DETAILED ACTION
Applicant’s arguments, filed on 01/20/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed on 01/20/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-16, 37-39, and 42 are the current claims hereby under examination.
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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-4, 12-16, 37-38, and 42 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mink (US 6303081).
Regarding independent claim 1, Mink teaches the oral sampling device (Abstract: “A device for collecting and transporting aqueous fluid from the oral cavity to a lateral chromatographic strip for test is disclosed.”) comprising:
a body (Fig. 1), wherein at least a portion of the body:
is sized to fit inside of a mouth of a human (Column 7, lines 36-37: “the device is inserted into the oral cavity”); and
comprises: an outer surface (Column 2, lines 52-54: “The apparatus comprises a capillary matrix having exposed a surface for insertion into an oral cavity”; Column 16, lines 54-58: “The capillary matrix (W) protrudes out from the housing (H) at the end (14) to provide a planar surface for insertion into the oral cavity where the capillary matrix face (3) can be contacted to the oral mucosa”. The exposed planar surface of the capillary matrix is the outer surface.); and
a recess defined in the outer surface, wherein a length of the recess extends along a plane parallel to the outer surface and/or the recess has a cross-section having at least one sharp corner (Column 16, lines 54-58: “The capillary matrix (W) protrudes out from the housing (H) at the end (14) to provide a planar surface for insertion into the oral cavity where the capillary matrix face (3) can be contacted to the oral mucosa”; Column 5, lines 52-56: “The terms "capillary matrix" or "porous matrix" are used herein to refer to a highly porous material characterized by a pore size sufficiently small that the material rapidly takes up aqueous solution (e.g., of oral fluid) predominantly by capillary action or "wicking"”. The pores of the capillary matrix is the recess. Since the pores are inside the capillary matrix, they extend along a plane parallel to the outer surface of the capillary matrix.),
a material of the body within the recess having been subjected to a surface treatment to promote capture of an analyte found in saliva (Column 9, lines 8-15: “In addition to having a pore size (channel size) that results in rapid uptake of the oral fluid, the surfaces of the capillary matrix should be chemically compatible with rapid uptake of the oral fluid. Thus, preferred capillary matrix materials are themselves hydrophilic or treated to be hydrophilic (e.g., by addition of a surfactant also referred to as a detergent or wetting agent). That is to say, water must flow on and be attracted to the surfaces of these materials.”. Since the hydrophilic treatment attracts water (saliva) to it, it promotes the capture of an analyte found in saliva.).
Regarding claim 2, Mink teaches the oral sampling device of claim 1, wherein the recess comprises at least one of a groove or a pit (Column 5, lines 52-56: “The terms "capillary matrix" or "porous matrix" are used herein to refer to a highly porous material characterized by a pore size sufficiently small that the material rapidly takes up aqueous solution (e.g., of oral fluid) predominantly by capillary action or "wicking"”. The pore is being interpreted as being a pit.).
Regarding claim 3, Mink teaches 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 (Column 5, lines 52-56: “The terms "capillary matrix" or "porous matrix" are used herein to refer to a highly porous material characterized by a pore size sufficiently small that the material rapidly takes up aqueous solution (e.g., of oral fluid) predominantly by capillary action or "wicking"”. The pore is being interpreted as being a pit, and they are spatially distributed across the outer surface since they are throughout the capillary matrix.).
Regarding claim 4, Mink teaches 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 (Column 9, lines 8-15: “In addition to having a pore size (channel size) that results in rapid uptake of the oral fluid, the surfaces of the capillary matrix should be chemically compatible with rapid uptake of the oral fluid. Thus, preferred capillary matrix materials are themselves hydrophilic or treated to be hydrophilic (e.g., by addition of a surfactant also referred to as a detergent or wetting agent). That is to say, water must flow on and be attracted to the surfaces of these materials”).
Regarding claim 12, Mink teaches the oral sampling device of claim 1, wherein the recess has a width equal to or less than 2 millimeters (Column 9, lines 4-7: “Preferred materials have an average pore size that ranges from about 40 µm to about 250 µm, more preferably from about 60 µm to about 200 µm, and most preferably from about 80 µm to about 120 µm.).
Regarding claim 13, Mink teaches 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 (Column 4, lines 14-24: “The bite portion may include a saliva-stimulating substance selected from the group consisting of citric or other acids (e.g., tartaric, fumaric, ascorbic, malic, etc.) acid, salt, and natural sweetener (e.g. fructose, glucose, sucrose etc.) or artificial sweetener (e.g. Nutrasweet.RTM.). The bite portion can optionally include other materials such as artificial or natural flavors and/or aromatic substances, and/or polysaccharides, gelatin, shellac, or other coating materials. The bite portion is connected to a housing having a cavity in which the lateral flow chromatography strip is at least partially disposed.”).
Regarding claim 14, Mink teaches 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 (Column 4, lines 14-24: “The bite portion may include a saliva-stimulating substance selected from the group consisting of citric or other acids (e.g., tartaric, fumaric, ascorbic, malic, etc.) acid, salt, and natural sweetener (e.g. fructose, glucose, sucrose etc.) or artificial sweetener (e.g. Nutrasweet.RTM.). The bite portion can optionally include other materials such as artificial or natural flavors and/or aromatic substances, and/or polysaccharides, gelatin, shellac, or other coating materials. The bite portion is connected to a housing having a cavity in which the lateral flow chromatography strip is at least partially disposed.”. Based on the materials that the flavored portion could be made up from, these substances are reasonably understood to dissolve over a period of time when placed in an aqueous solution, therefore teaching on this limitation.).
Regarding claim 15, Mink teaches 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 (Column 4, lines 14-24: “The bite portion may include a saliva-stimulating substance selected from the group consisting of citric or other acids (e.g., tartaric, fumaric, ascorbic, malic, etc.) acid, salt, and natural sweetener (e.g. fructose, glucose, sucrose etc.) or artificial sweetener (e.g. Nutrasweet.RTM.). The bite portion can optionally include other materials such as artificial or natural flavors and/or aromatic substances, and/or polysaccharides, gelatin, shellac, or other coating materials. The bite portion is connected to a housing having a cavity in which the lateral flow chromatography strip is at least partially disposed.”).
Regarding claim 16, Mink teaches 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 (Column 3, lines 63-64: “The housing can act as a handle for inserting the capillary matrix into the oral cavity”; Column 12, lines 63-65: “the capillary matrix is also paddle-shaped, but has a narrow handle portion widening to a relatively short head portion”).
Regarding claim 37, Mink teaches 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 (Column 4, lines 14-24: “The bite portion may include a saliva-stimulating substance selected from the group consisting of citric or other acids (e.g., tartaric, fumaric, ascorbic, malic, etc.) acid, salt, and natural sweetener (e.g. fructose, glucose, sucrose etc.) or artificial sweetener (e.g. Nutrasweet.RTM.). The bite portion can optionally include other materials such as artificial or natural flavors and/or aromatic substances, and/or polysaccharides, gelatin, shellac, or other coating materials. The bite portion is connected to a housing having a cavity in which the lateral flow chromatography strip is at least partially disposed.” Based on the materials that the flavored portion could be made up from, these substances are reasonably understood to dissolve over a period of time when placed in an aqueous solution, therefore teaching on this limitation.).
Regarding claim 38, Mink teaches 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 (Column 4, lines 14-24: “The bite portion may include a saliva-stimulating substance selected from the group consisting of citric or other acids (e.g., tartaric, fumaric, ascorbic, malic, etc.) acid, salt, and natural sweetener (e.g. fructose, glucose, sucrose etc.) or artificial sweetener (e.g. Nutrasweet.RTM.). The bite portion can optionally include other materials such as artificial or natural flavors and/or aromatic substances, and/or polysaccharides, gelatin, shellac, or other coating materials. The bite portion is connected to a housing having a cavity in which the lateral flow chromatography strip is at least partially disposed.”. Based on the materials that the flavored portion could be made up from, these substances are reasonably understood to dissolve over a period of time when placed in an aqueous solution, and once they are dissolved they will stop releasing flavor, therefore teaching on this limitation.).
Regarding claim 42, Mink teaches 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 (Column 4, lines 14-15: “The bite portion may include a saliva-stimulating substance”; Column 16, lines 46-47: “This invention also provides kits for the detection of an analyte in an oral fluid”. The analytes are in the saliva, therefore the saliva-stimulating substance simulates the human to produce the analyte.).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 7 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Mink as applied to claim 1 above.
Regarding claim 7, Mink teaches the oral sampling device of claim 4, wherein the affinity reagent is a binding molecule for the analyte (Column 13, lines 21-23: “the strip will include means for immunospecifically binding the analyte to be detected with its specific binding partner”. The binding partner is not located in the pores, however it would be a simple rearrangement of parts for it to be located in the pores.).
Regarding claim 11, Mink teaches the oral sampling device of claim 1.
However, Mink does not teach wherein the recess has a depth equal to or greater than 0.5 millimeter.
However, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to construct the pores to have a depth equal to or greater than 0.5 millimeter, since Mink is silent on the depth of the pores, and a mere change in size of a component is recognized as being within the level of ordinary skill in the art. See MPEP 2144.04(IV)(A).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Mink as applied to claim 4 above, and further in view of Zegarelli (US 20170347956).
Regarding claim 5, Mink teaches the oral sampling device of claim 4.
However, Mink does not teach wherein the affinity reagent is fibronectin or collagen.
Zegarelli discloses an oral data collecting device. Specifically, Zegarelli teaches wherein the affinity reagent is fibronectin or collagen ([0101]: “hydrogel materials provide an effective contact medium for gum compression and for collecting biological materials for diagnosis. The above can hold the sample (e.g., saliva, blood, cells, etc.) when the oral appliance is removed and then the oral appliance can be sent to the lab for testing”; [0102]: “Hydrogels obtained from natural sources are particularly appealing because they are more likely to be biocompatible for in vivo applications. Suitable hydrogels include natural hydrogels, such as for example, … collagen”). Mink and Zegarelli are analogous arts as they are both related to devices used to collect oral samples from a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the affinity reagent being collagen from Zegarelli into the device from Mink as it allows the device to use a natural material to hold the samples from the user, which is more biocompatible for in vivo applications (Zegarelli, [0102]).
Claims 6 and 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Mink as applied to claim 4 above, and further in view of Harley (US 20140370505).
Regarding claim 6, Mink teaches the oral sampling device of claim 4.
However, Mink does not teach wherein the affinity reagent is an aptamer.
Harley discloses a saliva collection device. Specifically, Harley discloses wherein the affinity reagent is an aptamer ([0133]: “The binding moieties can be any material that selectively binds cells targeted for separation. Materials that selectively bind target cells include, for example, polypeptides (e.g., antibodies, receptors) or nucleic acids (e.g., aptamers)”). Mink and Harley are analogous arts as they are both related to devices used to collect oral samples from a user.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the aptamer from Harley into the device from Mink as the properties of the capturing entities can change the ability of the device to capture different analytes, therefore it allows the device to be more versatile and capture different samples depending on the intended use of the device (Harley, [0120]).
Regarding claim 8, Mink teaches the oral sampling device of claim 7.
However, Mink does not teach wherein the binding molecule is a nucleic acid that hybridizes to the analyte or is a protein binding domain that binds the analyte.
Harley teaches wherein the binding molecule is a nucleic acid that hybridizes to the analyte or is a protein binding domain that binds the analyte ([0133]: “The binding moieties can be any material that selectively binds cells targeted for separation. Materials that selectively bind target cells include, for example, polypeptides (e.g., antibodies, receptors) or nucleic acids (e.g., aptamers)” ; [0134]: “A binding moiety may be any protein that selectively or specifically binds a target of interest. Thus, a binding domain protein may be, for example, a receptor ligand, a ligand receptor or a ligand binding domain thereof (e.g., an extracellular domain (ECD) thereof), an antibody, or antigen-binding fragment thereof, a single-chain antibody, or antigen-binding fragment thereof”).
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the nucleic acid and protein binding domain from Harley into the device from Mink as the properties of the capturing entities can change the ability of the device to capture different analytes, therefore it allows the device to be more versatile and capture different samples depending on the intended use of the device (Harley, [0120]).
Regarding claim 9, the Mink/Harley combination teaches the oral sampling device of claim 8, wherein the protein binding domain comprises an antibody or a binding fragment thereof (Harley, [0135]: “the binding moiety can be an antibody.”).
Regarding claim 10, the Mink/Harley combination teaches the oral sampling device of claim 9, wherein the binding fragment thereof is a single chain variable fragment (scFv) (Harley, [0135]: “he binding moiety can be an antibody. The term "antibody" refers to a polypeptide structure, e.g., an immunoglobulin, conjugate, or fragment thereof that retains antigen binding activity. The term includes but is not limited to polyclonal or monoclonal antibodies of the isotype classes IgA, IgD, IgE, IgG, and IgM, derived from human or other mammalian cells, including natural or genetically modified forms such as humanized, human, single-chain, chimeric, synthetic, recombinant, hybrid, mutated, grafted, and in vitro generated antibodies. The term encompasses conjugates, including but not limited to fusion proteins containing an immunoglobulin moiety (e.g., chimeric or bispecific antibodies or scFv's), and fragments, such as Fab, F(ab')2, Fv, scFv, Fd, dAb and other compositions.”).
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Mink as applied to claim 14 above, and further in view of Van Workum (US 20220143608).
Regarding claim 39, Mink teaches the oral sampling device of claim 14.
However, Mink does not teach 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.
Van Workum discloses a sample management module for collecting a fluid sample. Van Workum teaches 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 ([0055]: “The pad of porous material 24 provides a positive indicator such as a change of one or more colours or a change of transparency, in order to provide visible indication when sample has been collected.”). Mink and Van Workum are analogous arts as they are both related to devices used to collect fluid samples including saliva.
Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to include the color changing aspect from Van Workum as it allows the user to visually see when the sample has been collected, which can be easier for the user to interpret and ensures the sample is fully collected for analysis.
Response to Arguments
Applicant's arguments filed 01/20/2026 have been fully considered but they are not persuasive. Applicant argues that Mink does not teach the recess wherein the length of which extends along a plane parallel to the outer surface or that has a cross-section having at least one sharp corner. However, as stated in the 103 rejection above, the pores are a part of the capillary matrix, therefore they extend along a plane parallel to the outer surface (the exterior surface of the capillary matrix), and therefore Mink teaches on this limitation (Column 16, lines 54-58: “The capillary matrix (W) protrudes out from the housing (H) at the end (14) to provide a planar surface for insertion into the oral cavity where the capillary matrix face (3) can be contacted to the oral mucosa”; Column 5, lines 52-56: “The terms "capillary matrix" or "porous matrix" are used herein to refer to a highly porous material characterized by a pore size sufficiently small that the material rapidly takes up aqueous solution (e.g., of oral fluid) predominantly by capillary action or "wicking"”. The pores of the capillary matrix is the recess. Since the pores are inside the capillary matrix, they extend along a plane parallel to the outer surface of the capillary matrix.).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERIN K MCCORMACK whose telephone number is (703)756-1886. The examiner can normally be reached Mon-Fri 7:30-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Sims can be reached at 5712727540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/E.K.M./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
Prosecution Insights