DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This action is in reply to the amendment filed on 01/14/2026.
Claims 1, 6 and 11 have been amended.
Claims 1-18 are currently pending and have been examined.
Notice to Applicant
The 101 grounds of rejection in the PTAB decision mailed 11/18/2025 is incorporated in full. MPEP 1214.01(I) states: “If the examiner does not consider that the amendment and/or new evidence overcomes the rejection, the examiner will again reject the claims. If appropriate, the rejection will be made final.” While MPEP 1214.01(IV) states: “If the Board affirms the examiner’s rejection, but also enters a new ground of rejection under 37 CFR 41.50(b), the subsequent procedure depends upon the action taken by the appellant with respect to the 37 CFR 41.50(b) rejection. (A) If the appellant elects to proceed before the examiner with regard to the new rejection (see MPEP § 1214.01, subsection I., the Board’s affirmance will be treated as nonfinal, and no request for rehearing of the affirmance need be filed at that time.” As such, the finality of the present rejection is appropriate.
Claim Objections
Claims 1, 6 and 11 are objected to because of the following informalities: There are grammatical errors within phrase “… automatically recognized by the by computer…”. Appropriate correction is required.
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 1-18 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-5 and 16 are directed to a system (i.e., a machine), claims 6-10 and 17 are directed to a method (i.e., a process) and claim 12-15 and 18 are directed to non-transitory computer readable medium (i.e., a manufacture). Accordingly, claims 1-18 are all within at least one of the four statutory categories.
Step 2A - Prong One:
An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes.
Representative independent claim 1 includes limitations that recite an abstract idea. Note that independent claim 1 is the system claim, while claim 6 covers a method claim and claim 11 covers the matching computer readable medium.
Specifically, independent claim 1 recites:
A computerized system for answering at least one question in an electronic Case Report Form (eCRF) in a clinical trial study, the system comprising:
at least one processor running an EMR system on a first device including patient data stored independently of clinical trial data, wherein the EMR system includes at least one patient source document displayed on a display associated with the first device, the source document comprising a record of at least one data value of patient data associated with a patient also enrolled in a clinical trial;
the at least one processor or another processor providing a source document (SD) ingester, the SD document ingester configured to create a source document (SD) snippet, wherein the SD snippet consists of text automatically recognized by the by computer screen capture software installed on the first device from the at least one patient source document displayed on the first device, and wherein data, output by computer screen capture software included in the SD document ingester, is used to answer the at least one question in the eCRF from the image without requiring a transcription process;
the at least one processor or another processor having a SD snippet markup tool, the SD snippet markup tool configured to allow the SD snippet to be selected as relevant evidence to the answer of at least a portion of the at least one question in the eCRF; and wherein the system recognizes the selected SD snippet including the data as all or part of the answer to the at least one question in the eCRF.
The Examiner submits that the foregoing underlined limitations constitute: (a) “a mental process” because answering a question in a clinical trial, observing a displayed record as a data value associated with a patient also enrolled in a clinical trial and recognizing the selected SD snippet including data as all or part of the answer to the at least one question are observations/evaluations/analysis that can be performed in the human mind or with a pen and paper (See New Ground of rejection in the PTAB decision dated 11/18/2025 at numbered Pgs. 17-18). For example, but for the computerized system that provides an electronic Case Report Form (eCRF) and Electronic Medical Record (EMR) system, this claim encompasses a person thinking about pertinent information to recognize, capture or mark-up that would add as support to answering a clinical trial question. The foregoing underlined limitations also apply to claim 6 (similarly to claim 11).
Accordingly, the claim describes at least one abstract idea.
In relation to dependent claims 2-5, 7-10 and 12-18, these claims merely recite determining steps such as: claims 2, 7 & 12 – superimposing the at least one question on the display associated with the first device, where the person like an investigator thinks about revealing relevant portions of the SD to answer the questions, claims 3, 8 & 13 - the SD snippet is not saved to the first device, where the person decides what’s saved, claims 4, 9 & 14 - the SD snippet is handled independently of the first device native operating system, where the person makes a decision, claims 5, 10 & 15 - the electronic signature tool is configured to associate an electronic signature with the SD snippet, wherein the electronic signature provides confirmation that the SD snippet is representative of information from the source document, where the person confirms with a signature and claims 16, 17 & 18 - the data is automatically entered into the eCRF, where the person makes a decision to enter data.
Step 2A - Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted, it must be determined whether any additional elements in the claim beyond the abstract idea integrate the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.”
The limitations of claims 1, 6 and 11, as drafted is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components. That is, other than reciting a computerized system, an EMR system, a first device, at least one processor, computer screen capture software, a display, a first device display screen, a second computer program, electronic signature tool and a non- transitory computer-readable medium for use in a computerized clinical trial verification system to perform the limitations, nothing in the claim elements precludes the steps from practically being performed in the mind. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation within a health care environment in the mind but for the recitation of generic computer components, then it falls within the “Mental Process” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
The judicial exception is not integrated into a practical application. In particular, the computerized system, EMR system, first device, least one processor, computer screen capture software, display, first device display screen, second computer program, electronic signature tool and non- transitory computer-readable medium for use in a computerized clinical trial verification system are recited at high levels of generality (i.e., as generic computer components performing generic computer functions of receiving data/inputs, determining and providing data) such that it amounts no more than mere instructions to apply the exception using the generic computer components.
Regarding the additional limitation the “an electronic Case Report (eCRF)”, “a source document (SD)”, “a patient source document”, “a source document (SD) ingester” and “SD snippet markup tool” the Examiner submits that this additional limitation amount to merely using a computer to perform the at least one abstract idea (see MPEP § 2106.05(f)).
Regarding the additional limitation of dependent claims 2-5, 7-10 and 12-18, “the source document (SD)”, “the SD snippet”, “first device native operating system”, “an electronic signature tool” and “the SD snippet markup tool” the Examiner submits that this additional limitation amount to merely using a computer to perform the at least one abstract idea (see MPEP § 2106.05(f)).
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 add nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvements in the functioning of a computer or an improvement to another technology or technical field, apply or us the above-noted implement/use to above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is not more than a drafting effort designed to monopolize the exception (see MPEP §2106.05). Their collective functions merely provide conventional computer implementation.
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 the integration of the abstract idea into practical application, the additional elements amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using generic computer component provide an inventive concept. The claims are not patent eligible.
Step 2B:
Regarding Step 2B, in representative independent claim 1, regarding the additional limitations of the computerized system, EMR system, first device, least one processor, computer screen capture software, display, first device display screen, second computer program, electronic signature tool and non- transitory computer-readable medium for use in a computerized clinical trial verification system, the Examiner submits that these limitations amount to merely using a computer to perform the at least one abstract idea (see MPEP § 2106.05(f)).
Thus, representative independent claim 1 and analogous independent claims 6 and 11 do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
The dependent claims no not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reason discussed above with respect to determining that the dependent claims do not integrate the at least abstract idea into a practical application.
Therefore, claims 1-18 are ineligible under 35 USC §101.
Response to Arguments
Applicant argues that independent claims 1, 6 and 11 have been amended limitations to recite text automatically recognized by the by computer screen capture software installed on the first device, language the Examiner once deemed as "inventive software”. See pgs. 7-8 of Remarks – Examiner disagrees.
Upon reviewing overwhelming analysis set forth by the Appeal Board (See New Ground of rejection in the PTAB decision dated 11/18/2025 at numbered Pgs. 15-1621) and careful consideration, the Examiner finds the claims not patent eligible, rejected with the above analysis. Under prong one of the two-prong test in the 2019 Guidance, claims 1, 6 and 11 recite the abstract idea of mental processes and under prong two, additional elements in claims 1, 6 and 11 do not “apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception (See 2019 Guidance). As such, under step one of Alice framework, claims 1, 6 and 11 are directed to an abstract idea. Moving to step two, claims 1, 6 and 11 do not include additional elements or combination of elements other than the abstract idea.
The computer screen capture software in paragraph 44 of the Specification and recited in claims 1, 6 and 11 bares no indication that the claimed invention effects a transformation or reduction of a particular article to a different state or thing. Nothing was found of record that attributes an improvement in computer technology of functionality to the claimed invention. Even if the computer screen capture software was claimed to actually identify repeated patterns, speech or alphanumerical text characters, it doesn’t appear the computer’s operations are more efficient or improved upon based on the claimed functions of creating, recognizing and answering a clinical trial study question.
Applicant further argues that the Examiner failed to address 103 rejection arguments. See pgs. 8-9 of Remarks – Examiner disagrees.
Besides “the process of extracting textual information from present graphical material” not actually being claimed, the discrepancy is moot when PTAB made a decision to reverse the written description and prior art rejections, not an argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. (See Sumino (U.S. 2007/0271214 A1), Francois (U.S. 2016/0110523 A1) & Udani (U.S. 8,655,796 B2).).
THIS ACTION IS MADE FINAL. 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 TERESA S WILLIAMS whose telephone number is (571)270-5509. The examiner can normally be reached Mon-Fri, 8:30 am -6:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached at (571) 270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/T.S.W./Examiner, Art Unit 3687 02/12/2026
/MAMON OBEID/Supervisory Patent Examiner, Art Unit 3687