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 .
DETAILED ACTION
This is the first action on the merits. Claims 1-14 are currently pending.
Priority
This application claims priority from Provisional Application Nos. 63307759 dated 02/08/2022.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 05/08/2023 and 08/15/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(I) because the following figure(s) is/are unreadable and/or are unsatisfactory for reproduction:
Fig. 1 and 2
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1-14 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.
Claims 1, 9 and 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites a method and a system for clinical trial verification.
Regarding claim 1, the limitation of completing an electronic Case Report Form (eCRF) in a clinical trial study, maintaining the eCRF; maintaining and displaying a source document (SD) containing information relevant to at least one question in the eCRF; creating a source capture (SC) that is at least a portion of the SD; enabling a verification system for automatically marking the SC as verified or marking the SC as unverified; allow a remote user to review the SC and change the verification status of the SC and regarding claim 9, the limitation of managed by a first user and maintaining and displaying a source document (SD); managed by a second user and maintaining at least one source capture (SC) created from the SD, the SC containing information that is relevant to at least one question on the eCRF; permits the first user to permit remote access to the SD on the first device so that the second user can remotely compare information shown in the SD with information contained in the SC and regarding claim 10, the limitation of initiating a video conference between an investigator; the investigator selecting and displaying the SD and screen sharing; comparing information on the SD visible with the SC; determining, based on the visible information, whether the SC is authentic or not authentic as crafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. That is other than reciting (in claim 1) a computerized system, at least one processor and a video conference system, (in claim 9) a video conference system and (in claim 10) a monitor, the claimed invention amounts to managing personal behavior or interaction between people (i.e., rules or instructions). For example, but for a computerized system, at least one processor, a video conference system and monitor, the claims encompass maintaining the eCRF, maintaining, selecting and displaying a source document (SD), creating and maintaining a source capture (SC), automatically marking the SC as verified or marking the SC as unverified, allow a remote user to review the SC and change the verification status of the SC, permits the first user to permit remote access to the SD, compare information shown in the SD with information contained in the SC and determining, based on the visible information, whether the SC is authentic or not authentic in the manner described in the identified abstract idea, supra. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, claim 1 recites the additional elements of a computerized system, at least one processor and a video conference system. Claim 9 recites the additional element of a video conference system. Claim 10 recites the additional element of a monitor. These additional elements are not exclusively defined by the applicant and are recited at a high-level of generality (i.e., or generic computer components for performing generic computer functions) such that they amount to no more than mere instructions to apply the exception using generic computer components. As set forth in MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application. 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. The claim is directed to an abstract idea.
Claim 1 further recite the additional element of a first device. Claim 9 recite the additional elements of a first device and a second device. Claim 10 recite the additional element of an investigator's user interface. The additional element of a first and second device are recited at a high level of generality (i.e. a general means to output/receive/transmit data) and amount to extra solution activity. The additional element of an investigator's user interface merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
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, the additional elements of a computerized system, at least one processor, a video conference system and monitor to perform the noted steps amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”). Moreover, using generic computer components to perform abstract ideas does not provide a necessary inventive concept. See Alice, 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention”). Therefore, whether considered alone or in combination, the additional elements do not amount to significantly more than the abstract idea.
Also as discussed above with respect to integration of the abstract idea into a practical application, the additional element of a first device and a second device were considered extra-solution activity. The additional element of an investigator's user interface was determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under “significantly more” analysis and determined to be well-understood, routine and conventional activity in the field. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. MPEP 2016.05(d)(II) indicates that receiving and/or transmitting data over a network has been held by the courts to be well-understood, routine and conventional activity (citing Symantec, TLI Communications, OIP Techs., and buySAFE). Well-understood, routine and conventional activity cannot provide an inventive concept (“significantly more”). Therefore when considering the additional elements alone, and in combination, there is no inventive concept in the claim, and thus the claim is not patent eligible.
The examiner notes that: A well-known, general-purpose computer has been determined by the courts to be a well-understood, routine and conventional element (see, e.g., Alice Corp. v. CLS Bank; see also MPEP 2106.05(d));
Claims 2-8 and 11-14 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Claim(s) 2 further merely describe(s) maintaining a verified version of the SC, providing a view of the verified SC and maintaining a record of confirmation by the verifying party of the verified status of the SC, which further define/narrow the abstract idea. Claim(s) 3 further merely describe(s) permitting the verifying party to create a new SC of the SD, which further define/narrow the abstract idea. Claim(s) 4 further merely describe(s) a masking tool for redacting one or more portions of the new SC, which further define/narrow the abstract idea. Claim(s) 5 further merely describe(s) the redacted one or more portions of the new SC are not retained, which further define/narrow the abstract idea. Claim(s) 6 further merely describe(s) the redacted one or more portions of the new SC includes personally identifiable information, which further define/narrow the abstract idea. Claim(s) 7 further merely describe(s) the redacted one or more portions of the new SC are retained, which further define/narrow the abstract idea. Claim(s) 8 further merely describe(s) the retained one or more redacted portions of the new SC may be unredacted by an authorized user of the computerized system, which further define/narrow the abstract idea. Claim(s) 11 further merely describe(s) recording and storing the video conference, which further define/narrow the abstract idea. Claim(s) 12 further merely describe(s) taking a new SC when the SC is not authentic, which further define/narrow the abstract idea. Claim(s) 13 further merely describe(s) masking one or more portions of the new SC for redacting, which further define/narrow the abstract idea. Claim(s) 14 further merely describe(s) the redacted one or more portions of the new SC are not retained, which further define/narrow the abstract idea.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Ford (US 2017/0041296) and in further view of Emili (US 2017/0147793).
REGARDING CLAIM 1
Ford discloses a computerized system for completing an electronic Case Report Form (eCRF) in a clinical trial study, the system comprising: at least one processor maintaining the eCRF on a first device (Ford at [0328] teaches enrolling patients and monitoring clinical study, including ensuring that the staff is well versed with the trial's documentation (e.g., the protocol, informed consent forms, safety guidelines, case report forms), managing the product and drug inventory, scheduling patient visits, gathering data, reporting adverse events, and the like. The clinical trial management facility may improve this process through providing secure mobile platform facilities (e.g., mobile access to documentation associated with investigator sites) [0330] teaches a trial master file (TMF) and case report forms (CRFs). [0331] teaches the clinical trial management facility may provide for an electronic trial master file (eTMF), electronic investigator site file (eISF) and [0335] teaches filing and managing of essential documents in the electronic investigator-controlled site file (eISF), including through easy-to-use desktop integrated browsing of the electronic investigator site file (interpreted by examiner as at least one processor maintaining the eCRF on a first device)); at least one processor maintaining and displaying a source document (SD) containing information relevant to at least one question in the eCRF ([0102] teaches the display of various data. [0330] teaches the investigator site file contains source documents and [0333] teaches answer the study question and that the investigational site file provides support documentation to assess the quality of the study and its results. [0340] teaches source document stored in the enterprise database (interpreted by examiner as at least one processor maintaining and displaying a source document (SD) containing information relevant to at least one question in the eCRF)); at least one processor for creating a source capture (SC) that is at least a portion of the SD ([0210] teaches screen capture and [0479] teaches capturing user specific information (interpreted by examiner as means for creating a source capture (SC) that is at least a portion of the SD));
Ford does not explicitly disclose, however Emili discloses:
at least one processor enabling a verification system for automatically marking the SC as verified or marking the SC as unverified (Emili at [0002] teaches the verification of data in the medical files of the patients and [0003] teaches the administrator of the clinical data verifies the consistency and completeness of the medical files of the patients. [0004] teaches the clinical researcher is usually sent by the sponsor of the clinical trial with the task of verification of the source data, and in particular verification of the consistency and the correspondence of the data contained in the medical files with the content of the CRF signed by the doctor. Furthermore the researcher has the task of verifying that all the data necessary to the trial are present (interpreted by examiner as means for automatically marking the SC as verified or marking the SC as unverified). [0036] teaches means of acquisition comprise devices for the capture of an item of information associated with the data collected for the clinical trial and shown on the work surface (interpreted by examiner as the source capture of Ford)); and at least one processor maintaining a video conference system, wherein the video conferencing system may be activated to allow a remote user to review the SC and change the verification status of the SC (Emili at [0001] teaches remote monitoring and supervision of data, particularly for activities associated with clinical trials. [0033] teaches video conferencing and [0042] teaches a video call between the data administrator and the supervisor and the sharing of the content of the screen of the means 1a by way of conventional functionalities such as desktop sharing. [0048] teaches making requests for documents for examination and [0004] teaches verification of the consistency and the correspondence of the data contained in the medical files with the content of the CRF (interpreted by examiner as at least one processor maintaining a video conference system, wherein the video conferencing system may be activated to allow a remote user to review the SC and change the verification status of the SC)).
It would have been obvious for one of the ordinary skill in the art before the effective filling date of the claimed invention to have modified the systems and methods of secure clinical trial data exchange of Ford to incorporate the verification system and remote processes as taught by Emili, with the motivation of providing a system capable of enabling the remote supervision of data for clinical trials and at the same time of guaranteeing the protection of these data from unauthorized consultation or from loss. (Emili at [0012]).
REGARDING CLAIM 2
Ford and Emili disclose the limitation of claim 1.
Emili does not explicitly disclose, however Ford further discloses:
The computerized system of claim 1, further comprising: the at least one processor maintaining a verified version of the SC; the video conference system providing a view of the verified SC to a verifying party; and the at least one processor maintaining a record of confirmation by the verifying party of the verified status of the SC (Ford at [0182] teaches verifying changes to documents through indicators of modification, or “modification stamps”. [0339] teaches in embodiments, a document audit history being retained, such as for a period of time, until a verification step is completed in association with the document being stored within the document tracker database (interpreted by examiner as maintaining a verified version of the SC, providing a view of the verified SC and maintaining a record of confirmation by the verifying party of the verified status of the SC)).
REGARDING CLAIM 3
Ford and Emili disclose the limitation of claim 2.
Ford does not explicitly disclose, however Emili further discloses:
The computerized system of claim 2, wherein the system further comprises the video conference system further permitting the verifying party to create a new SC of the SD (Emili at [0061] teaches during the viewing of the documents, the supervisor remains in communication, for example by way of the video call that was set up previously, with the administrator so as to be able to make further requests such as for example for new documents thereof on the work surface (interpreted by examiner as wherein the system further comprises the video conference system further permitting the verifying party to create a new SC of the SD)).
REGARDING CLAIM 4
Ford and Emili disclose the limitation of claim 3.
Emili does not explicitly disclose, however Ford further discloses:
The computerized system of claim 3, further comprising a masking tool for redacting one or more portions of the new SC (Ford at [0220] teaches providing the ability to redact (interpreted by examiner as further comprising a masking tool for redacting one or more portions of the new SC)).
REGARDING CLAIM 5
Ford and Emili disclose the limitation of claim 4.
Emili does not explicitly disclose, however Ford further discloses:
The computerized system of claim 4, wherein the redacted one or more portions of the new SC are not retained by the computerized system (Ford at [0084] teaches other data exchanges, such as of particularly sensitive information, may be exchanged using orchestration services 165 in a manner that does not allow the intermediate host to have access to the data; that is, the capabilities of FIGS. 1A and 1B can be deployed as a hybrid secure exchange system that may include, for example, both centralized (for some data) and distributed (for other data) secure exchange functionality. [0184] teaches a secure viewing application may enable the sharing of the text of a document or proposal, but obfuscate the figures or images at various times, such as to prevent data leakage by the taking of screenshots or detecting another person looking over the reader's shoulder, etc. In embodiments, certain selective portions of a document (e.g., figures, images, text) may be obscured or redacted except while a user of the device is touching the touchscreen of the device, or while the user of the device is touching the touchscreen of the device and for a brief period thereafter (interpreted by examiner as wherein the redacted one or more portions of the new SC are not retained by the computerized system)).
REGARDING CLAIM 6
Ford and Emili disclose the limitation of claim 4.
Emili does not explicitly disclose, however Ford further discloses:
The computerized system of claim 4, wherein the redacted one or more portions of the new SC includes personally identifiable information (Ford at [0288] teaches some content may have a mix of relevant content and other content that needs to be redacted, or for which portions may be reviewed only by a limited set of eyes for the counter-party to a litigation or other dispute. For example, technology trade secrets in an intellectual property dispute may be limited to “counsel's eyes only,” so that non-attorney individuals of the counter-party are not supposed to see trade secret portions of materials. In such cases, document editing tools and rights management tools may be used, such as in a secure exchange, to block certain portions of content from access, except by individuals that have appropriate access credentials to view the content (interpreted by examiner as wherein the redacted one or more portions of the new SC includes personally identifiable information)).
REGARDING CLAIM 7
Ford and Emili disclose the limitation of claim 4.
Emili does not explicitly disclose, however Ford further discloses:
The computerized system of claim 4, wherein the redacted one or more portions of the new SC are retained by the computerized system (Ford at [0184] teaches in embodiments, only that portion of a document within a window on the touchscreen of the device is visible, with the window being movable as the user moves or scrolls their finger on screen in order to enable viewing of different portions of the document (interpreted by examiner as wherein the redacted one or more portions of the new SC are retained by the computerized system)).
REGARDING CLAIM 8
Ford and Emili disclose the limitation of claim 7.
Emili does not explicitly disclose, however Ford further discloses:
The computerized system of claim 7, wherein the retained one or more redacted portions of the new SC may be unredacted by an authorized user of the computerized system (Ford at [0184] teaches in embodiments, a list of documents may be presented on one side of the touchscreen, and by pressing and holding an item on the list, a preview or abstract of the associated document can be seen while the user continues to press and hold. A separate way may then exist in order for the user to obtain or view the full document. The secure viewing application may be embodied in software compatible with or utilizing functionality provided by the operating system of the mobile device on which it runs, implemented through device hardware associated with the mobile device touch screen, and the like (interpreted by examiner as wherein the retained one or more redacted portions of the new SC may be unredacted by an authorized user of the computerized system)).
REGARDING CLAIM 9
Claim 9 is analogous to Claim 1 thus Claim 9 is similarly analyzed and rejected in a manner consistent with the rejection of Claim 1. Emili further discloses a video conference system that permits the first user to permit remote access to the SD on the first device so that the second user can remotely compare information shown in the SD with information contained in the SC (Emili at [0033] teaches software for video conferencing. [0036] teaches means of acquisition comprise devices for the acquisition of video flows and stills and particularly for the capture of an item of information associated with the data collected for the clinical trial and shown on the work surface, which make it possible to optimally display images of the documents shown on the work surface. Preferably, the means of acquisition are provided with logic and hardware which are such as to be able to receive control commands from the processing means. [0060] teaches the supervisor asks the data administrator to exhibit some paper documents for example the medical file of the patient and the CRF document. The data administrator, after having retrieved them from the archive, exhibits them on the work surface. [0004] teaches the clinical researcher is tasked with supervising and verifying the quality and quantity of the data acquired during the trial and kept by the data administrator. Typically, the clinical researcher is usually sent by the sponsor of the clinical trial with the task of verification of the source data, and in particular verification of the consistency and the correspondence of the data contained in the medical files with the content of the CRF signed by the doctor. Furthermore the researcher has the task of verifying that all the data necessary to the trial are present.).
REGARDING CLAIM 10
Claim 10 is analogous to Claims 1 and 9 thus Claim 10 is similarly analyzed and rejected in a manner consistent with the rejection of Claims 1 and 9.
REGARDING CLAIM 11
Ford and Emili disclose the limitation of claim 10.
Ford does not explicitly disclose, however Emili further discloses:
The method as recited in claim 10, further comprising recording and storing the video conference (Emili at [0050] teaches saving of information relating to the documents placed on the work surface. In other words the means 2a′″ do not allow the saving of information, i.e. of the video stream and images of the documents (interpreted by examiner as recording and storing the video conference)).
REGARDING CLAIM 12
Ford and Emili disclose the limitation of claim 10.
Ford does not explicitly disclose, however Emili further discloses:
The method as recited in claim 10, further comprising taking a new SC when the SC is not authentic (Emili at [0061] teaches during the viewing of the documents, the supervisor remains in communication, for example by way of the video call that was set up previously, with the administrator so as to be able to make further requests such as for example for new documents thereof on the work surface (interpreted by examiner as comprising taking a new SC when the SC is not authentic)).
REGARDING CLAIM 13
Ford and Emili disclose the limitation of claim 12.
Ford does not explicitly disclose, however Emili further discloses:
The method as recited in claim 12, further comprising masking one or more portions of the new SC for redacting (Emili at [0003] teaches since the data collected are personal information and information relating to the state of health of the patients involved in the trial (i.e. sensitive data), the handling of such data requires not only that the patients sign an “informed consent” document but also that rigorous procedures be put in place, for which the administrator of the data is partially responsible, for protecting these data in order to safeguard the confidentiality of the patients (interpreted by examiner as comprising masking one or more portions of the new SC for redacting)).
REGARDING CLAIM 14
Ford and Emili disclose the limitation of claim 4.
Emili does not explicitly disclose, however Ford further discloses:
The computerized system of claim 4, wherein the redacted one or more portions of the new SC are not retained by the computerized system (Ford at [0084] teaches other data exchanges, such as of particularly sensitive information, may be exchanged using orchestration services 165 in a manner that does not allow the intermediate host to have access to the data; that is, the capabilities of FIGS. 1A and 1B can be deployed as a hybrid secure exchange system that may include, for example, both centralized (for some data) and distributed (for other data) secure exchange functionality. [0184] teaches a secure viewing application may enable the sharing of the text of a document or proposal, but obfuscate the figures or images at various times, such as to prevent data leakage by the taking of screenshots or detecting another person looking over the reader's shoulder, etc. In embodiments, certain selective portions of a document (e.g., figures, images, text) may be obscured or redacted except while a user of the device is touching the touchscreen of the device, or while the user of the device is touching the touchscreen of the device and for a brief period thereafter (interpreted by examiner as wherein the redacted one or more portions of the new SC are not retained by the computerized system)).
Conclusion
The prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Ikeguchi (US 2017/0147792) teaches electronic data document for use in clinical trial verification system and method.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIZA TONY KANAAN whose telephone number is (571)272-4664. The examiner can normally be reached on Mon-Thu 9:00am-6:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached on 571-272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.T.K./Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683
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