DETAILED ACTION
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 04/08/2026 has been entered.
Examiner’s Comment Regarding Current Claim Status
An examiner’s amendment was entered on 01/30/2026. An examiner’s amendment is considered “entered” when it is signed by the primary examiner and processed into the application file by technical support staff. Because the RCE did not contain an amendment to the claims, the claims under examination are the claims after the examiner’s amendment. If claim amendments are made in the response to the instant Office action, they should apply markup to the claims after the examiner’s amendment (i.e., as they are presented in the instant Office action).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/08/2026 is being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
the last paragraph of page 4 is improperly numbered;
in [0036], “heptangular” should read “heptagonal”;
in [0024] it recites that FIG. 12 is a photograph, however FIG. 12 is not a photograph;
in [0027] “plating mechanism” should read “pleating mechanism”;
in [0053] “Ridges 136” should read “Ridges 914”; and
in [0054] “recessed 916” should read “recesses 916”.
Appropriate correction is required.
Claim Objections
Claims 12-13 and 27-28 are objected to because of the following informalities:
Regarding claim 12, lines 1-2 (and claim 13 by dependency): “where in” should read “wherein”.
Regarding claim 27: “heptangular” should read “heptagonal”.
Regarding claim 28: the first instance of “porous sample collection media” should be preceded with “a” and all subsequent instances preceded with “an”; “the post and fingers also engaging” should read “the one or more posts and fingers also engaging”; the “and” at the end of the “a porous sample collection media” clause should be deleted as there is already an “and” at the end of the following clause; the last clause should be corrected as it recites “a sample testing portion” which is already recited earlier in the claim and should read “the sample testing portion.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-10, 12, 16, and 18-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claims 9-10 and 12 (and claim 13 by dependency): “the assay” lacks antecedent basis. For the purposes of examination and in light of the specification, each of these claims is interpreted as depending upon claim 2.
Regarding claims 16 and 18-19: each of these claims recite “[t]he method of claim 1”; however, claim 1 is a device claim, not a method claim. Further, claims 18-19 contain terms that lack antecedent basis if dependent upon claim 1. For the purposes of examination and in light of the specification, each of these claims is interpreted as depending upon claim 14.
Regarding claim 18: “the test fluid” lacks antecedent basis (even if claim 18 were dependent upon claim 14).
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 of this title, 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 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Maksym et al. (US 20130133663 A1, prior art of record via 01/05/2024 IDS) in view of Santamarina (EP 2745776 B1, prior art of record via 04/08/2026 IDS).Regarding claim 1:Maksym teaches (FIGS. 1-5) a sample collection device comprising:
a housing (12) extending from a first portion (16) to a second portion (18), the housing defining a fluid channel from the first portion to the second portion, wherein the first portion is configured to receive an exhalation airflow ([0022]-[0023]) and the second portion is configured to be an air outlet portion; a porous sample collection media comprising nonwoven filtration material (14; [0037]); and a fluid inlet port through which fluid may be introduced into the housing such that the fluid is incident on the porous sample collection media(FIG. 3 - mouthpiece 16 has an opening at a first end 20 through which air flow into the housing and through the filter. Under the broadest reasonable interpretation, consistent with [0027] of the instant specification, the opening receiving the exhalation may also be used as the fluid inlet port.)Maksym fails to teach:
the porous sample collection media having a frustoconical shape and disposed within the fluid channelSantamarina teaches:
the porous sample collection media having a frustoconical shape and disposed within the fluid channel(e.g., [0061] - “core 43 is shaped mating with the shape of the filtering element 14 to be obtained, in this case having a substantially truncated cone shape”)
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a frustoconical shape, as taught by Santamarina, instead of the purely conical shape of Maksym as they are art-recognized equivalent geometries for such filter elements. Further, within the same amount of volume, a frustoconical shape has more surface area, reducing flow resistance.
Regarding claim 6:Maksym and Santamarina all the limitations of claim 1, as mentioned above.Maksym also teaches:
wherein the porous sample collection media comprising nonwoven material has an electrostatic charge (e.g., [0037])
Claims 2-3, 9-10, 14, 16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Maksym et al. (US 20130133663 A1, prior art of record via 01/05/2024 IDS) in view of Santamarina (EP 2745776 B1, prior art of record via 04/08/2026 IDS) and further in view of Heanue et al. (US 20200245898 A1, prior art of record via 01/05/2024 IDS).Regarding claim 2:Maksym and Santamarina all the limitations of claim 1, as mentioned above.Maksym fails to teach:
a sample testing device comprising an assay attached to the sample collection device such that the assay and porous sample collection media are adjacent to or in direct contact with one anotherHeanue teaches:
a sample testing device comprising an assay attached to the sample collection device such that the assay and collection media are adjacent to or in direct contact with one another(FIGS. 3-5 and 7; [0031], [0036]-[0038], [0041])
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a sample testing device comprising an assay with the testing device in contact with the breath collector, as taught by Heanue, in the device of Maksym to allow for complex breath analysis.
Regarding claim 3:Maksym, Santamarina, and Heanue teach all the limitations of claim 2, as mentioned above.As combined in the claim 2 rejection above, Maksym, Santamarina, and Heanue teach or render obvious:
wherein the sample collection device and the sample testing device are attachable to and/or detachable from one another by at least one of snapping, sliding, screwing, clipping, or rotation
As taught by Heanue, the sample collection device and sample testing device may be attached and detached. The recitation of “at least one of snapping, sliding, screwing, clipping, or rotation” covers most ways of attachment in this scenario. Further, Heanue teaches using a solvent wash to move the sample from the breath collector to the sample testing device. The examiner takes Official notice that connection of such components by at least one of snapping, sliding, screwing, clipping, or rotation is well-known in the art.
Regarding claim 9, as best understood (see 112b rejection above):Maksym, Santamarina, and Heanue teach all the limitations of claim 2, as mentioned above.As combined in the claim 2 rejection above, Heanue teaches:
wherein the assay is capable of detecting virus or pathogen presence in the exhalation airflow and/or an eluent ([0023])
Alternatively, the examiner takes Official notice that it is well-known to use assay devices such as that of Heanue to detect viruses or pathogens.
Regarding claim 10, as best understood (see 112b rejection above):Maksym, Santamarina, and Heanue teach all the limitations of claim 2, as mentioned above.As combined in the claim 2 rejection above, Heanue teaches:
wherein the assay is a lateral flow assay or a vertical flow assay(FIGS. 3-5 and 7)
Regarding claim 14:Maksym teaches (FIGS. 1-5) a method comprising:
exhaling into a sample collection device comprising: a housing (12) having a fluid channel; a porous sample collection media (14; [0037]) disposed within the fluid channel, the porous sample collection media comprising nonwoven filtration material,
wherein the exhalation airflow flows through the porous sample collection media such that the exhalation airflow is incident upon the porous sample collection media and forms a loaded porous sample collection media (e.g., [0037]);
Maksym fails to teach:
the method is for testing an exhalation airflow for the presence or absence of a virus or pathogen
the porous sample collection media is frustoconical-shaped
placing a liquid in contact with the loaded porous sample media such that the liquid contacts and passes through the loaded porous sample media to form an eluent that is incident upon an assay; and
testing the eluent, by the assay, for presence of a virus or pathogen in the eluentSantamarina teaches:
the porous sample collection media is frustoconical-shaped (e.g., [0061] - “core 43 is shaped mating with the shape of the filtering element 14 to be obtained, in this case having a substantially truncated cone shape”) Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a frustoconical shape, as taught by Santamarina, instead of the purely conical shape of Maksym as they are art-recognized equivalent geometries for such filter elements. Further, within the same amount of volume, a frustoconical shape has more surface area, reducing flow resistance.Heanue teaches:
the method is for testing an exhalation airflow for the presence or absence of analytes, disease, target chemicals, etc.; placing a liquid in contact with the loaded porous sample media such that the liquid contacts and passes through the loaded porous sample media to form an eluent that is incident upon an assay; and testing the eluent, by the assay, for presence of analytes, disease, target chemicals, etc. in the eluent(FIGS. 3-5 and 7; [0023], [0031], [0036]-[0038], [0041])
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to test the breath by placing liquid in contact with the sample media to contact it and pass therethrough to form an eluent incident upon an assay, as taught by Heanue, in the device of Maksym to allow for complex breath analysis.
Regarding “a virus or pathogen”: the examiner takes Official notice that it is well-known to use assay devices such as that of Heanue to detect viruses or pathogens.
Regarding claim 16, as best understood (see 112b rejection above):Maksym, Santamarina, and Heanue teach all the limitations of claim 14, as mentioned above.Maksym also teaches:
wherein the porous sample collection media comprising nonwoven filtration material has an electrostatic charge (e.g., [0037])
Regarding claim 18, as best understood (see 112b rejection above):Maksym, Santamarina, and Heanue teach all the limitations of claim 14, as mentioned above.As combined in the claim 14 rejection above Heanue teaches:
wherein the test fluid is at least one of an aqueous fluid (e.g., [0038]-[0040]), an aqueous buffer solution, an aqueous fluid including a surfactant, a saline solution, or a saline solution including a surfactant
Regarding claim 19, as best understood (see 112b rejection above):Maksym, Santamarina, and Heanue teach all the limitations of claim 14, as mentioned above.As combined in the claim 14 rejection above Heanue teaches:
wherein the assay is a lateral flow assay or a vertical flow assay(FIGS. 3-5 and 7)
Claims 20-21, 23, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Maksym et al. (US 20130133663 A1, prior art of record via 01/05/2024 IDS) in view of Santamarina (EP 2745776 B1, prior art of record via 04/08/2026 IDS) and further in view of Yoshida (EP 3351171 A1, prior art of record via 10/07/2025 IDS).Regarding claim 20:Maksym teaches (FIGS. 1-5) a method of forming a sample collection device, comprising:
attaching a first portion (16) and a second portion (18) of a sample collection device to one another,
the first portion (16) comprising a fluid inlet portion and fluid channel through which fluid may flow(FIG. 3 - mouthpiece 16 has an opening at a first end 20 through which air flow into the housing and through the filter. Under the broadest reasonable interpretation, consistent with [0027] of the instant specification, the opening receiving the exhalation may also be used as the fluid inlet port.);
the second portion (18) comprising a media receptacle comprising a sample media holder (18 holds the sample media 14 via 36s and 46) and a porous sample collection media (15) adjacent to the sample media holder;
wherein the porous sample collection media comprises nonwoven filtration material (e.g., [0037])Maksym fails to teach:
wherein attaching the first portion and second portion to one another causes the porous sample collection media to change from a two-dimensional, flat shape or structure to a three-dimensional shape or structure,
the porous sample collection media having a frustoconical shapeSantamarina teaches:
the porous sample collection media having a frustoconical shape (e.g., [0061] - “core 43 is shaped mating with the shape of the filtering element 14 to be obtained, in this case having a substantially truncated cone shape”)
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a frustoconical shape, as taught by Santamarina, instead of the purely conical shape of Maksym as they are art-recognized equivalent geometries for such filter elements. Further, within the same amount of volume, a frustoconical shape has more surface area, reducing flow resistance.Yoshida teaches:
wherein attaching the first portion and second portion to one another causes the porous sample collection media to change from a two-dimensional, flat shape or structure to a three-dimensional shape or structure (FIG. 3 -> FIG. 4 -> FIG. 1)
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the attachment of the first and second portions to cause the porous sample collection media to change from a two-dimensional, flat shape to a three-dimensional shape, as taught by Yoshida, in the method of Maksym, to improve ease of assembly and simplicity of design.
Regarding claim 21:Maksym, Santamarina, and Yoshida teach all the limitations of claim 20, as mentioned above.As combined in the claim 20 rejection above, Yoshida teaches:
wherein the three-dimensional shape or structure created by the inverse of the shape or structure is provided by at least one of the media receptacle (FIG. 4 - 4 / 2), post(s), and/or fingers or contact elements
Regarding claim 23:Maksym, Santamarina, and Yoshida teach all the limitations of claim 20, as mentioned above.Maksym also teaches:
wherein the porous sample collection media comprises a nonwoven material having an electrostatic charge (e.g., [0037])
Regarding claim 27:Maksym, Santamarina, and Yoshida teach all the limitations of claim 20, as mentioned above.As combined in the claim 20 rejection above, Yoshida teaches:
wherein the two-dimensional porous sample collection media has a shape of at least one of circular, oval, elliptical, square, rectangular, triangular, trapezoidal, pentagonal, hexagonal, heptangular, or octagonal(FIG. 3; also see [0057]-[0062] of Santamarina)
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Maksym et al. (US 20130133663 A1, prior art of record via 01/05/2024 IDS) in view of Santamarina (EP 2745776 B1, prior art of record via 04/08/2026 IDS) in view of Yoshida (EP 3351171 A1, prior art of record via 10/07/2025 IDS) and further in view of Heanue et al. (US 20200245898 A1, prior art of record via 01/05/2024 IDS).Regarding claim 26:Maksym, Santamarina, and Yoshida teach all the limitations of claim 20, as mentioned above.Maksym fails to teach:
attaching the sample collection device to a lateral flow assay or a vertical flow assayHeanue teaches:
attaching the sample collection device to a lateral flow assay or a vertical flow assay(FIGS. 3-5 and 7; [0031], [0036]-[0038], [0041])
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to attach the sample collector to an assay, as taught by Heanue, in the method of Maksym to allow for complex breath analysis.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Maksym et al. (US 20130133663 A1, prior art of record via 01/05/2024 IDS) in view of Santamarina (EP 2745776 B1, prior art of record via 04/08/2026 IDS) and further in view of Rajagopal et al. (US 20180051313 A1)Regarding claim 30:Maksym and Santamarina teach all the limitations of claim 1, as mentioned above.Maksym fail to teach:
wherein the sample collection media is pleatedRajagopal teaches:
wherein the sample collection media is pleated ([0185])
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to pleat the sample collection media, as taught by Rajagopal, in the device of Maksym to increase surface area.
Allowable Subject Matter
Claims 12-13 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim 28 would be allowable if rewritten or amended to overcome the objections set forth in this Office action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Herbert Keith Roberts whose telephone number is (571)270-0428. The examiner can normally be reached 10a - 6p MT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Macchiarolo can be reached at (571) 272-2375. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HERBERT K ROBERTS/Primary Examiner, Art Unit 2855
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