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/Restrictions
Applicant’s election without traverse of claims 1-6 in the reply filed on 04/15/26 is acknowledged.
Information Disclosure Statement
The information disclosure statement filed 03/11/2026 fails to comply with the provisions of 37 CFR 1.98(a)(4) because it lacks the appropriate size fee assertion. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
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 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.
Regarding claim 1, the claim recites “a loading part in which a cartridge is loaded”. It is unclear if the claim is reciting the cartridge to be part of the system positively (in other word, already loaded into the loading part) or the loading part is configured to receive the cartridge (cartridge is not part of the claimed system).
Claims 2-6 are also rejected for being dependent on claim 1.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 2, 5, and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Catt (US 6235241).
Regarding claim 1, Catt teaches a test device that is used for an immunochromatographic test using an immunochromatographic method (Catt teaches a test device; Fig. 3), the test device comprising:
a loading part (slot 301, Fig. 3) in which a cartridge (plastic casing 200 and 201, Fig. 2) is loaded, the cartridge includes a carrier (test strip 101, Fig. 2) that is provided with a test region whose color development state changes depending on whether or not a sample is positive or negative (carrier is attenuated by the presence of the detectable material bound in the detection zone. Abstract), and a case (plastic casing 200 and 201, Fig. 2) in which the carrier is accommodated in an inner space defined by an outer shell (upper half 200, Fig. 2) formed of a translucent material (Col. 9, lines 16-18) and in which an opening portion (window/aperture 205, Fig. 2-3) for observing an observation region including the assay region is formed in a part of the outer shell (The upper half 200 of the casing includes a window or aperture 205 through which both detection zones 102 and 103 can be observed from outside the casing. Col. 8, lines 8-10);
an illumination unit (illuminator 303, Fig. 3) that has an emission end portion (LEDs 306, Fig. 3) for emitting light that illuminates the observation region (Col. 9, lines 43-45), where the illumination unit makes it possible to dispose at least a part of the emission end portion in a state of being brought into contact (a plurality of LEDs 306 to generate light, and this shines onto the assay strip via a diffuser 307 and the observation window 209 in the lower half of the assay device casing. Col. 9, lines 43-46), in a position separated from the opening portion on an outer surface of the outer shell of the cartridge in a loaded state (The light passes through the thin nitrocellulose strip 101 and exits the assay device through the result window 205 in the upper half of the casing. Col. 9, lines 46-49), the position being capable of guiding a light incident into the outer shell from the emission end portion to an inner edge of the opening portion by transmitting the incident light through the outer shell (Immediately outside window 205 is a second diffuser 308. Col. 9, lines 50-51); and
a detection unit that is disposed at a position facing the opening portion of the cartridge in a loaded state (Catt teaches a detection unit 321 at a top position facing the window on the upper surface side of the case; Fig. 3.) and detects (In principle, any electromagnetic radiation can be used to effect the transmission measurement in the invention…For example, if the label is a substance which is strongly coloured, ie. visible to the naked human eye when the material is concentrated, the ideal electromagnetic radiation is light of a complementary wavelength. Col. 4, lines 33-53) a color development of the assay region (Col. 15, lines 5-9; … with a substrate to produce a detectable material, Such as a coloured material, in the detection zone.), where the detection unit (The sensor(s) to detect emergent light can be conventional components such as photodiodes, e.g. silicon photodiodes. Col. 5, lines 55-56) optically detects the color development state by receiving a reflected light which is emitted (The five detectors 321 are mounted on the back face of a baffle plate. Each detector views the test strip through an aperture in the baffle. Col. 10, lines 44-46) from an inner edge of the opening portion and reflected by a surface of the observation region (Immediately outside window 205 is a second diffuser 308. After passing through the second diffuser 308, the light encounters a plate 309 having a plurality of apertures 310-314. Col. 9, lines 49-52).
Regarding claim 2, Catt teaches the test device as discussed above in claim 1. Catt teaches wherein in the emission end portion, a suppression part for suppressing light leakage, in which light emitted from the emission end portion is not incident on the outer shell and leaks to the periphery of the emission end portion, is provided (Catt teaches the portion of the device 303 around LED 306 in Figure 3 as a suppression part which prevents light from leaking to the surroundings; Fig. 3).
Regarding claim 5, Catt teaches the test device as discussed above in claim 1. Catt further teaches the assay apparatus has at least two illumination units are disposed on both sides of the opening portion in the outer shell one by one (306 in Figure 3).
Regarding claim 6, Catt teaches the test device as discussed above in claim 1. Catt teaches wherein the illumination unit has a semiconductor light source that emits the illumination light (Catt teaches the illumination unit is LED, which are semiconductors; col. 9 line 42-58).
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.
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Catt in view of Brown (US 20090084981).
Regarding claim 3, Catt teaches the claimed invention as discussed above in claim 2. Catt discloses the emission end portion has an emission window (diffuser 307, Fig. 3) and a window frame that surrounds the periphery of the emission window (interpret as the portion surrounding the diffuser and the LEDs in Fig. 3).
Catt does not specifically teach the suppression part is a light-shielding elastic member that is provided on the window frame and elastically deforms in a case of being pressed against the outer surface of the outer shell. However, Brown teaches the analogous art of an analysis device that includes a light source that contacts the sample via an elastomeric cap (Brown teaches light source 4/6 connects to the sample via an elastomeric cap; [161, 165, 167]). It would have been obvious to one of ordinary skill in the art to have modified the apparatus that includes the light emission end portion that provides light to the case of modified Catt to have incorporated a elastomeric cap for light shielding member as in Brown because Brown teaches that using an elastomeric cap helps to block ambient light from interfering with the reader (Brown; [161, 165, 167]).
Regarding claim 4, Catt teaches the claimed invention as discussed above in claim 1, with the emission end portion provides light to the outer surface facing the detection unit in the outer shell (see claim 1 above).
Catt does not specifically teach the emission end portion comes into contact with the outer surface. However, Brown teaches the analogous art of an analysis device that includes a light source that contacts the sample via an elastomeric cap (Brown teaches light source 4/6 connects to the sample via an elastomeric cap; [161, 165, 167]). It would have been obvious to one of ordinary skill in the art to have modified the assay apparatus that includes the light emission end portion that provides light to the case of modified Catt to have contacted the case via an elastomeric cap as in Brown because Brown teaches that using an elastomeric cap helps to block ambient light from interfering with the reader (Brown; [161, 165, 167]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICKEY HUANG whose telephone number is (571)272-7690. The examiner can normally be reached M-F 9:30-5:30 PM ET.
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/M.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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