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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/23/2025 has been entered.
Status of Claims
Claim 8-15 are under examination.
Claims 1-7 have been canceled.
Response to Amendment
Applicant’s amendments to the claims, received 12/23/2025, have overcome each of the 112(b) rejection(s) previously set forth in the Final Rejection mailed on 09/23/2025. However, based on the claim amendments, new 112(b) rejections have been set forth.
Based on the amended claims and remarks received on 12/23/2025, the prior art rejection over Miller has been withdrawn and a new prior art rejection is set forth (see below).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 8-15 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 pre-AIA the applicant regards as the invention.
Claim 8 lines 14, 16, 17, and 20 refer to “the dispensed sample”. However, this is ambiguous in view of lines 3-4, 6-7, and 9-11 which previously recite “an operation unit configured to operate the conveyance unit and convey a sample to the analysis device”, “a dispensing unit configured to dispense the quality control sample” and “the operation unit operates the conveyance unit to automatically convey a plurality of dispensed samples by the dispensing unit to an analysis device”.
(I) It is unclear to the examiner if/how applicant is intending to distinguish the quality control sample from the plurality of samples. In other words, it is unclear if the plurality of dispensed samples in line 10 are from a patient sample or a blood sample, or if the plurality of samples are from the quality control sample stored in the common storage cabinet to create plurality of dispensed quality control samples. If applicant is intending for the plurality of samples to be a plurality of quality control samples from the quality control sample stored in the common storage cabinet, the examiner suggests using the same terminology/modifiers when referring to the same feature of the claimed invention.
(II) The term “the dispensed sample” is ambiguous in that it could be referring to the quality control sample stored in the storage cabinet and configured to be dispensed by the dispensing unit, or “the dispensed sample” could also be referring to one of the “plurality of dispensed samples” and it is unclear if applicant is referring to the quality control sample stored in the storage cabinet, or one of the plurality of dispensed samples, or each of the plurality of dispensed samples. If applicant is referring to one of the plurality of dispensed samples, it is further unclear which sample among the plurality of dispensed samples applicant is referring to as “the dispensed sample”.
Claims 9-15 are also rejected by their dependency from claim 8. A similar rejection is also made over claims 11 and 15 with respect to “the dispensed sample”.
Claim 8 lines 13-14, 18, 19, and 20 refer to “the storage cabinet”. Claim 8 line 5 previously refers to “a common storage cabinet”. It is unclear if the storage cabinet and common storage cabinet are referring to the same feature or if applicant is intending to define two distinct features in the claim. If applicant is intending for the storage cabinet and the common storage cabinet to be the same feature, the examiner requests applicant use the same terminology/modifiers, and to carry the terminology/modifiers throughout the entire claim set. A similar rejection is also made over claims 11 and 13-15.
Claim 9 refers to “a dispensed sample”. However, claim 8 line 10 previously recites “a plurality of dispensed samples”. It is unclear if applicant is referring to one of the plurality of dispensed samples previously defined in claim 8, or if applicant is intending to introduce another dispensed sample. A similar rejection is also made over claims 12-13.
Claim 13 recites “a dispensing unit”. Claim 8 line 6 also refers to “a dispensing unit”. It is unclear if applicant is reciting an additional dispensing unit or if applicant is intending to refer to the dispensing unit previously recited. Perhaps applicant is intending to recite “the dispensing unit”?
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 8-10 and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Babson (US 2006/0245865 – hereinafter “Babson”), in view of Yano (US 2012/0179405; already of record – hereinafter “Yano”), and further in view of Shiba et al. (US 2017/0010292 – hereinafter “Shiba”).
Regarding claim 8, Babson disclose an automatic analysis system (Babson; fig. 1, [0019]) comprising:
an analysis devices (Babson; fig. 1, #107, [0020]);
a conveyance unit to which the analysis device are connected (Babson; fig. 1, #108, [0021]); and
an operation unit configured to operate the conveyance unit and convey a sample to the analysis device (Babson; fig. 1, #101, [0020]),
wherein the automatic analysis system includes a common storage cabinet that stores a quality control sample that is suppliable to the analysis device (Babson disclose control samples are loaded onto a linear rack which will be either transferred automatically from a rack loader using transfer mechanism 7 into the first carousel or will be manually placed on the transfer mechanism 7 for insertion into the first carousel. Thereafter, under computer control, the linear rack containing the control samples will be passed to the second carousel 3 and then be passed into the control storage element 4; fig. 2, #4, [0027]. Accordingly, storage element 4 is a common storage cabinet that stores a quality control sample that is supplied to the analysis device), and a dispensing unit configured to dispense the quality control sample (Babson disclose the control samples may be used to calibrate the analyzer prior to performance of certain tests and/or periodically during operation of the analyzer; [0027]. When needed, a transfer mechanism will transfer the linear rack with control samples back into the carousel 3, which will then transport the linear rack to the pipetting station 5. The control sample can then be either diluted at the diluting station 6, or pipetted directly into a vessel (not shown), which preferably passes along, under computer control, outside of platform 1; fig. 2, #5, #6, [0028]),
in accordance with a rule registered in advance for the analysis device, the operation unit operates the conveyance unit to automatically convey a plurality of dispensed samples dispensed by the dispensing unit to the analysis device (Babson disclose a sample in a linear rack that is loaded into a slot of carousel 2 can remain in carousel 2 for a period of time determined by the tests to be performed in the linear rack, the tests to be performed in all of the other linear racks loaded into carousels 2 and 3, any priorities which have been set by a technician to perform some tests more quickly than other; [0025]. Babson also teach the control samples are used to calibrate the analyzer prior to the performance of certain tests and/or periodically during operation of the analyzer; [0027]. Accordingly, Babson disclose a rule registered in advance. Babson also disclose the linear rack in carousel 3 is then rotated to one or more positions which are accessible by one or more pipettors 5 for obtaining sample and transferring the sample to a test vessel. If required, dilutions can be performed at station 6. Pipetting can be used to retrieve sample from the linear rack for transferring to a test vessel (not shown) used in, for example, an immunoassay analyzer. Samples can remain on carousel 3 or be transferred back to carousel 2 and remain on carousel 2 until all tests on the samples in the rack are completed. Once all tests have been initiated on all of the samples on a linear rack, the linear rack can be ejected back to the rack loader for storage; [0026]. Further, Babson disclose a bead subsystem 105 adds an appropriate substrate having a bound “analyte binding compound” to a test vessel in which, for example, an antibody-antigen binding interaction will be performed for testing the amount of an antibody or antigen of interest in the sample. A large number of different analytes can be tested using beads or other substrates that are added to a test vessel. In addition, multiple tests for different analytes in the same sample can be performed simply by adding the appropriate bead with bound analyte to each of several test vessels, and then adding sample from the sample tubes on the linear rack to each of the test vessels (i.e., immunoassay or chemical analyzers which include bead subsystems 105); [0020]. The control samples are added to the analyzer in the same manner as samples to be tested; [0028]. Therefore, the sample and control sample dispensed by the pipetting station 5 are a plurality of dispensed samples conveyed to the analyzer according to a rule), and
the dispensed sample that was measured by one of the plurality of analysis device is returned to the storage cabinet by the conveyance unit (As best understood, Babson disclose when the quality control sample is needed, a transfer mechanism will transfer the linear rack with control samples back into the carousel 3, which will then transport the linear rack to the pipetting station 5. The control sample can then be either diluted at the diluting station 6, or pipetted directly into a vessel (not shown), which preferably passes along, under computer control, outside of platform 1. Then, the control sample will be moved back into the control storage element 4 using movements of carousel 3 and the transfer mechanism located between the carousel and control storage element 4; fig. 2, #5, #6, [0028]. Further, Babson disclose multiple tests for different analytes in the same sample can be performed simply by adding the appropriate bead with bound analyte to each of several test vessels, and then adding sample from the sample tubes on the linear rack to each of the test vessels (i.e., immunoassay or chemical analyzers which include bead subsystems 105); [0020]. Samples can remain on carousel 3 or be transferred back to carousel 2 and remain on carousel 2 until all tests on the samples in the rack are completed. Once all tests have been initiated on all of the samples on a linear rack, the linear rack can be ejected back to the rack loader for storage; [0026]. When a control sample is needed, a transfer mechanism will transfer the linear rack with control samples back into the carousel 3, which will then transport the linear rack to the pipetting station 5. The control sample can then be either diluted at the diluting station 6, or pipetted directly into a vessel (not shown), which preferably passes along, under computer control, outside of platform 1. The control samples are added to the analyzer in the same manner as samples to be tested; [0028]. Therefore, the sample and control sample return to the storage cabinet), and the storage cabinet stores the dispensed sample, the storage cabinet temporarily stores the dispensed sample, and after a result of a quality control is obtained, the storage cabinet discards the temporarily stored dispensed sample, or conveys the dispensed sample to a housing unit outside the storage cabinet (Babson disclose the storage cabinet 4 stores the dispensed quality control sample and the storage cabinet 4 conveys the dispensed sample to a housing unit 3 outside of the storage cabinet when the control sample is needed; [0027-0028]. Accordingly, the common storage cabinet 4 stores the dispensed control sample and conveys the dispensed quality control sample to a housing 3 outside of the common storage cabinet 4 to calibrate the analyzer prior to the performance of certain tests and/or periodically during operation of the analyzer. Further, samples can remain on carousel 3 or be transferred back to carousel 2 and remain on carousel 2 until all tests on the sample in the rack are completed. Once all tests have been initiated on all of the samples on a linear rack, the linear rack can be ejected back to the rack loader for storage; [0025-0026]).
Babson does not explicitly teach a plurality of analysis devices.
However, Yano teach the analogous art of an automatic analysis system (Yano; fig. 1, [0015]) comprising: a plurality of analysis devices (Yano; fig. 1, #100, #200, #300, [0015]); a conveyance unit to which the analysis devices are connected (Yano; fig. 1, #16, #19, #20, #23, #24, #27, [0030]); and an operation unit configured to operate the conveyance unit and convey a sample to the analysis devices (Yano; fig. 1, #01, [0015, [0022]), wherein the automatic analysis system includes a common storage cabinet that stores a quality control sample that is suppliable to the plurality of analysis devices, and a dispensing unit configured to dispense the quality control sample (Yano teach a common storage cabinet 18/22/26 configured to store samples generated by a dispensing unit 12; [0015, 0017, 0020]. The samples include quality control samples; TABLE 1, “Retained samples”, “QC”), the operation unit operates the conveyance unit to automatically convey a plurality of dispensed samples dispensed by the dispensing unit to an analysis device of the plurality of analysis devices (Yano; TABLE 1, see “Retained Samples” & “QC”, TABLE 4, see “Queued samples” & “Processed samples”, [0019-0020]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the automatic analysis system of Babson to comprise a plurality of analysis devices in which a plurality of dispensed samples dispensed by the dispensing unit are convey, as taught by Yano, because Yano teach the plurality of analysis devices use item-specific reagents for analysis in which the samples to be analyzed according to the item-specific reagents are conveyed thereto; [0015]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Babson and Yano both teach test a sample according to plurality of assays.
Modified Babson does not teach the storage cabinet stores the dispensed sample when a predetermined condition including that a remaining volume of the dispensed sample is sufficient is satisfied; if the remaining volume of the dispensed sample is insufficient, the storage cabinet temporarily stores the dispensed sample, and after the storage cabinet discards the temporarily stored dispensed sample, or conveys the dispensed sample to a housing unit outside the storage cabinet.
However, Shiba teach the analogous art of an automatic analysis system (Shiba; fig. 1, [0016]) comprising a storage cabinet that stores a consumable (Shiba; fig. 1, #41, [0016]) wherein the storage cabinet stores the consumable when a predetermined condition including that a remaining volume of the consumable is sufficient is satisfied; if the remaining volume of the consumable is insufficient, the storage cabinet temporarily stores the consumable, and after the storage cabinet discards the temporarily stored consumable, or conveys the consumable to a housing unit outside of the storage cabinet (Shiba teach consumables of which the remaining amount is slight and which might become empty in course of analysis in a day are set in the loading gate 75 for the storage cabinet 40. The examiner notes that the consumable in which the remaining amount is slight is a previously dispensed consumable which is being temporarily stored in the cabinet and if an insufficient amount is determined, the temporarily stored consumable is conveyed to a housing unit outside of the cabinet).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the conditions for storing the dispensed sample(s) of modified Babson with the predetermined condition based on a remaining volume of the consumable, as taught by Shiba, because Shiba teach the predetermined condition based on a remaining volume of the consumable minimizes interruption of an analysis (Shiba; [0007]). One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since modified Babson and Shiba both teach temporarily storing a consumable in a storage cabinet and dispensing a portion of the consumable for analysis.
Regarding claim 9, modified Babson teach the automatic analysis system according to claim 8 above , wherein when one of the plurality of analysis devices notifies the operation unit of information that is a trigger of a quality control, the operation unit instructs the storage cabinet to take out the quality control sample, and the conveyance unit conveys the quality control sample to the dispensing unit, and the conveyance unit conveys a dispensed sample dispensed by the dispensing unit to the analysis device (Babson; 0027-0028]).
Regarding claim 10, modified Babson teach the automatic analysis system according to claim 8 above, wherein the rule includes at least one of a type of a sample used for a quality control, a time interval for implementing a quality control, and the number of measurements of a general sample as a condition for implementing a quality control (Babson; [0027]).
Regarding claim 12, modified Babson teach the automatic analysis system according to claim 8, wherein a plurality of dispensed samples dispensed by the dispensing unit are conveyed to the different analysis devices (The modification of the automatic analysis system of Babson to comprise a plurality of analysis devices in which a plurality of dispensed samples dispensed by the dispensing unit are convey, as taught by Yano, has previously been discussed in claim 8 above. Yano teach conveying a plurality of dispensed samples to the different analysis device; [0020, 0022]).
Regarding claim 13, modified Babson teach the automatic analysis system according to claim 8, further comprising: a dispensing unit configured to dispense the quality control sample (As best understood, Babson teach multiple pipetting stations 5 positioned on the end of the platform adjacent to carousel 3 so that two pipettors can be used to simultaneously pipette samples from two different sample tubes; [0024]), wherein a dispensed sample dispensed by the dispensing unit is conveyed to one of the plurality of analysis devices, and the quality control sample that is a dispensing source is conveyed to the storage cabinet, and is stored in the storage cabinet when the predetermined condition is satisfied (The modification of the automatic analysis system of Babson to comprise a plurality of analysis devices in which a plurality of dispensed samples dispensed by the dispensing unit are convey, as taught by Yano, and the modification of the conditions for storing the dispensed sample(s) of modified Babson with the predetermined condition based on a remaining volume of the consumable, as taught by Shiba, have previously been discussed in claim 8 above. Babson teach returning the control sample that is a dispensing source to the storage cabinet and conveying a dispensed sample dispensed by the dispensing unit to the analysis device; [0028]).
Regarding claim 14, modified Babson teach the automatic analysis system according to claim 8 above, further comprising: a plurality of storage cabinets, wherein the plurality of storage cabinets supplies the quality control sample to the plurality of analysis devices (Babson teach the storage element 4 comprise at least two cabinets for housing at least two linear storage racks filled with control samples; [0028]).
Regarding claim 15, modified Babson teach the automatic analysis system according to claim 12 above, wherein when the measurement by the one of the plurality of analysis devices is completed, the conveyance unit returns the dispensed sample, and the storage cabinet stores the dispensed sample when the predetermined condition is satisfied (The modification of the automatic analysis system of Babson to comprise a plurality of analysis devices in which a plurality of dispensed samples dispensed by the dispensing unit are convey, as taught by Yano, and the modification of the conditions for storing the dispensed sample(s) of modified Babson with the predetermined condition based on a remaining volume of the consumable, as taught by Shiba, have previously been discussed in claim 8 above. Babson teach prior to certain tests or periodically during operation, thus when a measurement is completed, the conveyance unit returns the dispensed sample and the storage cabinet stores the dispensed sample; [0027-0028]).
Modified Babson does not teach the conveyance unit returns the dispensed sample from the one of the plurality of analysis devices to the storage cabinet.
However, Yano teach the analogous art of an automatic analysis system (Yano; fig. 1, [0015]) comprising: a plurality of analysis devices (Yano; fig. 1, #100, #200, #300, [0015]); a conveyance unit to which the analysis devices are connected (Yano; fig. 1, #16, #19, #20, #23, #24, #27, [0030]); and an operation unit configured to operate the conveyance unit and convey a sample to the analysis devices (Yano; fig. 1, #01, [0015, [0022]), wherein the automatic analysis system includes a common storage cabinet that stores a quality control sample that is suppliable to the plurality of analysis devices, and a dispensing unit configured to dispense the quality control sample (Yano teach a common storage cabinet 18/22/26 configured to store samples generated by a dispensing unit 12; [0015, 0017, 0020]. The samples include quality control samples; TABLE 1, “Retained samples”, “QC”), the operation unit operates the conveyance unit to automatically convey a plurality of dispensed samples dispensed by the dispensing unit to an analysis device of the plurality of analysis devices, where when the measurement by the one of the plurality of analysis devices is completed, the conveyance unit returns the dispensed sample from the one of the plurality of analysis devices to the storage cabinet, and the storage cabinet stores the dispensed sample (Yano; TABLE 1, see “Retained Samples” & “QC”, TABLE 4, see “Queued samples” & “Processed samples”, [0019-0020]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the automatic analysis system and predetermined condition of Babson to return the dispensed sample from the one of the plurality of analysis devices to the storage cabinet when the measurement by the one of the plurality of analysis devices is completed, as taught by Yano, because Yano teach that returning the dispensed sample to the storage cabinet from one of the plurality of analysis devices allows a next sample to be processed by the one of the plurality of analysis devices; [0015-0016]. One of ordinary skill in the art would have expected this modification could have been performed with a reasonable expectation of success since Babson and Yano both teach test a sample according to plurality of assays.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Babson, in view of Yano, in view of Shiba, and further in view of Miller (US 2005/0037502; already of record – hereinafter “Miller”).
Regarding claim 11, modified Babson teach the automatic analysis system according to claim 8, wherein the storage cabinet stores the returned dispensed sample (The modification of the conditions for storing the dispensed sample(s) of modified Babson with the predetermined condition based on a remaining volume of the consumable, as taught by Shiba, has previously been discussed in claim 8 above. Babson teach returning the dispensed sample to the storage cabinet; [0027-0028]).
Modified Babson does not teach when none of a maximum storage time of the dispensed sample, a maximum usage time of the dispensed sample, and a maximum number of usages of the dispensed sample is exceeded, the storage cabinet stores the returned dispensed sample.
However, Miller disclose an automatic analysis system (Miller; fig. 1, #10, [0027]) comprising: a plurality of analysis devices (Miller; fig. 1, #32, #38, #42, [0028]); a conveyance unit to which the analysis devices are connected (Miller; fig. 1, #14, [0028]); and an operation unit configured to operate the conveyance unit and convey a sample to the analysis devices (Miller; fig. 1, #15, [0030]), wherein the automatic analysis system includes a common storage cabinet that stores a quality control sample that is suppliable to the plurality of analysis devices (Miller; [0127, 0163, 0259]), wherein when none of a maximum storage time of the dispensed sample, a maximum usage time of the dispensed sample, and a maximum number of usages of the dispensed sample is exceeded, the storage cabinet stores the returned dispensed sample (Miller; [0089, 0091, 0093, 0101, 0103, 0129, 0160]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the rule for the storage cabinet to store the returned dispensed sample such that when none of a maximum storage time of the dispensed sample, a maximum usage time of the dispensed sample, and a maximum number of usages of the dispensed sample is exceeded, the storage cabinet stores the returned dispensed sample, as taught by Miller, because Miller teaches the accuracy of QC materials are assigned time periods for which each of the analytes is known to be stable (Miller; [0068]).
Response to Arguments
Applicant’s arguments, filed on 12/23/2025, with respect to claim 8, have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to Applicant’s disclosure include:
Calatzis et al. (US 2017/0261526) disclose aliquoting quality control ingredients from a repository of a plurality of quality control ingredients to obtain a quality control sample that mimics the properties of a biological sample to be analyzed.
Yabutain et al. (US 2020/0241024) disclose when a preparation level of QC or calibration is lower than a set value, an alert is issued to notify an operator of necessity of preparation.
Okusa et al. (US 2015/0010436) disclose predicting a time required for calibration and/or QC for a reagent cassette.
Yano et al. (US 2015/0360239) disclose transfer operations for dispensed samples to a plurality of analysis devices.
Conclusion
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/C.A.T./Examiner, Art Unit 1798
/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798