DETAILED ACTION
Status of Claims
This action is in reply to the application filed on 09/11/2024.
Claims 1-30 have been cancelled.
Claims 31-49 have been newly added.
Claims 31-49 are currently pending and have been examined.
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 § 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 31-49 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 31-49 are directed to a system (i.e., a machine). Accordingly, claims 31-49 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 31 includes limitations that recite an abstract idea. Note that both independent claims 31 and 39 are system claims.
Specifically, independent claim 31 recites:
A computerized system for labeling a portion of a source document containing data relevant to the answer of one or more questions in a clinical trial questionnaire, comprising:
at least one processor configured to receive input from a user to label a portion of a source document as including a description that comprises an answer to one or more questions in a clinical trial questionnaire form, the description including one or more alphanumeric characters;
the at least one processor answering one or more of the one or more questions in the clinical trial questionnaire form without the user having to enter patient information into a new form; and
wherein the clinical trial questionnaire therefore shows the entry of the answer.
The Examiner submits that the foregoing underlined limitations constitute: (a) “certain methods of organizing human activity” because labelling a portion of a source document including a description that comprises an answer to questions in a clinical trial questionnaire form and answering questions in the clinical trial questionnaire form without the user having to enter patient information into a new form are a part of a clinical trial administrative workflow, which is managing human behavior/interactions between people. Furthermore, these limitations constitute (b) “a mental process” because labelling a portion of a source document containing data relevant to the answer of questions in a clinical trial questionnaire is making a decision which is an observation/evaluation/analysis that can be performed in the human mind or with a pen and paper. The foregoing underlined limitations also relate to claim 39 (similarly to claim 31).
Accordingly, the claim describes at least one abstract idea.
In relation to claims 35-36 and 43-44, these claims merely recite specific kinds of data, such as: claims 35 & 43 - the description corresponding to the labeled portion of the source document comprises a medical chart and claims 36 & 44 - the labeled portion of the source document is labeled with a device selected form the group comprising: a computer software drawing tool; a computer software labeling tool; a mobile telephone application software configured to receive stylus input; and mobile telephone application software configured to receive touch screen input, and claim 47 - select, by the input of the plurality of variables to the machine learning model, a set of predictor-parameters from the plurality of variables.
In relation to claims 32-34, 37-38, 40-42 and 45-49, these claims merely recite determining steps such as: claims 32 & 40 - questions is superimposed on a screen of a first display device, claims 33 & 41 - the answer to one or more of the one or more questions in the clinical trial questionnaire form is automatically entered into the clinical trial questionnaire form, claims 34 & 42 - the source document is selected from a portion of a document generated from the group comprising an output from, claims 37 & 48 - the user selects a label from a schedule of items, claims 38 & 49 - the schedule of items is generated from questions included in the clinical trial questionnaire, claim 45 - the identified portion of the source document is labeled to identify the relevant data the identified portion of the source document contains, claim 46 - the identified portion of the source document is labeled to add one or more comments relating to the data application to a clinical study and claim 47 - a user selects and labels a portion of a source document.
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 31 and 39, 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, a screen of a first display device, a device, a computer software drawing tool, a computer software labeling tool, a mobile telephone application software, a computer screen capture software, a portable computer and at least one processor 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 “certain methods of organizing human activity” and “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, screen of a first display device, device, computer software drawing tool, computer software labeling tool, mobile telephone application software, computer screen capture software, portable computer and at least one processor 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 “to receive input from a user ……” and “to receive touchscreen input” the Examiner submits that this additional limitation merely adds insignificant pre-solution activity (data gathering; selecting data to be manipulated) to the at least one abstract idea (see MPEP § 2106.05(g)).
Regarding claims 34 and 42, the additional limitations “a digital camera”, “a medical scanner” and “an imaging machine” the Examiner submits that this additional limitation amounts to merely using a computer, to gather information 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 claims 31 and 39, regarding the additional limitations of the computerized system, screen of a first display device, device, computer software drawing tool, computer software labeling tool, mobile telephone application software, computer screen capture software, portable computer and at least one processor, 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 31 and analogous independent claim 39 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 31-49 are ineligible under 35 USC §101.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 31- are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lyon (WO 2015/054290 A1).
Claim 31:
Lyon discloses A computerized system for labeling a portion of a source document containing data relevant to the answer of one or more questions in a clinical trial questionnaire (With the source document as interactive documentation described and recorded by a physician such as the patient’s complaints, prior conditions, medications, allergies, physical examination findings, lab tests, imaging tests, and plan, see the Digital Data Collection System (DDCS) with customizable digital data collection software and screenshots (Fig. 7-21) in P00087-P00088 and exemplary collections of a patient’s current and past medical history, past and/or current symptoms, complaints, medications, surgeries, VAS scores, Oswestry scores, questions and/or any combination in P000146-P000147, P000155.), comprising:
at least one processor configured to receive input from a user to label a portion of a source document as including a description that comprises an answer to one or more questions in a clinical trial questionnaire form, the description including one or more alphanumeric characters (See identification data tags in P000102-P000103 when identifying modified- validated questionnaires and custom questionnaires and see processor in P000149. Also see [P000137] the DDCS may allow the physician/clinician, staff, insurance payor, and/or patient to make comments, highlights, tag or status flags to any of the items during the trial IPP process.);
the at least one processor answering one or more of the one or more questions in the clinical trial questionnaire form without the user having to enter patient information into a new form (See, P000103-P000104 where the survey questions in the “patient dashboard” summary includes readily accessing full details of the patient’s results, visit, pain levels and scores without a need to convert the full details into a new form shown in Fig. 16B-17 Items 1250 & 1260. Also, see voice operated function in P000101 and attaching pdf, hyperlinks or html as supportive documents in P000136.); and
wherein the clinical trial questionnaire therefore shows the entry of the answer (See Fig. 16B-21, P000103-P000104 where the “patient dashboard” summary is reflected of answered questions about the patient’s full detail, leg pain levels, VAS scores, Oswestry scores and overall satisfaction.).
Regarding claims 32 and 40, Lyon discloses the computerized system of claim 31 and claim 40, wherein at least one of the at least one or more questions is superimposed on a screen of a first display device (See P0083 where the physician can report superimposed data on the graphs.).
Regarding claims 33 and 41, Lyon discloses the computerized system of claim 31 and claim 40, wherein the description that comprises the answer to one or more of the one or more questions in the clinical trial questionnaire form is automatically entered into the clinical trial questionnaire form by the processor (See automatic data entries in P00013 and automatically prepopulated form in P00021.).
Regarding claims 34 and 42, Lyon discloses the computerized system of claim 31 and claim 40, wherein the labeled portion of the source document is selected from a portion of a document generated from the group comprising an output from: a digital camera; a computer screen capture software; a mobile telephone; a medical scanner; an imaging machine; and a portable computer (See digital data capture in P0006, audio and video inputs in P00011, tablets, smart mobile phones, computers, PDAs, and other mobile computer type devices in P00017, P00066 and a patient-specific 3D virtual anatomical image and/or model in P000111.).
Regarding claims 35 and 43, Lyon discloses the computerized system of claim 31 and claim 40, wherein the description corresponding to the labeled portion of the source document comprises a medical chart (See medical chart mentioned in P000119-P000120.).
Regarding claims 36 and 44, Lyon discloses the computerized system of claim 31 and claim 40, wherein the labeled portion of the source document is labeled with a device selected form the group comprising: a computer software drawing tool; a computer software labeling tool; a mobile telephone application software configured to receive stylus input; and mobile telephone application software configured to receive touch screen input (See touchscreen, finger drawing a box, dragging, highlighting, shading, tagging, zooming, magnifying and 3D computer aided design (CAD) programs in P000114, P000116-P000117.).
Regarding claim 37, Lyon discloses the computerized system of claim 35, wherein the user selects a label from a schedule of items (See scheduling and ordering physician interaction with patient in P00012 and automated prescription feature in P000157.).
Regarding claim 38, Lyon discloses the computerized system of claim 37, wherein the schedule of items is generated from questions included in the clinical trial questionnaire (See P00012 question and survey responses automatically transmitted to practitioners and physicians, P000101 automatically continue to the next question after answering a previous question.).
Claim 39:
Lyon discloses A computerized system for answering of one or more questions in a clinical trial questionnaire from data contained in a source document (With the source document as interactive documentation described and recorded by a physician such as the patient’s complaints, prior conditions, medications, allergies, physical examination findings, lab tests, imaging tests, and plan, see the Digital Data Collection System (DDCS) with customizable digital data collection software and screenshots (Fig. 7-21) in P00087-P00088 and exemplary collections of a patient’s current and past medical history, past and/or current symptoms, complaints, medications, surgeries, VAS scores, Oswestry scores, questions and/or any combination in P000146-P000147, P000155.), comprising:
at least one processor configured to automatically identify a portion of a source document as including a description that comprises an answer to one or more questions in a clinical trial questionnaire form, the description including one or more alphanumeric characters (See identification data tags in P000102-P000103 when identifying modified- validated questionnaires and custom questionnaires and see processor in P000149. Also see [P000137] the DDCS may allow the physician/clinician, staff, insurance payor, and/or patient to make comments, highlights, tag or status flags to any of the items during the trial IPP process.);
the at least one processor allowing a user to answer one or more of the one or more questions in the clinical trial questionnaire form without the user having to enter patient information into a new form (See, P000103-P000104 where the survey questions in the “patient dashboard” summary includes readily accessing full details of the patient’s results, visit, pain levels and scores without a need to convert the full details into a new form shown in Fig. 16B-17 Items 1250 & 1260. Also, see voice operated function in P000101 and attaching pdf, hyperlinks or html as supportive documents in P000136.).
Lyon discloses A computerized system for labeling a portion of a source document containing data relevant to the answer of one or more questions in a clinical trial questionnaire (With the source document as interactive documentation described and recorded by a physician such as the patient’s complaints, prior conditions, medications, allergies, physical examination findings, lab tests, imaging tests, and plan, see the Digital Data Collection System (DDCS) with customizable digital data collection software in P00087-P00088 and exemplary collections of a patient’s current and past medical history, past and/or current symptoms, complaints, medications, surgeries, VAS scores, Oswestry scores, questions and/or any combination in P000146-P000147, P000155.), comprising:
at least one processor configured to receive input from a user to label a portion of a source document as including a description that comprises an answer to one or more questions in a clinical trial questionnaire form, the description including one or more alphanumeric characters (See identification data tags in P000102-P000103 when identifying modified- validated questionnaires and custom questionnaires and see processor in P000149. Also see [P000137] the DDCS may allow the physician/clinician, staff, insurance payor, and/or patient to make comments, highlights, tag or status flags to any of the items during the trial IPP process.);
the at least one processor answering one or more of the one or more questions in the clinical trial questionnaire form without the user having to enter patient information into a new form (See, P000103-P000104 where the survey questions in the “patient dashboard” summary includes readily accessing full details of the patient’s results, visit, pain levels and scores without a need to convert the full details into a new form shown in Fig. 16B-17 Items 1250 & 1260. Also, see voice operated function in P000101 and attaching pdf, hyperlinks or html as supportive documents in P000136.); and
wherein the clinical trial questionnaire therefore shows the entry of the answer (See Fig. 16B-21, P000103-P000104 where the “patient dashboard” summary is reflected of answered questions about the patient’s full detail, leg pain levels, VAS scores, Oswestry scores and overall satisfaction.).
Regarding claim 45, Lyon discloses the computerized system of claim 39, wherein the identified portion of the source document is labeled to identify the relevant data the identified portion of the source document contains (See [P00011] a variety of information input formats (i.e., accepting both sensory as well as audio input for patient answers to survey questions or utilize video inputs) that allow patients and/or caregivers to select an optimal combination of information "outputs" and "inputs" to facilitate the patient's completion of the survey and/or the caregiver's entry of relevant data. Also, see comments, highlights, tags or status flags to any of the items in P000137.).
Regarding claim 46, Lyon discloses the computerized system of claim 39, wherein the identified portion of the source document is labeled to add one or more comments relating to the data application to a clinical study (See comments mentioned in P00077, P00082 and P000137.).
Regarding claim 47, Lyon discloses the computerized system of claim 39, wherein a user selects and labels a portion of a source document (See menu, selectable options in P00064, P00077, P00082. Also, see identification data tags in P000102-P000103 when identifying modified- validated questionnaires and custom questionnaires.).
Regarding claim 48, Lyon discloses the computerized system of claim 47, wherein the user selects a label from a schedule of items (See scheduling and ordering physician interaction with patient in P00012 and automated prescription feature in P000157.).
Regarding claim 49, Lyon discloses the computerized system of claim 48, wherein the schedule of items is generated from questions included in the clinical trial questionnaire (See P00012 question and survey responses automatically transmitted to practitioners and physicians, P000101 automatically continue to the next question after answering a previous question.).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure (See Pierce (US 2008/0256128 A1) & Udani (US 2012/0323805 A1).).
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 04/14/2026
/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687
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