Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
In the preliminary amendment dated 06/27/2024, the following occurred: Claims 3, 4, 6, 8-12 and 14 were amended. Claims 17-30 and 32-45 were canceled. A substitute specification was submitted and para. [0001] was amended.
This is the first action on the merits. Claims 1-16 and 31 are currently pending.
Priority
This application claims priority from Provisional Application Nos. 63295050 dated 12/30/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/27/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(I) because the following figure(s) is/are unreadable and/or are unsatisfactory for reproduction:
Fig. 2I, 3C, 3I, 5E, 5P, 10A, 10B, 10C
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-16 and 31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1, 16 and 31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claim recites a method, system and non-transitory computer readable storage medium for producing an executable batch record for a clinical trial study, which are within a statutory category (or are interpreted to be within a statutory category for subject matter eligibility analysis purposes).
Step 2A1
Regarding claims 1, 16 and 31, the limitation of (claim 1 being representative) displaying […] for inputting batch record information comprising packaging instructions, a bill of materials, and a lot assignment, […] comprises a selection of inventory associated with a production site and a selection of inventory associated with a pharmaceutical batch customer; receiving the packaging instructions, the bill of materials, and the lot assignment from a user associated with the production facilitator; producing a preliminary batch record based on the information input by the user associated with the production facilitator; displaying […] that comprises the preliminary batch record and […] for approving the preliminary batch record; receiving an approval of the preliminary batch record from a user associated with the pharmaceutical batch customer; and in accordance with receiving the approval of the preliminary batch record producing an executable batch record for a producer to execute as crafted, is are processes that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. That is other than reciting a method (claim 1), one or more processors and a memory (claim 16) and a non-transitory computer readable storage medium, one or more processors and one or more electronic devices (claim 31), the claimed invention amounts to managing personal behavior or interaction between people (i.e., rules or instructions). For example, the claims encompass inputting batch record information, receiving the packaging instructions, the bill of materials, and the lot assignment, producing a preliminary batch record based on the information input, displaying the preliminary batch record and approving the preliminary batch record; receiving an approval of the preliminary batch record and in accordance with receiving the approval of the preliminary batch record producing an executable batch record for a producer to execute, in the manner described in the identified abstract idea, supra. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity – Managing Personal Behavior Relationships, Interactions Between People (e.g. social activities, teaching, following rules or instructions)” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. Claim 1 is not tied to any particular technological environment that implements the identified abstract idea. Claim 16 recites the additional elements of one or more processors and a memory. Claim 31 recites the additional elements of a non-transitory computer readable storage medium, one or more processors and one or more electronic devices. These additional elements are not exclusively defined by the applicant and are recited at a high-level of generality (i.e., a generic computer components for enabling access to medical information or for performing generic computer functions. See Spec at para. [0274]-[0282]) such that they amounts to no more than mere instructions to apply the exception using a generic computer component. As set forth in MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Claims 1, 16 and 31 recite the additional element of at a first electronic device, a user interface, at a second electronic device, a customer user interface and an interface. Claim 31 further recites the additional element of a display. These additional element are recited at a high level of generality (i.e. a general means to output/receive/produce/display data) and amount to extra solution activity. MPEP 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of the one or more processors, memory, non-transitory computer readable storage medium, and one or more electronic devices to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”). Moreover, using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention”). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Also as discussed with respect to integration of the abstract idea into a practical application, the additional elements of a first electronic device, a user interface, at a second electronic device, a customer user interface, an interface and a display were considered extra-solution activity. This has been re-evaluated under “significantly more” analysis and determined to be well-understood, routine and conventional in the field of healthcare. Well-understood, routine and conventional activity cannot provide an inventive concept (“significantly more”). As such the claim is not patent eligible.
The examiner notes that: A well-known, general-purpose computer has been determined by the courts to be a well-understood, routine and conventional element (see, e.g., Alice Corp. v. CLS Bank; see also MPEP 2106.05(d)); Receiving and/or transmitting data over a network (“a communications network”) has also been recognized by the courts as a well - understood, routine and conventional function (see, e.g., buySAFE v. Google; MPEP 2016(d)(II)); and Performing repetitive calculations is/are also well-understood, routine and conventional computer functions when they are claimed in a merely generic manner (see, e.g., Parker v. Flook; MPEP 2016.05(d)).
Claims 2-15 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Claim(s) 2 further merely describe(s) responsibilities of the user associated with the pharmaceutical batch customer. Claim(s) 3 further merely describe(s) receiving the packaging instructions. Claim(s) 4 further merely describe(s) receiving the lot assignment. Claim(s) 5 further merely describe(s) generating a second executable batch record for the clinical trial study. Claim(s) 6 further merely describe(s) receiving customer data, study information and output material information. Claim(s) 7 further merely describe(s) receiving the bill of materials. Claim(s) 8 further merely describe(s) the study information. Claim(s) 9 further merely describe(s) the output material information. Claim(s) 10 further merely describe(s) the executable batch record. Claim(s) 11 further merely describe(s) causing to present an audit history. Claim(s) 12 further merely describe(s) receiving study information, determining whether the batch record information comprises blinding information and presenting a restricted view of the preliminary batch record. Claim(s) 13 further merely describe(s) the blinding information. Claim(s) 14 further merely describe(s) the one or more customer approvers. Claim(s) 15 further merely describe(s) presenting to the second user associated with the pharmaceutical batch customer, an unrestricted view of the executable batch record.
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 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.
Claims 1-6, 8-16 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Juzeszyn (US 2004/0158475) and in further view of Warren (US 2018/0253533).
REGARDING CLAIM 1
Juzeszyn discloses a method for generating an executable batch record for a clinical trial study, the method comprising: at a first electronic device associated with a production facilitator: displaying a user interface for inputting batch record information, wherein the user interface comprises a selection of inventory associated with a production site and a selection of inventory associated with a pharmaceutical batch customer; receiving the batch record information from a user associated with the production facilitator; producing a preliminary batch record based on the information input by the user associated with the production facilitator ([0026] teaches the creation of a batch record corresponding to a pharmaceutical batch. [0033] teaches after batch record creation, certain initial information components corresponding to the batch could be added to the batch record by the BRPD handler module (step 103). The initial information components could include for instance, one or more controlled documents such as manufacturing procedures (MPRs), standard operating procedures (SOPs), specifications, computer program information, and/or equipment information associated with the batch (interpreted by examiner as producing a preliminary batch record based on the information input by the user associated with the production facilitator). [0041] teaches an individual logged in via a computer, terminal or the like (interpreted by examiner as a first electronic device) and [0053] teaches data entry by way of a computer, terminal or the like. [0076] teaches individual might enter the additional data. [0143] teaches an individual, appropriately logged in via a computer, terminal, or the like, could be presented with a GUI dialog box or the like providing information (interpreted by examiner as a user interface for inputting batch record information and means to receive batch record information)); at a second electronic device associated with the pharmaceutical batch customer: displaying a customer user interface that comprises the preliminary batch record and an interface for approving the preliminary batch record; receiving an approval of the preliminary batch record from a user associated with the pharmaceutical batch customer ([0040] teaches a recipient individual needed to indicate the batch record to be either acceptable or not acceptable. [0041] teaches accordingly, a recipient individual logged in via a computer, terminal, or the like could be presented with a notice indicating that a specified batch record, or a portion thereof, needed to be reviewed. The notice could additionally facilitate the individual's viewing of the batch record. For instance, the notice could include a graphical user interface (GUI) button, login panel, and/or electronic signature panel that the individual could employ to view the specified batch record or batch record portion (interpreted by examiner as displaying a customer user interface at a second electronic device associated with the pharmaceutical batch customer that comprises the preliminary batch record and an interface for approving the preliminary batch record). The notice could further facilitate an entity's indication of the acceptability of a batch record or batch record portion (interpreted by examiner as receiving an approval of the preliminary batch record from a user associated with the pharmaceutical batch customer)); and in accordance with receiving the approval of the preliminary batch record producing an executable batch record for a producer to execute ([0042] teaches one or more GUI elements that allowed the recipient individual to indicate the batch record to be "approved" or "not approved". For various embodiments of the invention, the individual could be required to submit an electronic signature along with the specification. [0050] teaches maintaining for a batch product a checklist of tasks or the like that needed to be performed before the product could be released. For such embodiments, the BRPD handler module could maintain a disposition checklist hold on the batch product until all items on the checklist had been executed. The BRPD handler module could learn of execution of a checklist item, for example, via received electronic signatures from authorized individuals (interpreted by examiner as in accordance with receiving the approval of the preliminary batch record producing an executable batch record for a producer to execute)).
Juzeszyn does not explicitly disclose, however Warren discloses:
batch record information comprising packaging instructions, a bill of materials, and a lot assignment (Warren at [0006] teaches screens that provide a data input mechanism as well as outputs that provide a range of reports (interpreted by examiner as the inputs and Batch record of Juzeszyn). [0026] teaches a “lot” is a uniquely identified batch of an item often associated with a formulated product (e.g., tablet, capsule), API, ingredient, and packaged product. A “lot assignment” allows for items to be traced back to an original manufacturing date or location. [0034] teaches the current invention models and maintains the entire product supply chain. This lifecycle includes all the steps from beginning to end including raw ingredient acquisition, batch manufacture, packaging and labeling. The budgeting module of the present invention considers the full spectrum of cost variables in order to provide accurate accounting both from a planning perspective and an actual perspective. One innovation is the ability to capture all costs including raw ingredient and APIs, manufacturing, packaging, labeling, storage, logistics, and destruction. These budgets are provided both as a planning tool in advance of trials, comparisons to forecasts during trials, and post mortem after trials have completed (interpreted by examiner as input information comprising packaging instructions, a bill of materials, and a lot assignment));
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the generation of an executable batch record for a clinical trial study of Juzeszyn to incorporate packaging instructions, a bill of materials, and a lot assignment as batch record information as taught by Warren, with the motivation of reducing and possibly eliminating the need for users to have a working knowledge of supply chain and clinical trial demands while providing important capabilities in that area. (Warren at [0007]).
REGARDING CLAIM 2
Juzeszyn and Warren disclose the limitation of claim 1.
Juzeszyn further discloses:
The method of claim 1, wherein the user associated with the pharmaceutical batch customer is configured to approve the preliminary batch record without editing the preliminary batch record (Juzeszyn at [0038] teaches individuals indicating batch record is acceptable and/or approved).
REGARDING CLAIM 3
Juzeszyn and Warren disclose the limitation of claim 1.
Juzeszyn does not explicitly disclose, however Warren further discloses:
The method of claim 1, wherein receiving the packaging instructions further comprises: receiving packaging instructions in a first language; determining whether the first language is used at the production site; in accordance with a determination that the first language is not used at the production site, generating a translation of the packaging instructions corresponding to a second language used at the production site (Warren at [0035] teaches considering source and destination regulations and language translation (interpreted by examiner as means to generating a translation of the packaging instructions corresponding to a second language used at the production site, in accordance with a determination that the first language is not used at the production site)).
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the generation of an executable batch record for a clinical trial study of Juzeszyn to incorporate language translation as taught by Warren, with the motivation of lowering costs and minimizing errors across the manufacture, distribution, and logistics process. (Warren at [0035]).
REGARDING CLAIM 4
Juzeszyn and Warren disclose the limitation of claim 1.
Juzeszyn does not explicitly disclose, however and Warren further discloses:
The method of claim 1, wherein receiving the lot assignment further comprises: receiving a quantity of output materials to be manufactured, each output material corresponding to one or more input materials; accessing an inventory of a production site; for each output material, assigning a first supplier lot number based on at least one of a first supplier lot size or a first supplier lot expiration date determined from the inventory; and for each input material, assigning a second supplier lot number based on at least one of a second supplier lot size or a second supplier lot expiration date determined from the inventory (Warren at [0034] teaches raw ingredient acquisition, batch manufacture, packaging and labeling, distribution and logistics, demand and supply, and destruction.[0035] and Fig. 5 teach all relevant aspects of manufacturing go into the model including formulating product, unlabeled package (e.g., bright stock), labeled material, and ultimately shipping units. The module enables tracing of lot lineage and [0036] teaches variables that drive this include shipping initial and seed quantities as well as ongoing resupplies. This module calculates the timing and quantity for each of these events while considering initial quantities, logistics, visit windows, utilization rates, and shipping frequency. [0047] teaches that once a scenario demand profile is complete, the system's supply module is invoked to plan and manage specific pack lots. The supply module allows data to be aggregated across multiple scenarios, trials, and compounds to enable oversight, management, and reporting at all visibility levels including trial, compound, and portfolio. Supply takes into account additional data for quantities of a specific lot, depot location, and enhanced expiry controls which include lead times for stopping distribution and dispensing activities at the depot and sites, respectively. Prior to the scenario being live, Depot supply is planned and anticipates and automates supply logistics. Depot-to-depot transfers are planned—if necessary—in a similar fashion. All depot inventory and depot transfers are tracked and reported during the planning and actualization over the course of the study.).
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the generation of an executable batch record for a clinical trial study of Juzeszyn to incorporate receiving the lot assignment as taught by Warren, with the motivation of lowering costs and minimizing errors across the manufacture, distribution, and logistics process. (Warren at [0035]).
REGARDING CLAIM 5
Claim 5 is analogous to Claims 1-4 and 6 thus Claim 5 is similarly analyzed and rejected in a manner consistent with the rejection of Claim 1-4 and 6.
REGARDING CLAIM 6
Juzeszyn and Warren disclose the limitation of claim 1.
Juzeszyn does not explicitly disclose, however Warren further discloses:
The method of claim 1, further comprising, at the first electronic device: receiving customer data associated with the pharmaceutical batch customer; receiving study information for the clinical trial study, the clinical trial study associated with the customer data; and receiving output material information, the output material information corresponding to one or more output materials associated for the clinical trial study (Warren at [0006] teaches provide a data input mechanism as well as outputs that provide a range of reports. [0051] teaches scope of trial as determined by trial sponsor. Clinical data, such as demographics, safety, and efficacy data, can be captured within the software of the system or integrated with other clinical electronic data capture devices or systems (interpreted by examiner as receiving study information for the clinical trial study, the clinical trial study associated with the customer data). [0017] teaches patients are recruited into the trial and that a potential participant is pre-qualified according to the study's particular parameters that might include demographic, medical, mental, and other measures (interpreted by examiner as means for receiving customer data associated with the pharmaceutical batch customer) [0018] teaches a “kit” or “packet” is a collection of items or goods (materials) that are provided to patients as part of a trial (interpreted by examiner as receiving output material information, the output material information corresponding to one or more output materials associated for the clinical trial study)).
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the generation of an executable batch record for a clinical trial study of Juzeszyn to incorporate receiving customer data, study information and output material information as taught by Warren, with the motivation of leveraging the robust variables it tracks and maintains in order to produce a wide range of useful capabilities. (Warren at [0006]).
REGARDING CLAIM 8
Juzeszyn and Warren disclose the limitation of claim 6.
Juzeszyn does not explicitly disclose, however Warren further discloses:
The method of claim 6, wherein the study information comprises packaging sites, study languages, destination countries, output materials, dosage codes, business units, approvers, or a combination thereof (Warren at [0020] teaches site information which is a specific location where recruited patients go to interact with medical staff and are dispensed medication. Patients are assigned to these sites through the trial setup and ongoing procedures. [0018] teaches materials in the kit support the specific dosing so everything is properly aligned. [0041] teaches country specific parameters (interpreted by examiner as the study information comprises packaging sites, destination countries, output materials, dosage codes)).
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the generation of an executable batch record for a clinical trial study of Juzeszyn to incorporate the study information as taught by Warren, with the motivation of leveraging the robust variables it tracks and maintains in order to produce a wide range of useful capabilities. (Warren at [0006]).
REGARDING CLAIM 9
Juzeszyn and Warren disclose the limitation of claim 6.
Juzeszyn does not explicitly disclose, however Warren further discloses:
The method of claim 6, wherein the output material information comprises output materials, input materials, drug categorizations, alternative materials, a storage temperature, time out environment details, humidity control details, light control details, label details or a combination thereof (Warren at [0018] teaches a “kit” or “packet” is a collection of items or goods that are provided to patients as part of a trial. These packets or kits might include a variety of items including but not limited to a specific dose of medication that is targeted for study. Materials in the kit support the specific dosing so everything is properly aligned. For example, if a specific kit contains a specific dose, then the label and supporting documentation also aligns with whatever is pertinent to that dose (interpreted by examiner as the output material information comprises label details)).
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the generation of an executable batch record for a clinical trial study of Juzeszyn to incorporate the output material information as taught by Warren, with the motivation of reducing and possibly eliminating the need for users to have a working knowledge of supply chain and clinical trial demands while providing important capabilities in that area. (Warren at [0007]).
REGARDING CLAIM 10
Juzeszyn and Warren disclose the limitation of claim 1.
Juzeszyn further discloses:
The method of claim 1, wherein the executable batch record is accessed by the user associated with the production facilitator prior to being accessed by the producer (Juzeszyn at [0034] teaches certain components associated with a manufacturing procedures (MPR) are required to be present and/or complete before the pharmaceutical batch associated with the MPR could be released (interpreted by examiner as the executable batch record is accessed by the user associated with the production facilitator prior to being accessed by the producer)).
REGARDING CLAIM 11
Juzeszyn and Warren disclose the limitation of claim 1.
Juzeszyn further discloses:
The method of claim 1, further comprising causing to present an audit history, the audit history corresponding to a list of actions associated with inputting the batch record information and receiving the approval of the preliminary batch record (Juzeszyn at [0152] one or more audit trails may be maintained. Such an audit trail might be kept with regard to data structure additions and/or changes of the sort just discussed, and may yield a complete and accurate history of additions and/or changes to the data structures, including indications of what additions and/or changes were made and indications of the individual or individuals responsible for each addition and/or change (interpreted by examiner as the audit history corresponding to a list of actions associated with inputting the batch record information and receiving the approval of the preliminary batch record)).
REGARDING CLAIM 12
Juzeszyn and Warren disclose the limitation of claim 1.
Juzeszyn further discloses:
The method of claim 1, further comprising: receiving, at the first electronic device, study information for the clinical trial study, the study information comprising one or more customer approvers, the one or more customer approvers comprising the user associated with the pharmaceutical batch customer; determining whether the batch record information comprises blinding information; in accordance with a determination that the batch record information comprises blinding information, causing to present, at the second electronic device, a restricted view of the preliminary batch record that omits the blinding information to the user associated with the pharmaceutical batch customer, wherein the user associated with the pharmaceutical batch customer is configured to be blinded (Juzeszyn at [0094] teaches notifying the one or more individuals that assigned the investigator of a need to review the investigation, of a need to determine necessity of a batch product stability hold, and/or of a need to assign approvers and teaches sending an indication of the selected approvers (interpreted by examiner as receiving study information comprising one or more customer approvers) [0146] teaches attempts at unauthorized use of electronic signatures would be detected and reported to a security unit or the like. [0159] teaches the authorization module might act to consult an accessible store in order to determine if the user ID and password corresponded to an individual having authority to perform log-in. Certain embodiments of the present invention may associate access privileges with individuals. Such access privileges could, for instance, define the operations that an individual is allowed to perform when logged in. For such embodiments, the authorization module might additionally consult an accessible store in order to determine the access privileges associated with a particular individual and [0160] teaches access privileges of the sort noted above might define, for instance, the ad-hoc query functions that an individual was allowed to perform. Accordingly, access privileges might, for instance, limit the set of data structures for which the user could perform ad-hoc query functions and [0206] teaches implementing a controlled security for gaining access to the system. The security subsystem also controls user access to functions by establishing application roles. Application roles can then be granted to, or revoked from, the user to allow application function access. During application login, the system accepts the user id and password. For the user id and password accepted, the system determines the application role assigned and grants access privileges (interpreted by examiner as means to present a restricted view of the preliminary batch record that omits the blinding information to the user associated with the pharmaceutical batch customer, wherein the user associated with the pharmaceutical batch customer is configured to be blinded)).
REGARDING CLAIM 13
Juzeszyn and Warren disclose the limitation of claim 12.
Juzeszyn further discloses:
The method of claim 12, wherein the blinding information comprises a medication list, an identification number, a kit number, a start sequence number, an end sequence number, or a combination thereof (Juzeszyn at [0206] teaches implementing a controlled security for gaining access to the system using the user id and password to determine the application role assigned and grants access privileges (interpreted by examiner as the blinding information comprises an identification number).
REGARDING CLAIM 14
Juzeszyn and Warren disclose the limitation of claim 12.
Juzeszyn further discloses:
The method of claim 12, wherein the one or more customer approvers further comprises a second user associated with the pharmaceutical batch customer, wherein the second user associated with the pharmaceutical batch customer is configured to not be blinded (Juzeszyn at [0206] teaches for the user id and password accepted, the system determines the application role assigned and grants access privileges (interpreted by examiner as wherein the second user associated with the pharmaceutical batch customer is configured to not be blinded).
REGARDING CLAIM 15
Juzeszyn and Warren disclose the limitation of claim 14.
Juzeszyn further discloses:
The method of claim 14, further comprising: in accordance with the determination that the batch record information comprises blinding information, causing to present to the second user associated with the pharmaceutical batch customer, an unrestricted view of the executable batch record that includes the blinding information (Juzeszyn at [0206] teaches for the user id and password accepted, the system determines the application role assigned and grants access privileges (interpreted by examiner as means to present to the second user associated with the pharmaceutical batch customer, an unrestricted view of the executable batch record that includes the blinding information).
REGARDING CLAIMS 16 and 31
Claims 16 and 31 are analogous to Claim 1 thus Claims 16 and 31 are similarly analyzed and rejected in a manner consistent with the rejection of Claim 1.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Juzeszyn (US 2004/0158475), in view of Warren (US 2018/0253533) and in further view of Lawrence (US 2003/0065574).
REGARDING CLAIM 7
Juzeszyn and Warren disclose the limitation of claim 1.
Juzeszyn and Warren do not explicitly disclose, however Lawrence further discloses:
The method of claim 6, wherein receiving the bill of materials further comprises: importing at least a portion of the output material information to the bill of materials; receiving a quantity associated with each of the one or more output materials and corresponding input materials from the output material information; and assign a customer identifier based on the customer inventory (Lawrence at [0028] teaches receiving customer order data that includes data identifying the customer's order information (such as part number or other identifying information of the requested item, unit description, quantity, unit cost, subtotal cost, shipping cost, tax, total cost, and other suitable order information) and [0030] teaches order planning data includes bill of material (BOM). [0031] teaches the materials order data can include data identifying the materials needed to fulfill the customer's order, the location of those materials, the need to order those materials, the vendor providing the materials, the cost, and other suitable information. [0043] teaches generating a bill of materials data that can include parts list data, parts number data, order approval data, and other suitable information (interpreted by examiner as importing at least a portion of the output material information to the bill of materials; receiving a quantity associated with each of the one or more output materials and corresponding input materials from the output material information) and [0037] teaches receiving customer identification data (interpreted by examiner as assigning a customer identifier)).
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the generation of an executable batch record for a clinical trial study of Juzeszyn and the Batch study information of Warren to incorporate importing at least a portion of the output material information to the bill of materials, receiving a quantity associated with each of the one or more output materials and corresponding input materials from the output material information and assign a customer identifier as taught by Lawrence, with the motivation of allowing an operator to determine which stages are causing delay in order fulfillment and to take appropriate corrective measures. (Lawrence at [0010]).
Conclusion
The prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Haraburda (US 2002/0077722) teaches method and system for electronic tracking of packaging.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIZA TONY KANAAN whose telephone number is (571)272-4664. The examiner can normally be reached on Mon-Thu 9:00am-6:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached on 571-272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LIZA TONY KANAAN/Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683