DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/22/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3-10, 12-14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 1, 3-9, 12-14 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, and further in view of Stephen (US 20200303044 A1), hereinafter Stephen.
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." Para. 21 see "the inventive subject matter allows a user (“the intended person”) to collect specimens and perform basic health checks on his/her own (e.g., at home), guided by assistance through a software program application and/or a video communication with biometric identity verification having anti-fraud and chain of custody methods."). 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: identify a specimen sampling kit; track a sampling action of a specimen provider by using images of the specimen provider handling the 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." 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." Para. 14 see "the kit includes a unique code labeled on the kit." 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."). verify whether or not the specimen provider is the same person as a person who has requested the 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 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.").
While Fung teaches continuously capturing images of a user providing a sample and guiding them through that process, as well as verifying the identity of the user through video by having them provide identity documents, Fung does not teach verifying 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 of the specimen provider used for the tracking; comparing the sampling action information, which is tracked from the images of the specimen provider, with reference sampling action information to be followed by the specimen provider when the specimen provider 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 compare the sampling action information, which is tracked from the images of the specimen provider, 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.
Fung in view of Bates does not teach by using at least one of the images of the specimen provider used for the tracking;
However, Stephen teaches by using at least one of the images of the specimen provider used for the tracking; (Para. 103 see "the camera 500 is configured to capture one or more images of the face of the subject being tested, including at least part of the face and/or face features sufficient for facial recognition, during the saliva sample deposition process. The image(s) of the face are used to authenticate the saliva test, for example, through a comparison of the face features to stored face feature information of the intended subject. In such a manner, it can be determined whether the subject using the test plate 10 is actually the intended subject.").
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 and Bates to incorporate the teachings of Stephen to use images of a user performing the actions to verify identity. Doing so would predictably increase security by reducing identity fraud by using images of the person performing the actions as opposed to verifying a user presenting a stolen identification document.
Regarding claim 3, Fung in view of Stephen and Bates teaches The self-sampling management electronic device of claim 1.
While Fung teaches recording a video of the user providing the sample, 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 and Stephen and Bates 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 4, Fung in view of Stephen and Bates teaches The self-sampling management electronic device of claim 1.
In addition, Fung teaches 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 in view of Stephen and Bates teaches The self-sampling management electronic device of claim 1.
In addition, Fung teaches 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 6, Fung in view of Bates and Stephen teaches The self-sampling management electronic device of claim 4.
In addition, Fung teaches 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.").
While Fung teaches guiding a user through the process of providing a sample, 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 and Bates and Stephen 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 7, Fung in view of Bates and Stephen teaches The self-sampling management electronic device of claim 4.
In addition, Fung teaches 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 in view of Stephen and Bates teaches The self-sampling management electronic device of claim 7.
In addition, Fung teaches 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 in view of Bates and Stephen teaches The self-sampling management electronic device of claim 4.
In addition, Fung teaches 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 identity verification is carried out. This includes during any actions that are 'adjacent'.)).
Regarding claim 13, Fung in view of Bates and Stephen teaches The self-sampling management method of claim 12.
In addition, 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 in view of Bates and Stephen teaches The self-sampling management method of claim 12.
In addition, 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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Fung et al. (US 20220369953 A1), hereinafter Fung, in view of Stephen (US 20200303044 A1), hereinafter Stephen, and Bates (US 20210090738 A1), hereinafter Bates, and Cizerle (US 20170302880 A1), hereinafter Cizerle.
Regarding claim 10, Fung in view of Stephen and Bates teaches The self-sampling management electronic device of claim 1.
While Fung teaches video communication and identity verification through video, 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 and Stephen and Bates 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.
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 VAUGHN whose telephone number is (571) 272-5253. The examiner can normally be reached M-F 11am-7pm.
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/ALEXANDER VAUGHN/Examiner, Art Unit 2675
/XIAO LIU/Primary Examiner, Art Unit 2664
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