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 .
Remarks
This office action fully acknowledges Applicant’s arguments and amendments set forth in the reply filed 20 February 2026.
Claims 1, 4-7, and 16 are pending.
Claims 2-3 and 8-15 are cancelled.
No claims are withdrawn from consideration.
No claims are newly added.
Claim Interpretation
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitations are:
“a first dispensing unit configured to perform” in Claim 1.
“a second dispensing unit configured to perform” in Claim 1.
“a detection unit for performing analysis” in Claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof:
A movable nozzle and a pump, as in para. [0010] of Applicant’s instant specification, and equivalents thereof.
3) A spectrophotometer, as in para. [0016] of Applicant’s instant specification, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4-7, and 16 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.
Claim 1 recites the limitation "the common disks" on page 3, line 4. There is insufficient antecedent basis for this limitation in the claim. Applicant may intend to recite “the common disk”.
Claim 1 recites the limitation "the possibility of carryover" on page 2, lines 2-3. There is insufficient antecedent basis for this limitation in the claim. Applicant may intend to recite “a possibility of carryover”.
Claim 1 requires that the processor be configured to sort analysis items based on a possibility of carryover. Therein, said processor is not provided with a particular means for determining/measuring the possibility of carryover. It appears that the high and low carryover is related to the type of analysis performed and its concordant touching or non-touching of the nozzle to the specimen. However, as currently recited, the processor is merely required to be capable of providing arbitrary carryover/non-carryover designations to sample containers. Applicant may wish to amend the claims to incorporate the user-input or label-read analysis information as an element considered by the processor when sorting the analysis items. As such, Applicant may wish to incorporate a barcode reader, camera, or other means for obtaining the sample information so as to determine the sorting.
Additionally, the processor itself does not appear to be intended to physically sort the sample containers into separate groups sequestered in separate locations, but rather merely designate the sequence of analysis of the containers. Does Applicant intend to incorporate a robotic means for physically sorting the sample vessels at the command of the controller?
Claim 1 recites that the processor is configured to: “create at least one table which stores a relationship between a plurality of types of analysis for a plurality of specimens based on labels attached to each of the specimens; acquire analysis information from the at least one table”. Therein, it is unclear what information the processor relates between the analysis type and the specimens given that no “and” recitation follows the introduction of a relationship. Applicant may wish to amend the claim with a recitation on the order of “stores a relationship between a respective analysis type of a plurality of analysis types, and a respective specimen of a plurality of specimens.
The claim further recites “labels attached to each of the specimens” wherein it appears Applicant intends the labels to be attached to the specimen vessels, not the actual specimens themselves.
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.
Claims 1, 4-7, and 16, as best understood in view of the indefiniteness discussed in the 35 USC 112 section avbove, are rejected under 35 U.S.C. 103 as being unpatentable over Joji (WO 2017/138285 A1), hereinafter “Joji”, in view of Suzuki et al. (US 2014/0363896 A1), hereinafter “Suzuki”, Matsubara et al. (JP 2001/20876 2A, as seen through the machine translation available on Google Patents and attached herein), hereinafter “Matsubara”, Yin (WO 2018/171619 A1, as seen through the machine translation available on Google Patents and attached herein), hereinafter “Yin”, and Aryev et al. (US PAT 6,581,012 B1), hereinafter “Aryev”.
Regarding Claim 1, Joji teaches an automatic analyzer 100 comprising:
a disk 102 which holds both reagent vessels that store reagents and specimen vessels that store specimens including at least one reagent vessel storing a reagent, a first specimen vessel 101 storing a first specimen related to the first analysis item group having the high possibility of carry over, and a second specimen vessel 101 storing a second specimen related to the second analysis item group having the lower possibility of carryover than the first analysis item group ([0018]: “The sample disk 102 holds a plurality of the sample vessels 101, and rotates in a clockwise or counterclockwise direction to transport a target one of the sample vessels 101 to a position where the sample dispensing mechanism 105 sucks the sample in the sample vessel 101.” – [0008]: “As one aspect for solving the above problems, a sample container that holds a sample, a reagent container that holds a reagent, a sample dispensing mechanism that dispenses a sample from the sample container, and a reagent that is dispensed from the reagent container”. -- Further, the claims do not recite any structural feature that distinguishes the reagent vessels from the specimen vessels, but rather merely characterizes the intended contents (specimens having various carryover) of the vessels (the specimens are not positively claimed elements). Herein, the vessels of Joji are structurally capable of containing any liquid used in the analysis, including specimens of varying carryover.);
a first dispensing unit 105 configured to perform both reagent dispensing from the reagent vessels and specimen dispensing from the specimen vessels to the reaction vessels and configured to dispense the specimen related to the first analysis item group having the high possibility of carryover (Fig. 1 and [0017-0019]: “sample dispensing mechanism 105” – Regarding dispensing of both specimen and reagent, the structure of the dispensing unit is not limited by the type of liquid it dispenses. Joji’s dispensing unit is capable of aspirating and dispensing any appropriate liquid contained in the vessels of the common disc. Thus, the limitation that the dispensing unit performs both reagent and specimen dispensing merely depends on what liquid a user chooses to place in the vessels, which is an intended use of the vessels and dispensing unit, not a structural distinction. – While Joji does not specifically teach the sample dispensing mechanism 105 as “for dispensing a specimen related to a first analysis item group having a high possibility of carryover” as claimed, this recitation is merely an intended use of the sample dispensing mechanism, wherein limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). Herein, the sample dispensing mechanism 105 of Joji is fully capable of dispensing a specimen related to a first analysis item group having a high possibility of carryover – wherein the “possibility” of carryover is not specifically required by the claim.);
a second dispensing unit 112 configured to perform both reagent dispensing from reagent vessels and specimen dispensing from the specimen vessels to the reaction vessels and configured to dispense the specimen related to the second analysis item group having the lower possibility of carryover than the first analysis item group (Fig. 1 and [0017-0018]: “reagent dispensing mechanism 112” – Regarding dispensing of both specimen and reagent, the structure of the dispensing unit is not limited by the type of liquid it dispenses. Joji’s dispensing unit is capable of aspirating and dispensing any appropriate liquid contained in the vessels. Thus, the limitation that the dispensing unit performs both reagent and specimen dispensing merely depends on what liquid a user chooses to place in the vessels, which is an intended use of the vessels and dispensing unit, not a structural distinction. – While Joji does not specifically teach the reagent dispensing mechanism 112 as “for dispensing a specimen related to a second analysis item group having a lower possibility of carryover than the first analysis item group” as claimed, this recitation is merely an intended use of the sample dispensing mechanism, wherein limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). Herein, the reagent dispensing mechanism 112 of Joji is fully capable of dispensing a specimen related to a second analysis item group having a low possibility of carryover.); and
a detection unit for performing analysis (“The light intensity from the reaction solution contained in the reaction vessel 107 inserted in the above is measured. Therefore, the reaction vessel installation unit 108 includes a light source (not shown) that irradiates the reaction solution with incident light and a detection unit (light sensor) that measures the light intensity. Has inside. The light source is installed on the bottom surface of the reaction container installation unit 108, and can irradiate light upward. Light scattered by the reaction solution is detected. The detection unit is disposed on the side surface of the reaction vessel installation unit 108, and performs photo / current conversion on the detected light, thereby outputting a photometric signal indicating the light intensity to the A / D converter.”),
wherein the processor 116 is further configured to:
acquire analysis information (Fig. 1 and [0024]: “The operating unit 115 is a computer that has an input terminal, such as a keyboard, a mouse, and an operation screen displayed on a display unit, as an input measure.” – Analysis information is sent from the operating unit 115 to the interface 118, and is acquired by the control unit 116. Further, the controller acquires measurement signals: “A measurement signal of the optical intensity A/D-converted in the A/D converter is sent via the interface 118 to the control unit 116 and to the storage unit 117.”),
classify the analysis information into the first analysis item group and the second analysis item group ([0008]: “a control unit for controlling the analysis unit based on the input information, wherein the control unit when information about a plurality of samples is input from the operating unit, compares predicted reaction time lengths of analysis items requested for the plurality of samples, while determining an analysis order so that analyses of the analysis items are performed in descending order of the predicted reaction time length” – As the control unit sorts sample specimens based on predicted reaction time length, and said reaction time lengths constitute item groups (first and second, for example), the control unit thereby classifies the analysis information into groups.); and
determine a dispensing sequence for each specimen for the first analysis item group and determine a dispensing sequence for each analysis item for the second analysis item group ([0028]: “Analysis information, such as the sensed optical intensity which is measurement data, the reaction port number used, the type of sample used, the placement position on the sample disk 102, the type of reagent used, and the placement position on the reagent disk 104, is stored in the storage unit 117.” – [0024]: “The storage unit 117 stores, for example, input information from the operating unit 115, operation information of the sample disk 102 and the like, and information about reagents and samples.” – As the storage unit holds information related to dispensing sequence for respective analysis items, and the storage unit receives sample information from the control unit and returns said information related to dispensing sequence for respective analysis items, and the storage unit is a subordinate system interfaced with the control unit which controls all the operations of the device, the control unit thereby determines a dispensing sequence for each specimen of each of the analysis groups.),
wherein the dispensing sequence for each specimen for the first analysis group is set to a dispensing sequence of specimens and types of analysis set forth in the analysis information for the first analysis group (Given that Joji discusses setting sample parameters and dispensing sequence via the operating unit 115: “Test items of samples to be analyzed are input from the keyboard or the operation screen provided in the operating unit 115 and then are input into the control unit 116. The control unit 116 controls the operations of the sample disk 102, the reagent disk 104, the sample dispensing mechanism 105, the reaction vessel transferring mechanism 109, the reaction port 111, the reagent dispensing mechanism 112, and the reagent dispensing mechanism washing mechanism.”, Joji thereby teaches the dispensing sequence for each specimen for the first analysis group being set to a dispensing sequence of specimens and analysis items set forth in the analysis information for the first analysis group. Further, Joji discusses the controller as handling different reagent types and selecting a “target reagent” according to the test: “Upon receiving an instruction to select a test item and start analysis from the operation unit 115, the target reagent container 103 is set according to the test item.” As such, the dispensing sequence for each specimen is set to a dispensing sequence of specimens and types of analysis set forth in the analysis information of a “group” (one or more samples) commensurately as claimed.),
and wherein the dispensing sequence for each analysis item for the second type of analysis group is set in descending order of reaction times for each type of analysis for the second analysis item group (Abstract: “When information about a plurality of samples is entered, the device compares the predicted reaction time length of each requested analysis item for the plurality of samples, determines an analysis sequence to carry out the analysis for each item in order from longest to shortest, and carries out the analysis on the basis of the determined analysis sequence.” Further, Joji discusses the controller as handling different reagent types and selecting a “target reagent” according to the test: “Upon receiving an instruction to select a test item and start analysis from the operation unit 115, the target reagent container 103 is set according to the test item.” As such, the dispensing sequence for each specimen is set to a dispensing sequence of specimens and types of analysis set forth in the analysis information of a “group” (one or more samples) commensurately as claimed.),
as in Claim 1.
Further regarding Claim 1, Joji does not specifically teach the automatic analyzer discussed above wherein the second dispensing unit accesses the common disk for retrieving specimen/reagent, as in Claim 1.
However, Suzuki teaches a respective automated analyzer comprising a common disk 108 holding vessels 113, wherein a plurality of dispensing probes 107/109 engage the vessels 113 for handling fluid contents held inside, further pipetting fluid from one vessel 113 to another on the common disk 108 ([0071]). Therein, this plural arrangement of probes reduces the waiting time between analysis operations via multiple processes happening in parallel (dispensing of both sample and reagent to the common disc), thereby improving the throughput ([0035-0041]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the automatic analyzer of Joji wherein the first and second probes commonly access a common disk, such as suggested by Suzuki, so as to reduce the waiting time between analysis operations via multiple processes happening in parallel, thereby improving the throughput, and would have a reasonable expectation of success therein given the similar probes and disks of Joji, merely requiring simple rearrangement inspired through Suzuki.
Further regarding Claim 1, Joji does not specifically teach the automatic analyzer discussed above comprising a processor configured to sort analysis items based on the possibility of carryover between specimens into a first analysis item group having a high possibility of carry over and a second analysis item group having a lower possibility of carryover than the first analysis item group, as in Claim 1.
However, Matsubara teaches a respective automated clinical/biological analyzer (abstract) comprising a control unit which sorts analysis items based on possibility of carryover into first and second analysis groups so as to alleviate the carryover effect and thereby reduce cross contamination so as to improve the analysis accuracy ([0017]: “a method of analyzing a biological sample in which sampling with a pipette used for an analysis item having a high carryover avoidance level is performed prior to sample collection with a pipette used for an analysis item having a low carryover avoidance level” – [0034]: “Analysis unit control unit 101 built in analysis unit 100
Manages operation control of each mechanism in the analysis unit 100 and calculation of measurement data of analysis items.”).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the automatic analyzer of Joji to further include a processor configured to sort analysis items based on the possibility of carryover between specimens into a first analysis item group having a high possibility of carry over and a second analysis item group having a lower possibility of carryover than the first analysis item group, such as suggested by Matsubara, so as to alleviate the carryover effect and thereby reduce cross contamination so as to improve the analysis accuracy.
Further regarding Claim 1, Joji does not specifically teach the automatic analyzer discussed above further comprising an incubator which holds reaction vessels, as in Claim 1.
However, Yin teaches a respective automated analyzer (Fig. 2) comprising sample vessels held in a fixing member 2-2 and reagent vessels held in a fixing member 2-3 being on a common disk 2-1 (“The apparatus 2 includes a sample reagent disk 2-1 and a sample tube fixing member 2-2, a working fluid/inhibitor solution fixing member 2-3, and a mixed reagent fixing member 2 which are uniformly distributed in the circumferential direction of the sample reagent disk 2-1, respectively.”). Said samples and reagents are respectively pipetted to reaction vessels held on an incubator/reaction disk 3-1 which maintains the reaction vessels at an incubation temperature provided through a temperature control device 8 (“The reaction device 3 is periodically rotated around the axis under the driving action of the driving system; the reaction device 3 includes: a reaction disk 3-1 and a plurality of cuvette fixing members 3-2 uniformly distributed along the circumferential direction of the reaction disk.” – “Specifically, the temperature control device 8 is a temperature control tank having a trough-like structure such that 81 cuvettes can be located inside the trough structure to keep the ambient temperature inside the reaction device at the reaction temperature and the incubation temperature during the reaction.”). Therein, this arrangement provides for the ability to perform analyses requiring particular temperature incubation, increasing the number of analytical capabilities of the device.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Joji to further include an incubator which holds reaction vessels, such as suggested by Yin, so as to provide for the ability to perform analyses requiring particular temperature incubation, thereby increasing the number of analytical capabilities of the device.
Further regarding Claim 1, the second dispensing unit of Joji dispenses reagent from a second disk to vessels in a reaction area and does not reach the common disk. However, as discussed above, Yin teaches a respective automatic analyzer where both samples and reagents are specifically recited as being held on a common disk 2-1, and wherein dispensing unit 4 reaches to pipet fluid from both the reagent and sample vessels held on the common disk 2-1 to vessels held on the reaction disk 3-1 (See Fig. 2.). Therein, this particular arrangement commensurate with the claimed arrangement of Claim 1 is a mere obvious alternative means for arranging sample/reagent/reaction vessels within an automated system wherein their respective positions within the device do not affect its function of mixing samples with reagents and performing analyses.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the automatic analyzer of Joji wherein the samples and reagents are held in vessels on a common disk reachable by both dispensing units, such as suggested by Yin, as this would be a mere obvious alternative arrangement achieving the same goals as in Joji. Further, when implemented in Joji, the two separate dispensing units serve to aspirate both sample and reagent commensurately as in the dispensing unit 4 of Yin. However, even if the dispensing units of modified Joji-Yin are not interpreted as dispensing both sample and reagent, mere duplication of parts has no patentable significance unless a new and unexpected result is produced – see MPEP 2144.04(VI)(B). As such, one skilled in the art would find it obvious to provide an additional dispensing unit 4 of Yin to the analyzer of Joji to increase throughput.
Further regarding Claim 1, Joji does not specifically teach the automatic analyzer discussed above wherein the processor is further configured to create at least one table which stores a relationship between a plurality of types of analysis for a plurality of specimens based on labels attached to each of the specimens; acquire analysis information from the at least one table, as in Claim 1.
However, Aryev teaches an automated laboratory software architecture wherein user input based on sample labels is input through a user interface 58 regarding sample identity and intended analysis type is tabulated, organized, and retrieved by the controller of the analyzer for test planning, allocation, and scheduling (“According to one aspect of the invention, the work flow automation programming further includes programming for allocating and scheduling a set of test requests as between different ones of the specimen processing modules when a plurality of requests for tests have been received and are in need of processing.” – “One important aspect of the invention is that the work flow automation programming is assembled from a plurality of system user objects, each encapsulating a separate user operational category.” – “A work flow automation layer 56 is provided below the user interface layer 58. The work flow automation layer 56 encompasses and implements complete test request processing, result data management, workload management and multiple instrument control.”). Therein, this arrangement allows for workflow optimization so as to improve throughput and the speed of obtaining results for particular samples as defined by a user (See the “Background of the Invention” section.). – Note that while Aryev may not specifically utilize the term “table”, the commensurate data entry and comparison in Aryev compared to the instant claims must necessarily comprise generation of a table or equivalent to store user-entered sample data and sort the items for a particular analysis sequence, as is typical fashion for automated analyzers.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the automated analyzer of Joji wherein the processor is further configured to create at least one table which stores a relationship between a plurality of types of analysis for a plurality of specimens based on labels attached to each of the specimens; acquire analysis information from the at least one table, such as suggested by Aryev, so as to improve throughput and the speed of obtaining results for particular samples as defined by a user.
Regarding Claim 4, the prior art meets the limitations of Claim 1 as discussed above. Further, Joji teaches the automatic analyzer discussed above wherein the processor is further configured to:
when the second analysis item group includes a priority item having a higher priority than a general item that requires normal accuracy, arrange the dispensing sequence of the priority item to be positioned first in the second analysis item group and arranges the dispensing sequence of the same specimen as the specimen included in the first analysis item group and including the priority item to be positioned last in the first analysis item group (Figs. 2 and 3, and [col. 6, line 50]: “Monitoring whether or not there is a request of an extra analysis, for example, an analysis of an urgent specimen which has to be analyzed as a top priority is performed in the analyses (step S204). Here, the monitoring refers to regular communication of the automatic analysis device 100 with the operating unit 115. When an analysis of an urgent specimen is requested, the operating unit 115 sends the content of the analysis request to the automatic analysis device 110 in the regular communication. When an extra analysis arises, the test item of the extra analysis is read out (step S205). – See also [col. 8, line 60] and [col. 10, line 8] which discuss routing of sample to a priority port depending on the priority of the sample as set by a user, such as an urgent sample. – See also [col. 9, line 27]: “When the test items requiring 1 minute become absent or when, for example, an analysis for a higher-priority item such as an urgent specimen is allocated, the 6th port as a priority port may be used for another analysis.”), as in Claim 4.
Regarding Claim 5, the prior art meets the limitations of Claim 4 as discussed above. Further, Joji teaches the automatic analyzer discussed above wherein the processor is further configured to:
when the second analysis item group includes a plurality of the priority items, set a dispensing sequence of the plurality of the priority items to be in descending order of the reaction time, and sets, after the plurality of the priority items, a dispensing sequence of the general items to be in descending order of the reaction time (Figs. 2 and 4, and [col. 6, line 50]: “Next, in step S206, the test item read in step S205 is combined with the test items which are read in step S201 and are sorted in step S202, and the combined test items are re-sorted in descending order of the measurement time length (step S206).” – Given that, as hhown in Figs. 2 and 4, priority items are further subject to the step of sorting by order of reaction time, Joji thereby teaches when the second analysis item group includes a plurality of the priority items, set a dispensing sequence of the plurality of the priority items to be in descending order of the reaction time, and sets, after the plurality of the priority items, a dispensing sequence of the general items to be in descending order of the reaction time as claimed.), as in Claim 5.
Regarding Claim 6, the prior art meets the limitations of Claim 1 as discussed above. Further, Joji teaches the automatic analyzer discussed above wherein the processor is further configured to:
when receiving input of information related to an emergency specimen, determine a dispensing sequence so as to start the analysis of the emergency specimen after the analysis of the specimen currently being analyzed is completed (Figs. 2 and 3, and [col. 6, line 50]: “Monitoring whether or not there is a request of an extra analysis, for example, an analysis of an urgent specimen which has to be analyzed as a top priority is performed in the analyses (step S204). Here, the monitoring refers to regular communication of the automatic analysis device 100 with the operating unit 115. When an analysis of an urgent specimen is requested, the operating unit 115 sends the content of the analysis request to the automatic analysis device 110 in the regular communication. When an extra analysis arises, the test item of the extra analysis is read out (step S205). – See also [col. 8, line 60] and [col. 10, line 8] which discuss routing of sample to a priority port depending on the priority of the sample as set by a user, such as an urgent sample. – Herein, an emergency sample is interpreted as a priority sample. – See also [col. 9, line 27]: “When the test items requiring 1 minute become absent or when, for example, an analysis for a higher-priority item such as an urgent specimen is allocated, the 6th port as a priority port may be used for another analysis.”), as in Claim 6.
Regarding Claim 7, the prior art meets the limitations of Claim 1 as discussed above. Further, Joji teaches the automatic analyzer discussed above wherein the processor is further configured to:
set a dispensing sequence in the first analysis item group to be in descending order of one specimen analysis time ([col. 2, line 30]: “compares predicted reaction time lengths of analysis items requested for the plurality of samples, while determining an analysis order so that analyses of the analysis items are performed in descending order of the predicted reaction time length”), as in Claim 7.
Regarding Claim 16, the prior art meets the limitations of Claim 1 as discussed above. Further, Joji does not specifically teach the automatic analyzer discussed above wherein the types of analysis for the first analysis item are related to biochemistry, and the types of analysis for the second analysis item group are related to immunity, as in Claim 16.
However, the above recitation of Claim 16 is merely drawn to an intended use, wherein limitations based on the intended use of a structure do not confer patentability if the prior art is capable of performing the same function – see MPEP 2111.02(II). -- "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II). As discussed above, the cited prior art of Joji provides to commensurately disclose the positively claimed structural elements of first and second dispensing units, an input unit, a classification unit, and a determination unit of Claim 1, which are fully capable of use with a various types of analysis related to biochemistry and/or immunity.
Further, the automated analyzer of Matsubara is taught as processing analysis items through assays related to biochemistry and immunity (“The analysis item having a high carryover avoidance level may be an immunological analysis or a DNA analysis, and the analysis item having a low carryover avoidance level may be a biochemical analysis.”), so as to obtain sample information through such particular assays.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to perform through the automated analyzer of Joji assays related to immunity and biochemistry, such as suggested by Matsubara, so as to obtain sample information through such particular assays.
Additionally as in Claim 4, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide the controller of an automatic patient sample analyzer, such as that of Joji, such that when the second analysis item group includes a priority item having a higher priority than a general item that requires normal accuracy, arrange the dispensing sequence of the priority item to be positioned first in the second analysis item group and arranges the dispensing sequence of the same specimen as the specimen included in the first analysis item group and including the priority item to be positioned last in the first analysis item group so as to reduce the processing time of priority samples, thereby allowing for more rapid initiation of treatment in priority/urgent patient conditions, and to arrange such same samples among the at least two groups to be measured one after the other to further improve measurement accuracy and reduce the time required to obtain a measurement result; and would have a reasonable expectation of success therein.
The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law – see MPEP 2144(I).
Herein, it is well-known in medicine that urgent patient conditions require rapid identification/analysis and treatment to provide the best patient outcomes so as to reduce organ and tissue damage related to such time-sensitive conditions (Such as measuring troponin in a patient suspected of experiencing a cardiac event.).
Additionally as in Claim 6, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to provide a controller of an automatic patient sample analyzer, such as that of Joji, such that when receiving input of information related to an emergency specimen, determine a dispensing sequence so as to start the analysis of the emergency specimen after the analysis of the specimen currently being analyzed is completed, thereby allowing for more rapid initiation of treatment in priority/urgent patient conditions; and would have a reasonable expectation of success therein.
The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law – see MPEP 2144(I).
Herein, it is well-known in medicine that urgent patient conditions require rapid identification/analysis and treatment to provide the best patient outcomes so as to reduce organ and tissue damage related to such time-sensitive conditions (Such as measuring troponin in a patient suspected of experiencing a cardiac event.).
Response to Arguments
35 USC 112
Applicant’s amendments sufficiently overcome those indefiniteness rejections of Claims 1 and 19 set forth by the previous office action under 35 USC 112(b). As such, those rejections of Claims 1 and 19 under 35 USC 112(b) are withdrawn. Note that a new grounds of rejection is set forth herein over Claim 1 being indefinite under 35 USC 112(b).
35 USC 103
Applicant’s remarks submit that the substance of the interview performed on 11 February 2026 was incorporated into the amended claims of the supplemental response filed 02/20/2026 and that the instant amended claims are thereby allegedly allowable. However, upon further search and consideration, Examiner has cited the additional references of Matsubara, Yin, and Aryev as providing for the additional limitations provided by Applicant as discussed above in the body of the action. The combination of Joji in view of Suzuki, Matsubara, Yin, and Aryev provides for each and every limitation of the instant claims and they are thereby not allowable under 35 USC 103.
Further, in Applicant’s arguments filed on 01/20/2026, Applicant argues that Joji teaches separate dispensing units for dispensing reagent from a reagent disk, and sample from a sample disk.
Applicant’s arguments are not persuasive because the prior art of Yin is applied herein, as necessitated by Applicant’s amendments specifying: “the reagent vessels on the common disk” and “the specimen vessels on the common disk”. Yin teaches sample and reagent both being positioned on a common disk wherein the dispensing unit 4 dispenses both sample and reagent. Implementation of this arrangement into Joji as a mere obvious alternative means of organizing samples and reagents would result in both dispensing units of Joji operating on the common disk (commensurately as in the dispensing unit 4 for obtaining both samples and reagents) as both reagents and samples are stored on said common disk.
Thus, Examiner sets forth the rejection of Claims 1, 4-7, and 16 under 35 U.S.C. 103 as being unpatentable over Joji in view of Suzuki, Matsubara, Yin, and Aryev.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN KASS whose telephone number is (703)756-5501. The examiner can normally be reached Monday - Friday from 9:00 A.M. to 5:00 P.M. EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi, can be reached at telephone number (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
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 https://www.uspto.gov/patents/uspto-automated-interview-request-air-form.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center; and visit https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you need assistance from a USPTO Customer Service Representative, call (800) 786-9199 (IN USA OR CANADA) or (571) 272-1000.
/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798
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