DETAILED ACTION
This final Office action is responsive to amendments filed March 4th, 2026. Claims 1, 3, 4, and 10 have been amended. Claims 1-14 are presented for examination.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/04/26 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant’s arguments, see pages 5-6, filed 03/04/26, with respect to claims 1, 3, and 4 have been fully considered and are persuasive. The objections of 12/04/25 has been withdrawn.
Applicant's arguments regarding claim rejections under 35 USC 101 filed 03/04/26 have been fully considered but they are not persuasive.
On pages 6-7 of the provided remarks, Applicant argues that the amended claims recite statutory subject matter. Specifically, on page 7 of the provided remarks, Applicant argues “the claimed step of implementing the drug production process according to the shortest sequence of steps in order to produce the at least one drug product, as recited in claim 1, is an active step involving the production of the at least one drug product and not merely the organization of human activity as alleged by the Examiner.” Examiner respectfully disagrees and asserts that while Applicant argues that the “implementing” step is “an active step involving the production of the at least one drug product”, Examiner states that the argued “implementing” is recited with a high-level of generality with no limitations of who or what is producing the at least one drug product. Under broadest reasonable interpretation, the implementation of the production of the at least one drug product could include an operator or user performing the steps which is directed to the abstract idea of Certain Methods of Organizing Human Activity in the form of managing personal behavior. Therefore, the 35 USC 101 rejection is maintained. Applicant’s arguments are not persuasive.
Applicant's arguments regarding claim rejections under 35 USC 103 filed 03/04/26 have been fully considered but they are not persuasive.
On pages 7-10 of the provided remarks, Applicant argues that the cited prior art does not disclose the amended claims. Specifically, on page 9 of the provided remarks, Applicant argues, “Brown places no particular importance on the lyophilization step, and does not teach or suggest a method for producing at least on drug product that includes the downtime constraint considerations required in the instant claims.” Examiner respectfully disagrees and begins by reviewing the present claim language. While, Applicant argues that “Brown places no particular importance on the lyophilization step”, the present claims simply recite “receiving, at the computing system, downtime constraints off equipment required for the drug production process, wherein the downtime constraints comprise time periods when the lyophilization step cannot be initiated” and “identifying, at the computing system, a total duration of the drug production process for a plurality of different candidates for a sequence of steps of the drug production process, based on the process requirements and the downtime constraints”. Therefore, execution of the claimed method additionally places no particular importance on the lyophilization step as the selected candidate with the shortest sequence of steps and consideration of downtime constraints does not include the lyophilization step. While Applicant argues “There is no suggestion in Brown that the lyophilization step can be a key bottleneck in the efficiency of a drug production process, much less the specific method recited in independent claim 1”, Examiner asserts that the present claim does not recite the argued, “key bottleneck in the efficiency of a drug production process”. The cited prior art discloses the claimed limitations. The 35 USC 103 rejection is maintained. Applicant’s arguments are not persuasive.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter;
When considering subject matter eligibility under 35 U.S.C. 101, it must be determined whether the claim is directed to one of the four statutory categories of invention, i.e., process, machine, manufacture, or composition of matter. If the claim does fall within one of the statutory categories, it must then be determined whether the claim is directed to a judicial exception (i.e., law of nature, natural phenomenon, and abstract idea), and if so, it must additionally be determined whether the claim is a patent-eligible application of the exception. If an abstract idea is present in the claim, any element or combination of elements in the claim must be sufficient to ensure that the claim amounts to significantly more than the abstract idea itself.
Step 1: Independent claims 1 (method), and dependent claims 2-14, respectively, fall within at least one of the four statutory categories of 35 U.S.C. 101: (i) process; (ii) machine; (iii) manufacture; or (iv) composition of matter. Claim 1 is directed to a method (i.e. process).
Step 2A Prong 1: The independent claims recite method for producing at least one drug product using a lyophilization step, the method comprising: receiving, at a computing system, process requirements of a drug production process for the at least one drug product to be produced, the drug production process comprising at least one pre-processing step, the lyophilization step, and at least one post-processing step, wherein the process requirements comprise: required steps of the drug production process for the/each drug product; operator requirements of each step; and an approximate duration of each step; receiving, at the computing system, downtime constraints of equipment required for the drug production process, wherein the downtime constraints comprise time periods when the lyophilization step cannot be initiated, but where at least one or more steps, or portions of steps, of the drug production process can be implemented; identifying, at the computing system, a total duration of the drug production process for a plurality of different candidates for a sequence of steps of the drug production process, based on the process requirements and the downtime constraints; identifying, at the computing system, a shortest sequence of steps of the drug production process by selecting, from the plurality of different candidates, the sequence of steps with a shortest total duration as the shortest sequence of steps; and implementing the drug production process according to the shortest sequence of steps in order to produce the at least one drug product (Certain Method of Organizing Human Activity & Mental Process), which are considered to be abstract ideas (See PEG 2019 and MPEP 2106.05). [Examiner notes the underlined limitations above recite the abstract idea].
The steps/functions disclosed above and in the independent claims recite the abstract idea of Certain Methods of Organizing Human Activity because the claimed limitations are producing at least one drug product using a lyophilization step including implementing a drug production process according to the shortest sequence of steps in order to produce the at least one drug product, which is commercial interactions in the form of sales activity. The Applicant’s claimed limitations are producing at least one drug product using a lyophilization step, which recite the abstract idea of Organizing Human Activity.
The steps/functions disclosed above and in the independent claims recite the abstract idea of Mental Processes because the claimed limitations are identifying, at the computing system, a total duration of the drug production process for a plurality of different candidates for a sequence of steps of the drug production process, based on the process requirements and the downtime constraints; identifying, at the computing system, a shortest sequence of steps of the drug production process by selecting, from the plurality of different candidates, the sequence of steps with the shortest total duration as the shortest sequence of steps; and implementing the drug production process according to the shortest sequence of steps in order to produce the at least one drug product, which are observations, judgments, and evaluations of the human mind. The Applicant’s claimed limitations are implementing a drug production process, which recite the abstract idea of Mental Process.
In addition, dependent claims 2-13 further narrow the abstract idea and recite further defining the pre & post processing step of the drug production process; determining the approximate duration of each step; the historical data and downtime constraints of the production process; identifying the shortest sequence of steps; the process requirements of the production process; identifying the order which results in the shortest sequence of steps; and implementing the drug production process according to the identified shortest sequence of steps. These processes are similar to the abstract idea noted in the independent claims because they further the limitations of the independent claims which recite a certain method of organizing human activity which include commercial interactions such as sales activity as well as mental processes. Accordingly, these claim elements do not serve to confer subject matter eligibility to the claims since they recite abstract ideas. Dependent claim 14 will be discussed in Prong 2 analysis.
Step 2A Prong 2: In this application, the above “receiving, at a computing system, process requirements of a drug production process for the at least one drug product to be produced, the drug production process comprising at least one pre-processing step, the lyophilization step, and at least one post-processing step, wherein the process requirements comprise: required steps of the drug production process for the/each drug product; operator requirements of each step; and an approximate duration of each step; receiving, at the computing system, downtime constraints of equipment required for the drug production process, wherein the downtime constraints comprise time periods when the lyophilization step cannot be initiated, but where at least one or more steps, or portions of steps, of the drug production process can be implemented” steps/functions of the independent claims would not account for additional elements that integrate the judicial exception (e.g. abstract idea) into a practical application because receiving/storing data and displaying data merely add insignificant extra-solution activity and merely adds the words to apply it with the judicial exception. Also, the claimed “a computing system; A computer system comprising one or more processors, the one or more processors configured to perform the method” would not account for additional elements that integrate the judicial exception (e.g. abstract idea) into a practical application because the claimed structure merely adds the words to apply it with the judicial exception and mere instructions to implement an abstract idea on a computer (See PEG 2019 and MPEP 2106.05).
In addition, dependent claims 2-13 further narrow the abstract idea and dependent claim 3 additionally recites “receiving, for each step, historical data indicative of an actual duration of a respective step when implemented previously” which do not account for additional elements that integrate the judicial exception (e.g. abstract idea) into a practical application because receiving/storing data and displaying data merely add insignificant extra-solution activity and the claimed “the computing system” which do not account for additional elements that integrate the judicial exception (e.g. abstract idea) into a practical application because the claimed structure merely adds the words to apply it with the judicial exception and mere instructions to implement an abstract idea on a computer (See PEG 2019 and MPEP 2106.05). Additionally, dependent claim 14 recites, “A computer system comprising one or more processors, the one or more processors configured to perform the method” which do not account for additional elements that integrate the judicial exception (e.g. abstract idea) into a practical application because the claimed structure merely adds the words to apply it with the judicial exception and mere instructions to implement an abstract idea on a computer (See PEG 2019 and MPEP 2106.05).
The claimed “a computing system; A computer system comprising one or more processors, the one or more processors configured to perform the method” are recited so generically (no details whatsoever are provided other than that they are general purpose computing components and regular office supplies) that they represent no more than mere instructions to apply the judicial exception on a computer. These limitations can also be viewed as nothing more than an attempt to generally link the use of the judicial exception to the technological environment of a computer. Even when viewed in combination, the additional elements in the claims do no more than use the computer components as a tool. There is no change to the computers and other technology that is recited in the claim, and thus the claims do not improve computer functionality or other technology (See PEG 2019).
Step 2B: When analyzing the additional element(s) and/or combination of elements in the claim(s) other than the abstract idea per se the claim limitations amount(s) to no more than: a general link of the use of an abstract idea to a particular technological environment and merely amounts to the application or instructions to apply the abstract idea on a computer (See MPEP 2106.05 and PEG 2019). Further, method claims 1-14 recite “a computing system; A computer system comprising one or more processors, the one or more processors configured to perform the method”; however, these elements merely facilitate the claimed functions at a high level of generality and they perform conventional functions and are considered to be general purpose computer components which is supported by Applicant’s specification in Page 8 lines 10-20 & Figure 3. The Applicant’s claimed additional elements are mere instructions to implement the abstract idea on a general purpose computer and generally link of the use of an abstract idea to a particular technological environment. Also, the above “receiving, at a computing system, process requirements of a drug production process for the at least one drug product to be produced, the drug production process comprising at least one pre-processing step, the lyophilization step, and at least one post-processing step, wherein the process requirements comprise: required steps of the drug production process for the/each drug product; operator requirements of each step; and an approximate duration of each step; receiving, at the computing system, downtime constraints of equipment required for the drug production process, wherein the downtime constraints comprise time periods when the lyophilization step cannot be initiated, but where at least one or more steps, or portions of steps, of the drug production process can be implemented” steps/functions of the independent claims would not account for significantly more than the abstract idea because receiving data and displaying/presenting data (See MPEP 2106.05) have been identified as well-known, routine, and conventional steps/functions to one of ordinary skill in the art. When viewed as a whole, these additional claim element(s) do not provide meaningful limitation(s) to transform the abstract idea into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself.
In addition, claims 2-13 further narrow the abstract idea identified in the independent claims. The Examiner notes that the dependent claims merely further define the data being analyzed and how the data is being analyzed. Similarly, claim 3 additionally recites “receiving, for each step, historical data indicative of an actual duration of a respective step when implemented previously” which do not account for additional elements that amount to significantly more than the abstract idea because receiving data and displaying/presenting data (See MPEP 2106.05) have been identified as well-known, routine, and conventional steps/functions to one of ordinary skill in the art and the claimed “the computing system” which do not account for additional elements that amount to significantly more than the abstract idea because the claimed structure merely amounts to the application or instructions to apply the abstract idea on a computer and does not move beyond a general link of the use of an abstract idea to a particular technological environment (See MPEP 2106.05). Additionally, dependent claim 14 recites, “A computer system comprising one or more processors, the one or more processors configured to perform the method” which do not account for additional elements that amount to significantly more than the abstract idea because the claimed structure merely amounts to the application or instructions to apply the abstract idea on a computer and does not move beyond a general link of the use of an abstract idea to a particular technological environment (See MPEP 2106.05). The additional limitations of the independent and dependent claim(s) when considered individually and as an ordered combination do not amount to significantly more than the abstract idea. The examiner has considered the dependent claims in a full analysis including the additional limitations individually and in combination as analyzed in the independent claim(s). Therefore, the claim(s) are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brown (U.S 2009/0265025 A1) in view of Vacha (U.S 2019/0347603 A1).
Claim 1
Regarding Claim 1, Brown discloses the following:
A method for producing at least one drug product using a lyophilization step, the method comprising [see at least Paragraph 0021 for reference to a method and system for simulating, modeling and scheduling equipment preparation in the biopharmaceutical production process while optimizing the use of process vessels; Paragraph 0021 for reference to the method including the steps of identifying soiled process components and their associated equipment preparation procedures; Paragraph 0138 for reference to the method for generating scheduling information which accurately defines; Paragraph 0199 for reference to the computer simulation method for the design and scheduling of equipment prep operations; the example ‘Master Process Parameters Table’ including a ‘Lyophilzation’ step and completion time]
receiving, at a computing system, process requirements of a drug production process for the at least one drug product to be produced, the drug production process comprising at least one pre-processing step, the lyophilization step, and at least one post-processing step, wherein the process requirements comprise: required steps of the drug production process for the/each drug product; operator requirements of each step; and an approximate duration of each step [see at least Paragraph 0021 for reference to the method including the steps of identifying soiled process components and their associated equipment preparation procedures; Paragraph 0090 for reference to the unit operation sequence for production of the biopharmaceutical product is determined; Paragraph 0091 for reference to scheduling cycles and cycle offset duration for each of the unit operations in the biopharmaceutical production process are determined; Paragraph 0095 for reference to the process parameters tables obtaining all operational parameters for each unit operation including individual tasks and task durations; Paragraph 0014 for reference to the parameters from the process parameter table defining the key operational parameters and equipment sizing rations for each unit operation in the unit operation sequence; Paragraph 0137 for reference to pre-process support activities including solution preparation, and equipment prep and sterilization, required to support the core process, including the labor, reagents, etc. can be scheduled, cost forecasted and provided for; Paragraph 0137 for reference to post-process support activities such as product formulation, aseptic fill, freeze drying, vial capping, vial labeling and packaging required to ship the purified product in a form ready for use may be added to the process time line and managed; Paragraph 0137 for reference to based on the process time line, labor, reagents, etc., required to support these post-process support functions can be acquired and managed; the example ‘Master Process Parameters Table’ including a ‘Lyophilzation’ step and completion time; Figure 1 and related text regarding items 104, 106, & 108; Figure 13 and related text regarding the overview of the process for scheduling and simulating solution preparation in a biopharmaceutical production process]
receiving, at the computing system, downtime constraints of equipment required for the drug production process, wherein the downtime constraints comprise time periods when the lyophilization step cannot be initiated, but where at least one or more steps, or portions of steps, of the drug production process can be implemented [see at least Paragraph 0090 for reference to scheduling systems being iterations of unit operations within the unit operations sequence; Paragraph 0091 for reference to each scheduling cycle having a offset duration that dictates the time period between the beginnings of successive scheduling cycles; Paragraphs 0092-0094 for reference to the various operation cycles that can be scheduled within the cycle; Paragraph 0137 for reference to the process time line being used to determine peak utility loading and utility requirements for the facility; the example ‘Master Process Parameters Table’ including a ‘Lyophilzation’ step and completion time; Figure 1 and related text regarding item 106; Figure 48 and related text regarding the process of generating preparation equipment utility time lines based on utility requirements and item 4810 ‘preparation equipment utility timelines’ ]
identifying, at the computing system, a total duration of the drug production process for a plurality of different candidates for a sequence of steps of the drug production process, based on the process requirements and the downtime constraints [see at least Paragraph 0214 for reference to the equipment preparation procedure table including data associated with each equipment preparation procedure, including the sequence of preparation equipment protocols and their individual durations as well as their cumulative duration over the entire procedure; Paragraph 0216 for reference to task durations for each of the preparation equipment protocols are totaled to yield the equipment preparation procedure duration; Paragraph 0216 for reference to cumulative totals for the equipment preparation procedure duration which are the sum of all the previous preparation equipment protocol durations in the equipment preparation procedure; Figures 37A and 37B and related text regarding equipment preparation procedure tables]
implementing the drug production process according to the sequence of steps in order to produce the at least one drug product [see at least Paragraph 0098 for reference to process time line is generated from the unit operation list, the tasks associated with each of the unit operations, the scheduling cycles for each of the unit operations in the process, the process parameters from the master process parameters table and the volume of the material as calculated from the block flow diagram; Figure 1 and related text regarding item 112]
While Brown discloses the limitations above, it does not disclose identifying, at the computing system, a shortest sequence of steps of the drug production process by selecting, from the plurality of different candidates, the sequence of steps with a shortest total duration as the shortest sequence of steps; and implementing the drug production process according to the shortest sequence of steps in order to produce the at least one drug product.
However, Vacha discloses the following:
identifying, at the computing system, a shortest sequence of steps of the drug production process by selecting, from the plurality of different candidates, the sequence of steps with a shortest total duration as the shortest sequence of steps [see at least Paragraph 0004 for reference to factories producing active pharmaceutical ingredients creating a wide variety of products, each of which typically necessitates the customization of factory equipment prior to production; Paragraph 0020 for reference to the turnaround management system generating schedules for sets of tasks; Paragraph 0021 for reference to tasks of the system including a chemical factory, tasks may be activities needed to be completed before production of an active pharmaceutical ingredient (API); Paragraph 0046 for reference to the graph analysis engine producing multiple schedules; Paragraph 0046 for reference to the graph analysis engine selecting the schedule with the shortest total temporal duration as the optimized schedule; Paragraph 0046 for reference to if there are more than one schedule with the same lowest overall total temporal duration, the graph analysis engine selects as the optimal schedule the schedule that minimizes finish]
implementing the drug production process according to the shortest sequence of steps in order to produce the at least one drug product [see at least Paragraph 0004 for reference to factories producing active pharmaceutical ingredients creating a wide variety of products, each of which typically necessitates the customization of factory equipment prior to production; Paragraph 0020 for reference to the turnaround management system generating schedules for sets of tasks; Paragraph 0021 for reference to tasks of the system including a chemical factory, tasks may be activities needed to be completed before production of an active pharmaceutical ingredient (API); Paragraph 0024 for reference to the turnaround optimization engine generating optimized schedules and generating user interfaces to display a visual representation of the optimized schedule to enable the user to understand the optimized schedule]
Before the effective filing date, it would have been obvious to one of ordinary skill in the art to modify the drug production method of Brown to include the shortest sequence determination of Vacha. Doing so would provide optimized or near-optimized scheduling of tasks, allowing for less turnaround and therefore increased efficiency, as stated by Vacha (Paragraph 0083).
Claim 2
While the combination of Brown and Vacha disclose the limitations above, regarding Claim 2, Brown discloses the following:
wherein the at least one pre-processing step comprises a compounding step and/or a filling step; and the at least one post-processing step comprises an unloading step [see at least Paragraph 0137 for reference to pre-process support activities including solution preparation, and equipment prep and sterilization, required to support the core process, including the labor, reagents, etc. can be scheduled, cost forecasted and provided for; Paragraph 0137 for reference to post-process support activities such as product formulation, aseptic fill, freeze drying, vial capping, vial labeling and packaging required to ship the purified product in a form ready for use may be added to the process time line and managed; Paragraph 0137 for reference to based on the process time line, labor, reagents, etc., required to support these post-process support functions can be acquired and managed; Figure 1 and related text regarding items 104, 106, & 108; Figure 13 and related text regarding the overview of the process for scheduling and simulating solution preparation in a biopharmaceutical production process]
Claim 3
While the combination of Brown and Vacha disclose the limitations above, Brown does not disclose determining, at the computing system, the approximate duration of each step by: receiving, for each step, historical data indicative of an actual duration of a respective step when implemented previously; determining, for each step, an average duration of the historical data; and determining the approximate duration of each step based on a respective average duration.
Regarding Claim 3, Vacha discloses the following:
determining, at the computing system, the approximate duration of each step by: receiving, for each step, historical data indicative of an actual duration of a respective step when implemented previously [see at least Paragraph 0051 for reference to the graph analysis engine analyzing the constructed graph for potential delays based on a linear regression model developed using historical schedule data; Paragraph 0051 for reference to the graph analysis engine constructs the linear regression model on historical schedule data for a particular variable such as process time of the task]
determining, for each step, an average duration of the historical data [see at least Paragraph 0051 for reference to the graph analysis engine utilizing performance data for schedules including actual temporal duration of tasks]
determining the approximate duration of each step based on a respective average duration [see at least Paragraph 0049 for reference to the graph analysis engine determining an amount of increase in total temporal duration of the schedule; Paragraph 0051 for reference to the graph analysis engine utilizing performance data for schedules including actual temporal duration of tasks]
Before the effective filing date, it would have been obvious to one of ordinary skill in the art to modify the drug production method of Brown to include the approximate duration determination of Vacha. Doing so would provide optimized or near-optimized scheduling of tasks, allowing for less turnaround and therefore increased efficiency, as stated by Vacha (Paragraph 0083).
Claim 4
While the combination of Brown and Vacha disclose the limitations above, regarding Claim 4, Brown discloses the following:
wherein the historical data is limited to historical data of the drug production process implemented under same downtime constraints as those received at the computing system [see at least Paragraph 0132 for reference to begin and end times for each successive unit operation are calculated from the duration of the unit operation and end time of the previous unit operation]
Claim 5
While the combination of Brown and Vacha disclose the limitations above, regarding Claim 5, Brown discloses the following:
wherein the downtime constraints include time periods when the equipment required for one or more steps, or portions of steps, is unavailable [see at least Paragraph 0090 for reference to scheduling systems being iterations of unit operations within the unit operations sequence; Paragraph 0091 for reference to each scheduling cycle having a offset duration that dictates the time period between the beginnings of successive scheduling cycles; Figure 1 and related text regarding item 106]
Claim 6
While the combination of Brown and Vacha disclose the limitations above, Brown does not disclose wherein identifying the shortest sequence of steps comprises identifying a start time which provides the implementation of the drug production process with the shortest total duration.
Regarding Claim 6, Vacha discloses the following:
wherein identifying the shortest sequence of steps comprises identifying a start time which provides the implementation of the drug production process with the shortest total duration [see at least Paragraph 0039 for reference to the time property may be a parameter included in the set of tasks (e.g. , associated with the task or part of a data structure for the task) included start time; Paragraph 0046 for reference to the graph analysis engine producing multiple schedules; Paragraph 0046 for reference to the graph analysis engine selecting the schedule with the shortest total temporal duration as the optimized schedule; Paragraph 0046 for reference to if there are more than one schedule with the same lowest overall total temporal duration, the graph analysis engine selects as the optimal schedule the schedule that minimizes finish]
Before the effective filing date, it would have been obvious to one of ordinary skill in the art to modify the drug production method of Brown to include the start time determination of Vacha. Doing so would provide optimized or near-optimized scheduling of tasks, allowing for less turnaround and therefore increased efficiency, as stated by Vacha (Paragraph 0083).
Claim 7
While the combination of Brown and Vacha disclose the limitations above, regarding Claim 7, Brown discloses the following:
wherein the process requirements comprise a predefined start time and a predefined end time of the drug production process [see at least Paragraph 0132 for reference to the day and the week each unit operation is performed is calculated from the start time of the process, as well as the cumulative duration of each of the previous unit operations; Paragraph 0135 for reference to start and finish date and times for the set up and clean up operations of each of the unit operations are valuable because they ensure that the equipment will be available for each unit operation if the process time line is followed]
Claim 8
While the combination of Brown and Vacha disclose the limitations above, Brown does not disclose wherein identifying the shortest sequence of steps of the drug production process comprises identifying a maximum batch capacity of the drug product based on the process requirements and the downtime constraints.
Regarding Claim 8, Vacha discloses the following:
wherein identifying the shortest sequence of steps of the drug production process comprises identifying a maximum batch capacity of the drug product based on the process requirements and the downtime constraints [see at least Paragraph 0004 for reference to factories producing active pharmaceutical ingredients creating a wide variety of products, each of which typically necessitates the customization of factory equipment prior to production; Paragraph 0020 for reference to the turnaround management system generating schedules for sets of tasks; Paragraph 0021 for reference to tasks of the system including a chemical factory, tasks may be activities needed to be completed before production of an active pharmaceutical ingredient (API); Paragraph 0023 for reference to often it is desirable to schedule the performance of tasks in a set of tasks in an optimized manner (or as near optimal as possible) to require as little time and/or resources as possible while still completing all of the tasks and factoring for their constraints; Paragraph 0029 for reference to the task analysis engine identifies each property and constraint of each task in the set of tasks and generates a set of formalized parameters for use in the graph construction engine; Paragraph 0066 for reference to scheduling a set of tasks factors for the maximum available resources (e.g., physical resources) for performance of the tasks in the set]
Before the effective filing date, it would have been obvious to one of ordinary skill in the art to modify the drug production method of Brown to include the identification of capacity constraints of Vacha. Doing so would provide optimized or near-optimized scheduling of tasks, allowing for less turnaround and therefore increased efficiency, as stated by Vacha (Paragraph 0083).
Claim 9
While the combination of Brown and Vacha disclose the limitations above, regarding Claim 9, Brown discloses the following:
wherein the method is for producing at least two different drug products, the required steps of the drug production process for each drug product comprising a lyophilization step [see at least Paragraph 0207 for reference to a facility producing multiple biopharmaceutical products in multiple processes; the example ‘Master Process Parameters Table’ including a ‘Lyophilzation’ step and completion time]
Claim 10
While the combination of Brown and Vacha disclose the limitations above, Brown does not disclose wherein identifying the shortest sequence of the steps of the drug production process for the at least two drug products comprises identifying an order for producing the at least two drug products which results in the shortest sequence of steps, based on the process requirements and the downtime constraints.
Regarding Claim 10, Vacha discloses the following:
wherein identifying the shortest sequence of the steps of the drug production process for the at least two drug products comprises identifying an order for producing the at least two drug products which results in the shortest sequence of steps, based on the process requirements and the downtime constraints [see at least Paragraph 0046 for reference to the graph analysis engine producing multiple schedules; Paragraph 0046 for reference to the graph analysis engine selecting the schedule with the shortest total temporal duration as the optimized schedule; Paragraph 0046 for reference to if there are more than one schedule with the same lowest overall total temporal duration, the graph analysis engine selects as the optimal schedule the schedule that minimizes finish; Paragraph 0063 for reference to the TMS schedules the tasks based on priority, such that a minimal number of tasks exceed their FBD, or such that the schedule provides for a minimal amount of time spent performing tasks past their FBD; Figures 4A-4C and related text regarding examples of optimized schedules]
Before the effective filing date, it would have been obvious to one of ordinary skill in the art to modify the drug production method of Brown to include the order identification of Vacha. Doing so would provide optimized or near-optimized scheduling of tasks, allowing for less turnaround and therefore increased efficiency, as stated by Vacha (Paragraph 0083).
Claim 11
While the combination of Brown and Vacha disclose the limitations above, Brown does not disclose wherein identifying the order which results in the shortest sequence of steps comprises: identifying the total duration of the sequence of steps of the drug production process for the at least two drug products for a plurality of different candidates of the order of steps; and selecting the sequence of steps with the shortest total duration as the order which results in the shortest sequence of steps.
Regarding Claim 11, Vacha discloses the following:
wherein identifying the order which results in the shortest sequence of steps comprises: identifying the total duration of the sequence of steps of the drug production process for the at least two drug products for a plurality of different candidates of the order of steps [see at least Paragraph 0046 for reference to the graph analysis engine producing multiple schedules; Paragraph 0046 for reference to the graph analysis engine selecting the schedule with the shortest total temporal duration as the optimized schedule; Paragraph 0046 for reference to if there are more than one schedule with the same lowest overall total temporal duration, the graph analysis engine selects as the optimal schedule the schedule that minimizes finish; Paragraph 0063 for reference to the TMS schedules the tasks based on priority, such that a minimal number of tasks exceed their FBD, or such that the schedule provides for a minimal amount of time spent performing tasks past their FBD; Figures 4A-4C and related text regarding examples of optimized schedules]
selecting the sequence of steps with the shortest total duration as the order which results in the shortest sequence of steps [see at least Paragraph 0046 for reference to the graph analysis engine producing multiple schedules; Paragraph 0046 for reference to the graph analysis engine selecting the schedule with the shortest total temporal duration as the optimized schedule; Paragraph 0046 for reference to if there are more than one schedule with the same lowest overall total temporal duration, the graph analysis engine selects as the optimal schedule the schedule that minimizes finish]
Before the effective filing date, it would have been obvious to one of ordinary skill in the art to modify the drug production method of Brown to include the total duration & order identification of Vacha. Doing so would provide optimized or near-optimized scheduling of tasks, allowing for less turnaround and therefore increased efficiency, as stated by Vacha (Paragraph 0083).
Claim 12
While the combination of Brown and Vacha disclose the limitations above, Brown does not disclose before implementing the drug production process according to the identified shortest sequence of steps: identifying, at the computing system, a predicted total duration of the drug production process based on the identified shortest sequence of steps and historical data indicative of an actual duration of each step when implemented previously in the production of the same drug product.
Regarding Claim 12, Vacha discloses the following:
before implementing the drug production process according to the identified shortest sequence of steps: identifying, at the computing system, a predicted total duration of the drug production process based on the identified shortest sequence of steps and historical data indicative of an actual duration of each step when implemented previously in the production of the same drug product [see at least Paragraph 0046 for reference to the graph analysis engine producing multiple schedules; Paragraph 0046 for reference to the graph analysis engine selecting the schedule with the shortest total temporal duration as the optimized schedule; Paragraph 0046 for reference to if there are more than one schedule with the same lowest overall total temporal duration, the graph analysis engine selects as the optimal schedule the schedule that minimizes finish; Paragraph 0051 for reference to the graph analysis engine analyzing the constructed graph for potential delays based on a linear regression model developed using historical schedule data; Paragraph 0051 for reference to the graph analysis engine constructs the linear regression model on historical schedule data for a particular variable such as process time of the task]
Before the effective filing date, it would have been obvious to one of ordinary skill in the art to modify the drug production method of Brown to include the total duration & order identification of Vacha. Doing so would provide optimized or near-optimized scheduling of tasks, allowing for less turnaround and therefore increased efficiency, as stated by Vacha (Paragraph 0083).
Claim 13
While the combination of Brown and Vacha disclose the limitations above, Brown does not disclose identifying the predicted total duration of the drug production process a plurality of times, using different historical data indicative of an actual duration of each step when implemented previously in the production of the same drug product; comparing each of the plurality of predicted total times to a predefined duration threshold; and identifying an indicator representing the percentage of times the predicted total time is less than the predefined threshold.
Regarding Claim 13, Vacha discloses the following:
identifying the predicted total duration of the drug production process a plurality of times, using different historical data indicative of an actual duration of each step when implemented previously in the production of the same drug product [see at least Paragraph 0051 for reference to the graph analysis engine analyzing the constructed graph for potential delays based on a linear regression model developed using historical schedule data; Paragraph 0051 for reference to the graph analysis engine constructs the linear regression model on historical schedule data for a particular variable such as process time of the task]
comparing each of the plurality of predicted total times to a predefined duration threshold [see at least Paragraph 0048 for reference to a particular schedule may be considered optimal if the difference between the metrics calculated for that schedule and the metrics calculated for that schedule and the metrics calculated from the lower bound is less than a threshold; Paragraph 0083 for reference to techniques described herein also enable the generation of multiple schedules based on factors such as different task priorities, enabling the comparison of various scheduling options for a set of tasks, e.g., to achieve different goals]
identifying an indicator representing the percentage of times the predicted total time is less than the predefined threshold [see at least Paragraph 0049 for reference to the graph analysis engine determining a percentage of tasks with new positions within the schedule; Paragraph 0050 for reference to categorization of the schedule may depend upon one or more thresholds of amount of increase in total temporal duration , one or more thresholds of amount of increase in tasks that do not satisfy FBD constraints, or one or more other thresholds based on other changes from the original schedule to the regenerated schedule]
Before the effective filing date, it would have been obvious to one of ordinary skill in the art to modify the drug production method of Brown to include the comparison of predicted total duration to a threshold of Vacha. Doing so would provide optimized or near-optimized scheduling of tasks, allowing for less turnaround and therefore increased efficiency, as stated by Vacha (Paragraph 0083).
Claim 14
While the combination of Brown and Vacha disclose the limitations above, regarding Claim 14, Brown discloses the following:
A computer system comprising one or more processors, the one or more processors configured to perform the method of any one of the preceding claims claim 1 [see at least Paragraph 0021 for reference to a method and system for simulating, modeling and scheduling equipment preparation in the biopharmaceutical production process while optimizing the use of process vessels; Paragraph 0021 for reference to the system including the steps of identifying soiled process components and their associated equipment preparation procedures]
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kawasaki, Hidenori, Toshinori Shimanouchi, and Yukitaka Kimura. "Recent development of optimization of lyophilization process." Journal of chemistry 2019.1 (2019): 9502856.
DOCUMENT ID
INVENTOR(S)
TITLE
WO2013147125 A1
Okada et al.
DRUG INTAKE ENHANCER
US 2020/0158431 A1
Trout et al.
Freeze-drying methods and related methods
WO2014084921 A1
Stuart, Rose
PHARMACEUTICAL MANUFACTURING METHOD AND COMPOSITIONS
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTIN ELIZABETH GAVIN whose telephone number is (571)270-7019. The examiner can normally be reached M-F 7:30-4:30 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerry O'Connor can be reached at 571-272-6787. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KRISTIN E GAVIN/Primary Examiner, Art Unit 3624
Prosecution Insights