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 January 20, 2026 has been entered.
Claims 1-11, 13-14, and 16 remain pending and examined in the application. Claims 12 and 15 are canceled.
Applicant’s amendments to the Claims have overcome each and every 112(b) rejection previously set forth in the Non-Final Office Action mailed October 23, 2025.
Claim Interpretation
The limitation “a storage” has been interpreted as a region of space capable of storing an object.
The limitation “an additional storage” has been interpreted as a region of space capable of storing an object.
The limitation “a disposal unit” has been interpreted as any device, apparatus, or section capable of housing control sample aliquots that are unwanted, or to be discarded.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-11, 13-14, and 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The subject matter eligibility test for the claims is shown below:
Subject Matter Eligibility Test, Step 1
Independent claim 1 is drawn to a method, and is therefore drawn to a statutory category. Independent claim 11 is drawn to a system, and is therefore drawn to a statutory category. Independent claim 14 is drawn to a non-transitory computer readable medium, and is therefore drawn to a statutory category.
Subject Matter Eligibility Test, Step 2A Prong One
In Step 2A Prong One, it is determined if the claims recite an abstract idea, law of nature, or natural phenomenon. Independent claim 1 recites a method of measuring control sample aliquots according to a validation time schedule, where the validation time schedule is used to determine the total number of control sample aliquots and an aliquot volume for each control sample aliquot, generating unique identification tags for one or more vessels containing the total control sample volume, and displaying information for distributing the one or more vessels to either a storage or to one of at least two analyzers in a laboratory system. The process of sorting control sample aliquots between either a storage or one of at least two analyzers in a laboratory system is a determination step, which is a mental process. The process of generating unique identification tags is an assigning process that can be reasonably performed in the mind, and is therefore a mental process. Additionally, the process of using a validation time schedule to determine the total number of control sample aliquots and an aliquot volume for each control sample aliquot is a calculation that can be reasonably performed in the mind, and is therefore a mental process. (Note: these abstract ideas correspond to the limitations “a) determining a total number of control sample aliquots and an aliquot volume for each control sample aliquot based on a validation time schedule…b) causing the generation of unique identification tags for tagging one or more vessels for containing the total control sample volume…c)… distributing the one or more vessels to a storage…or to one of the at least two analyzers…according to the validation time schedule”). The independent claim is therefore a mental process form of abstract idea, which is a judicial exception.
Similarly, independent claim 11 recites a laboratory system comprising a storage, at least two analyzers, a transport system, and a control unit programmed and configured to execute a method identical to that claimed in independent claim 1, and independent claim 14 recites a non-transitory computer readable medium storing a computer program product comprising instructions to execute a method identical to that claimed in independent claim 1. Therefore, independent claims 11 and 14 recite a mental process form of abstract idea, which is a judicial exception.
Subject Matter Eligibility Test, Step 2A Prong Two
In step 2A Prong Two, it is determined if the claims recite additional elements that integrate the judicial exception into a practical application. In the independent claims, besides the determination of the total number of control sample aliquots and aliquot volume, the generation of unique identification tags, and sorting control sample aliquots between either a storage or one of at least two analyzers in a laboratory system, the only additional steps are attaching the unique identification tag to the one or more vessels as a physical tag, displaying information for distributing the one or more vessels to either of the storage or one of the at least two analyzers, and controlling, by a control unit, a transport system to automatically distribute the one or more vessels according to a distribution schedule of the distribution information. The attaching of the unique identification tag to the one or more vessels as a physical tag is insignificant extra-solution activity, as it is merely amounts to outputting the processed data in a physical manner, while the displaying of information is also insignificant extra-solution activity, as it amounts merely to necessary data outputting. See MPEP 2106.05(g). Further, the step recited in claims 1, 11, and 14 of controlling, by a control unit, a transport system to automatically distribute the one or more vessels according to a distribution schedule of the distribution information amounts to nothing more than the words “apply it” in regards to the judicial exception, particularly as this step is recited at a high level of generality, without providing any specifics as to how the one or more vessels are automatically distributed according to the distribution schedule. See MPEP 2106.05(f). The dependent claims additionally recite: i) the specifics of how the validation time schedule includes time segments that include specific time periods at which control sample aliquots are transported to one or more of the at least two analyzers (claim 2), ii) the time segments are related to the control sample onboard stability time (claim 3), iii) the specifics of how the validation time schedule determines the total number of control sample aliquots, the number of control sample aliquots per time segment (claims 4-5), iv) the specifics of how validation time schedule dictates the timing for distributing the control samples, and ensuring that the volume difference of each control sample aliquot is equal to or less than one volume of a control sample (claim 6), v) the specifics of how information is displayed (claim 7), vi) providing an additional storage, and using the validation time schedule to determine where control sample aliquots travel between the storage, additional storage, and the at least two analyzers (claim 8), vii) the transport of further control sample aliquots between the storage, additional storage, and the at least two analyzers (claim 9), viii) determining if control sample aliquots should be disposed based on calculating how long a control sample aliquot has been exposed to a given temperature, comparing the calculated time to a stability time, where control sample aliquots are determined to be passed to a disposal unit if the calculated time exceeds a stability time (claims 10 and 13), ix) reading an identification tag, and recording a time stamp that each reading was performed at (claim 16), and independent claim 11 further recites x) a laboratory system comprising a storage, at least two analyzers, a transport system, and a control unit for performing the method. With the exception of x), these are all mental steps, which are not integrated into a particular application. Rather, the mental processes have not been applied at all. Step x) recites little more than applying the judicial exception, or using generic lab equipment and a computer to implement the judicial exception. Alternatively, employing a computer to automate an analytical laboratory in the generic sense recited is well-understood, routine and conventional in the automatic analysis art. Further, at least limitations i)-ix) are further abstract ideas, as they are mental processes involving evaluating and determining.
Subject Matter Eligibility Test, Step 2B
In step 2B, it is determined if the claim recites additional elements that amount to significantly more than the judicial exception. In this case, the claims recite a laboratory system with at least two analyzers, a computer, one or more vessels, a storage, an additional storage, a disposal unit, a reader, a transport system, a control unit, a unique identification tag attached to the one or more vessels as a physical tag. These generically recited elements are nothing more than well-understood, routine, and conventional components that are well-known in the art. Further, the step recited in claims 1, 11, and 14 of displaying information for distributing the one or more vessels to the storage or to one of the at least two analyzers, amounts to nothing more than insignificant extra-solution activity, and does not integrate the judicial exception into a practical application. Further, the step recited in claims 1, 11, and 14 of controlling, by a control unit, a transport system to automatically distribute the one or more vessels according to a distribution schedule of the distribution information amounts to nothing more than the words “apply it” in regards to the judicial exception, particularly as this step is recited at a high level of generality, without providing any specifics as to how the one or more vessels are automatically distributed according to the distribution schedule. See MPEP 2106.05(f). Still further, the application of these mental processes into an analytical laboratory environment is nothing more than generally linking the mental process judicial exception to a particular technological environment or field of use. See MPEP 2106.04(d) and MPEP 2106.04(d)(2), section c.
Further, with regards to the generically recited computer, control unit, and generically recited lab equipment being nothing more than well-understood, routine, and conventional components that are well-known in the art, the following prior art is relied upon to show that the above elements are well-understood, routine, and conventional:
Akutsu (US Pub. No. 2008/0219887; already of record) teaches a laboratory system with at least two analyzers ([0029], see Fig. 1 at analysis modules 31, 32), a computer ([0029], see Fig. 1 at management computers 1, 2), one or more vessels ([0035]), a storage ([0029], see Fig. 1 at sample rack storage part 11), an additional storage ([0029], see Fig. 1 at sample rack buffer unit 21), a reader ([0029], see Fig. 1 at ID reader 12), a transport system ([0029], see Fig. 1 at transfer line 13), and a control unit ([0029], [0033], the management computers perform necessary control of the components in the system).
Suzuki et al. (US Pub. No. 2015/0031143; hereinafter Suzuki; already of record) teaches a reader ([0036], see Fig. 1 at reading unit 24), a storage (see Fig. 7 at storage unit), and a unique identification tag attached to the one or more vessels as a physical tag ([0022]).
Lindsey et al. (US Pub. No. 2002/0015665; hereinafter Lindsey; already of record) teaches a laboratory system with at least two analyzers ([0033], see Fig. 1 at automated general chemical analyzer 10 and automated immunodiagnostic analyzer 20), a computer ([0044]-[0045]), one or more vessels ([0015]), a storage ([0036], see Fig. 1 at sample rack input area 32), an additional storage ([0036], see Fig. 1 at bypass area 34), a disposal unit ([0036], see Fig. 1 at sample rack output area 36. Racks are capable of being disposed of from this area), a reader ([0036], see Fig. 1 at bar code reader 42), a transport system ([0036], see Fig. 1 at external shuttle 38 and internal shuttle 40), and a control unit ([0044]-[0045]).
Claims 2-10, 13, and 16 are rejected as depending on a claim rejected under 35 U.S.C. 101.
Response to Arguments
Applicant's arguments filed January 20, 2026 have been fully considered but they are not persuasive.
Applicant argues on Pgs. 9-11 of their Remarks that the claimed subject matter should no longer be rejected under 35 USC 101 as being directed to an abstract idea without significantly more, as the claims specify that a control unit automatically controls a transport system to distribute the one or more vessels according to a distribution schedule of the distribution information. The Applicant argues that Example 45 of the 101 training examples is similar to the instantly claimed subject matter, and as Claims 2 and 3 of Example 45 were found to be subject matter eligible, and recite a controller configured to perform a positively recited action, that the instantly claimed subject matter should also be subject matter eligible for reciting a controller configured to perform a positively recited action. The Examiner respectfully disagrees. The instantly recited control unit is generically recited, and performing the actions automatically is insufficient to make the claimed subject matter patent eligible. The actions recited in the instant claims are in fact not particular at all. Controlling a transport system to automatically distribute vessels according to a distribution schedule is an action that is recited at a high level of generality, and does not impart sufficient meaning to the judicial exception such that the judicial exception is integrated into a practical application. It still amounts to "apply it", which is insignificant extra-solution activity. See MPEP 2106.05(f). While the claims recited in Claims 2 and 3 of Example 45 recite what action is being automatically performed by the controller with a level of specificity sufficient to integrate the judicial exception into a practical application, the same cannot be said for the instant claims. Therefore, the instant claims remain rejected under 35 USC 101. For a more detailed explanation, please see the Claim Rejections-35 USC 101 section of this instant Office Action.
Further, with regards to Applicant’s argument on Pg. 11 of their Remarks that at least multiple dependent claims do provide details of how the distribution information is determined in detail, the Examiner disagrees that the details included in the dependent claims are sufficient to integrate the judicial exception into a practical application. Rather, the dependent claims provide further details about what the judicial exception is.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to John McGuirk whose telephone number is (571)272-1949. The examiner can normally be reached M-F 8am-530pm.
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/JOHN MCGUIRK/Examiner, Art Unit 1798