Researchers Submit Patent Application, “Oral Sampling Device”, for Approval (USPTO 20240122582): Patent Application

2024 MAY 03 (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 Berthier, Erwin Stefan Peter (Seattle, WA, US); Hieber, Damielle Leticia (Kenmore, WA, US); Lee, Ulri Nicole (Seattle, WA, US); Su, Xiaojing (Seattle, WA, US); Theberge, Ashleigh Brooks (Seattle, WA, US); Thongpang, Sanitta (Seattle, WA, US), filed on February 18, 2022, was made available online on April 18, 2024.

No assignee for this patent application has been made.

News editors obtained the following quote from the background information supplied by the inventors: “Pathogens cause infections in humans, some of which are life-threatening. Acute respiratory infections are common with children, averaging three to five upper respiratory infections per year, some of which may lead to additional complications, if left untreated. In developing countries, illnesses can be even more severe than developed countries, with gaps in healthcare increasing the risk of morbidity and mortality. In order to diagnose and treat certain diseases, a sample of saliva from a human subject can be collected and tested for a specific pathogen.

“Traditional sample collection methods used for disease diagnosis include swabbing the posterior pharynx with a pharyngeal swab, extracting sputum, or placing a roll of cotton or an absorbent sponge in the mouth of the human subject to absorb saliva. These sample collection methods are quite unpleasant. For example, swabbing the posterior pharynx or keeping a cotton roll in the mouth for a lengthy period of time can cause discomfort, which makes these collection methods difficult to perform by oneself in a home setting. In addition, visiting a clinic to collect a sample is inconvenient, if not impossible for some people. For example, even in developed countries, residents of rural areas and/or those without health insurance may have limited access to clinics, making it difficult for a portion of the population to receive appropriate diagnosis and treatment. This can discourage adults and children alike from seeking proper testing and treatment. In young children, the aforementioned sample collection methods can cause fear and frustration, resulting in a high rate of non-compliance of sample collection for children. These barriers to adequate sample collection limit the ability to diagnose diseases like strep throat, influenza, tuberculosis, and pneumonia, among others. The disclosure made herein is presented with respect to these and other considerations.”

As a supplement to the background information on this patent application, NewsRx correspondents also obtained the inventors’ summary information for this patent application: “This disclosure provides an oral sampling device, as well as methods of making and using the oral sampling device. The oral sampling device is configured to be placed inside of a human mouth (oral cavity) to capture an analyte(s) found in bodily fluid, such as saliva, produced within the mouth. This disclosure describes various types of analytes that may be captured using the disclosed oral sampling device. In some examples, the oral sampling device is agnostic to the type of analyte(s) that is to be captured by the oral sampling device, meaning that the oral sampling device can be used to capture any type of analyte, and possibly multiple different types of analytes from an individual human subject. In other examples, the oral sampling device is tailored for capturing a specific type of target analyte(s).

“An example oral sampling device described herein includes a body. At least a portion of the body is sized to fit inside of a mouth of a human, has an outer surface, and a recess(es) defined in the outer surface. The oral sampling device is an open-fluidic sampling device, meaning that open access to the recess provides a point(s) of ingress for bodily fluid, such as saliva, to enter the recess. Furthermore, the geometry of the recess (e.g., a shape of the recess, a depth of the recess, and/or a width of the recess, etc.) may promote the capture of an analyte(s) found in the bodily fluid (e.g., saliva). For example, the shape of the recess, the depth of the recess, and/or the width of the recess may prevent a tongue from physically scraping the analyte(s) out of the recess without inhibiting entry of the bodily fluid containing the analyte(s) into the recess, thereby mitigating loss of captured analytes. Moreover, increasing (e.g., maximizing) the surface area coverage of the recess(es) on the outer surface of the body can also promote the capture of a greater amount of the analyte(s). Accordingly, in some examples, the recess(es) defined in the outer surface of the body may cover or span at least a threshold percentage of the outer surface. In some examples, at least the portion of the body that is to be received inside of a mouth of a human is made of a rigid porous material in lieu of, or in addition to, having a recess(es) defined in its outer surface. The rigid porous material may allow a bodily fluid, such as saliva, to enter the body of the oral sampling device through pores in the material and may further promote the capture of an analyte(s) found in the bodily fluid (e.g., saliva).

“In some examples, a material of the body within the recess(es) was subjected to a surface treatment to promote the capture of an analyte(s) found in bodily fluid, such as saliva. This disclosure describes various types of surface treatment to which the material of the body may have been subjected in order to promote the capture and/or the accumulation of an analyte(s) found in the bodily fluid (e.g., saliva). Example surface treatments include oxygen plasma treatment, coating the material with an affinity reagent(s), and/or hydrophilic treatment, among other surface treatments. The surface treatment may promote the capture and/or the accumulation of the analyte(s) by capturing and/or retaining more of the analyte(s) within the recess(es), as compared to an oral sampling device having a body made of a material that has not been subjected to a surface treatment. In general, the surface treatment may improve the quality of sample collection by ensuring that a sufficient amount of the analyte(s) is/are captured. In some examples, the surface treatment may configure the oral sampling device to capture, and/or accumulate more of, a specific type of target analyte(s).

“In some examples, the oral sampling device includes a flavored substance disposed on at least the portion of the body that is to be received inside of a mouth of a human. In some examples, the flavored substance does not cover the recess(es) and/or the flavored substance does not cover at least some of the rigid porous material of the body. This is to allow a bodily fluid (e.g., saliva) containing an analyte(s) to enter the recess(es) and/or the rigid porous material of the body while at least the portion of the body is disposed inside of the mouth of a human subject. The flavored substance is configured to release a flavor over a period of time while at least the portion of the body is disposed inside of the mouth of the human. This period of time may correspond to a target amount of time the oral sampling device is to remain inside of the mouth. Accordingly, the flavored substance may function as a built-in, analog timer by providing a flavor-based indication to the human subject of how long he or she is supposed to keep the oral sampling device in his or her mouth. In other words, the human subject is naturally encouraged to enjoy the flavor while it is released by the flavored substance, and once the flavored substance ceases releasing the flavor, the human subject knows, from the lack of flavor, that it is time to remove the oral sampling device from his or her mouth. The flavored substance may also improve compliance of sample collection in human subjects by making sample collection an enjoyable, fun, and/or appetizing experience, among other benefits. In some examples, the body of the oral sampling device includes a handle and a head coupled to the handle, the head being the portion of the body that is sized to fit inside of a mouth of a human, and a majority of the handle being configured to remain outside of the mouth and grasped by a hand. In this example configuration, the oral sampling device is akin to a lollipop, which is familiar to adults and children alike, and which improves compliance of sample collection. In the case of children, the oral sampling device is a child-friendly device that may reduce anxiety, fear and/or frustration that may otherwise cause a child to resist sample collection. The disclosed oral sampling device also expands the range of diseases that can be detected from a bodily fluid, such as saliva at least because the sensitivity of the diagnostic process is increased by enabling longer accumulation times of the analyte(s).

“The present disclosure also provides methods of manufacturing the oral sampling device disclosed herein, as well as methods of using the oral sampling device disclosed herein. In some examples, the manufactured oral sampling device may be packaged and sold to consumers and/or to clinics as a kit for disease diagnosis. Methods of using the oral sampling device include collecting a sample using the oral sampling device and/or extracting a sample (e.g., elution) from the oral sampling device to test the sample for an analyte(s) of interest.”

The claims supplied by the inventors are:

“1. An oral sampling device comprising: a body, wherein at least a portion of the body: is sized to fit inside of a mouth of a human; and comprises: an outer surface; and a recess defined in the outer surface, a material of the body within the recess having been subjected to a surface treatment to promote capture of an analyte found in saliva.

“2. The oral sampling device of claim 1, wherein the recess comprises at least one of a groove or a pit.

“3. The oral sampling device of claim 2, wherein: the groove is at least one of: a spiral groove having more than one turn; or one or more grooves having a radial pattern; or the pit is one of multiple pits spatially distributed across the outer surface.

“4. The oral sampling device of claim 1, wherein the surface treatment comprises at least one of: oxygen plasma treatment; coating the material with an affinity reagent; or hydrophilic treatment.

“5. The oral sampling device of claim 4, wherein the affinity reagent is fibronectin or collagen.

“6. The oral sampling device of claim 4, wherein the affinity reagent is an aptamer.

“7. The oral sampling device of claim 4, wherein the affinity reagent is a binding molecule for the analyte.

“8. The oral sampling device of claim 7, wherein the binding molecule is a nucleic acid that hybridizes to the analyte or is a protein binding domain that binds the analyte.

“9. The oral sampling device of claim 8, wherein the protein binding domain comprises an antibody or a binding fragment thereof.

“10. The oral sampling device of claim 9, wherein the binding fragment thereof is a single chain variable fragment (scFv).

“11. The oral sampling device of claim 1, wherein the recess has a depth equal to or greater than 0.5 millimeter.

“12. The oral sampling device of claim 1, wherein the recess has a width equal to or less than 2 millimeters.

“13. The oral sampling device of claim 1, further comprising a flavored substance disposed on at least the portion of the body, wherein the flavored substance does not cover the recess.

“14. The oral sampling device of claim 13, wherein the flavored substance is configured to release a flavor over a period of time while at least the portion of the body is disposed inside of the mouth.

“15. The oral sampling device of claim 13, wherein the flavored substance is at least one of a gel, a hard candy, a gummy material, an artificial sweetener, or flavored isomalt.

“16. The oral sampling device of claim 1, wherein the body comprises a handle and a head coupled to the handle, wherein at least the portion of the body comprises the head.

“17-36. (canceled)

“37. The oral sampling device of claim 14, wherein the flavored substance is configured to dissolve over the period of time while at least the portion of the body is disposed inside of the mouth.

“38. The oral sampling device of claim 14, wherein the flavored substance is configured to cease releasing the flavor after at least the portion of the body has been disposed inside of the mouth for the period of time.

“39. The oral sampling device of claim 14, wherein the flavored substance is configured to change color after at least the portion of the body has been disposed inside of the mouth for the period of time.

“40. (canceled)

“41. (canceled)

“42. The oral sampling device of claim 13, wherein the flavored substance is configured to stimulate a neurological response that causes the human to produce the analyte.

“43-45. (canceled)”

For additional information on this patent application, see: Berthier, Erwin Stefan Peter; Hieber, Damielle Leticia; Lee, Ulri Nicole; Su, Xiaojing; Theberge, Ashleigh Brooks; Thongpang, Sanitta. Oral Sampling Device. U.S. Patent Application Number 20240122582, filed February 18, 2022 and posted April 18, 2024. Patent URL (for desktop use only): https://ppubs.uspto.gov/pubwebapp/external.html?q=(20240122582)&db=US-PGPUB&type=ids

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