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
Response to Amendment
In the amendment dated 04/15/2026, the following occurred: Claims 1, 2, 13-16 and 31 were amended. Claims 12, 17-30 and 32-45 were canceled.
Claims 1-11, 13-16 and 31 are currently pending.
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. 5M, 5Q
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 1-11, 13-16 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; and receiving a blinding protocol for the clinical trial study; producing a preliminary batch record based on the information input by the user associated with the production facilitator; determining that a user associated with a pharmaceutical batch customer is blinded to the clinical study; automatically redacting the preliminary batch record based on the blinding protocol; displaying […] that comprises the redacted preliminary batch record and […] for approving the redacted preliminary batch record; receiving an approval of the redacted preliminary batch record from a user associated with the pharmaceutical batch customer; and in accordance with receiving the approval of the redacted preliminary batch record, producing an executable batch record for a producer to execute as drafted, 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. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to display an area for inputting batch record information, receive the packaging instructions, the bill of materials, and the lot assignment; receive a blinding protocol; produce a preliminary batch record; determine that a user associated with a pharmaceutical batch customer is blinded to the clinical study; redact the preliminary batch record; display the redacted preliminary batch record and an area for approving the redacted preliminary batch record; receive an approval of the redacted preliminary batch record; and produce an executable batch record in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “displaying…receiving…receiving… producing…determining… redacting…displaying… receiving…and producing batch record” as indicated supra.
Other than reciting generic computer components (discussed infra), i.e., 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). The Examiner notes that Claim 1 is not tied to any particular technological environment. 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 merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use 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 determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. Accordingly, even in combination, this additional element does not provide 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)); 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 2-11 and 13-15 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) 13 further merely describe(s) the blinding protocol and binding information. Claim(s) 14 further merely describe(s) a second user is configured to not be blinded. Claim(s) 15 further merely describe(s) presenting an unrestricted view of the executable batch record that is not redacted. Claims 2-11 and 13-15 further define the abstract idea and are rejected for the same reason presented above with respect to claims 1, 16 and 31.
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, 8-11, 13-16 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Juzeszyn (US 2004/0158475), in view of Warren (US 2018/0253533), in further view of Finken (US 2014/0237950).
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, via the user interface, 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 redacted preliminary batch record and an interface for approving the redacted preliminary batch record; and receiving an approval of the redacted preliminary batch record from the 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 redacted preliminary batch record of Finken below, 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 redacted preliminary batch record of Finken below from a user associated with the pharmaceutical batch customer)); and in accordance with receiving the approval of the redacted 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 redacted preliminary batch record, of Finken below, producing an executable batch record for a producer to execute)).
Juzeszyn does not explicitly disclose batch record information comprising packaging instructions, a bill of materials, and a lot assignment, 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]).
Juzeszyn and Warren do not explicitly disclose receiving, via the user interface, a blinding protocol for the clinical trial study; determining that a user associated with a pharmaceutical batch customer is blinded to the clinical trial study; automatically redacting the preliminary batch record based on the blinding protocol, however Finken discloses:
and receiving, via the user interface, a blinding protocol for the clinical trial study; determining that a user associated with a pharmaceutical batch customer is blinded to the clinical trial study; automatically redacting the preliminary batch record based on the blinding protocol (Finken at [0004] teaches blinded studies. [0027] teaches a label sheet may be used in a clinical pharmaceutical trial study and label sheet may include instructions and label information such as blinding information (interpreted by Examiner as a blinding protocol and redacting the preliminary batch record of Juzeszyn above based on blinding protocol, where the blinding information is interpreted as the redacted preliminary batch record of Juzeszyn above));
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 packaging instructions, a bill of materials, and a lot assignment as batch record information of Warren to incorporate the blinding protocol for the clinical trial study and redacting the preliminary batch record based on the blinding protocol as taught by Finken, with the motivation of providing significant cost and time savings over traditional methods used for labeling study materials. (Finken at [0001]).
REGARDING CLAIM 2
Juzeszyn, Warren and Finken disclose the limitation of claim 1.
Juzeszyn further discloses:
The method of claim 1, wherein the user associated with the redacted pharmaceutical batch customer is configured to approve the redacted 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, Warren and Finken disclose the limitation of claim 1.
Juzeszyn and Finken do not explicitly disclose 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, 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 and the blinding protocol for the clinical trial study and redacting the preliminary batch record based on the blinding protocol of Finken 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, Warren and Finken disclose the limitation of claim 1.
Juzeszyn and Finken do not explicitly disclose 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, 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 and the blinding protocol for the clinical trial study and redacting the preliminary batch record based on the blinding protocol of Finken 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, Warren and Finken disclose the limitation of claim 1.
Juzeszyn and Finken do not explicitly disclose 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, 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 and the blinding protocol for the clinical trial study and redacting the preliminary batch record based on the blinding protocol of Finken 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, Warren and Finken disclose the limitation of claim 6.
Juzeszyn and Finken do not explicitly disclose wherein the study information comprises packaging sites, study languages, destination countries, output materials, dosage codes, business units, approvers, or a combination thereof, 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 and the blinding protocol for the clinical trial study and redacting the preliminary batch record based on the blinding protocol of Finken 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, Warren and Finken disclose the limitation of claim 6.
Juzeszyn and Finken do not explicitly disclose 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, 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 and the blinding protocol for the clinical trial study and redacting the preliminary batch record based on the blinding protocol of Finken 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, Warren and Finken 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, Warren and Finken 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 13
Juzeszyn, Warren and Finken disclose the limitation of claim 12.
Juzeszyn further discloses:
The method of claim 12, wherein the blinding protocol comprises an indication of blinding information, 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, Warren and Finken disclose the limitation of claim 12.
Juzeszyn further discloses:
The method of claim 12, a 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, Warren and Finken disclose the limitation of claim 14.
Juzeszyn further discloses:
The method of claim 14, further comprising: presenting to the second user associated with the pharmaceutical batch customer, an unrestricted view of the executable batch record that is not redacted (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 is not redacted).
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), in view of Finken (US 2014/0237950) and in further view of Lawrence (US 2003/0065574).
REGARDING CLAIM 7
Juzeszyn, Warren and Finken disclose the limitation of claim 1.
Juzeszyn, Warren and Finken 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, the blinding protocol for the clinical trial study and redacting the preliminary batch record based on the blinding protocol of Finken 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]).
Response to Arguments
Drawing Objections
Regarding the drawing objection(s), the Applicant has amended most figures to overcome the basis/bases of objection. However, Figures 5M, 5Q are still unreadable/unsatisfactory for production.
Rejection under 35 U.S.C. § 101
Regarding the rejection of claims 1-11, 13-16 and 31, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
The eligibility rejection should be withdrawn because amended claim 1 does not recite a judicial exception under prong one of Step 2A. The Examiner asserts that claim 1 fails prong one of Step 2A because it recites certain methods of human activity. Specifically, the Examiner alleges that "the claimed invention amounts to managing personal behavior or interaction between people (i.e., rules or instructions)." (Action at p. 4.) However, this characterizes the invention at an inappropriately high level of abstraction that ignores the actual claim language… Moreover, the "managing personal behavior or interactions between people" subcategory of abstract ideas is inapplicable to amended claim 1 because amended claim 1 does not recite any of the ideas encompassed by this subcategory. This subcategory covers "social activities, teaching, and following rules or instructions." (MPEP 2106.04(a)(2)(II)(C).) The Examiner asserts that claim 1 recites "following rules or instructions." (Action at p. 4.) However, the examples of "following rules or instructions" in the MPEP are directed to concepts such as a method of playing a dice game, assigning hair designs to balance head shape, and a series of instructions for how to hedge risk. (Id.) Amended claim 1 is not analogous to any of these examples-it does not recite any rules for an individual to follow but rather recites a process in which every step is performed by electronic devices. Therefore, amended claim 1 does not recite "managing personal behavior or interactions between people."
Regarding 1, The Examiner respectfully disagrees. The claim as drafted, is 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. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to display an area for inputting batch record information, receive the packaging instructions, the bill of materials, and the lot assignment; receive a blinding protocol; produce a preliminary batch record; determine that a user associated with a pharmaceutical batch customer is blinded to the clinical study; redact the preliminary batch record; display the redacted preliminary batch record and an area for approving the redacted preliminary batch record; receive an approval of the redacted preliminary batch record; and produce an executable batch record in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “displaying…receiving…receiving… producing…determining… redacting…displaying… receiving…and producing batch record” as indicated supra.
Amended claim 1 recites a technological solution to a technological problem in blinded clinical trial studies. As explained in the specification, existing techniques for blinding a study rely heavily on manual labor (e.g., manual redacting of information) and are subject to human error. (Published App. at [ 0268].) This can make the study insecure, since the production facilitator responsible for redacting information could neglect to redact a piece of information and unwittingly unblind the study to a customer reviewer who is approving the batch record. (Id.) The claimed invention solves this problem by receiving a blinding protocol from a production user inputting study information and "automatically redact[ing] and/or withhold[ing] unblinding information from the blinded customer users." (Id. at [0269].) As a result, the invention "provide[s] a secure method to maintain a blinded study throughout the process of generating an executable batch record." (Id.) This technological solution is reflected in the claims… Moreover, amended claim 1 recites an improved user interface for an electronic device, which the Federal Circuit has recognized is eligible subject matter because it improves computer functionality. For example, in Core Wireless Licensing S.A.R.L. v. LG Electronics, Inc., 880 F.3d 1356, 1362-63 (Fed. Cir. 2018), the Federal Circuit held that claims directed to "an improved user interface for electronic devices that displays an application summary of unlaunched applications" were eligible because, "although the generic idea of summarizing information certainly existed prior to the invention, these claims are directed to a particular manner of summarizing and presenting information in electronic devices" (emphasis added).
Regarding 2, The Examiner respectfully disagrees. The claims do not provide a practical application. The claims use generic computer components to produce a batch record, which is an abstract idea. They are no technical improvements nor improvements to a computer. The Specification discuses improvements in ensuring there is sufficient inventory prior to sending the study batch records to a packaging site, reducing waste by assigning supplier lots with earlier expiration dates to be used first, and reducing the amount of manual labor associated with confirming the inventory at para. 0066. This is neither a technical improvement nor an improvement to the functioning of a computer but rather a non-technical improvement to field of clinical trial studies and batch record production. Moreover, the user interface is not improved upon. The claims use a generic user interface to receive, display and approve data. The user interface has been analyzed as an additional element that merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application.
Even assuming, arguendo, that amended claim 1 were considered to be directed to an abstract idea under Step 2A of the subject matter eligibility framework, amended claim 1 amounts to significantly more than any such abstract idea under Step 2B. As explained above, amended claim 1 recites a technological improvement to blinded clinical trial studies and an improved user interface for an electronic device that amounts to an improvement to computer technology. According to MPEP 2106.05(a), a claim amounts to significantly more than a judicial exception when the claim recites an improvement to a computer or to any other technology or technical field. Therefore, amended claim 1 satisfies Step 2B.
Regarding 3, The Examiner respectfully disagrees. The claims do not provide significantly more. There are no technical improvements nor improvements to a user interface in the claim and the Applicants disclosure does not support such improvements.
Rejection under 35 U.S.C. § 103
Regarding the rejection of claims 1-11, 13-16 and 31, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
Therefore, the cited references fail to disclose or suggest "receiving, via the user interface, a blinding protocol for the first clinical trial study," "determining that a user associated with a pharmaceutical batch customer is blinded to the clinical trial study," and "automatically redacting the preliminary batch record based on the blinding protocol," as recited in amended claim 1. Accordingly, the rejection of claim 1 should be withdrawn. Independent claims 16 and 31 have been amended to recite limitations analogous to those discussed above and, thus, the rejection of claims 16 and 31 should be withdrawn for at least the same reasons. The rejection of claims 2-15 should be withdrawn at least for their respective dependencies.
Regarding 1, The Examiner has cited new reference to teach blinding protocol and redacting the preliminary batch record based on the blinding protocol. Please refer to the new rejection under 35 U.S.C. § 103. Given the broadest reasonable interpretation, the cited references in combination teach the claimed features.
Conclusion
Applicant’s amendment necessitated the new grounds of rejection presented in this Office action. THIS ACTION IS MADE FINAL. See MPEP §706.07(a). 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.
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:
Young (US 2011/0307267) discloses distributed randomized and supply management in clinical trials.
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/L.T.K./Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683
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