DETAILED ACTION
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 .
Notice to Applicant
The following is a Final Office Action for Application Serial Number: 18/620,010, filed on March 28, 2024. In response to Examiner’s Non-Final Rejection dated June 30, 2025, Applicant arguments and remarks on September 24, 2025 and on January 27, 2026, amended claims 7 and 9. Claims 1-9 are pending in this application and have been rejected below.
It appears the inventor(s) filed the current application pro se (i.e., without the benefit of representation by a registered patent practitioner). While inventors named as applicants in a patent application may prosecute the application pro se, lack of familiarity with patent examination practice and procedure may result in missed opportunities in obtaining optimal protection for the invention disclosed. The inventor(s) may wish to secure the services of a registered patent practitioner to prosecute the application, because the value of a patent is largely dependent upon skilled preparation and prosecution. The Office cannot aid in selecting a patent practitioner.
A listing of registered patent practitioners is available at https://oedci.uspto.gov/OEDCI/. Applicants may also obtain a list of registered patent practitioners located in their area by writing to Mail Stop OED, Director of the U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.
Response to Amendment
Applicant's amendments to the title are acknowledged.
Applicant's amendments are acknowledged.
The 35 U.S.C. § 112 rejections of claims 7 and 9, are hereby withdrawn in light of Applicant’s amendments to claims 7 and 9.
Regarding the 35 U.S.C. 101 rejection, Applicants arguments and amendments have been considered but are insufficient to overcome the rejection.
The 35 U.S.C. § 102 rejection of claims 1-6, 8 and 9 are maintained in light of Applicant’s arguments.
The 35 U.S.C. § 103 rejection of claim 7 is maintained in light of Applicant’s arguments.
Response to Arguments
Applicant's Arguments/Remarks filed September 24, 2025 (hereinafter Applicant Remarks) have been fully considered but are not persuasive. Applicant’s Remarks regarding the pending rejections will be addressed herein below in the order in which they appear in the response filed September 24, 2025.
Regarding the 35 U.S.C. 101 rejection, Applicant states the claimed invention is not directed merely to an abstract idea, but rather to a specific, novel software system that uses internal rules and information from internal databases and domain-specific trained AI tools to generate intended use and indication of use statements which are used by the system to generate device requirement specifications and software requirement specifications (requirements) in compliance with requirements set by the FDA and regulatory bodies.
Unlike mental processes and certain methods of organizing human activity, the claimed invention recites specific technical and system based improvements to the operation of regulatory compliance processes for medical devices and in vitro diagnostic (IVD) tests, producing tangible, non-abstract outputs such as regulatory documentation and specifications directly usable in quality management and design control workflows for medical devices and IVD tests.
The Applicants respectfully request that the Examiner reconsider the rejection of claims 2-5 and 8 under U.S.C. § 101 based on the following additional elements that are disclosed in these dependent claims:
creation of design deliverables from linked product requirements (claim 2);
creation of product requirements (claim 3);
creation of user, business, and regulatory requirements and further creation of product
design requirements (claim 4);
categorization of product requirements to identify specific deliverables or design outputs
(claim 5); and propagation of any change in product and project backward and forward to
assess change impact on activities and timelines (claim 8).
Further, additional elements that take the claim out of the mental processes and certain methods of organizing human activity grouping are the internal rules in the software system and Al tools. These steps produce operationally executable artifacts that directly alter and control the operation of downstream design and project management systems. Such integration of regulatory information through Al with technical documentation generation constitutes a concrete improvement in the functioning of regulated product development systems for medical devices and IVD tests.
In response, Examiner respectfully disagrees. Examiner respectfully reminds Applicant claims are evaluated to ensure that the claim itself reflects the disclosed improvement; MPEP 21060.04(d)(1). Examiner finds the pending claims and original disclosure do not fully reflect the methods and techniques Applicant describes above.
However, Examiner finds the pending claims are not technological in nature and merely limits the abstract idea to a particular environment. Examiner notes the advancements disclosed in RCT v. Microsoft, Diamond v. Diehr, SiRF Technology v. ITC and Ex Parte Desjardins recite improvements to the functioning of a computer, or an improvement to another technology or technical field. Specifically, in RCT v. Microsoft, the claims are directed to a process of halftoning an image comprising the steps of generating a mask, comparing pixels, and using the results of the comparison to convert a binary image to a halftoned image. The process uses less memory, had faster computation times, and processed improved image quality compared to other masks, Diamond v. Diehr utilized the Arrhenius equation to improve the process of controlling the operations of a mold in curing rubber parts, SiRF Technology v. ITC disclosed a GPS receiver utilizing software that applies a mathematical formula to improve the ability to determine its position in weak environments and in Ex Parte Desjardins, the specification identified the improvement to machine learning technology by explaining how the machine learning model is trained to learn new tasks while protecting knowledge about previous tasks to overcome the problem of “catastrophic forgetting”, and the claims reflect the improvement identified in the specification. The improvements identified in the Desjardins specification included disclosures of the effective learning of new tasks in succession in connection with specifically protecting knowledge concerning previously accomplished tasks; allowing the system to reduce use of storage capacity; and the enablement of reduced complexity in the system. Such improvements were tantamount to how the machine learning model itself would function in operation and therefore not subsumed in the identified mathematical calculation. In contrast, Examiner finds there are no similar improvements here. Examiner finds Applicant’s arguments are directed to improvements to an existing business process (e.g. managing project planning and timelines) and the claims do not recite any additional elements (e.g., system or AI tools) for consideration. Examiner maintains the present claims are directed to an abstract idea, reciting mental processes and certain methods of organizing human activity without providing meaningful limitations that integrates the abstract idea into a practical application. Applicant has not identified any disclosure in the claimed invention showing and/or submitting that the technology used is being improved or there was a technical problem in the technology that the claimed invention solves. For at least these reasons, claims 1-9 remain rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
Regarding the 35 U.S.C. 102 rejection, Applicant argues the Wolff reference in comparison between claims 1, 2, 5, 6 and 8 (see p. 3-5, Applicant Remarks).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features regarding claims 1, 2, 4-6 and 8 upon which applicant relies are not recited in the rejected claims nor are some of these features sufficiently supported by the original disclosure. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Examiner finds given the broadest reasonable interpretation, Wolff is sufficient in teaching the current claim language as presented.
Regarding the 35 U.S.C. 102 rejection of claim 3, Applicant argues Wolff does not teach what is taught by the claimed invention because the claimed invention provides "...guidance and recommendations based on regulatory requirements and market environment," and Wolff does not address regulatory requirements in the prior art. Wolff's prior art only contains one mention of the word 'regulatory' [0316], which refers to an example that is not pertinent to the claimed invention: "...such as local government regulatory requirements... [0316]" The claimed invention provides for "...guidance and recommendations based on regulatory requirements" that were not anticipated by Wolff.
In response, Examiner respectfully disagrees. Given the broadest reasonable interpretation, see MPEP § 2111.01, Examiner finds Wolff teaches regulatory requirements because the reference discloses the use of intellectual property protections in order to protect the market to have a successful product (see at least par. 0040). Examiner considers intellectual property protections to be a type of regulatory requirement and therefore is sufficient in teaching the aforementioned element.
Regarding the 35 U.S.C. 102 rejection of claim 4, Applicant argues Wolff does not teach what is taught by the claimed invention because the claimed invention creates "...user, business, and regulatory requirements and further create product design requirements," and Wolff does not address regulatory requirements in the prior art. Wolff's prior art only contains one mention of the word 'regulatory' [0316], which refers to an example that is not pertinent to the claimed invention: "...such as local government regulatory requirements... [0316]" The claimed invention creates system-generated external regulatory requirements, which are foundational to the claimed invention and not anticipated by Wolff.
In response, Examiner respectfully disagrees. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., creates system-generated external regulatory requirements) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). As stated above, Examiner considers intellectual property protections to be a type of regulatory requirement and therefore is sufficient in teaching the aforementioned element.
Regarding the 35 U.S.C. 102 rejection of claim 9, Applicant argues claim 9 is not anticipated by this prior art. Second, the prior art by Simonsen is significantly narrower than the claimed invention. Specifically:
Claim 9 of the claimed invention addresses "...creating regulatory filing timelines and deliverables." Simonsen's prior art addresses regulatory requirements, but does not address regulatory filing timelines. Additionally, mention of the creation of timelines is absent from Simonsen's prior art. For example, there is one reference to 'regulatory deadlines' [0068] which refers to a 'scheduling risk' [0067], not the creation of regulatory filing timelines. As noted by the Examiner, Simonsen writes that, "Time- sensitive commercial translation activities are often subject to critical time frames and deadlines [0068];" however, this is a general remark and does not anticipate the creation of regulatory filing timelines. The claimed invention would uniquely create regulatory filing, which was not anticipated by Simonsen's prior art.
Further, Simonsen's prior art is narrowly based on verifying translation for medical device labeling. The claimed invention would be applied to medical devices and IVD tests, of which labeling is just one part of bringing a product from concept to commercialization.
Therefore, the Applicants respectfully traverse the rejection and request reconsideration.
In response, Examiner respectfully disagrees. Given the broadest reasonable interpretation, Examiner finds a regulatory filing timeline can be interpreted as a schedule and/or a plan. Examiner find Simonsen teaches the aforementioned limitation because the reference discloses the formulation of a project risk assessment plan (see at least par. 0059-0062). Specifically, an initial phase and first steps involve gathering information to identify the scope and nature of the project, the customer's expectations, and applicable functional and production data, which are all integrated and analyzed to formulate a risk management plan for managing and mitigating translation-related risks associated with the project. The second or execution phase involves executing the risk assessment plan. At the onset, during the initial phase, manufacturers provide and exchange job- or task-specific information interactively (STEP 1) and the service provider also collects historical risk management input from various production and functional areas (STEP 2) that will be involved to bring the project to completion. Using and integrating the results of STEP 1 and STEP 2 as input, the service provider then performs a safety-related analysis of project requirements and specifications (STEP 3) and, further, formulates a project risk assessment (STEP 4). The purpose or role of the project risk assessment (STEP 4) is to establish processes and resources that are most appropriate for satisfying project requirements while mitigating serious error risk. Examiner considers creation of a project risk assessment to be a creation of a regulatory filing timeline because it includes establishing processes and resources that are most appropriate for satisfying project requirements and therefore is sufficient in teaching the aforementioned element. Examiner notes, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. Applicants should amend claim limitations to include detailed features supported by the specification to distinguish the pending invention from the prior art.
Additionally, in response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., The claimed invention would be applied to medical devices and IVD tests, of which labeling is just one part of bringing a product from concept to commercialization) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Examiner finds given the broadest reasonable interpretation, Simonsen is sufficient in teaching the current claim language as presented. For at least these reasons, claims 1-6, 8 and 9 remain rejected under 35 U.S.C. § 102 as being unpatentable over Wolff
Regarding the 35 U.S.C. 103 rejection of claim 7, Applicant request that the Examiner reconsider this rejection as the prior art by Joseph et al. does not render the claim obvious as the teaching is not applicable to the claimed invention. Specifically:
Joseph's prior art is for "...a system that provides visibility, tracking, and traceability to the product's design, procurement, manufacture, supply chain, and post-market activities. (Joseph, [0002]." Claim 7, on the other hand, addresses how this invention creates a product traceability matrix, which is a specific deliverable that includes requirements, design elements, test cases, and results, and issues and modifications. Traceability is a more general term as applied by Joseph and is different from a traceability matrix, cited in claim 7.
Joseph's prior art does not teach, as claim 7 does, creation of a product traceability matrix linked with a timeline to support design verification. Joseph's prior art does not reference timelines or dates.
Finally, although Joseph's prior art applies to medical devices, the purpose, scope, intended users, and deliverables generated by this art differ substantially from the claimed invention. For example, Joseph's prior art does not generate next steps according to requirements; does not link to requirements; and is instead used as a repository for record-keeping for monitoring and audits and by individual patients.
Therefore, the Applicants respectfully traverse the rejection and request reconsideration.
In response, Examiner respectfully disagrees. Given the broadest reasonable interpretation Examiner finds a traceability matrix is a document determining the completeness of a relationship by correlating data. Examiner find Joseph teaches the aforementioned limitation because the reference discloses distribute ledgers (see at least par. 0029-0043). Specifically, the system integrates documentation of the product's lifecycle through a distributed ledger system. The distributed ledger tracks each “event” in the product's lifecycle (e.g., a design change, a manufacturing deviation, an inventory move transfer, a sale, post-sale event, etc.), by generating blocks in the blockchain to capture these events, regardless of which system along the lifecycle creates an event. The tracking data could be accessed for a variety of purposes, such as to ensure compliance with regulatory authorities. Examiner considers the distribution ledgers to teach the travelability matrix because they track activities including a design change, a manufacturing deviation, an inventory move transfer (see par. 0026, 0029, 0038), which is sufficient in teaching a link between the matrix and timeline to support design verification activities. Examiner notes, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. Applicants should amend claim limitations to include detailed features supported by the specification to distinguish the pending invention from the prior art.
Furthermore, given the broadest reasonable interpretation Examiner notes the pending claims do not recite dates and finds Joseph teaches timelines because the reference discloses product lifecycles and design control processes (see at least par. 0033). Specifically, tracking documentation changes, change requests, or other associated change points which occur through the product's lifecycle, such as within the design control process, which is sufficient in teaching a timeline. Examiner notes, although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. Applicants should amend claim limitations to include detailed features supported by the specification to distinguish the pending invention from the prior art. For at least these reasons, claim 7 remains rejected under 35 U.S.C. § 103 as being unpatentable over Joseph.
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.
Step 1: The claimed subject matter falls within the four statutory categories of patentable subject matter.
Claims 1-9 are directed towards methods, which is among the statutory categories of invention.
Step 2A – Prong One: The claims recite an abstract idea.
Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite managing project planning and timelines.
Claim 1 recites limitations directed to an abstract idea based on mental processes and certain methods of organizing human activity. Specifically, developing and linking product requirements to project planning to generate timelines and project plans with start and end dates recited in claim 1, identifying and creating design deliverables from design inputs/requirements and linking with project timelines recited in claim 6, creating a product traceability matrix linked with timeline to support design verification activities for medical devices and in-vitro diagnostics recited in claim 7, and identifying and creating regulatory filing timelines and deliverables recited in claim 9 all constitute methods based on observations, evaluations, judgements and/or opinion that can be performed mentally by a combination of the human mind and a human using pen and paper, as well as, methods based on business relations. The claims do not recite any additional elements that can take the claim out of the mental processes and certain methods of organizing human activity groupings. Thus claims 1, 6, 7 and 9 recites an abstract idea.
Step 2A – Prong Two: The judicial exception is not integrated into a practical application.
The judicial exception is not integrated into a practical application because the claims do not recite any additional elements for consideration under Step 2A – Prong Two. Claims 1, 6, 7 and 9 are directed to an abstract idea.
Step 2B: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any additional elements for consideration under Step 2B. Therefore, there are no limitations in the claim that transform the abstract idea into a patent eligible application such that the claim amounts to significantly more than the abstract idea itself. Claims 1, 6, 7 and 9 are rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
§ 101 Analysis of the dependent claims.
Regarding the dependent claims, dependent claims 2-5 and 8 recite steps that further narrow the abstract idea. No additional elements are disclosed in the dependent claims. Therefore claims 2-5 and 8 do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wolff, U.S. Publication No. 2004/0143477 [hereinafter Wolff].
Referring to Claim 1, Wolff teaches:
A method of developing and linking product requirements to project planning to generate timelines and project plans with start and end dates (Wolff, [0042]-[0046]), “Sub-activities for the Priorities Module… assist team members in setting priorities and assuring that trade-offs are made in the design process, the module again includes identification and refinement (or the opportunity for refinement) of product requirements, including product features, configuration/packaging options and related goods or services… other sub-activities include the priorities and relative importance of the time to get the product to market, the cost and price points for the products, the tolerable risks associated with the product… a Master Schedule can be developed. A Master Schedule can include not only a project time line with mile stones, but can also track assumptions made for the product development, target release features and services and include contingency options for situations that do not occur as planned”, Examiner considers timeline to teach start and end dates; (Wolff, [0192]; [0194]; [0198]).
Referring to Claim 2, Wolff teaches the method of claim 1. Wolff further teaches:
to create design deliverables from linked product requirements (Wolff, [0041]-[0043]), “the priorities of the project are identified. The Priorities Module includes an assessment of the importance of various aspects of the project, such as the various features of the product…the module again includes identification and refinement (or the opportunity for refinement) of product requirements, including product features, configuration/packaging options and related goods or services…A product "feature" refers to product or services capabilities offered to a customer. A tangible product may have, for example, many features such as size, color, remote controls, etc. A product "feature" may include other service related aspects, such as the warranty period, training courses, 24 hour hot-line, etc. Each is considered a product "feature" because each relates to the overall success of the product”; (Wolff, [0143]), “the deliverable of this activity might be a product definition statement which is automatically generated based on the content input as a result of processing the Product Definition Activity. This result may then be fed forward to the Concept Module template, to fulfill a deliverable for it”; (Wolff, [0302]), “allowing automatic population of affected templates each time that new feedback information is identified as relevant to this particular product development project. The algorithms that identify this feedback as relevant to a particular resource, activity, sub-activity, deliverable, project, etc.”
Referring to Claim 3, Wolff teaches the method of claim 1. Wolff further teaches:
to create product requirements by providing guidance and recommendations based on regulatory requirements and market environment (Wolff, [0037]), “The Concept Module may further include market analysis. This includes identifying, gathering and organizing available data about the market for the product. Separately, or as a part of the market analysis, strategic and tactical fit information may be included. For example, certain products are necessary to offer in order to complete a product line--whether or not a substantial number of sales for that particular product are expected. Accordingly, strategic/tactical information concerning the concept of the product may be formalized as well”; (Wolff, [0040]), “… Feasibility Module, some of the sub-activities may include: formulation of a business plan to identify revenue, profit and cash flow issues for the product, if applicable; construction of a crude prototype or other demonstration that a critical component of the product can feasibly be performed (that prototype may be refined or reconstructed in future steps as well); preliminary identification of factors to determine the success of the product (e.g., using market analysis and strategic and tactical placement information determined in module 10); and definition of intellectual property that may either block production of the product (or certain features of the product) and preliminary identification of intellectual property that may be available to protect the product. When identifying available intellectual property protection in a preliminary phase, the market analysis and business plan may be used to assess the need for intellectual property protection in order to protect the market to have a successful product; where entry barriers are very low, intellectual property protection may be very important for a successful product”;
Referring to Claim 4, Wolff teaches the method of claim 1. Wolff further teaches:
to create user, business, and regulatory requirements and further create product design requirements (Wolff, [0108]), “an initial cut is made at determining the project team, resources and labor costs. Where available, this may include retrieving a table of available resources (e.g., employees) and the applicable resource costs for budgeting purposes…the people necessary to approve or signoff on different modules and activities of the project may be put in the templates as well”; (Wolff, [0111]), “resource threshold”; (Wolff, [0316]), “adaptation of those mechanisms to particular requirements of individual organizations, such as local government regulatory requirements or product life cycle process requirements for a particular organization”; (Wolff, [0217]-[0220]), “…it is determined whether the various product design possibilities can meet the design goals for the project… contingency and other priority alert thresholds may be determined. For example, it may be determined that if the cost calculation in the future exceeds a certain percentage of the target, an alert may be sent to all team members or to a selected group of advisors (or some combination thereof). This may, for example, trigger a new set of trade offs among product features…the process is ended and final targets and alert thresholds are stored”; (Wolff, [0040]; [0124]; [0127]; [0154]-[0156]; [0215])
Referring to Claim 5, Wolff teaches the method of claim 1. Wolff further teaches:
to further categorize product requirements to identify specific deliverables or design output (Wolff, [0033]), “certain classes of products… the use of common modules allows product meta-knowledge (i.e., knowledge about the particular products' design, development, or management) to be employed, helping to guide the focus of the various product management processes. For these embodiments, one can increase the chance that every important aspect of product management is considered and, when it is considered, that the appropriate inputs are available. While the modules described below are inventive, however, all aspects of the inventions described in this specification are not limited to use of these particular modules”; (Wolff, [0039]; [0124]; [0209]-[0212]).
Referring to Claim 6, Wolff teaches:
A method of identifying and creating design deliverables from design inputs/requirements and linking with project timelines (Wolff, [0041]-[0046]), “the priorities of the project are identified. The Priorities Module includes an assessment of the importance of various aspects of the project, such as the various features of the product… Sub-activities for the Priorities Module… assist team members in setting priorities and assuring that trade-offs are made in the design process, the module again includes identification and refinement (or the opportunity for refinement) of product requirements, including product features, configuration/packaging options and related goods or services… A product "feature" refers to product or services capabilities offered to a customer. A tangible product may have, for example, many features such as size, color, remote controls, etc. A product "feature" may include other service related aspects, such as the warranty period, training courses, 24 hour hot-line, etc. Each is considered a product "feature" because each relates to the overall success of the product… other sub-activities include the priorities and relative importance of the time to get the product to market, the cost and price points for the products, the tolerable risks associated with the product… a Master Schedule can be developed. A Master Schedule can include not only a project time line with mile stones, but can also track assumptions made for the product development, target release features and services and include contingency options for situations that do not occur as planned”, Examiner considers timeline to teach start and end dates; (Wolff, [0192]; [0194]; [0198]).
Referring to Claim 8, Wolff teaches the method of claim 1. Wolff further teaches:
where any change in product and project are propagated backward and forward and assess change impact on activities and timelines (Wolff, [0079]-[0084]), “… iterative feedback in completion of tasks (such as modules or activities) during the product development cycle… information from linked predecessor activities is received… this information is fed into an activity template… The activity is completed as will be done for the ordinary design process… As a result of the performing of the design activity in the first pass 31, information may be fed back to the predecessor activities 30. That is, the information learned in subsequent activities can be used to revise the result of earlier ones. For example, it may be learned in a later activity that a certain product feature is undesirable. This information may be fed back to the module where the priorities were set. The prioritization step may then be performed anew…other decisions made in a predecessor activity may be impacted by assumptions about what would happen in later activities. For example, one feature of a product may be regarded as particularly important because of the way it relates to others. If in subsequent activities it is determined that one of that feature set is not feasible, it may be desirable to eliminate not just that feature but others as well. In light of the elimination of that feature, it may also be desirable to substitute in a new feature or features. By passing the results of later activities back for consideration by earlier activities, a more informed process is allowed. This can save a substantial amount of time later (avoiding the need for a complete redesign, or at least identifying the need for a complete redesign earlier) and may also result in the development of a superior product…After the information is fed from first pass 31 to linked predecessor activities 30, the updated information from the predecessor activities may be fed forward so that a second pass 33 may be performed for the activity”; (Wolff, [0334]-[0338]), “it is determined (in the methodology layer 1002) whether the updated data alters the Master Schedule and Budget beyond certain alert thresholds. In order to make this assessment, an external interface may be accessed at 132 to check the appropriate information… the impact of any alterations is determined. Where appropriate, alert conditions (e.g., color-coded alarms or alerts that have been assigned different priority levels) may be issued for the individual as identified in the templates… Where there is no impact or the team member is satisfied that they wish to submit this pass for assessment, processing continues as step 135. At step 135, the team member submits the first pass data for a completeness and criteria assessment…This is submitted again to the methodology layer 1002, which calculates whether the activity data meets the defined success criteria… A success and exceptions report may be issued as a result of evaluation of completion of this activity”; (Wolff, [0240]; [0039])
Claim 9 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Simonsen et al., U.S. Publication No. 2008/0183459 [hereinafter Simonsen].
Referring to Claim 9, Simonsen teaches:
A method of identifying and creating regulatory filing timelines and deliverables (Simonsen, [0090]), “The calculation of initial project risk (STEP 4), also takes into account the device document type and the intended use for the document (STEP 6). Device document types can include labeling such as information for use (IFU), product inserts, training letters or memoranda, product recall letters, software user interfaces, Web sites, regulatory submissions”; (Simonsen, [0068]), “Time-sensitive commercial translation activities are often subject to critical time frames and deadlines. Production schedules, regulatory deadlines, filing dates, product launch dates, and other time-to-market considerations can restrict the amount or availability of time allocated to the translation of product documentation in such a way that translation process requirements cannot be effectively fulfilled. Hence, there exists an independent, temporal scheduling risk, which is a part of the project management risk”; (Simonsen, [0122]), “Once the final linguistic inspection has been completed (STEP 30), a Final Project Audit (FPA) is performed (STEP 31)… The scope of the FPA (STEP 31) can include verifying that all production and QA/QC steps have been executed in accordance with project specifications… performing a high-level review of all project deliverables, for example, to verify the correct target language, to observe any obvious non-conformances, and the like; and spot checking critical areas and special risk items such as non-conformance with respect to client-, project-, and/or task-specific instructions and specifications and remarkably-high-risk linguistic and formatting elements”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Joseph et al., U.S. Publication No. 2021/0343401 [hereinafter Joseph].
Referring to Claim 7, Joseph teaches:
A method of creating a product traceability matrix linked with timeline to support design verification activities for medical devices and in-vitro diagnostics (Joseph, [0025]-[0026]), “a blockchain-based system 100 that provides visibility, tracking, and traceability to a product's design, procurement, manufacture, supply chain, and post-market activities on an individualized product level. Although the system 100 will be discussed primarily with respect to medical and pharmaceutical devices… The system 100 facilitates identification, traceability, and integrity of product lifecycles for individual products. In the example shown, the system 100 includes a plurality of lifecycle phases 102 each of which generate events related to an individual product as that product goes through the phases 102. For example, there could be a plurality of computing systems that generate events relating to design…”; (Joseph, [0029]), “…The term “product lifecycle” is broadly intended to encompass each phase of the product from design and development, procurement, manufacture, supply chain, sale, usage, and post-market activities. Instead of manually attempting to cobble together data from disparate systems to comply with regulatory requirements, which is time consuming and potentially error-prone, the system 100 integrates documentation of the product's lifecycle in a secure”; (Joseph, [0033]), “integration engine 210 provides the ability to capture tracking documentation to the distributed ledger 226 and creates a consolidated approach to tracking documentation changes, change requests, or other associated change points which occur through the product's lifecycle, such as within the design control process, and allows a product history to be created in a cloud environment by the server 128”; (Joseph, [0035]; [0038]; [0043]).
Joseph teaches a system with respect to medical and pharmaceutical devices that provides visibility, tracking, and traceability to a product's design, procurement, manufacture, supply chain, and post-market activities on an individualized product level (see par. 0025). At the time the invention was filed, it would have been predictable to one of ordinary skill in the art to interpret in-vitro diagnostics as a medical device disclosed in Joseph with a reasonable expectation of success.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Clark et al. (US 20160350823 A1) – A system is provided for generating compliance manuals from modularized data and taxonomy-based classifications of regulatory obligations. The system comprises a plurality of databases storing regulatory compliance data and a plurality of processors that process the regulatory compliance data to generate business requirements for complying with regulatory obligations and corresponding compliance information related to the business requirements. A taxonomy engine receives business operating parameters related to a first business and identifies a subset of the business requirements and compliance information related to the business operating parameters of the first business. The taxonomy engine further aggregates the business requirements and the compliance information related to the business operation parameters and generates a compliance manual containing the business requirements and the compliance information for use by the first business.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, 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.
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/CRYSTOL STEWART/Primary Examiner, Art Unit 3624