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 .
Status of the Claims
The office action is in response to the claims filed on March 14, 2025 for the application filed March 14, 2025 which claims priority to a provisional application filed on March 14, 2024 and July 1, 2024. A review of the specification indicates that the only the provisional application filed July 1, 2024 provides support for claims 1-20. Therefore, the effective filing date for the instant application is determined to be July 1, 2024. Claims 1-20 are currently pending 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 1-20 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.
Eligibility Step 1:
Under step 1 of the 2019 Revised Patent Subject Matter Eligibility Guidance, claims 1-10 are directed towards a computer-implement method (i.e. a process), which is a statutory category. Claims 11-20 are directed towards a non-transitory computer-readable storage medium (i.e. a manufacture), which is a statutory category. Since the claims are directed toward statutory categories, it must be determined if the claims are directed towards a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea). In the instant application, the claims are directed towards an abstract idea.
Eligibility Step 2A, Prong One:
Under step 2A, prong one of the 2019 Revised Patent Subject Matter Eligibility Guidance, independent claims 1 and 10 are determined to be directed to an judicial exception because an abstract idea is recited in the claims which fall within the subject matter groupings of abstract ideas. The abstract idea (identified in bold) recited in the representative claim 1 is identified as:
A computer-implemented method for management of pooled medicinal product across studies, the method comprising:
pooling medicinal product across a plurality of clinical trial studies into one or more pools based on characteristics of the clinical trial studies;
allocating one or more batches of medicinal product to each pool of studies;
for each pool of studies, assigning a unique identifier to each medicinal product in the one or more batches of medicinal product allocated to the pool of studies;
receiving, from a treatment-site client device, an order request for a quantity of medicinal product;
identifying a first pool of studies associated with the treatment-site client device;
generating a fulfillment list of medicinal product selected from the one or more batches of medicinal product allocated to the first pool of studies; and
providing the fulfillment list for filling the order request.
.
The identified limitations fall within the subject matter grouping of certain methods of organizing human activity and the sub grouping of commercial or legal interactions and/or fundamental economic principles or practices. Managing pooled products, including pooling product, allocating product, assigning identifiers to product, receiving an order request for product, generating a fulfillment list for product and providing the fulfillment list to fill the order request are all examples commercial interactions, such as business relations between a client and a product supplier. Furthermore, pooling medicinal products across clinical trial studies and allocating batches medicinal products is the fundamental economic practice of drug pooling and supply allocation in clinical trial supply chains used to reduce costs and increase efficiency.
The identified limitations of pooling, allocating, assigning, identifying and generating also fall within the subject matter grouping of mental processes as these steps can be performed in the human mind using observations , evaluations, judgments and opinions. If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea.
Accordingly, claims 1 and 11 recite an abstract idea under step 2A, prong one.
Eligibility Step 2A, Prong Two:
Under step 2A, prong two of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether the identified abstract ideas are integrated into a practical application. After evaluation, there is no indication that any additional elements or combination of elements integrate the abstract idea into a practical application, such as through: an additional element that reflects an improvement to the functioning of a computer, or an improvements to any other technology or technical field; an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition; an additional element that implements the judicial exception with, or uses the judicial exception in connection with, a particular machine or manufacture that is integral to the claim; an additional element that effects a transformation or reduction of a particular article to a different state or thing; or an additional element that applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. As shown below, the additional elements, other than the abstract idea per se, when considered both individually and as an ordered combination, amount to no more than a recitation of: generally linking the abstract idea to a particular technological environment or field of use; insignificant extra-solution activity to the judicial exception; and/or adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea as evidenced below.
The additional elements recited in representative claim 1 are identified in italics as:
A computer-implemented method for management of pooled medicinal product across studies, the method comprising:
pooling medicinal product across a plurality of clinical trial studies into one or more pools based on characteristics of the clinical trial studies;
allocating one or more batches of medicinal product to each pool of studies;
for each pool of studies, assigning a unique identifier to each medicinal product in the one or more batches of medicinal product allocated to the pool of studies;
receiving, from a treatment-site client device, an order request for a quantity of medicinal product;
identifying a first pool of studies associated with the treatment-site client device;
generating a fulfillment list of medicinal product selected from the one or more batches of medicinal product allocated to the first pool of studies; and
providing the fulfillment list for filling the order request.
The additional limitations of are determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f).The “computer-implemented” language, device and non-transitory computer-readable storage medium of claim 11 are recited at a high level of generality and amount to no more than a recitation of the words "apply it" (or an equivalent) or no more than mere instructions to implement an abstract idea or other exception on a computer or no more than merely using a computer as a tool to perform an abstract idea.
Accordingly, claims 1 and 11 do not recite additional elements which integrate the abstract idea into a practical application.
Eligibility Step 2B:
Under step 2B of the 2019 Revised Patent Subject Matter Eligibility Guidance, it must be determined whether provide an inventive concept by determining if the claims include additional elements or a combination of elements that are sufficient to amount to significantly more than the judicial exception. After evaluation, there is no indication that an additional element or combination of elements are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional limitations are determined to be mere instructions to apply an abstract idea under MPEP §2106.05(f), which is do not amount to significantly more than the 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. There is no indication that the combination of elements amounts to an inventive concept.
Dependent Claims:
The dependent claims merely present additional abstract information in tandem with further details regarding the elements from the independent claims and are, therefore, directed to an abstract idea for similar reasons as given above. None of these limitations are deemed to integrate the claims into a practical application or to amount to significantly more than the abstract idea as detailed below.
Regarding claims 2-3 and 12-3, further defining identifying specific characteristics to pool the medical product is encompassed by the abstract idea of claims 1 and 12.
Regarding claims 4-5 and 14-15, forecasting demand of products and allocating medical product based on the forecast is directed the fundamental economic practice of demand forecasting and inventory allocation. Furthermore, using a model to forecast demand and allocating product based on the forecasts is directed to a mental process, as this can be performed in the human mind using observations, evaluations, judgments and opinions.
Regarding claims 6 and 16, using random assignment of double permutated alphanumeric identifiers both directed to the mental process of assigning random identifiers and the mathematical concept of double permutation.
Regarding claims 7 and 17, the additional element of storing data in a relational database (i.e. storing identifiers and associated protocols in a database) is determined to be no more than the insignificant extra-solution activity to the judicial exception of mere necessary data gathering under MPEP §2106.05(g) and well-understood, routine and conventional under step 2B as evidenced by MPEP §2106.05(d), subsection II.
Regarding claims 8 and 18, the claims recite the additional elements of data retrieval and data transmission which is the mere data gathering and data output under MPEP §2106.05(g) and well-understood, routine and conventional under step 2B as evidenced by MPEP §2106.05(d).
Regarding claims 9-10 and 19-20, identifying protocol labeling parameters, accessing a label image for a product based on the protocol label parameters and encoding the label image for presentation on a label affixed to a product falls within the subject matter grouping of certain method of organizing human activities performed during clinical trial supply management, which includes interactions between and person a computer. The “for presentation on digital display labels…” is determined to be intended use.
Therefore, whether taken individually or as an ordered combination, 1-20 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Subject Matter Allowable Over the Prior Art
Claims 1-20 are determined to be allowable over the prior art.
While the concept of drug pooling in clinical trials and the general strategies thereof are known and there is commercially available clinical trial supply management software solutions available which purport to offer drug pooling across clinical trials, product allocation, and IRT integration for order requests/fulfillment and protocol management, the details of the specific software implementations and workflows is not discussed in detail in the available prior art and therefore, the prior art to does disclose, teach or suggest every limitation in claims 1 or 10, when viewed as a whole.
Regarding the closest prior art:
Nicholson (Optimizing Clinical Supply Management) discusses using a Clinical Supplies Management (CSM) system to pool clinical trial supplies across programs/studies and compounds by associating supplies with multiple study protocols such that protocol specific Interactive Response Technology (IRT) systems can simply request a needed product and the CSM system will release the order and provide necessary fulfillment information.
Sodhi (Drug Pooling in the Clinical Trial Supply Chain) discusses the high level concepts of drug pooling across based on clinical trial characteristics such as location and drug along with considerations for labeling and country-specific pooling strategies when implementing drug pooling.
McCory et al. (WO 2024/073353) discuss a system to aggregate claim trial supply orders based on country/location and product type in order to reduce production runs. However, McCory is aggregates site orders for the same study as opposed to pooling products across a plurality of clinical trial studies prior to receiving the orders.
Warren et al. (U.S. Pub. No. 2018/0253533) discusses a clinical trial management and supply system with functionality to view demand and supply across multiple studies, simulate demand, associate trials to products and end-end clinical trial supply chain functionality but only discuses high level concepts and not the details of the implementation.
Park et al. (U.S. Pub. No. 2025/0266155) discusses a method for clinical supplies management which focuses on clinical trial site ordering and inventory updating but does not discuss drug pooling.
Medidata (Advantages of Drug Pooling in Clinical Trials) discusses the Medidata Rave RSTM software for drug pooling solution which pools drugs across multiple clinical trial studies and allows users to create pooling groups, add studies to a pooling group and define supply plans.
Tourtellote et al. (U.S. Pub. No. 2019/096510) discusses methods for demand and supply forecasting for clinical trials based on parameters of a clinical trial.
Manning et al. (U.S. Pub. No. 2003/0220849) discusses a system for projecting, allocating and tracking supplies in clinical trials.
Riege (Drug Pooling: Power and Pitfalls) discusses general pooling strategies and considerations.
Singh (Dipping Into the Drug Pool) discusses general pooling strategies and considerations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Devin C. Hein whose telephone number is (303)297-4305. The examiner can normally be reached 9:00 AM - 5:00 PM M-F MDT.
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/DEVIN C HEIN/Examiner, Art Unit 3686
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