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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. JP2022-003879, filed on01/13/2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 103
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 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) 1-4, 7-14, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Tono et al. (US20150355077A1) and Hattori et al. (US20090301227A1).
Regarding Claim 1, Tono et al. teaches a test kit (See the Abstract, Claim(s) 1-15, the cartridge 10, i.e. a test kit, in [0030]-[0078] in Fig. 1-24) comprising:
a dropping device configured to drop a droplet (See the pipet 30, i.e. a dropping device, and the droplet 20 in [0004], [0066] in Fig. 6-8); and
a test device (See the chip 1, i.e. a test device, in [0031]-[0045] in Fig. 1-8 and Claim 1) including:
a reaction tank having an opening into which the droplet is dropped (See the combination of housing 2 and container 8, i.e. a reaction tank, has the inlet hole 4a-c and the upper opening 7 in [0031]-[0078] in Fig. 1-8), the reaction tank being configured to house the droplet (See illustrated in Fig. 6-8); and
a reaction detector arranged below the opening inside the reaction tank (See how the chip 1 comprises an optical waveguide sensor below the container 8, i.e. a reaction tank, in [0041]-[0049] in Fig. 1-8 and Claim 11) and
comprising a surface with a substance to be bound to a detection target substance (See how the optical waveguide sensor has an optical waveguide part comprising a functional layer corresponds to the bottom surface among the surfaces that define the container 8, i.e. a reaction tank, that reacts to a test subject in [0041]-[0049] in Fig. 1-8), and the reaction tank has an internal volume substantially equal to twice an amount of the droplet, or smaller than or equal to twice the amount (See in [0070]-[0079] in Fig. 1-24).
Tono et al. fails to explicitly teach a test kit comprising a surface having lyophilicity.
However, in the analogous art of liquid contact structures for controlling the movement of liquids, Hattori et al. teaches a liquid contact surface (See the Abstract, Claim(s) 1-10, the liquid contact surface 1, in [0008]-[0022] in Fig. 1-8) comprising: a surface having lyophilicity (See how the surface 2 has inherent lyophilicity for a certain kind of a liquid, but the effect of the increase in the area of the surface further improves the degree of lyophilicity in [0051]-[0066] in Fig. 1).
Thus, it would be obvious to one with ordinary skills in the arts to modify the test kit of Tono et al. by incorporating a surface having lyophilicity (as taught by Hattori et al.) for the benefit of controlling the movement of liquid around a reaction detector in a test kit.
Regarding Claim(s) 2-4, The combination of Tono et al. and Hattori et al. teaches the kit limitations of claim 1.
Tono et al. further teaches a test kit (See the Abstract, Claim(s) 1-15, the cartridge 10, i.e. a test kit, in [0030]-[0078] in Fig. 1-24), wherein the reaction tank enters a filled state in which the reaction tank is filled with the droplet, in a case where the droplet is dropped into the reaction tank; and wherein the filled state is a state in which an upper surface and a lower surface of the reaction tank are in contact with the droplet (See the droplet 20 and the retention fluid 21 in container 8, i.e. a reaction tank, in [0065]-[0079] in Fig. 1-8);
wherein the amount of the droplet corresponds to one droplet or two droplets by the dropping device (See in [0050] in Fig. 1-24).
Regarding Claim(s) 7-9, The combination of Tono et al. and Hattori et al. teaches the kit limitations of claim 1.
Tono et al. further teaches a test kit (See the Abstract, Claim(s) 1-15, the cartridge 10, i.e. a test kit, in [0030]-[0078] in Fig. 1-24), wherein a size of the opening is determined according to an outer diameter of a tip of the dropping device from which the droplet is dropped (See the combination of housing 2 and container 8, i.e. a reaction tank, has the inlet hole 4a-c and the upper opening 7 in [0031]-[0078] in Fig. 1-8); wherein a size of the opening is larger than a diameter of the droplet to be dropped from the dropping device (NOTE: MPEP § 2144 IV. A. concerning changes in the size or portions of a claimed invention. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). The current claims regarding the diameter of the opening or the dropping device tip, does not change the function of the claimed invention in comparison to the prior art.); and
wherein the opening is formed at a position in a vicinity of a center of the reaction detector, where the droplet is dropped (NOTE: MPEP § 2144 VI. concerning the rearrangement of parts of a claimed invention in comparison to the prior art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975); MPEP § 2114 I-II. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). The current claims regarding the center location of the opening, does not change the function of the claimed invention in comparison to the prior art.
Regarding Claim(s) 10-14, The combination of Tono et al. and Hattori et al. teaches the kit limitations of claim 1.
Tono et al. further teaches a test kit (See the Abstract, Claim(s) 1-15, the cartridge 10, i.e. a test kit, in [0030]-[0078] in Fig. 1-24), comprising a first assisting structure protruding from a housing of the test device toward an outside, arranged around the opening, and configured to assist in guiding the droplet to the opening (See how the housing 2 has a rectangular parallelepiped shape having an upper surface 2a, a bottom surface 2b, and a middle surface 2c, i.e. first assisting structures, that forms openings 4a and 7a in [0031]-[0040], [0050] in Fig. 1-8);
a second assisting structure extending from the opening to an inside of the reaction tank and configured to assist in guiding the droplet to the reaction detector (See how the upper surface 2a includes a first recessed surface 5a i.e. second assisting structures, in [0031]-[0040], [0050] in Fig. 1-8);
wherein the opening is formed in a top surface of the reaction tank, and the test kit further comprises a third assisting structure protruding from the top surface toward an inside of the reaction tank (See how the upper surface 2a includes a third recessed surface 3a, i.e. second assisting structures, in [0031]-[0040], [0050] in Fig. 1-8);
wherein at least one of the first assisting structure and the third assisting structure has a concave structure centered on the opening; and wherein at least one of the first assisting structure and the second assisting structure has a surface structure that suppresses a surface tension of the droplet (See illustrated in Fig. 1-8 in [0031]-[0040], [0050], [0068], [0073]).
Regarding Claim(s) 19-20, The combination of Tono et al. and Hattori et al. teaches the kit limitations of claim 1.
Tono et al. teaches a test kit (See the Abstract, Claim(s) 1-15, the cartridge 10, i.e. a test kit, in [0030]-[0078] in Fig. 1-24), wherein a distance between a top surface of the reaction tank and the reaction detector is 1±0.2 millimeter (See how the chip 1 comprises an optical waveguide sensor below the container 8, i.e. a reaction tank, in [0041]-[0049] in Fig. 1-8 and Claim 11); and
Tono et al. fails to explicitly teach a test kit wherein the droplet in the reaction tank spreads with a wetting action over an entirety of the surface due to the lyophilicity and a capillarity phenomenon with the distance.
However, in the analogous art of liquid contact structures for controlling the movement of liquids, Hattori et al. teaches a liquid contact surface (See the Abstract, Claim(s) 1-10, the liquid contact surface 1, in [0008]-[0022] in Fig. 1-8), wherein the droplet on the surface spreads with a wetting action over an entirety of the surface due to the lyophilicity and a capillarity phenomenon with the distance (See in [0051]-[0066] in Fig. 1).
Thus, it would be obvious to one with ordinary skills in the arts to modify the test kit of Tono et al. and Hattori et al. by incorporating a droplet on the surface spreads with a wetting action over an entirety of the surface due to the lyophilicity and a capillarity phenomenon with the distance (as taught by Hattori et al.) for the benefit of controlling the movement of liquid around a reaction detector in a test kit.
Claim(s) 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Tono et al. (US20150355077A1) and Hattori et al. (US20090301227A1) as applied to claim 1 above, and further in view of Takase et al. (US20150355089A1 and Chou et al. (US10324009B2).
Regarding Claim(s) 5-6, The combination of Tono et al. and Hattori et al. teaches the kit limitations of claim 1.
The combination of Tono et al. and Hattori et al. fails to explicitly teach a test kit, wherein the reaction detector includes a plurality of detection regions, and each of the detection regions contains an antibody for measuring whether or not the droplet contains a detection target substance.
However, in the analogous art of optical measurement systems, Takase et al. teaches a test kit (See the Abstract, Claim(s) 1-12, the optical waveguide system 10, i.e. a test kit, in [0035]-[0069] in Fig. 1-26), wherein the reaction detector includes a plurality of detection regions, and each of the detection regions contains an antibody for measuring whether or not the droplet contains a detection target substance (See the reaction space 102 and how the functional layer 105 formed of a plurality of first antibodies 6 that are arranged on the main surface and is laminated to form the sensing surface 101, i.e. a reactor detector, on the optical waveguide sensor chip 20 in [0057]-[0069] in Fig. 1-3; Also, see the processor 60 in [0136]-[0142]).
Furthermore, in the analogous art of biochemical assay devices, Chou et al. teaches a test kit (See the Abstract and Claim(s) 1-134 in Fig. 1-12), wherein the reaction detector includes a plurality of detection regions, and each of the detection regions contains an antibody for measuring whether or not the droplet contains a detection target substance (See the multiple binding sites for antibodies in [Col. 101 lines 3-67]-[Col. 102-lines 1-24] in Fig. 10-13B).
Thus, it would be obvious to one with ordinary skills in the arts to modify the reaction detector of Tono et al. and Hattori et al. by incorporating a plurality of detection regions that contain an antibodies (as taught by Takase et al. and Chou et al.) for the benefit of measuring whether or not a droplet contains a detection target substance.
Claim(s) 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Tono et al. (US20150355077A1) and Hattori et al. (US20090301227A1) as applied to claim 1 above, and further in view of Chou et al. (US10324009B2).
Regarding Claim(s) 15-17, The combination of Tono et al. and Hattori et al. teaches the kit limitations of claim 1.
The combination of Tono et al. and Hattori et al. fails to explicitly teach a test kit, wherein the surface structure has at least one of a fine uneven structure and a lyophilic structure; wherein the opening is formed in a top surface of the reaction tank, and the top surface has at least one of a fine uneven structure and lyophilicity; and wherein the surface of the reaction detector has lyophilicity.
However, in the analogous art of biochemical assay devices, Chou et al. teaches a test kit (See the Abstract and Claim(s) 1-134 in Fig. 1-12), wherein the surface structure has at least one of a fine uneven structure and a lyophilic structure; wherein the opening is formed in a top surface of the reaction tank, and the top surface has at least one of a fine uneven structure and lyophilicity; and wherein the surface of the reaction detector has lyophilicity. (See the multiple binding sites for antibodies in [Col. 101 lines 3-67]-[Col. 102-lines 1-24] in Fig. 10-13B; See the various devices and structures in Fig. 1-24; Also, see how the wetting of structure and surfaces properties can be changed in [Col. 115 in lines 56-63], [Col. 172 lines 19-62]).
Thus, it would be obvious to one with ordinary skills in the arts to modify the reaction tank, detector, and surfaces of Tono et al. and Hattori et al. by incorporating lyophilicity (as taught by Chou et al.) for the benefit of measuring whether or not a droplet contains a detection target substance in a detection region.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Tono et al. (US20150355077A1) and Hattori et al. (US20090301227A1) as applied to claim 1 above, and further in view of Takase et al. (US20150355089A1.
Regarding Claim 18, The combination of Tono et al. and Hattori et al. teaches the kit limitations of claim 1.
The combination of Tono et al. and Hattori et al. fails to explicitly teach a test system comprising the test kit according to claim 1 and a measuring device, wherein the test device further includes: a first grating configured to cause light to enter a region inside the reaction tank filled with the droplet, the region serving as an optical waveguide; and a second grating configured to emit light having transmitted through the optical waveguide to an outside, and the measuring device includes: a light source; a light detector configured to receive light from the second grating; and a detector configured to measure a substance amount of the detection target substance contained in the droplet in the reaction tank by detecting an optical change and to generate a measurement result of the detection target substance.
However, in the analogous art of optical measurement systems, Takase et al. teaches a test system comprising a test kit (See the Abstract, Claim(s) 1-12, the optical waveguide system 10, i.e. a test kit, in [0035]-[0069] in Fig. 1-26), and
a measuring device (See the measurement unit 30 in [0037]-[0069] in Fig. 1-3), wherein the test device (See the optical waveguide sensor chip 20, i.e. a test device, in Fig. 1-3)
further includes: a first grating configured to cause light to enter a region inside the reaction tank filled with the droplet, the region serving as an optical waveguide (See how the grating 2a, i.e. a first grating, deflects the optical path of incident light L1 from the window 610 in the optical waveguide part 3 to enable optical waveguiding in the reaction space 102 in [0050]-[0054] in Fig. 1-3); and
a second grating configured to emit light having transmitted through the optical waveguide to an outside, and the measuring device includes (See how the grating 2b, i.e. a second grating, deflects the optical path of light wave-guided by the optical waveguide part 3 so that the light can be output to the outside in [0050]-[0054] in Fig. 1-3):
a light source (See how the light generator 51 includes, for example, two independent light sources 51a in [0186]-[0201] in Fig. 23);
a light detector configured to receive light from the second grating (See how the light receiver 52 can receive a plurality of light beams (light flux) emitted from the optical waveguide sensor chip 20 through the light entrance 52b. The light receiver 52 includes, for example, two independent light receiving devices 52a in [0186]-[0201] in Fig. 23); and
a detector configured to measure a substance amount of the detection target substance contained in the droplet in the reaction tank by detecting an optical change and to generate a measurement result of the detection target substance (See how the optical waveguide sensor chip 20 includes two independent sensing surfaces 101)in the lateral direction of the window 610, and a light beam is incident on each of the sensing surfaces 101. For example, in the optical waveguide sensor chip 20, by providing different functional layers 105 to the two independent sensing surfaces 101, two items can be measured by one test liquid. For example, as the examination of diabetes requires the measurement of hemoglobin as well as the measurement of A1C, these measurements can be performed with one optical waveguide sensor chip 20 in [0186]-[0201] in Fig. 23).
Thus, it would be obvious to one with ordinary skills in the arts to modify the test kit Tono et al. and Hattori et al. by incorporating a test system comprising measuring device and a test device further comprising optical gating, a light source, and a light detector (as taught by Takase et al.) for the benefit of measuring whether or not a droplet contains a detection target substance in a detection region.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following prior art teaches similar devices and methods Wagner et al. (US8941062B2) and Kasai et al. (US20140105789A1).
THIS ACTION IS MADE FINAL. 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 BRITNEY N WASHINGTON whose telephone number is (703)756-5959. The examiner can normally be reached Monday-Friday 7:00am - 3:30pm CT.
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/BRITNEY N. WASHINGTON/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
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