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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/08/2026 has been entered.
Status of Claims
In the amendment filed 09/08/2026 the following occurred: Claims 1, 3, 7, 9, 11, 13, and 16 were amended; Claim 4-6 and 14-15 were cancelled; and Claims 21-24 were added as new. Claims 1-3, 7-13, 16-19, and 21-24 are presented for examination.
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 1-3, 7-13, 16-19, and 21-24 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.
Step 1
Claims 1-3, 7-13, 16-19, and 21-24 are drawn to methods, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One
Independent claim 1 recites receiving a source file including first medical product data, wherein the first medical product data includes a plurality of data fields; querying a first database of the provider to select a first rule, wherein the first rule includes at least one first rule criterion; determining the first medical product data of the source file does not fulfill the at least one first rule criterion; querying, in response to the first medical product data of the source file not fulfilling the at least one first rule criterion, the first database of the provider to select the second rule, wherein the second rule includes a target medical product and at least one second rule criterion, wherein the at least one second rule criterion includes: (i) a target data field of the plurality of data fields and (ii) a matches-registration function associated with the target data field; querying, in response to the at least one second rule criterion identifying the matches-registration function, a second database to select a medical product registration record associated with the target medical product, wherein the medical product registration record identifies a specific health agency and includes a registration value, and wherein the specific health agency is the Food and Drug Administration (FDA); determining the first medical product data of the source file fulfills the at least one second rule criterion by comparing the target data field of the first medical product data to the registration value of the medical product registration record; generating, in response to the target data field matching the registration value, a case dataset by populating a data element of the case dataset corresponding to the target data field with the registration value of the medical product registration record; and outputting and in response to the medical product registration record identifying the FDA, the case dataset.
Independent claim 11 recites receiving a source file including first medical product data, wherein the first medical product data includes a medical product alias and a pluriaty of data fields; querying a first database of the provider to select a ruleset in response to the ruleset including the medical product alias, wherein the ruleset includes at least the first rule and a second rule, wherein the first rule includes at least one rule criterion and a target medical product, and wherein the at least one rule criterion identifies (i) a target data field of the plurality of data fields and (ii) a matches-registration function associated with the target data field; querying, and in response to the at least one rule criterion identifying the matches-registration function, a second database to select a medical product registration record associated with the target medical product, wherein the medical product registration record includes a registration value, wherein the medical product registration record identifies a specific health agency, and wherein the specific health agency is the Food and Drug Administration (FDA); determining the first medical product data of the source file fulfills the at least one rule criterion by comparing the target data field of the first medical product data to the registration value; generating, and in response to the target data field matching the registration value, a case dataset by populating a data element of the case dataset corresponding to the target data field with the registration value of the medical product registration record; and outputting and in response to the medical product registration record identifying the FDA, the case dataset.
The respective dependent claims 2-3, 7-10, 12-13, 16-19, and 21-24, but for the inclusion of the additional elements specifically addressed below, provide recitations further limiting the invention of the independent claim(s).
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity, as reflected in the specification, which states that the invention is “for querying an executable condition (also referred to as a rule) stored in a database” (see: specification paragraph 1). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The present claims cover certain methods of organizing human activity because “[r]esearchers, scientists, industry players, academics, government regulators, and other stakeholders are increasingly in need of efficient and simple ways to retrieve and execute conditions stored in databases” (see: specification paragraph 2), where such need is addressed by the invention to “help and improve the pharmacovigilance industry by more accurately and more quickly tracking, capturing, and reporting adverse events…the present systems can speed up adverse event intake and processing and bypass any manual steps (e.g., medical product coding) in the case dataset generation process, thereby shortening the time it takes for adverse events to be processed, case datasets to be generated and reported to the relevant health authorities…the present systems and methods can automatically verify medical products thereby not requiring manual correction and checks…by not communicating with the user computing device for medical product verification, corrections of the adverse event data, and the like, which also allows for quicker and more efficient case dataset generation and reporting” (see: specification paragraph 10). Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).
Step 2A Prong Two
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including an “by a provider computing system…by the provider computing system…provider computing system…by the provider computing system…by the provider computing system and…provider computing system…by the provider computing system…by the provider computing system…of the provider computing system…by the provider computing system and…by the provider computing system…by the network interface…to the Electronics Submission Gateway (ESG) associated with the FDA via an Applicability Statement 2 (AS2) communication protocol as an E2B (R2) XML file or an E2B(R3) XML file” (claim 1), “by the provider computing system…” (claim 3), “by the provider computing system…” (claim 4), “by the provider computing system and…provider computing system…by the provider computing system…” (claim 5), “by the provider computing system…” (claim 6), “by the provider computing system…” (claim 7), “provider computing system…provider computing system…” (claim 8), “an E2B XML file…an E2B XML file…” (claim 9), “by a provider computing system…by the provider computing system…provider computing system…by the provider computing system…by the provider computing system and…of the provider computing system…provider computing system…by the provider computing system…by the network interface…to the Electronics Submission Gateway (ESG) associated with the FDA via an Applicability Statement 2 (AS2) communication protocol as an E2B (R2) XML file or an E2B(R3) XML file” (claim 11), “by the provider computing system…” (claim 13), “by the provider computing system and…provider computing system…by the provider computing system…” (claim 14), “by the provider computing system…by the provider computing system…” (claim 15), “by the provider computing system…” (claim 16), “an E2B XML file…an E2B XML file…” (claim 17) “provider computing system…” (claim 18), and “by the provider computing system…by the provider computing system…” (claim 19), which are additional elements that are recited at a high level of generality (e.g., the “provider computing system” is configured to perform claimed steps through no more than a statement that said steps are performed “by” said provider computing system; the “network interface” and “Applicability Statement 2 (AS2) communication protocol” are configured though no more than a statement than that outputting is performed “by” said network interface “via” said protocol; the “Electronics Submission Gateway (ESG) associated with the FDA” is configured though no more than a statement than that it is entity to which the file is output “to”; the “E2B (R2) XML file or an E2B(R3) XML file” is/are configured though no more than a statement than that said file(s) is/are that which the data is output “as”; the “E2B XML file” is configured though no more than a statement than that they are they type the source file “is” or a file is “output as”) such that they amount to no more than mere instruction to apply the exception using generic computer elements. See: MPEP 2106.05(f).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer elements. Accordingly, even in combination, these additional elements do not integrate the abstract idea(s) into a practical application because they do not impose any meaningful limits on practicing the abstract idea(s). Accordingly, the claims are directed to an abstract idea(s) (Step 2A Prong Two: NO).
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(s) into a practical application, using the additional elements to perform the abstract idea(s) amounts to no more than mere instructions to apply the exception using generic elements. Mere instructions to apply an exception using generic elements cannot provide an inventive concept. See MPEP 2106.05(f).
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea(s) with routine, conventional activity specified at a high level of generality in a particular technological environment. Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea(s) (Step 2B: NO).
Dependent claim(s) 2-3, 7-10, 12-13, 16-19, and 21-24, when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea(s) without significantly more. These claims fail to remedy the deficiencies of their parent claims above and are therefore rejected for at least the same rationale as applied to their parent claims above and incorporated herein.
Response to Arguments
Applicant’s arguments from the response filed on 09/08/2026 have been fully considered and will be addressed below in the order in which they appeared.
In the remarks, Applicant argues in substance that (1) the 35 U.S.C. 101 rejections should be withdrawn in view of the amendments because “Independent claims 1 and 11 are not directed to an abstract idea...that independent claims 1 and 11 do not cite features that manage personal behavior…As compared to any of the sub-groupings, the present independent claims include claim limitations that provide for a rule-driven product-coding subsystem of an automated pharmacovigilance case-processing pipeline. For instance, amended claim 1 recites features that replace static, hard-coded rule criteria with a criterion that identifies a target data field and a matches-registration function, so that the comparison value is dereferenced from an agency-specific registration record in a second database at execution time and the resolved registration value is then written into the corresponding data element of the outbound E2B submission. By doing so, the claims recite a data-resolution mechanism that neither the ruleset nor the case generation pipeline could perform when each rule had to carry its own literal comparison values. Moreover, no person appears anywhere in the steps of claims 1 and 11. The actors are a provider computing system, a first database storing rules, a second database storing registration records, and a receiving gateway. Nobody's behavior is managed, no relationship is administered, and no interaction between people is organized. The claims are structurally closer to the guidance's own examples of claims that do not recite abstract ideas, including example 27 for BIOS system software and Example 37 for a method of rearranging icons on a graphical user interface. Each of those patent eligible claims recites machine operations performed on machine-held data to produce a machine-side result, which is precisely what the present claims recite.”
The Examiner respectfully disagrees. Applicant’s arguments are not persuasive.
A person does not have to be present in the claims for the claims to be directed toward certain methods of organizing human activity (CMOHA). The Office has previously categorized such disparate cases such as generating menus on a computer (Ameranth), classifying and storing digital images in an organized manner (TLI Comms.), collecting information, analyzing it, and displaying certain results of the collection and analysis (Electric Power Group), creating an index, and using that index to search for and retrieve data (Int. Ventures v. Erie Indemnity I: ‘434 patent), and virus screening (Int. Ventures v. Symantec I: ‘610 patent) as CMOHA. The rejection recognizes that there are additional elements that perform the claims, not people, but that a person is claimed as performing the claims is not a requirement for the abstract recitations of a claim to be categorized a CMOHA. The specification states that the present claims are to an invention that is “for querying an executable condition (also referred to as a rule) stored in a database” (see: specification paragraph 1), which is a concept relating to the tracking or organizing of information, which is a recognized CMOHA.
As per argued Example 37, claim 1 of this example illustrates the previous explanation where the claim recites a mental process despite a processor’s performance of that mental process instead of a person. The specification supports the classification under CMOHA in paragraph 10, which states that “the present systems can speed up adverse event intake and processing and bypass any manual steps (e.g., medical product coding) in the case dataset generation process, thereby shortening the time it takes for adverse events to be processed, case datasets to be generated and reported to the relevant health authorities.” Here it is clear that the problem is one of a case data generation process, which is not a technical problem, but an abstract problem that can involve manual medical product coding steps, and further, the outcomes of shortening adverse event processing and case dataset generation are the result of automation, and automatically verifying medical products thereby not requiring manual correction and checks indicates that the verification of medical products can be manually performed and that the present invention has automated such a process, where mere automation of manual processes cannot show improvement in computer-functionality per MPEP 2106.05(a)(I)(iii).
Argued example 27 concerns loading BIOS into a local computer where “(a) responding to powering up of the local computer system by requesting from a memory location remote from the local computer system the transfer to and storage in the volatile memory of the local computer system of BIOS configured for effective use of the local computer system, (b) transferring and storing such BIOS, and (c) transferring control of the local computer system to such BIOS.” There is nothing similarly technical claimed here. In the present claims, the “provider computing system” is configured to perform rule-based abstract steps through no more than a statement that said steps are performed “by” said provider computing system. Example 37, claim 2, concerned rearranging icons on a GUI by “determining the amount of use of each icon using a processor that tracks how much memory has been allocated to each application associated with each icon over a predetermined period of time; and automatically moving the most used icons to a position on the GUI closest to the start icon of the computer system based on the determined amount of use.” This example is particular to the functioning of the computer, whereas the present claims cover certain methods of organizing human activity because “[r]esearchers, scientists, industry players, academics, government regulators, and other stakeholders are increasingly in need of efficient and simple ways to retrieve and execute conditions stored in databases” (see: specification paragraph 2), where such need is addressed by the invention to “help and improve the pharmacovigilance industry by more accurately and more quickly tracking, capturing, and reporting adverse events…the present systems can speed up adverse event intake and processing and bypass any manual steps (e.g., medical product coding) in the case dataset generation process, thereby shortening the time it takes for adverse events to be processed, case datasets to be generated and reported to the relevant health authorities…the present systems and methods can automatically verify medical products thereby not requiring manual correction and checks…by not communicating with the user computing device for medical product verification, corrections of the adverse event data, and the like, which also allows for quicker and more efficient case dataset generation and reporting” (see: specification paragraph 10).
In the remarks, Applicant argues in substance that (2) the 35 U.S.C. 101 rejections should be withdrawn in view of the amendments because “in McRo…the Federal Circuit held that the claims at issue, for a process of automatically animating characters in video games, were directed to patent-eligible subject matter because they involved a specific, inventive solution to a technological problem… Similar to McRo, the present claims provide a combined order of specific rules that define the specific computerized method and provide an improvement to the relevant technology. For instance, the present claims provide technical improvements to rule-driven product coding systems via the use of rule criterion, a medical product registration record, and specific registration functions. In doing so: For instance, well-designed rule sets can handle a wide range of medical products and their associated aliases, regardless of complexity. This can be especially beneficial for organizations dealing with a large and ever-growing inventory of medical supplies and devices. In comparison, by relying on a flexible rule-based system, the present systems and methods can be updated dynamically to reflect changes in coding standards or regulatory requirements, thereby ensuring the coding process remains compliant and reflects the latest best practices. (Present Application, para. [0011]). These improvements are represented by the independent claims. For instance, by reciting "querying ... a second database of the provider computing system to select a medical product registration record associated with the target medical product, wherein the medical product registration record identifies a specific health agency and includes a registration value, and wherein the specific health agency is the Food and Drug Administration (FDA)" "determining, by the provider computing system, the first medical product data of the source file fulfills the at least one second rule criterion by comparing the target data field of the first medical product data to the registration value of the medical product registration record," and "generating, by the provider computing system and in response to the target data field matching the registration value, a case dataset by populating a data element of the case dataset corresponding to the target data field with the registration value of the medical product registration record" the present systems and methods provide a system that dynamically and automatically "reflect s] changes in coding standards or regulatory requirements, thereby ensuring the coding process remains compliant and reflects the latest best practices (Present Application, para. [0011]).”
The Examiner respectfully disagrees. Applicant’s arguments are not persuasive.
In McRO, the process of automatically animating characters in video games is a technical problem directed to an improvement in computer-related technology allowing computers to produce “accurate and realistic lip synchronization and facial expressions in animated characters”, whereas the present solution to “dynamically and automatically reflect changes in coding standards or regulatory requirements, thereby ensuring the coding process remains compliant and reflects the latest best practices” is an abstract problem concerning concepts relating to tracking or organizing information. There is no practical application of the claimed rules akin to accurate and realistic lip synchronization and facial expressions in animated characters in McRO.
McRO illustrates that an identification of an abstract idea within the claims does not automatically render the claims as a whole abstract, but instead merely indicates that an abstract idea is present in the claims and that additional analysis must take place. It is further because the claims do not amount to significantly more than the abstract idea that render the claims nonstatutory. In this case, inclusion of the additional elements does not meaningfully transform the abstract idea into a patent eligible application that is significantly more than the abstract idea itself.
In the remarks, Applicant argues in substance that (3) the 35 U.S.C. 101 rejections should be withdrawn in view of the amendments because “The Examiner erred because the claims are rooted in complex computer technology and solve problems that specifically arise in product coding systems, not generic computer components. Applicant respectfully submits that "[m]uch of the advancement made in computer technology consists of improvements to software that, by their very nature, may not be defined by particular physical features but rather by logical structures and processes. Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1339 (Fed. Cir. 2016). As result, the Federal Circuit held that the eligibility determination should tum on whether "the claims are directed to an improvement to computer functionality versus being directed to an abstract idea." Id. at 1336. The claims do not merely recite "mere instructions to apply," but rather a specific mechanism that replaces static, hard-coded rule criteria with a criterion that identifies a target data field of the plurality of data fields and a matches-registration function associated with the target data field, so that the comparison value is retrieved at execution time from an agency-specific medical product registration record in a second database and the resolved registration value is then written into the corresponding data element of the outbound E2B submission. This improves the computer's ability to resolve an ambiguous product identifier in an inbound source file against the correct one of multiple near-identical, agency-partitioned registration records held in the second database, and to populate the outgoing submission from that resolved record, which is an operation the rule-execution engine cannot perform when each rule must carry its own literal comparison value.”
The Examiner respectfully disagrees. Applicant’s arguments are not persuasive.
The outputting argued includes additional elements not considered abstract and instead considered recited at a high level of generality such that they amount to no more than a mere instruction to apply the exception using generic computer elements. For example, the “network interface” and “Applicability Statement 2 (AS2) communication protocol” are configured though no more than a statement than that outputting is performed “by” said network interface “via” said protocol. The “Electronics Submission Gateway (ESG) associated with the FDA” is configured though no more than a statement than that it is entity to which the file is output “to”. And the “E2B (R2) XML file or an E2B(R3) XML file” is/are configured though no more than a statement than that said file(s) is/are that which the data is output “as”. The claims here are not directed to a specific improvement to computer functionality that amount to a practical application. Rather, they are directed to the use of conventional or generic technology in a well-known environment, without any claim that the invention reflects an inventive solution to a technical problem presented by combining the two. In the present case, the claims fail to recite any elements that individually or as an ordered combination transform the identified abstract idea(s) in the rejection into a patent-eligible application of that idea.
It is argued that the “claims are rooted in complex computer technology and solve problems that specifically arise in product coding system, not generic computer components”, but the argued additional elements themselves are not what the invention is directed toward and are merely claimed at a high level. For example, regarding the “recite[d] specific digital communication protocol (e.g., the “(AS2) Communication protocol,”)”, specification paragraph 22 states: “The AS2 gateway logic 127 includes programmable instructions that facilitate communication (transmission and receipt) using the Applicability Statement 2 (AS2) communication protocol (as specified in Request for Comment (RFC) 4130) over the network 118 via the network interface circuit 126. For example, using the AS2 gateway logic 127, the network interface 126 may transmit or receive files (e.g., the source file, a case, etc.) or other data to the partner computing systems 108 or client computing devices 112 using the AS2 Gateway protocol. In other embodiments, the AS2 gateway logic 127 may transmit or receives files using the most updated Applicability Statement communication protocol (e.g., AS3, etc.).” These types of protocols are shown to be merely examples (“[f]or example”, “e.g.”, “may”) that themselves are selectable and interchangeable (“AS2”/“e.g., AS3, etc.”) without affecting the core concept of the invention, and the particulars of the protocol in question need not be described to satisfy the 35 U.S.C. 112(a) requirements. The claims and specification do not describe how the protocol itself operates to facilitate communication for transmission and receipt – it is essentially a black box. Hence, the protocol is either to be understood to be a broad element employed by the invention, or it should be understood to lack written description support under 35 U.S.C. 112(a). The present case represents the former, and the presently claimed additional elements are recited at a high level of generality such that they amount to no more than a mere instruction to apply the exception using generic computer elements.
Conclusion
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/ROBERT A SOREY/Primary Examiner, Art Unit 3682
