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 .
Response to Arguments
Applicant's arguments filed April 28, 2026 have been fully considered but they are not persuasive.
The claims have not been amended to overcome all 112 rejections. See rejections herein.
As to the 103 rejections, applicant asserts that the recitation of amended claim 1, "the pressed part has a rigidity such that the pressed part does not deform when a pressing force of less than 50 N is applied, but deforms when a pressing force of 50 N or more is applied" is novel and nonobvious. The examiner disagrees. Providing for, manufacturing a part from a material and to have dimensions such that the part can deform by application of a force 50N or more does not require any knowledge and skills beyond that of one of ordinary skill in the art. Various polymer, plastic, glass, etc. and other materials of manufacture are conventionally known in the art. See rejection herein.
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 (not structurally defined in claim 1), a sample, a first reagent, external force, and a second reagent. 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 applicant regards as his invention.
Claims 1, 6, and 11 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. Therefore, it appears as if the preamble of the claim should read as “A cartridge that can be, is configured to be attachably and detachably loaded into an immunochromatographic assay apparatus, the cartridge comprising:”
Although no pressing force is ever required to be applied to the pressing part, it is unclear how the application of such force alone would result in the breakage of the sheet because this not consistent with the specification that describes the sheet being pressed against a protrusion 34 that breaks the sheet. However, the claim does not provide for such. Therefore, it is unclear how the invention as claimed can function as recited in the claim without providing for the protrusion.
Claims 6 and 11 are rejected via dependency upon a rejected claim.
As to claim 11, it is unclear what is the nexus of “an immunochromatographic assay apparatus” recited in line 3 to the “an 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 required of the pressing mechanism. To be an internal mechanism because such is not claimed as being located in (internal) any structure.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 6, and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yumbe, Hirona et al., WO 2018/150846 in view of Fujifilm Corp, JP 5 276568 B2 and in further view of Gould; Jason, US 2011/0081641.
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]) and sheet member (Figure 3).
Yumbe does not disclose a suppression structure (pressing part) that has a rigidity such that the pressed part does not deform when a pressing force of less than 50 N is applied, but deforms when a pressing force of 50 N or more is applied".
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 (pressing mechanism) 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.
Gould disclose within body 221, there is provided a test strip 224 which, will typically include an indicating portion (not shown) reflecting the result of the assay. Also within body 221, there is provided a package 226 (sheet member) containing a reagent to be applied to strip 224. Positioned above package 226 is a liquid actuated trigger 210, to the bottom of which is attached at element 228, for example a piercing element, to open package 226. A solution introduced to well 222 is introduced onto test strip 224 through outlet 222a. At the same time, liquid is also introduced to trigger 210 through a capillary tube 230 and begins swelling trigger 210. At the same time, test strip 224 is adequately loaded with a specimen liquid. At a time determined by the construction of capillary tube 230, element 228 is forced into package 226, breaking it open and allowing the reagent therein to leak upon test strip 224 as indicated by the arrow. This reagent is then absorbed by the test strip, allowing the intended test to take place. (paragraph 0045).
It 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 and Gould that will deform under application of an applied force as a means to inhibit an erroneous operation by a user to allow for breakage and 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 claim 6, providing a coating member (label, barcode, QR code, etc.) on any part of the apparatus 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 identify each of the parts, provide for instructions, content, etc. or other product information as such does not require any special skills and knowledge beyond that one of ordinary skill in the art. .
As to claim 11, the modified teachings of Yumbe above discloses a cartridge of claim 1 detachably loaded into an immunochromatographic assay apparatus including an internal pressing mechanism.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Neuman; Toomas et al.; NGUYEN; Michael Thomas et al.; Mayer; Markus; Lowe; Phillip et al.; Handique; Kalyan et al.; and Tung, Hsiaoho Edward et al. disclose testing devices that provide for reagents.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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.
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/BRIAN R GORDON/Primary Examiner, Art Unit 1798
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