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 .
DETAILED ACTION
This action is in reference to the communication filed on 10 DEC 2025.
Amendments to claims 1, 7, 8, 10, 11, 14, 16, 20, are entered and considered as is the cancellation of claims 2, 4-6, 15 17-19.
Claims 1, 3, 7-14, 16, 20, are present and have been examined.
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, 3, 7-14, 16, 20, rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. As explained below, the claim(s) are directed to an abstract idea without significantly more.
Step One: Is the Claim directed to a process, machine, manufacture or composition of matter? YES
With respect to claim(s) 1, 3, 7-14, 16, 20, the independent claim(s) 1, 14 recite(s) a method and a device, each of which is a statutory category of invention.
Step 2A – Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? YES
With respect to claim(s) 1, 3, 7-14, 16, 20, the independent claim(s) (claims 1, 14) is/are directed, in part:
Clinical supplies management method performed by a clinical supplies management
registering a user associated with a clinical trial according to user types, the user types including study center type, study monitor type, depot type, pharmaceutical general type, and pharmaceutical administrator type;
receiving a request for providing clinical supplies related to the clinical trial;
receiving providing completion information for the clinical supplies; and
updating clinical supplies information corresponding to the providing completion information,
providing supply consumption status sharing
receiving a secondary user registration request for registering another user associated with the clinical trial by users corresponding to the study center type or the study monitor type among the study center type, the study monitor type, the depot type, the pharmaceutical general type, and the pharmaceutical administrator type,
wherein the supply consumption status sharing
Claim 14 recites similar limitations. These claim elements are considered to be abstract ideas because they are directed to a method of organizing human activity which include fundamental economic principles/practices, and/or commercial or legal interactions. Managing supplies for an endeavor, including receiving a request, providing completion information, and updating the supply information are all examples of economic principles (supply/demand) as well as commercial interactions (supply/demand and supply chain considerations). Further, the claimed limitations are directed to a mental process, as they are examples of concepts performed in the human mind such as observation, evaluation, judgment and/or opinion. Registering a user, receiving a request, fulfilling the request, and updating the information are all concepts performed in the human mind. If a claim limitation, under its broadest reasonable interpretation, covers commercial and legal interactions and/or fundamental economic practices, then it falls within the “method of organizing human activity” grouping of abstract ideas. If a claim limitation under its broadest reasonable interpretation, covers concepts performed in the huma mind, then it falls within the “mental processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A – Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application? NO.
This judicial exception is not integrated into a practical application. In particular, the claim(s) recite(s) additional elements: Claims 1, 14 recite a device, with claim 14 reciting a “processor,” and a “memory” to perform the claim steps. Claims 1, 14 have been amended to include an “interface” The “device,” as well as the “processor” sending and receiving information, and the “memory” storing information, are all recited at a high level of generality and as such amount to no more than adding the words “apply it” to the judicial exception, or mere instructions to implement the abstract idea on a computer, or merely uses the computer as a tool to perform the abstract idea (see MPEP 2106.05f), or generally links the use of the judicial exception to a particular technological field of use/computing environment (see MPEP 2106.05h). Examiner also notes that a processor sending information, and a memory storing information, are generally found to be evidence of adding insignificant extra solution activity to the judicial exception(s) identified (see MPEP 2106.05g). Similarly, the interface is found to at best be used to apply the abstract idea to the computing realm, and further notes that displaying information on an interface is generally found to be an example of insignificant extra solution activity as discussed above. Examiner finds no improvement to the functioning of the computer, the display/interface or any other technology or technical field as claimed (see MPEP 2106.05a), nor any other application or use of the judicial exception in some meaningful way beyond a general like between the use of the judicial exception to a particular technological environment (see MPEP 2106.05e). Examiner notes that the “device” with regard to claim 1 in particular is only nominally recited and is addressed at this step in the interest of compact prosecution only – i.e. the device itself is understood to be a computer of sorts.
Accordingly, this/these additional element(s) do(es) not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception? NO.
The independent claim(s) is/are additionally directed to claim elements such as: Claims 1, 14 recite a device, with claim 14 reciting a “processor,” and a “memory” to perform the claim steps, with claims 1, 14 amended to recite an interface. When considered individually, these identified claim elements only contribute generic recitations of technical elements to the claims. It is readily apparent, for example, that the claim is not directed to any specific improvements of these elements. Examiner looks to Applicant’s specification in:
[0242] … As shown in FIG. 20, the computer system 2000 may include one or more processors 2010, memory 2030, user interface input device 2040, user interface output device 2050, and storage 2060 that communicate with each other via the bus 2020. In addition, the computer system 2000 may further include a network interface 2070 that connects to the network 2080. The processor 2010 may be a semiconductor device that executes processing instructions stored in the central processing unit or memory 2030 or storage 2060. The memory 2030 and the storage 2060 may be various forms of volatile or non-volatile storage media. For example, the memory may include ROM 2031 or RAM 2032.”
These passages, as well as others, makes it clear that the invention is not directed to a technical improvement. The processor/memory, and interface, are defined throughout the specification in functional terms only – i.e. the capabilities of the processor/memory to send/store data and as such any suitable device with said capabilities is appropriate for use in the invention. When the claims are considered individually and as a whole, the additional elements noted above, appear to merely apply the abstract concept to a technical environment in a very general sense – i.e. a generic computer receives information from another generic computer, processes the information and then sends information back. The most significant elements of the claims, that is the elements that really outline the inventive elements of the claims, are set forth in the elements identified as an abstract idea. The fact that the generic computing devices are facilitating the abstract concept is not enough to confer statutory subject matter eligibility.
As per dependent claims 3, 7-13, 16, 20:
Dependent claims 3, 7-12, 14, 16, 20 are not directed any additional abstract ideas and are also not directed to any additional non-abstract claim elements. Rather, these claims offer further descriptive limitations of elements found in the independent claims and addressed above – such as additional management roles/permissions in the clinical trial, additional supply management issues (such as labeling, returns). While these descriptive elements may provide further helpful context for the claimed invention these elements do not serve to confer subject matter eligibility to the invention since their individual and combined significance is still not heavier than the abstract concepts at the core of the claimed invention.
Dependent claim 13 does not recite any additional abstract ideas, however, it does nominally recite a computer readable medium. Examiner finds this feature to be analogous to the computing elements identified above with respect to claims 1, 14, and therefore does not find this additional element to be anything beyond “applying” the abstract idea using a computer and/or using it as a tool. Examiner finds no improvement nor any meaningful limitations therein. Examiner makes reference to [0233] of the specification:
“The computer-readable medium may include program instructions, data files, data structures, and the like, alone or in combination. The program instructions recorded in the medium may be specifically designed and configured for the present disclosure or may be known and available to those skilled in the art in the computer software. Examples of computer-readable recording media include magnetic media such as hard disks, floppy disks, and magnetic tapes, optical media such as CD-ROMs and DVDs, magneto-optical media such as floptical disks, and any type of hardware device specifically configured to store and execute program commands such as ROMs, RAM, flash memory, and the like.”
This passage identifies this element in functional terms only – i.e. any of these devices are capable of executing the instructions/claimed limitations. As such Examiner does not find a practical application nor evidence of significantly more.
Claim 13 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The United States Patent and Trademark Office (USPTO) is obliged to give claims their broadest reasonable interpretation consistent with the specification during proceedings before the USPTO. See In re Zletz, 893 F.2d 319 (Fed. Cir. 1989) (during patent examination the pending claims must be interpreted as broadly as their terms reasonably allow). The broadest reasonable interpretation of a claim drawn to a computer readable medium (also called machine readable medium and other such variations) typically covers forms of non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of computer readable media, particularly when the specification is silent. See MPEP 2111.01. When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. § 101 as covering non-statutory subject matter. See In re Nuijten, 500 F.3d 1346, 1356-57 (Fed. Cir. 2007) (transitory embodiments are not directed to statutory subject matter) and Interim Examination Instructions for Evaluating Subject Matter Eligibility Under 35 U.S.C. §101, Aug. 24, 2009; p. 2.
The USPTO recognizes that applicants may have claims directed to computer readable media that cover signals per se, which the USPTO must reject under 35 U.S.C. § 101 as covering both non-statutory subject matter and statutory subject matter. In an effort to assist the patent community in overcoming a rejection or potential rejection under 35 U.S.C. § 101 in this situation, the USPTO suggests the following approach. A claim drawn to such a computer readable medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. § 101 by adding the limitation “non-transitory” to the claim. Cf. Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (suggesting that applicants add the limitation “non-human” to a claim covering a multi-cellular organism to avoid a rejection under 35 U.S.C. § 101). Such an amendment would typically not raise the issue of new matter, even when the specification is silent because the broadest reasonable interpretation relies on the ordinary and customary meaning that includes signals per se. The limited situations in which such an amendment could raise issues of new matter occur, for example, when the specification does not support a non-transitory embodiment because a signal per se is the only viable embodiment such that the amended claim is impermissibly broadened beyond the supporting disclosure. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998). Appropriate correction is required.
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.
The factual inquiries 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.
Claim(s) 1, 3, 7, 8, 13, 14, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tourtellotte et al (US 20190096510 A1, hereafter Tourtellotte), in view of Baker (US 20120130746 A1).
In reference to claim 1:
Tourtellotte teaches: Clinical supplies management method performed by a clinical supplies management device, comprising:
a user associated with a clinical trial according to user types (at least [027-030] “For example, in a given trial, the RTSM system 14 may provide an input/output interface for a clinical trial sponsor 18 (e.g., a pharmaceutical company). The RTSM system 14 may be in electronic communication with one or more trial sites 20, such as hospitals or clinics, for example…The RTSM system 14 may be in electronic communication with one or more trial sites 20, such as hospitals or clinics, for example. The RTSM system 14 may further be in communication with one or more distribution facilities 22, such as depots, warehouses, or other facilities involved in the distribution of drug lots and placebos involved in the trial to trial sites 20. One or more doctors 24 may also be in electronic communication with the RTSM system 14. The RTSM system 14 may output to such doctors 24 information about the drugs involved in the trial and information about the trial to enable the doctor to inform patients about the trial as appropriate. ”), wherein the user types include study center type, study monitor type, depot type, pharmaceutical general type, and pharmaceutical administrator type (at least [027-030] “For example, in a given trial, the RTSM system 14 may provide an input/output interface for a clinical trial sponsor 18 (e.g., a pharmaceutical company). The RTSM system 14 may be in electronic communication with one or more trial sites 20, such as hospitals or clinics, for example…The RTSM system 14 may be in electronic communication with one or more trial sites 20, such as hospitals or clinics, for example. The RTSM system 14 may further be in communication with one or more distribution facilities 22, such as depots, warehouses, or other facilities involved in the distribution of drug lots and placebos involved in the trial to trial sites 20. One or more doctors 24 may also be in electronic communication with the RTSM system 14. The RTSM system 14 may output to such doctors 24 information about the drugs involved in the trial and information about the trial to enable the doctor to inform patients about the trial as appropriate. ”);
receiving a request for providing clinical supplies related to the clinical trial (at least [fig 1 and related text] “..supply planning module 32, the supply forecasting system may generally generate a plan for supplies of the drug under trial and placebos for the trial before complete information for the trial (or a stage of the trial) is available. The supply forecasting system 12 may then output the supply plan for the trial to the trial sponsor 18 to enable the trial sponsor 18 to properly budget for the trial, acquire appropriate sites and logistical channels for the trial, and the like…. A user (e.g., via a user computing device which, as noted above, may be associated with a trial sponsor) may submit, and supply forecasting system 12 may receive, information indicative of parameters of a trial. ”);
receiving providing completion information for the clinical supplies (at least [fig 1 and related text] “The RTSM system 14 may issue shipping instructions to such a facility 22, for example. Such shipping instructions may be generated and/or transmitted automatically by the RTSM system 14, in embodiments, based on a supply plan. The RTSM system may also receive data from such facilities 22, such as shipping records and inventory information, such that the RTSM system 14 has data indicative of distributed inventories of drugs involved in the trial and remaining inventories, and the locations of those inventories.” – confirmation of distribution to facilities); and
updating clinical supplies information corresponding to the providing completion information (at least [fig 1, 2, and related text] “such that the RTSM system 14 has data indicative of distributed inventories of drugs involved in the trial and remaining inventories, and the locations of those inventories.” “…an inventory of the drug under trial at each testing site may be compared to the supply plan forecast to determine if the order schedule should be or must be altered, or if the distribution schedule should or must be altered, to ensure that each testing site is provided with sufficient stock to provide to its testing patients.”),
providing supply consumption status sharing interface for sharing the consumption status of the entire supplies allocated to the clinical trial to participants involved in the clinical trial (at least [027-030] types of users within the system itself; at [031-0037] supply information updated to the user types i.e.: “The supply forecasting system 12 may also be in electronic communication with the RTSM system 14. During a trial, the supply forecasting system 12 may retrieve data respective of the trial from the RTSM system 14. For such information retrieval, the supply forecasting system 12 may communication with the RTSM system 14 via an application programming interface (API) 36 of the RTSM system 14. Based on a plan comparison module 36, the supply forecasting system 12 may compare the retrieved information about the status of the trial to the forecast supply plan and may generate alerts for the trial sponsor when the trial status deviates substantially from the forecast supply plan.”);
wherein the supply consumption status sharing interface is provided only for user types other than the depot type among the user types (at least [027] users and access rights, at [029] depot users are considered.
While Tourtellotte teaches user types, as well as enrolling information about the participants, it does not specifically disclose registering a user according to types. Baker however does teach:
registering a user associated with a clinical trial according to user types (at least [074-081] general registration process, at [fig 3 and related text] various sponsors/companies/investigators are registered individually for separate trials: “Referring now to FIG. 3, a schematic relationship diagram 300 illustrates the basic relationship of the various parties using a customized IRB operational management system for clinical trials accordance with a preferred embodiment of the present invention. As shown in FIG. 3, for this example, there are three different Sponsors (Sponsor 1, Sponsor 2, and Sponsor 3). Sponsor 1, with SP 1 as the project manager, has elected to employ Company 1 to conduct clinical trial or study TRIAL 1. Similarly, Sponsor 1, with SP 2 as the project manager, has elected to employ Company 2 to conduct clinical trial or study TRIAL 2. Company 1 operates TRIAL 1 at Site 1, with Investigator 1 and Investigator 2 being the medical professionals involved in the actual conducting of TRIAL 1. Similarly, Company 2 operates TRIAL 2 at Site 2, with Investigator 3 and Investigator 4 being the medical professionals involved in the actual conducting of TRIAL 2.”, at [fig 6 and related text] personnel/role information may be modified.);
receiving a secondary user registration request for registering another user associated with the clinical trial by users corresponding to the study center type or the study monitor type (at least [074-081] general registration process, at [087] “Reviewing diagram 300 for information for Sponsor 3, it should be noted that Sponsor 3 has also elected to contract with SMO 1 to assist Sponsor 3 with the management of two additional clinical trials, TRIAL 4 and TRIAL 5. Additionally, Sponsor 3 has identified a project manager as an SPA and SPA 1 is responsible for managing both TRIAL 4 and TRIAL 5. TRIAL 4, with an SP 4 designation, is being conducted by Company 4 at Site 5 and Site 6 with investigators 9-13. Similarly, TRIAL 5, with an SP5 designation, is being conducted at Site 4 by Company 5. Regardless of the identity of the various participants, all clinical trials are being conducted in conjunction with an IRB that is using the IRB SaaS of the present invention. This allows each entity involved in the study or clinical trial to have a central point of contact for communications regarding the various clinical trials and to have access to all relevant documents related to the clinical trials. The security and access features of the IRB SaaS limit access to the materials, ensuring that only authorized personnel can access the documents that are approved for their study and their specific role in completing the study.” (ex. Note: SMO is site management organization, “…that may also facilitate the overall management of one or more studies. The role of the SMO is to generally handle the administrative burden of the company conducting the trial, so as to allow the company to focus on the medical aspects of the trial and not the administrative tasks”)
Tourtellotte and Baker are analogous references as both disclose a means of managing a roles based clinical trial. One of ordinary skill in the art would have found the user type registration as taught by Baker to be an obvious improvement to the communication required between the different participants and provided for in Tourtellotte, as Baker specifically discloses the challenges of maintaining consistent communication and the necessary documentation as required by all stakeholders (see 0014). Baker teaches that role based registration would significantly improve the “sometimes haphazard nature of the ad-hoc communications flow, spread amongst various constituencies, each with the own objectives, processes and procedures, coupled with the inefficient shuffling of paper-based documents, “ (see 017), and streamline participation in multiple studies at once as is common (see 077-081). Such a process “greatly simplifies the management of multiple simultaneous clinical trials for the SPA.” (see 081).
In reference to claim 3, 16:
Tourtellotte/Baker teaches all the limitations above. Tourtellotte further teaches: wherein the supply consumption status sharing interface includes graphs representing the total cumulative order quantities of the entire participants involved in the clinical trial, the total cumulative delivery completion quantities of the entire participants, and the total delivery quantities in progress of the entire participants (at least [fig 3a, 3b and related text, see also 072] “The method 110 may further include a step 122 that includes calculating region demands based on site-group demands, a step 124 that includes calculating depot demands based on region demands, and a step 126 calculating a total supply demand based on depot demands. Steps 122, 124, and 126 may include simple arithmetic as well as statistical computations, in embodiments—e.g., adding the demands for each site-group in a region to determine the total demand for that region, adding the demands for each region serviced by a particular depot to determine the total demand for that depot, and so on, either in terms of expected value or in terms of statistical distributions.”
In reference to claim 7:
Tourtellotte/Baker teaches all the limitations above. Tourtellotte further teaches: wherein providing completion information includes temperature excursion information and physical damage information corresponding to the clinical supplies (at least [027] “…shipments and operations on shipments, temperature excursions and their management, return of dispensed or non-dispensed drugs and related approvals and parameter, destruction status of inventory,”).
In reference to claim 8:
Tourtellotte further teaches: receiving contract information corresponding to the contract related to the clinical trial (at least [027] (The trial sponsor 18 may input complete parameters of a clinical trial, or stage thereof, for the RTSM system 14, “),
wherein the contract information includes investigator information related to the clinical trial, clinical supplies information, and information on individuals who have received approval for the clinical trial plan of the clinical trial (at least [027] “Such a complete set of parameters may include, for example, patient visits or other actions on patients, lots and operations on lots, inventory and operations on inventory at a site or depot level, shipments and operations on shipments,” [030] “The RTSM system 14 may output to such doctors 24 information about the drugs involved in the trial and information about the trial to enable the doctor to inform patients about the trial as appropriate. The RTSM system 14 may receive from such doctors enrollment information (e.g., the number of patients that the doctor has recommended for the trial, the characteristics of those patients, the specific patients that have enrolled, etc.), such that the RTSM system 14 has data indicative of enrollment quantities and characteristics of enrolled patients.” See also [0027]).
In reference to claim 13:
Tourtellotte further teaches: A computer program stored on a computer-readable medium to execute the clinical supplies management method claimed in claim 1 (at least [fig 8 and related text] “FIG. 8 is a diagrammatic view of an illustrative computing system that includes a general purpose computing system environment 150, such as a desktop computer, laptop, smartphone, tablet, or any other such device having the ability to execute instructions, such as those stored within a non-transient, computer-readable medium. Furthermore, while described and illustrated in the context of a single computing system 150, those skilled in the art will also appreciate that the various tasks described hereinafter may be practiced in a distributed environment having multiple computing systems 150 linked via a local or wide-area network in which the executable instructions may be associated with and/or executed by one or more of multiple computing systems 150.”).
In reference to claim 14:
Tourtellotte teaches: a processor that [manages] a user associated with a clinical trial according to user types (at least [027-030] “For example, in a given trial, the RTSM system 14 may provide an input/output interface for a clinical trial sponsor 18 (e.g., a pharmaceutical company). The RTSM system 14 may be in electronic communication with one or more trial sites 20, such as hospitals or clinics, for example…The RTSM system 14 may be in electronic communication with one or more trial sites 20, such as hospitals or clinics, for example. The RTSM system 14 may further be in communication with one or more distribution facilities 22, such as depots, warehouses, or other facilities involved in the distribution of drug lots and placebos involved in the trial to trial sites 20. One or more doctors 24 may also be in electronic communication with the RTSM system 14. The RTSM system 14 may output to such doctors 24 information about the drugs involved in the trial and information about the trial to enable the doctor to inform patients about the trial as appropriate. ”), the user types include study center type, study monitor type, depot type, pharmaceutical general type, and pharmaceutical administrator type (at least [027-030] “For example, in a given trial, the RTSM system 14 may provide an input/output interface for a clinical trial sponsor 18 (e.g., a pharmaceutical company). The RTSM system 14 may be in electronic communication with one or more trial sites 20, such as hospitals or clinics, for example…The RTSM system 14 may be in electronic communication with one or more trial sites 20, such as hospitals or clinics, for example. The RTSM system 14 may further be in communication with one or more distribution facilities 22, such as depots, warehouses, or other facilities involved in the distribution of drug lots and placebos involved in the trial to trial sites 20. One or more doctors 24 may also be in electronic communication with the RTSM system 14. The RTSM system 14 may output to such doctors 24 information about the drugs involved in the trial and information about the trial to enable the doctor to inform patients about the trial as appropriate. ”);
receives a request for providing clinical supplies related to the clinical trial (at least [fig 1 and related text] “..supply planning module 32, the supply forecasting system may generally generate a plan for supplies of the drug under trial and placebos for the trial before complete information for the trial (or a stage of the trial) is available. The supply forecasting system 12 may then output the supply plan for the trial to the trial sponsor 18 to enable the trial sponsor 18 to properly budget for the trial, acquire appropriate sites and logistical channels for the trial, and the like…. A user (e.g., via a user computing device which, as noted above, may be associated with a trial sponsor) may submit, and supply forecasting system 12 may receive, information indicative of parameters of a trial. ”) providing supply consumption status sharing interface for sharing the consumption status of the entire supplies allocated to the clinical trial to participants involved in the clinical trial (at least [027-030] types of users within the system itself; at [031-0037] supply information updated to the user types i.e.: “The supply forecasting system 12 may also be in electronic communication with the RTSM system 14. During a trial, the supply forecasting system 12 may retrieve data respective of the trial from the RTSM system 14. For such information retrieval, the supply forecasting system 12 may communication with the RTSM system 14 via an application programming interface (API) 36 of the RTSM system 14. Based on a plan comparison module 36, the supply forecasting system 12 may compare the retrieved information about the status of the trial to the forecast supply plan and may generate alerts for the trial sponsor when the trial status deviates substantially from the forecast supply plan.”);
receives providing completion information for the clinical supplies (at least [fig 1 and related text] “The RTSM system 14 may issue shipping instructions to such a facility 22, for example. Such shipping instructions may be generated and/or transmitted automatically by the RTSM system 14, in embodiments, based on a supply plan. The RTSM system may also receive data from such facilities 22, such as shipping records and inventory information, such that the RTSM system 14 has data indicative of distributed inventories of drugs involved in the trial and remaining inventories, and the locations of those inventories.” – confirmation of distribution to facilities); and
updates clinical supplies information corresponding to the providing completion information (at least [fig 1, 2, and related text] “such that the RTSM system 14 has data indicative of distributed inventories of drugs involved in the trial and remaining inventories, and the locations of those inventories.” “…an inventory of the drug under trial at each testing site may be compared to the supply plan forecast to determine if the order schedule should be or must be altered, or if the distribution schedule should or must be altered, to ensure that each testing site is provided with sufficient stock to provide to its testing patients.”); and
a memory that stores the clinical trial supplies information (at least [fig 1 and related text] memory 30).
wherein the supply consumption status sharing interface is provided only for user types other than the depot type among the user types (at least [027] users and access rights, at [029] depot users are considered.
While Tourtellotte teaches user types, as well as enrolling information about the participants, it does not specifically disclose registering a user according to types. Baker however does teach:
registering a user associated with a clinical trial according to user types (at least [074-081] general registration process, at [fig 3 and related text] various sponsors/companies/investigators are registered individually for separate trials: “Referring now to FIG. 3, a schematic relationship diagram 300 illustrates the basic relationship of the various parties using a customized IRB operational management system for clinical trials accordance with a preferred embodiment of the present invention. As shown in FIG. 3, for this example, there are three different Sponsors (Sponsor 1, Sponsor 2, and Sponsor 3). Sponsor 1, with SP 1 as the project manager, has elected to employ Company 1 to conduct clinical trial or study TRIAL 1. Similarly, Sponsor 1, with SP 2 as the project manager, has elected to employ Company 2 to conduct clinical trial or study TRIAL 2. Company 1 operates TRIAL 1 at Site 1, with Investigator 1 and Investigator 2 being the medical professionals involved in the actual conducting of TRIAL 1. Similarly, Company 2 operates TRIAL 2 at Site 2, with Investigator 3 and Investigator 4 being the medical professionals involved in the actual conducting of TRIAL 2.”, at [fig 6 and related text] personnel/role information may be modified.)
receiving a secondary user registration request for registering another user associated with the clinical trial by users corresponding to the study center type or the study monitor type (at least [074-081] general registration process, at [087] “Reviewing diagram 300 for information for Sponsor 3, it should be noted that Sponsor 3 has also elected to contract with SMO 1 to assist Sponsor 3 with the management of two additional clinical trials, TRIAL 4 and TRIAL 5. Additionally, Sponsor 3 has identified a project manager as an SPA and SPA 1 is responsible for managing both TRIAL 4 and TRIAL 5. TRIAL 4, with an SP 4 designation, is being conducted by Company 4 at Site 5 and Site 6 with investigators 9-13. Similarly, TRIAL 5, with an SP5 designation, is being conducted at Site 4 by Company 5. Regardless of the identity of the various participants, all clinical trials are being conducted in conjunction with an IRB that is using the IRB SaaS of the present invention. This allows each entity involved in the study or clinical trial to have a central point of contact for communications regarding the various clinical trials and to have access to all relevant documents related to the clinical trials. The security and access features of the IRB SaaS limit access to the materials, ensuring that only authorized personnel can access the documents that are approved for their study and their specific role in completing the study.” (ex. Note: SMO is site management organization, “…that may also facilitate the overall management of one or more studies. The role of the SMO is to generally handle the administrative burden of the company conducting the trial, so as to allow the company to focus on the medical aspects of the trial and not the administrative tasks”)
Tourtellotte and Baker are analogous references as both disclose a means of managing a roles based clinical trial. One of ordinary skill in the art would have found the user type registration as taught by Baker to be an obvious improvement to the communication required between the different participants and provided for in Tourtellotte, as Baker specifically discloses the challenges of maintaining consistent communication and the necessary documentation as required by all stakeholders (see 0014). Baker teaches that role based registration would significantly improve the “sometimes haphazard nature of the ad-hoc communications flow, spread amongst various constituencies, each with the own objectives, processes and procedures, coupled with the inefficient shuffling of paper-based documents, “ (see 017), and streamline participation in multiple studies at once as is common (see 077-081). Such a process “greatly simplifies the management of multiple simultaneous clinical trials for the SPA.” (see 081).
Claim(s) 9, 10, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tourtellotte in view of Baker further in view of Lauwers et al ( US 20230307110 A1, hereinafter Lauwers).
In reference to claim 9 :
Tourtellotte/Baker teaches all the limitations above. Tourtellotte considers labeling requirements (see 0018), but does not specifically teach labeling requirements/information. Lauwers further teaches: requesting confirmation of variable text information to be displayed on the packaging of the clinical supplies (at least [051-053] variable label information is “commissioned” i.e. approved after the sealing of the package – “That is, the visible indications on an e-label 130 may be altered electronically after packaging at any point in the supply chain or in use. This is highly advantageous for improving logistics, in as much as clinical materials do not have to be mated to printed materials prior to distribution and dispensing. A single inventory of un-commissioned supply packs may be maintained, and then commissioned per particular requirements at the time of distribution, shipment, or dispensing.”). Lauwers is analogous to Tourtellotte as both references disclose management of pharmaceuticals in a supply chain. One of ordinary skill in the art would have found the confirmation/dynamic information of the packaging requirements to have been obvious at the time, as Lauwers specifically teaches that the management of the appropriate data presents a challenge in coordinating pharmaceutical production as information is subject to change at any time (see 0027, 028), and that considering the final requirements of the packaging/labeling would be an improvement in the natural supply chain (see 027), as it allows for the appropriate information to be determined at any point in the life cycle, and the packaging adjusted accordingly/reassigned, thereby reducing waste and improving efficiency (see 0031).
In reference to claim 10:
Tourtellotte/Baker teaches all the limitations above. Tourtellotte considers labeling requirements (see 0018), but does not specifically teach labeling requirements/information. Lauwers further teaches: the confirmation of variable text information is requested from pharmaceutical administrator type user to pharmaceutical general type user (at least [051-053, 087-090] commissioning information from central interface; at [027, 034] confirmation with local authorities and/or confirming with a caregiver or patient who prefers selective language), and
the variable text information includes the information on individuals who have received approval for the clinical trial plan of the clinical trial (at least [fig 2 and related text] “For a clinical trial, a label may include protocol number or other identifier, medication number, reference number, route of administration, information regarding the global sponsor of the trial and the local sponsor of the trial. For prescription medicines that are not involved in a clinical trial, a label may alternatively include things like the name of the prescribing physician, dispensary, or the like, as well as the name of patient. “ at [031-032] “ Traditionally, in a clinical trial, the investigator identification is determined when dispensing of the clinical supply pack to a patient. With electronic labeling, the association of a clinical supply pack to a patient, trial, or investigator, can be identified at any point in the life cycle, and the label adjusted accordingly. Re-assignment to a different protocol is possible.” Patient information at [032]). The motivation to combine Tourtellotte and Lauwers as per the packaging requirements is the same as explained with regard to claim 9 and is therefore incorporated herein.
In reference to claim 20:
Lauwers further teaches: wherein the processor requests confirmation of variable text information to be displayed on the packaging of the clinical supplies (at least [051-053] variable label information is “commissioned” i.e. approved after the sealing of the package – “That is, the visible indications on an e-label 130 may be altered electronically after packaging at any point in the supply chain or in use. This is highly advantageous for improving logistics, in as much as clinical materials do not have to be mated to printed materials prior to distribution and dispensing. A single inventory of un-commissioned supply packs may be maintained, and then commissioned per particular requirements at the time of distribution, shipment, or dispensing.”).,
wherein: the confirmation of variable text information is requested from pharmaceutical administrator type user to pharmaceutical general type user (at least [051-053, 087-090] commissioning information from central interface; at [027, 034] confirmation with local authorities and/or confirming with a caregiver or patient who prefers selective language), and
the variable text information includes the information on individuals who have received approval for the clinical trial plan of the clinical trial (at least [fig 2 and related text] “For a clinical trial, a label may include protocol number or other identifier, medication number, reference number, route of administration, information regarding the global sponsor of the trial and the local sponsor of the trial. For prescription medicines that are not involved in a clinical trial, a label may alternatively include things like the name of the prescribing physician, dispensary, or the like, as well as the name of patient. “ at [031-032] “ Traditionally, in a clinical trial, the investigator identification is determined when dispensing of the clinical supply pack to a patient. With electronic labeling, the association of a clinical supply pack to a patient, trial, or investigator, can be identified at any point in the life cycle, and the label adjusted accordingly. Re-assignment to a different protocol is possible.” Patient information at 032). The motivation to combine Tourtellotte and Lauwers as per the packaging requirements is the same as explained with regard to claim 9 and is therefore incorporated herein.
Claim(s) 11, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tourtellotte in view of Baker in view of Byrom et al (US 20080065418 A1, hereinafter Byrom), further in view of Lauwers.
In reference to claim 11:
Tourtellotte/Baker teaches all the limitations above. Tourtellotte contemplates returns at [027] but does not specifically disclose a returns process. Byrom further teaches:
receiving a return request corresponding to the clinical supplies, wherein the return request includes information on the reason for return, information on whether the transportation temperature is controlled during return, departure point information, and supplies information to be returned (at least [fig 8 and related text] “With respect to the creation of a returns consignment, system requirements may include: [0169] Enable selection of returns consignment destination [0170] Create a consignment from the set of reconciled and unused/expired/damaged packs at site. Automatically create a consignment number or enable the user to specify a consignment number.” [0171] Create consignment documentation to accompany physical shipment” – i.e. the consignment/request is created, the reason for return is indicated at 0170, the departure information is included in the tracking info from the site, and the supplies are identified in the set of reconciled packs at a site. At [025-026] “ Next, return shipments are sent to a designated depot accompanied by a document detailing quantities, individual contents and format of medication. A unique identifier is assigned to each shipment, and very often this is the only tracking device to link the shipment received at the depot with the individual medication packs sent from the site.”
Byrom is analogous to Tourtellotte, as both references disclose a supply chain management for pharmaceuticals. One of ordinary skill would have found it obvious to further clarify the return of drugs contemplated by Tourtellotte with the teachings of Byrom, as Byrom teaches that “or practically all clinical trials it is necessary to perform drug accountability, reconciliation, returns and destruction ("ARRD") activities. ARRD activities form part of the total drug supply chain management that is part of any clinical trial. More particularly, ARRD activities require full documentation of the chain of custody for study material. Clinical trial Sponsors are required to provide an audit trail for product (i.e. medication unit, treatment pack, packets, consignments, etc.) at all times during the lifecycle of the product.” (see 010). As such, given the requirements common to all clinical trial drug management, one of ordinary skill in the art would have found the inclusion of a returns process as taught by Byrom to have been an obvious requirement to the supply chain management of Tourtellotte.
Tourtellotte/Baker/Byrom does not specifically disclose temperature control during the transit included in the information. Lauwers however does teach:
[shipping information] including information on whether the transportation temperature is controlled during [transit] (at least [085] “For example, the central system 240 may inform the communication device 220 that the supply pack 100 labeled for a first patient is to be diverted to a second patient, marked for destruction or return for analysis” - i.e. returned, at [fig 6 and related text] “Any number of environmental sensors may be employed. For example, environmental sensor 116 may be a temperature sensor, and may include a logging function to storage a record of temperatures at various times and/or a number of excursions beyond safe storage or use temperature.” At [figs 2, 3, and related text] temperature storage instructions included on the label compared to excursion information above). Lauwers is analogous to any reference disclosing supply chain management of pharmaceutical products. One of ordinary skill in the art would have found the temperature management/monitoring of Lauwers to be an important part of safe supply chain management, as Lauwers teaches such information is useful “to determine the fitness of dose units 112 the clinical supply 110 for use, e.g., whether dose units are to be deemed expired, unsafe, or suitable for current use.” (see 046). As such, one would have been motivated to use temperature information as taught by Lauwers to monitor the integrity of the product throughout the supply chain.
In reference to claim 12:
Tourtellotte/Baker/Byrom/Lauwers teaches all the limitations above. Byrom further teaches: wherein the information on the reason for return includes any one or more of the clinical trial termination, expiration date expired, breakage/ temperature excursion, and recall due to drug abnormalities (at least [0065] “Returns may also include undispensed treatment drug (e.g., superfluous, damaged, or expired units). “ see also [fig 8 and related text] the reason for return is selected). The motivation to combine Byrom with Tourtellotte as per the return is the same as explained with regard to claim 11 and is therefore incorporated herein.
Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20150286802 A1 to Kansara discloses a clinical trial management program to manage roles based permissions/responsibilities.
US 20110313782 A1 to DeMeyer discloses a logistics supply/demand system for a clinical trial on a large scale.
Response to Arguments
Applicant’s remarks as filed on 10 DEC 2025 have been fully considered.
Examiner acknowledges the priority request as noted on page 7. Examiner notes no denial of priority was present in the previously mailed Non-Final Office Action.
Applicant summarizes the prior office action on page 7.
Examiner finds the amendments to claim 10 to be satisfactory and as such the rejection under 35 USC 112b is withdrawn as noted above.
Applicant recites various portions of MPEP/USPTO Guidance regarding subject matter eligibility on pages 7-8 of the remarks, and concludes with discussion of the presence of the abstract idea(s) as outlined above. Examiner respectfully disagrees with Applicant’s conclusions regarding the presence of the abstract idea(s), which have been amended above.
Applicant subsequently turns to a discussion of the additional elements in claims 1, 14, on pages 8, 9. Examiner notes that the amended limitations as taken from claims 2, 4, 5, 6 were not previously found to recite eligible subject matter. Contrary to Applicant’s conclusions regarding Ex parte Desjardins, the addition of user types and an interface are not found to be improvements to a technical problem. As noted above, the use of an interface to display information is generally found to be insignificant extra solution activity. Further, as currently claimed, the second registration request and the “five user types” are more appropriately considered in the abstract idea identification rather than the additional elements to support a finding of an improvement.
Further to Applicant’s discussion on page 9, Examiner does not find the additional user types to be an improvement to a technical problem, instead, these are descriptive terms for the roles of different users in the clinical trial.
Applicant’s discussion of the supply consumption status interface is noted, however again as discussed above in the remarks and the rejection, the interface itself is an additional element, but the technical aspects of the interface are not being improved by the type of information being shared on it. The sharing of the information, again, as claimed, is best discussed with regard to the abstract idea. The interface itself is merely being used to apply the abstract idea to the technical computing environment. No improvement is present. Examiner does not dispute that the sharing of information regarding clinical study supplies is important in the field of investigator initiated clinical trials is important, and that such an information sharing is perhaps improved in some way by the interface, however, clinical trials are not per se, a technical problem for the purposes of the analysis.
When turning to the secondary user registration request, as currently claimed, Examiner finds that this is not an additional element. No computing device is required to complete this step – it could instead be accomplished verbally between two participants in the clinical trial process. Similarly to above, Examiner does not find the secondary interface to be indicative of an improvement to computer technology per Desjardins.
Applicant turns to a discussion of step 2b, what is well understood, routine and/or conventional in the industry. Applicant does not appear to identify on page 12 what exactly is believed to be significantly more than what is well understood routine or conventional about the claimed limitations as presented. On page 13 Applicant argues the interface and the secondary user registration request amount to such a finding, however, in view of the present prior art rejection and Applicant’s discussion above, Examiner does not find this line of reasoning persuasive. Examiner notes that there was no specific assertion in the non-final rejection of a conclusion of well understood routine and/or conventional. Examiner reiterates from the rejection above that it is not possible to consider the claims as currently written to require anything but a general purpose computer, if claim 1 even supports such a requirement to begin with.
Applicant turns to the prior art rejection on page 14 of the remarks, with citations to the specification throughout page 16, and a conclusion that the prior art does not teach the secondary registration. Applicant provides additional citations to the specification of the present application on page 17, 18, and again concludes the cited references do not teach the claimed limitations. Examiner respectfully disagrees, at least in view of the above prior art rejections. The claimed references are believed to teach the combination of roles, registration, and information as claimed.
Examiner finds the remaining remarks on page 19 to be unpersuasive at least in view of the discussion above.
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.
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/KATHERINE . KOLOSOWSKI-GAGER/
Primary Examiner
Art Unit 3687
/KATHERINE KOLOSOWSKI-GAGER/Primary Examiner, Art Unit 3687