DETAILED ACTION
Notice to Applicant
This action is in reply to the filed on 10/31/2025.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 21, 31-33 and 40-41 have been amended.
Claims 1-20, 26 and 36 have been cancelled.
Claim 21-25, 27-35 and 37-41 currently pending and have been examined.
Response to Amendments
The Applicant’s amendments, and cancellation, of the claims as currently submitted have been noted by the Examiner. Said amendments, and cancellation(s), are not sufficient to overcome the rejection previously set forth under 35 U.S.C. §101. As such, said rejection is herein maintained for reasons set forth below.
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.
Human Interactions Organized
Applicant discloses (Applicant’s Specification, [0003]) that patient randomization, blinding, drug dispensing and automatic drug resupply are critical function for clinical trials. So a need exists to organize these human interactions by programming and configuring RTSM systems for clinical trials using the steps of “generating RTSM systems, determining usage, generating messages, receiving usage, dividing specifications, extracting information, selecting configurations, interpreting text, generating information, configuring RTSM systems,” etc. Applicant’s method/computer readable medium/apparatus is therefore a certain method of organizing the human activities as described and disclosed by Applicant.
Rejection
Claim(s) 21-25, 27-35 and 37-41 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim(s) 21, 33 and 40 is/are directed to the abstract idea of “programming and configuring RTSM systems for clinical trials,” etc. (Applicant’s Specification, Abstract, paragraph(s) [0002], [0008]), etc., as explained in detail below, and thus grouped as a certain method of organizing human interactions. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional computer elements, which are recited at a high level of generality, provide conventional computer functions that do not add meaningful limits to practicing the abstract idea. Accordingly, claims 21-25, 27-35 and 37-41 recite an abstract idea.
Step 2A Prong 1 – The Judicial Exception
The claim(s) recite(s) in part, method/computer readable medium/apparatus for performing the steps of “generating RTSM systems, determining usage, generating messages, receiving usage, dividing specifications, extracting information, selecting configurations, interpreting text, generating information, configuring RTSM systems,” etc., that is “programming and configuring RTSM systems for clinical trials,” etc. which is a method of managing personal behavior or relationships or interactions between people (social activities, teaching, following rules, instructions) and thus grouped as a certain method of organizing human interactions. Accordingly, claims 21-25, 27-35 and 37-41 recite an abstract idea.
Step 2A Prong 2 – Integration of the Judicial Exception into a Practical Application
This judicial exception is not integrated into a practical application because the generically recited additional computer elements (i.e. system generating platform, processors, memories, user interfaces, file system modules, communication interfaces (Applicant’s Specification [0080]-[0081]), etc.) to perform steps of “generating RTSM systems, determining usage, generating messages, receiving usage, dividing specifications, extracting information, selecting configurations, interpreting text, generating information, configuring RTSM systems,” etc. do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer and this is nothing more than an attempt to generally link the product of nature to a particular technological environment. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limit on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea.
Insignificant extra-solution activity
Claim(s) 21-25, 27-35 and 37-41 recites storing data steps, retrieving data steps, providing data steps, output steps (Bilski v. Kappos, 561 U.S. 593, 610-12 (2010), Bancorp Servs., L.L.C. v. Sun Life Assur. Co. of Can., 771 F.Supp.2d 1054, 1066 (E.D. Mo. 2011), aff’d, 687 F.3d at 1266), and/or transmitting data step (buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355 (Fed. Cir. 2014), Apple, Inc. v. Ameranth, Inc., 842 F.3d 1299, 1241-42 (Fed. Cir. 2016)) that is/are insignificant extra-solution activity. Extra-solution activity limitations are insufficient to transform judicially excepted subject matter into a patent-eligible application (MPEP §2106.05(g)).
Step 2B – Search for an Inventive Concept/Significantly More
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations (i.e. system generating platform, processors, memories, user interfaces, file system modules, communication interfaces, etc.) only store and retrieve information and perform repetitive calculations, and these are well-understood, routine, conventional computer functions as recognized by the Symantec, TLI, and OIP Techs. court decisions listed in MPEP § 2106.05(d)(II) (Berkheimer- Court Decisions). These court decisions indicate that mere collection or receipt of data over a network is a well-understood, routine and conventional function when it is claimed in a merely generic manner as it is here. Mere instructions to apply an exception using generic computer components cannot provide an inventive concept. Accordingly, the claims are not patent eligible.
Individually and in Combination
The additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. The additional elements amount to no more than generic computer components that serve to merely link the abstract idea to a particular technological environment (i.e. system generating platform, processors, memories, user interfaces, file system modules, communication interfaces, etc.). At paragraph(s) [0080]-[0081], Applicant’s specification describes conventional computer hardware for implementing the above described functions including “system generating platform, processors, memories, user interfaces, file system modules, communication interfaces,” etc. to perform the functions of “generating RTSM systems, determining usage, generating messages, receiving usage, dividing specifications, extracting information, selecting configurations, interpreting text, generating information, configuring RTSM systems,” etc. The recited “system generating platform, processors, memories, user interfaces, file system modules, communication interfaces,” etc. does/do not add meaningful limitations to the idea of beyond generally linking the system to a particular technological environment, that is, implementation via computers. Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation. Therefore, claims 21-25, 27-35 and 37-41 do not amount to significantly more than the underlying abstract idea of “an idea of itself” (Alice).
Dependent Claims
Dependent claim(s) 22-25, 28-32, 34-35, 37-39 and 41 include(s) all the limitations of the parent claims and are directed to the same abstract idea as discussed above and incorporated herein.
Although dependent claims 22-25, 28-32, 34-35, 37-39 and 41 add additional limitations, they only serve to further limit the abstract idea by reciting limitations on what the information is and how it is received and used. Dependent claims 22-25, 28-32, 34-35, 37-39 and 41 merely describe physical structures to implement the abstract idea. These information and physical characteristics do not change the fundamental analogy to the abstract idea grouping of certain method of organizing human interactions, and when viewed individually or as a whole, they do not add anything substantial beyond the abstract idea. Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore, the claims when taken as a whole are ineligible for the same reasons as independent claim(s) 21 and 33.
Response to Arguments
Applicant’s arguments filed 10/31/2025 with respect to claims 21-25, 27-35 and 37-41 have been fully considered but they are not persuasive. Applicant’s arguments will be addressed herein below in the order in which they appear in the response filed 10/31/2025.
Applicant’s arguments filed on 10/31/2025 with respect to claims 21-25, 27-35 and 37-41 have been fully considered but are moot in view of the new ground(s) of rejection.
Applicant argues that (A) the Applicant’s claimed invention is directed to statutory matter.
101 Responses
As per Applicant’s argument (A), Applicant’s remarks with regard to the statutory nature of Applicant’s claimed invention are addressed above in the Office Action.
Affidavits and Declarations
As per Applicants’ argument (A), the Examiner respectfully submits that in considering evidence presented in the Affidavits and Declarations, Applicant(s) does not establish a nexus between the claimed invention. In particular, Applicant’s Exhibits do not describe the recited claim language. Furthermore, Applicant’s conclusions that the Exhibits establish the claimed invention are not an evidentiary fact, per se. Moreover, Applicants have not demonstrated how the Exhibits and Declarations provide a nexus to Applicant's recited claimed language. The Examiner would like the Applicant(s) to point-out the direct correlation between the claim language and the presented Exhibits.
Rehash
Applicant's remarks and arguments merely rehash issues addressed in the Office Action mailed 4/23/2025 and incorporated herein.
Applicant’s Amendments
Applicant amended claims recite “generating…an instance,” “wherein the RTSM system is automatically configured,” “building…the instance of the RTSM system…,” “wherein the built instance of the RTSM system is usable to conduct the clinical trial.” These are information processing steps (e.g. generating computer code, building computer code, running computer code) that are part of Applicant’s abstract idea and do not move Applicant’s invention into eligible subject matter. Applicant’s argument is not persuasive.
2019 PEG Neither Limiting nor Exhaustive
Further, the enumerated examples in the 2019 PEG are neither limiting nor exhaustive. They are exemplary. Applicant’s argument is not persuasive.
Improvements – Advantageous over previous methods
The test for patent-eligible subject matter is not whether the claims are advantageous over previous methods (e.g. partially- or manually-configurable RTSM systems, advanced NLP processing). Even if Applicant’s claims provide advantages over manual collection of data, Applicant’s claims no technological improvement beyond improvement beyond the use of generic computer components. Applicant’s argument is not persuasive.
Improvements
Despite recitation of system generating platform, processors, memories, user interfaces, file system modules, communication interfaces, Applicant’s claims are, at bottom, directed to the collection, organization, grouping and storage of data using techniques such as natural language processing. The system generating platform, processors, memories, user interfaces, file system modules, communication interfaces recited in Applicant’s claims are merely tools used for organizing human activity, and are not an improvement to computer technology. This, the claims do not present any specific improvement in computer capabilities. Applicant’s arguments are nothing more than conclusory statements unmoored from specific claim language. Applicant’s argument is not persuasive.
Improved – Technology
The Examiner respectfully disagrees. MPEP 2106.04(d)(1) states “the word ‘improvements’ in the context of this consideration is limited to improvements to the functioning of a computer or any other technology/technical field, whether in Step 2A Prong Two or in Step 2B.” Here, there is no improvement to the computer nor is there an improvement to another technology of natural language processing.. Because neither type of improvement is present in the claims, an improvement to technology is not present and there is no practical application. The “improvement” appears to be to the application of natural language processing applied to data correction, but not necessarily to steps or the techniques in natural language processing that result in improvement such as the efficiency, speed, and/or resources used in natural language processing. Applicant’s argument is not persuasive.
PTAB Decisions
The Examiner respectfully submits the cited non-precedential PTAB decisions are specific to the facts before the panel, have not be subject to appellate review, and are not binding on the present rejection. As such, the Examiner declines to address them. A list of precedential and/or informative PTAB decisions that the Applicant may rely upon are listed at the following website: https://www.uspto.gov/patents/ptab/precedential-informative-decisions .
Additional Elements - Ex parte Argyris
Applicant argues that “Claim 21 recites additional elements other than generic computer… for reasons similar to the reasons articulated by the PTAB in Ex parte Argyris.” Applicant states that 1. the PTAB noted that the claim language "is arguably suggestive of an improvement in technology" because it "presents a technique more related to configuring a risk assessment software . . . as opposed to merely managing operational risk, 2. The PTAB further noted that "generating risk assessment software ... is not something that can be performed mentally.", and 3. the PTAB observed that the Examiner had not adequately explained how "tokenizing the text corpus using the NLP engine" could be regarded as a mental process or certain method of organizing human activity.
Applicant has not claimed “configuring a risk assessment software” and “configuring…the RTSM system” is not equivalent to “configuring a risk assessment software.” The Examiner respectfully submits the cited non-precedential PTAB decisions are specific to the facts before the panel, have not be subject to appellate review, and are not binding on the present rejection. Applicant’s argument is not persuasive.
The Examiner is not arguing that Applicant’s claims are directed to or recite a mental process. Applicant’s argument is not persuasive.
Applicant has not claimed “tokenizing the text corpus using the NLP engine” so it is not clear how this argument is relevant to Applicant’s claimed invention. The Examiner respectfully submits the cited non-precedential PTAB decisions are specific to the facts before the panel, have not be subject to appellate review, and are not binding on the present rejection. Applicant’s argument is not persuasive.
Improvement to Compute-Related Techniques - Ex parte Allen
Applicant argues that the “additional elements of amended independent claim 21 integrate the claimed subject matter into a practical application by improving a computer-related technology” for reasons similar to the reasons articulated by the PTAB in Ex parte Allen. Applicant states “In Ex parte Allen, the claims at issue related to ‘a medical treatment recommendation system that analyzes a patient's EMR…in relation to medical guidelines and other medical documentation to generate a recommendation as to how to treat a medical malady or medical condition of the patient,’” and “The claims specifically related to techniques for detecting entities and relationships between entities in medical text, ‘an important aspect of natural language processing for medical text.’”
Applicant has not claimed “a medical treatment recommendation system”, nor has Applicant claimed or recited “techniques for detecting entities and relationships between entities in medical text.” so it is not clear how this argument is relevant to Applicant’s claimed invention. The Examiner respectfully submits the cited non-precedential PTAB decisions are specific to the facts before the panel, have not be subject to appellate review, and are not binding on the present rejection. Applicant’s argument is not persuasive.
Conclusion
Applicant’s amendment necessitated the new ground(s) for 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 for 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 extension free 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 date of this final action.
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/C. P. C./
Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683