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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted March 28, 2025 was filed before the mailing date of this non-final rejection. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Preliminary Amendment/Status of the Claims
A preliminary amendment was filed on March 28, 2025. Claims 3, 5-8, and 10 were amended. Claims 12-20 and 22-30 were cancelled. No new matter was added. Therefore, claims 1-11 and 21 are currently pending and subject to the following non-final rejection.
Claim Objection
Claim 9 recites “assigning the plurality of kit identifiers to the first assembly order and the assembly order.” As claim 1 recites “assigning…. a plurality of kit identifiers to the first assembly order and the second assembly order”, it appears claim 9 should recite “assigning the plurality of kit identifiers to the first assembly order and the second assembly order.” Appropriate correction is required.
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 1-11 and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 1-10 recite a method (i.e., process), claim 11 recites a system comprising one or more processors (i.e., a machine), and claim 21 recites a non-transitory computer readable medium (i.e., a machine). Therefore, the claims all fall within one of the four statutory categories of invention.
Step 2A, Prong One
Claims 1, 11 and 21 recite: receiving a plurality of supply orders associated with one or more clinical trials; determining for each of the plurality of supply orders: a clinical trial study, a site location, and a treatment type; assigning a first plurality of supply orders associated with a first clinical trial study to a packaging site based on the site location; associating a first sub-group of the first plurality of supply orders with a first assembly procedure based on the treatment type to create a first assembly order; and associating a second sub-group of the first plurality of supply orders with a second assembly procedure based on the treatment type to create a second assembly order; receiving the first assembly order and the second assembly order; and assigning, randomly, a plurality of kit identifiers to the first assembly order and the second assembly order, thereby creating a plurality of blinded kits; and confidentially producing shipment orders for the first plurality of clinical trials based on the plurality of blinded kits.
The claims recite a certain method of organizing human activity. The limitations recited above, under broadest reasonable interpretation, recite the abstract idea of a certain method of organizing human activity, e.g., commercial interactions, or managing personal behavior or interactions between people. Therefore, the claims recite an abstract idea.
Step 2A, Prong Two
The judicial exception is not integrated into a practical application. Claims 1, 11 and 21 as a whole amount to no more than mere instructions to apply the judicial exception using generic computer components. See MPEP 2106.05(f).
The claims recite the additional elements: (i) first computer system comprising one or more processors and one or more memories, and a second computer system comprising a second one or more processors and a second one or more memories (claims 1, 11 and 21); (ii) one or more processors; a memory; and one or more programs, wherein the one or more programs are stored in the memory and configured to be executed by the one or more processors (claim 11); and (iii) a non-transitory computer-readable storage medium storing one or more programs, the one or more programs comprising instructions, which when executed by one or more processors of one or more electronic devices having a display, cause the one or more electronic devices to perform a method (claim 21).
The above additional elements of: (i)-(iii) are recited at a high-level of generality such that, when viewed as whole/ordered combination, they both amount to no more than mere instructions to apply the judicial exception using generic computer components. See MPEP 2106.05(f).
Accordingly, these additional elements, when viewed as a whole/ordered combination (See Fig. 1) do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. Thus, claims 1, 11 and 21 are directed to an abstract idea.
Step 2B
Additionally, as discussed above with respect to Step 2A Prong Two, the additional elements of claims 1, 11 and 21 amount to no more than mere instructions to apply the judicial exception using generic computer components. The same analysis applies here in 2B, i.e., mere instructions to apply the judicial exception using generic computer components, does not integrate the abstract idea into a practical application at Step 2A or provide an inventive concept at Step 2B.
Therefore, the additional elements discussed above do not integrate the abstract idea into a practical application at Step 2A or provide an inventive concept at Step 2B. Thus, even when viewed as a whole/ordered combination, nothing in the claims add significantly more (i.e., an inventive concept) to the abstract idea. Thus, claims 1,11 and 21 are also ineligible.
Dependent claims 2-6 and 8-10 further recite details which merely narrow the previously recited abstract idea limitiaitions. For these reasons, as described above with respect to claim 1, these judicial exceptions are not meaningfully integrated into a practical application or significantly more than the abstract idea. Thus, claims 2-6, and 8-10 are also ineligible.
Claim 7 recites wherein the plurality of supply orders are received via a customer communication or client - which narrows the previously recited abstract idea.
The additional element unencompassed by the abstract idea includes that the receiving is via an application programming interface (associated with the client). The abstract idea is not integrated into a practical application because the additional element amounts to no more than mere instructions to apply the judicial exception using generic computer components. See MPEP 2106.05(f).
The claim does not include limitations sufficient, either alone or in combination, to amount to significantly more than the claimed abstract idea because the aforementioned additional element amounts to no more than mere instructions to apply the judicial exception using generic computer components. See MPEP 2106.05(f).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 6-7, 11 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2011/0307267 to Young et al. (hereinafter “Young”) in view of U.S. Patent Application Publication No. 2002/0029155 to Hetzel et al. (hereinafter “Hetzel”).
In regard to claims 1 and 21, Young discloses at a first computer system comprising one or more processors and one or more memories: receiving a plurality of supply orders associated with one or more clinical trials (Fig. 1; Paras. 50-53, 58, 94, 164) (The communication network 102 is configured to transmit one or more messages associated with clinical trial system 100 (i.e., a first computer system)… The clinical trial system can also include…at least one shipper manager 113…. implemented or operated with respective computing devices (i.e., comprising one or more processors and one or more memories )… The shipping algorithm 165 can then issue (and transmit) an email to the supply managers 112, as well as any shipper manager 113 associated with a depot 115 (associated with the trial site), alerting them to the existence of a new pending shipment (shipment record) (i.e., plurality of supply orders associated with one or more clinical trials).)
Young discloses determining for each of the plurality of supply orders: a clinical trial study, a site location, and a treatment type (Paras. 7, 56, 63) (The site setup module 105 is configured to enable the trial planner 110 to setup example trial sites 114, 116, 118 (site IDs) and associate these trial sites with the clinical trial (i.e., a clinical trial study, a site location) and one or more users set up via the user setup module 106… subjects assigned to one arm (e.g., “control”) can receive a placebo, while subjects assigned to another arm can receive the medication being tested….The arm and arm-subject ratio module 128 is configured to allow designation of arms in the clinical trial and ratio of subjects among the arms of the clinical trial (i.e., a treatment type).)
Young discloses assigning a first plurality of supply orders associated with a first clinical trial study to a packaging site based on the site location (Paras. 58, 88-90, 90) (The inventory depot setup module 109 is configured to enable the trial planner 110 to setup one or more depots 115 (i.e., packaging site) associated with trial sites 114-118 (i.e., based on the site location) and shipper managers 113 in the clinical trial system 100. Each depot 115 can be associated with one or more of the trial sites and one or more of the shipper managers 113…A supply plan determines the triggers and supply levels that the shipper algorithm 165 will aim to maintain for the trial sites (e.g., trial sites 114-118) that are assigned that supply plan… For each trial site, site module 168 is configured to allow setup of a supply plan and assignment of a depot (e.g., depot 115) for the trial site, (i.e., assigning a first plurality of supply orders to a packaging site).)
Young discloses associating a first sub-group of the first plurality of supply orders with a first assembly procedure based on the treatment type to create a first assembly order; and associating a second sub-group of the first plurality of supply orders with a second assembly procedure based on the treatment type to create a second assembly order (Paras. 7, 79-80, 98 and 124-135; Figs. 21 and 22) (…subjects assigned to one arm (e.g., “control”) can receive a placebo, while subjects assigned to another arm can receive the medication being tested. …The arm treatment module 152 is configured to receive from the trial planner 110 a treatment associated with of each arm of the clinical trial (i.e., first sub-group, second sub-group). The treatment is composed by the indication of an “article type” and a “number of units” for the article type. For example, arm 1 can receive a treatment composed of 1 unit of “article type 1” (i.e., a first assembly procedure based on the treatment type), arm 2 can receive 1 unit of “article type 2” (i.e., a second assembly procedure based on the treatment type)…,an inventory associated with a depot 115 is generated for the trial ID according to the selected treatment design, such as in the runtime database 158. An inventory batch that indicates units of articles (article IDs) that are available to ship by the depot 115 are received into the inventory of the depot at operation 512 (i.e., a first assembly order; a second assembly order).)
Young does not explicitly disclose or teach, however, Hetzel teaches at a second computer system comprising a second one or more processors and a second one or more memories: receiving the first assembly order and the second assembly order (Fig. 2; Paras. 1, 50-52; Figs. 11 and 12) (This invention relates to a process and system for managing blinded studies such as medical clinical trials…The electronic clinical supply shipping order system (ECSSO) (i.e., at a second computer system comprising a second one or more processors and a second one or more memories) has been created to ensure sites are approved for use…The first thing that is set up is the kit description ( 17). This description is prepared based on the parameters set out in a particular study protocol, approved (19) and entered into database (9) in FIG. 2. It describes the identity of the samples that need to be sent to each study participant and identifies the ancillary materials that may be needed for a particular study or sub-routine in a study (i.e., receiving the first assembly order and the second assembly order)…. On[c]e the kit description is prepared and recorded, it becomes the basis for programming the clinical supply shipping order system and integrating it with voice recognition technology ( 23).
Young does not explicitly disclose or teach, however, Hetzel teaches assigning, randomly, a plurality of kit identifiers to the first assembly order and the second assembly order, thereby creating a plurality of blinded kits (Paras. 1, 73-75, and 86; Figs. 10-12) (Following creation of a protocol document, the description(s) of the packaged study medication to be supplied in the protocol are entered into the database by a designated party. A kit is created as follows:…This accesses the Kit Definition Form… Following selection of the protocol, designated managers must enter a three digit Kit number for proper supply identification with the first Kit assigned to each individual specific protocol starting with 001…Information as to whether these are randomized supplies the number of patients supplied per kit, use by date by batch, must also be entered in the appropriate fields…. Operationally, all supplies that have been issued a specific, unique container/randomization number should be defined in the database as randomized (i.e., assigning, randomly, a plurality of kit identifiers)…. the Kits required to supply the selected investigator with appropriate medication is selected from the pre-approved packaged products. For studies supplied with randomized double blind medication, the system requires entry of the actual randomization numbers or container numbers to be sent to an investigation site (that is, Examiner is interpreting this to teach creating a plurality of blinded kits).)
Young does not explicitly disclose or teach, however, Hetzel teaches at the first computer system, confidentially producing shipment orders for the first plurality of clinical trials based on the plurality of blinded kits (Paras. 1, 86 and 89; Fig. 16) (In order to process supply shipments…the shipping operations staff can select and print the label and shipping documents….Once the ECSSO is processed, packaged and dispatched, shipping operations issues an electronic confirmation of shipment via E-mail by depressing the Confirm Shipment button at the top of the view) (i.e., producing shipment orders for the first plurality of clinical trials based on the plurality of blinded kits).)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include kit identification of Hetzel with the system of Young in order to provide a more efficient system for shipping blinded testing items.
In regard to claim 2, Young discloses wherein the first treatment type corresponds to an active group and the second treatment type corresponds to a control group (Para. 7) (For example, subjects assigned to one arm (e.g., “control”) can receive a placebo, while subjects assigned to another arm can receive the medication being tested.).
In regard to claim 3, Young discloses determining a shipment type for the first plurality of supply orders order (Paras. 7, 79-80, 98 and 124-135; Figs. 21 and 22) (…subjects assigned to one arm (e.g., “control”) can receive a placebo, while subjects assigned to another arm can receive the medication being tested. …The arm treatment module 152 is configured to receive from the trial planner 110 a treatment associated with of each arm of the clinical trial (i.e., first sub-group, second sub-group). The treatment is composed by the indication of an “article type” and a “number of units” for the article type. For example, arm 1 can receive a treatment composed of 1 unit of “article type 1” (i.e., a shipment type for the first plurality of supply orders)…an inventory associated with a depot 115 is generated for the trial ID according to the selected treatment design, such as in the runtime database 158. An inventory batch that indicates units of articles (article IDs) that are available to ship by the depot 115 are received into the inventory of the depot at operation 512 ),
Young discloses in accordance with a determination one or more supply orders are associated with a first shipment type, producing shipment orders for the one or more supply orders associated with the first shipment type (Figs. 19-21) (Paras. 160-162) (FIG. 19 illustrates an example webpage for management of one or more article shipments in a clinical trial. The example webpage can be generated by generated by the shipment module 172 (i.e., producing shipment orders). Each shipment can include a name of the shipment, status, time status was changes, trial site, depot, tracking number associated with shipment (is status is “shipped”), and units of articles (items of inventory) (i.e., producing shipment orders for the one or more supply orders associated with the first shipment type).)
Young discloses in accordance with a determination one or more supply orders are associated with a second shipment type, producing instructions to store the one or more supply orders associated with the second shipment type (Paras. 7, 95-98) (…a shipper manager 113 associated with the depot 115 can access the shipment record… shipper manager 113 can also dissolve the shipment, resetting the status of the items in the shipment to “available for shipment” once again. It should be noted that dissolving a shipment assigns the inventory items in that shipment to an “available for shipment” status at the depot 115 with which their batch is currently associated (i.e., producing instructions to store the one or more supply orders associated with the second shipment type).)
In regard to claim 6, Young discloses wherein the determined site locations of the first plurality of supply orders are associated with a same country (Para. 58. 156; Figs. 17A and 17C) (one or more depots 115 associated with trial sites 114-118 ….For each trial site, the webpage displays a study name, trial site number (site ID), country. That is Figures 17A and 17C show that teach Depot is limited to its country – EU depot LTD to United Kingdom and US Shipping Inc to USA)
In regard to claim 7, Young discloses wherein the plurality of supply orders are received via a customer communication or an application programming interface associated with a client (Fig. 1; Paras., 50-52, 57) (The user setup module 106 is configured to enable the trial planner 110 to setup users who are associated with the trial planner 110, at least one shipper manager 113, trial sites 114, 116, 118, users of any other role in the clinical trial, as well as their authorizations in the clinical trial system 100).
In regard to claim 11, Young discloses one or more processors; a memory; and one or more programs, wherein the one or more programs are stored in the memory and configured to be executed by the one or more processors, the one or more programs including instructions (Paras. 164-167; Fig. 23).
Young in view of Hetzel teaches the limitations of claim 11, as discussed above in regard to claim 1.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Young in view of Hetzel, as applied to claim 1, and further in view of “Pre-Packaged Inventory vs Pack-to-Order” by Cultivera Pro, dated Augst 12, 2024 (hereinafter “Cultivera”).
In regard to claim 4, Young in view of Hetzel does not explicitly disclose or teach, however, Cultivera teaches wherein the first shipment type corresponds to a pack- to-order request and the second shipment type corresponds to a pack-to-stock request (Pages 1-2) (….products are set up to be 'pre-packaged' inventory, this indicates that the end-products (such as packaged flower or prerolls) are converted from the bulk material ahead of time to have on hand for sales (i.e., pack to stock request)… Products that are set up as 'pack-to-order' typically won't have units 'Available for Sale', as they will be converted from the bulk material at the time an order is being processed (i.e., pack-to-order request).)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the different types of packaging of Cultivera with the system of Young in view of Hetzel in order to provide a more efficient system for handling active arms of the clinical trial versus the control arm of the clinical trial.
In regard to claim 5, Young discloses receiving a request from a first clinical trial site associated with a first supply order of the one or more supply orders associated with the second shipment type; and producing a shipment order for the first supply order based on the request from the first clinical trial site (Paras. 92-97) (…the shipping algorithm 165 will allocate new items of that article type that are available for shipping at the trial site's associated depot 115 to a new shipment (i.e., receiving a request from a first clinical trial site associated with a first supply order of the one or more supply orders associated with the second shipment type)….The shipping algorithm 165 will traverse through all the article types, and once done, all the items allocated for shipment for the specific trial site will be collected into a new shipment record. The shipping algorithm 165 can then issue (and transmit) an email to the supply managers 112, as well as any shipper manager 113 associated with a depot 115 (associated with the trial site), alerting them to the existence of a new pending shipment (shipment record) (i.e., producing a shipment order for the first supply order based on the request from the first clinical trial site).)
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Young in view of Hetzel, as applied to claim 1, and further in view of “Investigational Product Expiry Management” by Kurt Lumsden, dated December, 2022 (hereinafter “Lumsden”).
In regard to claim 8, Young does not explicitly disclose or teach, however, Hetzel teaches kit identifiers for one or more of the first plurality of supply orders (Paras. 1, 73-75, and 86; Figs. 10-12) (Following creation of a protocol document, the description(s) of the packaged study medication to be supplied in the protocol are entered into the database by a designated party. A kit is created as follows:…This accesses the Kit Definition Form… Following selection of the protocol, designated managers must enter a three digit Kit number for proper supply identification with the first Kit assigned to each individual specific protocol starting with 001…Information as to whether these are randomized supplies the number of patients supplied per kit, use by date by batch, must also be entered in the appropriate fields…. Operationally, all supplies that have been issued a specific, unique container/randomization number should be defined in the database as randomized (i.e., kit identifiers)…. the Kits required to supply the selected investigator with appropriate medication is selected from the pre-approved packaged products. For studies supplied with randomized double blind medication, the system requires entry of the actual randomization numbers or container numbers to be sent to an investigation site (i.e., for one or more of the first plurality of supply orders).)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the teachings of Hetzel to the system of Young, for the same reasons as discussed above in regard to claim 1.
Young in view of Hetzel does not explicitly disclose or teach, however, Lumsden teaches receiving an input from a client associated with the first clinical trial study corresponding to updated kit identifiers for…orders; and updating the plurality of kit identifiers associated with the…orders (Page 2) (Interactive response technologies (IRT) have long been used to manage IP expiry (i.e., receiving an input from a client). Flexible systems typically allow updating product expiry at the lot level… (i.e., updated kit identifiers for…orders; and updating the plurality of kit identifiers associated with the…order), or single-panel labels that do not include the expiry date or by lot/kit and location where the expiry dating requires a relabeling campaign).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the ability to handle expired goods of Lumsden with the system of Young in view of Hetzel in order to provide a more efficient system for handling all issues with the clinical goods.
etIn regard to claim 9, as discussed above in regard to claim 1, Young in view of Hetzel teaches assigning the plurality of kit identifiers to the first assembly order and the assembly order.
Young in view of Hetzel does not explicitly discloses or teach, however, Lumsden teaches wherein updating the plurality of kit identifiers is performed prior to the above assigning (Page 2) (Interactive response technologies (IRT) have long been used to manage IP expiry Flexible systems typically allow updating product expiry at the lot level…at “available” (i.e., prior to assigning).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the ability to handle expired goods of Lumsden with the system of Young in view of Hetzel in order to provide a more efficient system for handling all issues with the clinical goods.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Young in view of Hetzel, as applied to claim 1, and further in view of U.S. Patent No. 7,318,043 to Silver et al. (hereinafter “Silver”).
In regard to claim 10, Young in view of Hetzel does not explicitly disclose or teach, however, Silver teaches at the first computer system: receiving a rejection from a user associated with the first computer system for the first assembly order; and flagging a rejected assembly order for manual shipment processes (Col. 3, lines 40- Col.4, line 5) (In addition, after a current order is automatically identified as being potentially erroneous, the handling of such orders can occur in various ways in various embodiments….For example, in situations in which a potential order is automatically identified as being potentially erroneous, the user may be warned as part of the normal order completion process in order to allow the user to use that information when deciding whether to finish placing the potential order (i.e., for manual shipment processes). In other embodiments, orders identified as being potentially erroneous may instead in at least some situations be automatically canceled or prevented from being placed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the ability to handle erroneous orders of Silver with the system of Young in view of Hetzel in order to provide a more efficient system for handling all issues with the clinical goods.
Prior Art
The following prior art, made of record and not relied upon, is considered pertinent to Applicant’s disclosure:
U.S. Patent Application Publication No. 2006/0143047 to Briegs et al. (hereinafter “Breigs”). Breigs discloses allowing a user to create shipping instructions for these materials so they will be available at the trial sites and/or allows the user to revise the trial, e.g. use different supplies, based on the materials which are available.
Conclusion
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/RUPANGINI SINGH/
Examiner, Art Unit 3628
Prosecution Insights