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
After further consideration, the finality of the previous office action has been withdrawn, and a new rejection is set forth below.
Applicant’s arguments, see pages 4-5 of applicant’s remarks, filed October 6th, 2025, with respect to the rejection(s) of claim(s) 1 and 15 under 35 U.S.C. 103 as being obvious over Lee in view of Ymeti have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made below.
Examiner’s Note
It is noted that claim 8, which was previously withdrawn (see nonfinal office action, dated March 4, 2025), has the incorrect status identifier. The correct status identifier should have been “withdrawn”. For the purposes of prosecution, this claim is considered withdrawn.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 13th, 2026 and May 28th, 2026 has been considered by the examiner.
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 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fujimoto et al. (2010/0209964), as cited by the applicant.
In regards to claims 1 and 15, Fujimoto discloses an analysis device and method (figs. 1 and 5) that analyzes a sample including a substance to be tested (blood BL and ⁋ 52) and that uses a single or a plurality of analysis chips (B which is shown in fig. 3) having two regions of a first region (34A), which has a reagent reacting with the substance to be tested (reagent 40 reacts with blood BL), and a second region (34B), which does not have the reagent (as discussed in ⁋ 52), both of the two regions being regions onto which the sample is spotted (both are spotted with blood BL as can be seen in fig. 5), the analysis device and method comprising: a light source that irradiates the analysis chip (fig. 1, 11a and ⁋ 32), onto which the sample has been spotted in both the first region and the second region, with light (as can be seen in fig. 5, both regions are illuminated with light); a photodetector that detects output light (11b), which is output from the analysis chip in a case in which the analysis chip is irradiated with the light, and that outputs a first detection signal corresponding to the output light from the first region (D0) and a second detection signal corresponding to the output light from the second region (D1); and a processor (2) that is configured to acquire the first detection signal and the second detection signal from the photodetector, and correct the first detection signal with the second detection signal to derive a concentration of the substance to be tested included in the sample (⁋ 52 discloses that the processor takes the light from the second region, D1, and corrects the data D0 in order to determine a concentration of a particular component in the blood).
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.
Claim(s) 1-4, 9, 13-14 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kazuyoshi (JP2012-211782, translation provided) in view of Fujimoto et al. (2010/0209964), both cited by the applicant.
In regards to claims 1 and 15, Kazuyoshi discloses an analysis device and method (fig. 1) that analyzes a sample including a substance to be tested (whole blood, bottom of pg. 1 translation) and that uses a single or a plurality of analysis chips (10) having a first region (14), which has a reagent reacting with the substance to be tested (page 2, ⁋ 3 under “Description of Embodiments”), wherein the region is a region onto which the sample is spotted (as can be seen in fig. 1 20 is spotted onto chip 10), the analysis device comprising: a light source that irradiates the analysis chip (40), onto which the sample has been spotted in the first region with light (as can be seen in fig. 1); a photodetector that detects output light (51), which is output from the analysis chip in a case in which the analysis chip is irradiated with the light, and that outputs a first detection signal corresponding to the output light from the first region (page 2, ⁋ 5 under “Description of Embodiments”); and a processor (70) that is configured to acquire the first detection signal from the photodetector, to derive a concentration of the substance to be tested included in the sample (as described on page 4 of the translation). Kazuyoshi is silent to a second analysis chip comprising a second region, which does not have the reagent, also being a region onto which the sample is spotted, the analysis device comprising: a light source that irradiates the analysis chip onto which the sample has been spotted in the second region, with light; a photodetector that detects output light, which is output from the analysis chip in a case in which the analysis chip is irradiated with the light, and that outputs a second detection signal corresponding to the output light from the second region; and a processor that is configured to acquire the second detection signal from the photodetector, and correct the first detection signal with the second detection signal to derive a concentration of the substance to be tested included in the sample. However, this is known in the art, and done in order to correct for any light that may react with the reagent and cause inaccuracies of the calculation.
For example, Fujimoto, in the same field of endeavor as Kazuyoshi of blood analysis (⁋ 1), discloses an analysis chip and method (figs. 1 and 5) that analyzes a sample including a substance to be tested (blood BL and ⁋ 52) and that uses a single or a plurality of analysis chips (B which is shown in fig. 3) having two regions of a first region (34A), which has a reagent reacting with the substance to be tested (reagent 40 reacts with blood BL), and a second region (34B), which does not have the reagent (as discussed in ⁋ 52), both of the two regions being regions onto which the sample is spotted (both are spotted with blood BL as can be seen in fig. 5), comprising: a light source that irradiates the analysis chip (fig. 1, 11a and ⁋ 32), onto which the sample has been spotted in both the first region and the second region, with light (as can be seen in fig. 5, both regions are illuminated with light); a photodetector that detects output light (11b), which is output from the analysis chip in a case in which the analysis chip is irradiated with the light, and that outputs a first detection signal corresponding to the output light from the first region (D0) and a second detection signal corresponding to the output light from the second region (D1); and a processor (2) that is configured to acquire the first detection signal and the second detection signal from the photodetector, and correct the first detection signal with the second detection signal to derive a concentration of the substance to be tested included in the sample (⁋ 52 discloses that the processor takes the light from the second region, D1, and corrects the data D0 in order to determine a concentration of a particular component in the blood). Having a second region which does not have the reagent and onto which the sample is spotted, and using this to correct the signal from the first region, allows a more precise measurement of the concentration, as it allows the signal to be corrected for the light interacting with the reagent (⁋ 52). Therefore, it would be obvious to one of ordinary skill in the art to include into Kazuyoshi the teachings of Fujimoto, including a second analysis chip comprising a second region, which does not have the reagent, also being a region onto which the sample is spotted, and having the analysis device and method further include: a light source that irradiates the analysis chip onto which the sample has been spotted in the second region, with light; a photodetector that detects output light, which is output from the analysis chip in a case in which the analysis chip is irradiated with the light, and that outputs a second detection signal corresponding to the output light from the second region; and a processor that is configured to acquire the second detection signal from the photodetector, and correct the first detection signal with the second detection signal to derive a concentration of the substance to be tested included in the sample in order to correct for any light that may react with the reagent and cause inaccuracies of the calculation.
In regards to claim 2, the combination is described above. Further, with the analysis chip of Kazuyoshi showing a single analysis chip (10), it would be obvious to one of ordinary skill in the art, in light of the combination to include a second analysis chip having the second region (14), which does not have the reagent for the combination in order to perform the correction as described above, while still maintaining the set-up of Kazuyoshi.
In regards to claim 3, the combination is described above. Further, each of the first analysis chip (Kazyoshi, 10) and the second analysis chip (a second 10 without the reagent, as described above) includes a carrier (12) having a development layer (18, and page 2, ⁋ 3 under “Description of Embodiments”), in which the sample is developed and a reaction layer (14) which is capable of holding the reagent and in which the reagent and the substance to be tested are capable of reacting with each other (as discussed in Kazuyoshi, page 2, ⁋ 3 under “Description of Embodiments”).
In regards to claim 4, combination is discussed above. The apparatus of the combination further comprises a loading unit on which the first analysis chip and the second analysis chip are selectively loaded (Kazuyoshi, fig. 1, 30).
In regards to claim 9, combination is discussed above. The apparatus of the combination further comprises wherein the output light is light which has been emitted from the light source (Kazuyoshi 40) and reflected by the first region or the second region (as can be seen in fig. 1).
In regards to claim 13, the reagent is a dry reagent (Kazuyoshi, page 3, ⁋4).
In regards to claim 14, the sample is whole blood (Kazuyoshi, page 1, “whole blood”), and the substance to be tested is a specific substance included in blood plasma or in blood serum (⁋ bridging pages 1 and 2; the substance is a substance within the whole blood, which would inherently be including in either the blood plasma or the blood serum, as these are parts of whole blood. Further, it is noted that language in an apparatus or product claim directed to the function, operation, intent-of-use, and materials upon which the components of the structure work that does not structurally limit the components or patentably differentiate the claimed apparatus or product from an otherwise identical prior art structure will not support patentability. See, e.g., In re Rishoi, 197 F.2d 342, 344-45 (CCPA 1952); In re Otto, 312 F.2d 937, 939-40 (CCPA 1963); In re Ludtke, 441 F.2d 660, 663-64 (CCPA 1971); In re Yanush, 477 F.2d 958, 959 (CCPA 1973).
In regards to claim 16, the combination is disclosed above. While the combination does disclose the processor being configured to correct the first detection signal by using the second detection signal (as discussed above, the combination is silent to specifically doing this by calculating a difference or a ratio between the two detection signals. However, the examiner takes official notice that it is well-known in the art of sample analysis to correct a signal with a reference signal by calculating a difference or a ratio between the sample signal and the reference signal in order to allow the system to remove the background that is affecting the signal. Therefore, it would be obvious to one of ordinary skill in the art to include into the combination that the processer is configured to correct the first detection signal by calculating a difference or a ratio between the first detection signal and the second detection signal, as this is well-known to do, and in order to allow the system to remove the background that is affecting the signal.
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kazuyoshi (JP2012-211782, translation provided) in view of Fujimoto et al. (2010/0209964), as applied to claims 1-4, 9, and 13-14 above, and further in view of Kimura (US 2015/0110674), previously cited.
In regards to claim 10, the combination is discussed above. The combination is silent to the photodetector being an image sensor that has an imaging surface in which a plurality of light-receiving elements are two-dimensionally arranged and that is capable of imaging the first region and outputting a first region image obtained by imaging the first region as the first detection signal, and the processor is configured to identify a development region in which the sample has been developed in the first region on the basis of the first region image and correct the first detection signal according to the development region.
Kimura, in the same field of endeavor as the combination of blood analysis (⁋ 46 and abstract) teaches the photodetector is an image sensor that has an imaging surface in which a plurality of light-receiving elements are two-dimensionally arranged (fig. 4, 121, abstract and ⁋ 11) and that is capable of imaging the first region and outputting a first region image obtained by imaging the first region as the first detection signal, and the processor is configured to identify a development region in which the sample has been developed in the first region on the basis of the first region image and correct the first detection signal according to the development region (130, and abstract and ⁋ 11). This is done in order to correct for effects of irradiation intensity unevenness and position sensitivity (abstract). Therefore, it would be obvious to one of ordinary skill in the art to include into the combination that the photodetector is an image sensor that has an imaging surface in which a plurality of light-receiving elements are two-dimensionally arranged and that is capable of imaging the first region and outputting a first region image obtained by imaging the first region as the first detection signal, and the processor is configured to identify a development region in which the sample has been developed in the first region on the basis of the first region image and correct the first detection signal according to the development region, as taught by Kimura, in order to correct for effects of irradiation intensity unevenness and position sensitivity.
In regards to claim 11, a wavelength range of light emitted from the light source to the first region includes a specific wavelength range that is determined according to at least one of the substances to be tested or the reagent (Kazuyoshi, page 2, ⁋ 4 in “Description of Embodiments”).
In regards to claim 12, the combination is disclosed above. Kazuyoshi is silent to the light source being capable of emitting light in a plurality of different wavelength ranges as the light in the specific wavelength range. However, the examiner takes official notice that this is well-known in the art, and is done in order to allow for multiple substances to be analyzed by the same device.
For example, Fujimoto, in the same field of endeavor as Kazuyoshi of blood analysis (⁋ 1), discloses using a light source that is capable emitting light in a plurality of different wavelength ranges as the light in the specific wavelength range (⁋ 32), which is done in order to determine the absorbances of different substances in the sample (⁋ 48). Therefore, it would be obvious to one of ordinary skill in the art to include into the combination that the light source is capable of emitting light in a plurality of different wavelength ranges as the light in the specific wavelength range, as taught by Fujimoto, in order to determine the absorbances of different substances in the sample.
Conclusion
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/KARA E. GEISEL/
Art Unit 2877
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