DETAILED ACTION
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 30, 2025 has been entered.
Response to Amendment
This non-final office action is in response to the claims filed on June 30, 2025.
Claims 1, 8, and 15 have been amended.
Claims 2, 3, 7, 9-10, 14 and 16-17 were previously canceled.
Claims 1, 4-6, 8, 11-13, 15, and 18-20 remain pending and have been examined.
Subject Matter Free of Art
Claims 1, 4-6, 8, 11-13, 15, and 18-20 include subject matter that is free of prior art. The cited prior art of record fails to expressly teach or suggest, either alone or in combination, the features found within independent claims 1, 8, and 15. In particular, the cited prior art fails to expressly teach or suggest the combination of:
receiving, by a computing system, a request to generate a protocol portal from a client device;
generating, by the computing system, the protocol portal for the client device, the protocol portal comprising one or more protocol portal templates;
receiving, by the computing system, content for a protocol associated with the protocol portal from the client device, the content comprising video content and text-based content;
transforming, by the computing system, the received content into a format compatible with the protocol portal, the transforming comprising:
generating time-stamps for the text-based content, wherein the time-stamps represent portions of the text-based content that correspond to portions of the video content;
generating, by the computing system, a hypertext markup language (HTML) version of the protocol and the received contents, the HTML version corresponding to a hidden mirrored version of the protocol, the HTML version enabling search functionality across the protocol;
dynamically tagging, by the computing system, the content uploaded by the client device;
generating, by the computing system, one or more graphical user interfaces for the protocol portal using the received content and the one or more protocol portal templates;
causing, by the computing system, presentation of the received content via the one or more graphical user interfaces, wherein a subset of the text-based content is automatically presented side-by-side with the video content when a first time-stamp corresponding to the subset of the text-based content maps to a current position in the video content;
receiving, by the computing system via the one or more graphical user interfaces a search query from the client device or a user device;
executing, by the computing system, the search query against the HTML version of the protocol to identify potential search results;
generating, by the computing system, search results based on the query, wherein each search result is hyperlinked to the HTML version of the protocol, and wherein the search result is one of a matched multimedia asset, a matched protocol section, or a matched word or phrase; and
causing, by the computing system, presentation of the search results to the client device or the user device, wherein the presentation of the search results comprises a visual highlighting of portions of the received content based on the HTML version of the protocol.
The closest cited prior art Bleicher et al. (US 6820235 B1) teaches receiving a request to generate a web page; generating a template populated with application data based on clinical trial protocol database and content received from client; transforming the received content into a format compatible with the protocol portal; and generating one or more graphical user interfaces for the protocol portal.
The closest cited prior art Otsubo et al. (US 20100229078 A1) teaches correlating time stamps for the text-based content with corresponding portions of video content and presentation of text content side-by-side with the video content where a time-stamp corresponding to a subset of the text-based content maps to a current position in the video content.
The closest cited prior art Choubey et al. (US 20040148403 A1) teaches generating an HTML version of the protocol and received contents; receiving a search query from the client device or a user device, executing the search query to identify potential search results; generating search results based on the query, wherein each search result is hyperlinked to the HTML version of the protocol; and causing the presentation of the search results to the client device or the user device.
The closest cited prior art Bahrami et al. (US 20180260389 A1) teaches using HTML as hidden metadata.
The closest cited prior art Denninghoff (US 20190220487 A1) teaches wherein the presentation of the search results comprises a visual highlighting of portions of the content based on the HTML version of the protocol, and wherein the search results are one of a matched word or phrase.
However, the Examiner does not find that the cited reference separately nor in combination fairly teach the limitations of the amended claims. In particular, the Examiner does not find that the cited references fairly teach generating an HTML version of the protocol and received contents, the HTML version corresponding to a hidden mirrored version of the protocol, and dynamically tagging the content uploaded by the client device.
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, 4-6, 8, 11-13, 15, and 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Eligibility Step 1 (does the subject matter fall within a statutory category?):
Claims 1, 4-6 are drawn to a method, claims 8, 11-13 are drawn to a computer readable medium and claims 15, 18-20 are drawn to a system, all of which are within the four statutory categories.
Eligibility Step 2A-1 (does the claim recite an abstract idea, law of nature, or natural phenomenon?):
Claims 1, 4-6, 8, 11-13, 15, and 18-20 are further directed to an abstract idea on the grounds set out in detail below:
The Examiner has identified independent method claim 1 as the claim that represents the claimed invention for analysis and is similar to independent claims 8 and 15.
Claims 1, 8, and 15 recite a series of step for generating a clinical trial protocol portal to provide resources and support to investigators and staff at clinical trial sites, which, under the broadest reasonable interpretation, is an abstract idea that falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas such as managing behavior or relationships or interactions between people (i.e., following a set of rules or instructions).
Claim 1 recites the following limitations which set forth the abstract idea:
receiving, […], a request to generate a protocol portal from a client device;
generating, […], the protocol portal for the client device, the protocol portal comprising one or more protocol portal templates;
receiving, […], content for a protocol associated with the protocol portal from the client device, the content comprising video content and text-based content;
transforming, […], the received content into a format compatible with the protocol portal, the transforming comprising:
generating time-stamps for the text-based content, wherein the time-stamps represent portions of the text-based content that correspond to portions of the video content;
generating, […], output for the protocol portal using the received content and the one or more protocol portal templates; and
receiving, […], a search query
executing, […], the search query against the HTML version of the protocol to identify potential search results;
generating, […], search results based on the query, wherein each search result is hyperlinked to the HTML version of the protocol; and wherein the search result is one of a matched multimedia asset, a matched protocol section, or a matched word or phrase;
The noted above limitations are merely directed to managing interactions between the clinical trial organization and the clinical trial site staff and investigators. As recited in the above noted limitations, the clinical trial organization can manually send a request for a clinical trial protocol portal to be created, along with the contents of the protocol that should be included in the portal. A web developer can convert the contents of the protocol into code, convert and tag the contents, generate a website, and present the content.
Eligibility Step 2A-2 (does the claim recite additional elements that integrate the judicial exception into a practical application?):
This judicial exception is not integrated into a practical application.
Limitations that are not indicative of integration into a practical application include: (1) Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea (MPEP 2106.05.f), (2) Adding insignificant extra- solution activity to the judicial exception (MPEP 2106.05.g), (3) Generally linking the use of the judicial exception to a particular technological environment or field of use (MPEP 2106.05.h).
Claims 1, 8, and 15 recite the following additional element:
a computing system having a graphical user interface (Claim 1)
a non-transitory computer-readable medium including one or more instructions (Claim 8)
the one or more instructions to be executed by a computing system having a graphical user interface (Claim 8)
a processor (Claim 15)
a memory having programming instructions stored thereon having a graphical user interface (Claim 15)
client device or user device
generating, by the computing system, a hypertext markup language version of the protocol and the received contents, the HTML version corresponding to a hidden mirrored version of the protocol, the HTML version enabling search functionality across the protocol;
dynamically tagging, by the computing system, the content uploaded by the client device;
generating, by the computing system, one or more graphical user interfaces for the protocol portal using the received content and the one or more protocol portal templates;
causing, by the computing system, presentation of the received content, wherein a subset of the text-based content is automatically presented side-by-side with the video content when a first time-stamp corresponding to the subset of the text-based content maps to a current position in the video content;
causing, by the computing system, presentation of the search results, wherein the presentation of the search results comprises a visual highlighting of portions of the received content based on the HTML version of the protocol.
The noted above additional elements are recited at a high-level of generality (i.e., as a generic computing system performing a generic computer function – [e.g., receiving a request, transforming and tagging content, generating interfaces, and presenting content/results]) such that it amounts to no more than mere instructions to implement an abstract idea by adding the words ‘apply it’ (or an equivalent) with the judicial exception. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea (see MPEP 2106.04 (d)(I) which states that merely having the words “apply it” and/or “generally linking” the claimed invention to a particular technological environment or field of use is insufficient to provide a practical application or significantly more). Therefore, claims 1, 8, and 15 are directed to an abstract idea without a practical application.
The use of additional elements noted above as tools to implement/automate the abstract idea does not render claims 1, 8, and 15 to be patent eligible because it does not provide meaningful limitations and requires no more than a computer performing functions that correspond to acts required to carry out the abstract idea. See MPEP 2106.05.
Eligibility Step 2B (Does the claim amount to significantly more?):
Claims 1, 8, and 15 do not include additional elements that are sufficient to amount to significantly more than the abstract idea. As discussed above with respect to integration of the abstract idea into a practical application, using the additional elements noted above to perform the generic computer functions amount to no more than mere instructions to apply the abstract idea using a generic computer component or generally link the claimed invention to a particular technological environment or field of use (see MPEP 2106.05 (I)(A)). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Claims 1, 8, and 15 are, therefore, not patent eligible.
The dependent claims 4-6, 11-13, and 18-20 further define the abstract idea that is present in their respective dependent claims and hence are abstract for at least the reasons presented above.
Dependent claims 5-6, 12-13, and 19-20 do not recite any new additional elements not already recited in their respective independent claims.
Dependent claims 4, 11, and 18 recite the following additional element:
A user device
The user device is recited at a high-level of generality (i.e., as a generic computing system performing a generic computer function) such that it amounts to no more than mere instructions to implement an abstract idea by adding the words ‘apply it’ (or an equivalent) with the judicial exception. Accordingly, this additional element, when considered separately and as an ordered combination, does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea (see MPEP 2106.04 (d)(I) which states that merely having the words “apply it” and/or “generally linking” the claimed invention to a particular technological environment or field of use is insufficient to provide a practical application or significantly more). Therefore, claims 4, 11, and 18 are directed to an abstract idea without a practical application.
Claims 4, 11, and 18 do not include additional elements that are sufficient to amount to significantly more than the abstract idea. As discussed above with respect to integration of the abstract idea into a practical application, using the additional elements noted above to perform the generic computer functions amount to no more than mere instructions to apply the abstract idea using a generic computer component or generally link the claimed invention to a particular technological environment or field of use (see MPEP 2106.05 (I)(A)). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Claims 4, 11, and 18 are, therefore, not patent eligible.
The dependent claims do not include any additional elements that integrate the abstract idea into a practical application or are sufficient to amount to significantly more than the judicial exception when considered both individually and as an ordered combination. Therefore, the dependent claims are directed to an abstract idea. Claims 4-6, 11-13, and 18-20 are, therefore, not patent eligible.
Response to Arguments
35 U.S.C § 101 REJECTION OF CLAIMS 1, 3-6, 8-13, and 15-20
Regarding the rejection of claims 1-20, the Applicant has canceled claims 9 and 16 rendering the rejection of those claims moot.
Issue #1:
Applicant argues: “the Office alleges that the claims recite an abstract idea by (1) focusing on the functional limitations of the claims in a vacuum; and (2) only identifying the hardware components in the claim (e.g., computing system, non-transitory computer-readable medium, processor, memory, client device, user device) and concluding that those elements alone do not integrate the judicial exception into a practical application. The Applicant disagrees and submits that the Office's analysis is entirely without merit as it dismisses several technical improvements because the Office is only looking to a specific improvement to how a computer functions. Specifically, the Office alleges that the claims merely automate a manual process and do not improve computer technology. This is an oversimplification of the claim language. The application describes several technical improvements:
* Hidden HTML Mirrored Version: The Office has provided zero weight to this limitation. The hidden HTML mirrored version of the protocol enables advanced search and hyperlinking and allows for visual highlights within the multimedia content. It is unclear how this limitation is included in the set of limitations that recites an abstract idea. These are not routine and conventional uses of computers. Moreover, the generation of a hidden HTML mirrored version is not a routine and conventional step in the context of a clinical trial protocol.
* Dynamic Tagging and Search: The system dynamically tags uploaded content (including video, audio, and text) and enables search across all content types, not just within static documents. This is more than mere data organization; it enables a new way of interacting with protocol information, improving efficiency and accuracy in clinical trial management.
* Synchronized Content Presentation: The system presents synchronized video and text content, with time-stamped mapping between the two, allowing users to view relevant protocol text alongside corresponding video segments. This is a technical solution to the problem of correlating multimedia content for training and compliance (e.g., transforming, by the computing system, the received content into a format compatible with the protocol portal, the transforming comprising: generating time-stamps for the text-based content, wherein the time-stamps represent portions of the text-based content that correspond to portions of the video content, causing, by the computing system, presentation of the received content via the one or more graphical user interfaces, wherein a subset of the text- based content is automatically presented side-by-side with the video content when a first time-stamp corresponding to the subset of the text-based content maps to a current position in the video content).
The above functionality illustrates that the claim includes significantly more than the alleged abstract idea of "following a set of rules or instructions" for a protocol and instead provides a specific improvement to the way protocol information is processed, searched, and presented using computer technology. Only looking for an improvement to the functioning of the computer, the Office ignores the other ways through which a practical application can be shown. Accordingly, for at least the foregoing reasons, the Applicant submits that the claims are subject matter eligible and request that the rejection be withdrawn.”
The Examiner respectfully disagrees. The Examiner has reconsidered the limitations above and has characterized them as additional elements that are merely “apply it”. Additionally, in regards to the dynamic tagging, the Examiner would like to point out that the Specification does not describe how the content is dynamically tagged. The limitations describe the electronic version that the document exists in and further describes how the search results are presented. This does not amount to a technological improvement, and therefore there is no practical application.
35 U.S.C § 103 REJECTION OF CLAIMS 1, 4-6, 8, 11-13, 15, 18-20
Regarding the prior art rejection of claims 1, 4-6, 8, 11-13, 15, 18-20, Applicant’s arguments with respect to claim(s) 1, 8, and 15 have been fully considered and are persuasive. As such, the prior art rejection has been withdrawn.
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure and is listed in the attached form PTO-892 (Notice of References Cited). Unless expressly noted otherwise by the Examiner, all documents listed on form PTO-892 are cited in their entirety.
Hwang et al. (US 20150127375 A1) teaches: Methods and Systems for Cloud-Based Medical Database Management.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALAK M NASSER whose telephone number is (703)756-4610. The examiner can normally be reached M-F 8:00 AM-5:00 PM.
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/MALAK M NASSER/Examiner, Art Unit 3687
/MAMON OBEID/Supervisory Patent Examiner, Art Unit 3687