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 .
Status of Claims
In the amendment filed 1/12/2026 the following occurred: Claims 1, 5-6, 11, and 14-15 were amended; and Claim 20 was cancelled. Claims 1-19 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 1-19 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 1-19 are drawn to methods, which is/are statutory categories of invention (Step 1: YES).
Independent claim 1 recites receiving a source file including first medical product data; 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 at least one second rule criterion and a target medical product; determining the first medical product data of the source file fulfills the at least one second rule criterion; querying, in response to the first medical product data of the source file fulfilling the at least one second rule criterion, a second database of the provider to medical product registration data associated with the target medical product, wherein the medical product registration data identifies a specific health agency, and wherein the specific health agency is the Food and Drug Administration (FDA); generating a case dataset including at least a portion of the second medical product data; and outputting and in response to the medical product data 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; 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, and wherein the first rule includes at least one rule criterion and a target medical product; determining the first medical product data of the source file fulfills the at least one rule criterion; querying in response to the first medical product data of the source file fulfilling the at least one rule criterion, a second database of the provider to select medical product registration data associated with the target medical product, wherein the medical product registration data identifies a specific health agency, and wherein the specific health agency is the Food and Drug Administration (FDA); generating a case dataset including at least a portion of the second medical product data; and outputting and in response to the medical product data identifying the FDA, the case dataset.
The respective dependent claims 2-10 and 12-19, 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).
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 and…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 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…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).
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) 2-10 and 12-19, 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 1/12/2026 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 “the independent claims recite pertinent technical details that define the computerized processes being performed and not a certain method of organizing human activity. As compared to managing personal behavior, claim 1 describes specific technical details that “automatically verify medical products thereby not requiring manual correction and checks.” (Present Application, para. [0010])…Similar to McRo, the present claims provide a combined order of specific rules and technological features that define the specific computerized method and provide an improvement to the relevant technology. For instance, the present claims provide technical improvements to medical coding systems by automatically coding medical products of case datasets, and then reporting the case datasets to relevant health authorities: The systems and methods described herein provide for automatic adverse event processing, medical product coding, and case dataset generation, and thereby help and improve the pharmacovigilance industry by more accurately and more quickly tracking, capturing, and reporting adverse events. For example, by collaborating with a trusted computer system or device for the intake of source files, 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. For instance, because the present systems and methods receive medical product verification rules including rule criteria and a target medical product, the present systems and methods can automatically verify medical products thereby not requiring manual correction and checks. Further, because the systems and methods described herein remove time-consuming and laborious manual checks of the medical products and generated case data, the present systems use less computing power and memory than typical case generation systems 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. (Present Application, para. [0010]). Moreover, the claims define a specific digital transformation whereby raw medical data is dynamically mapped through a multi-step database querying process, utilizing a “target medical product” to bridge first and second databases, to generate a payload specifically formatted for the AS2 communication protocol. This is not the mere automation of human activity, as a human cannot manually “output” an AS2-compliant E2B XML file to a high-speed electronic gateway. These improvements are represented by the independent claims. For instance, by reciting “determining…the first medical product data of the source file fulfills the at least one second rule criterion,” “querying… in response to the first medical product data of the source file fulfilling the at least one second rule criterion, a second database of the provider computing system to select medical product registration data associated with the target medical product,” “generating…a case dataset including at least a portion of the second medical product data,” and “outputting… in response to the medical product data identifying the FDA, the case dataset 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,” the present systems and methods “remove time-consuming and laborious manual checks of the medical products and generated case data, the present systems use less computing power and memory than typical case generation systems 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.” (Present Application, para. [0010])”.
The Examiner respectfully disagrees. Applicant’s arguments are not persuasive.
The argument that the invention can “automatically verify medical products thereby not requiring manual correction and checks” (Present Application, para. [0010]), implies that verification of medical products can be manually performed but that the present invention has automated that manual process, and mere automation of manual processes cannot show improvement in computer-functionality per MPEP 2106.05(a)(I)(iii). Further, the arguments support the conclusion in the rejection that the claims are directed toward certain methods of organizing human activity because cited specification paragraph 10 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. As per McRO, the basis for the McRO court's decision was that the claims were directed to an improvement in computer-related technology (allowing computers to produce "accurate and realistic lip synchronization and facial expressions in animated characters" that previously could only be produced by human animators), and thus did not recite a concept similar to identified abstract idea. There is no such application of the outputting case dataset file(s) claimed here to compare with animated lip synchronization claimed in McRO.
The outputting argued is to the amendments including additional elements, and these are not considered abstract in the rejection above; however, the arguments amendments are additional elements 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 such output as amended represent “define a specific digital transformation whereby raw medical data is dynamically mapped through a multi-step database querying process, utilizing a “target medical product” to bridge first and second databases, to generate a payload specifically formatted for the AS2 communication protocol.” But outputting files in particular formats are not representative of a transformation of data as argued. MPEP 2106.05(c) provides for a claim limitation which can integrate a judicial exception by effecting a transformation or reduction of a particular article to a different state or thing. Note that transformation of an article means that the “article”, which is a physical object or substance, has changed to a different state or thing. A new or different function or use can be evidence that an article has been transformed. Purely abstract processes that are “changed” are not considered an eligible transformation. For data, mere manipulation of data such as into a particular format is not a transformation at the generic level currently claimed. The claimed limitations argued do not include additional elements to be considered significantly more, and instead manipulate data, which is not considered a transformation of data commiserate with MPEP 2106.05(c).
That the argued “present systems use less computing power and memory than typical case generation systems by not communicating with the user computing device for medical product verification” may be true, but is not evidence of computer improvement. If fewer actions are taken by a case generation system, the power consumption required for those actions is not altered by the invention. The actions themselves are directed toward the performance of the abstract ideas as outlined in the rejection above and do not alter the power consumptions of the claimed device(s) or otherwise reduce data processing. Even if data processing were reduced, “reducing the amount of calculations in known and established computations” is known to be an abstract idea under the Alice heading of mathematical relationships/formulas (see for example the USPTO IEG July 2015 Quick Ref Sheet, page 2).
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 “present claims are rooted in complex computer technology, data structures, and transmission protocols, not generic computer components. The claims do not merely recite “conventional activity,” and “routine elements” but rather recite specific digital communication protocol (e.g., the “(AS2) Communication protocol,”), a specific file type (e.g., E2B (R2) or (R3) XML file), and the technical process of “outputting… in response to the medical product data identifying the FDA, the case dataset 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.” Accordingly, Applicant respectfully submits amended claim 1 describes specific computerized steps, data types, computer systems, and limitations which are not recited at a high level of generality, but rather provide specific technical details that define the present claims and integrate any alleged abstract idea into a practical application. Moreover, in Subject Matter Eligibility Example #42, the Office indicated that claims directed to a method for transmission of notification when medical are updated were integrated into a practical application because: The claim recites a combination of additional elements including storing information, providing remote access over a network, converting updated information that was input by a user in a non-standardized form to a standardized format, automatically generating a message whenever updated information is stored, and transmitting the message to all of the users. The claim as a whole integrates the method of organizing human activity into a practical application. Specifically, the additional elements recite a specific improvement over prior art systems by allowing remote users to share information in real time in a standardized format regardless of the format in which the information was input by the user. Thus, the claim is eligible because it is not directed to the recited judicial exception (abstract idea). (Subject Matter Eligibility Example #42). Applicant respectfully submits the present claims are analogous to the claims of subject matter eligibility example #42 because both sets of claims recite a specific improvement over prior art systems and provide a high-level of detail about the specific systems and networks thereon. In Example #42, the claims recite a specific manner of storing information, providing remote access, and converting non-standardized data into a standardized format. Similarly, the present claims recite specific computing systems (e.g., the provider computing system, the Electronics Submission Gateway of the FDA, first database…), as well as a specific file types, communication protocols, and novel methods of automatically coding medical products of a case dataset based on rule criterion and then outputting the case dataset. By reciting these specific technical features, the present claims include multiple meaningful limitations that act as the technical bridge between the non-standardized source file and the standardized case datasets, which again integrates any alleged abstract idea into a practical application.”
The Examiner respectfully disagrees. Applicant’s arguments are not persuasive.
It is argued that the “present claims are rooted in complex computer technology, data structures, and transmission protocols, 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. It is further argued that such elements “rather provide specific technical details that define the present claims and integrate any alleged abstract idea into a practical application”, but it is unclear from the arguments what the technical details are but for the limitations themselves, which is tautologically circular in reasoning.
As per Example 42, said example was found eligible due to an ordered combination of elements including providing remote access over a network, converting updated information that was input by a user in a non-standardized form to a standardized format, automatically generating a message whenever updated information is stored, and transmitting the message to all of the users. In this way, remote users share information in real time in a standardized format regardless of the format in which the information was input by the user. Though the claims of Example 42 and the present claims may share some of the drafting similarities argued of “storing information, providing remote access, and converting non-standardized data into a standardized format”, there is no directly claimed distributed functionality within the network that achieves a technical effect comparable to Example 42’s disparate and differently formatted records systems automatically pushing updates to displays in real time according to their respective formats based on a local change to a record at one of the systems – the present claims instead receive, process, and output information. Further, the current claims were considered as a whole and no non-conventional and non-generic arrangement of the additional elements was found which could be considered an inventive concept. As shown in the rejection above, when applying the Supreme Court’s two-part framework as set forth in Alice Corp., the claims are drawn to an abstract idea without significantly more.
Conclusion
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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/ROBERT A SOREY/Primary Examiner, Art Unit 3682
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