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 Amendment
The amendment filed December 29, 2025 has been entered.
Claims 1-16 remain pending and examined in the application.
Applicant’s amendments to the Claims have overcome each and every 112(b) rejection previously set forth in the Non-Final Office Action mailed September 29, 2025. However, a new 112(b) rejection has been raised, as shown in the Claim Rejections-35 USC 112 section of this instant Office Action.
Based on Applicant’s amendments and remarks, the previous prior art rejection has been modified to address the claim amendments.
Claim Interpretation
The limitation “a reaction bath” has been interpreted as any structure that holds the reaction tube holders and the photometry portions.
The limitation “a storage” has been interpreted as any region of space capable of storing air.
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.
Claim 14 is 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.
The term “the first fan cools the heating concentrator in a concentrated manner” in claim 14 is a relative term which renders the claim indefinite. The term “a concentrated manner” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear how the air from the first fan must be sent towards the heating concentrator in order to be considered for the first fan to cool in “a concentrated manner”.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Chappelle et al. (US Pat. No. 3,756,920; hereinafter Chappelle; already of record) in view of Izawa et al. (Translation of JP Pub. No. 2020-91207; hereinafter Izawa).
Regarding claim 1, Chappelle discloses an automatic analyzer (Col. 1 Lns. 19-34, see Figs. 2-3). The automatic analyzer comprises:
a plurality of reaction tube holders each configured to hold a reaction tube housing a mixed solution of a specimen and a reagent (Col. 7 Lns. 8-22, see Figs. 2-3 at light slot 59 in table housing 15 and photomultiplier assembly 70).
A photometry portion provided with respect to the reaction tube holders and configured to perform photometry on the mixed solution housed in the reaction tube (Col. 7 Lns. 8-22, see Figs. 2-3 at light slot 59 in table housing 15 and photomultiplier assembly 70).
A reaction bath to which the reaction tube holders and the photometry portion are fixed, the reaction bath being configured to repeat rotating and stopping to thereby convey the reaction tube held by each of the reaction tube holders (Col. 6 Ln. 55-Col. 7 Ln. 22, see Figs. 2-3 at rotary table 40 and table housing 15).
A driver configured to rotate the reaction bath (Col. 5 Lns. 21-30, see Figs. 2-3 at motor 3 that rotates shaft 18 under housing 15).
Chappelle fails to explicitly disclose:
that the automatic analyzer is for performing a blood coagulation analysis test;
a plurality of photometry portions each of which is provided with respect to each of the reaction tube holders, each of the photometry portions including a light source and a light receiver and being configured to perform photometry on the mixed solution housed in the reaction tube;
that the plurality of photometry portions are fixed to the reaction bath; and
that the driver is configured to rotate the reaction bath together with the reaction tube holders and the photometry portions.
Izawa is in the analogous field of automatic analyzers (Izawa Pg. 1 1st Para.). Izawa teaches a plurality of photometry portions each of which is provided with respect to each of a set of reaction tube holders, each of the photometry portions including a light source and a light receiver and being configured to perform photometry on a mixed solution housed in a reaction tube (Izawa; Pg. 5 2nd-3rd Paras., see Fig. 3). The plurality of photometry portions are fixed to a reaction bath (Izawa; Pg. 5 2nd-3rd Paras., see Fig. 3). A driver is configured to rotate the reaction bath together with the reaction tube holders and photometry portions (Izawa Pg. 3 Last Para.-Pg. 4 2nd Para.). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the automatic analyzer of Chappelle with the teachings of Izawa so that the automatic analyzer comprises a plurality of photometry portions each of which is provided with respect to each of the reaction tube holders, each of the photometry portions including a light source and a light receiver and being configured to perform photometry on the mixed solution housed in the reaction tube, the plurality of photometry portions are fixed to the reaction bath, and the driver is configured to rotate the reaction bath together with the reaction tube holders and the photometry portions. The motivation would have been to provide an automatic analyzer where photometry of each reaction tube can be performed individually in parallel, thereby shortening analysis time even when there are a plurality of test samples (Izawa Pg. 5 5th Para.).
Further, with regards to the automatic analyzer being for performing a blood coagulation test, see MPEP 2111.02, which states that, “if the body of a claim fully and intrinsically sets forth all the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.”
Note: The instant Claims contain a large amount of functional language (ex: “configured to hold a reaction tube…”, “configured to perform photometry …”, “configured to repeat rotating and stopping”, etc.). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
Claims 2-11 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Chappelle in view of Izawa as applied to claim 1 above, and further in view of Horne (US Pat. No. 4,430,299; already of record).
Regarding claim 2, modified Chappelle discloses the automatic analyzer according to claim 1, and all limitations recited therein.
Modified Chappelle fails to explicitly disclose a first unit fixed to an inside of the reaction bath and connected to each of the photometry portions,
wherein the first unit includes at least one of a first function of supplying power acquired from a power source to each of the photometry portions, or a second function of processing a signal acquired from each of the photometry portions.
Horne is in the analogous field of apparatuses for monitoring chemical reactions (Horne Col. 3 Lns. 51-58). Horne teaches a first unit fixed to an inside of a reaction bath and connected to an analysis portion, where the first unit includes at least one of a first function of supplying power acquired from a power source to each of the photometry portions, or a second function of processing a signal acquired from each of the photometry portions (Horne; Col. 7 Ln. 60-Col. 8 Ln. 62, see Fig. 2 at electronic circuitry 52, which act to process signals from eight photometers). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the automatic analyzer of modified Chappelle with the teachings of Horne to include a first unit fixed to an inside of the reaction bath and connected to each of the photometry portions, wherein the first unit includes at least one of a first function of supplying power acquired from a power source to each of the photometry portions, or a second function of processing a signal acquired from each of the photometry portions. The motivation would have been to be able to translate analog signals to digital so that data from the photometry portions can be sent to a computer for subsequent data processing and analysis (Horne; Col. 7 Ln. 60-Col. 8 Ln. 62, see Fig. 2, see also Claim 4).
Regarding claim 3, modified Chappelle discloses the automatic analyzer according to claim 2, and all limitations recited therein.
Modified Chappelle fails to explicitly disclose a rotation connector configured to electrically connect between a second unit provided outside the reaction bath and the first unit.
Horne further teaches a rotation connector configured to electrically connect between a second unit provided outside a reaction bath and a first unit (Horne; Col. 7 Ln. 49-Col. 8 Ln. 66, see Fig. 2 at slip-ring connector 74 which connects electronic circuitry 52 to data processing equipment 102, which includes a power source). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the automatic analyzer of modified Chappelle with the further teachings of Horne to include a rotation connector configured to electrically connect between a second unit provided outside the reaction bath and the first unit, in order to provide power to the first unit from an external power source (Horne; Col. 7 Ln. 49-Col. 8 Ln. 66, see Fig. 2).
Regarding claim 4, modified Chappelle discloses the automatic analyzer according to claim 2, and all limitations recited therein.
Modified Chappelle fails to explicitly disclose that wires that connect between a second unit provided outside the reaction bath and the first unit are smaller in number than wires that connect between the first unit and each of the photometry portions.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to provide a smaller number of wires that connect between the second unit and the first unit compared to the number of wires that connect between the first unit and each of the photometry portions. As the second unit connected to a single first unit, and the first unit is connected to a plurality of photometry portions in the automatic analyzer of modified Chappelle, only a single wire as a power source would be required to electrically connect the first unit to the second unit, while a plurality of wires as power sources would be required to electrically connect the second unit to each of the photometry portions, provided that the plurality of photometry portions are configured to operate in parallel, as in Izawa (Izawa Pg. 5 5th Para.).
Regarding claim 5, modified Chappelle discloses the automatic analyzer according to claim 4, and all limitations recited therein.
Modified Chappelle fails to explicitly disclose that the second function includes:
a function of acquiring from each of the photometry portions an analog signal indicating a photometry result by the corresponding photometry portion;
a function of amplifying the acquired analog signal;
a function of converting the amplified analog signal to a digital signal; and
a function of outputting the converted digital signal to the second unit.
Horne further teaches a second function that includes: acquiring from an analysis portion an analog signal indicating a result by the analysis portion, amplifying the acquired analog signal, converting the amplified analog signal to a digital signal, and outputting the converted digital signal to the second unit (Horne; Col. 7 Ln. 60-Col. 8 Ln. 62, Col. 11 Lns. 33-50, the electrical circuitry may include amplifiers, A/D converters, a multiplexer, etc., see Fig. 2 at electronic circuitry 52, which act to process signals from eight photometers, converts the analog signal to a digital signal, amplifies the signal, and sends the digital signal to data processing unit 102). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the automatic analyzer of modified Chappelle with the further teachings of Horne so that the second function includes: a function of acquiring from each of the photometry portions an analog signal indicating a photometry result by the corresponding photometry portion; a function of amplifying the acquired analog signal; a function of converting the amplified analog signal to a digital signal; and a function of outputting the converted digital signal to the second unit. The motivation would have been to be able to translate analog signals to digital so that data from the photometry portions can be sent to a computer for subsequent data processing and analysis (Horne; Col. 7 Ln. 60-Col. 8 Ln. 62, Col. 11 Lns. 33-50, see Fig. 2, see also Claim 4).
Regarding claim 6, modified Chappelle discloses the automatic analyzer according to claim 4, and all limitations recited therein. Modified Chappelle further discloses a heat suppressor configured to suppress heat generated in the first unit from being transferred to the photometry portions (Chappelle; Col. 6 Lns. 55-68, see Fig. 2 at apertures 46 to provide for flow of cooling air. See also Claim 1 at Izawa teaching the photometry portions in Pg. 5 2nd-3rd Paras., see Fig. 3).
Regarding claim 7, modified Chappelle discloses the automatic analyzer according to claim 6, and all limitations recited therein.
Modified Chappelle fails to explicitly disclose that the heat suppressor includes a partition provided between the photometry portions and the first unit inside the reaction bath.
Horne further teaches a material that is a partition provided between analysis portions and a first unit inside a reaction bath (Horne; Col. 5 Lns. 52-63, Col. Col. 7 Ln. 60-Col. 8 Ln. 62, see Fig. 2 at wall 80 between electronic circuitry 52 and cartridge 22). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the automatic analyzer of modified Chappelle with the further teachings of Horne to include a material that is a partition provided between the photometry portions and the first unit inside the reaction bath, and further to make the material a heat suppressor. The motivation would have been to protect the photometry portions from being exposed to heat from the first unit, thereby ensuring that the photometry portions remain at a desired temperature for conducting an assay (Horne Col. 9 Lns. 14-20).
Regarding claim 8, modified Chappelle discloses the automatic analyzer according to claim 6, and all limitations recited therein. Modified Chappelle further discloses that the heat suppressor includes a first fan configured to generate a flow of air for cooling the first unit (Chappelle; Col. 6 Lns. 7-19, see Fig. 8 at fan 201, which is meant to provide cooling air flow through the apertures 46 in Fig. 2).
Regarding claim 9, modified Chappelle discloses the automatic analyzer according to claim 8, and all limitations recited therein. Modified Chappelle further discloses that the heat suppressor includes a vent for allowing air outside the reaction bath to flow into the reaction bath, and the first fan exhausts air inside the reaction bath to an outside of the reaction bath (Chappelle; Col. 6 Lns. 7-19, see Fig. 8 at fan 201, which is meant to provide cooling air flow through the apertures 46 in Fig. 2. Further, the vent is an implicit feature because the fan 201 is meant to provide air for cooling inside the reaction bath).
Regarding claim 10, modified Chappelle discloses the automatic analyzer according to claim 9, and all limitations recited therein. Modified Chappelle further discloses a second fan (Chappelle; Col. 6 Lns. 20-27, see Fig. 8 at fan 202).
Modified Chappelle fails to explicitly disclose that the second fan is provided outside the reaction bath and configured to cause air in a vicinity of the vent to flow.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to provide the second fan outside the reaction bath and be configured to cause air in a vicinity of the vent to flow, since the particular placement of the second fan is an obvious matter of design choice. See In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975), and MPEP 2144.04(VI)(C). The motivation would have been to ensure that cooling air passes into the reaction bath to regulate the temperature of the reaction bath and prevent it from reaching an undesirably high temperature.
Regarding claim 11, modified Chappelle discloses the automatic analyzer according to claim 10, and all limitations recited therein.
Modified Chappelle fails to explicitly disclose:
a sensor configured to detect a temperature of air in the vicinity of the vent; and
a controller configured to control an activation state of the second fan in accordance with a detection result by the sensor.
However, Chappelle further teaches a temperature sensor, and a controller configured to control an activation state of the second fan (Chappelle; Col. 11 Lns. 46-75, see Fig. 8 at electrical control system, which includes temperature probe 196, and line 199 which is connected via fan switch 173 to fans 201, 202). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the automatic analyzer of modified Chappelle to include a sensor configured to detect a temperature of air in the vicinity of the vent, and a controller configured to control an activation state of the second fan in accordance with a detection result by the sensor. The motivation would have been to ensure that the samples are maintained at a predetermined temperature (Chappelle Col. 6 Ln. 70-Col. 7 Ln. 7), in order to ensure the accuracy of assays performed on the samples.
Regarding claim 14, modified Chappelle discloses the automatic analyzer according to claim 9, and all limitations recited therein.
Modified Chappelle fails to explicitly disclose that the first unit includes a heating concentrator in which heat generating elements are arranged, and the first fan cools the heating concentrator in a concentrated manner by sending air toward the heating concentrator.
However, Horne further teaches a first unit that includes heat generating elements (Horne; Col. 7 Ln. 60-Col. 8 Ln. 62, see Fig. 2 at electronic circuitry 52, which will intrinsically include heat generating elements). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the automatic analyzer of modified Chappelle so that the first unit includes a heating concentrator in which heat generating elements are arranged, and the first fan is arranged such that the first fan cools the heating concentrator in a concentrated manner by sending air toward the heating concentrator, since the particular placement of the heat generating elements and the first fan is an obvious matter of design choice. See In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975), and MPEP 2144.04(VI)(C). The motivation would have been that arranging the heat generating elements such that they are in a heating concentrator and the first fan such that the first fan cools the heating concentrator in a concentrated manner by sending air toward the heating concentrator would allow for the heat generating elements to be cooled more efficiently, thereby minimizing the effect of the heat generating elements on the temperature of samples to be analyzed in the analyzer.
Regarding claim 15, modified Chappelle discloses the automatic analyzer according to claim 3, and all limitations recited therein.
Modified Chappelle fails to explicitly disclose that the first unit includes one of the first function and the second function, and the second unit includes another one of the first function and the second function, which is different from the one included in the first unit.
Horne further teaches a first unit that includes one of the first function and the second function, and a second unit that includes a different one of the first function and second function from the first unit (Horne; Col. 7 Ln. 49-Col. 8 Ln. 66, Col. 11 Lns. 33-50, the electrical circuitry may include amplifiers, A/D converters, a multiplexer, etc., see Fig. 2 at electronic circuitry 52, which act to process signals from eight photometers, converts the analog signal to a digital signal, amplifies the signal, and sends the digital signal to data processing unit 102, and data processing unit 102, which also includes provides power to the system). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the automated analyzer of modified Chappelle with the further teachings of Horne so that the first unit includes one of the first function and the second function, and the second unit includes another one of the first function and the second function, which is different from the one included in the first unit, so that the automatic analyzer is capable of processing signals from the photometry portions for subsequent data processing and analysis of results, as well as providing power to the automated analyzer, thereby increasing the versatility of the device.
Regarding claim 16, modified Chappelle discloses the automatic analyzer according to claim 3, and all limitations recited therein.
Modified Chappelle fails to explicitly disclose that the rotation connector electrically connects between the first unit and the second unit through contact between solid forms.
However, Horne further teaches a rotation connector that electrically connects between the first unit and second unit through contact between solid forms (Horne; Col. 7 Ln. 49-Col. 8 Ln. 66, see Fig. 2 at slip-ring connector 74 which connects electronic circuitry 52 to data processing equipment 102, which includes a power source). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the automatic analyzer of modified Chappelle with the further teachings of Horne so that the rotation connector electrically connects between the first unit and the second unit through contact between solid forms, as Horne teaches that a slip-ring connector, which is a solid form, can be used to connect a data processing device to a power source (Horne; Col. 7 Ln. 49-Col. 8 Ln. 66, see Fig. 2).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Chappelle in view of Izawa and Horne as applied to claims 2-11 and 14-16 above, and further in view of Kawamoto et al. (US Pub. No. 2020/0355713; hereinafter Kawamoto; already of record).
Regarding claim 12, modified Chappelle discloses the automatic analyzer according to claim 9, and all limitations recited therein.
Modified Chappelle fails to explicitly disclose:
a storage provided outside the reaction bath and configured to store air which is to flow into the reaction bath through the vent; and
a third fan provided for the storage and configured to cause air outside the storage to flow into the storage.
Kawamoto is in the analogous field of sample measuring apparatuses (Kawamoto [0002]). Kawamoto teaches a storage provided outside of a reaction bath and configured to store air which is to flow into the reaction bath through a vent, and a fan provided for the storage and configured to cause air outside the storage to flow into the storage (Kawamoto; [0094], air inside reagent storage 20 is sent to cooling mechanisms 22 by a fan, and the cooled air is circulated in the reagent storage 20. See Fig. 3 at reagent storage 20 and cooling mechanisms 22. The area surrounding cooling mechanisms 22 can be considered a storage configured to store air, and the air passes throughout the reagent storage 20 via vents, i.e. apertures in the reagent storage). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the automatic analyzer of modified Chappelle with the teachings of Kawamoto to include a storage provided outside the reaction bath and configured to store air which is to flow into the reaction bath through the vent; and a third fan provided for the storage and configured to cause air outside the storage to flow into the storage. The motivation would have been to be able to keep temperature within the reaction bath at a desired temperature (Kawamoto; [0090]-[0094), see Fig. 3).
Regarding claim 13, modified Chappelle discloses the automatic analyzer according to claim 12, and all limitations recited therein.
Modified Chappelle fails to explicitly disclose:
a sensor configured to detect a temperature of air inside the storage; and
a controller configured to control an activation state of the third fan in accordance with a detection result by the sensor.
However, Chappelle further teaches a temperature sensor, and a controller configured to control an activation state of a fan (Chappelle; Col. 11 Lns. 46-75, see Fig. 8 at electrical control system, which includes temperature probe 196, and line 199 which is connected via fan switch 173 to fans 201, 202). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the automatic analyzer of modified Chappelle to include a sensor configured to detect a temperature of air inside the storage; and a controller configured to control an activation state of the third fan in accordance with a detection result by the sensor. The motivation would have been to ensure that the samples are maintained at a predetermined temperature (Chappelle Col. 6 Ln. 70-Col. 7 Ln. 7), in order to ensure the accuracy of assays performed on the samples.
Response to Arguments
Applicant's arguments filed December 29, 2025 have been fully considered but they are not persuasive.
Applicant’s arguments filed on 12/29/2025 have been considered but are moot because applicant’s arguments are towards the amended claims and not the current grounds of rejection.
Conclusion
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.
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/JOHN MCGUIRK/Examiner, Art Unit 1798