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 12/12/2025, the following occurred: Claims 1, 6, 9, 15, 16 and 20 were amended. Claims 11 and 17 were canceled. Claim 21 is new.
Claims 1-10, 12-16 and 18-21 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. 1-6 and 8,
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 1-10, 12-16 and 18-21 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, 9 and 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites a method and a system for quality inspection and regulation adherence.
Regarding claims 1, 9 and 16, the limitation of (claim 1 being representative) store data received from data entry, store data retrieved in a vector-based format, and store data related to transactions performed; enabling communication; performing the data entry by receiving information from a plurality of sources, wherein the plurality of sources comprise data relating to regulations provided by a plurality of official regulatory bodies uploaded by a first preauthorized user; converting the data received into vector-based format and storing the converted data; receiving an input query and generating in real time an output answer summary in response to the input query to quickly search the data stored, generate an answer summary and present the answer summary; providing reference information relating to the output answer summary, derive the reference information from the data in the first database and present the reference information; providing guided tutorials for a plurality of tasks, wherein at least a portion of the guided tutorials are generated from the data received from the data entry; providing access to the data received from the data entry according to a second preauthorized user’s access level; creating assignments associated with an entity; controlling access by a plurality of users to the assignments of the created assignments, such that each user of the plurality of users is provided with a tier level of access, to allow access by multiple users to an individual assignment, such that simultaneous access to the individual assignment by more than one user is possible; connecting a first user; connecting a second user; providing communication between the first user and the second user; transmitting visual and audio information between the first user and the second user, wherein the first user is located on-site, and wherein the second user is located remote to the pharmaceutical facility and participates remotely in an on-site inspection in real time; and creating a report related to the individual assignment by compiling assignment information provided by at least one user having access to the assignment and regarding claim 9- the limitation of receiving assignment information from the plurality of users and regarding claim 16- the limitation of receiving visual information and audio information and communicating the visual information and the audio information; recording the visual information and the audio information; storing the recorded visual information the recorded audio information; 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 (in claim 1) a system, a computing device, processor, a database server, a file storage system, software module, an online network, a first computing device and a second computing device (in claim 9) a computing device, a database server, a processor, a file storage system and (in claim 16) a system, a computing device, a database server, a processor, a file storage system a first computing device and a second computing device, the claimed invention amounts to managing personal behavior or interaction between people (i.e., rules or instructions). For example, but for the system, database server, file storage system, software module, online network, computing device, processor, a first computing device and a second computing device, the claims encompass quality inspection and regulation adherence in the manner described in the identified abstract idea, supra. 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.
This judicial exception is not integrated into a practical application. In particular, claim 1 recites the additional elements of a computing device, a system, a database server, a file storage system, software module, an online network and a camera. Claim 9 recites the additional element of a computing device, a database server, a processor and a file storage system. Claim 16 recites the additional element of a system, a computing device, a database server, a processor, a file storage system, a first computing device and a second computing device. These additional elements are not exclusively defined by the applicant and are recited at a high-level of generality (i.e., a generic server or generic computer components for enabling access to medical information or for performing generic computer functions) 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 it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Claim 1 further recite the additional elements of a display, a camera, a first database, a second database, a user interface. Claim 9 recite the additional elements of a display, a camera, a first database, a second database and a user interface. Claim 16 recite the additional elements of a display, a camera, a first database, a second database, a first user interface and a second user interface. These additional element are recited at a high level of generality (i.e. a general means to output/receive/transmit/display/store 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.
Claim 1 further recite the additional element of a generative artificial intelligence software module to generate an output answer summary and derive/present the reference information. This has been interpreted as (“apply it”) to the abstract idea. MPEP 2106.04(d)(I) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide a practical application.
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 element of the system, database server, file storage system, software module, online network, computing device, processor, a first computing device and a second computing device 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.
As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of the first database, second database, user interface, display, camera, first user interface and the second user interface were considered extra-solution activity. This has been re-evaluated under “significantly more” analysis and determined to be well-understood, routine and conventional activity in the field. Well-understood, routine and conventional activity cannot provide an inventive concept (“significantly more”). Therefore when considering the additional elements alone, and in combination, there is no inventive concept in the claim, and thus the claim is not patent eligible.
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional element of the generative artificial intelligence software module to generate an output answer summary and derive/present the reference information was determined to be the application of artificial intelligence to the identified abstract idea. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP2106.05(1)(A) indicates that merely saying “apply it’ or equivalent to the abstract idea 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 2-8, 10, 12-15 and 16-21 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) the information. Claim(s) 3 further merely describe(s) each of the official regulatory bodies. Claim(s) 4, 5, 12 and 13 further merely describe(s) the individual assignment. Claim(s) 6 and 20 further merely describe(s) the inspections. Claim(s) 7 further merely describe(s) the entity. Claim(s) 8 further merely describe(s) the plurality of tasks. Claim(s) 10 further merely describe(s) receiving information from a camera. Claim(s) 14 further merely describe(s) the plurality of sources. Claim(s) 15 further merely describe(s) receiving an input and generating an output. Claim(s) 18 and 19 further merely describe(s) the assignment request. As can be seen the dependent claims further define/narrow the abstract idea.
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 1-10, 12-16 and 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over Bui (WO 2018/156781), in view of Lawton (US 2007/0198477) and in further view of Gulati (US 2019/0354551).
REGARDING CLAIM 1
Bui discloses a system for assessing adherence to pharmaceutical regulations and performing inspections of pharmaceutical facilities, the system comprising: a computing device that includes a processor, a display, and a camera; a database server that includes a file storage system configured to store data received from data entry, a first database configured to store data retrieved from the file storage system in a vector-based format, and a second database configured to store data related to transactions performed using the system; generative artificial intelligence software module having a connection to the database server and to an online network; a user interface accessible through the computing device, the user interface enabling communication with the database server ([0269] teaches a server. [0031] teaches electronic displays. [0147 store images, video received from, or is made accessible to, users of the user devices (e.g., user device 110) (interpreted by examiner as a computing device that includes a camera) [0018] teaches use of a structured database and [0148] teaches data storage database 120-129 (interpreted as the database server, the first database and the second database) [0018] teaches utilizing the website through internet/network connection (interpreted by examiner as the software module) and an interactive user interface and computer (interpreted by examiner as the user interface accessible through a computer device) [0157] teaches the communication platform includes artificial intelligence (interpreted by examiner as the generative artificial intelligence software module)); wherein the system is configured to perform operations comprising: performing the data entry by receiving information from a plurality of sources, wherein the plurality of sources comprise data relating to regulations provided by a plurality of official regulatory bodies uploaded into the file storage system by a first preauthorized user ([0013] the use of electronic form and transaction system that may reduce the burden and increase the effectiveness of regulatory compliance measures and [0016] teaches input to electronic forms from user (interpreted by examiner as performing data entry). [0017] teaches various regulations, audit requirements, or other legal or contractual rules may necessitate the administrative user to generate reports. [0026] teaches data entry); converting the data received from the data entry into vector-based format and storing the converted data in the first database ([0314] teaches an input field (interpreted by examiner as the data entry information) and capturing and storing input in a vector format); connecting a first user to the system via a first computing device; connecting a second user to the system via a second computing device; providing communication between the first user and the second user through the user interface accessed on the first computing device and the user interface accessed on the second computing device ([0124] teaches two entities performing a complex series of tasks having access to a document and [0129] teaches the system can present (e.g., in one or more user interfaces, such as in a web page being rendered on user devices of users) information identifying a current task that is to be completed along with one or more users assigned the current task. In this way, each user can rapidly determine (1) a present task to be completed (e.g., a task, according to the graph, that causes progression towards the goal), (2) one or more users assigned the present task, and (3) the ability to provide notifications to the assigned users (interpreted by examiner as connecting a first user to the system via a first computing device and connecting a second user to the system via a second computing device). [0137] teaches communication with user devices and [0157] teaches the system may also provide a platform for communication amongst users or groups of users, such as a messaging system or chat (interpreted by examiner providing communication between the first user and the second user through the user interface accessed on the first computing device and the user interface accessed on the second computing device)); transmitting visual and audio information between the first user and the second user, wherein the first user uses a camera of the first computing device and is located on-site, and wherein the second user is located remote to the pharmaceutical facility and participates remotely in an on-site inspection in real time ([0033] teaches visual representations and [0147] teaches a data storage database 129 that can store documents, images, video, or any arbitrary information that is received from, or is made accessible to, users of the user devices (e.g., user device 110) (interpreted by examiner as means for transmitting visual and audio information) [0124] teaches a counsel for a first entity (e.g., a venture capital firm) may prepare an initial term sheet or contract (interpreted by examiner as the first user located on-site) and a second entity (e.g., a company requesting funding from the venture capital firm) may review, negotiate, and ultimately sign, the term sheet/contract (interpreted by examiner as the second user located remotely))
Bui does not explicitly disclose, however Lawton discloses:
wherein the generative artificial intelligence software module is used to derive the information from the data in the first database ([0010] teaches regulatory data (interpreted by examiner as the reference information of Gulati below) identified by a processing module (interpreted by examiner as the generative artificial intelligence software module)); receiving an input query through the user interface and generating in real time an output answer summary in response to the input query by using the generative artificial intelligence software module to quickly search the data stored in the first database, generate an answer summary, and present the answer summary on the display (Lawton at [0020] teaches a user interface for a search function and [0046] teaches a search function that processes search query requests (interpreted by examiner as input query) received by server, accesses the regulatory data in databases 240 to 280 (interpreted by examiner as the first database) in response to those requests, and retrieves the requested regulatory data for presentation (interpreted by examiner as present/output the output answer summary and/or the answer summary) and [0010] teaches using a processing module (interpreted by examiner as using the generative artificial intelligence software module, of Bui above, to quickly search the data stored in the first database) for identifying, in response to a received request, regulatory data); providing access to the data received from the data entry according to a second preauthorized user’s access level (Lawton at [0049] teaches a login prompt and [0050] teaches a security process that controls access to regulatory server and its services. For example, security module may determine a security profile for the user upon the user logging into server and [0051] teaches if the user's security profile indicates that the user does not have authorization to access or modify certain regulatory records, then the presented template may be configured to not enable the user to perform such functions (interpreted by examiner as providing access to the data received from the data entry according to a second preauthorized user’s access level)); controlling access by a plurality of users to the assignments of the created assignments, such that each user of the plurality of users is provided with a tier level of access, wherein the system is configured to allow access by multiple users to an individual assignment, such that simultaneous access to the individual assignment by more than one user is possible (Lawton at [0045] teaches security module for controlling user access and that different users may be provided varying levels of authorization (interpreted by examiner as the tier level of access) Each user, for example, may be assigned a security profile that may define: the functions the user may perform using server 110; the records (interpreted by examiner as the assignment) associated with specific products the user may access or modify (e.g., read or write); and/or the interface templates which server 110 is to present to the user (interpreted by examiner as means to allow access by multiple users to an individual assignment, such that simultaneous access to the individual assignment by more than one user is possible). [0048] teaches user accessing documents (also interpreted by examiner as the assignment) [0035] teaches preparing regulatory reports.);
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 data entry system of Bui to incorporate the system for managing regulatory information as taught by Lawton, with the motivation of efficiently managing regulatory data in the healthcare industry, so that it can be tracked, e.g., with respect to a region, a particular product or group of products, a manufacturing site, a regulation, and so forth. (Lawton at [0008]).
Bui and Lawton do not explicitly disclose, however Gulati discloses:
providing reference information relating to the output answer summary, and present the reference information on the display (Gulati at [0004] Examples of FDA Form 483s issued to drug manufacturers and other categories like food, cosmetics, etc.) can be found at the FDA's website (www.fda.gov). [0016] teaches other entities that provide information in this domain (full text Warning Letters and/or 483s and related materials published by FDA) for a fee are fdanews.com, fdazilla.com, fdainfo.com, foiservices.com. These companies primarily obtain “full-text documents” from FDA FOI Office for a fee, organize them to enable basic search and then resell such documents to the users, and [0007] also teaches providing a reference to the particular section of the regulation whose requirement has been violated (e.g. 21 CFR Part 211.192 for a Finished Pharmaceutical); or a title heading where a recommendation is being made (interpreted by examiner as present on the display the reference information relating to the output answer summary of Lawton)); providing guided tutorials for a plurality of tasks, wherein at least a portion of the guided tutorials are generated from the data received from the data entry (Gulati at [0007] teaches providing information on what response the FDA expects from the firm and references to FDA Guidances and [0061] teaches the FDA Guidances for Industry, which lay down concepts and frameworks based on which firms can build their systems and operations to achieve regulatory compliance (interpreted by examiner as means to provide guided tutorials for a plurality of tasks)); creating assignments associated with an entity; and creating a report related to the individual assignment by compiling assignment information provided by at least one user of plurality of users having access to the assignment, wherein the report provides recommendations for improving the entity’s manufacturing process and controls if regulatory compliance deficiencies are found (Gulati at [0022] teaches creating recordings and reporting to summarize data on regulatory (e.g. CGMP) violations, deviations and recommendations and [0051] teaches creating checklists. [0003] teaches routinely perform their inspections (interpreted by examiner as the assignments associated with an entity) of pharmaceutical manufacturers and at the conclusion of an inspection, an FDA Form 483 is issued to the firm when an FDA investigator(s) has observed any conditions that in their judgement may constitute violations of the FD&C Act and related Acts. The FDA Form 483 lists observations made by the FDA representative(s) during the inspection of the facility (interpreted by examiner as the report related to the individual assignment by compiling assignment information provided by at least one user having access to the assignment, wherein the report provides recommendations for improving the entity’s manufacturing process and controls if regulatory compliance deficiencies are found)).
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 systems of Bui and Lawton to incorporate the regulatory intelligence system as taught by Gulati, with the motivation of enabling individuals to take informed regulatory compliance decisions for the Product Type that matters to them, efficiently and effectively. (Gulati at [0020]).
REGARDING CLAIM 2
Bui, Lawton and Gulati disclose the limitation of claim 1.
Bui and Lawton do not explicitly disclose the information from a plurality of sources comprise publicly available data relating to pharmaceutical manufacture and use, however Gulati further discloses:
The system of claim 1, wherein the information from a plurality of sources comprise publicly available data relating to pharmaceutical manufacture and use (Gulati at [0006] teaches the FDA website (www.fda.gov) for public access of information under the Freedom of Information Office).
REGARDING CLAIM 3
Bui, Lawton and Gulati disclose the limitation of claim 1.
Bui and Lawton do not explicitly disclose wherein each of the official regulatory bodies is associated with a governing body of a country, however Gulati further discloses:
The system of claim 1, wherein each of the official regulatory bodies is associated with a governing body of a country (Gulati at [0023] teaches selecting a country).
REGARDING CLAIM 4
Bui, Lawton and Gulati disclose the limitation of claim 1.
Bui and Lawton do not explicitly disclose wherein an individual assignment of the created assignments requests adherence to regulations provided by at least one official regulatory body of the plurality of official regulatory bodies, however Gulati further discloses:
The system of claim 1, wherein an individual assignment of the created assignments requests adherence to regulations provided by at least one official regulatory body of the plurality of official regulatory bodies (Gulati at [0002] and [0003] teaches performing inspection for assessing compliance with the Food and Drug Administration (FDA) regulations and Current Good Manufacturing Practice (CGMP) regulations).
REGARDING CLAIM 5
Bui, Lawton and Gulati disclose the limitation of claim 1.
Bui and Lawton do not explicitly disclose wherein an individual assignment of the created assignments requests adherence to regulations provided by at least two official regulatory bodies of the plurality of official regulatory bodies, however Gulati further discloses:
The system of claim 1, wherein an individual assignment of the created assignments requests adherence to regulations provided by at least two official regulatory bodies of the plurality of official regulatory bodies (Gulati at [0002] teaches complying with the Food and Drug Administration (FDA) regulations and [0003] teaches complying Current Good Manufacturing Practice (CGMP) regulations (interpreted by examiner as the at least two official regulatory bodies of the plurality of official regulatory bodies)).
REGARDING CLAIM 6
Bui, Lawton and Gulati disclose the limitation of claim 1.
Bui and Lawton do not explicitly disclose wherein the inspections of pharmaceutical facilities comprise audits of the entity, inspections of equipment, inspections of operating protocols and practices within the pharmaceutical facilities, and inspection of manufacturing processes within the pharmaceutical facilities, however Gulati further discloses:
The system of claim 1, wherein the inspections of pharmaceutical facilities comprise audits of the entity, inspections of equipment, inspections of operating protocols and practices within the pharmaceutical facilities, and inspection of manufacturing processes within the pharmaceutical facilities (Gulati at [0003] teaches pharmaceutical manufacturer facilities are required to comply with Current Good Manufacturing Practice (CGMP) regulations and assessing the CGMP compliance status of such manufacturing facilities by FDA investigators routinely perform their inspections. [0011] teaches to manufacture each Product Type, there are different departments or functional areas that have specific responsibilities with regards to completing specific steps of the drug manufacturing process e.g. Production, Laboratory, Quality, Packaging and Labeling, Material Management, Facilities and Equipment. Each functional area needs to have their ‘System’ designed to meet the CGMP requirements for their Product Type in order to stay in compliance with regulations).
REGARDING CLAIM 7
Bui, Lawton and Gulati disclose the limitation of claim 1.
Bui and Lawton do not explicitly disclose wherein the entity is a company, however Gulati further discloses:
The system of claim 1, wherein the entity is a company (Gulati at [0002]).
REGARDING CLAIM 8
Bui, Lawton and Gulati disclose the limitation of claim 1.
Bui and Lawton do not explicitly disclose wherein the plurality of tasks comprises assessments of adherence to regulations provided by a selected regulatory body, walk-through inspections of a pharmaceutical facility, and completion of citation reports, however Gulati further discloses:
The system of claim 1, wherein the plurality of tasks comprises assessments of adherence to regulations provided by a selected regulatory body, walk-through inspections of a pharmaceutical facility, and completion of citation reports (Gulati at [0003] teaches assessing compliance with Current Good Manufacturing Practice (CGMP) regulations, performing inspections at manufacturing facilities and [0007] teaches generating warning letters that contain citations).
REGARDING CLAIM 10
Bui, Lawton and Gulati disclose the limitation of claim 1.
Bui further discloses:
The method of claim 9, further comprising receiving visual information and audio information from the camera, recording the visual information and the audio information, and storing the recorded visual information and the recorded audio information in the file storage system (Bui at [0147] teaches a data storage database that can store documents, images, video, or any arbitrary information that is received from, or is made accessible to, users of the user devices (e.g., user device 110) and [0281] teaches visual structure of documents (interpreted by examiner as receiving visual information and audio information from the camera, recording the visual information and the audio information, and storing the recorded visual information and the recorded audio information in the file storage system)).
REGARDING CLAIMS 9, 12-16 and 18-20
Claims 9, 12-16 and 18-20 are analogous to Claims 1-8, 10 thus Claims 9, 12-16 and 18-20 are similarly analyzed and rejected in a manner consistent with the rejection of Claims 1-8, 10.
Moreover, REGARDING CLAIM 16, Gulati further discloses: the first user using a guided tutorial provided by the system for a plurality of tasks during the assessment and inspections; ([0007] teaches providing information on what response the FDA expects from the firm and references to FDA Guidances and [0061] teaches the FDA Guidances for Industry, which lay down concepts and frameworks based on which firms can build their systems and operations to achieve regulatory compliance (interpreted by examiner as the guided tutorial provided by the system for a plurality of tasks during the assessment and inspections and means for a first user to use them)) and Gulati further discloses: the first user using a camera of the first computing device during an on-site inspection of the pharmaceutical facility to capture visual information and audio information ([abstract] teaches collection audio recordings, and that records are made accessible through a database on webserver upon user's request from a desktop, a mobile computing device or like devices via a graphical user interface, [0050] teaches the tabulated records can contain text, graphs, hyperlinks to related documents for each record (e.g. link to the specified FDA Guidance for Industry, Full-Text Warning Letter), and/or links to audio player to play the Audio Recordings and [0083] teaches a user can listen to the Audio Recording of the contents of the Warning Letter issued to this company using user's computer or mobile device screen (interpreted by examiner as the captured visual and audio information)).
REGARDING CLAIM 21
Bui, Lawton and Gulati disclose the limitation of claim 9.
Bui further discloses:
The method of claim 9, wherein the second user participates remotely in an interview conducted at the pharmaceutical facility (Bui at [0157] teaches a user may be also able to use the communication platform to contact support; this may include either a human representative, or a chatbot, artificial intelligence, or expert system that interacts with the user in a way similar to human interaction (interpreted by examiner as means for the second user participates remotely in an interview conducted at the pharmaceutical facility)).
Response to Arguments
Drawing Objections
Regarding the drawing objection(s), the Applicant has amended Figs. 1-6 and 8 but does not overcome the basis/bases of objection.
Rejection under 35 U.S.C. § 101
Regarding the rejection of claims 1-10, 12-16 and 18-21, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
Applicant submits that recitation of a camera that is used by an on-site user to transmit visual and audio data in real time to a remote user, allowing the remote user to actively participate in an inspection in real time in order to more quickly and efficiently conduct an assessment of regulatory compliance and create a report, which provides recommendations for improving manufacturing processes and controls, overcomes the cited 35 U.S.C. § 101 rejection to extend beyond being an abstract idea without significantly more. This feature allows an on-site inspection by a team without requiring the entire team to travel to the site of the inspection, reducing travel cost and time and reducing the inefficiency of having different team members reviewing inspection information at different times and potentially requiring repeat inspections. Improvements to technology for conducting regulatory assessments, including audits and on-site inspections, also provide improvements to pharmaceutical manufacturing since those assessments are an integral part of improving safety of both the manufacturing process and the manufactured product.
Regarding 1, The Examiner respectfully disagrees. The additional element of a camera is recited at a high level of generality (i.e. a general means to capture 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, this additional element does not integrate the abstract idea into a practical application. Moreover, allowing an on-site inspection by a team without requiring the entire team to travel to the site of the inspection, reducing travel cost and time and reducing the inefficiency of having different team members reviewing inspection information at different times and potentially requiring repeat inspections does not provide improvements to the functioning of a computer not to a technical field. The Applicant is not improving upon the functioning of a camera but rather using a generic functions of a camera.
Applicant submits that recitation of a generative artificial intelligence software to search a large database of regulatory data and generate an answer summary and references in real time overcomes the cited 35 U.S.C. § 101 rejection to extend beyond being an abstract idea without significantly more. The generative artificial intelligence software searches through large amounts of information more quickly than a human is capable of and can receive queries and provide answer summaries in a natural language format that is easier for a user to utilize than traditional search tools, allowing the user to work more quickly and efficiently.
Regarding 2, the Examiner respectfully disagrees. The additional element of a generative artificial intelligence software module to generate an output answer summary and derive/present the reference information has been interpreted as (“apply it”) to the abstract idea. The Applicant is applying know AI methods to process data. There are no improvements to AI technology and allowing a user to work more quickly and efficiently does not improve upon AI technology nor the functioning of a computer. Moreover, MPEP 2106.04(d)(I) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide a practical application.
Applicant submits that recitation of a guided tutorial and the use of a camera by a first on- site user to transmit visual and audio data in real time to a second remote user, allowing the second remote user to guide and train the first on-site user more easily and efficiently, overcomes the cited 35 U.S.C. § 101 rejection to extend beyond being an abstract idea without significantly more. These features improve on current methods of training by providing a guided experience with prompts that can be used by an inexperienced inspector in real time during an inspection, and by having a trainer guide an inexperienced inspector without requiring the trainer to be present on- site, reducing travel cost and time and providing effective real-time training when a trainer is not able to be present on-site.
Regarding 3, the Examiner respectfully disagrees. The above does not provide technical improvements nor improvements to the functioning of a computer.
Rejection under 35 U.S.C. § 103
Regarding the rejection of claims 1-10, 12-16 and 18-21, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
Office Action, and solely to expedite prosecution, Applicant has incorporated the limitations of original Claims 11 and 17 into Claim 1, and Claim 1 is further amended herein to recite" connecting a first user to the system via a first computing device; connecting a second user to the system via a second computing device; providing communication between the first user and the second user through the user interface accessed on the first computing device and the user interface accessed on the second computing device; transmitting visual and audio information between the first user and the second user, wherein the first user uses a camera of the first computing device and is located on-site, and wherein the second user is located remote to the pharmaceutical facility and participates remotely in an on-site inspection in real time" Bui, Lawton and Gulati, alone or in combination, provide no teaching, suggestion or motivation for the combination of features recited above, including providing communication through a user interface between a first user using a first computing device and camera and a second user using a second computing device, transmitting visual and audio information between the first user and the second user, wherein the first user is located on-site and the second user is located remote to a pharmaceutical facility, allowing the second remotely located user to participate in an on-site inspection in real time.
Regarding 1, The Examiner respectfully disagrees. Bui discloses the above amended limitation. Bui at [0124] teaches two entities performing a complex series of tasks having access to a document and [0129] teaches the system can present (e.g., in one or more user interfaces, such as in a web page being rendered on user devices of users) information identifying a current task that is to be completed along with one or more users assigned the current task. In this way, each user can rapidly determine (1) a present task to be completed (e.g., a task, according to the graph, that causes progression towards the goal), (2) one or more users assigned the present task, and (3) the ability to provide notifications to the assigned users (interpreted by examiner as connecting a first user to the system via a first computing device and connecting a second user to the system via a second computing device). [0137] teaches communication with user devices and [0157] teaches the system may also provide a platform for communication amongst users or groups of users, such as a messaging system or chat (interpreted by examiner providing communication between the first user and the second user through the user interface accessed on the first computing device and the user interface accessed on the second computing device). Moreover, Bui at [0033] teaches visual representations and [0147] teaches a data storage database 129 that can store documents, images, video, or any arbitrary information that is received from, or is made accessible to, users of the user devices (e.g., user device 110) (interpreted by examiner as means for transmitting visual and audio information) [0124] teaches a counsel for a first entity (e.g., a venture capital firm) may prepare an initial term sheet or contract (interpreted by examiner as the first user located on-site) and a second entity (e.g., a company requesting funding from the venture capital firm) may review, negotiate, and ultimately sign, the term sheet/contract (interpreted by examiner as the second user. The Examiner notes that it inherent that the second user is located remotely).
Given the broadest reasonable interpretation, the cited references in combination teach the claimed features.
… Claim 16 is further amended to recite, "...training a user in assessing adherence...using a system including at least one computing device...", "the first user using a guided tutorial for performing a plurality of tasks during the assessment and inspections; the first user using a camera of the first computing device during an on-site inspection of the pharmaceutical facility to capture visual information and audio information; from the camera of the first computing device and", "communicating the visual information and the audio information to the second computing device for real-time access the second user, wherein the second user is remote to the pharmaceutical facility and guides the first user remotely in real time", and "assisting the first user in creating an inspection a report... wherein the guided tutorial prompts the first user to provide information for the report and generates pre-defined assignment information for routine assessment findings."
Regarding 2, please refer to the new rejection under 35 U.S.C. § 103 as Gulati discloses: the first user using a guided tutorial provided by the system for a plurality of tasks during the assessment and inspections ([0007] teaches providing information on what response the FDA expects from the firm and references to FDA Guidances and [0061] teaches the FDA Guidances for Industry, which lay down concepts and frameworks based on which firms can build their systems and operations to achieve regulatory compliance (interpreted by examiner as the guided tutorial provided by the system for a plurality of tasks during the assessment and inspections and means for a first user to use them)) and discloses: the first user using a camera of the first computing device during an on-site inspection of the pharmaceutical facility to capture visual information and audio information ([abstract] teaches collection audio recordings, and that records are made accessible through a database on webserver upon user's request from a desktop, a mobile computing device or like devices via a graphical user interface, [0050] teaches the tabulated records can contain text, graphs, hyperlinks to related documents for each record (e.g. link to the specified FDA Guidance for Industry, Full-Text Warning Letter), and/or links to audio player to play the Audio Recordings and [0083] teaches a user can listen to the Audio Recording of the contents of the Warning Letter issued to this company using user's computer or mobile device screen (interpreted by examiner as the captured visual and audio information)).
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.
Messana (US 2017/0316424) teaches management solutions and related methods.
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/LIZA TONY KANAAN/Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683