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. Drawings Applicant’s drawings are objected to because the lack of reference numbers in the drawings (and specification) leaves it unclea r as to which drawing features correspond to elements of the invention that are described in the specification. For example, the Brief Summary notes that in some embodiments the structure connected to the hollow component comprises a cap. Figure 1C identifies “cotton insert” and the specification notes that the material insert housed on an inner surface of the structure connected to the hollow component . It is unclear what structures are the cap and the hollow structure is in the drawings. All the claimed elements of the invention need to be show n and identified in the drawing figures. Claim Objections Claim 6 depends on canceled claim 3. For examination purposes claim 6 will be examined as depending on claim 4 which supports the material insert recited in claim 6 . Claim 10 depends on canceled claim 3. For examination purposes claim 10 will be examined as depending on claim 4 which supports the porous material recited in claim 10 . Claim 39 depends from canceled claim 36. For examination purposes claim 39 will be examined as depending on claim 37 which supports the reagents recited in claim 39 . Claim 40 depends from canceled claim 36. For examination purposes claim 4 0 will be examined as depending on claim 37 which supports the reagents recited in claim 40 . 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 appl icant regards as his invention. Claim 15 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 15 recites “the portion of air exiting the device” in line 2. There is insufficient antecedent basis for this limitation in the claim. 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. (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. 1. Claim s 1, 2, 4, 6, 7, 10, 14, 15, 17 and 19 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by U.S. Patent Application Publication No. 2002/0023651 to Japuntich et al. (cited by applicant) 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 (f iltering material 27 ) is housed within the device. [0061] I.) Regarding applicant’s claim 1, as noted above Japuntich et al. teaches all the elements of claim 1. Therefore, Japuntich et al anticipates claim 1. II.) Regarding appl icant’s claim 2, as noted above Japuntich et al . anticipates claim 1 from which claim 2 depends. Claim 2 recites that the structure connected to the hollow component is removable. Japuntich et al. teaches that the filter element 39 is removable and replaceable. [0065] Therefore, Japuntich et al. anticipates claim 2. III.) Regarding applicant’s claim 4 , as noted above Japuntich et al. anticipates claim 1 from which claim 4 depends. Claim 4 recites in one alterative that the sample collection material comprises a material insert placed within the hollow component of the device, wherein the material insert comprises a porous material . The filter element 39 of Japuntich et al. is removable and replaceable and porous. Therefore , Japuntich et al. anticipates claim 4. IV.) Regarding applicant’s claim 6 , as noted above Japuntich et al. anticipates claim 4 from which claim 6 depends. Claim 6 recites that material insert 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. anticipates claim 6. V.) Regarding applicant’s claim 7 , as noted above Japuntich et al. anticipates claim 1 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 t he exhalation valves that were used are described in U.S. Pat. No. 5,325,892 to Japuntich et al. [0082] U.S. Pat. No. 5,325,892 teaches that Valve seat 26 preferably is made from a relatively light-weight plastic that is molded into an integral one-piece body. (column 7, lines 24-26) Therefore, Japuntich et al, anticipates claim 7. VI.) Regarding applicant’s claim 10 , as noted above Japuntich et al. anticipates claim 4 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. The filter element 39 of Japuntich et al. is porous and would permit a portion of air expelled by the subject to exit the device through the porous material. Therefore, Japuntich et al. anticipates claim 10. VII.) Regarding applicant’s claim 14 , as noted above Japuntich et al. anticipates claim 1 from which claim 14 depends. Claim 14 recites that the structure connects to the hollow component such that a portion of air expelled by the subject is able to exit the device. In Japu n tich et al. the structure connected to the exhalation valve (a 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. anticipates claim 14. VIII.) Regarding applicant’s claim 15 , as noted above Japuntich et al. anticipates claim 7 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. would remove some contaminant s from the portion of the air exiting the device. Therefore, Japuntich et al. anticipates claim 15. IX.) Regarding applicant’s claim 17 , claim 17 recites a system comprising the device of claim 1 and a face mask. As no above Japuntich et al. anticipates claim 1 and teaches that the device of claim 1 is incorporated into/onto a face mask. Therefore, Japuntich et al. anticipates claim 17 X.) Regarding applicant’s claim 19 , claim 19 recites a method of collecting a sample from a subject, comprising: providing to the subject the device of claim 1 and obtaining the sample collection material or particles captured by the sample collection material from the device. As noted above, Japuntich et al. teaches that the device of claim 1 is incorporated into/onto a face mask that a subject wears and when breathing the s ample collection material (filtering material 27) or particles captured by the sample collection material would be obtained. Therefore, Japuntich et al. anticipates claim 19 . 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. 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. 2. Claim 5 is rejected under 35 USC 103 as being unpatentable over Japuntich et al. as applied to claim 1 and further in view of U.S. Patent No. 8 , 678 , 002 to Stewart et al. I.) Regarding applicants claim 5, as noted above Japun ti ch et al, anticipates claim 1 from which claim 5 depends. Claim 5 recites that the sample collection material comprises at least one target-binding carrier that binds to a target pathogen, if present in the particles expelled by the subject. Japuntich et al does not teach that the sample collection material comprises at least one target-binding carrier that binds to a target pathogen, if present in the particles expelled by the subject. 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 Japun ti ch et al. to include a pathogen binding substance on the removable filter as taught by Stewart et al. for purposes of collecting pathogens. Therefore, Japun ti ch et al. in view of Stewart et al. renders claim 5 obvious, 3. Claim 16 is rejected under 35 USC 103 as being unpatentable over Japun ti ch et al. in view of U.S. Patent No. 4,744,953 to Wolf. I.) Regarding applicant’s claim 16, as noted above Japun ti ch et al. anticipates 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. Japun ti ch 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 Japun ti ch et al. to include a sound indicator in the valve for purposes of monitor 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, Japun ti ch et al. in view of Wolf renders claim 16 obvious. 4. Claim 34 stan ds rejected under 35 USC 103 as being unpatentable over Japun ti ch et al. I.) Regarding applicant’s claim 3 4 , as noted above Japuntich et al, anticipates claim 19 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. Japun ti ch et al. teaches protecting others from being exposed to pathogens expelled by a wearer of the mask, but 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 Japun ti ch 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, Japun ti ch et al. renders claim 34 obvious. 5 . Claims 35 , 37, 39, 40, 42 and 44 are rejected under 35 USC 103 as being unpatentable over Japun ti ch et al. as applied to claim 34 above and further in view of U.S. Patent Application Publication No. 2019/0105653 to Jiang et al. I.) Regarding applicant’s claim 35, as noted above It would have been obvious to one of ordinary skill in the art before applicant’s effective filing date to modify Japun ti ch 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. Claim 35 recites 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. Japun ti ch 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 Japun ti ch 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 Japun ti ch 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, Japun ti ch et al. in view of Jiang et al. renders claim 35 obvious. II.) Regarding applicant’s claim 3 7 , as noted above Japun ti ch et al. in view of Jiang et al. renders claim 35 obvious from which claim 3 7 depends. Claim 36 recites that t he 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 Japun ti ch 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, Japun ti ch et al. in view of Jiang et al. renders claim 37 obvious. III.) Regarding applicant’s claim 3 9 , as noted above Japun ti ch et al. in view of Jiang et al. renders claim 3 7 obvious from which claim 3 9 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 Japun ti ch et al. in view of Jiang et al. to include reagent primers to detect one or more of the pathogens listed in claim 39. Therefore, Japun ti ch et al. in view of Jiang et al. renders claim 39 obvious. IV.) Regarding applicant’s claim 40 , as noted above Japun ti ch et al. in view of Jiang et al. renders claim 3 7 obvious from which claim 40 depends. Claim 40 recites that the reagents are retained within the test vessel by a temperature-sensitive sealant. In Japun ti ch et al. in view of 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, Japun ti ch et al. in view of Jiang et al. renders claim 40 obvious. V.) Regarding applicant’s claim 4 2 , as noted above Japun ti ch et al. in view of Jiang et al. renders claim 40 obvious from which claim 4 2 depends. Claim 42 recites inverting the test vessel after placing the sample collection material or particles eluted from the sample collection material into the test vessel, and 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 would have been obvious. Therefore, Japun ti ch et al. in view of J ia ng et al. renders claim 42 obvious. VI.) Regarding applicant’s claim 44 , as noted above Japun ti ch et al. in view of Jiang et al. renders claim 42 obvious from which claim 44 depends. Claim 44 recites cooling the test vessel in an upright position and detecting one or more pathogens in the tube, optionally wherein the test vessel is cooled at a temperature of 0 ° C-10 ° C for 1-10 minutes. 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 conduct routine engineering optimization experimentation to determine and use a suitable temperature for cooling the test vessel for analyzing a desired pathogen, including 0 - 1 0°C for 1 -10 minutes. Up righting the test vessel to during cooling would have been obvious. Therefore, Japun ti ch et al. in view of Ji a ng et al. renders claim 4 4 obvious. 6. Claim 41 is rejected under 35 USC 103 in view of Japun ti ch et al. in view of Jiang et al. as applied to claim 40 above and further in view of U.S. Patent Application Publication No 2006/0194207 to Mitani et al. I.) Regarding applicant’s claim 41, as noted above Japun ti ch et al. in view of Jiang et al. renders claim 40 obvious from which claim 41 depends. Claim 41 recites that the temperature-sensitive seal comprises wax or oil. Japun ti ch et al. in view if Jiang et al. does not teach a seal comprising wax or oil. Mitani et al. teaches using wax to seal reagent s 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 Japun ti ch et al. in view of 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 Jiang et al. and Mitani et al. renders claim 41 obvious. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT MICHAEL S. GZYBOWSKI whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-3487 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8:30-5:00 . 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, Charles Capozzi can be reached at 571-270-3638. 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. /MICHAEL STANLEY GZYBOWSKI/ Examiner, Art Unit 1798