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, 9, 18, 23, 26 and 35 have been amended. Claims 1-35 are pending.
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 1-35 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 1-17 are drawn to a method for specimen management for clinical research study systems which is within the four statutory categories (i.e. process). Claims 18-34 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 1-17 (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;
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; 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.
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 18-34 and Claim 35 is identical as the abstract idea for Claims 1-17 (Group I), because the only difference is the claims groups are directed towards different statutory categories.
Dependent Claims 2-17 and 19-34 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 5 and 22 recite 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, 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; 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 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 aliquots including the aliquot, 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, and 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, 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 1-35 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 2-17 and 19-34 include other limitations, but they do not include an 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 1-35 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1-3, 13, 15, 18-20, 30, 32 and 25 re rejected under 35 U.S.C. 103 as being unpatentable over Malfait (U.S. Pub. No. 2022/0005558 A1) in view of Jain (U.S. Pat. No. 11,789,837 B1).
Regarding claim 1, Malfait discloses a method comprising:
obtaining, by processing circuitry, 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 (Paragraphs [0022], [0082] and [0117] discuss receiving by processing circuity, input specifying elements for a study and includes obtaining, including specimens to be collected during the trial for an arm, construed as a subject group. Examiner notes that the instant specification states that specimens can also be digital specimens and include measurements like pulse rate and blood pressure ([0004]).);
presenting, by the processing circuitry, a specimen management user interface 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 (Paragraphs [0013-0014] discuss a graphical user interface clinical study protocol designer that allows a study design practitioner to graphically model the conceptual structure of a Study Protocol. Paragraphs [0007] and [0082] discuss the samples taken include blood glucose and blood pressure and heart rate, construed as specimens.);
obtaining, by the processing circuitry, 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 (Paragraph [0087] discusses specifying repeated activities during a single study event called a timepoint schedule and requiring collecting of specimens, such as blood pressure and heart (which paragraph [0004] of the instant specification states are specimens) on a periodic basis, such as daily, weekly, or monthly, for example.); and
presenting, by the processing circuitry and via the management user interface, the proto-plan for modification, including defining override operational details that override the default operation details for the study (Paragraphs [0170] and [0213-0220] discuss the study designer being able to make changes to a default schedule.),
but Malfait does not appear to explicitly disclose 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.
Jain teaches 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 (Col. 76: lines 7-14 and col 225: lines 1-27 state that the program data may describe the requirements of each monitoring program, including default elements, which may be modified based on profile data associated with the monitored group and a control group.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify the subjects of Malfait to use specific factors, as taught by Jain, in order to “dynamically enable or disable the use of various of the cohorts when an appropriate criteria has been determined to be satisfied by the rules engine (Jain, Col. 225: lines 22-25).”
Regarding claim 2, Malfait discloses wherein defining the default operational details comprises defining the default operational details prior to the schedule of activities being locked from further editing (Paragraphs [0153] and [0215] discuss locking the elements of the study after they are configured.).
Regarding claim 3, Malfait discloses 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 (Paragraph [0216] discusses that once the study is set to read-only, the schedule is deployed.).
Regarding claim 13, Malfait discloses:
wherein the default operational details apply to each of the one or more events at the corresponding one or more timepoints (Paragraphs [0087] and [0218] discuss a default schedule for an arm of the study which includes timepoint schedules.), 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 (Paragraphs [0170] and [0213-0220] discuss the study designer being able to make changes to a default schedule.).
Regarding claim 15, Malfait discloses defining, via the specimen management user interface, the subject group as a categorized subset of the subjects in terms of a defined subject characteristic (Paragraphs [0088] and [0154] discuss property groups having defined by attributes/properties.).
2025Attorney Docket No. 317EP.001US01
Claim 18 recites substantially similar limitations as those already addressed in claim 1, and, as such, is rejected for similar reasons as given above.
Claim 18 further recites:
a memory configured to store a schedule of activities that defines one or more activities for completing a trial arm of a clinical study; and
processing circuitry configured to….
Malfait discloses the computing devices of the system comprising memory to store data and processing circuitry (see paragraph [0092]).
2025Attorney Docket No. 317EP.001US01
Claim 19 recites substantially similar limitations as those already addressed in claim 2, and, as such, is rejected for similar reasons as given above.
2025Attorney Docket No. 317EP.001US01
Claim 20 recites substantially similar limitations as those already addressed in claim 4, and, as such, is rejected for similar reasons as given above.
2025Attorney Docket No. 317EP.001US012025Attorney Docket No. 317EP.001US012025Attorney Docket No. 317EP.001US01
Claim 30 recites substantially similar limitations as those already addressed in claim 13, and, as such, is rejected for similar reasons as given above.
2025Attorney Docket No. 317EP.001US012025Attorney Docket No. 317EP.001US01
Claim 32 recites substantially similar limitations as those already addressed in claim 15, and, as such, is rejected for similar reasons as given above. 2025Attorney Docket No. 317EP.001US01
Claim 35 recites substantially similar limitations as those already addressed in claim 1, and, as such, is rejected for similar reasons as given above.
Claim 35 further recites a non-transitory computer-readable storage medium having instructions stored thereon that, when executed, cause one or more processors to…, which is disclose by Malfait (Paragraph [0024] discusses a non-transitory computer readable medium comprising instructions causing the processor perform the method.).
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 4 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Malfait in view of Jain and in further view of O’Malley (U.S. Pub. No. 2025/0166102 A1).
Regarding claim 4, Malfait does not appear to explicitly disclose:
obtaining a region that identifies a geographical region or 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.
O’Malley teaches:
obtaining a region that identifies a geographical region or political region (Paragraph [1591] and [1607] discusses that the study protocol includes location data and political affiliation of participants.);
obtaining a cohort that identifies a type of the at least one subject in terms of one or more of age, race, and weight (Paragraphs [0727], [2349] and 2356] discuss grouping patients by age, race and weight.); and
obtaining the subject group based on the region and the cohort (Paragraphs [2098] discusses grouping subjects based on the above criteria.).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention to modify the subjects of Malfait to use specific factors, as taught by O’Malley, in order to “compare others within a similar demographic (O’Malley, Paragraph [2078]).”
Claim 21 recites substantially similar limitations as those already addressed in claim 4, and, as such, is rejected for similar reasons as given above.
Response to Arguments
Applicant's arguments filed 02/24/2026 have been fully considered.
Objections to the Drawings
The previous drawing objections have been withdrawn in view of the replacement drawings submitted 02/24/2026.
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 1-18).
Specifically, Applicant argues that the “foregoing subject matter of amended claim 1 defines a specific hierarchical data inheritance model” and “employs processing circuitry to maintain a dual-state data structure where a "default" persists for some entities (different subject groups) while an "override" is simultaneously active for others ("the at least one subject group" recited by amended claim 1) (Remarks, page 17).” Examiner disagrees as defining rules for a particular group is considered to be 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 amendments to the “system improves the integrity of the study design data (Remarks, page 17),” which supports the position that the study design data is what is being improved, rather than a technical problem.
Applicant further argues that the specimen management user interface is a specific tool, citing to Core Wireless (Remarks, page 17). Simply displaying data is a not a technical improvement. There are no similarities between the Core Wireless case and the instant application as in the instant claims are not directed towards a technical problem with a technical solution.
Applicant further asserts that the claims amount to significantly more than the abstract idea because they include an inventive concept (Remarks, page 18). Applicant further argues that limitations that are part of the abstract are not well-understood, routine or conventional. The well-understood, routine and conventional activity analysis 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. § 102
The arguments regarding the prior art rejection have been considered, but are moot in view of the new grounds of rejection necessitated by amendment.
Claim Rejection under 35 U.S.C. § 103
The arguments regarding the prior art rejection have been considered, but are moot in view of the new grounds of rejection necessitated by amendment.
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 Rachelle Reichert whose telephone number is (303)297-4782. The examiner can normally be reached M-F 9-5 MT.
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 http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason Dunham can be reached at (571)272-8109. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RACHELLE L REICHERT/Primary Examiner, Art Unit 3686
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