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. Specification The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification. Claim Interpretation Content of Specification (k) CLAIM OR CLAIMS : See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p). The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”. A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus. It is noted that the apparatus claims, for example claim 1 and further dependent claims mention an immunochromatographic assay apparatus (only defined as a broad, vague “internal mechanism”) , a sample, a first reagent, external force, a second reagent, internal mechanism, user, member of the internal mechanism, and finger of the user. However, none of such are positively claimed as structural elements of the apparatus/cartridge. All of such are articles and/or materials that are intended to be/can be worked upon by or with the cartridge. It is noted that no force is structure nor is any structure nor user that can apply any force are positively claimed as structures of the cartridge. The claims are directed to an apparatus defined by the positively structural elements listed in the claims, not a process of use. There is no requirement for of any spotting, color changing /developing/amplifying , supplying, applying/exerting of any force by anything/anyone, force suppressing, pressing , deforming, displacing , reacting of anything, nor any other actions/process steps to ever be performed. It is noted that the term “or” is directed to alternative options, not requirements. 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. Claims 1-13 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. As to claim 1, it is unclear if applicant intends for the invention to comprise a cartridge and an immunochromatographic assay apparatus . However as presently drafted, an immunochromatographic assay apparatus is not positively claimed as an element of the invention. See Claim Interpretations. The invention of claim 1 is directed to a cartridge. It is unclear if the cartridge is intended to comprise a sample spotted on the carrier, a first reagent, and a second reagent because the phrases such as “is spotted….” and “that holds…” are directed to what can be done rather that what the carrier and first and second reagent holding parts actually comprise. See Claim interpretations. Although no sample is ever required to be present, it is unclear what required for a sample to considered as “positive or negative” because the claim does not recite such. As to claims 1 and 9-10, it is unclear what is structurally required to be “a color development state” because such is not provided for in the claims. As to claims 1-2, 4-6, and 12-13, although no force is structur e, it is unclear what is considered an external force because there is no relative basis provided for in the claim as to what claimed structure the forces are required to be external to . Claims 2-13 are rejected via dependency upon a rejected claim. As to claim 2, it is unclear how the opening can be defined relative to the broad, unclaimed internal mechanism and a finger of a user because no dimensions of the opening, internal mechanism, and finger have been provided for in the claim. It is noted that fingers can have different dimensions. There is nothing precluding a finger from having a width of less than 5 mm (see claim 3) which would allow such finger to be inserted in the opening. Furthermore, it is noted that the phrase “for exerting external force” is directed to intended use of the opening. The opening itself is not capable of exerting any external force. As to claim 4, it is unclear if the pressed part is already required to be deformed or displaced because the “that is” phrase appears to be directed to what can be done to the pressed part rather that what such part is. This is a lso applicable to the “pressed part” of claims 6 and 13. As to claim 4, although no force is structure, it is unclear what/which external force is being refenced by the phrase “the external force” because claim 1 previously mentions different external forces including that of the internal mechanism and that of a user. Furthermore, it is unclear what deformation or displacement of what is being referenced by the phrase “the deformation or the displacement” because the claim does not recite such. It is unclear what is further structurally required by claim 5 because the claim does not provide for any further structural element no further structure of any prior positively claimed element. The claim appears to provide what is possible, can be done in a specific situation/condition as indicated by the phrase “in a case where”. As previously noted, there is no required for any exerting/applying of any force to be performed. Also applicable to the phrase “in a case where…” in claims 9-10. As to claim 6, it is unclear what is the structural nexus of the cover member and the suppression structure because the claim does not provide for such. It is unclear what the phrase “or an opening for exerting….” in the last line of the first paragraph is directed to because the claim does not recite such. It is presumed the cover. However, it is unclear how the cover can and suppression structure both comprise the opening because the claim does not recite such. As to claim 6, i t is unclear what deformation or displacement of what is being referenced by the phrase “the deformation or the displacement” because the claim does not recite such. Claims 7-8 do not provide for any further structural element no further structurally limit any previously positively claimed elements. The claims are directed to the unclaimed first and second reagents. However, it is unc lear it is unclear what the phrase “reacting with both of the first reagent and second reagent” is directed to (what can react with both reagents) because the claim does not provide for such. As to claim 11, it is unclear what is the nexus of “an i mmunochromatographic assay apparatus ” to the immunochromatographic assay apparatus previously recited in claim 1, if such are the same or different because the claim does not clearly recite such. Furthermore, it is unclear what is structurally required to define an immunochromatographic assay apparatus because such is not clearly defined in claims by any definitive structural elements. Therefore, it is unclear what is considered as “in a loading part”. Furthermore, it is unclear what is the distinction between and structural nexus of the cartridge and internal mechanism. It the cartridge is in the apparatus so it is an internal mechanism. Claims 12-13 employ the same or similar language as claims 2 and 4. See above applicable rejections of claims above. 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. Claim(s) 1 -13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yumbe, Hirona et al., WO 2018/150846 and further in view of Fujifilm Corp, JP 5 276568 B2 . Yumbe discloses a cartridge (abstract; paragraph [0001 ]-[0009]) that is attachably and detachably loaded into an immunochromatographic assay apparatus (paragraph [0009]), the cartridge comprising: a carrier (Figure 3(3)) having a spotting region (paragraph [0032]) on which a sample is spotted and an assay region (paragraph [0032]: "test region 31") in which a color development state changes depending on whether the sample is positive or negative (paragraph [0032]); a first reagent holding part (Figure 3(37)) that holds a first reagent (paragraph [0022]) and that starts a supply of the first reagent to the carrier by directly or indirectly receiving an external force (paragraph [0027]); a second reagent holding part (Figure 3(38)) that holds a second reagent that is supplied to the carrier after the first reagent is supplied to the carrier (paragraph [0022]) and that starts a supply of the second reagent to the carrier by directly or indirectly receiving an external force exerted by an internal mechanism provided in the immunochromatographic assay apparatus (paragraph [0028]). Yumbe does not disclose a suppression structure (cover). Fujifilm discloses a cartridge for detachable use in an immunochromatographic assay apparatus (abstract; paragraphs [0001], [0021], [0029], [0032], [0039], [0043], [0045], [0051], [0052], [0058], [0062]; Figures 1 and 4-7). Fujifilm teaches the use of a cover having a press part that can be deformed, displaced and holes therein (Figure 6(32)) that allow a rod to penetrate and activate the crushing of a reagent container. The holes are sized so that a finger cannot be inserted therethrough (Figure 6(32), Figure 7(62); paragraph [0043]). The Applicant is advised that the Supreme Court recently clarified that a claim can be proved obvious merely by showing that the combination of known elements was obvious to try. In this regard, the Supreme Court explained that, “[w]hen there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill in the art has a good reason to pursue the known options within his or her technical grasp.” An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of the case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. Furthermore, the simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR Int’l v. Teleflex Inc. , 127 Sup. Ct. 1727, 1742, 82 USPQ2d 1385, 1397 (2007) (see MPEP § 2143). Common sense, predictability, knowledge, and skill of one of ordinary skill in the art may suffice to establish obviousness. I t would have been obvious to and with the common sense, knowledge, and skill of one of ordinary skill in the art before the effective filing date of the invention to use a suppression structure as disclosed by Fujifilm as a means to inhibit an erroneous operation by a user regarding supply of a reagent in the cartridge of Yumbe in order to be able to allow the correct performance of the immunochromatographic assay. As to the width of the opening (hole), it is noted that a change in size of component is generally recognized as being within the level of ordinary skill in the art. It is noted that claim 5 is directed to a process step, process of use of the cartridge. Claims 7-8 are directed to the unclaimed fi r st and second reagents. As to claims 11-13, the modified teachings of Yumbe above discloses a cartridge of claim 1 detachably loaded into an immunochromatographic assay apparatus. Conclusion The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zucker; Steven et al. ; Battrell; C. Frederick et al. ; Yang; Bo et al. ; Tung, Hsiaoho Edward et al. ; Douglas; Joel S. et al. ; and Oberhardt; Bruce disclose testing devices that provide for color changes of a material upon reactions with reagents . Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT BRIAN R GORDON whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-1258 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F, 8-5:30pm; off every other Friday. . 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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. /BRIAN R GORDON/ Primary Examiner, Art Unit 1798