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 .
Claims 1, 6, 7, 18, 23, 24 and 35 have been amended. Claims 36 and 37 are new. Claims 5 and 22 have been cancelled. Claims 1-4, 6-21 and 23-37 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/25/2026 has been entered.
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 1-4, 6-21 and 23-37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1-4, 6-17 and 36-37 are drawn to a method for specimen management for clinical research study systems which is within the four statutory categories (i.e. process). Claims 18-21 and 23-34 are drawn to a system for specimen management for clinical research study systems which is within the four statutory categories (i.e. machine). Claim 35 is drawn to a non-transitory medium for specimen management for clinical research study systems which is within the four statutory categories (i.e. manufacture).
Claims 1-4, 6-17 and 36-37 (Group I) recite a method comprising:
obtaining, by processing circuitry (apply it, MPEP § 2106.05(f)), a schedule of activities that defines one or more activities for completing a trial arm of a clinical study, wherein at least one of the one or more activities includes an assay requiring collection of a specimen from at least one subject group of subjects in the clinical study, and wherein the at least one of the one or more activities includes a plurality of assays requiring collection of one or more specimens from two different subject groups in the clinical study;
presenting, by the processing circuitry (apply it, MPEP § 2106.05(f)), a specimen management user interface (apply it, MPEP § 2106.05(f)) with which a study designer for the clinical study interacts to manage the collection of the specimen for the assay, wherein managing the collection of the specimen includes defining default operational details for the collection of the specimen;
obtaining, by the processing circuitry (apply it, MPEP § 2106.05(f)), a proto-plan defining a sequence of one or more events and a corresponding one or more timepoints during which the collection of the specimen occurs for the at least one subject group in the clinical study, wherein obtaining the proto-plan comprises identifying two or more assays requiring collection of an identical specimen of the one or more specimens, combining the two or more assays as an aliquot that compacts the collection for the identical specimen for a same subject group of the two or more subject groups, and obtaining the proto-plan as the one or more events and the corresponding one or more timepoints during which the collection of the identical specimen for the same subject group is combined for the aliquot; and
presenting, by the processing circuitry and via the specimen management user interface (apply it, MPEP § 2106.05(f))0, the proto-plan for modification, including defining override operational details that override the default operation details for the collection of the specimen for at least one subject group while the default operational details are maintained for a different subject group in the clinical study, wherein presenting the proto-plan further comprises presenting the proto-plan as a hierarchical view of aliquots within a collection element along with the sequence of the one or more events and the corresponding one or more timepoints during which the collection of the identical specimen occurs for the same subject group of the two or more subject groups, the hierarchical view of the aliquots including the aliquot.
The bolded limitations, given the broadest reasonable interpretation, cover a certain method of organizing human activity because it recites fundamental economic practices, commercial or legal interactions, and/or managing personal behavior or relationships or interactions between people. Any limitations not identified above as part of the abstract are underlined and are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for Claims 18-21 and 23-34 and Claim 35 is identical as the abstract idea for Claims 1-4, 6-17 and 36-37 (Group I), because the only difference is the claims groups are directed towards different statutory categories.
Dependent Claims 2-4, 6- 17, 19-21, 23- 34 and 36-37 include other limitations, for example Claims 2 and 19 recite wherein defining the default operational details comprises defining the default operational details prior to the schedule of activities being locked from further editing, Claims 4 and 20 recite obtaining, responsive to the schedule of activities being locked from further editing, receiving the default operational details via the specimen management user interface, and committing the proto-plan, a plan, Claims 4 and 21 recite obtaining a region that identifies a geographical region or a political region; obtaining a cohort that identifies a type of the at least one subject in terms of one or more of age, race, and weight; and obtaining the subject group based on the region and the cohort, Claims 6 and 23 recite wherein obtaining the proto-plan further comprises: identifying at least one different assay of the plurality of assays that requires collection of one or more of a different specimen of the one or more specimens for the same subject group of the two or more subject groups, the same specimen for the different subject group of the two or more subject groups, and a different specimen of the one or more specimens for the different subject group of the two or more subject groups; and obtaining a different aliquot for the collection element that includes the at least one different assay, and wherein the hierarchical view of aliquots within the collection element includes the aliquot and the different aliquot, Claims 7 and 24 recite receiving, via the specimen management user interface, a split aliquot input from a user indicating that the aliquot is to be split; and splitting, responsive to receiving the split aliquot input, the aliquot into a first aliquot having a first aliquot of the two or more aliquots and a second aliquot of the two or more aliquots, the first aliquot different than the second aliquot, wherein presenting the proto-plan includes presenting the proto-plan as the hierarchical view of aliquots that includes the first aliquot and the second aliquot, Claims 8 and 25 recite receiving, via the specimen management user interface, a merge aliquot input from the user indicating that the first aliquot and the second aliquot is to be merged; and merging, responsive to receiving the merge aliquot input, the first aliquot and the second aliquot back into the aliquot, Claims 9 and 26 recite wherein the at least one of the one or more activities includes a plurality of assays, including the assay, requiring collection of one or more specimens from one or more subject groups of the subjects in the clinical study, wherein obtaining the proto-plan comprises identifying a different assay of the plurality of assays that requires collection of one or more of a different specimen of the one or more specimens for the same subject group of the two or more subject groups, the same specimen for the different subject group of the two or more subject groups, and a different specimen of the one or more specimens for the different subject group, and wherein the hierarchical view of aliquots within the collection element includes a first aliquot comprising the assay and a second aliquot comprising the different assay, Claims 10 and 27 recite receiving, via the specimen management user interface, a split collection input from a user indicating that the collection element is to be split; and splitting, responsive to receiving the split collection input, the collection element into a first collection element including a first view hierarchy comprising the first aliquot and a second collection element including a second hierarchical view of aliquots comprising the second aliquot,
wherein presenting the proto-plan includes presenting the proto-plan as the first hierarchical view of aliquots within the first collection element and the second hierarchical view of aliquots within the second collection element, Claims 11 and 28 recite receiving, via the specimen management user interface, a merge collection input from the user indicating that the first collection element and the second collection element is to be merged; and merging, responsive to receiving the merge collection input, the first collection element and the second collection element back into the collection element, Claims 12 and 29 recite wherein the default operational details include one or more of a default isolate indication of whether to isolate the specimen, a default store remainder indication specifying whether any remainder of the specimen is to be stored, a default subject group indication identifying the default subject group, a default shipped from indication indicating a vendor from which the specimen is shipped, a default shipped matrix indication specifying a type of specimen, a default shipped medium indication specifying a medium for shipping, a default shipped to indication specifying where any remainder is to be shipped, a default amount indication specifying an amount of the specimen to collect, and a default unit indication specifying a unit for the amount of the specimen to collect, and wherein the override operational details include one or more of an override isolate indication that overrides whether to isolate the specimen for the assay at the one or more events for the one or more corresponding timepoints, an override store remainder indication specifying an override for whether any remainder of the specimen is to be stored, an override subject group indication identifying an override subject group, an override shipped from indication overriding the vendor from which the specimen is shipped, an override shipped matrix indication overriding the type of specimen, an override shipped medium indication overriding the medium for shipping, an override shipped to indication overriding where any remainder is to be shipped, an overriding amount indication overriding the amount of the specimen to collect, and an overriding unit indication overriding the unit for the amount of the specimen to collect, Claims 13 and 30 recite wherein the default operational details apply to each of the one or more events at the corresponding one or more timepoints, and wherein the override operational details apply to at least one of the one or more events at the corresponding at least one of the one or more timepoints, Claims 14 and 31 recite wherein the at least one subject group is not explicitly defined and includes all of the subjects for the clinical study, Claims 15 and 32 recite further comprising defining, via the specimen management user interface, the subject group as a categorized subset of the subjects in terms of a defined subject characteristic, Claims 16 and 33 recite receiving, via the specimen management user interface, a decouple plan input specifying that at least one event of the one or more events and at least one corresponding timepoint of the one or more timepoints is to be decoupled into a first proto-plan that includes remaining events of the one or more events and not the at least one event and a second proto-plan distinct form the first proto-plan, the second proto-plan including the at least one event; and decoupling, responsive to receiving the decouple plan input, the proto-plan into the first proto-plan and the second proto-plan, Claims 17 and 34 recite receiving, via the specimen management user interface, a rejoin plan input specifying that the first proto-plan and the second proto-plan are to be rejoined; and rejoining, responsive to receiving the rejoin plan input the first proto-plan and the second proto-plan to obtain the proto-plan, Claim 36 recites receiving, via the specimen management user interface, an omit assay input specifying that the assay is to be omitted for the at least one subject group; and reducing a collection amount of the specimen for the at least one subject group responsive to receiving the omit assay input, and Claim 37 recites wherein the default operational details include a process at site indication specifying whether the specimen is to be processed into the aliquot at a collection site or at a central lab, and wherein the hierarchical view of aliquots comprises a specimen journey depicting how the specimen is processed into the aliquot and shipped to the central lab or an analytical lab based on the process at site indication, but these only serve to further limit the abstract idea, and hence are nonetheless directed towards fundamentally the same abstract idea as independent Claims 1, 18 and 35.
Furthermore, Claims 1-4, 6-21 and 23-37 are not integrated into a practical application because the additional elements (i.e. the limitations not identified as part of the abstract idea) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of a memory, processing circuity, user interface, a computing device, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see paragraph [0112] of the present Specification, see MPEP 2106.05(f)
generally link the abstract idea to a particular technological environment or field of use – for example, the recitation of computing device, which amounts to limiting the abstract idea to the field of computing, see MPEP 2106.05(h)).
Furthermore, the Claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because, the additional elements (i.e. the elements other than the abstract idea) amount to no more than limitations which are recited at an apply it level. Specifically, paragraph [0112] of the Specification discloses that the additional elements (i.e. a memory, processing circuity, user interface, a computing device) comprise a plurality of different types of generic computing systems that are configured to implement the recited abstract idea.
Dependent Claims 2-4, 6-17, 19-21, 23-34 and 36-37 include other limitations, but they do not include any additional elements beyond those recited in the independent claims.
Thus, taken alone, the additional elements do not amount to “significantly more” than the above-identified abstract idea. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 1-4, 6-21 and 23-37 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Subject Matter Free from Prior Art
The prior art of recording, including Malfait (U.S. Pub. No. 2022/0005558 A1), Jain (U.S. Pat. No. 11,789,837 B1) and O’Malley (U.S. Pub. No. 2025/0166102 A1), do not disclose or render obvious the combination of limitations found in the independent claims 1, 18 and 35. The dependent claims 2-4, 6-17, 19-21, 23-34 and 36-37 are free from prior art as they depend from claims 1, 18 and 35. Malfait discloses lean protocol for clinical research including activities that include an assay requiring collection of a specimen with a user interface. Jain teaches defining override operational details that override the default operation details for the collection of the specimen for at least one subject group while the default operational details are maintained for a different subject group in the clinical study. However, these references, both alone or in combination, fail to disclose the newly amended limitations in combination with the remaining limitations of the independent claims.
Response to Arguments
Applicant's arguments filed 06/25/2026 have been fully considered.
Claim Rejection under 35 U.S.C. § 101
Applicant asserts that the amended claims are not directed towards an abstract and that they integrate the alleged abstract into a practical application (Remarks, pages 14-15).
Specifically, Applicant argues that “the claim requires identifying two or more assays requiring collection of an identical specimen, combining those assays as an aliquot that compacts the collection for the identical specimen, and presenting the proto-plan as a hierarchical view of aliquots within a collection element along with the sequence of events and timepoints (Remarks, page 14).” Examiner disagrees as these limitations are considered to be a part of the abstract idea. There is nothing to indicate that there is a technical problem, so even if the solution was technical in nature, it would not rise to the level of a practical application per the MPEP. Applicant further states that the “hierarchical visualization and the underlying data compaction are specific, concrete implementations that govern how the system organizes and displays specimen data, which goes far beyond well-understood, routine, and conventional computer functions (Remarks, pages 14-15.)” The well-understood, routine and conventional activity analysis under Step 2B is for the additional elements, particular those reciting extra-solution activity. There is no extra-solution activity, insignificant or otherwise, recited in the claim and therefore, nothing to analyze under this part of the 101 analysis. The abstract idea itself cannot be used to result in significantly more. The additional elements are generic computer components as indicated in the above rejection.
The claims remain rejected as being directed towards ineligible subject matter.
Claim Rejection under 35 U.S.C. § 103
The prior art rejection has been withdrawn in view of the amendments.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rachelle Reichert whose telephone number is (303)297-4782. The examiner can normally be reached M-F 9-5 MT.
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/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
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