits for collecting a specimen and/or biological information from a person at a first location to be provided to a second location with the person being verified as the intended person." Para. 13 see "confirming the identification of the person to the verification assistant through the internet communication, comprises the person/user providing identifying information that is received and confirmed through the internet communication. In some embodiments, the identifying information includes a unique code from a provided kit and/or an image capture of a form of identification, including a government-issued identification card, driver's license, or any identifying pages of a passport.").
Regarding claim 4, Fung teaches The self-sampling management electronic device of claim 1, wherein the tracked sampling action comprises at least one of: a first action of unpacking the specimen sampling kit; a second action of grasping a swab included in the unpacked specimen sampling kit; a third action of inserting the grasped swab into a nose or a mouth of the specimen provider; a fourth action of taking the swab out from the nose or the mouth of the specimen provider; a fifth action of putting the swab into a receiving vessel included in the specimen sampling kit; and a sixth action of sealing the receiving vessel in which the swab is received. (Para. 33 see "He/she will be instructed to open all packages which are pre-sealed with tamper-evident containers in the view of the operator" Para. 44 see "Once saliva collection is complete, the saliva kit is placed in a tamper evident bag (or equivalent tamper-evident container) with a serial number (number stored in the Registration and Tracking system for verification) and placement in the bag is recorded, to verify the chain of custody." Para. 47 see "Collection of a mucosal sample from a nasal sampling may be included in a kit for testing for mucosal infections such as those caused by betacoronaviruses—e.g., MERS-CoV, SARS-CoV, and SARS-CoV2, the latter causing the current COVID-19 disease. The muscosal collection device may include nasal swabs for unassisted mid-nasal swabbing as described and reported.").
Regarding claim 5, Fung teaches The self-sampling management electronic device of claim 1, wherein the tracked sampling action comprises at least one of: a first action of unpacking the specimen sampling kit; a second action in which the specimen provider spits saliva into a receiving vessel included in the specimen sampling kit; and a third action of sealing the receiving vessel. (Para. 33 see "He/she will be instructed to open all packages which are pre-sealed with tamper-evident containers in the view of the operator" Para. 44 see "Once saliva collection is complete, the saliva kit is placed in a tamper evident bag (or equivalent tamper-evident container) with a serial number (number stored in the Registration and Tracking system for verification) and placement in the bag is recorded, to verify the chain of custody." Para. 47 see "Collection of a mucosal sample from a nasal sampling may be included in a kit for testing for mucosal infections such as those caused by betacoronaviruses—e.g., MERS-CoV, SARS-CoV, and SARS-CoV2, the latter causing the current COVID-19 disease. The muscosal collection device may include nasal swabs for unassisted mid-nasal swabbing as described and reported.").
Regarding claim 7, Fung teaches The self-sampling management electronic device of claim 4, wherein the image for the verification comprises an image obtained from the third action. (Para. 10 see "the inventive subject matter provides methods and kits for collecting a specimen and/or biological information from a person" and "the method includes obtaining one or more specimens from the person or one or more types of biological information of the person, wherein the obtaining the one or more specimens of the person includes at least one of: i) videoing the person while obtaining the one or more specimens and videoing the obtained one or more specimens being placed into a coded tamper-evident sample container; ii) before the obtaining, electronically communicating/videoing a code on a collection device and/or videoing the removal of a collection device from a coded tamper-evident container or iii) videoing the one or more obtained specimens being placed in a coded tamper-evident sample container, and wherein obtaining at least one type of biological information of the person includes videoing the person while obtaining at least one type of biological information of the person." Para. 33 see " the user is videoed as instructed through a smartphone, computer tablet device, or any suitable computer at the first location for the entire process." Para. 39 see "The instructions also provide an overview of the process that includes all of the particular steps in the process: ...mucosal collection (e.g., nasal swab)" (The person is videoed during the whole process and identify verification is carried out. This includes during the third action.)).
Regarding claim 8, Fung teaches The self-sampling management electronic device of claim 7, wherein the image for the verification comprises an image randomly selected from the images obtained from the first to the sixth actions. (Para. 10 see "the inventive subject matter provides methods and kits for collecting a specimen and/or biological information from a person" and "the method includes obtaining one or more specimens from the person or one or more types of biological information of the person, wherein the obtaining the one or more specimens of the person includes at least one of: i) videoing the person while obtaining the one or more specimens and videoing the obtained one or more specimens being placed into a coded tamper-evident sample container; ii) before the obtaining, electronically communicating/videoing a code on a collection device and/or videoing the removal of a collection device from a coded tamper-evident container or iii) videoing the one or more obtained specimens being placed in a coded tamper-evident sample container, and wherein obtaining at least one type of biological information of the person includes videoing the person while obtaining at least one type of biological information of the person." Para. 33 see " the user is videoed as instructed through a smartphone, computer tablet device, or any suitable computer at the first location for the entire process." Para. 39 see "The instructions also provide an overview of the process that includes all of the particular steps in the process: ...mucosal collection (e.g., nasal swab)" (The person is videoed during the whole process and identify verification is carried out. This includes during any action that is randomly selected.)).
Regarding claim 9, Fung teaches The self-sampling management electronic device of claim 4, wherein the image for the verification comprises an image obtained from at least two adjacent actions among the first to sixth actions. (Para. 10 see "the inventive subject matter provides methods and kits for collecting a specimen and/or biological information from a person" and "the method includes obtaining one or more specimens from the person or one or more types of biological information of the person, wherein the obtaining the one or more specimens of the person includes at least one of: i) videoing the person while obtaining the one or more specimens and videoing the obtained one or more specimens being placed into a coded tamper-evident sample container; ii) before the obtaining, electronically communicating/videoing a code on a collection device and/or videoing the removal of a collection device from a coded tamper-evident container or iii) videoing the one or more obtained specimens being placed in a coded tamper-evident sample container, and wherein obtaining at least one type of biological information of the person includes videoing the person while obtaining at least one type of biological information of the person." Para. 33 see " the user is videoed as instructed through a smartphone, computer tablet device, or any suitable computer at the first location for the entire process." Para. 39 see "The instructions also provide an overview of the process that includes all of the particular steps in the process: ...mucosal collection (e.g., nasal swab)" (The person is videoed during the whole process and identify verification is carried out. This includes during any actions that are 'adjacent'.)).
Regarding claim 13, Fung teaches A computer readable recording medium storing a computer program configured to perform operations included in the method of claim 12. (Para. 10 see "the method includes establishing a video communication between the person and a verification program through a computer or smartphone." Para. 32 see "direct the user to go to a webpage on their smartphone or any computer device with a camera and internet connection, to initiate an internet communication." and "a software application program that is programmed to instruct the user step-wise through the components of the kit for the specimen and biological data collection." (Software application means there is memory storing instructions and a processor.)).
Regarding claim 14, Fung teaches A computer program stored in a computer readable recording medium configured to perform operations included in the method of claim 12. (Para. 10 see "the method includes establishing a video communication between the person and a verification program through a computer or smartphone." Para. 32 see "direct the user to go to a webpage on their smartphone or any computer device with a camera and internet connection, to initiate an internet communication." and "a software application program that is programmed to instruct the user step-wise through the components of the kit for the specimen and biological data collection." (Software application means there is memory storing instructions and a processor.)).
Claim 12 is rejected under the same analysis as claim 1 above.
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.
Claims 2-3, 6, 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Fung et al. (US 20220369953 A1), hereinafter Fung, in view of Bates (US 20210090738 A1), hereinafter Bates.
Regarding claim 2, Fung teaches The self-sampling management electronic device of claim 1.
Fung does not teach wherein the processor is configured, by executing the instructions, to: compare the tracked sampling action information with reference sampling action information to be followed by the specimen provider when the specimen provider performs the sampling action; and generate contents to be provided to the specimen provider on basis of a result of the comparison.
However, Bates teaches wherein the processor is configured, by executing the instructions, to: compare the tracked sampling action information with reference sampling action information to be followed by the specimen provider when the specimen provider performs the sampling action; and generate contents to be provided to the specimen provider on basis of a result of the comparison. (Para. 36 see "machine vision software may be used to track and overlay or superimpose, e.g., on a screen, the position of the IR LED with the desired target location at which the patient should place diagnostic equipment 108, thereby, aiding the patient to properly place or align a sensor and ensure accurate and reliable readings." Para. 37 see "A patient may be instructed to adjust an angle, location, or motion of diagnostic equipment 108, e.g., to adjust its state to avoid low-accuracy or faulty measurement readings." and "one or more sensors that may be attached to diagnostic equipment 108 monitor the placement and usage of diagnostic equipment 108 by periodically or continuously recording data and comparing measured data, such as location, movement, and angles, to an expected data model and/or an error threshold to ensure measurement accuracy." (The expected data model contains reference sampling information.)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fung to incorporate the teachings of Bates to compare the tracked sampling action information with reference sampling action information and generate contents on the basis of the comparison. Doing so would predictably increase action detection accuracy by using preset information that can reliably identify if the action is being performed by the user properly and prompt the user to take appropriate action.
Regarding claim 3, Fung in view of Bates teaches The self-sampling management electronic device of claim 2.
Fung does not teach wherein the reference sampling action information comprises information regarding a reference depth of insertion and/or a reference angle of insertion required when a swab of the specimen sampling kit is inserted into a nose or a mouth of the specimen provider, and the tracked sampling action information comprises information regarding a measured depth of insertion and/or a measured angle of insertion measured from an image of the swab inserted into the nose or the mouth of the specimen provider.
However, Bates teaches wherein the reference sampling action information comprises information regarding a reference depth of insertion and/or a reference angle of insertion required when a swab of the specimen sampling kit is inserted into a nose or a mouth of the specimen provider, (Para. 37 see "A patient may be instructed to adjust an angle, location, or motion of diagnostic equipment 108, e.g., to adjust its state to avoid low-accuracy or faulty measurement readings." Para. 46 see "If the score is below a certain threshold, the system will give detailed guidance in taking a correct image, i.e., change angle or depth of an otoscope in nose/ear and mouth to receive a complete image."). and the tracked sampling action information comprises information regarding a measured depth of insertion and/or a measured angle of insertion measured from an image of the swab inserted into the nose or the mouth of the specimen provider. (Para. 36 see "machine vision software may be used to track and overlay or superimpose, e.g., on a screen, the position of the IR LED with the desired target location at which the patient should place diagnostic equipment 108, thereby, aiding the patient to properly place or align a sensor and ensure accurate and reliable readings." Para. 37 see "one or more sensors that may be attached to diagnostic equipment 108 monitor the placement and usage of diagnostic equipment 108 by periodically or continuously recording data and comparing measured data, such as location, movement, and angles, to an expected data model and/or an error threshold to ensure measurement accuracy." Para. 46 see "If the score is below a certain threshold, the system will give detailed guidance in taking a correct image, i.e., change angle or depth of an otoscope in nose/ear and mouth to receive a complete image." Para. 111 see "automated diagnostic module 400 may comprise: video images and key identifiers of kit image of actual equipment measurement and usage 412 and ideal image and key identifiers library for measurement data accuracy score 414, where the images, video, sensor data stored in the two components 412 and 414 are used by measurement data accuracy score generator 410 to determine the kit usage measurement method sensor accuracy.").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fung to incorporate the teachings of Bates to compare the sampling action information with reference sampling action information regarding a measured depth or angle of insertion. Doing so would predictably increase action detection accuracy by using preset information that can reliably identify if the action is being performed by the user properly and prompt the user to take appropriate action.
Regarding claim 6, Fung teaches The self-sampling management electronic device of claim 4. wherein the processor is configured, by executing the instructions, to: verify whether or not the tracked sampling action includes all the sampling actions; (Para. 25 see “As used herein, “assistant”, “verification assistant”, “assistance” may refer to a human assistant, a virtual assistant, and/or virtual assistance in the form of a software application program that includes audio and video instructions for the intended person to use for effective and valid collection of specimens and biological data from the intended person. Para. 39 see "each component provided will have a corresponding set of instructions which are at least provided by the verification assistant" and "a particular order is disclosed such that each step can be verified and is carried out by the user most effectively.").
Fung does not teach and generate contents to be provided to the specimen provider on basis of a result of the verification.
However, Bates teaches and generate contents to be provided to the specimen provider on basis of a result of the verification. (Para. 46 see "data associated with a physical condition is automatically recorded and usage accuracy of the diagnostic equipment is tracked. The system may analyze each clinical measured image data and compare traits from a database that detect an incomplete image for each target body part to track accuracy of measurement and provide a score. If the score is below a certain threshold, the system will give detailed guidance in taking a correct image, i.e., change angle or depth of an otoscope in nose/ear and mouth to receive a complete image.").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fung to incorporate the teachings of Bates to generate contents on the basis of the verification. Doing so would predictably increase the likelihood of a quality sample by verifying the sample was taken using the appropriate actions.
Regarding claim 15, Fung teaches A self-sampling management method performed by a self-sampling management electronic device, the method comprising: (Para. 9 see "The contemplated subject matter includes a system for a person to provide biological data using a self-administered method and kit with verification that the biological data was obtained from the intended person in a way that does not require in-person, professional administration." Para. 10 see "the method includes establishing a video communication between the person and a verification program through a computer or smartphone."). tracking a sampling action of a specimen provider by using images of the specimen provider handling a specimen sampling kit; (Para. 10 see "the inventive subject matter provides methods and kits for collecting a specimen and/or biological information from a person" and "the method includes obtaining one or more specimens from the person or one or more types of biological information of the person, wherein the obtaining the one or more specimens of the person includes at least one of: i) videoing the person while obtaining the one or more specimens and videoing the obtained one or more specimens being placed into a coded tamper-evident sample container; ii) before the obtaining, electronically communicating/videoing a code on a collection device and/or videoing the removal of a collection device from a coded tamper-evident container or iii) videoing the one or more obtained specimens being placed in a coded tamper-evident sample container, and wherein obtaining at least one type of biological information of the person includes videoing the person while obtaining at least one type of biological information of the person.").
Fung does not teach comparing the tracked sampling action with a reference action to be followed by the specimen provider when the specimen performs the sampling action; and generating contents to be provided to the specimen provider on basis of a result of the comparison.
However, Bates teaches comparing the tracked sampling action with a reference action to be followed by the specimen provider when the specimen performs the sampling action; and generating contents to be provided to the specimen provider on basis of a result of the comparison. (Para. 36 see "machine vision software may be used to track and overlay or superimpose, e.g., on a screen, the position of the IR LED with the desired target location at which the patient should place diagnostic equipment 108, thereby, aiding the patient to properly place or align a sensor and ensure accurate and reliable readings." Para. 37 see "A patient may be instructed to adjust an angle, location, or motion of diagnostic equipment 108, e.g., to adjust its state to avoid low-accuracy or faulty measurement readings." and "one or more sensors that may be attached to diagnostic equipment 108 monitor the placement and usage of diagnostic equipment 108 by periodically or continuously recording data and comparing measured data, such as location, movement, and angles, to an expected data model and/or an error threshold to ensure measurement accuracy." (The expected data model contains reference sampling information.)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fung to incorporate the teachings of Bates to compare the tracked sampling action information with reference sampling action information and generate contents on the basis of the comparison. Doing so would predictably increase action detection accuracy by using preset information that can reliably identify if the action is being performed by the user properly and prompt the user to take appropriate action.
Regarding claim 16, Fung teaches The self-sampling management electronic device of claim 5. wherein the processor is configured, by executing the instructions, to: verify whether or not the tracked sampling action includes all the sampling actions; (Para. 25 see As used herein, “assistant”, “verification assistant”, “assistance” may refer to a human assistant, a virtual assistant, and/or virtual assistance in the form of a software application program that includes audio and video instructions for the intended person to use for effective and valid collection of specimens and biological data from the intended person. Para. 39 see "each component provided will have a corresponding set of instructions which are at least provided by the verification assistant" and "a particular order is disclosed such that each step can be verified and is carried out by the user most effectively.").
Fung does not teach and generate contents to be provided to the specimen provider on basis of a result of the verification.
However, Bates teaches and generate contents to be provided to the specimen provider on basis of a result of the verification. (Para. 46 see "data associated with a physical condition is automatically recorded and usage accuracy of the diagnostic equipment is tracked. The system may analyze each clinical measured image data and compare traits from a database that detect an incomplete image for each target body part to track accuracy of measurement and provide a score. If the score is below a certain threshold, the system will give detailed guidance in taking a correct image, i.e., change angle or depth of an otoscope in nose/ear and mouth to receive a complete image.").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fung to incorporate the teachings of Bates to to generate contents on the basis of the verification. Doing so would predictably increase the likelihood of a quality sample by verifying the sample was taken using the appropriate actions.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Fung et al. (US 20220369953 A1), hereinafter Fung, in view of Cizerle (US 20170302880 A1), hereinafter Cizerle.
Regarding claim 10, Fung teaches The self-sampling management electronic device of claim 1.
Fung does not teach wherein the processor is configured, by performing the instructions, to generate a message to be displayed to the specimen provider or a message to be transmitted to a terminal of a diagnosis center managing the specimen sampling kit when the specimen provider is not the same person as the person who has requested the specimen sampling kit.
However, Cizerle teaches wherein the processor is configured, by performing the instructions, to generate a message to be displayed to the specimen provider or a message to be transmitted to a terminal of a diagnosis center managing the specimen sampling kit when the specimen provider is not the same person as the person who has requested the specimen sampling kit. (Abstract see "The system guides the user through the process via on-screen prompts on the mobile device, and includes tracking of the collected specimen from the moment of collection until it is sealed in a tamper-proof container to be mailed for external testing at a lab." Para. 20-25 see "The rules include:" and "I will not attempt to falsify the test or use any additional devices or assistance from other people to provide the device with a false reading." Para. 28 see "The results of the test are shown on the screen, and are conveyed automatically to a remote server for authentication and recording to the account of the user.").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fung to incorporate the teachings of Cizerle to generate a message to be displayed when the person sampled is not the person who requested the sample. Doing so would predictably increase the accuracy of the sampling by ensuring that the person who requested the sample is the person sampled. Additionally, this would allow the diagnosis center to take appropriate subsequent actions.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Fung et al. (US 20220369953 A1), hereinafter Fung, in view of Chun (US 20230141831 A1), hereinafter Chun.
Regarding claim 11, Fung teaches The self-sampling management electronic device of claim 1. and the images used for the tracking are obtained from the sampling action performed by the delivery person. (Para. 10 see "the inventive subject matter provides methods and kits for collecting a specimen and/or biological information from a person" and "the method includes obtaining one or more specimens from the person or one or more types of biological information of the person, wherein the obtaining the one or more specimens of the person includes at least one of: i) videoing the person while obtaining the one or more specimens and videoing the obtained one or more specimens being placed into a coded tamper-evident sample container; ii) before the obtaining, electronically communicating/videoing a code on a collection device and/or videoing the removal of a collection device from a coded tamper-evident container or iii) videoing the one or more obtained specimens being placed in a coded tamper-evident sample container, and wherein obtaining at least one type of biological information of the person includes videoing the person while obtaining at least one type of biological information of the person.").
Fung does not teach wherein the sampling action is performed on the specimen provider by a delivery person who has delivered the specimen sampling kit to the specimen provider.
However, Chun teaches wherein the sampling action is performed on the specimen provider by a delivery person who has delivered the specimen sampling kit to the specimen provider, (Para. 111 see "The test agency may require the specimen from the client to be collected by participating personnel for delivery or retrieval of the sampling kit." and "when the sampling kit is delivered from the test agency to a personal place such as client's home, company, or current residence, the client is set to perform self-sampling. However, if necessary, a specimen collector who can assist with specimen collection for the client who have difficulty in the self-sampling is required to participate in the delivery or collection of the sampling kit, so that the sampling is collected by the client at the time of delivery or collection of the sampling kit.").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Fung to incorporate the teachings of Chun to have the delivery person perform the actions and track those actions by imaging. Doing so would predictably increase the end users experience by having the delivery person perform the sampling when the end user may not be capable of performing the sampling themselves. Additionally, this would predictably increase accuracy and quality of sampling because the delivery person may be trained or have experience performing the sampling.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Nakatsugawa et al. (US 20210010998 A1) discloses a sample acquisition information management device, a sample acquisition information management system, and a sample acquisition information management method that allow a subject who is to collect a sample by oneself to reliably perform a sample acquisition operation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J VAUGHN whose telephone number is (571) 272-5253. The examiner can normally be reached M-F 8:30-5.
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/ALEXANDER JOSEPH VAUGHN/Examiner, Art Unit 2675
/EDWARD PARK/Primary Examiner, Art Unit 2675