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
Status of Claims
The present Office Action is pursuant to Applicant’s communication on 05-25-2023; this application1 is a 371 of PCT/US21/62095 12/07/2021; PCT/US21/62095 has PRO of 63122677 12/08/2020.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 05-25-2023, have been acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Patentability Summary
Independent claim(s) 1 and dependent claim(s) 2-10 is/are directed to a technical solution to a technical problem associated with verifying that one or more captured screenshots is of a correct study subject by using one or more data points for verification by employing an EMR system, wherein logging into the EMR system is performed on behalf of a user using securely stored credentials, automatically selecting correct navigation links of the EMR page with desired information for a correct study subject’s record and visit date, capturing one or more screenshots of one or more relevant pages containing the desired information for answering one or more questions on a case report form2.
Thus, based on the aforementioned summary, the combination of limitations corresponding to the aforementioned claim(s) is/are patent eligible.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-10 are rejected, consisting of independent claim(s): 1 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. The rejection is based upon MEPP 2161.01 whose last paragraph is included here:
I. DETERMINING WHETHER THERE IS ADEQUATE WRITTEN DESCRIPTION FOR A COMPUTER-IMPLEMENTED FUNCTIONAL CLAIM LIMITATION
When examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter. Specifically, if one skilled in the art would know how to program the disclosed computer to perform the necessary steps described in the specification to achieve the claimed function and the inventor was in possession of that knowledge, the written description requirement would be satisfied. Id. If the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention including how to program the disclosed computer to perform the claimed function, a rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, for lack of written description must be made. For more information regarding the written description requirement, see MPEP § 2161.01- § 2163.07(b). The specification does not indicate that the Applicant had possession of the invention. See also LizardTech, Inc. v. Earth Res. Mapping, Inc., 424 F.3d 1336, 1343-46 (Fed.Cir. 2005) and MPEP § 2161.01- § 2163.07(b). Specifically, the following limitation(s) element(s) are at issue:
Automatically selecting correct navigation links of the EMR system and filling out the appropriate navigation forms to reach an EMR page with desired information for a correct study subject’s record and visit date; [claim(s) 1]
“verifying that one or more captured screenshots is of the correct study subject by using one or more data points for verification” [claim(s) 1]
As currently written, Applicant’s claims read as a generic invention capable of said element(s). Regarding the aforementioned element(s), while the Applicant discusses these elements at a high level of generality (see disclosure citations), the disclosure’s reference to these limitation in general terms but not providing the specific technology details, said functional language constituting a wish, the Applicant describing a wish for a final result in the specification, or a wish for a final result(s). Disclosure of function alone does not satisfy the written description requirement; it amounts to little more than a wish for possession (see Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing “a result that one might achieve if one made that invention”); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984)). Not only has Applicant failed to provide support for the genus of said element(s), the specific examples provided by Applicant only illustrate the aforementioned steps at a high level of generality or abstraction, but also do not adequately disclose the specific algorithm and/or sequence of solution step(s) required to demonstrate possession of the aforesaid element(s).
The Office notes that one of skill in the art may be able to make and use an invention that comprises the aforementioned steps. However, this finding supports the enablement requirement of § 112(a) rather than the written description requirement – it should also be noted that connectedly, “predictability or lack thereof in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention3”, a determination thereof which supports the enablement requirement, rather than the written description requirement4; it is even “possible for a specification to enable the practice of invention as broadly as it is claimed, and still not describe that invention”5 - it should also be noted that “conclusive evidence of a claim's enablement is not equally conclusive of that claim's satisfactory written description” and that “The ‘written description’ requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed” Capon v. Eshhar, 418 F.3d 1349,1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent’s term; it should be further noted that Compliance with the written description requirement is a question of fact which must be resolved on a case-by-case basis. Vas-Cath, Inc. v. Mahurkar, 935F.2d at 1563, 19 USPQ2d at 1116 (Fed. Cir. 1991)6. The Applicant is duly reminded that as stated in the MPEP regarding, “determining whether there is adequate written description for a computer-implemented functional claim limitation”, if “the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of skill in the art that the inventor possessed the invention, including how to program the disclosed computer to perform the claimed functions, a rejection under 35 U.S.C. 112, first paragraph for lack of written description must be made”7. Consequently, Independent claim(s): 1 and dependent claim(s) 2-10 is/are respectively rejected as lacking sufficient detail such that one of ordinary skill in the art can reasonably conclude that the Applicant invented the claimed subject matter.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ikeguchi (US 2017/0147792) in view of Sethre (US 2021/0210175) and further in view of Vcelak8.
Regarding claim(s) 1, Ikeguchi discloses: A method for electronic verification of a source for a source capture in a clinical trial workflow system, the method comprising:
opening an EMR system (i.e., having access to patient information in an EMR, consistent with Ikeguchi disclosure, FIG 7); [FIG 3)
logging into the EMR system on behalf of a user using securely stored credentials (i.e., wherein public key/private key pair encryption is employed in electronic communications wherein a server confirms authenticity of users communicating with a server, said users logging on with authenticated private credentials, wherein any information stored while they are being transferred are protected by encryption); [¶53]
Regarding [b], Ikeguchi does not explicitly disclose, as disclosed by Sethre logging into the EMR system on behalf of a user using securely stored credentials (i.e., employing mechanisms such as OAuth to enabling access on behalf of a user); [¶28: employing an “OAuth. … authorization framework … to access EHR resources”, resources such as “104A … [and 104B … 104C as depicted in FIG 1]” from EHR system … “10]
Sethre discloses:
automatically selecting correct navigation links of the EMR system and filling out the appropriate navigation forms to reach an EMR page with desired information for a correct study subject's record and visit date (i.e., based on delegated permissions provided by Oauth mechanism and authorizations provided, to navigate to required resources, consistent with Ikeguchi disclosure, ¶119); [As depicted in ¶28, FIG 1)]
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Ikeguchi, including mechanism(s) [c], as taught by Sethre. One of ordinary skill would have been so motivated to employ said mechanism(s) to ensure not HIPAA data compliance in association with ensuring data integrity and permissions on behalf of a user. [¶28, FIG 1)]
Regarding [c] Ikeguchi discloses information for a correct study subject's record and visit date (i.e., thereby allowing the investigator to note that the EDD is truthful and representative of the patient, dates, and information submitted in response to the clinical trial questionnaire); [¶41: “thereby allowing the investigator to note that the EDD is truthful and representative of the patient, dates, and information submitted in response to the clinical trial questionnaire”]
Ikeguchi discloses:
capturing one or more screenshots of one or more relevant pages containing the desired information for answering one or more questions on a case report form (CRF) (i.e., capturing snippets that map answers corresponding to evidence with questions associated with a clinical study participant); [¶¶38-40: “what is the patient’s blood pressure?” and marking associated with response to question “[b]ood pressure” to “link the question to the revealed portion (“the evidence”)”, employing questions that are “automatically superimposed … such that the investigator could reveal relevant portions of the SD to answer questions”] and
verifying that the one or more captured screenshots is of the correct study subject by using one or more data points for verification (i.e., employing electronic signatures to enable an investigator confirm a study’s veracity by confirming patient information and dates related to a clinical trial); [¶41: “thereby allowing the investigator to note that the EDD is truthful and representative of the patient, dates, and information submitted in response to the clinical trial questionnaire”]
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Ikeguchi, including mechanism(s) [b]-[c], as taught by Sethre. One of ordinary skill would have been so motivated to employ said mechanism(s) to ensure HIPAA data compliance. [13:1-25, claim 1; 16:1-53]
Regarding [c], [e], while Ikeguchi discloses in ¶41 information corresponding to visit dates as represented by “dates” associated with a clinical trial to ensure information is “truthful and representative of the patient”, Ikeguchi does not explicitly disclose information for a correct study subject’s record (i.e., a study’s name) before redaction, as disclosed by Vcelak; [Page 128, wherein “controlled searching in archives where reversibly de-identified medical images are stored” and Page 129 section 2.1 wherein “address, age, birth date/number, name and sex” are identified, employing OCR technologies]
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Ikeguchi, including mechanism(s) [c], [e], as taught by Vcelak. One of ordinary skill would have been so motivated to employ said mechanism(s) to ensure not only HIPAA data compliance but also compliance with a clinical trial’s goals. [Pages 128-129]
Regarding claim(s) 2, Ikeguchi-Sethre-Vcelak as a combination discloses: The method as recited in claim 1, Vcelak disclosing: wherein the verifying includes:
real-time scanning by the clinical trial system of the one or more screenshot captures to detect the presence of keywords of the one or more data points (i.e., employing OCR mechanisms to identify keywords); [Page 128, wherein “controlled searching in archives where reversibly de-identified medical images are stored” and Page 129 section 2.1 wherein “address, age, birth date/number, name and sex” are identified, employing OCR technologies]
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Ikeguchi, including mechanism(s) [a], as taught by Vcelak. One of ordinary skill would have been so motivated to employ said mechanism(s) to ensure not only HIPAA data compliance but also compliance with a clinical trial’s goals. [Pages 128-129] and
Ikeguchi discloses:
assessing if the one or more captured screenshots is verified or unverified, wherein the one or more captured screenshots is labeled verified if a defined number of the one or more data points is positively identified in the one or more captured screenshots by the clinical trial system, wherein the one or more captured screenshots is labeled unverified if the defined number of the one or more data points are not positively identified by the clinical trial system (i.e., wherein a threshold number of questions and answers represented by questions that must be submitted by an investigator and responded to, as identified by employing a CRF, consistent with Ikeguchi disclosure, ¶4). [¶3]
Regarding claim(s) 3, Ikeguchi-Sethre-Vcelak as a combination discloses: The method as recited in claim 2, wherein the data points include
Vcelak discloseing:
a study subject's first and last name, a study subject's date of birth [Page 129 section 2.1]
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Ikeguchi, including mechanism(s) [a], as taught by Vcelak. One of ordinary skill would have been so motivated to employ said mechanism(s) to ensure not only HIPAA data compliance but also compliance with a clinical trial’s goals. [Pages 128-129]
Ikeguchi disclosing:
a study subject's visit date (i.e., wherein “dates” associated with a clinical trial correspond to a subject’s visit dates). [¶41]
Regarding claim(s) 4, Ikeguchi-Sethre-Vcelak as a combination discloses: The method as recited in claim 2, Ikeguchi discloses: further comprising a manual review of the one or more captured screenshots labeled unverified, wherein the user manually reviews the source of the one or more captured screenshots to determine if a correct study subject's data was used, if the correct study subject's data was used in the one or more captured screenshots, the one or more captured screenshots is accepted and labeled verified, wherein if an incorrect study subject's data was used in the one or more captured screenshots, the one or more captured screenshots is rejected and discarded (i.e., employing a review tool to examine screenshots and further enabling an acceptance or rejection based on said review). [¶13]Regarding claim(s) 5, Ikeguchi-Sethre-Vcelak as a combination discloses: The method as recited in claim 2, Ikeguchi disclosing: wherein the defined number of data points to be positively identified for verification assessment is set in a configuration setting (i.e., wherein a threshold number of questions and answers represented by questions that must be submitted by an investigator and responded to, as identified by employing a CRF, consistent with Ikeguchi disclosure, ¶4). [¶3]
Regarding claim(s) 6, Ikeguchi-Sethre-Vcelak as a combination discloses: The method as recited in claim 4, Ikeguchi discloses: wherein if the one or more captured screenshots is rejected and discarded, the one or more captured screenshots and related snippets are disassociated from questions on the CRF and returned to an investigator user to start over (i.e., employing a review tool to examine screenshots and further enabling an acceptance or rejection based on said review). [¶13] Regarding claim(s) 7, Ikeguchi-Sethre-Vcelak as a combination discloses: The method as recited in claim 1, Ikeguchi disclosing: wherein the electronic verification includes a secure and encrypted two-way communication comprising:
a handshake when a connection is established and verified to be the EMR system providing the source for the one or more captured screenshots (i.e., wherein public key/private key pair encryption is employed in electronic communications wherein a server confirms authenticity of users communicating with a server, said users logging on with authenticated private credentials); [¶¶52-53]and
once the source is verified, requesting the EMR system to confirm it is displaying information about the correct study subject (i.e., enabling screenshot display of information subsequent to handshake). [¶54: Enabling “[s]creenshot captures .. [to] be obtained from any EMR software running on the same machine as the inventive software, such that the EMR software displays its information on the same screen(s) as are accessible by software implementing the invention”]Regarding claim(s) 8, Ikeguchi-Sethre-Vcelak as a combination discloses: The method as recited in claim 7, Ikeguchi disclosing: wherein the electronic verification takes place each time a screenshot is captured (i.e., as source document snippets are made, verification is made). [FIG 6A]
Regarding claim(s) 9, Ikeguchi-Sethre-Vcelak as a combination discloses: The method as recited in claim 7, Ikeguchi disclosing: wherein the electronic verification is recorded, such that a human-readable log is generated (i.e., a handshake corresponding to an encrypted communication exists between an EMR system and an investigator’s application). [¶¶52-53]
Regarding claim(s) 10, Ikeguchi-Sethre-Vcelak as a combination discloses: The method as recited in claim 7, Vcelak disclosing [a]: wherein the EMR system confirms it is displaying information about the correct study subject using screen optical recognition, inter-process communication or web-based API's (i.e., employing OCR technologies). [Page 128, wherein “controlled searching in archives where reversibly de-identified medical images are stored” and Page 129 section 2.1 wherein “address, age, birth date/number, name and sex” are identified by employment of OCR technologies]
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to have modified Ikeguchi, including mechanism(s) [a], as taught by Vcelak. One of ordinary skill would have been so motivated to employ said mechanism(s) to ensure not only HIPAA data compliance but also compliance with a clinical trial’s goals. [Pages 128-129]
Conclusion
The prior art made of record9 and NOT relied upon is considered pertinent to applicant's disclosure: Newhauser, Elsevier, 2014, pp134-140.
Summary, Newhauser:
The anonymization of DICOM-associated images is accomplished through several key steps that ensure the removal or de-identification of protected health information (PHI) while maintaining the integrity of the data necessary for clinical trials and may comprise:
Removal of PHI from DICOM Tags: DICOM files contain metadata that may include PHI, such as patient names, IDs, and dates. Anonymization involves removing or modifying these identifiers in accordance with HIPAA guidelines. For example, specific tags are anonymized based on predefined lists, ensuring no PHI remains in the textual version of the DICOM files.
Handling Burned-In Text in Images: Images may contain burned-in text (e.g., patient names or medical information) that is not stored in DICOM metadata but is directly embedded in the image pixels. Techniques such as optical character recognition (OCR) and threshold-redaction algorithms are used to detect and remove this text, ensuring anonymization
Anonymizing Unique Identifiers (UIDs): While UIDs in DICOM files are not typically considered PHI, they can still potentially link anonymized data back to the original patient. To prevent unintentional re-identification, UIDs are anonymized as part of the process. This step is critical for maintaining HIPAA compliance and ensuring data privacy.
Ensuring Data Integrity for Clinical Use: The anonymization process must preserve the clinical utility of DICOM files. For example, dose prescriptions, beam parameters, and other treatment-related data in radiotherapy plans remain unchanged during anonymization. This ensures that the de-identified data can still be used effectively for clinical trials.
Verification and Compliance Checks: After anonymization, the DICOM files are reviewed to confirm that no PHI remains. This includes checking both the metadata and image content. Such verification steps ensure adherence to HIPAA guidelines while meeting the goals of clinical trials by providing high-quality, de-identified data.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL EZEWOKO whose telephone number is 571 272 7850. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kambiz Abdi can be reached on 571 272 6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-7850.
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/MICHAEL I EZEWOKO/Primary Examiner, Art Unit 3682
1 Applicant specification may hereinafter be referenced as “Ikeguchi disclosure”
2 Pertaining to a Clinical Trial and enforcing privacy regulatory requirements of HIPAA while accomplishing goals of said Trial: see Ikeguchi’s disclosure, comprising ¶¶2-50, ¶119
3 Ikeguchi disclosure treats limitations i, ii, at a high level:
i: see ¶¶23, 57 with regard to use of “robotic process automation”, “AI”, “pattern recognition” and “OCR (to identify key words from the CRF on the EMR page)” and
ii: see ¶108 with regard to employing verification “driven by OCR” respectively
4 MPEP 2164.03: “The “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention.”
5 Vas-Cath Inc. v. Mahurkar, 935 F.2d at 1561: as depicted in the “Emphasis added”, “One may wonder what purpose a separate “written description” requirement serves, when the second paragraph of § 112 expressly requires that the applicant conclude his specification “with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention” One explanation is historical: the “written description” requirement was a part of the patent statutes at a time before claims were required. A case in point is Evans v. Eaton, 20 U.S. (7 Wheat.) 356, 5 L.Ed. 472 (1822), in which the Supreme Court affirmed the circuit court’s decision that the plaintiff’s patent was “deficient” and that the plaintiffs could not recover infringement thereunder. The patent laws then in effect, namely the Patent Act of 1793, did not require claims, but did require, in its 3d section, that the patent applicant “deliver a written description of his invention, and of the manner of using, or process of compounding, the same, in such full, clear and exact terms, as to distinguish the same from all things before known, and to enable any person skilled in the art or science of which it is a branch, or with which it is most nearly connected, to make, compound and use the same” (emphasis in original).
6 MPEP 2163
7 MPEP 2161.01
8 See Form 892: Non-Patent Literature
9 Please see Form 892 for complete listing
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