DETAILED ACTION
Notice to Applicant
This communication is in response to the amendment submitted February 2, 2026. The present application claims priority under 35 U.S.C. § 119 to Indian Patent Application No. 202321078787, filed on November 20, 2023. Claims 1 – 2, 8, and 15 are amended. Claims 4 – 5, 7, 11 – 12, 14, and 18 – 19 are cancelled. Claims 1 – 3, 6, 8 – 10, 13, 15 – 17, and 20 are pending.
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 .
Claim Rejections - 35 USC § 112
The rejection of Claims 1, 8, and 15 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn based upon the amendment submitted February 2, 2026.
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, 6, 8 – 10, 13, 15 – 17, and 20 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 One
Claims 1 – 3, 6, 8 – 10, 13, 15 – 17, and 20 are drawn to a method, system, and non-transitory machine readable information storage medium, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One
Independent claims 1, 8, and 15 recite receiving (i) one or more medical writing boilerplates associated with one or more disease types, wherein the one or more medical writing boilerplates include common clinical trial information source documents associated with the one or more disease types, and disease specific information sources related documents, (ii) one or more historical clinical trial documents, (iii) a plurality of clinical trial standard template documents defined for a drug regulatory authority, and (iv) a trial use case text to perform clinical trials for a drug; preprocessing (i) the one or more medical writing boilerplates associated with the one or more disease types, and (ii) the one or more historical clinical trial documents, to obtain (i) one or more pre-processed medical writing boilerplates associated with the one or more disease types, and (ii) one or more pre-processed historical clinical trial documents; executing on (i) the one or more pre-processed medical writing boilerplates associated with the one or more disease types, and (ii) the one or more pre-processed historical clinical trial documents, and wherein the clinical trial knowledge comprises instances of (i) a plurality of medical writing (MW) concepts, (ii) a plurality of MW infotypes, (iii) a plurality of MW contexts, wherein the plurality of MW contexts classifies the MW concept and the MW infotype, (iv) a plurality of MW groups, (v) one or more relations between each of the plurality of MW concepts, the plurality of MW infotypes, the plurality of MW contexts, and the plurality of MW groups, and (vi) one or more recommendation rules; preprocessing the trial use case text to identify one or more trial use case MW context parameters and one or more trial use case MW infotypes, and to create a clinical trial instance of the trial use case text; recommending (i) a plurality of relevant MW infotypes and (ii) a plurality of relevant MW concepts, using the one or more trial use case MW context parameters and the one or more trial use case MW infotypes identified from the trial use case text; wherein recommending the plurality of relevant MW infotypes, using the one or more trial use case MW context parameters and the one or more trial use case MW infotypes identified from the trial use case text, comprising: identifying a first set of MW infotypes out of the plurality of MW infotypes present based on relationships between the one or more trial use case MW context parameters of the trial use case text and the plurality of MW infotypes present: identifying a second set of MW infotypes out of the plurality of MW infotypes present by inferring the first set of MW infotypes with respect to the one or more recommendation rules; identifying a third set of MW infotypes out of the plurality of MW infotypes present using one or more inclusion and exclusion dependency relationships obtained for the first set of MW infotypes and the second set of MW infotypes; and combining the first set of MW infotypes, the second set of MW infotypes, and the third set of MW infotypes, to obtain the plurality of relevant MW infotypes, wherein recommending the plurality of relevant MW concepts, using the one or more trial use case MW context parameters and one or more trial use case MW infotypes identified from the trial use case text, comprising: identifying a first set of MW concepts out of the plurality of MW concepts present, based on (i) relationships between the plurality of relevant MW infotypes and the plurality of MW concepts present, and (ii) relationships between the one or more trial use case MW context parameters and the plurality of MW concepts present: identifying a second set of MW concepts out of the plurality of MW concepts present by inferring the first set of MW concepts and the plurality of relevant MW infotypes with respect to the one or more recommendation rules: identifying a third set of MW concepts out of the plurality of MW concepts present, using one or more inclusion and exclusion dependency relationships obtained for the first set of MW concepts and the second set of MW concepts: and combining the first set of MW concepts, the second set of MW concepts, and the third set of MW concepts, to obtain the plurality of relevant MW concepts; generating a clinical trial recommendation, by attaching the plurality of relevant MW infotypes, the plurality of relevant MW concepts and the one or more trial use case MW context parameters, to the clinical trial instance; executing a template extraction pattern on the plurality of clinical trial standard template documents to extract a clinical trial template, wherein the clinical trial template comprises a plurality of MW templates; generating a plurality of clinical trial documents for the trial use case text, using the clinical trial recommendation model and the clinical trial template; receiving one or more recommendations from a user, based on the plurality of clinical trial documents generated for the trial use case text.
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 disclosure “relates generally to methods and systems for automated generation of clinical trial documents….. Methods and systems of the present disclosure employ a clinical trial knowledge model that contains concepts, infotypes and contexts, a configurable dynamic recommendation model, and a clinical trial template model for generating the clinical trial documents. The present disclosure enables the digitalization of information from different sources of information using meta-model based approach. …… The recommendation provides a guided search of information, reduces search complexity, and finally generates formatted clinical trial documents.” (Abstract of the published application). 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 they address “unresolved problems of automated generation of clinical trial documents using the trial use case text. The present disclosure enables the digitalization of information from different sources of information using meta-model based approach” (paragraph 169 of the published specification). The present invention discloses receiving recommendations from a user based on the clinical trial documents generated (paragraph 9 of the published specification). 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:
Claim 1: “a processor”, “one or more hardware processors”, “natural language processing (NLP) techniques”, “clinical trial knowledge meta model”, “clinical trial knowledge model”, “domain dictionary”, “model”, “clinical trial recommendation meta model”, “clinical trial template meta model”, “clinical trial template model”
Claim 2: “processor”, “meta model”
Claim 3: “processor”, “natural language processing (NLP) techniques”, “clinical trial knowledge meta model”, “domain dictionary”, “traversing a logical subtree of the trial use case text, to identify a stream of words comprising variants of noun, verb, adjective, and adverb, using the one or more NLP techniques”, “matching algorithm”
Claim 6: “processor”, “model”, “one or more NLP techniques”, “saving the clinical trial document created for each MW template”
Claim 8: “system”, “a memory storing instructions”, “one or more input/output (I/O) interfaces”, “one or more hardware processors coupled to the memory via the one or more I/O interfaces, wherein the one or more hardware processors are configured by the instructions”, “natural language processing (NLP) techniques”, “clinical trial knowledge meta model”, “clinical trial knowledge model” “domain dictionary”, “model”
Claim 9: “system”, “meta model”
Claim 10: “system”, “processor”, “natural language processing (NLP) techniques”, “clinical trial knowledge meta model”, “domain dictionary”, “traversing a logical subtree of the trial use case text, to identify a stream of words comprising variants of noun, verb, adjective, and adverb, using the one or more NLP techniques”, “matching algorithm”
Claim 13: “system”, “processor”, “model”, “one or more NLP techniques”, “saving the clinical trial document created for each MW template”
Claim 15: “One or more non-transitory machine-readable information storage mediums comprising one or more instructions which when executed by one or more hardware processors”, “natural language processing (NLP) techniques”, “clinical trial knowledge meta model”, “domain dictionary”, “model”
Claims 16: “one or more non-transitory machine-readable information storage mediums”, “model”
Claim 17: “one or more non-transitory machine-readable information storage mediums”, “natural language processing (NLP) techniques”, “clinical trial knowledge meta model”, “domain dictionary”, “traversing a logical subtree of the trial use case text, to identify a stream of words comprising variants of noun, verb, adjective, and adverb, using the one or more NLP techniques”, “matching algorithm”
Claim 20: “one or more non-transitory machine-readable information storage mediums”, “model”, “natural language processing (NLP) techniques”
These features are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (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 into a practical application, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The published specification supports this conclusion as follows:
[0037] The one or more hardware processors 104 may be implemented as one or more microprocessors, microcomputers, microcontrollers, digital signal processors, central processing units, state machines, logic circuitries, and/or any devices that manipulate signals based on operational instructions. Among other capabilities, the one or more hardware processors 104 are configured to fetch and execute computer-readable instructions stored in the memory 102. In the context of the present disclosure, the expressions 'processors' and 'hardware processors' may be used interchangeably. In an embodiment, the system 100 can be implemented in a variety of computing systems, such as laptop computers, portable computers, notebooks, hand-held devices, workstations, mainframe computers, servers, a network cloud and the like.
[0038] The memory 102 may include any computer-readable medium known in the art including, for example, volatile memory, such as static random access memory (SRAM) and dynamic random access memory (DRAM), and/or non-volatile memory, such as read only memory (ROM), erasable programmable ROM, flash memories, hard disks, optical disks, and magnetic tapes. In an embodiment, the memory 102 includes a plurality of modules 102a and a repository 102b for storing data processed, received, and generated by one or more of the plurality of modules 102a. The plurality of modules 102a may include routines, programs, objects, components, data structures, and so on, which perform particular tasks, or implement particular abstract data types.
[0039] The plurality of modules 102a may include programs or computer-readable instructions or coded instructions that supplement applications or functions performed by the system 100. The plurality of modules 102a may also be used as, signal processor(s), state machine(s), logic circuitries, and/or any other device or component that manipulates signals based on operational instructions. Further, the plurality of modules 102a can be used by hardware, by computer-readable instructions executed by the one or more hardware processors 104, or by a combination thereof. In an embodiment, the plurality of modules 102a can include various sub-modules (not shown in FIG. 1). Further, the memory 102 may include information pertaining to input (s)/output(s) of each step performed by the processor(s) 104 of the system 100 and methods of the present disclosure.
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 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 (Step 2B: NO).
Dependent claim(s) 2 – 3, 6, 9 – 10, 13, 16 – 17, and 20 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 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.
Claim Rejections - 35 USC § 103
The closest prior art of record, neither alone nor in combination, teach the invention as claimed in independent claims 1, 8, and 15; therefore, the closest prior art of record does not anticipate or otherwise render the claimed invention obvious. The rejection of the amended claims would require an unreasonable combination of the available prior art. Thus, the cited prior art fails to address the limitations in the claimed combination in independent claims 1, 8, and 15.
Response to Arguments
Applicant's arguments filed February 2, 2026 have been fully considered but they are not persuasive. The Applicant’s arguments have been addressed in the order in which they were presented.
Rejections of Claims under 35 USC § 101
The Applicant argues the claims recite a method and system for automated generation of clinical trial documents thereby integrating the exception into a practical application based on the combination of additional elements. The Examiner respectfully disagrees. The additional elements of the present claims fail to integrate the exception into a practical application of the exception. The 2019 PEG defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception. For example, the 2019 PEG guidelines recite limitations that are indicative of integration into a practical application when recited in a claim with a judicial exception include:
Improvements to the functioning of a computer, or to any other technology or technical field, as discussed in MPEP 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine, as discussed in MPEP 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP 2106.05(e) and the Vanda Memo issued in June 2018.
The present claims fail to demonstrate an improvement to the functioning of a computer or to any other technology or technical field. Thus, Applicant’s argument is not persuasive, and the rejection is maintained.
The Applicant argues the claims recite additional element(s) that amount to significantly more than the judicial exception(s). The Examiner respectfully disagrees. The Applicant’s specification states “The one or more hardware processors 104 may be implemented as one or more microprocessors, microcomputers, microcontrollers, digital signal processors, central processing units, state machines, logic circuitries, and/or any devices that manipulate signals based on operational instructions. Among other capabilities, the one or more hardware processors 104 are configured to fetch and execute computer-readable instructions stored in the memory 102. In the context of the present disclosure, the expressions 'processors' and 'hardware processors' may be used interchangeably. In an embodiment, the system 100 can be implemented in a variety of computing systems, such as laptop computers, portable computers, notebooks, hand-held devices, workstations, mainframe computers, servers, a network cloud and the like” (paragraph 37 of the published specification). The generic computer cited by the Applicant is a general link to execute the abstract idea. The processor, as used in the recited claims, is at best the equivalent of merely adding the words “apply it” to the judicial exception. Mere instructions to apply an exception cannot provide an inventive concept. Thus, Applicant’s argument is not persuasive and the rejection is maintained.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINE K RAPILLO whose telephone number is (571)270-3325. The examiner can normally be reached Monday - Friday 7:30 - 4 pm.
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/K.K.R/Examiner, Art Unit 3682
/ROBERT A SOREY/Primary Examiner, Art Unit 3682
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