DETAILED ACTION 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. Election/Restriction REQUIREMENT FOR UNITY OF INVENTION As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art. The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e). When Claims Are Directed to Multiple Categories of Inventions: As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories: (1) A product and a process specially adapted for the manufacture of said product; or (2) A product and a process of use of said product; or (3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or (4) A process and an apparatus or means specifically designed for carrying out the said process; or (5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process. Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c). Restriction is required under 35 U.S.C. 121 and 372. This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1. In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted. Group I, claim(s) 1 , 6, 8, 9, 11-14 and 17 , drawn to a microfluidic diagnostic device . Group II, claim(s) 39 , 44, 47-49, 51-54, 56 and 57 , drawn to a system for testing a biological sample . The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons: Groups I-II lack unity of invention because even though the inventions of these groups require the technical feature of a microfluidic device comprising: a sample collector containing a biological sample to be tested; an adaptor; an interface channel containing a reaction mixture; and a membrane separating said interface channel and a microfluidic testing device , this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Pais et al. (US 2018/0372595 A1) , as noted in the International Search Report and the Written Opinion of the International Searching Authority, filed 11/06/2023 . Accordingly, these groups lack a common special technical feature that makes a contribution over the cited prior art and therefore lack unity of invention. During a telephone conversation with Patent Practitioner David S. Kerr on 03/30/2026 a provisional election was made without traverse to prosecute the invention of Group I , claim s 1, 6, 8, 9, 11-14 and 17 . Affirmation of this election must be made by applicant in replying to this Office action. Claim s 39, 44, 47-49, 51-54, 56 and 57 have been withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention. Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i). Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “ configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: wherein said membrane is configured to be perforated after depression of said adaptor thereby allowing pressurized fluid communication between said reaction mixture and said microfluidic testing device in claim 1 ; and wherein said cap comprises a foil cap configured to be removed or punctured by said sample collector in claim 14. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. 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. Claim s 1, 6, 8, 9, 11-14 and 17 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 1, 11 are not clear with respect to what the applicant is claiming. The claims do not clearly set forth the metes and bounds of the patent protection desired. Claim 1 is unclear reciting “wherein said adaptor is inserted into said interface channel forming a seal and introducing said biological sample to said reaction mixture; [...] wherein said membrane is configured to be perforated after depression of said adaptor thereby allowing pressurized fluid communication between said reaction mixture and said microfluidic testing device” because the recitation appears to be a descriptive statement defining the result to be achieved using the device. It is unclear whether the applicant is trying to claim a device or a method of using of the device. Further, it is unclear what structural configuration of the membrane is being claimed. For this reason, dependent claims relating to the above limitations are also unclear. Claim 12 recites the limitation "the internal aperture" in L2 /L3 . There is insufficient antecedent basis for this limitation in the claim. Claim 13 recites the limitation "the external aperture" in L2 . 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. 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. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claim(s) 1, 6, 8, 9, 11-14 and 17 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Pais et al. (US 2018/0372595 A1). Regarding claim 1, Pais et al. teach : 1. A microfluidic diagnostic device (Abstract + ) comprising: a sample collector (e.g., swab tip 105, Fig. 1, ¶ 0045) containing a biological sample to be tested (i.e., sample is present on the swab tip 105, Fig. 1, ¶ 0045); an adaptor (e.g., lid 102 coupled to shaft 103, Fig. 1, ¶ 0045) having: a coupler securing said sample collector (i.e., lid 102 is attached to shaft 103 which is secured to swab tip 105. Fig. 1); a seal (e.g., O -ring 104, Fig. 1, ¶ 0045); an interface channel (i.e., channel of sample extraction container 106, Fig. 1, ¶ 0045) containing a reaction mixture (i.e., container 106 contains liquid medium to elute the sample into, Fig. 1, ¶ 0045); wherein said adaptor is inserted into said interface channel (i.e., shaft 103 is inserted into extraction container 106, Fig. 2, Step 1, ¶ 0046) forming a seal (i.e., form an airtight seal between swab shaft and container, Fig. 2, Step 3, ¶ 0046) and introducing said biological sample to said reaction mixture (i.e., swab is pushed down through the squeezing structure into the solution contained at the bottom of the sample extraction container, Fig. 2, Step 1, ¶ 0046); and a membrane separating said interface channel and a microfluidic testing device (i.e., bottom of the sample extraction container is sealed with a frangible or pierceable seal material 109 and allows it to be connected to a fluidic unit such as a microfluidic cartridge, Fig. 1, ¶ 0045), wherein said membrane is capable of being perforated after depression of said adaptor (i.e., the sample extraction device is then connected to an inlet on the microfluidic device 202 through a fitting 203 on the microfluidic device, Fig. 2, Step 5, ¶ 0046; the twisting or pressing forces applied when connecting the sample extraction container to the fitting on the microfluidic device can rupture the frangible material sealing it, ¶ 0048). With regard to limitations in claims 1, 11 (e.g., [...] to be perforated after depression of said adaptor thereby allowing pressurized fluid communication between said reaction mixture and said microfluidic testing device , etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex , 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham , 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley , 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb , Inc. , 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault , 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young , 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto , 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115). Regarding claim s 6, 8, 9 , 12-14, 17 , Pais et al. teach : 6. The device of claim 1, wherein said adaptor and said sample collector comprise a single integral component (see Fig. 1). 8. The device of claim 1, wherein said seal comprises an O-ring seal, or an integral extension ( e.g., O-ring 104, Fig. 1, ¶ 0045). 9. The device of claim 8, further comprising one or more catch positions configured to mate with said seal ( i.e., void within lid 102 to mate with O-ring 104, Fig. 1, ¶ 0045). 12. The device of claim 1, further comprising a filter positioned between said membrane and an internal aperture of said interface channel, or positioned between said membrane and said internal aperture of said interface channel ( i.e., a filter, semipermeable or porous membrane may be present on the microfluidic device, ¶ 0048). 13. The device of claim 1, further comprising a cap secured to an external aperture of said interface channel ( i.e., top frangible seal 111 secured to channel of container 106, Fig. 1, ¶ 0045). 14. The device of claim 13, wherein said cap comprises a foil cap ( i.e., frangible seal includes aluminum foils, ¶ 0063) configured to be removed or punctured by said sample collector ( i.e., frangible seal may be ruptured by the swab, ¶ 0045). 17. The device of claim 1, further comprising a biological sample loader comprising: a cap holder (i.e., screw top of container 106 for coupling to screw top lid 102; see also shaft 103, Fig. 1); a joint (i.e., joint of the fitting connector 402 such as a luer, screw, press or snap fitting); and one or more fasteners (e.g., fitting connector 402 such as a luer, screw, press or snap fitting). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT DEAN KWAK whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-7072 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-TH, 4:30 am - 2:30 pm EST . 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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. /DEAN KWAK/ Primary Examiner, Art Unit 1798 FILLIN "Examiner Stamp" \* MERGEFORMAT DEAN KWAK Primary Examiner Art Unit 1798