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 .
Response to Amendment
The amendment filed February 17, 2026 has been entered. Claims 1-5 remain pending in the application. Claim 1 is noted as amended. The amendment to the claims fails to overcome the previous claim objections in the Final Office Action mailed May 21, 2025. The amendment to the claims fails to overcome the previous 112(a) rejection in the Non-Final Office Action mailed October 16, 2025, and new rejections are discussed below. The amendment to the claims overcomes the previous 112(b) rejection, but new rejections are discussed below.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, lines 2, “item generation item generation” should read “item generation”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The amended limitation of claim 1 of “wherein said automatic item generation operates direct code combination rather than by application of a natural language generator, machine learning, or artificial intelligence in its processes for generating said test items” is a negative limitation. Per MPEP 2173.05(i), any negative limitation or exclusionary proviso must have basis in the original disclosure and the mere absence of a positive recitation in the specification is not basis for an exclusion. The specification does not recite a NLG, ML, or AI, but the mere absence of such recitations is not sufficient to support the negative limitation. Further, “direct code combination”, while a positive recitation as Applicant discusses in the Remarks filed February 17, 2026, interpreted under its broadest reasonable interpretation would include implementations by NLG, ML, and/or AI but for the recitation of “rather than by application of” in the claim limitation. That is why this limitation is interpreted and recites a negative limitation which is not sufficiently supported by the specification. Therefore, claim 1 is rejected under 35 U.S.C. 112(a).
Further, the limitation “wherein said pre-existing taxonomy of codes used to describe a specific data element are developed and maintained by the World Health Organization”, while supported by the specification, is indefinite as further discussed above and due to the limitation being “maintained by the World Health Organization” means the taxonomy can be changed and further developed by the World Health Organization and therefore is not explicitly defined and can be changed in such a way that the applicant would not, at the time the application was filed, have possession of the claimed invention. Therefore, claim 1 is further rejected under 35 U.S.C. 112(a).
Claims 2-5 are rejected by virtue of their dependency from claim 1.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “wherein said pre-existing taxonomy of codes used to describe a specific data element are developed and maintained by the World Health Organization”. The limitation is indefinite as the taxonomy can be changed (maintained) by the World Health Organization similar to an industry standard, and thereby the metes and bounds of the claim can change as the taxonomy/standards of the World Health Organization change. As the taxonomy is not definite, the claim is rendered indefinite.
Claims 2-5 are rejected by virtue of their dependency from claim 1.
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 1-5 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 1 recites a system including a computing device configured to perform a process, the process including the steps of receive a request from said user to generate test items from at least one of said test model containing the pre-existing taxonomy of codes used to describe a specific data element selected by said user; generating test items from at least one of said test model containing content coding and eliminating all combinations that do not include the pre-existing taxonomy of codes used to describe a specific data element selected by said user; and display on said graphical user interface generated test items selected for display by said user; wherein said pre-existing taxonomy of codes used to describe a specific data element are developed and maintained by the World Health Organization. The recited steps, under their broadest reasonable interpretation, are receiving a request to generate test items, thereby generating the test items, and presenting the generated test items, wherein the items are generated in part based on a pre-existing taxonomy of codes selected from the group. The recited steps, as drafted, are a process that is a method of applying an abstract idea, specifically a mental process (receiving a request (observation) and generating the test items (judgement)) and certain methods of organizing human activity in the form of teaching (generating the test items, based in part on pre-existing taxonomy of codes, and displaying said test items). If claim limitations, under their broadest reasonable interpretation, include a mental process and/or certain methods of organizing human activity, the limitations fall under the abstract ideas judicial exception and therefore recite ineligible subject matter. Accordingly, claim 1 recites abstract ideas.
This judicial exception is not integrated into a practical application because the claims do not recite additional elements that are significantly more than the judicial exception or meaningfully limit the practice of the judicial exception. The additional elements are the hardware elements of one or more processors; a graphical user interface; and one or more computer-readable media having stored thereon instructions that are executable by the one or more processors to configure the computer system to perform the process; and the steps of display on said graphical user interface a model identifier correlating with those test models containing a pre-existing taxonomy of codes used to describe a specific data element selected by said user; display on said graphical user interface the number of items that may be generated by each test model containing a pre-existing taxonomy of codes used to describe a specific data element selected by said user; record the remaining test items as generated test items from at least one of said test model containing pre-existing taxonomy of codes used to describe a specific data element selected by said user; display on said graphical user interface an item identifier correlating with generated test items; communicate in digital or written form from the record of generated test items those generated test items selected by said user to a system of said user's choice; and wherein test models are data structures comprising an item generation model and at least one item of a pre-existing taxonomy of codes used to describe a specific data element associated with said item generation mode; and wherein said automatic item generation operates direct code combination rather than by application of natural language generator, machine learning, or artificial intelligence in its processes for generating said test items. The additional elements are insignificant extra-solution activity and instructions for applying the judicial exception with a generic computing device as, under their broadest reasonable interpretation, the additional step(s) is/are merely displaying identifiers of the selected test models, displaying a number of items that can be generated by the test model, recording/storing the generated items, displaying identifiers of the test items, transmitting data over a network, and defining the type of data to be manipulated (item generation models with at least one item of a taxonomy of codes and the taxonomy being non-descriptive alpha-numeric codes). The steps of displaying are merely displaying the data that is being manipulated and are recited at such a high level of generality that one of ordinary skill would understand the limitations to merely be displaying the results of collecting the selected criteria (i.e. number of questions to generate) and creating the test items in such a way as to practically be performed in the human mind (see MPEP 2106.04(a)(2)(III)) while merely generally linking the abstract idea with generic computing technology. Further, the step of communicating the test items to another system is merely transmitting data over a network in a conventional method (see MPEP 2106.05(a)(I) and 2106.05(d)(II)), storing the generated items is merely storing data in the memory of the system (see MPEP 2106.05(d)(II)), and defining the test models is merely selecting a type of data to be manipulated (see MPEP 2106.05(g)). The additional hardware elements of one or more processors; a graphical user interface; and one or more computer-readable media having stored thereon instructions that are executable by the one or more processors to configure the computer system are generic computer components for performing the above method, per MPEP 2106.05(f). Under their broadest reasonable interpretation, the additional elements are generic components of a computing device used to apply the abstract idea. Further, paragraphs 0043-004 of the specification describe the computing device in general terms of generic computing components including a processor and memory. As such, these additional hardware elements are interpreted as merely instructions to apply the judicial exception with a generic computing device. The limitations, taken in combination, add nothing that is not already present when looking at the elements taken individually. Accordingly, the additional elements and steps do not integrate the abstract idea into a practical application because they do not impose any meaningful limitations on practicing the abstract idea. Therefore, the claims are directed to an abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, as discussed above, the additional step(s) of displaying various results and steps of the process, storing/recording the generated test items, communicating the test items, and defining the data of the test model are insignificant extra-solution activity performed during the abstract idea. The additional elements of processors, a GUI, and storage media having instructions stored therein used to perform the process are generic computing components/device used to apply the judicial exception and therefore fall under the “apply it” limitation of the judicial exception and do not amount to significantly more per MPEP 2106.05(f). As such, the claims do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception because, under their broadest reasonable interpretation, the additional elements do not meaningfully limit the practice of the abstract idea and/or are well-understood, routine, and conventional. Therefore, claim 1 is not directed to eligible subject matter as they are abstract ideas without significantly more.
Claims 2-5 are dependent from claim 1 and include all the limitations of the independent claims. Therefore, the dependent claims recite the same abstract idea. The limitations of the dependent claims fail to amount to significantly more than the judicial exception. For example:
The limitations of claims 2-3 recite further clarification of the types of data used/comprising the data structure including variables and being QTI compliant. The limitations, under their broadest reasonable interpretation, are merely defining/selecting a type of data to be manipulated which, per MPEP 2106.05(g), is insignificant extra-solution activity. Therefore, the limitations fail to provide any teaching that integrates the judicial exceptions into a practical application or amount to significantly more than the judicial exception. For this reason, the analysis performed on the independent claim is also applicable on these claims.
The limitation of claim 4 similarly recites selection of types of data to be manipulated and are further abstract ideas as the limitations under their broadest reasonable interpretation are including constraints selected by the user as part of the request wherein the constraints could be understood and applied mentally by one of ordinary skill and/or merely instructions to follow that would fall under certain methods of organizing human activity in the form of teaching including a maximum number of test items and instructions for distributing the test items. Therefore, the limitations fail to provide any teaching that integrates the judicial exceptions into a practical application or amount to significantly more than the judicial exception. For this reason, the analysis performed on the independent claim is also applicable on these claims.
The limitation of claim 5 recites the data structure comprising a list of all previously generated items which under its broadest reasonable interpretation is merely storing previously generated data which is insignificant extra-solution activity per MPEP 2106.05(d)(II). Therefore, the limitations fail to provide any teaching that integrates the judicial exceptions into a practical application or amount to significantly more than the judicial exception. For this reason, the analysis performed on the independent claim is also applicable on this claim.
Accordingly, claims 2-5 recite abstract ideas without significantly more and are not drawn to eligible subject matter.
Response to Arguments
Applicant's arguments, see Remarks, filed February 17, 2026, with respect to the rejection(s) of claim(s) 1-5 under 35 U.S.C. 112(a) and 101 have been fully considered but they are not persuasive. With regard to the rejection(s) under 35 U.S.C. 112(a), Applicant argues the “negative limitation is not a mere absence of positive recitation” but a specific method with exclusion of alternative methods that perform intermediary transformation. By Applicant’s own admission, the limitation is an exclusionary proviso intended to exclude NLG, ML, or AI algorithms and as such is correctly interpreted as a negative limitation. Therefore, per MPEP 2173.05(i), the specification must provide basis for the limitation in the original disclosure by positively reciting in the specification reasons or basis for the exclusion and “the mere absence of a positive recitation” of the intermediary elements is not basis for the exclusion as the limitations can reasonably be performed by a system or method using NLG, ML, and/or AI algorithms as discussed in the prior art rejection of the Office Action mailed May 21, 2025. The reason for the withdrawing of that prior art rejection and lack of similar rejection using other available art is the cited art teaching the use of NLG, ML, or AI algorithm for performing the functions. The specification provides no support for the exclusion of these algorithms beyond the lack of recitation which is thereby insufficient support for the exclusionary proviso. Therefore, the claims stand rejected under 35 U.S.C. 112(a).
With regard to the rejection(s) under 35 U.S.C. 101, Applicant argues the following: A) the claim limitations recite steps that are performed by a machine and the human mind is not equipped to perform the claimed features, and B) the amended limitations provide a particular concrete solution to a problem . With regard to Applicant Argument A, the argument disregards that the limitations are also reciting Certain Methods of Organizing Human Activity in the form of teaching. Regardless, the argument is not persuasive as previously discussed in previous actions as the steps can be performed under their broadest reasonable interpretation as a mental process and/or certain method of organizing human activity except for Applicant’s assertion of efficiency and large data sets. Such efficiency via implementation/application of a computing device is claiming the improved speed or efficiency inherent with applying the abstract idea on a computer does not integrate a judicial exception into a practical application or provide an inventive concept per MPEP 2106.05(f) and Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015). With regard to Argument B, Applicant asserts a plurality of “technical solutions/improvements” but the claims are conclusory and without support in the claims and specification. Specifically, Applicant asserts the claims recite a “system reconfiguration” improving a computer’s handling of AIG models but there is not sufficient evidence of a technological improvement or practical application. Addressing items directly, “Test models are data structures requiring at least one item…” is defining the data to be manipulated, “The system displays model identifiers and computed numbers of generatable items” is displaying results and intermediary data of the process and such displaying is insignificant extra-solution activity, “generation is constrained to models with content coding, eliminating all combinations that lack the selected taxonomy codes” is defining the data to be manipulated and an evaluation mental process as a user could observe and determine if combinations lack the selected codes, and “Results are recorded, identified, displayed, and communicated to user-chose systems” is storing, transmitting and displaying results as discussed above. Applicant’s assertions of additional “practical applications” are conclusory and not supported by the claim limitations under their broadest reasonable interpretation when considered alone and in combination. Therefore, the claims stand rejected under 35 U.S.C. 101 as discussed above.
Conclusion
Accordingly, claims 1-5 are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CORRELL T FRENCH whose telephone number is (571)272-8162. The examiner can normally be reached M-Th 7:30am-5pm; Alt Fri 7:30am-4pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kang Hu can be reached on (571)270-1344. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CORRELL T FRENCH/Examiner, Art Unit 3715
/KANG HU/Supervisory Patent Examiner, Art Unit 3715
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