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 .
Remarks
This Office Action fully acknowledges applicant’s remarks filed 06/30/2026. Claims 1, 4, 6, 7, 10, 14-17, 19, 34-35, 37, 39-42 and 76-78 are pending. (Applicant’s statement of the pending claim in the response filed 06/30/2026 is incorrect) Claims 2, 5 and 44 have been canceled. Claims 1, 4, 6, 10, 13, 15, 19, 35, 39, 40 and 42 have been amended. New claims 76-78 have been added.
Claim Rejections - 35 USC § 103
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claims 1, 4, 6, 7, 10, 14, 15 and 17 are rejected under 35 USC 103 as being unpatentable over Japuntich et al. in view of Stewart et al. and U.S. Patent No. 4,793,343 to Cummins et al.
Japuntich et al. discloses a device for collecting a sample from a subject in the form of a face mask 20 that includes a hollow component (exhalation valve 22) having a first opening 52 that permits entry of particles expelled by a subject into the exhalation valve 22 and an inner surface including filter element 39 for controlling flow of the particles expelled. [0065] A structure connected to the exhalation valve (a filter element 39) limits transmission of particles expelled by the user to the external environment. [0065] Sample collection material (filtering material 27) is housed within the device. [0061].
As for the “removable” structure recited in claim 1, it is noted that applicant discloses that the removable structure is a cap. Note, any structural element is removable in the sense that it can be removed.
Japuntich et al. teaches that filter element 39 can be configured to snap onto and form a tight seal to the valve cover 54 or may be attached in other manners known in the art, but does not specifically teach a structure that could be interpreted as a cap.
Cummins et al. teaches a face mask, that as shown in Fig. 2, includes a filter 48 that is attached to air inlet 24 (hallow structure) by threaded cap 50.
It would have been obvious to one of ordinary skill in the art to modify Japuntich et al. to attach filter element 39 using a threaded cap a taught by Cummins et al. for purposes of removably securing the filter element 39 in place.
Japuntich et al in view of Cummins et al. does not teach that the filter 39 comprises at least one target-binding carrier that binds to a target pathogen.
Stewart et al. teaches a face mask that can include a human pathogen binding substance that captures pathogens, including providing the pathogen binding substance on a removable filter. (column 4, lines 11-24)
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Japuntich et al. in view of Cummins et al. to include a pathogen binding substance on the filter element as taught by Stewart et al. for purposes of collecting pathogens.
I.) Regarding applicant’s claim 1, as noted above Japuntich et al. in view of Cummins et al. and Stewart et al. renders all the limitations of claim 1 obvious.
Therefore, Japuntich et al. in view of Cummins et al. and Stewart et al. renders claim 1 obvious.
II.) Regarding applicant’s claim 4, as noted above Japuntich et al. in view of Cummins et al. and Stewart et al. renders claim 1 obvious from which claim 4 depends.
Claim 4 recites that the he sample collection material comprises a porous material housed on an inner surface of the removable structure such that the porous material collects particles expelled by the subject.
Japuntich et al teaches that: “exhale filter element" means a porous structure through which exhaled air can pass and which is capable of removing contaminants from an exhale flow stream. [0025]
Therefore, Japuntich et al. in view of Cummins et al. and Stewart et al. renders claim 4 obvious.
III.) Regarding applicant’s claim 6, as noted above Japuntich et al. in view of Cummins et al. and Stewart et al. renders claim 4 obvious from which claim 6 depends.
Claim 6 recites that the porous material comprises cotton, polystyrene, polyurethane, polypropylene, or nylon.
Japuntich et al teaches that a preferred exhale filter element comprises a polypropylene spunbonded web. [0072]
Therefore, Japuntich et al. in view of Cummins et al. and Stewart et al. renders claim 6 obvious.
IV.) Regarding applicant’s claim 7, as noted above Japuntich et al. in view of Cummins et al. and Stewart et al. renders claim 1 obvious from which claim 7 depends.
Claim 7 recites that the inner surface of the hollow component comprises a solid material, wherein the solid material comprises plastic, metal, or ceramic.
Japuntich et al. teaches that a number of elements can be made from plastic, including the filtering cover 38, and valve cover. [0064] (claim 18)
It would have been obvious to one of ordinary skill in the art to make the valve in Japuntich et al. in view of Cummins et al. and Stewart et al. of plastic since it has been held that selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination. (MPEP 2144.07)
Therefore, Japuntich et al. in view of Cummins et al. and Stewart et al. renders claim 7 obvious.
V.) Regarding applicant’s claim 10, as noted above Japuntich et al. in view of Cummins et al. and Stewart et al. renders claim 4 obvious from which claim 10 depends.
Claim 10 recites that the porous material permits a portion of air expelled by the subject to exit the device through the porous material.
As noted above, the filter element 39 of Japuntich et al. is porous, which would permit a portion of air expelled by the subject to exit the device through the porous material.
Therefore, Japuntich et al. in view of Cummins et al. and Stewart et al. renders claim 10 obvious.
VI.) Regarding applicant’s claim 14, as noted above Japuntich et al. in view of Cummins et al. and Stewart et al. renders claim 1 obvious from which claim 14 depends.
Claim 14 recites that the removable structure connects to the hollow component such that a portion of air expelled by the subject is able to exit the device.
In Japuntich et al. in view of Cummins et al. and Stewart et al. the structure connected to the exhalation valve (filter element 39) limits transmission of particles expelled by the user to the external environment, but allows a portion of air expelled by the subject to exit the device.
Therefore, Japuntich et al. in view of Cummins et al. and Stewart et al. renders claim 14 obvious.
VII.) Regarding applicant’s claim 15, as noted above Japuntich et al. in view of Cummins et al. and Stewart et al. renders claim 14 obvious from which claim 15 depends.
Claim 15 recites a filter that removes contaminants from the portion of the air exiting the device.
The filter element 39 of Japuntich et al. in view of Cummins et al. and Stewart et al. would remove some contaminants from the portion of the air exiting the device.
Therefore, Japuntich et al. in view of Cummins et al. and Stewart et al. renders claim 15 obvious.
VIII.) Regarding applicant’s claim 17, as noted above Japuntich et al. in view of Cummins et al. and Stewart et al. renders claim 1 obvious from which claim 17 depends.
Claim 17 recites the device of claim 1 and a face mask.
As no above Japuntich et al. in view of Cummins et al. and Stewart et al. renders claim 1 obvious and teaches that the device of claim 1 is incorporated into/onto a face mask.
Therefore, Japuntich et al. in view of Cummins et al. and Stewart et al. renders claim 17 obvious.
2. Claim 16 is rejected under 35 USC 103 as being unpatentable over Japuntich et al. in view of Cummins et al. and Stewart et al. as applied to claim 1, and further in view of Wolf.
I.) Regarding applicant’s claim 16, as noted above Japuntich et al. in view of Cummins et al. and Stewart et al. renders claim 1, from which claim 16 depends.
Claim 16 recites an indicator for determining the amount of sample that has been collected from the subject.
Japuntich et al. in view of Cummins et al. and Stewart et al. does not teach an indicator for determining the amount of sample that has been collected from the subject.
Wolf teaches a sound indicator (whistle) that is used to monitor the time a person provides a breath sample. (column 3, lines 20-30)
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Japuntich et al. in view of Cummins et al. and to include a sound indicator in the valve for purposes of monitoring the time period over which a person exhales through the valve as taught by Wolf for purposes of confirming that a sufficient amount of sample has been passed through the valve and collected by the sample collection material.
Therefore, Japuntich et al. in view of Cummins et al., Stewart et al. and Wolf renders claim 16 obvious.
3. Claim 19 and 34 are rejected under 35 USC 103 as being unpatentable over Japuntich et al. in view of Cummins et al. and Stewart et al.
As noted above, Japuntich et al. discloses a device for collecting a sample from a subject in the form of a face mask 20 that includes a hollow component (exhalation valve 22) having a first opening 52 that permits entry of particles expelled by a subject into the exhalation valve 22 and an inner surface including filter element 39 for controlling flow of the particles expelled. [0065] A structure connected to the exhalation valve (a filter element 39) limits transmission of particles expelled by the user to the external environment. [0065] Sample collection material (filtering material 27) is housed within the device. [0061].
As for the “removable” structure recited in claim 1, it is noted that applicant discloses that the removable structure is a cap.
Japuntich et al. teaches that filter element 39 can be configured to snap onto and form a tight seal to the valve cover 54 or may be attached in other manners known in the art, but does not specifically teach a structure that could be interpreted as a cap.
Cummins et al. teaches a face mask, that as shown in Fig. 2, includes a filter 48 that is attached to air inlet 24 (hallow structure) by threaded cap 50.
It would have been obvious to one of ordinary skill in the art to modify Japuntich et al. to attach filter element 39 using a threaded cap a taught by Cummins et al. for purposes of removably securing the filter element 39 in place.
Japuntich et al in view of Stewart et al. does not teach that the filter 39 comprises at least one target-binding carrier that binds to a target pathogen.
Stewart et al. teaches a face mask that can include a human pathogen binding substance that captures pathogens, including providing the pathogen binding substance on a removable filter. (column 4, lines 11-24)
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Japuntich et al. in view of Cummins et al. to include a pathogen binding substance on the filter element as taught by Stewart et al. for purposes of collecting pathogens.
Japuntich et al. in view of Cummins et al. and Stewart et al. provides a face mask that a subject wears and when breathing the sample collection material (filtering element) or particles captured by the sample collection material would be obtained.
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to obtain the removable structure housing the filtering element in Japuntich et al. in view of Cummins et al. and Stewart et al. to purposes of preserving any collected pathogens for testing for purposes of determining exposure of the subject or others to the pathogens.
Therefore, Japuntich et al. in view of Cummins et al. and Stewart et al. renders claim 19 obvious.
II.) Regarding applicant’s claim 34, as noted above Japuntich et al. in view of Cummins et al. and Stewart et al. renders claim 19 obvious from which claim 34 depends.
Claim 34 recites further comprising detecting one or more pathogens in the sample collection material or the particles captured by the sample collection material.
Japuntich et al. teaches protecting others from being exposed to pathogens expelled by a wearer of the mask; however, Japuntich et al. in view of Cummins et al. and Stewart et al. does not teach detecting one or more pathogens in the sample collection material or the particles captured by the sample collection material. [0002]
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Japuntich et al. in view of Cummins et al. and Stewart et al. to perform analysis on any pathogens in the sample material or particles captured by the sample collection material to determine the presence of any pathogens that others might have been exposed to.
Therefore, Japuntich et al. in view of Cummins et al. and Stewart et al. renders claim 34 obvious.
4. Claims 35, 37, 39, 40, 42 and 76-78 are rejected under 35 USC 103 as being unpatentable over Japuntich et al. in view of Cummins et al. and Stewart et al. as applied to claim 34 above and further in view of Jiang et al.
I.) Regarding applicant’s claim 35, as noted above Japuntich et al. in view of Cummins et al. and Stewart et al. renders claim 34 obvious from which claim 35 depends.
Claim 35 recites that detecting one or more pathogens comprises placing the removable structure housing the sample collection material onto a test vessel containing reagents for detection of the one or more pathogens, and bringing the reagents into contact with the sample collection material.
Japuntich et al. in view of Cummins et al. and Stewart et al. does not teach placing the sample collection material or particles eluted from the sample collection material into a system test vessel containing reagents for detection of the one or more pathogens.
Jiang et al. teaches analysis of pathogens using amplification is achieved via loop-mediated isothermal amplification (LAMP) and associated reagents. [0014].
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Japuntich et al. in view of Cummins et al. and Stewart et al. and conduct analysis of pathogens using amplification is achieved via loop-mediated isothermal amplification (LAMP) and associated reagents as taught by Jiang et al.
Eluting pathogens from the sample collection material in Japuntich et al. in view of Cummins et al. and Stewart et al. and combining the pathogens in reagents in a test vessel would have been an obvious manner to conduct loop-mediated isothermal amplification (LAMP).
Therefore, Japuntich et al. in view of Cummins et al., Stewart et al. and Jiang et al. renders claim 35 obvious.
II.) Regarding applicant’s claim 37, as noted above Japuntich et al. in view of Cummins et al., Stewart et al. and Jiang et al. renders claim 35 obvious from which claim 37 depends.
Claim 36 recites that the reagents for detection of the one or more pathogens comprise reagents for a loop mediated isothermal amplification (LAMP)-based assay.
As noted above, It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Japuntich et al. in view of Cummins et al., and Stewart et al. and conduct analysis of pathogens using amplification is achieved via loop-mediated isothermal amplification (LAMP) and associated reagents as taught by Jiang et al.
Therefore, Japuntich et al. in view of Cummins et al, Stewart et al. and Jiang et al. renders claim 37 obvious.
III.) Regarding applicant’s claim 39, as noted above Japuntich et al. in view of Cummins et al., Stewart et al. and Jiang et al. renders claim 35 obvious from which claim 39 depends.
Claim 39 recites that the reagents comprise primers for detecting a SARS-CoV-2, a coronavirus, a rhinovirus, an influenza virus, a respiratory syncytial virus, an adenovirus, a parainfluenza virus, a human immunodeficiency virus, a human papillomavirus, a rotavirus, a hepatitis B,C or D virus, zika virus, Ebola virus, tuberculosis, borrelia burgdorferi, staphylococcus, aspergillus, or Streptococcus pyogenes.
Jiang et al. teaches analysis and hence reagents for analyzing a number of pathogens recited in claim 39 in paragraph [0044], including staphylococcus, tuberculosis, burgdorferi, etc.
Accordingly, it would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Japuntich et al. in view of Cummins et al, Stewart et al. and Jiang et al. to include reagent primers to detect one or more of the pathogens listed in claim 39.
Therefore, Japuntich et al. in view of Cummins et al. and Stewart et al. and Jiang et al. renders claim 39 obvious.
IV.) Regarding applicant’s claim 40, as noted above Japuntich et al. in view of Cummins et al., Stewart et al. and Jiang et al. renders claim 35 obvious from which claim 40 depends.
Claim 40 recites that the reagents are retained within the test vessel by a temperature-sensitive sealant.
In Japuntich et al. in view of Cummins et al., Stewart et al. and Jiang et al it would have been obvious to seal the test vessel, any such seal would be temperature-sensitive in terms of expanding, contracting, softening, melting, etc.
Therefore, Japuntich et al. in view of Cummins et al., Stewart et al. and Jiang et al. renders claim 40 obvious.
V.) Regarding applicant’s claim 42, as noted above Japuntich et al. in view of Cummins et al., Stewart et al. and Jiang et al. renders claim 40 obvious from which claim 42 depends.
Claim 42 recites that bringing the reagents into contact with the sample collection material comprises inverting the test vessel after placing the removable structure onto the test vessel.
It would have been obvious for one of ordinary skill in the art before applicant’s effective filing date to modify Japuntich et al. in view of Cummins et al., Stewart et al. and Jiang et al. and analyze pathogens using amplification via loop-mediated isothermal amplification (LAMP) and bring the reagents into contact with the sample collection material in a test vessel and invert the test vessel after placing the removable structure onto the test vessel to contact and mix the reagents with the sample collection material.
Therefore, Japuntich et al. in view of Cummins et al., Stewart et al. and Jiang et al. renders claim 42 obvious.
VI.) Regarding applicant’s claim 76, as noted above Japuntich et al. in view of Cummins et al., Stewart et al. and Jiang et al. renders claim 42 obvious from which claim 76 depends.
Claim 76 recites incubating the inverted test vessel at a temperature of 50-70°C for 10-60 minutes.
Japuntich et al. in view of Cummins et al., Stewart et al. and Jiang et al. does not teach incubating the inverted test vessel at a temperature of 50-70°C for 10-60 minutes.
Jiang et al teaches using heating (incubation) and cooling cycles in analyzing pathogens using amplification is achieved via loop-mediated isothermal amplification (LAMP). [0019]
It would have been obvious for one of ordinary skill in the art before applicant’s effective filing date to conduct routine engineering optimization experimentation to determine and use a suitable incubation temperature for analyzing a desired pathogen, including 50-70°C for 10-60 minutes. Inverting the test vessel to achieve mixing before incubating would have been obvious.
Therefore, Japuntich et al. in view of Cummins et al. Stewart et al. and Jiang et al. renders claim 76 obvious.
VII.) Regarding applicant’s claim 77, as noted above Japuntich et al. in view of Cummins et al., Stewart et al. and Jiang et al. renders claim 76 obvious from which claim 77 depends.
Claim 77 recites cooling the test vessel in an upright position and detecting one or more pathogens in the tube.
Japuntich et al. in view of Cummins et al., Stewart et al. and Jiang et al. does not teach cooling the test vessel in an upright position and detecting one or more pathogens in the tube.
As noted above, Jiang et al teaches using heating (incubation) and cooling cycles in analyzing pathogens using amplification is achieved via loop-mediated isothermal amplification (LAMP). [0019]
It would have been obvious for one of ordinary skill in the art before applicant’s effective filing date to modify Japuntich et al. in view of Cummins et al., Stewart et al. and Jiang et al. and conduct routine engineering optimization experimentation to determine and use a suitable temperature for cooling the test vessel. Up righting the test vessel during cooling would have been obvious once the incubation period is over.
Therefore, Japuntich et al. in view of Cummins et al., Stewart et al. and Jiang et al. renders claim 77 obvious.
VI.) Regarding applicant’s claim 78, as noted above Japuntich et al. in view of Cummins et al., Stewart et al. and Jiang et al. renders claim 77 obvious from which claim 78 depends.
Claim 78 recites cooling the test vessel at a temperature of 0°C-10°C for 1-10 minutes.
Japuntich et al. in view of Cummins et al., Stewart et al. and Jiang et al. does not teach cooling the test vessel at a temperature of 0°C-10°C for 1-10 minutes.
It would have been obvious for one of ordinary skill in the art before applicant’s effective filing date to modify Japuntich et al. in view of Cummins et al., Stewart et al. and Jiang et al. and conduct routine engineering optimization experimentation to determine and use a suitable temperature for cooling the test vessel for analyzing a desired pathogen, including 0-10°C for 1-10 minutes. Up righting the test vessel during cooling would have been obvious once the incubation period is over.
Therefore, Japuntich et al. in view of Cummins et al., Stewart et al. and Jiang et al. renders claim 78 obvious.
5. Claim 41 stands rejected under 35 USC 103 as being unpatentable over Japuntich et al. in view of Cummins et al., Stewart et al. and Jiang et al. as applied to claim 35 above and further in view of Mitani et al.
I.) Regarding applicant’s claim 41, as noted above Japuntich et al. in view of Cummins et al., Stewart et al. and Jiang et al. renders claim 35 obvious from which claim 41 depends.
Claim 41 recites that the temperature-sensitive seal comprises wax or oil.
Japuntich et al. in view of Cummins et al. Stewart et al. and Jiang et al. does not teach a seal comprising wax or oil.
Mitani et al. teaches using wax to seal reagents in isothermal amplification analysis [0048], [0063]-[0064].
It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Japuntich et al. in view of Cummins et al. Stewart et al. and Jiang et al. to use a wax seal in the test vessel in view of Mitani et al. teaching using wax seals in in isothermal amplification analysis.
Therefore, Japuntich et al. in view of Cummins et al., Stewart et al, Jiang et al. and Mitani et al. renders claim 41 obvious.
Response to Arguments
Applicant’s arguments with respect to claims 1, 4, 6, 7, 10, 14-17, 19, 34, 35, 37, 39-42 and 76-78 have been considered but are moot because the new ground of rejection which relies upon Cummins et al. as teaching a removable structure that holds a sample collecting material, as necessitated by applicant’s amendments to the claims.
On page 9 of applicant’s response filed 06/30/2026 applicant argues that Japuntich et al. does not teach a component that binds target pathogens and that Stewart et al. does not teach a hollow component comprising a first opening and an inner surface that controls flow of expelled particles, wherein a removable structure containing the sample collection material containing a target-binding carrier.
On page 11 of applicant’s response applicant argues that Japuntich et al. does not disclose or suggest placing the removable structure housing the sample collection material onto a test vessel containing reagents for detection of the one or more pathogens, and bringing the reagents into contact with the sample collection material as recited in claim 35. Indeed, Japuntich does not disclose or suggest any removable structure housing a porous material containing moieties for capture of pathogen.
One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. (MPEP 2145(IV))
On page 11 of applicant’s response applicant argues Jiang et al. does not compensate for the deficiencies of Japuntich et al., as Jiang is not related to devices containing any component that captures a pathogen.
As noted above, Japuntich et al. teaches protecting others from being exposed to pathogens expelled by a wearer of the mask. This recognition of pathogens supports and renders it obvious to modify Japuntich et al. in view of Cummins et al. to include a pathogen binding substance on the filter element as taught by Stewart et al. for purposes of collecting pathogens.
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.
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/M.S.G./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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