DETAILED ACTION
Notice to Applicant
1. The following is a NON-FINAL Office action upon examination of application number 18/603,862 filed on 03/13/2024. Claims 1-25 are pending in the application and have been examined on the merits discussed below.
2. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
3. Application 18/603,862 filed 03/13/2024 claims Priority from Provisional Application 63/490,380, filed 03/15/2023.
Response to Arguments
5. Applicant's arguments filed February 19, 2026, have been fully considered.
6. Applicant submits “Cited references do not disclose “determining an occurrence of [an] event during preparation of [a] product in response to a parameter being applied to the product [that] causes a change to the product rendering the product inoperable for use.”” [Appeal Brief, 02/19/2026, page 1]
Applicant's arguments with respect to claim 1 have been considered but are moot because the arguments do not apply to the combination of references being used in the current rejection.
7. Applicant submits “Cited references do not disclose determining an event occurs "in response to [an] instrumentation applying a parameter that physically interacts with the product, such that the product experiences a change that renders it inoperable.”” [Appeal Brief, 02/19/2026, page 4]
Applicant's arguments with respect to claim 22 have been considered but are moot because the arguments do not apply to the combination of references being used in the current rejection.
8. Applicant submits “Cited references do not disclose “a structural change to the product, a change in a level of sterility of the product, or a change in a level of fluid stored in the product.”” [Appeal Brief, 02/19/2026, page 5]
Applicant's arguments with respect to claim 16 have been considered but are moot because the arguments do not apply to the combination of references being used in the current rejection.
Claim Rejections - 35 USC § 101
9. 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.
10. Claims 1-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
11. Claims 1-25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The eligibility analysis in support of these findings is provided below, in accordance with MPEP 2106.
With respect to Step 1 of the eligibility inquiry (as explained in MPEP 2106), it is first noted that the methods (claims 1-25) is directed to at least one potentially eligible category of subject matter (i.e., process). Thus, Step 1 of the Subject Matter Eligibility test for claims 1-25 is satisfied.
With respect to Step 2A Prong One, it is next noted that the claims recite an abstract idea that falls into the “Mental Processes” abstract idea set forth in MPEP 2106 since the claims set forth steps for sales/marketing purposes, which amounts to sales or marketing activities or behaviors (under “commercial or legal interactions” in MPEP 2106) within the “Certain Methods of Organizing Human Activity” abstract idea grouping, and steps that can be performed in the human mind (including observation, evaluation, judgment, opinion), and therefore fall under the “Mental Processes” abstract idea grouping. With respect to independent claim 1, the limitations reciting the abstract idea are indicated in bold below: preparing a product during the supply chain process based on an automated operation of an instrumentation configured for preparing the product; determining an occurrence of the event during preparation of the product pursuant to the automated operation in response to a parameter being applied to the product during the supply chain process, wherein the event causes a change to the product rendering the product inoperable for use; and identifying a modification to the automated operation of the instrumentation in the supply chain process that adjusts application of the parameter to inhibit occurrences of the event rendering the product inoperable for use during subsequent preparations of the product in the supply chain process. Considered together, these steps set forth an abstract idea of managing supply chain interactions, which falls under the realm of managing commercial interactions (e.g., marketing or sales activities or behaviors), thus falling under the “Certain methods of organizing human activity” grouping set forth in MPEP 2101, as well as the “Mental Processes” abstract idea grouping via recitation of activities that be performed in the human mind.
Because the above-noted limitations recite steps falling within the “Certain methods of organizing human activity” abstract idea grouping and the “Mental Processes” abstract idea grouping, they have been determined to recite at least one abstract idea when evaluated under Step 2A Prong One of the eligibility inquiry. Independent claims 17 and 22 recite similar limitations as those recited in claim 1 and therefore are found to recite the same abstract idea(s) as claim 1.
Therefore, because the limitations above set forth activities falling within the “Certain methods of organizing human activity” and “Mental Processes” abstract idea groupings described in MPEP 2106, the additional elements recited in the claims are further evaluated, individually and in combination, under Step 2A Prong Two and Step 2B below.
With respect to Step 2A Prong Two, the judicial exception is not integrated into a practical application. With respect to the independent claims, the additional elements are: the automated operation of an instrumentation (claim 1), automated operation of an instrumentation (claim 17), automated operation of an instrumentation and the instrumentation (claim 22). These elements have been considered individually and in combination, but fail to integrate the abstract idea into a practical application because they amount to using generic computing elements or instructions (software) to perform the abstract idea, similar to adding the words “apply it” (or an equivalent), which merely serves to link the use of the judicial exception to a particular technological environment (network computing environment). See MPEP 2106.05(f) and 2106.05(h). Even if the step for preparing is not deemed part of the abstract idea, this step is at most directed to insignificant extra-solution activity, which is not sufficient to amount to a practical application. See MPEP 2106.05(g).In addition, these limitations fail to provide an improvement to the functioning of a computer or to any other technology or technical field, fail to apply the exception with a particular machine, fail to apply the judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, fail to effect a transformation of a particular article to a different state or thing, and fail to apply/use the abstract idea in a meaningful way beyond generally linking the use of the judicial exception to a particular technological environment.
Accordingly, because the Step 2A Prong One and Prong Two analysis resulted in the conclusion that the claims are directed to an abstract idea, additional analysis under Step 2B of the eligibility inquiry must be conducted in order to determine whether any claim element or combination of elements amount to significantly more than the judicial exception.
With respect to Step 2B of the eligibility inquiry, it has been determined that the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. With respect to the independent claims, the additional elements are: the automated operation of an instrumentation (claim 1), automated operation of an instrumentation (claim 17), automated operation of an instrumentation and the instrumentation (claim 22). These elements have been considered individually and in combination, but fail to add significantly more to the claims because they amount to using generic computing elements or instructions (software) to perform the abstract idea, similar to adding the words “apply it” (or an equivalent), which merely serves to link the use of the judicial exception to a particular technological environment (network computing environment) and does not amount to significantly more than the abstract idea itself. Notably, Applicant’s Specification acknowledges that the claimed invention relies on nothing more than a general purpose computer executing instructions to implement the invention (Specification at paragraphs 0025, 0054). Therefore, the additional elements merely describe generic computing elements or computer-executable instructions (software) merely serve to tie the abstract idea to a particular operating environment, which does not add significantly more to the abstract idea. See, e.g., Alice Corp., 134 S. Ct. 2347, 110 USPQ2d 1976; Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015).
Even if the step for preparing is not deemed part of the abstract idea, this step is at most directed to insignificant extra-solution activity, which has been recognized as well-understood, routine, and conventional, and thus insufficient to add significantly more to the abstract idea. See MPEP 2106.05(d) - Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network).
In addition, when taken as an ordered combination, the ordered combination adds nothing that is not already present as when the elements are taken individually. There is no indication that the combination of elements integrate the abstract idea into a practical application. Their collective functions merely provide generic computer implementation. Therefore, when viewed as a whole, these additional claim elements do not provide meaningful limitations to transform the abstract idea into a practical application of the abstract idea or that, as an ordered combination, amount to significantly more than the abstract idea itself.
Dependent claims 2-16, 18-21, and 23-25 recite the same abstract idea as recited in the independent claims, and when evaluated under Step 2A Prong One are found to merely recite details that serve to narrow the same abstract idea recited in the independent claims accompanied by the same generic computing elements or software as those addressed above in the discussion of the independent claims, which is not sufficient to amount to a practical application or add significantly more, or other additional elements that fail to amount to a practical application or add significantly more, as noted above. In particular, dependent claims 2-16, 18-21, and 23-25 recite the limitations “determining a source in the supply chain process causing the occurrence of the event,” “wherein prior to identifying the modification, the method comprises: determining the parameter is applied to the product during the event, with the parameter causing damage to the product,” “detect the parameter applied to the product during the occurrence of the event,” “wherein prior to identifying the modification, the method comprises: transmitting the parameter, determine a value of the parameter,” “wherein prior to identifying the modification, the method comprises: comparing the value of the parameter to a threshold; and identifying the modification in response to the value of the parameter exceeding the threshold, and forgoing identification of the modification in response to the value of the parameter not exceeding the threshold,” “wherein the parameter includes a temperature, a pressure, a force, a velocity, a light intensity, a fluid level, an impedance, a compression, a tilt, or a rotation experienced by the product during the event,” “wherein: the product includes a device, a tool, a machine, an instrument, a mechanism, an appliance, a gadget, or an apparatus; and performing operations in the supply chain process to prepare the product,” “wherein the product includes a medical device, such that identifying the modification to the supply chain process includes an adjustment,” “wherein the medical device includes an autoinjector or a syringe,” “wherein preparing the product during the supply chain process includes one or more of manufacturing, assembling, testing, sterilizing, packaging, labeling or marking, storing, shipping, selling, or delivering the product,” “wherein the event is a first event occurring during a first stage of the supply chain process for preparing the product,” “further comprising: determining an occurrence of a second event during preparation of the product during a second stage of the supply chain process, wherein the second stage is different than the first stage of the supply chain process; and determining a second source in the supply chain process causing the occurrence of the second event, wherein the second source is different than the first source,” “identifying a second modification to an operation in the supply chain process to inhibit occurrences of the second event during subsequent preparations of the product in the supply chain process,” “wherein the change includes a structural change to the product, a change in a level of sterility of the product, or a change in a level of fluid stored in the product,” “wherein prior to determining the modification, the method comprises: determining a source responsible for preparing the product in the supply chain process is causing the occurrence of the event; determining the parameter applied to the product by the source during the occurrence of the event; comparing a value of the parameter to a threshold; and determining the modification in response to the value of the parameter exceeding the threshold, and forgoing determination of the modification in response to the value of the parameter not exceeding the threshold,” “wherein the product includes a device, a tool, a machine, an instrument, a mechanism, an appliance, a gadget, or an apparatus; performing operations in the supply chain process to prepare the product; and wherein the parameter includes a temperature, a pressure, a force, a velocity, a light intensity, a fluid level, an impedance, a compression, a vibration, a shock, a tilt, or a rotation experienced by the product during the event,” “wherein preparing the product during the supply chain process includes one or more of manufacturing, assembling, testing, sterilizing, packaging, labeling or marking, storing, shipping, selling, or delivering the product,” “wherein the change to the product includes a structural change, a change in a level of sterility, or a change in a level of fluid stored in the product,” “wherein prior to identifying the modification, the method comprises: determining a source of the event that applies the parameter to the product and causes the change to the product; comparing the parameter to a threshold; and identifying the modification when the parameter exceeds the threshold, and forgoing identification of the modification when the parameter does not exceed the threshold,” “wherein preparing the product during the supply chain process includes one or more of manufacturing, assembling, testing, sterilizing, packaging, labeling or marking, storing, shipping, selling, or delivering the product; and performs operations in the supply chain process for preparing the product,” “wherein the change to the product includes a structural change, a change in a level of sterility, or a change in a level of fluid stored in the product,” however, these limitations fall under the same “Certain Methods of Organizing Human Activity” and “Mental Processes” abstract idea groupings by describing additional details for organizing human activity and mental activity that can be accomplished via human observation, judgment, or evaluation. The additional elements recited in the dependent claims include: the source including the instrumentation (claim 3), a sensing device (claim 4), a remote processor that is communicatively coupled to the sensing device (claim 5), wherein the sensing device includes an accelerometer, a gyro sensor, a temperature probe, a pressure sensor, a fluid level sensor, a vaporized hydrogen peroxide (VHP) sensor, a photometer sensor, a photodetector, or a chemical sensor (claim 8), the instrumentation includes a surface, a tool, an assembly, a machinery, an equipment, or a system (claim 9), the source includes the instrumentation for manufacturing the medical device, such that identifying the modification to the automated operation of the instrumentation in the supply chain process includes an adjustment to computer-executable instructions defining the automated operation of the instrumentation (claim 10), the source causing the occurrence of the event is a first source (claim 13), a second instrumentation, wherein the second source includes the second instrumentation (claim 15), wherein the source includes the instrumentation (claim 18), wherein the instrumentation includes a surface, a tool, an assembly, a machinery, an equipment, or a system (claim 19), wherein the instrumentation includes a surface, a tool, an assembly, a machinery, an equipment, or a system (claim 24). However, when evaluated under Step 2A Prong Two and Step 2B, these additional elements rely on generic computing elements or software for generally linking the judicial exception to a particular technological environment, which does not amount to a practical application. MPEP 2106.05(g)/(h). Under Step 2B, the use of such generic computing elements has been recognized by courts as insufficient to amount to significantly more than the abstract idea. See, Alice Corp., 134 S. Ct. 2347, 110 USPQ2d 1976; Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQe2d 1681, 1701 (Fed. Cir. 2015). Next, the step for transmitting is considered insignificant extra-solution activity, which has been recognized as well-understood, routine, and conventional, and thus insufficient to add significantly more to the abstract idea. See MPEP 2106.05(d).
The ordered combination of elements in the dependent claims (including the limitations inherited from the parent claim(s)) add nothing that is not already present as when the elements are taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide generic computer implementation. Accordingly, the subject matter encompassed by the dependent claims fails to amount to a practical application or significantly more than the abstract idea itself.
For more information, see MPEP 2106.
Claim Rejections - 35 USC § 103
12. 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 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.
13. 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 of this title, 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.
14. 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.
15. 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.
16. Claims 1-2, 9, 12-13, 17, 19-20, 22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Iskandar et al., Pub. No.: US 2017/0343999 A1, [hereinafter Iskandar], in view of Brown et al., Pub. No.: US 2003/0147770 A1, [hereinafter Brown].
As per claim 1, Iskandar teaches a method for identifying an event during a supply chain process (paragraphs 0016, 0017, 0079), comprising:
preparing a product during the supply chain process based on an automated operation of an instrumentation configured for preparing the product (paragraph 0002, discussing that manufacturing facilities across many different industries are responsible for producing products that are used in every facet of life; paragraph 0018, discussing monitoring a plurality of runs of a plurality of recipes for fabricating one or more devices within a manufacturing environment; paragraph 0024, discussing that a software component monitors a plurality of runs of a recipe for fabricating one or more semiconductor devices within a manufacturing environment and collects runtime data from a plurality of sensors within the manufacturing environment; paragraph 0025, discussing that each recipe can include multiple distinct steps that are executed in order to manufacture the product; paragraph 0039);
determining an occurrence of the event during preparation of the product pursuant to the automated operation during the supply chain process, wherein the event causes a change to the product rendering the product inoperable for use (paragraph 0006, discussing that problems can periodically arise in manufacturing environments that result in faulty runs of the product being manufactured. For example, equipment failures can result in a product being manufactured outside of a designated range of tolerances, rendering the manufactured product inoperable or unsuitable for its intended purposes; paragraph 0019, discussing that production flows within manufacturing facilities are often uncertain, loading within the manufacturing facilities can change frequently (e.g., due to equipment failures, processing speeds of different tools, etc.), different products can require different amounts of resources, and so on. Additionally, problems can occur within the manufacturing environment, resulting in faulty, unsuitable or otherwise less desirable manufactured products. For example, worn parts within the manufacturing equipment, gas leaks, and the like can all negatively impact the products being manufactured; paragraph 0020, discussing determining that a problem has occurred within the manufacturing environment (e.g., resulting in defective products being manufactured); paragraph 0029, discussing that the data model could specify that a particular temperature sensor within the manufacturing environment reaching or exceeding a predefined level is indicative of a faulty run; paragraph 0031, discussing that the software component could classify the subsequent run of the recipe into one of multiple groups (e.g., good run, faulty run, etc.) through the use of compressed sensor data; paragraph 0036, discussing a fault detection component. In one embodiment, the fault detection component is configured to generate a data model by analyzing compressed historical recipe run data and to use such a data model for detecting anomalous runs of the recipe (e.g., good, faulty, etc.); paragraph 0037, discussing that the data model could specify conditions for multiple sensors within the manufacturing environment that, when satisfied by sensor readings from a current run, are indicative of a particular anomalous classification for the current run (e.g., a faulty run); paragraph 0039, discussing that a particular rate of temperature increase detected by a particular sensor could be indicative of a faulty run…; paragraph 0044, discussing that the fault detection component can be configured to generate a data model from the compressed sensor data for use in detecting anomalous runs of a recipe); and
identifying a modification to the automated operation of the instrumentation in the supply chain process to inhibit occurrences of the event rendering the product inoperable for use during subsequent preparations of the product in the supply chain process (paragraph 0047, discussing that upon classifying the subsequent run as a faulty run, the fault detection component could determine one or more maintenance operations that have historically influenced the classification of runs of the recipe within the manufacturing environment from the faulty group into normal group. For example, for a particular type of faulty run, the fault detection component could access predefined data describing maintenance operations that have historically been performed to correct the fault(s) causing runs to be classified as the particular type of faulty run. The fault detection component could then initiate the performance of the one or more maintenance operations within the manufacturing environment, without requiring user interaction [i.e., identifying a modification to the automated operation of the instrumentation in the supply chain process]. For example, the one or more maintenance operations could include (i) an auto-calibration operation for one or more pieces of equipment within the manufacturing environment and (ii) initiating a run of a maintenance recipe, distinct from the recipe, within the manufacturing environment. Doing so enables the fault detection component to perform automated maintenance operations to correct problems within the manufacturing environment, without requiring user intervention, improving the performance of the manufacturing environment itself).
While Iskandar teaches determining an occurrence of the event during preparation of the product pursuant to the automated operation, it does not explicitly teach that the determining is in response to a parameter being applied to the product during the supply chain process; and identifying a modification to the automated operation of the instrumentation in the supply chain process that adjusts application of the parameter. However, Brown in the analogous art of product management systems teaches these concepts. Brown teaches:
determining an occurrence of the event during preparation of the product pursuant to the automated operation in response to a parameter being applied to the product during the supply chain process (paragraph 0126, discussing that the system is able to measure the pressure of the fluid flow at the input and the output of the treatment chamber, as well as monitor any changes in the temperature of the fluid flow due to the light treatment. It is noted that Xenon gas flashlamps and other pulsed light sources may generate significant heat, which may increase the temperature of the fluid. Thus, depending on the sensitivity to heat of the fluid being tested, the fluence of the light source may be adjusted in response to the measurements taken by the pressure transducers and thermocouples; paragraph 0406, discussing that the control system uses feedback from use to implement the settings, or to fine tune the settings during use, or to maintain the settings throughout the test or treatment. In some embodiments, the control system operates fully automatically…; paragraph 0413, discussing that the control system is a computer-based system that inputs settings as desired by the user and automatically implements these settings for the appropriate test or treatment. The system uses feedback from use to initialize and implement the settings; paragraph 0197, discussing that with some products that are treated, such shifts in the absorption profile indicate when a product is overtreated. Particularly with sensitive biological fluid products, too much light treatment damages the product itself. For example, in blood products, such as BSA, the absorption of wavelengths around 320 nm increases as proteins within the product are damaged. With careful monitoring of the absorption profile by being able to simultaneously measure the fluence at each wavelength across the spectrum of light and generate real time absorption profiles, overtreatment of a product may be avoided; paragraph 0385, discussing that the viscosity of the fluid product also affects the variances in particle flows across the thickness of the treatment chamber. The mass flow rate of the fluid is another factor. For example, altering the velocity at which a fluid is flowed through the treatment chamber may affects the variances in particle flow velocities within the fluid flow; paragraph 0397, discussing that the mass flow rate is adjusted such that the particular velocity is increased or decreased to better match the flash rate. In another example, the viscosity of the fluid product is adjusted. Furthermore, the flash rate and one or more of the fluid viscosity, the treatment chamber thickness or the mass flow rate may be adjusted together; paragraph 0426, discussing that once the product to be treated is flowing, the parameters of the light treatment are again checked. Thus, measurements of the fluence across multiple wavelengths of the light treatment illuminating the product and transmitting through the product are measured. Again, this calibration data is input to the calibration data input module and analyzed by the analysis module of the control software. If need be, additional adjustments may be made in response to the measurements to ensure uniform treatment due to changes in the system or changes in properties of the fluid product, such as concentration may be changing); and
identifying a modification to the automated operation of the instrumentation in the supply chain process that adjusts application of the parameter (paragraph 0413, discussing that the system uses feedback from use to initialize and implement the settings, or to fine tune the settings during use, or to maintain the settings throughout the test or treatment. The system operates fully automatically in response to initial user input. Additionally, the system stores all test data and performs analysis of the results; paragraph 0327, discussing that the fluence level of a light treatment for treating a product is adjustable by an automatic adjustment of the distance of the light source to a product to be treated. In one embodiment, the steps may be performed by the apparatus in use within a treatment system using light as described…; paragraph 0342, discussing that the fluence level of the light treatment is adjusted over time (during the flowing) as the initial property of the fluid product changes in order to maintain a preselected level of treatment. In preferred embodiments, the adjustment is an automatic adjustment is response to system measurements and/or light treatment measurements. In many embodiments, the fluence level is adjusted by automatically adjusting a distance from the one or more light sources providing the light treatment to the product, such as variously described herein. Advantageously, by adjusting the distance of the light source(s) to the product, the fluence is uniformly adjusted across the spectrum of wavelengths of the light treatment; paragraph 0343, disusing that a control signal is sent to the actuator assemblies to control the flow of fluid product and buffer fluid appropriately. Any of the controller devices described may be configured to analyze light treatment measurements and automatically cause changes in the concentration of the fluid product. A system implementing such a controller should have one or more light sources, a treatment chamber for flowing the fluid product, one or more detectors to measure a portion of the light treatment, a controller, and means to adjust the concentration of the fluid product within the fluid flow; paragraph 0409, discussing that the control system receives calibration data, e.g., measurements taken during use in order to implement or maintain the system settings. For example, before a product is flowed through the treatment zone and illuminated, the treatment zone is illuminated with a flash of light. In preferred embodiments, a spectrometer is used to determine measurements of the fluence and spectrum of the emitted light, which are fed back to the control system of the computer operating system/user interface to verify the proper parameters and to make the necessary changes to implement the proper settings….In some applications, particularly in applications treating sensitive biological products, precise treatment is required in order to achieve the proper inoculation level without damaging the fluid product itself; paragraph 0417, discussing that all implementation of user inputs is automated, i.e., the user does not make any manual adjustments to implement the settings. Further in contrast to known control systems for light treatment devices, feedback measurements are used to verify and fine tune such settings automatically).
Iskandar is directed toward a system and method for fault detection for manufacturing environments. Brown relates to product management systems. Therefore they are deemed to be analogous references as they both are directed toward product management systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Iskandar with Brown because the references are analogous art because they are both directed to solutions for product monitoring and management, which falls within applicant's field of endeavor (systems and methods for identifying occurrence of an event), and because modifying Iskandar to include Brown’s features for determining an occurrence of the event during preparation of the product pursuant to the automated operation in response to a parameter being applied to the product during the supply chain process and identifying a modification to the automated operation of the instrumentation in the supply chain process that adjusts application of the parameter, in the manner claimed, would serve the motivation of not to damage the products since they may be unusable if damaged too much, and determining the optimal set of parameters that will effectively treat a given product (Brown at paragraphs 0009, 0411); and further obvious because the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
As per claim 2, the Iskandar-Brown combination teaches the method of claim 1. Iskandar further teaches further comprising: determining a source in the supply chain process causing the occurrence of the event (paragraph 0006, discussing that problems can periodically arise in manufacturing environments that result in faulty runs of the product being manufactured. For example, equipment failures can result in a product being manufactured outside of a designated range of tolerances, rendering the manufactured product inoperable or unsuitable for its intended purposes; paragraph 0019, discussing that problems can occur within the manufacturing environment, resulting in faulty, unsuitable or otherwise less desirable manufactured products. For example, worn parts within the manufacturing equipment, gas leaks, and the like can all negatively impact the products being manufactured; paragraph 0020, discussing determining that a problem has occurred within the manufacturing environment (e.g., resulting in defective products being manufactured); paragraph 0030, discussing that the data model could describe a relative importance of each of a plurality of sensor types of the plurality of sensors in indicating the respective group. For example, the data model could indicate that while the temperature sensor data reaching or exceeding the predefined level is indicative of a particular classification, a gas sensor detecting a gas leak of a particular type of gas is greatly indicative of the particular classification; paragraphs 0029, 0037, 0039).
As per claim 9, the Iskandar-Brown combination teaches the method of claim 2. Iskandar further teaches wherein: the product includes a device, a tool, a machine, an instrument, a mechanism, an appliance, a gadget, or an apparatus (paragraph 0002, discussing that manufacturing facilities across many different industries are responsible for producing products that are used in every facet of life; paragraph 0018, discussing monitoring a plurality of runs of a plurality of recipes for fabricating one or more devices within a manufacturing environment; paragraph 0024, discussing that a software component monitors a plurality of runs of a recipe for fabricating one or more semiconductor devices within a manufacturing environment and collects runtime data from a plurality of sensors within the manufacturing environment); and
the instrumentation includes a surface, a tool, an assembly, a machinery, an equipment, or a system responsible for performing operations in the supply chain process to prepare the product (paragraph 0003, discussing that the semiconductor manufacturing production process is generally divided into two parts, “front-end” and “back-end,” both of which use different types of semiconductor manufacturing equipment. Front-end typically refers to wafer fabrication. For example, front-end manufacturing facilities generally start with blank semiconductor wafers (e.g., silicon wafers) and perform various processes, such as photolithography, deposition, etching, cleaning, ion implantation, chemical and mechanical polishing, etc., to fabricate a completed wafer with many semiconductor die on the wafer. Back-end typically refers to the assembly and testing of individual semiconductor devices. For example, once the front-end production process is completed, the completed wafers are transferred to a back-end manufacturing facility, which typically performs functions such as dicing the completed wafer into individual semiconductor die, testing, assembly, packaging, etc.; paragraph 0006, discussing that equipment failures can result in a product being manufactured outside of a designated range of tolerances, rendering the manufactured product inoperable or unsuitable for its intended purposes; paragraph 0047, discussing that the one or more maintenance operations could include (i) an auto-calibration operation for one or more pieces of equipment within the manufacturing environment; paragraph 0034).
As per claim 12, the Iskandar-Brown combination teaches the method of claim 9. Iskandar further teaches wherein preparing the product during the supply chain process includes one or more of manufacturing, assembling, testing, sterilizing, packaging, labeling or marking, storing, shipping, selling, or delivering the product (paragraph 0002, discussing that manufacturing facilities across many different industries are responsible for producing products that are used in every facet of life; paragraph 0003, discussing that each manufacturing environment is unique and extremely complex, often requiring immense amounts of capital for the necessary equipment, tools, facilities, etc. In semiconductor manufacturing environments, for example, the semiconductor manufacturing production process is generally divided into two parts, “front-end” and “back-end,” both of which use different types of semiconductor manufacturing equipment. Front-end typically refers to wafer fabrication. For example, front-end manufacturing facilities generally start with blank semiconductor wafers and perform various processes to fabricate a completed wafer with many semiconductor die on the wafer. Back-end typically refers to the assembly and testing of individual semiconductor devices. For example, once the front-end production process is completed, the completed wafers are transferred to a back-end manufacturing facility, which typically performs functions such as dicing the completed wafer into individual semiconductor die, testing, assembly, packaging, etc.; paragraph 0018, discussing monitoring a plurality of runs of a plurality of recipes for fabricating one or more devices within a manufacturing environment; paragraph 0025, discussing that each recipe can include multiple distinct steps that are executed in order to manufacture the product).
As per claim 13, the Iskandar-Brown combination teaches the method of claim 2. Iskandar further teaches wherein the event is a first event occurring during a first stage of the supply chain process for preparing the product, and the source causing the occurrence of the event is a first source in the supply chain process for preparing the product at the first stage (paragraph 0006, discussing that problems can periodically arise in manufacturing environments that result in faulty runs of the product being manufactured. For example, equipment failures can result in a product being manufactured outside of a designated range of tolerances, rendering the manufactured product inoperable or unsuitable for its intended purposes; paragraph 0019, discussing that problems can occur within the manufacturing environment, resulting in faulty, unsuitable or otherwise less desirable manufactured products. For example, worn parts within the manufacturing equipment, gas leaks, and the like can all negatively impact the products being manufactured; paragraph 0020, discussing determining that a problem has occurred within the manufacturing environment (e.g., resulting in defective products being manufactured); paragraph 0029, discussing that the data model could specify that a particular temperature sensor within the manufacturing environment reaching or exceeding a predefined level is indicative of a faulty run; paragraph 0030, discussing that the data model could describe a relative importance of each of a plurality of sensor types of the plurality of sensors in indicating the respective group. For example, the data model could indicate that while the temperature sensor data reaching or exceeding the predefined level is indicative of a particular classification, a gas sensor detecting a gas leak of a particular type of gas is greatly indicative of the particular classification; paragraph 0037, discussing that the data model could specify conditions for multiple sensors within the manufacturing environment that, when satisfied by sensor readings from a current run, are indicative of a particular anomalous classification for the current run (e.g., a faulty run); paragraph 0039, discussing that a particular rate of temperature increase detected by a particular sensor could be indicative of a faulty run…).
Claim 17 recites substantially similar limitations that stand rejected via the art citations and rationale applied to claim 1, as discussed above. Further, as per claim 17 the Iskandar-Brown combination teaches determining a modification to the automated operation of the instrumentation in the supply chain process that reduces the occurrence of the event in the supply chain process during subsequent preparations of the product, thereby reducing the occurrence of the change to the product (Iskandar, paragraph 0047, discussing that upon classifying the subsequent run as a faulty run, the fault detection component could determine one or more maintenance operations that have historically influenced the classification of runs of the recipe within the manufacturing environment from the faulty group into normal group. For example, for a particular type of faulty run, the fault detection component could access predefined data describing maintenance operations that have historically been performed to correct the fault(s) causing runs to be classified as the particular type of faulty run. The fault detection component could then initiate the performance of the one or more maintenance operations within the manufacturing environment, without requiring user interaction [i.e., identifying a modification to the automated operation of the instrumentation in the supply chain process]. For example, the one or more maintenance operations could include (i) an auto-calibration operation for one or more pieces of equipment within the manufacturing environment and (ii) initiating a run of a maintenance recipe, distinct from the recipe, within the manufacturing environment. Doing so enables the fault detection component to perform automated maintenance operations to correct problems within the manufacturing environment, without requiring user intervention, improving the performance of the manufacturing environment itself), but it does not explicitly teach determining a modification to the automated operation of the instrumentation in the supply chain process that adjusts application of the parameter. However, Brown in the analogous art of product management systems teaches this concept. Brown teaches:
determining a modification to the automated operation of the instrumentation in the supply chain process that adjusts application of the parameter (paragraph 0413, discussing that the system uses feedback from use to initialize and implement the settings, or to fine tune the settings during use, or to maintain the settings throughout the test or treatment. The system operates fully automatically in response to initial user input. Additionally, the system stores all test data and performs analysis of the results; paragraph 0327, discussing that the fluence level of a light treatment for treating a product is adjustable by an automatic adjustment of the distance of the light source to a product to be treated. In one embodiment, the steps may be performed by the apparatus in use within a treatment system using light as described…; paragraph 0342, discussing that the fluence level of the light treatment is adjusted over time (during the flowing) as the initial property of the fluid product changes in order to maintain a preselected level of treatment. In preferred embodiments, the adjustment is an automatic adjustment is response to system measurements and/or light treatment measurements. In many embodiments, the fluence level is adjusted by automatically adjusting a distance from the one or more light sources providing the light treatment to the product, such as variously described herein. Advantageously, by adjusting the distance of the light source(s) to the product, the fluence is uniformly adjusted across the spectrum of wavelengths of the light treatment; paragraph 0343, disusing that a control signal is sent to the actuator assemblies to control the flow of fluid product and buffer fluid appropriately. Any of the controller devices described may be configured to analyze light treatment measurements and automatically cause changes in the concentration of the fluid product. A system implementing such a controller should have one or more light sources, a treatment chamber for flowing the fluid product, one or more detectors to measure a portion of the light treatment, a controller, and means to adjust the concentration of the fluid product within the fluid flow; paragraph 0409, discussing that the control system receives calibration data, e.g., measurements taken during use in order to implement or maintain the system settings. For example, before a product is flowed through the treatment zone and illuminated, the treatment zone is illuminated with a flash of light. In preferred embodiments, a spectrometer is used to determine measurements of the fluence and spectrum of the emitted light, which are fed back to the control system of the computer operating system/user interface to verify the proper parameters and to make the necessary changes to implement the proper settings….In some applications, particularly in applications treating sensitive biological products, precise treatment is required in order to achieve the proper inoculation level without damaging the fluid product itself; paragraph 0417, discussing that all implementation of user inputs is automated, i.e., the user does not make any manual adjustments to implement the settings. Further in contrast to known control systems for light treatment devices, feedback measurements are used to verify and fine tune such settings automatically).
Iskandar is directed toward a system and method for fault detection for manufacturing environments. Brown relates to product management systems. Therefore they are deemed to be analogous references as they both are directed toward product management systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Iskandar with Brown because the references are analogous art because they are both directed to solutions for product monitoring and management, which falls within applicant's field of endeavor (systems and methods for identifying occurrence of an event), and because modifying Iskandar to include Brown’s feature for determining a modification to the automated operation of the instrumentation in the supply chain process that adjusts application of the parameter, in the manner claimed, would serve the motivation of not to damage the products since they may be unusable if damaged too much, and determining the optimal set of parameters that will effectively treat a given product (Brown at paragraphs 0009, 0411); and further obvious because the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Claim 19 recites substantially similar limitations that stand rejected via the art citations and rationale applied to claim 9, as discussed above. As per claim 19, although not explicitly taught by Iskandar, Brown in the analogous art of product management systems teaches wherein the parameter includes a temperature, a pressure, a force, a velocity, a light intensity, a fluid level, an impedance, a compression, a vibration, a shock, a tilt, or a rotation experienced by the product during the event (paragraph 0126, discussing that the system is able to measure the pressure of the fluid flow at the input and the output of the treatment chamber, as well as monitor any changes in the temperature of the fluid flow due to the light treatment. It is noted that Xenon gas flashlamps and other pulsed light sources may generate significant heat, which may increase the temperature of the fluid. Thus, depending on the sensitivity to heat of the fluid being tested, the fluence of the light source may be adjusted in response to the measurements taken by the pressure transducers and thermocouples; paragraph 0413, discussing that the control system is a computer-based system that inputs settings as desired by the user and automatically implements these settings for the appropriate test or treatment…; paragraph 0197, discussing that with some products that are treated, such shifts in the absorption profile indicate when a product is overtreated. Particularly with sensitive biological fluid products, too much light treatment damages the product itself. For example, in blood products, such as BSA, the absorption of wavelengths around 320 nm increases as proteins within the product are damaged. With careful monitoring of the absorption profile by being able to simultaneously measure the fluence at each wavelength across the spectrum of light and generate real time absorption profiles, overtreatment of a product may be avoided; paragraph 0385, discussing that the viscosity of the fluid product also affects the variances in particle flows across the thickness of the treatment chamber. The mass flow rate of the fluid is another factor. For example, altering the velocity at which a fluid is flowed through the treatment chamber may affects the variances in particle flow velocities within the fluid flow; paragraph 0397, discussing that the mass flow rate is adjusted such that the particular velocity is increased or decreased to better match the flash rate. In another example, the viscosity of the fluid product is adjusted. Furthermore, the flash rate and one or more of the fluid viscosity, the treatment chamber thickness or the mass flow rate may be adjusted together; paragraph 0426, discussing that once the product to be treated is flowing, the parameters of the light treatment are again checked. Thus, measurements of the fluence across multiple wavelengths of the light treatment illuminating the product and transmitting through the product are measured. Again, this calibration data is input to the calibration data input module and analyzed by the analysis module of the control software. If need be, additional adjustments may be made in response to the measurements to ensure uniform treatment due to changes in the system or changes in properties of the fluid product, such as concentration may be changing).
Iskandar is directed toward a system and method for fault detection for manufacturing environments. Brown relates to product management systems. Therefore they are deemed to be analogous references as they both are directed toward product management systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Iskandar with Brown because the references are analogous art because they are both directed to solutions for product monitoring and management, which falls within applicant's field of endeavor (systems and methods for identifying occurrence of an event), and because modifying Iskandar to include Brown’s feature for including wherein the parameter includes a temperature, a pressure, a force, a velocity, a light intensity, a fluid level, an impedance, a compression, a vibration, a shock, a tilt, or a rotation experienced by the product during the event, in the manner claimed, would serve the motivation of not to damage the products since they may be unusable if damaged too much, and determining the optimal set of parameters that will effectively treat a given product (Brown at paragraphs 0009, 0411); and further obvious because the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Claim 20 recites substantially similar limitations that stand rejected via the art citations and rationale applied to claim 12, as discussed above.
Claim 22 recites substantially similar limitations that stand rejected via the art citations and rationale applied to claim 1, as discussed above. Further, as per claim 22 the Iskandar-Brown combination teaches a method for identifying an event causing a change to a product during a supply chain process (Iskandar, paragraph paragraphs 0006, 0016, 0017, 0079).
Claim 24 recites substantially similar limitations that stand rejected via the art citations and rationale applied to claims 9 and 12, as discussed above.
17. Claims 3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Iskandar in view of Brown, in further view of Prater et al., Patent No.: US 7,050,938 B1, [hereinafter Prater].
As per claim 3, the Iskandar-Brown combination teaches the method of claim 2. Although not explicitly taught by the Iskandar-Brown combination, Prater in the analogous art of product handling systems teaches wherein prior to identifying the modification, the method comprises: determining the parameter is applied to the product during the event by the source, the source including the instrumentation with the parameter causing damage to the product (col. 15, lines 48-61, discussing that in addition to processing the kicked-out package for resolution of the error, the Kickout Tool Subroutine also compiles and sends data related to the error to a Process Modification Subroutine. FIG. 6 is a flow chart of an embodiment of a Process Modification Subroutine. The kickout tool uses this subroutine to provide self-correcting feedback loops and feed forward loops that can automatically modify the processing system to correct the root cause of processing errors. The process modification subroutine can also be configured to automatically update data used by the controller to help increase accuracy and efficiency of the package processing system. Accordingly, this automatic modification will help alleviate future kickout of package for the same problem; col. 15, lines 62-67 & col. 16, lines 1-9, discussing that the Process Modification Subroutine begins in step 174, wherein the kickout tool analyzes kickout information related to a kicked-out package and kickout information related to other packages. At step 176, the kickout tool determines whether there appears to be a common reason, quality control check, or error for the kicked-out packages from the processing line. As an example, the kickout tool may determine that a common reason for package kickout is a human error, such as if packages are not being gift-wrapped or over-wrapped by an operator working at a particular wrapping station. As another example, the kickout tool may determine that there is a hardware failure, such as a malfunction in a scanner at an identified location in the package processing path; FIG. 6, step 174).
The Iskandar-Brown combination described features related to product and supply chain management. Prater is directed toward a package handling system. Therefore they are deemed to be analogous references as they both are directed toward product management systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the Iskandar-Brown combination with Prater because the references are analogous art because they are both directed to solutions for supply chain management, which falls within applicant’s field of endeavor (supply chain management system), and because modifying the Iskandar-Brown combination to include Prater’s feature for including wherein prior to identifying the modification, the method comprises: determining the parameter is applied to the product during the event by the source, the source including the instrumentation with the parameter causing damage to the product, in the manner claimed, would serve the motivation of maintaining customer retention, inventory control, tracking, cost-effectiveness, and efficiency (Prater at col. 1, lines 38-40); and further obvious because the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
As per claim 7, the Iskandar-Brown-Prater combination teaches the method of claim 3. Although not explicitly taught by Iskandar, Brown in the analogous art product management systems teaches wherein the parameter includes a temperature, a pressure, a force, a velocity, a light intensity, a fluid level, an impedance, a compression, a tilt, or a rotation experienced by the product during the event (paragraph 0126, discussing that the system is able to measure the pressure of the fluid flow at the input and the output of the treatment chamber, as well as monitor any changes in the temperature of the fluid flow due to the light treatment. It is noted that Xenon gas flashlamps and other pulsed light sources may generate significant heat, which may increase the temperature of the fluid. Thus, depending on the sensitivity to heat of the fluid being tested, the fluence of the light source may be adjusted in response to the measurements taken by the pressure transducers and thermocouples; paragraph 0413, discussing that the control system is a computer-based system that inputs settings as desired by the user and automatically implements these settings for the appropriate test or treatment…; paragraph 0197, discussing that with some products that are treated, such shifts in the absorption profile indicate when a product is overtreated. Particularly with sensitive biological fluid products, too much light treatment damages the product itself. For example, in blood products, such as BSA, the absorption of wavelengths around 320 nm increases as proteins within the product are damaged. With careful monitoring of the absorption profile by being able to simultaneously measure the fluence at each wavelength across the spectrum of light and generate real time absorption profiles, overtreatment of a product may be avoided; paragraph 0385, discussing that the viscosity of the fluid product also affects the variances in particle flows across the thickness of the treatment chamber. The mass flow rate of the fluid is another factor. For example, altering the velocity at which a fluid is flowed through the treatment chamber may affects the variances in particle flow velocities within the fluid flow; paragraph 0397, discussing that the mass flow rate is adjusted such that the particular velocity is increased or decreased to better match the flash rate. In another example, the viscosity of the fluid product is adjusted. Furthermore, the flash rate and one or more of the fluid viscosity, the treatment chamber thickness or the mass flow rate may be adjusted together; paragraph 0426, discussing that once the product to be treated is flowing, the parameters of the light treatment are again checked. Thus, measurements of the fluence across multiple wavelengths of the light treatment illuminating the product and transmitting through the product are measured. Again, this calibration data is input to the calibration data input module and analyzed by the analysis module of the control software. If need be, additional adjustments may be made in response to the measurements to ensure uniform treatment due to changes in the system or changes in properties of the fluid product, such as concentration may be changing).
Iskandar is directed toward a system and method for fault detection for manufacturing environments. Brown relates to product management systems. Therefore they are deemed to be analogous references as they both are directed toward product management systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Iskandar with Brown because the references are analogous art because they are both directed to solutions for product monitoring and management, which falls within applicant's field of endeavor (systems and methods for identifying occurrence of an event), and because modifying Iskandar to include Brown’s feature for including wherein the parameter includes a temperature, a pressure, a force, a velocity, a light intensity, a fluid level, an impedance, a compression, a tilt, or a rotation experienced by the product during the event, in the manner claimed, would serve the motivation of not to damage the products since they may be unusable if damaged too much, and determining the optimal set of parameters that will effectively treat a given product (Brown at paragraphs 0009, 0411); and further obvious because the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
18. Claims 4-6, 8, and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Iskandar in view of Brown, in further view of Mirov, Pub. No.: US 2018/0165422 A1, [hereinafter Mirov].
As per claim 4, the Iskandar-Brown combination teaches the method of claim 1, but it does not explicitly teach wherein the product includes a sensing device configured to detect the parameter applied to the product during the occurrence of the event. However, Mirov in the analogous art supply chain management teaches this concept. Mirov teaches:
wherein the product includes a sensing device configured to detect the parameter applied to the product during the occurrence of the event (paragraph 0025, discussing that as shown in FIG. 2, the plunger head may include a number of components, including a transducer, a microcontroller, a power source, and an antenna (e.g., for near field communication (NFC)) or a transceiver. In some embodiments, the transceiver may include or incorporate an antenna. As shown in FIG. 2, the plunger head may also include a temperature sensor. The temperature sensor may be configured to measure a temperature of plunger head, which may be affected by the ambient temperature and/or temperature of medication. In some embodiments, additional or other sensors may be provided to measure one or more variables. In addition to temperature, examples of other variables include voltage, current, linear acceleration, angular acceleration, amplitude of sound, light intensity, and gas mixture. Examples of other types of sensors include an accelerometer, a gyroscope, a microphone, a light sensor, and a gas sensor; paragraph 0032, disusing that antenna or a transceiver may be used to communicate with a variety of remote devices (e.g., smart phones, glucose monitors, insulin pumps, computers, etc.). Plunger head may transmit the information via any suitable wireless communication method. For example, in some embodiments, plunger head may utilize radio data transmission, BLUETOOTH or (BLE), near field communication (NFC), infrared data transmission or other suitable method. In some embodiments, information may also be wirelessly transmitted from a remote device to plunger head via the antenna. For example, the date and time may be set by writing to microcontroller 26 via the wireless communication).
The Iskandar-Brown combination describes features related to supply chain and product management. Mirov is directed toward supply chain management. Therefore they are deemed to be analogous references as they both are directed toward product management systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the Iskandar-Brown combination with Mirov because the references are analogous art because they are both directed to solutions for supply chain management, which falls within applicant’s field of endeavor (supply chain management system), and because modifying the Iskandar-Brown combination to include Mirov’s feature for including wherein the product includes a sensing device configured to detect the parameter applied to the product during the occurrence of the event, in the manner claimed, would serve the motivation of enabling products to benefit from enhanced functionality and/or reliability (Mirov at paragraph 0004); and further obvious because the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
As per claim 5, the Iskandar-Brown-Mirov combination teaches the method of claim 4. Although not explicitly taught by the Iskandar-Brown combination, Mirov in the analogous art supply chain management teaches wherein prior to identifying the modification, the method comprises: transmitting the parameter to a remote processor that is communicatively coupled to the sensing device, wherein the remote processor is configured to determine a value of the parameter (paragraph 0008, discussing periodically measuring the at least one variable using the sensor; paragraph 0025, discussing that as shown in FIG. 2, the plunger head may include a number of components, including a transducer, a microcontroller, a power source, and an antenna (e.g., for near field communication (NFC)) or a transceiver. In some embodiments, the transceiver may include or incorporate an antenna. As shown in FIG. 2, the plunger head may also include a temperature sensor. The temperature sensor may be configured to measure a temperature of plunger head, which may be affected by the ambient temperature and/or temperature of medication. In some embodiments, additional or other sensors may be provided to measure one or more variables. In addition to temperature, examples of other variables include voltage, current, linear acceleration, angular acceleration, amplitude of sound, light intensity, and gas mixture. Examples of other types of sensors include an accelerometer, a gyroscope, a microphone, a light sensor, and a gas sensor; paragraph 0032, disusing that antenna or a transceiver may be used to communicate with a variety of remote devices (e.g., smart phones, glucose monitors, insulin pumps, computers, etc.). Plunger head may transmit the information via any suitable wireless communication method. For example, in some embodiments, plunger head may utilize radio data transmission, BLUETOOTH or (BLE), near field communication (NFC), infrared data transmission or other suitable method. In some embodiments, information may also be wirelessly transmitted from a remote device to plunger head via the antenna. For example, the date and time may be set by writing to microcontroller 26 via the wireless communication; paragraph 0050).
The Iskandar-Brown combination describes features related to supply chain and product management. Mirov is directed toward supply chain management. Therefore they are deemed to be analogous references as they both are directed toward product management systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the Iskandar-Brown combination with Mirov because the references are analogous art because they are both directed to solutions for supply chain management, which falls within applicant’s field of endeavor (supply chain management system), and because modifying the Iskandar-Brown combination to include Mirov’s feature for including wherein prior to identifying the modification, the method comprises: transmitting the parameter to a remote processor that is communicatively coupled to the sensing device, wherein the remote processor is configured to determine a value of the parameter, in the manner claimed, would serve the motivation of enabling products to benefit from enhanced functionality and/or reliability (Mirov at paragraph 0004); and further obvious because the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
As per claim 6, the Iskandar-Brown-Mirov combination teaches the method of claim 5. Although not explicitly taught by Iskandar-Brown combination, Mirov in the analogous art supply chain management teaches wherein prior to identifying the modification, the method comprises: comparing the value of the parameter to a threshold (paragraph 0044, discussing that the syringe may be reused to inject the remaining medication at least once after the first injection. In such cases, the syringe may be controlled to transition into the low-power operational state between injections. The syringe may be stored in the refrigerator between the injections, and the syringe may transition into the low-power operational state, for example, when the change in temperature is detected. Alternatively, the syringe may be stored outside the refrigerator between injections, and the syringe may transition into the low-power operational state, for example, when the measured acceleration is below a threshold amount; paragraph 0039); and
identifying the modification in response to the value of the parameter exceeding the threshold, and forgoing identification of the modification in response to the value of the parameter not exceeding the threshold (paragraph 0044, discussing that the syringe may be reused to inject the remaining medication at least once after the first injection. In such cases, the syringe may be controlled to transition into the low-power operational state between injections. The syringe may be stored in the refrigerator between the injections, and the syringe may transition into the low-power operational state, for example, when the change in temperature is detected. Alternatively, the syringe may be stored outside the refrigerator between injections, and the syringe may transition into the low-power operational state, for example, when the measured acceleration is below a threshold amount; paragraph 0039).
The Iskandar-Brown combination describes features related to supply chain and product management. Mirov is directed toward supply chain management. Therefore they are deemed to be analogous references as they both are directed toward product management systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the Iskandar-Brown combination with Mirov because the references are analogous art because they are both directed to solutions for supply chain management, which falls within applicant’s field of endeavor (supply chain management system), and because modifying the Iskandar-Brown combination to include Mirov’s feature for including wherein prior to identifying the modification, the method comprises: transmitting the parameter to a remote processor that is communicatively coupled to the sensing device, wherein the remote processor is configured to determine a value of the parameter, in the manner claimed, would serve the motivation of enabling products to benefit from enhanced functionality and/or reliability (Mirov at paragraph 0004); and further obvious because the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
As per claim 8, the Iskandar-Brown-Mirov combination teaches the method of claim 4. While Iskandar describes temperature sensors (paragraph 0021, discussing that a given manufacturing environment may include hundreds of sensors, each collecting sensor data over multiple steps of multiple runs of a recipe. Examples of such sensors include, without limitation, temperature sensors, gas detection sensors, laser and fiber optic sensors, camera sensors, and so on. Generally, any form of sensor suitable for collecting data within a manufacturing environment can be used, consistent with the disclosure; paragraph 0036, discussing collecting runtime data from a plurality of sensors, e.g., temperature sensors, gas detection sensors, laser and fiber optic sensors, camera sensors, and so on; paragraph 0029), Iskandar does not explicitly teach wherein the sensing device includes an accelerometer, a gyro sensor, a temperature probe, a pressure sensor, a fluid level sensor, a vaporized hydrogen peroxide (VHP) sensor, a photometer sensor, a photodetector, or a chemical sensor. However, Mirov in the analogous art supply chain management teaches this concept. Mirov teaches:
wherein the sensing device includes an accelerometer, a gyro sensor, a temperature probe, a pressure sensor, a fluid level sensor, a vaporized hydrogen peroxide (VHP) sensor, a photometer sensor, a photodetector, or a chemical sensor (paragraph 0025, discussing that as shown in FIG. 2, the plunger head may include a number of components, including a transducer, a microcontroller, a power source, and an antenna (e.g., for near field communication (NFC)) or a transceiver. In some embodiments, the transceiver may include or incorporate an antenna. As shown in FIG. 2, the plunger head may also include a temperature sensor. The temperature sensor may be configured to measure a temperature of plunger head, which may be affected by the ambient temperature and/or temperature of medication. In some embodiments, additional or other sensors may be provided to measure one or more variables. In addition to temperature, examples of other variables include voltage, current, linear acceleration, angular acceleration, amplitude of sound, light intensity, and gas mixture. Examples of other types of sensors include an accelerometer, a gyroscope, a microphone, a light sensor, and a gas sensor).
The Iskandar-Brown combination describes features related to supply chain and product management. Mirov is directed toward supply chain management. Therefore they are deemed to be analogous references as they both are directed toward product management systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the Iskandar-Brown combination with Mirov because the references are analogous art because they are both directed to solutions for supply chain management, which falls within applicant’s field of endeavor (supply chain management system), and because modifying the Iskandar-Brown combination to include Mirov’s feature for including wherein the sensing device includes an accelerometer, a gyro sensor, a temperature probe, a pressure sensor, a fluid level sensor, a vaporized hydrogen peroxide (VHP) sensor, a photometer sensor, a photodetector, or a chemical sensor, in the manner claimed, would serve the motivation of enabling products to benefit from enhanced functionality and/or reliability (Mirov at paragraph 0004); and further obvious because the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
As per claim 10, the Iskandar-Brown combination teaches the method of claim 9. Iskandar further teaches such that identifying the modification to the automated operation of the instrumentation in the supply chain process includes an adjustment to computer-executable instructions defining the automated operation of the instrumentation (paragraph 0047, discussing that upon classifying the subsequent run as a faulty run, the fault detection component could determine one or more maintenance operations that have historically influenced the classification of runs of the recipe within the manufacturing environment from the faulty group into normal group. For example, for a particular type of faulty run, the fault detection component could access predefined data describing maintenance operations that have historically been performed to correct the fault(s) causing runs to be classified as the particular type of faulty run. The fault detection component could then initiate the performance of the one or more maintenance operations within the manufacturing environment, without requiring user interaction.. For example, the one or more maintenance operations could include (i) an auto-calibration operation for one or more pieces of equipment within the manufacturing environment and (ii) initiating a run of a maintenance recipe, distinct from the recipe, within the manufacturing environment. Doing so enables the fault detection component to perform automated maintenance operations to correct problems within the manufacturing environment, without requiring user intervention, improving the performance of the manufacturing environment itself).
The Iskandar-Brown combination does not explicitly teach wherein the product includes a medical device and the source includes the instrumentation for manufacturing the medical device. However, Mirov in the analogous art supply chain management teaches this concept. Mirov teaches:
wherein the product includes a medical device and the source includes the instrumentation for manufacturing the medical device (paragraph 0026, discussing that the microcontroller may be programmed with instructions to control the overall operation of the components of plunger head 22; paragraph 0035, discussing that at manufacturing stage 410, the syringe is manufactured, assembled, and/or prepared for distribution to a storage facility. As shown in FIG. 4, manufacturing stage 410 may include a number of sub-stages. At a sub-stage 412, for example, plunger head 22 is formed using a molding process, which may involve pouring hot, liquid elastomer over the components to be embedded in plunger head 22 using a mold, etc. In other embodiments, 3-D printing or another additive manufacturing process may be used to form plunger head 22 by, for example, encapsulating the components in an elastomer or other material that forms plunger head 22; paragraph 0030).
The Iskandar-Brown combination describes features related to supply chain and product management. Mirov is directed toward supply chain management. Therefore they are deemed to be analogous references as they both are directed toward product management systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the Iskandar-Brown combination with Mirov because the references are analogous art because they are both directed to solutions for supply chain management, which falls within applicant’s field of endeavor (supply chain management system), and because modifying the Iskandar-Brown combination to include Mirov’s feature for including wherein the product includes a medical device and the source includes the instrumentation for manufacturing the medical device, in the manner claimed, would serve the motivation of enabling products to benefit from enhanced functionality and/or reliability (Mirov at paragraph 0004); and further obvious because the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
As per claim 11, the Iskandar-Brown-Mirov combination teaches the method of claim 10. Although not explicitly taught by the Iskandar-Brown combination, Mirov in the analogous art supply chain management teaches wherein the medical device includes an autoinjector or a syringe (paragraph 0035, discussing that at manufacturing stage 410, the syringe is manufactured, assembled, and/or prepared for distribution to a storage facility. As shown in FIG. 4, manufacturing stage 410 may include a number of sub-stages. At a sub-stage 412, for example, plunger head 22 is formed using a molding process, which may involve pouring hot, liquid elastomer over the components to be embedded in plunger head 22 using a mold, etc. In other embodiments, 3-D printing or another additive manufacturing process may be used to form plunger head 22 by, for example, encapsulating the components in an elastomer or other material that forms plunger head 22).
The Iskandar-Brown combination describes features related to supply chain and product management. Mirov is directed toward supply chain management. Therefore they are deemed to be analogous references as they both are directed toward product management systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the Iskandar-Brown combination with Mirov because the references are analogous art because they are both directed to solutions for supply chain management, which falls within applicant’s field of endeavor (supply chain management system), and because modifying the Iskandar-Brown combination to include Mirov’s feature for including wherein the medical device includes an autoinjector or a syringe, in the manner claimed, would serve the motivation of enabling products to benefit from enhanced functionality and/or reliability (Mirov at paragraph 0004); and further obvious because the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
19. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Iskandar in view of Brown, in further view of Zhang et al., Pub. No.: US 2023/0185640 A1, [hereinafter Zhang].
As per claim 14, the Iskandar-Brown combination teaches the method of claim 13. Iskandar further teaches further comprising: determining an occurrence of a second event during preparation of the product during a second stage of the supply chain process, wherein the second stage is different than the first stage of the supply chain process (paragraph 0019, discussing that problems can occur within the manufacturing environment, resulting in faulty, unsuitable or otherwise less desirable manufactured products. For example, worn parts within the manufacturing equipment, gas leaks, and the like can all negatively impact the products being manufactured; paragraph 0020, discussing determining that a problem has occurred within the manufacturing environment (e.g., resulting in defective products being manufactured); paragraph 0029, discussing that the data model could specify that a particular temperature sensor within the manufacturing environment reaching or exceeding a predefined level is indicative of a faulty run; paragraph 0030, discussing that the data model could describe a relative importance of each of a plurality of sensor types of the plurality of sensors in indicating the respective group. For example, the data model could indicate that while the temperature sensor data reaching or exceeding the predefined level is indicative of a particular classification, a gas sensor detecting a gas leak of a particular type of gas is greatly indicative of the particular classification; paragraph 0037, discussing that the data model could specify conditions for multiple sensors within the manufacturing environment that, when satisfied by sensor readings from a current run, are indicative of a particular anomalous classification for the current run (e.g., a faulty run); paragraph 0039, discussing that the fault detection component is configured to consider the step of the recipe during which the additional runtime data was collected when comparing the additional runtime data with values in the data model. That is, each recipe can include multiple distinct steps that are executed in order to manufacture the product, and the fault detection component (or a monitoring system within the manufacturing environment) can record which step of the recipe a given unit of data was collected during. The fault detection component could then collect sensor data from the plurality of sensors during each step of the recipe, and could compare the collected sensor data with data within the model for the corresponding step of the recipe in order to classify the current run. For example, the data model could specify a rate of temperature increase for a particular sensor during a particular step of the recipe is indicative of a particular classification, and could specify a much lesser rate of temperature increase for the same sensor during a later step of the recipe is indicative of the same classification. As such, the fault detection component could classify a current run into a different group, depending on the step during which a particular sensor reading was taken. In other words, a particular rate of temperature increase detected by a particular sensor could be indicative of a good run during a certain step of the recipe, while the same rate of temperature increase detected by the same sensor could be indicative of a faulty run during another step [i.e., second stage] of the same recipe. By taking into account which step of the recipe the current production run is executing, embodiments can more accurately classify the current run of the recipe; paragraph 0003).
The Iskandar-Brown combination does not explicitly teach determining a second source in the supply chain process causing the occurrence of the second event, wherein the second source is different than the first source. However, Zhang in the analogous art of event monitoring systems teaches this concept. Zhang teaches:
determining a second source in the supply chain process causing the occurrence of the second event, wherein the second source is different than the first source (paragraph 0042, discussing that the metrics engine may provide one or more metrics service configured to support the definition, computation, and reporting of one or more metrics for consumption by a software application. As shown in FIG. 1, the software application may be a web-based application and/or a cloud-based application hosted at one or more data centers including, for example, a first data center, a second data center, and/or the like. The one or more metrics services may be event-driven in nature. That is, the one or more metrics services may be configured to compute and update metrics based on events occurring at one or more event sources including, for example, a first event source, a second event source, and/or the like).
The Iskandar-Brown combination describes features related to supply chain and product management. Zhang is directed toward event monitoring systems. Therefore they are deemed to be analogous references as they both are directed toward event management systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the Iskandar-Brown combination with Zhang because the references are analogous art because they are both directed to solutions for supply chain management, which falls within applicant’s field of endeavor (supply chain management system), and because modifying the Iskandar-Brown combination to include Zhang’s feature for including determining a second source in the supply chain process causing the occurrence of the second event, wherein the second source is different than the first source, in the manner claimed, would serve the motivation of improving performance (Zhang at paragraph 0040); and further obvious because the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
20. Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Iskandar in view of Brown, in view of Zhang, in further view of De et al., Pub. No.: US 2019/0137982 A1, [hereinafter De].
As per claim 15, the Iskandar-Brown-Zhang combination teaches the method of claim 14. Although not explicitly taught by the Iskandar-Brown-Zhang combination, De in the analogous art of product handling systems teaches further comprising: identifying a second modification to an operation of a second instrumentation in the supply chain process to inhibit occurrences of the second event during subsequent preparations of the product in the supply chain process, wherein the second source includes the second instrumentation (paragraph 0034, discussing that the set of controllers may use measurements from one or more sensors to control the operation of one or more actuators. A second set of controllers could be used to optimize the control logic or other operations performed by the first set of controllers. A third set of controllers could be used to perform additional functions; paragraph 0061, discussing that for reducing off-specification production, the iBATCH can monitor a golden batch, a cost of over quality, batch re-processing, etc. To monitor the golden batch, the iBATCH can track the current batch with the golden batch parameters and advise the user on key decisions it can take to make the current batch meet the golden batch trends. The golden batch parameters are parameters or indicators that suggest the product or process is performing optimally, where the optimal performance could be an acceptable threshold for a product or process. In certain embodiments, the iBATCH system monitors the golden batch parameters and can determine if a parameter can be adjusted automatically to improve the product or process. iBATCH can determine a root cause of a deviation of a batch trend against the golden batch trends and assist batch operators in making the right decision to recover the batch. Live tracking of critical batch parameters are used against a reference trend, such as a golden batch trend. Detection and alert deviation in batch performance can be detected early on and assist operators based on process knowledge, equipment knowledge, and historical knowledge on how to recover the batch. When the iBATCH can adjust operating controls to improve the parameter without requiring user assistance, the iBATCH can make the adjustments to components or controls of the manufacturing system; paragraph 0063, discussing that for reducing batch re-processing, iBATCH can provide actionable instructions to the user on how to recover a batch that has not met the quality standards. The iBATCH 305 can also proceed with the instructions when it is determined that a user's interaction is not necessary. In other words, when the iBATCH system determines a solution for reducing batch re-processing that does not require a user to perform a function outside the control of the system, iBATCH can take any necessary steps to automatically reduce the re-processing; paragraph 0098, discussing that the iBATCH system can send data or commands to the different section of the manufacturing system in order to correct and defects or irregularities. The iBATCH system also can operate the batch process to obtain a product level that meets the golden batch trends; paragraph 0084, discussing that as examples when a sudden breakdown of a heating jacket around a process reactor occurs, different design choices could include re-routing a current product from a first reactor to a second reactor by operating a sequence of valves; re-scheduling the batch that was planned on the line of the second reactor to a later point taking into account the planning and scheduling data; and based on the batch quality parameters and historical data to resolve similar the heating jacket problems, make a decision to wait for a threshold time, for example approximately 30 minutes, without having to impact the quality of the batch. The impacts of each of these alternatives can be provided as a process visualization to the user to take an informed decision; paragraph 0038).
The Iskandar-Brown-Zhang combination describes features related to supply chain and product management. De relates to industrial process control and automation systems. Therefore they are deemed to be analogous references as they both are directed toward product management systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the Iskandar-Brown-Zhang combination with De because the references are analogous art because they are both directed to solutions for supply chain management, which falls within applicant’s field of endeavor (supply chain management system), and because modifying the Iskandar-Brown-Zhang combination to include De’s feature for including identifying a second modification to an operation of a second instrumentation in the supply chain process to inhibit occurrences of the second event during subsequent preparations of the product in the supply chain process, wherein the second source includes the second instrumentation, in the manner claimed, would serve the motivation of facilitating control over components in industrial plants (De at paragraph 0031); and further obvious because the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
21. Claims 16, 21, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Iskandar in view of Brown, in further view of Yamamoto, Pub. No.: US 2019/0035067 A1, [hereinafter Yamamoto].
As per claim 16, the Iskandar-Brown combination teaches the method of claim 1. While Brown describes fluid product changes (paragraph 0016), the Iskandar-Brown combination does not explicitly teach wherein the change includes a structural change to the product, a change in a level of sterility of the product, or a change in a level of fluid stored in the product. However, Yamamoto in the analogous art of production management systems teaches this concepts. Yamamoto teaches:
wherein the change includes a structural change to the product, a change in a level of sterility of the product, or a change in a level of fluid stored in the product (paragraph 0007, discussing that in an actual production factory or the like, the importance of the image sometimes changes after some time. For example, in the case where a shape abnormality of a product is detected and the cause of the abnormality is change in the product shape due to malfunction of a processing machine, sometimes it is necessary to refer to images of the past; paragraph 0031, discussing that a workpiece or a production apparatus serves as the object. Whether the object is in the specific state is determined on the basis of, for example, a result of image processing performed on image data obtained by an image capturing portion. Examples of the specific state include a product being good or defective, and an operation being normal or abnormal. Particularly in the present exemplary embodiment, the object is an industrial product or a part that is being produced, an image of the object is captured by the image capturing portion for product quality inspection of the object, and image processing is performed on the image data thereof; paragraph 0153, discussing deviation of the state of the object that is a workpiece or a production apparatus detected by the sensors from a normal range as a trigger may be performed).
The Iskandar-Brown combination describes features related to supply chain and product management. Yamamoto relates to a production management system. Therefore they are deemed to be analogous references as they both are directed toward product management systems. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the Iskandar-Brown combination with Yamamoto because the references are analogous art because they are both directed to solutions for supply chain management, which falls within applicant’s field of endeavor (supply chain management system), and because modifying the Iskandar-Brown combination to include Yamamoto’s feature for including wherein the change includes a structural change to the product, a change in a level of sterility of the product, or a change in a level of fluid stored in the product, in the manner claimed, would serve the motivation of prevention of releasing a defective product (Yamamoto at paragraph 0077); and further obvious because the claimed invention is merely a combination of old elements, and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable.
Claim 21 recites substantially similar limitations that stand rejected via the art citations and rationale applied to claim 16, as discussed above.
Claim 25 recites substantially similar limitations that stand rejected via the art citations and rationale applied to claim 16, as discussed above.
22. Claims 18 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Iskandar in view of Brown, in view of Prater, in further view of Mirov.
Claim 18 recites substantially similar limitations that stand rejected via the art citations and rationale applied to claims 3 and 6, as discussed above. Further, as per claim 18 Iskandar teaches determining a source responsible for preparing the product in the supply chain process is causing the occurrence of the event (paragraph 0006, discussing that problems can periodically arise in manufacturing environments that result in faulty runs of the product being manufactured. For example, equipment failures can result in a product being manufactured outside of a designated range of tolerances, rendering the manufactured product inoperable or unsuitable for its intended purposes; paragraph 0019, discussing that problems can occur within the manufacturing environment, resulting in faulty, unsuitable or otherwise less desirable manufactured products. For example, worn parts within the manufacturing equipment, gas leaks, and the like can all negatively impact the products being manufactured; paragraph 0020, discussing determining that a problem has occurred within the manufacturing environment (e.g., resulting in defective products being manufactured); paragraph 0030, discussing that the data model could describe a relative importance of each of a plurality of sensor types of the plurality of sensors in indicating the respective group. For example, the data model could indicate that while the temperature sensor data reaching or exceeding the predefined level is indicative of a particular classification, a gas sensor detecting a gas leak of a particular type of gas is greatly indicative of the particular classification; paragraphs 0029, 0037, 0039).
Claim 23 recites substantially similar limitations that stand rejected via the art citations and rationale applied to claim 18, as discussed above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
DeMaster et al., Pub. No.: US 2023/0118339 A1 – describes that plant items that are assessed to be defective and/or of an unsuitable quality grade are sorted out.
Chait, Pub. No.: US 2014/0222522 A1 – describes an integrated real time monitoring and management capability for a distributed environment, in which problems may be detected and mitigated proactively, potentially before they propagate to other parts of the distributed environment.
Smith et al., Pub. No.: US 2013/0289927 A1 – describes that gathering information about cold storage units in real time allows researchers, doctors, and product manufacturers to ensure that these kinds of violations do not damage their products or reduce product efficacy.
Lee et al., Pub. No.: US 2025/0137969 A1 – describes a quality inspecting process for removing the defective products.
Nakanuma et al., Patent No.: US 6,715,915 B1 – describes a defective product determination signal that can be output. When a warning system is provided and a defective product is found, the detection of the defective products can be reported to a worker. Moreover, when the defective product determination signal is output to another control means an automatic control depending on the fluidity can be performed.
Bradley, James R. "An improved method for managing catastrophic supply chain disruptions." Business Horizons 57.4 (2014): 483-495 – analyzes the differences between frequent and rare risks for supply chain disruptions, and proposes a new, improved risk measurement and prioritization method to account for the characteristics of rare risks.
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/Darlene Garcia-Guerra/
Primary Examiner, Art Unit 3625
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