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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 21-36) in the reply filed on 11/10/2025 is acknowledged. Claims 37-42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention. Since the restriction requirement properly made, the restriction requirement is now made final.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 21-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over McBride et al., US 2021/0224419 in view of Burg et al., US 2015/0308961.
Regarding claim 21, McBride discloses a system for securely updating personal electronic medical records with image information captured by a mobile communications device (fig. 1; para 0010; a system for providing an efficient and secure interface for transferring protected electronic information), the system comprising:
at least one processor configured to:
generate a token for a specific patient in need of a medical test (para 0004; the electronic information system may be configured to generate a unique access link (uniform resource locator, or URL) for that user);
transmit the token to a mobile communications device (para 0013; a mobile device of the user) of the specific patient (fig. 1, element 104; para 0004 and 0069; the link may be sent to the user via electronic communication, such as a text message or email);
enable a token-based communications session to take place between the mobile communications device of the specific patient and at least one remote server (fig. 1, element 106; para 0072; when a user has received a unique link, the user may access the unique link by a properly-equipped device, which may create a secure, encrypted connection between a web browser of the user and the system), wherein the communications session includes transmission from the mobile communications device of image-related information obtained via an image sensor associated with the mobile communications device (fig. 1, element 112; para 0075-0077; a user may be permitted to submit one or more forms, photos, documents, or any other type of information; a user may be required to use a smartphone application to take a photograph of the one or more forms of identity of the user);
verify, based on the token, that the image-related information is associated with the specific patient (fig. 1; element 112; para 0004 and 0075; when the user follows the link with a web browser, the system prompts the user to enter an additional piece of personal information (i.e., a photo) that is not known to the general public for verification); and
update a personal electronic medical record (para 0008-0009; protected health information (PHI) of the system) of the specific patient with the verified image-related information (fig. 1, element 112; para 0075 and 0077; a user may be permitted to submit one or more forms, photos, documents, or any other type of information to the system (i.e., updating the PPI of the system with user’s information)).
McBride discloses claim 21 as enumerated above, but McBride does not explicitly disclose wherein the image-related information reflects a resulting color of a chemical reaction between a biological substance and a reagent of a test result as claimed.
However, Burg discloses the diagnostic instrument 10 includes the test strip 14 of may be a reagent dipstick. In that case, each test strip 14 includes a plurality of test media, such as chemical test pads (CTP) 22, containing a color-changing reagent for identifying the concentration of certain analytes in a patient fluid, such as urine, blood, or saliva (para 0047). The user then exposes 212 the diagnostic instrument to a biological sample, which exposes the plurality of CTP to analytes contained in the sample and begins a chemical reaction between the CTP and analytes. The user captures 214 the digital image of the diagnostic instrument 10 using the camera sensor of the portable electronic device (figs. 2-3; para 0063-0064).
Therefore, taking the combined disclosures of McBride and Burg as a whole, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the diagnostic instrument 10 includes the test strip 14 of may be a reagent dipstick. In that case, each test strip 14 includes a plurality of test media, such as chemical test pads (CTP) 22, containing a color-changing reagent for identifying the concentration of certain analytes in a patient fluid, such as urine, blood, or saliva. The user then exposes 212 the diagnostic instrument to a biological sample, which exposes the plurality of CTP to analytes contained in the sample and begins a chemical reaction between the CTP and analytes. The user captures 214 the digital image of the diagnostic instrument 10 using the camera sensor of the portable electronic device as taught by Burg into the invention of McBride for the benefit of detecting the presence or absence of a variety of analytes in a fluid sample using a diagnostic instrument (Burg: para 0003).
Regarding claim 22, the system of claim 21, McBride in the combination further disclose wherein the token is indicative of an authorization for an image-based medical test for the specific patient, and the at least one processor that generates the token is part of the at least one remote server (para 0004 and 0010).
Regarding claim 23, the system of claim 22, McBride in the combination further disclose wherein the at least one remote server is associated with at least one of a healthcare provider and an agent of the healthcare provider (para 0068).
Regarding claim 24, the system of claim 21, McBride and Burg in the combination further disclose wherein the token-based communication session includes sending a link from a healthcare provider to the mobile communications device associated with the specific patient after obtaining an indication that the specific patient needs the medical test (McBride: fig. 1, elements 102-106; para 0067-0072 and Burg: para 0010; medical test).
Regarding claim 25, the system of claim 21, McBride and Burg in the combination further disclose wherein enabling a token-based communication session includes sending an identifying detail of a patient to the remote server after obtaining an indication that the specific patient needs the medical test (McBride: fig. 1, elements 106-112; para 0072-0077 and Burg: para 0010; medical test).
Regarding claim 26, the system of claim 21, Burg in the combination further disclose wherein the token-based communications session includes causing the mobile communications device of the specific patient to provide guidance to the specific patient on how to successfully complete the medical test (para 3; para 0063-0064).
Regarding claim 27, the system of claim 26, Burg in the combination further disclose wherein the guidance includes instructions to do at least two of: opening a medical kit, expanding a collapsed measuring cup, dipping a dipstick, blotting the dipstick, placing the dipstick on a colorized test surface; capturing an image of the dipstick on the colorized test surface, and recapturing the image of the dipstick on the colorized test surface (para 3; para 0063-0064 and 0085).
Regarding claim 28, the system of claim 26, Burg in the combination further disclose wherein the guidance includes instructions to expose the reagent to a biological fluid and to capture an image of the exposed reagent within a predefined time window (para 3; para 0063-0064).
Regarding claim 29, the system of claim 21, Burg in the combination further disclose wherein the at least one processor is further configured to:
determine that the specific patient needs the medical test (fig. 1; para 0048); and
in response to the determination that the specific patient needs the medical test, trigger sending of a home testing kit to the specific patient (fig. 1; para 0048).
Regarding claim 30, the system of claim 29, McBride and Burg in the combination further disclose wherein the at least one processor is further configured to send reminders to the specific patient (McBride: para 0096) when the transmission of image-related information is not received within a selected time period after the home testing kit was sent (McBride: para 0070-0071 and 0073-0074 and Burg: fig. 1; para 0048).
Regarding claim 31, the system of claim 21, Burg in the combination further disclose wherein the at least one processor is further configured to cause a generation of a medical prescription for treating the specific patient based on the test result reflective of the verified image-related information (para 0147).
Regarding claim 32, the system of claim 21, Burg in the combination further disclose wherein the transmitted image-related information is an image of at least one test reagent adjacent a colorized test surface (figs. 1-3; para 0063-0064).
Regarding claim 33, the system of claim 21, Burg in the combination further disclose wherein the transmitted image-related information is data derived from image analysis of at least one test reagent adjacent a colorized test surface (figs. 1-3; para 0063-0064).
Regarding claim 34, the system of claim 21, Burg in the combination further disclose wherein the transmitted image-related information reflects resulting colors of multiple chemical reactions between a biological fluid and a plurality of test reagents for measuring differing urinary properties (para 0004, 0045, and 0047).
Regarding claim 35, the system of claim 21, Burg in the combination further disclose wherein the transmitted image-related information reflects resulting colors of multiple chemical reactions between a biological fluid and a plurality of test reagents for measuring differing saliva properties (para 0045 and 0047).
Regarding claim 36, the system of claim 21, Burg in the combination further disclose wherein the transmitted image-related information reflects resulting colors of multiple chemical reactions between a biological secretion and a plurality of test reagents for measuring differing stool properties (para 0007 and 0051).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pulitzer et al., US 2018/0166171 discloses a method for handing off diagnostic test results to a telemedicine provider.
Tambasco, Jr., US 2015/0379198 discloses various embodiments manage access to patient health-related information in a health care patient portal.
Faybishenko et al., US 2014/0121487 discloses systems and methods of the present disclosure may enable monitoring of urine content, as well as trend and statistical analysis that can identify slow changes in hydration and kidney function, impending infections, and other potential metabolic and endocrine disease states.
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/VAN D HUYNH/Primary Examiner, Art Unit 2665