DETAILED ACTION
Continued Examination Under 37 CFR 1.114
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has beentimely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/3/2025 has been entered.
Notice to Applicant
This action is in reply to the filed on 12/3/2025.
Claims 1, 3-4, 6-7, 9-11, 13-14 and 16-20 have been amended.
Claim 1-20 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 rejections previously set forth under 35 U.S.C. §101. As such, said rejections are herein maintained for reasons set forth below.
With the amendment of claims 1, 3-4, 6-7, 9-11, 13-14 and 16-20, applicant has successfully overcome the Examiner’s 35 USC 103 rejection and Examiner withdraws his 35 USC 103 rejection. Tourtellotte et al. and Stookey et al. do not teach “verifying that a randomness of the patient assignments in the randomized list of patient assignments exceeds a predetermined randomness threshold,” etc.
Subject Matter Free of Prior Art
Tourtellotte et al. 510 (US 2019/0096510) and Stookey et al. (US 2005/0038673) teach a method for configuring an RTSM system. Tourtellotte et al. and Stookey et al. do not teach “verifying that a randomness of the patient assignments in the randomized list of patient assignments exceeds a predetermined randomness threshold...,” etc. Therefore, the Applicant has successfully overcome the Examiner’s 35 USC 103 rejection and Examiner withdraws his 35 USC 103 rejection.
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, [0012]) the need to enables efficient configuration of an RTSM system with statistically-sound randomization that is more reliably confirmed that under known manual processes. So a need exists to organize these human interactions by/through validating randomized lists in clinical trial management using the steps of “receiving files, performing natural language processing on files, generating and validating randomized lists of patient assignments, verifying balances and thresholds, configuring RTSM systems,” etc. Applicant’s method is therefore a certain method of organizing the human activities as described and disclosed by Applicant.
Rejection
Claim(s) 1-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim(s) 1, 7 and 11 is/are directed to the abstract idea of “validating randomized lists in clinical trial management,” etc. (Applicant’s Specification, Abstract, paragraph(s) [0002]), 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 1-20 recite an abstract idea.
Step 2A Prong 1 – The Judicial Exception
The claim(s) recite(s) in part, method for performing the steps of “receiving files, performing natural language processing on files, generating and validating randomized lists of patient assignments, verifying balances and thresholds, configuring RTSM systems,” etc., that is “validating randomized lists in clinical trial management,” 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 1-20 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. processors, display, memories, localization hardware (Applicant’s Specification [0020], [0067]-[0068], [0073]), etc.) to perform steps of “receiving files, performing natural language processing on files, generating and validating randomized lists of patient assignments, verifying balances and thresholds, 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) 1-20 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. processors, display, memories, localization hardware, 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. processors, display, memories, localization hardware, etc.). At paragraph(s) [0020], [0067]-[0068], [0073], Applicant’s specification describes conventional computer hardware for implementing the above described functions including “processors, display, memories, localization hardware,” etc. to perform the functions of “receiving files, performing natural language processing on files, generating and validating randomized lists of patient assignments, verifying balances and thresholds, configuring RTSM systems,” etc. The recited “processors, display, memories, localization hardware,” 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 1-20 do not amount to significantly more than the underlying abstract idea of “an idea of itself” (Alice).
Dependent Claims
Dependent claim(s) 2-6, 8-10 and 12-20 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 2-6, 8-10 and 12-20 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 2-6, 8-10 and 12-20 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 grouping of abstract ideas, 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) 1, 7 and 11.
Response to Arguments
Applicant’s arguments filed 12/3/2025 with respect to claims 1-20 have been fully considered and they are partially persuasive. Applicant’s arguments will be addressed herein below in the order in which they appear in the response filed 12/3/2025.
Applicant’s arguments filed on 12/3/2025 with respect to claims 1-20 have been fully considered but are moot in view of the new ground(s) of rejection.
Applicant argues that (A) Tourtellotte et al. and Stookey et al. do not render obvious the present invention because Tourtellotte et al. and Stookey et al. do not disclose “verifying that a randomness of the patient assignments in the randomized list of patient assignments exceeds a predetermined randomness threshold,” etc. in the previously presented and/or presently amended claims, (B) the Applicant’s claimed invention is directed to statutory matter.
103 Responses
In response to Applicant’s argument (A), Applicant’s arguments with regard to the application of Tourtellotte et al. and Stookey et al. to the amended limitations have been found persuasive. Tourtellotte et al. and Stookey et al. do not teach “verifying that a randomness of the patient assignments in the randomized list of patient assignments exceeds a predetermined randomness threshold.” Applicant has successfully overcome the Examiner’s 35 USC 103 rejection and Examiner withdraws his 35 USC 103 rejection.
101 Responses
As per Applicant’s argument (B), Applicant’s remarks with regard to the statutory nature of Applicant’s claimed invention are addressed above in the Office Action.
Rehash
Applicant's remarks and arguments merely rehash issues addressed in the Office Action mailed 2/11/2025 and incorporated herein.
Applicant’s Amendments
Applicant amended claims recite “receiving files, performing natural language processing on files, generating and validating randomized lists of patient assignments, verifying balances and thresholds, configuring RTSM systems.” These are information processing steps 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.
Data Processing Step
Applicant’s amended steps of “receiving files, performing natural language processing on files, generating and validating randomized lists of patient assignments, verifying balances and thresholds, configuring RTSM systems,” are abstract compurational steps that are part of Applicant’s abstract idea. In Electric Power Group the collection, manipulation and display of data has been found to be an abstract process. When claims, such as Applicant’s claims, are “directed to an abstract idea” and “merely requir[e] generic computer implementation,” they “do[] not move into [§] 101 eligibility territory.” buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1354 (Fed. Cir. 2014). Further, analysis of information by steps people go through in their minds, or by mathematical algorithms, without more, is essentially a mental processes within the abstract-idea category (Electric Power Group, 830 F.3d at 1354). Further, Applicant appears to be claiming generic computer implementation of a certain method of organsing human interaction. Therefore, 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.
August 4, 2025 Memorandum
The Examiner thanks the Applicant remarks regarding the advisory August 4, 2025 Memorandum. The Examiner notes that the August 4, 2025 Memorandum contained advisory remarks but the remarks did not change the nature of examination of Applications under 35 USC 101. The Examiner asserts that the Examiner’s analysis and rejection of the Applicant’s claims under 35 USC 101 is compliant with the Office’s examination procedures under the MPEP. Applicant’s argument is not persuasive.
Integration into a Practical Application
Integration into a practical application requires additional elements or a combination of additional elements in the claims 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 (e.g. Enfish, McRO and Vanda) (2019 PEG).
Applicant’s “processors, display, memories, localization hardware” is/are not an additional element(s) that reflects in the an improvement in the functioning of a computer, is/are not an additional element(s) that applies or uses the judicial exception to effect a particular treatment or prophylaxis, is/are not an additional element(s) that effects a transformation or reduction of a particular article to a different state or things, and is/are not an additional element(s) that applies or uses the judicial exception beyond generally linking the use of the judicial exception to a particular technological environment for the reasons explained in the 101 rejection above. Applicant’s “processors, display, memories, localization hardware” is/are merely tools used by Applicant to implement data processing. Data processing is an abstract idea. Applicant’s argument is not persuasive.
Significantly More
Further, the Examiner is not persuaded that “receiving files, performing natural language processing on files, generating and validating randomized lists of patient assignments, verifying balances and thresholds, configuring RTSM systems,” etc. constitutes significantly more than the abstract idea. “[M]erely selecting information, by content or source, for collection, analysis, and display does nothing significant to differentiate a process from ordinary mental processes, whose implicit exclusion from § 101 undergirds the information-based category of abstract ideas.” Electric Power Group, 830 F.3d at 1355. Moreover, the claims “do not include any requirement for performing the claimed functions…by use of anything but entirely conventional, generic technology. The claims therefore do not state an arguably inventive concept.” Id. at 1356. In short, each step does no more than require a generic computer processor to perform generic computer functions. See Applicant’s specification at paragraph(s) [0020], [0067]-[0068], [0073] describing generic computer components (i.e. “processors, display, memories, localization hardware”, etc.). And considered as an ordered combination, the computer components of Applicant’s method add nothing that is not already present when the steps are considered separately. Applicant’s argument is not persuasive.
Considering each of the claim elements in turn, the function performed by the computer at each step of the process is purely conventional. For example, “receiving files, performing natural language processing on files, generating and validating randomized lists of patient assignments, verifying balances and thresholds, configuring RTSM systems,” etc. is/are purely conventional in computer systems and its use in the claim both individually and in the ordered combination fails to transform the nature of the claim. Each step of the claimed method does no more than require a generic computer to form a generic computer function. Applicant’s argument is not persuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES P. COLEMAN whose telephone number is (571) 270-7788. The examiner can normally be reached on Monday through Thursday 7:30a-5:00p.
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/C. P. C./
Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683