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 17 JUN 2026.
Amendments to claims 1, 10, 14, 20 are entered and considered as is the cancellation of claims 2, 4-6, 9, 13, 15 17-19.
Claims 1, 3, 7, 8, 10-12, 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, 8, 10-12, 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, 8, 10-12, 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, 8, 10-12, 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
requesting confirmation of variable text information to be printed on packaging of the clinical supplies; and
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 a first alarm is sent to at least one user of the pharmaceutical general type in response to receipt of the secondary user registration request, and a second alarm is sent to at least one user of the pharmaceutical administrator type after the secondary user registration request is confirmed by the at least one user of the pharmaceutical general type,
wherein the supply consumption status sharing
wherein the confirmation of the variable text information is requested by at least one user of the pharmaceutical administrator type from at least one user of the pharmaceutical general type, and a third alarm is sent to the at least one user of the pharmaceutical administrator type after the variable text information is confirmed by the at least one user of the pharmaceutical general type,
wherein a confirmation request date on which the confirmation of the variable text information is requested from the at least one user of the pharmaceutical general type and a confirmation date on which the variable text information is confirmed by the at least one user of the pharmaceutical general type are recorded in the clinical supplies management
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 also recite 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 also reciting 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, 8, 10-12, 16, 20:
Dependent claims 3, 7, 8, 10-12, 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.
Prior Art
Claims 1, 3, 7, 8, 10-12, 14, 16, 20 are believed to be free of the prior art.
The closest prior art of record is believed to be:
Tourtellotte (US 20190096510 A1)
Baker (US 20120130746 A1)
Lauwers ( US 20230307110 A1)
Byrom (US 20080065418 A1)
Tourtellotte teaches a managing a clinical trial based on the one or more roles of the personnel and stakeholders as included, and providing supplies for the trial based on the request and monitoring ongoing completion information about the trial in order to update the supplies information and consumption speed based on the users’ permissions and roles. Baker teaches wherein a participant is registered within the campaign/trial, and wherein said participant may invite or suggest other people to request registration based on the authority of the first participant to invite. Lauwers discloses a means of variable text information on a given supply item or other consumable, and wherein someone must confirm the information based on, again, a given role within the trial/study/facility/supply chain. Lauwers also teaches particular applicability of hierarchy/permission of roles within a given supply chain. Byrom teaches additional means of controlling and/or alerting participants in the trial based on the users role and the type of information. However, the references when taken separately and/or in combination do not fairly teaches the order of confirmation of the variable text and the order and type of alarms generated in response to the confirmation. Examiner particularly finds the sequencing itself not fairly taught in the prior art.
The Examiner hereby asserts that the totality of the evidence neither anticipates nor renders obvious the particular combination of elements as claimed. That is, the Examiner emphasizes the claims as a whole and hereby asserts that the totality of the evidence fails to set forth, either explicitly or implicitly, an appropriate rationale for combining or otherwise modifying the available prior art to arrive at the claimed invention. The combination of features as claimed would not be obvious to one of ordinary skill in the art because any combination of the evidence at hand to reach the combination of features as claimed would require a substantial reconstruction of Applicant’s claimed invention relying on improper hindsight bias.
Response to Arguments
Applicant’s remarks as filed on 17 JUN 2026 have been fully considered.
Applicant’s remarks regarding the 9 JUN 2026 interview are noted on page 8.
Applicant summarizes the rejections on page 9, and summarizes the amended limitations further on. Examiner believes the conclusions on page 10 are directed to the 101 rejection; Examiner does not find these remarks persuasive. Improving registration and management of a clinical trial is identified in the abstract idea(s) above. While Applicant references a technical solution in the use of computing, the problem or improvement itself is not technical. Managing a clinical trial is not a technical problem, nor is the functioning of the computing element(s) or any other technical elements improved by the claimed invention. As such, the computing elements and interfaces are not found to be a practical application therein.
Applicant restates amendments made to claims 1, 14 on page 10. Examiner does not find these amendments nor remarks persuasive. Again, the workflow of the clinical supplies management method is not itself a technical problem. Applicant does not purport to be improving any mentioned technical aspects (i.e. email as mentioned on page 10). Prompt recognition and processing of a registration is not itself a practical application as again, there is no improvement to anything technical.
Applicant turns to a discussion of the prior art rejection on page 11. Examiner makes reference to the discussion of the prior art above.
Applicant returns to the 101 rejection on page 12, Examiner again does not find that a practical application is found in a registration/workflow setting, nor in the use of a secondary registration, nor in a first and second alarm. Again, there are no technical aspects nor improvements in the discussion presented by Applicant on page 12. Confirmation of a text or any other data, and alarming based on it is, also, not found to be an additional element and therefore these remarks are unpersuasive.
Examiner does not dispute the importance of the variable text as discussed on page 13, however, Examiner respectfully submits again that this is not an additional element and therefore more appropriately discussed with regard to the abstract idea. Verifying validity is not itself a technical problem nor is anything technical improved or even recited.
Applicant again turns to a discussion of the prior art on page 14. Examiner makes reference to the discussion of the prior art above.
Applicant returns to 101 on page 14/15, and again, Examiner respectfully submits that a pre packaging verification is also not a technical improvement and/or a practical application. Again, these limitations are more appropriately discussed with regard to the abstract idea(s). Applicant’s conclusions regarding the prior art and the use of a computer on page 15 are not found persuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE KOLOSOWSKI-GAGER whose telephone number is (571)270-5920. The examiner can normally be reached Monday - Friday.
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, Mamon Obeid can be reached at 571-270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE . KOLOSOWSKI-GAGER/
Primary Examiner
Art Unit 3687
/KATHERINE KOLOSOWSKI-GAGER/Primary Examiner, Art Unit 3687
Prosecution Insights