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
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/20/2026 has been entered.
Status of Claims
This action is in reply to the present application filed on 02/20/2026.
Claims 18, 25, 31, and 35 have been amended.
Claims 18-37 are currently pending and have been examined.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/16/2025 was filed before the mailing date of the first office action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 18-37 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.
Step 1 Analysis:
Independent Claims 18 and 35 are both directed to a method and therefore fall into one of the four statutory categories. Dependent Claims 19-34 and 36-37 are further directed toward a method and therefore also fall into one of the four statutory categories.
Step 2A Analysis – Prong One:
The substantially similar independent method claims, taking Claim 18 as exemplary, recite the following:
A method for managing electronic communications for assessing a predetermined medical condition, wherein a medical test-kit is provided, the medical test-kit comprising an access code and a sampling unit for obtaining a medical sample, the method comprising the steps of:
scanning and verifying the access code by a user communication device;
generating, in response to the scanning, a unique identifier by the user communication device, the user communication device being configured for receiving messages addressed to the unique identifier;
receiving the medical sample obtained from the user using components of the sampling unit, wherein the medical sample is labeled with a sample identifier associated with the unique identifier, wherein the sample identifier is (1) identical to the access code or (2) associated with the unique identifier during the verification of the access code by a database linking the access code to the sample identifier;
and analyzing the received medical sample using a first analysis method, thereby obtaining one of a first negative test result and a first positive test result,
wherein in the case of the first negative test result, the method further by a laboratory communication device, sending a message addressed by using the unique identifier to the user communication device, the message informing the user about the first negative test result,
and wherein in the case of the first positive test result, the method further comprising: analyzing the received medical sample using a second analysis method, thereby obtaining one of a second negative test result and a second positive test result,
wherein in the case of the second negative test result, the method further comprising by the laboratory communication device or a second laboratory communication device, sending a message addressed by using the unique identifier to the user communication device, the message informing the user about the second negative test result,
and wherein in the case of the second positive test result, the method further comprising establishing consultation, wherein the establishing comprises:
sending, by the laboratory communication device or the second laboratory communication device, a message to a practitioner communication device, the message comprising an indication of the unique identifier and at least one of the first positive test result and the second positive test result;
and establishing, by the practitioner communication device, a communication with the user, wherein the practitioner communication device is configured to contact the user communication device identified by using the unique identifier.
The series of steps in underline above, given the broadest reasonable interpretation, recite the abstract idea of certain methods of organizing human activity because they recite managing personal behavior or interactions between people (including social activities, teaching, and following rules or instructions- in this case, the steps of receiving and verifying an access code, generating a unique identifier, receiving a medical sample, analyzing a sample, and sending a message regarding the result of the test), e.g. see MPEP 2106.04(a)(2). Any limitations not identified as part of the abstract idea are deemed “additional elements” and will be discussed in further detail below.
Dependent Claims 20-23, 25-30, 33, and 36-37 recite other limitations directed toward the abstract idea. For example, Claim 20 recites the unique identifier is generated randomly, Claims 21-23 recite the types of analysis methods used and the conditions they test for, Claim 25 recites the use of a scanning code, Claim 26 recites the communications establishing involves the unique identifier, Claim 27 recites providing detailed instructions explaining how to perform and send the medical test, Claim 28 recites scheduling an appointment for the user, Claim 29 recites sending a message by using the unique identifier, Claim 30 recites determining whether the user is high risk and if so, offering additional testing, Claim 33 recites the medical test kit comprises a reference, Claim 36 recites obtaining a result of the second analysis of the sample and if it is negative, sending the message to the user, if positive, sending a message to a practitioner, Claim 37 recites sending the message about the first negative test result is triggered by the first negative test result. These additional limitations only serve to further narrow the abstract idea, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, see MPEP2106.04, and/or do not further narrow the abstract idea and instead only recite additional elements, which will be further addressed below. Hence, dependent Claims 20-23, 25-30, 33, and 36-37 are nonetheless directed toward fundamentally the same abstract idea of Claims 18 and 35 and are further grouped as certain methods of organizing human activity.
Step 2A Analysis – Prong Two:
Claims 18 and 35 are not integrated into practical application because the additional elements (i.e. the non-underlined limitations above- in this case, the medical test kit, user communication device, laboratory communication device, and practitioner communication device of Claim 18 and the user communication device, laboratory communication device, and practitioner communication device of Claim 35) are recited at a high level of generality (i.e., as a generic processor performing generic computer functions) such that they amount to no more than mere instructions to apply the exceptions using a generic computer component. Further, the medical test-kit is merely the general linking of the abstract idea to a technical environment (i.e. online environment) which cannot integrate the abstract idea into a practical application (see MPEP 2106.05.h). For example, Applicant’s specification explains that the user communication device, the laboratory communication device, if present the further laboratory communication device and/or the further practitioner communication device is a smart device such as a smartphone or a tablet, or is an internet enabled PC. Such a communication device is essentially a general purpose computer comprising a processor and memory, wherein the processor is configured to execute instructions of a computer program which may be stored in the memory (applicant’s specification, page 6, lines 13-18). This distributed communication system protects the privacy of the user of the medical test as the user communication device is only addresses by means of the unique identifier (p. 4, lines 26-28). Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into practical application because they do not impose any meaningful limits on practicing the idea. Therefore, Claims 18 and 35 are directed to an abstract idea without practical application.
Dependent Claims 19-20, 24-34, and 36 also recite additional elements. Claim 19 recites the previously recited additional elements of the user communication device, laboratory communication device, and practitioner communication device as well as a new additional element of a central server and specifies the devices communicate with a central server. Claim 20 recites a new additional element of a database and specifies the unique identifier communicates with a database. Claim 24 recites the previously recited additional elements of the user communication device, laboratory communication device, and practitioner communication device and specifies these devices are one of a smartphone, tablet, or an internet enabled PC (new additional elements). Claim 25 recites the user communication device and a new additional element of a camera and specifies verifying the access code by scanning a matrix code with the camera of the user communication device. Claim 26 recites the user and practitioner communication devices and new elements of a voice and video link and specifies using a voice and video link between the user and practitioner devices. Claim 27 recites the user communication device and medical test kit and specifies providing to the user device instructions to the user for how to use the test kit. Claim 28 recites the user communication device and specifies the unique identifier is transmitted by the user communication device to an appointment booking system (new). Claim 29 recites the previously recited user communication device and specifies sending messages to the device. Claim 30 recites the previously recited user communication device and specifies obtaining a user input by the user communication device and generating a reminder for the user or offering further testing for the user in the event they are in a high risk group. Claim 31 recites the previously recited user communication device and specifies the device comprises a camera (new element) or an RFID reader (new). Claim 32 recites the user communication device and new additional elements of a computer program and computer and specifies the computer program is executed by a computer to carry out the steps of the user device of the method of Claim 18. Claim 33 recites the medical test-kit and specifies the kit comprises a reference for a downloadable computer program (new element) to be executed by the user communication device. Claim 34 recites the previously recited central server and specifies the server is configured to carry out the steps of the method of Claim 19. Claim 36 recites the previously recited additional elements of the user communication device, laboratory communication device, and practitioner communication device and specifies sending messages to the practitioner and user devices based on the results of the test by the laboratory device.
Step 2B Analysis:
The claims, when considered separately or as an ordered combination, do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed with respect to step 2A prong two, the additional elements of the user communication device, laboratory communication device, and practitioner communication device of Claims 18 and 35 amount to mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”) in step 2B. MPEP2106.05(I)(A) indicates that merely saying "apply it” or equivalent to the abstract idea cannot provide an inventive concept ("significantly more").
Furthermore, as discussed above with respect to the integration of the abstract idea into a practical application, the additional element of the medical test-kit was considered to generally link the abstract idea to a particular technological environment or field of use. This has been reevaluated under the ‘significantly more’ analysis and has been found insufficient to provide significantly more. MPEP2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide an inventive concept (‘significantly more"). Accordingly, even in combination, the additional elements do not provide significantly more. For these reasons, claims 18 and 35 are not patent eligible.
Claims 20-23 and 37 do not recite any additional elements and solely narrow the abstract idea. Claim 20 narrows the abstract idea by specifying how the medical entity is selected. Claim 21 further narrows the abstract idea by specifying what the analysis methods detect. Claims 22 and 23 narrow the abstract idea by specifying what kind of disease causes the medical tests are for. Claim 37 narrows the abstract idea by specifying the message informing the user about the first negative test result is triggered by the first negative test result.
Dependent Claims 19-20, 24-26, 28-29, and 31-33 recite new additional elements. Claim 19 recites the previously recited additional elements of the user communication device, laboratory communication device, and practitioner communication device and a new additional element of a central server and specifies the devices communicate with a central server. Claim 20 recites a new additional element of a database and specifies the unique identifier communicates with a database. Claim 24 recites the previously recited additional elements of the user communication device, laboratory communication device, and practitioner communication device and specifies these devices are one of a smartphone, tablet, or an internet enabled PC (new elements). Claim 25 recites the user communication device and a new additional element of a camera and specifies verifying the access code by scanning a matrix code with the camera of the user communication device. Claim 26 recites the user and practitioner communication devices and new elements of a voice and video link and specifies using a voice and video link between the user and practitioner devices. Claim 28 recites the user communication device and specifies the unique identifier is transmitted by the user communication device to an appointment booking system (new). Claim 31 recites the previously recited user communication device and specifies the device comprises a camera (new element) or an RFID reader (new). Claim 32 recites the user communication device and new additional elements of a computer program and computer and specifies the computer program is executed by a computer to carry out the steps of the user device of the method of Claim 18. Claim 33 recites the medical test-kit and specifies the kit comprises a reference for a downloadable computer program (new element) to be executed by the user communication device..
Claims 27, 29-30, 34, and 36 recite previously recited additional elements, which are not eligible for the reasons stated above, and further narrow the abstract idea. Claim 27 recites the user communication device and medical test kit and specifies providing to the user device instructions to the user for how to use the test kit. Claim 29 recites the previously recited user communication device and specifies sending messages to the device. Claim 30 recites the previously recited user communication device and specifies obtaining a user input by the user communication device and generating a reminder for the user or offering further testing for the user in the event they are in a high risk group. Claim 34 recites the previously recited central server and specifies the server is configured to carry out the steps of the method of Claim 19. Claim 36 recites the previously recited user communication device, laboratory communication device, and practitioner communication device and specifies sending messages to the practitioner and user devices based on the results of the test by the laboratory device. Hence, Claims 19-34 and 36-37 do not include any additional elements that amount to “significantly more” than the judicial exception.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination does not add anything that is already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 18-37 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory 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 (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.
Claims 18, 31, and 35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Quattrocchi et al. (US 20020137025 A1) in view of Katz et al. (US 20150064695 A1), Dieben et al. (EP 2385690 A1), and Pulitzer et al. (US 20200152339 A1).
Regarding Claim 18, Quattrocchi discloses the following:
A method for managing electronic communications for assessing a predetermined medical condition, wherein a medical test-kit is provided, the medical test-kit comprising an access code and a sampling unit for obtaining a medical sample, (Quattrocchi discloses a method and testing system for a human malady. The System comprises a test kit for creating a Sample of body fluid, a personal code for anonymously identifying the Sample and the person, and an electronic file telephonically created and accessed by the person taking the test and identified by the personal code (abstract). When the kit is used to test for HIV, the equipment in the kit will be used to obtain a sufficient amount of a body fluid that can be subsequently analyzed for HIV antibodies [0025].)
the method comprising the steps of: … verifying the access code by a user communication device; (Quattrocchi discloses the caller responds to prompts from the computer program to obtain results as by inputting the correct code known only to the caller. At Step 122, the caller would input the personal code as by pushing those buttons 76 on the telephone station 68 corresponding to the code 44 associated with the kit 10. After the code 44 is entered at step 122, the computer program 84 checks the code entered against a predetermined valid Set of codes as at Step 124 [0089]. The correct code associated with the kit is interpreted as the access code.)
…the user communication device being configured for receiving messages addressed to the…identifier; (Quattrocchi discloses if the code entered at Step 122 is invalid, the voice generator 82 instructs the caller to reenter the code and, thus, returns the computer program 84 to step 122. To protect the confidentiality of the caller, a predetermined number of attempts at entering the correct code arm provided before the computer system 84 terminates the telephone call [0089]. If the caller responds with a proper code at step 124, the computer program proceeds to allow the caller to telephonically obtain the test results as at step 126 [0090].)
receiving the medical sample obtained from the user using components of the sampling unit, wherein the medical sample is labeled with a sample identifier… (Quattrocchi discloses the blood specimen sample sheet 56 further includes a bar code 60 having the same personal code 44 as was randomly assigned to the top sheet 40. The bar code is used by the laboratory to identify the specimen as belonging to the person being tested [0054, see also Fig. 4A-B].)
wherein the sample identifier is (1) identical to the access code or (2) associated with the unique identifier during the verification of the access code by a database linking the access code to the sample identifier; (Quattrocchi discloses the blood specimen sample sheet 56 further includes a bar code 60 having the same personal code 44 as was randomly assigned to the top sheet 40. The bar code is used by the laboratory to identify the specimen as belonging to the person being tested [0054, see also Fig. 4A-B]. The sample identifier is interpreted as being identical to the access code.)
and analyzing the received medical sample using a first analysis method, thereby obtaining one of a first negative test result and a first positive test result, (Quattrocchi discloses upon receipt of the test specimen, the laboratory matches the test Specimen with the order request form that was automatically generated by the System of the present invention when the person to the test created the personal electronic file. In the situation where the person taking the test is concerned about HIV, the laboratory analyzes the test specimen to determine if the HIV antibodies are present therein. At the testing Site, the Sample is tested, and the results are updated into the electronic file with a corresponding personal code [0021].
wherein in the case of the first negative test result, the method further comprising by a laboratory communication device, sending a message addressed by using the … identifier to the user communication device, the message informing the user about the first negative test result, (Quattrocchi discloses if the test results are negative, the telephone-operated computer program or software 84 of the computer system 48 will inform the person being tested of the negative results [0081].)
and wherein in the case of the second positive test result, the method further comprising establishing consultation, wherein the establishing comprises: (Quattrocchi discloses if the test results reported by the laboratory are positive, the computer program 84 shifts the program to Step 134 whereat a counselor informs the caller of the test results. At Step 134, the counselor further takes the opportunity to counsel the person being tested about how to get proper medical attention, face-to-face counseling [0092].)
by the laboratory communication device or the second laboratory communication device, sending a message to a practitioner communication device,… …sending a message addressed by using the…identifier to the user communication device,… (Quattrocchi discloses if the test results reported by the laboratory are positive, the computer program 84 shifts the program to step 134 whereat a counselor informs the caller of the test results [0092]. In order for the counselor to inform the caller, they must be informed by the laboratory device of the results via a message.)
Quattrocchi does not disclose the following limitations met by Katz:
and wherein in the case of the first positive test result, the method further comprising analyzing the received medical sample using a second analysis method, (Katz teaches if in step 101, the first test produces a positive result (e.g., the level of a measured bio chemical marker is above or below some threshold level), indicating increased risk or presence of a fetal genetic condition, then a second screening or diagnostic test (step 102) is performed using a second portion of the biological sample [0040].)
thereby obtaining one of a second negative test result and a second positive test result, wherein in the case of the second negative test result, the method further comprising by the laboratory communication device or a second laboratory communication device,…the message informing the user about the second negative test result, (Katz teaches alternatively, if in step 102 the test result is negative (e.g., no fetal genetic variation is detected in a cell-free nucleic portion), then the negative result is reported (step 105) leading to an endpoint [0041].)
…and at least one of the first positive test result and the second positive test result; (Katz teaches if in step 102, the second test produces a positive result (e.g., a fetal genetic variation is detected in a cell-free nucleic acid portion), indicating increased risk or presence of a fetal genetic condition, then the positive result is reported (step 112) leading to an endpoint [0041].)
Katz is an analogous art to Quattrocchi because both references solve the same problem of improving the patient medical testing process. It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate a second test in the situation that the first test result is positive as taught by Katz. This modification would create a system and methods which can accurately determine whether or not the user has the medical condition they are being tested for so that the user might receive the treatment they require as efficiently as possible (see Katz, ¶ 0006-0007).
Quattrocchi and Katz do not teach scanning the access code and generating a unique identifier which is met by Dieben:
the method comprising the steps of: scanning …the access code by a user communication device; (Dieben teaches machine readable codes can be displayed on the screen of a communication device, such that the ma chine readable code can be scanned from the display by another communication device. Through visual scanning, information, i.e. a barcode image is transferred from a first device to a second device without the need of a physical or wireless network connection [0019]. The Examiner interprets the machine readable code as an access code.)
generating, in response to the scanning, a unique identifier by the…communication device, the…communication device being configured for receiving messages addressed to the unique identifier; (Dieben teaches the unique identifier may be generated by the communication device itself and/or may be generated by the server when the machine readable code is scanned [0007]. The unique identifiers may comprise the communication address (for instance IP address) of the communication device [0005]. The Examiner interprets communication address being associated with the communication device.)
… the message comprising an indication of the unique identifier,…to contact the …device identified by means of the unique identifier. (Dieben teaches at least two or more communication devices scan said machine readable code and send a first message comprising at least said machine readable code to a server [0012]. The first messages may comprise a machine readable code and a (generated) unique identifier [0029].)
Dieben is an analogous art to Quattrocchi because both references communicate messages between a plurality of devices for managing information. It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate scanning the access code and generating a unique identifier as taught by Dieben. This modification would create a system and method which enables communication between a plurality of communication devices while identifying the correct device (see Dieben, ¶ 0001-0002).
Quattrocchi, Katz, and Dieben do not teach the practitioner device establishing contact with the user device which is met by Pulitzer:
establishing, by the practitioner communication device, a communication with the user, wherein the practitioner…is configured to contact the user device… (Pulitzer teaches the medical professional may authenticate the user and the test results from the analog testing device, gather medical history information from the user, discuss the results of the test with the user, provide medical suggestions based on the results from the testing device and the user's medical history, suggest prescriptions options as a result of the information gather, and the like [0094]. The Examiner interprets this as the practitioner using a device contacting the user via the user device.)
…with a sample identifier associated with the unique identifier…(Pulitzer teaches Each time a diagnostic test is conducted on a biologic sample, the biologic sample is associated with the unique profile record 1900, which means the unique biologic ID database table 2000 (which includes data about the test) is associated with the unique profile record 1900 and the user [0121]. A biologic ID header 2002 is provided that shows that the biologic sample has been given a unique ID [0123]. The Examiner interprets the unique profile record as the unique identifier.)
Dieben is an analogous art to Quattrocchi because both references are in the field of endeavor of remote medical testing and communication of results via a plurality of devices. It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate the practitioner device establishing contact with the user device as taught by Pulitzer. This modification would create a system and methods to establish a physician-patient relationship to complete a telemedicine session (see Pulitzer, ¶ 0003-4).
Regarding Claim 31, Quattrocchi, Katz, Dieben, and Pulitzer teach the limitations as shown in the rejection of Claim 18 above. Quattrocchi, Katz, Dieben, and Pulitzer do not teach the following limitations met by Sobti:
the user communication device comprises a camera or an RFID reader. (Pulitzer teaches the user is displayed on the application program interface a medical professional to conference with via the mobile device's audio and video device, i.e. the camera… [0094].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate the user device having a camera as taught by Pulitzer. This modification would create a system and methods which can establish a physician-patient relationship and communication remotely (see Pulitzer, ¶ 0003-4).
Regarding Claim 35, Quattrocchi discloses the following:
A method for electronic communications for assessing a predetermined medical condition…[obtaining] by the user communication device an access code provided in a test-kit for assessing the predetermined medical condition, (Quattrocchi discloses according to another aspect of the present invention, when the person taking the test anonymously activates the personal code thereby creating the electronic file, the System of the present invention generates an order request form for the laboratory [0019].)
the user communication device being configured to verify the access code, verifying the access code by the user communication device; (Quattrocchi discloses the caller responds to prompts from the computer program to obtain results as by inputting the correct code known only to the caller. At Step 122, the caller would input the personal code as by pushing those buttons 76 on the telephone station 68 corresponding to the code 44 associated with the kit 10. After the code 44 is entered at step 122, the computer program 84 checks the code entered against a predetermined valid Set of codes as at Step 124. If the code entered at Step 122 is invalid, the voice generator 82 instructs the caller to reenter the code and, thus, returns the computer program 84 to step 122. To protect the confidentiality of the caller, a predetermined number of attempts at entering the correct code arm provided before the computer system 84 terminates the telephone call [0089]. If the caller responds with a proper code at step 124, the computer program proceeds to allow the caller to telephonically obtain the test results as at step 126 [0090].)
providing suggestions to a user in order to assist in obtaining a medical sample using components of a sampling unit provided in the test-kit on a display of the user communication device; (Quattrocchi discloses the kit 10 can also contain an instruction booklet (not shown) which Serves to help the person being tested obtain a specimen and answer any questions [0059].)
providing instructions to the user for providing the medical sample obtained to a laboratory entity for analysis on the display of the user communication device, the medical sample being labeled with a sample identifier associated to the unique identifier; (Quattrocchi discloses the kit 10 can also contain an instruction booklet (not shown) which Serves to help the person being tested obtain a specimen and answer any questions [0059]. Personal code 44 is used to identify the test specimen and the person being tested rather than a name and/or address. The personal code 44 is assigned So that each kit has a unique code 44 associated there with. Because each number is unique, the person being tested can remain completely anonymous while having his or her blood specimen analyzed [0049].)
obtaining, by the laboratory communication device, the …identifier associated with the medical sample and providing instructions to a laboratory entity to perform a first analysis of the medical sample; (Quattrocchi discloses according to another aspect of the present invention, when the person taking the test anonymously activates the personal code thereby creating the electronic file, the system of the present invention generates an order request form for the laboratory. The order request form is automatically generated and authorizes the laboratory to perform analyzation or testing of the specimen identified by the anonymous code on the Specimen [0019]. Upon receipt of the test specimen, the laboratory matches the test specimen with the order request form that was automatically generated by the system of the present invention when the person to the test created the personal electronic file [0021].)
and obtaining a result of the first analysis of the medical sample by the laboratory communication device, and, if the result is negative with respect to the predetermined medical condition, sending a message about the negative test result to the user communication device… (Quattrocchi discloses if the test results are negative, the telephone-operated computer program or software 84 of the computer system 48 will inform the person being tested of the negative results [0081].)
Quattrocchi does not disclose the following limitations met by Katz:
and, if the test result is positive with respect to the predetermined medical condition, providing instructions …to the laboratory entity or to a further laboratory entity to perform a second analysis of the medical sample using a second analysis method. (Katz teaches if in step 101, the first test produces a positive result (e.g., the level of a measured biochemical marker is above or below some threshold level), indicating increased risk or presence of a fetal genetic condition, then a second screening or diagnostic test (step 102) is performed using a second portion of the biological sample [0040].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, providing instructions for obtaining the sample, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate a second test in the situation that the first test result is positive as taught by Katz. This modification would create a system and method which can accurately determine whether or not the user has the medical condition they are being tested for so that the user might receive the treatment they require as efficiently as possible while maintaining security in their information (see Katz, ¶ 0006-0007).
Quattrocchi and Katz do not teach scanning the access code and generating a unique identifier which is met by Dieben:
the method comprising the steps of: scanning, by the user communication device, an access code; (Dieben teaches machine readable codes can be displayed on the screen of a communication device, such that the machine readable code can be scanned from the display by another communication device. Through visual scanning, information, i.e. a barcode image is transferred from a first device to a second device without the need of a physical or wireless network connection [0019]. The Examiner interprets the machine readable code as an access code.)
generating, in response to the scanning, a unique identifier by the…communication device, the…communication device being configured for receiving messages addressed to the unique identifier; (Dieben teaches the unique identifier may be generated by the communication device itself and/or may be generated by the server when the machine readable code is scanned [0007]. The unique identifiers may comprise the communication address (for instance IP address) of the communication device [0005]. The Examiner interprets communication address being associated with the communication device.)
…wherein the …device is further configured to receive and display messages addressed to the unique identifier; (Dieben teaches at least two or more communication devices scan said machine readable code and send a first message comprising at least said machine readable code to a server [0012]. The first messages may comprise a machine readable code and a (generated) unique identifier [0029].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate scanning the access code and generating a unique identifier as taught by Dieben. This modification would create a system and method which enables communication between a plurality of communication devices while identifying the correct device (see Dieben, ¶ 0001-0002).
Regarding Claim 36: Quattrocchi, Katz, Dieben, and Pulitzer teach the limitations as shown in the rejection of Claim 35 above. Quattrocchi further discloses:
sending a message about the negative test result to the user communication device… (Quattrocchi discloses as shown in FIG. 8, and to…protect the confidentiality /anonymity the person taking the test, the caller is provided access to the test results only through providing the code associated with this particular caller. Only after entering the correct code is access to the test results provided to the caller. If the test results are negative, the telephone-operated computer program or software 84 of the computer system 48 will inform the person being tested of the negative results [0081].)
if the test result is positive with respect to the predetermined medical condition, sending a message comprising the unique identifier to a practitioner communication device for establishing consultation by a medical entity (Quattrocchi discloses on the other hand, a counselor will inform the user of the positive results. This way the user can be told how to get the proper medical attention and to determine if the user has possibly infected others with the HIV virus. At no point in the process is the identity of the user revealed. Also, if the test results are positive, the local health department and/or the Center for Disease Control can be informed [0082].)
Quattrocchi does not disclose the following limitations met by Katz:
further comprising obtaining a result of the second analysis of the medical sample by at least one of the laboratory communication device and a further laboratory communication device, (Katz teaches if in step 101, the first test produces a positive result (e.g., the level of a measured biochemical marker is above or below some threshold level), indicating increased risk or presence of a fetal genetic condition, then a second screening or diagnostic test (step 102) is performed using a second portion of the biological sample [0040].)
and, if the test result of the second analysis is negative with respect to the predetermined medical condition, sending a message about the negative test result to the user communication…, (Katz teaches alternatively, if in step 102 [second test] the test result is negative (e.g., no fetal genetic variation is detected in a cell-free nucleic portion), then the negative result is reported (step 105) leading to an endpoint [0041, see also Fig. 1].)
and, if the test result is positive with respect to the predetermined medical condition, sending a message comprising the unique identifier to a practitioner communication device for establishing consultation by a medical entity, such as a medical doctor. (Katz teaches in step 102, the second test produces a positive result (e.g., a fetal genetic variation is detected in a cell-free nucleic acid portion), indicating increased risk or presence of a fetal genetic condition, then the positive result is reported (step 112) leading to an endpoint [0041].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, providing instructions for obtaining the sample, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate a second test in the situation that the first test result is positive and to provide further assistance if the second result is positive as taught by Katz. This modification would create a system and methods which can accurately determine whether or not the user has the medical condition they are being tested for so that the user might receive the treatment they require as efficiently as possible (see Katz, ¶ 0006-0007).
Katz and Quattrocchi do not teach the use of a unique identifier which is met by Dieben:
… by means of the unique identifier… (Dieben teaches at least two or more communication devices scan said machine readable code and send a first message comprising at least said machine readable code to a server [0012]. The first messages may comprise a machine readable code and a (generated) unique identifier [0029]. The unique identifiers may comprise the communication address (for instance IP address) of the communication device [0005]. The Examiner interprets communication address being associated with the communication device.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate scanning the access code and generating a unique identifier as taught by Dieben. This modification would create a system and method which enables communication between a plurality of communication devices while identifying the correct device (see Dieben, ¶ 0001-0002).
Claims 19, 24-27, and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Quattrocchi, Katz, Dieben, and Pulitzer further in view of Sobti et al. (US 20220130535 A1).
Regarding Claim 19, Quattrocchi, Katz, Dieben, and Pulitzer teach the limitations as shown in the rejection of claim 18 above. Quattrocchi further discloses:
wherein the user communication device, the laboratory communication device, and the practitioner communication device are configured to communicate (Quattrocchi discloses if the test results reported by the laboratory are positive, the computer program 84 shifts the program to Step 134 whereat a counselor informs the caller of the test results. At Step 134, the counselor further takes the opportunity to counsel the person being tested about how to get proper medical attention, face-to-face counseling [0092]. If the test results are negative, the telephone-operated computer program or software 84 of the computer system 48 will inform the person being tested of the negative results [0081]. This is interpreted as the devices being configured to communicate.)
Quattrocchi, Katz, Dieben, and Pulitzer do not teach the following limitations met by Sobti:
with a central server for relaying messages between the user communication device, the laboratory communication device, and the practitioner communication device. (Sobti teaches the apparatus can be operatively coupled to a server 304. The server 304 can be configured to receive updates from external devices pertaining to health applications, that can then be transmitted to the apparatus. The channel of communication 308 between the server 304 and the apparatus 320 is made secure. In another example embodiment, the server can be further operatively coupled to other apparatus. Further, the server 304 can be configured to receive updates from external devices pertaining to health applications, that can then be transmitted to the apparatus [0067]. Further, the server 304 may be operatively coupled with any one or more authenticated networks such as networks of healthcare organizations, where data from the server 304 may be shared across the one or more authenticated networks 302 [0068]. Each apparatus 320 can be registered with the server by means of a unique ID. The registration can further be used as any of one or a combination of authenticating means required for transfer of data between the apparatus and the server and between the server and the external devices [0071].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition with a unique access code, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate the use of a user, laboratory, and medical device systems for communication between the groups as taught by Sobti. This modification would create a system and methods which can accurately determine whether or not the user has the medical condition they are being tested for, and connecting them to the proper clinician so that the user might receive the treatment they require as efficiently as possible, and the user can receive as much interactive help as necessary (see Sobti, ¶ 0004-0006).
Regarding Claim 24, Quattrocchi, Katz, Dieben, and Pulitzer teach the limitations as shown in the rejection of claim 18 above. Quattrocchi, Katz, Dieben, and Pulitzer do not teach the following limitations met by Sobti:
wherein at least one of the user communication device, the laboratory communication device, and the practitioner communication device is selected from a smartphone, a tablet and an internet enabled PC. (Sobti teaches the digital interface device can be any device capable of audio-video interfacing such as tablet, smartphone, laptop etc. In another example embodiment, the dock can comprise a stand to accommodate interface devices such as a tablet or a smartphone [0051].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate the ability for a user to use a smartphone, tablet, or PC as their communication device as taught by Sobti. This modification would create a system and methods which can provide the user most convenient form of communication with the testing location and their physician for ease of interaction (see Sobti, ¶ 0004-0006).
Regarding Claim 25, Quattrocchi, Katz, Dieben, and Pulitzer teach the limitations as shown in the rejection of claim 18 above.
Quattrocchi and Katz do not teach scanning the access code and generating a unique identifier which is met by Dieben:
scanning …the access code…by a user communication device; (Dieben teaches machine readable codes can be displayed on the screen of a communication device, such that the ma chine readable code can be scanned from the display by another communication device. Through visual scanning, information, i.e. a barcode image is transferred from a first device to a second device without the need of a physical or wireless network connection [0019]. The Examiner interprets the machine readable code as an access code.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate scanning the access code and generating a unique identifier as taught by Dieben. This modification would create a system and method which enables communication between a plurality of communication devices while identifying the correct device (see Dieben, ¶ 0001-0002).
Quattrocchi, Katz, Dieben, and Pulitzer do not teach the following limitations met by Sobti:
wherein receiving and verifying the access code comprises at least one of (i) scanning of a 1D or 2D matrix code using a camera of the user communication device, and (ii) scanning of an RFID tag. (Sobti teaches the above-mentioned information can be encoded into the QR code, the QR code being attached with the SAT kit. The QR code can also be a part of the tamper proof seal of the SAT kit, where, if the integrity of the seal is compromised, the QR can also be compromised [0085]. The Examiner interprets QR code as a 2D barcode.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate the ability for the user to scan a barcode with their communication device to get their unique code as taught by Sobti. This modification would create a system and methods which can provide the user with a secure means for ensuring the sample is valid while maintaining anonymity (see Sobti, ¶ 0004-0006).
Regarding Claim 26, Quattrocchi, Katz, Dieben, and Pulitzer teach the limitations as shown in the rejection of claim 18 above. Quattrocchi, Katz, Dieben, and Pulitzer do not teach the following limitations met by Sobti:
wherein establishing the communicating with the user comprises establishing, using the unique identifier, at least one of a voice link and a video link between the user communication device and the practitioner communication device. (Sobti teaches the SAT kit can be delivered to the patient from an authorized vendor through a delivery service. An authentication pertaining to the SAT kit can be provided to the patient. The authentication code can be any such as QR code, bar code and other visual identification codes [0083]. On successful authentication, the system may further provide for remote operation by the second user 104 of the sensor module coupled to the system, including the authentication and instruction to transmit information through a set of audio, video or textual messages through the respective first computing device 16 associated with the first user 102 and the second computing device 14 associated with the second user 104 or through a communication module 12 operatively coupled to the system 110 [0030].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate the ability for the user to get assistance and interact with the other entities in the form of videos and voice links as taught by Sobti. This modification would create a system and methods which can provide the user with a secure means for ensuring the sample is valid while maintaining anonymity (see Sobti, ¶ 0006).
Regarding Claim 27, Quattrocchi, Katz, Dieben, and Pulitzer teach the limitations as shown in the rejection of claim 18 above. Quattrocchi further discloses:
…by the user communication device… (Quattrocchi discloses the person taking the test proceeds by creating or activating a personal electronic file through a software program in a computer system that can be both created and subsequently accessed anonymously and remotely from a telephone [0017]. The user communication device is the subject’s phone.)
Quattrocchi, Katz, Dieben, and Pulitzer do not teach the following limitations met by Sobti:
further comprising…providing detailed instructions to the user explaining (i) how to use of the medical test-kit to obtain the medical sample or (ii) how to mail the medical sample to a laboratory entity, (Sobti teaches a result of the test indicating a presence or an absence of infection may be coded into the QR code or barcode on the certificate , and where a scan of the code may additionally instruct the entity or persons performing the scan of any subsequent steps to be taken as per an established protocol (para. 0048). Further, the system 110 can include an approach to receive… and administer, by the patient…a self-administering test (herein, abbreviated as “SAT” ) kit as per guidelines established for the SAT test [0036-0037].)
the instructions comprising at least one of text, images, audio and video. (Sobti teaches the SAT kit can be configured with a QR code with information including, but without limitations, the purpose of the testing kit and attributes of the testing kit such as date and place of manufacture of the testing kit [0102]. On successful authentication, the system may further provide for remote operation by the second user 104 of the sensor module coupled to the system, including the authentication and instruction to transmit information through a set of audio, video or textual messages through the respective first computing device 16 associated with the first user 102 [0030].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate instructions for properly administering the test via the user’s device as taught by Sobti. This modification would create a system and methods which can ensure the test is properly administered and therefore produces valid results (see Sobti, ¶ 0004-0006).
Regarding Claim 33, Quattrocchi, Katz, Dieben, and Pulitzer teach the limitations as shown in the rejection of claim 18 above. Quattrocchi further discloses:
on the user communication device (Quattrocchi discloses the person taking the test proceeds by creating or activating a personal electronic file through a software program in a computer system that can be both created and subsequently accessed anonymously and remotely from a telephone [0017]. The user communication device is the subject’s phone.)
Quattrocchi, Katz, Dieben, and Pulitzer do not teach following limitations met by Sobti:
wherein the medical test-kit further comprises a reference for a downloadable computer program to be executed… (Sobti teaches a scanning device coupled to the apparatus can be adapted to scan the QR code of the testing kit, and the veracity of the testing kit can be authenticated by the apparatus. The authentication can include verification of the identity of the apparatus at the location of the patient and the identity of the patient, and the corresponding purpose of the testing kit [0086]. The apparatus 200 can be a dock that is capable of being operatively coupled to an interface device for remote health applications. The digital interface device can be any device capable of audio-video interfacing such as tablet, smartphone, laptop etc. [0051]. )
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate a downloadable application as taught by Sobti. This modification would create a system and methods which can provide the user with a source for following along on the progression of their test and the results (see Sobti, ¶ 0006).
Regarding Claim 34, Quattrocchi, Katz, Dieben, and Pulitzer teach the limitations as shown in the rejection of Claim 19 above. Quattrocchi further discloses:
… to carry out the steps of the central server of the method of claim 18. (Quattrocchi, Katz, Dieben, and Pulitzer teach the method of Claim 18 above.)
Quattrocchi, Katz, Dieben, and Pulitzer do not teach following limitations met by Sobti:
A central server configured to carry out the steps of the central server of the method… (Sobti teaches the apparatus can be operatively coupled to a server 304. The server 304 can be configured to receive updates from external devices pertaining to health applications, that can then be transmitted to the apparatus. The channel of communication 308 between the server 304 and the apparatus 320 is made secure. The server can be further operatively coupled to other apparatus. Further, the server 304 can be configured to receive updates from external devices pertaining to health applications, that can then be transmitted to the apparatus [0067].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate a central server as taught by Sobti. This modification would create a system and methods which can connect all of the communication devices for efficient information sharing and interaction (see Sobti, ¶ 0006).
Claims 20-23, 28-29, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Quattrocchi, Katz, Dieben, and Pulitzer in view of Calabrese et al. (US 20050075543 A1).
Regarding Claim 20, Quattrocchi, Katz, Dieben, and Pulitzer teach the limitations as shown in the rejection of claim 18 above. Quattrocchi and Katz do not teach the following limitation met by Dieben:
wherein the unique identifier is generated… (Dieben teaches the first messages may comprise a machine readable code and a (generated) unique identifier [0029]. The unique identifiers may comprise the communication address (for instance IP address) of the communication device [0005]. The Examiner interprets communication address being associated with the communication device.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate scanning the access code and generating a unique identifier as taught by Dieben. This modification would create a system and method which enables communication between a plurality of communication devices while identifying the correct device (see Dieben, ¶ 0001-0002).
Quattrocchi, Katz, Dieben, and Pulitzer do not teach the following limitations met by Calabrese:
identifier… (i) randomly, (ii) by communicating with a database comprising pre-generated identifiers, or (iii) based on a deterministic mathematical function. (Calabrese teaches a PIN, which may be performed by a computer that generates a unique random number or character set…[0045].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate the identifier being generated randomly as taught by Calabrese. This modification would create a system which ensure anonymity to users by making them verify their identity before accessing their data to protect sensitive information (see Calabrese, ¶ 0045).
Regarding Claim 21, Quattrocchi, Katz, Dieben, and Pulitzer teach the limitations as shown in the rejection of claim 18 above. Quattrocchi, Katz, Dieben, and Pulitzer do not teach the following limitations met by Calabrese:
wherein the first analysis method detects a protein and the second analysis method detects a nucleic acid. (Calabrese teaches the test may be based on saliva, hair, blood, urine, stool, or other biological samples or fluids. These tests may utilize assays that include, but are not limited to, Enzyme Linked Immunosorbent Assay (ELISA), Western Blot tests, hybridization, PCR, GC/MS, TLC and other nucleic acid and protein based tests [0022].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate the test comprising protein and nucleic acid based tests as taught by Calabrese. This modification would create a system and methods which can provide the user with two different kinds of tests to effectively verify their results (see Calabrese, ¶ 0007).
Regarding Claim 22, Quattrocchi, Katz, Dieben, and Pulitzer teach the limitations as shown in the rejection of claim 18 above. Quattrocchi, Katz, Dieben, and Pulitzer do not teach the following limitations met by Calabrese:
wherein at least one of the first and second analysis methods test for the predetermined medical condition, wherein the predetermined medical condition (i) correlates with a sexually transmitted disease, or (ii) is a disease caused by one of a virus, a bacterium, a fungus and a parasite. (Calabrese teaches representative tests that may be used in relation to the current system and methods include, but are not limited to, Alzheimer’s, Osteoporosis, Drug Use, DNA Genetics, Infertility, Paternity, HIV/Aids, Hepatitis, Body Fat Scales, Breathalyzers, CardioChek, Cholesterol, Diabetes, Sexually Transmitted Diseases (STDs), Carpal Tunnel and Cancers, such as, Breast, Prostate, Colon and Skin cancer. The test may be based on saliva, hair, blood, urine, stool, or other biological samples or fluids [0022]. This is interpreted as a sexually transmitted disease or a virus.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate a second test in the situation that the first test result is positive as taught by Katz, and further to incorporate the health condition being either a sexually transmitted disease or a disease caused by a virus, bacteria, parasite, or fungus as taught by Calabrese. Although Calabrese does not explicitly teach the limitation of a disease caused by a parasite or fungus, this is known work in the field of endeavor and would have been the use of a simple substitution of one known element for another to obtain predictable results. This modification would create a system and methods which can provide the user with different kinds of tests depending upon their medical condition (see Calabrese, ¶ 0007).
Regarding Claim 23, Quattrocchi, Katz, Dieben, Pulitzer, and Calabrese teach the limitations as shown in the rejection of claim 22 above. Quattrocchi, Katz, Dieben, and Pulitzer do not teach the following limitations met by Calabrese:
wherein the disease is caused by one of human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), human papillomaviruses (HPV), Chlamydia trachomatis, herpes simplex virus (HSV), Treponema pallidum, and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). (Calabrese teaches representative tests that may be used in relation to the current system and methods include, but are not limited to, Alzheimer’s, Osteoporosis, Drug Use, DNA Genetics, Infertility, Paternity, HIV/Aids, Hepatitis, Body Fat Scales, Breathalyzers, CardioChek, Cholesterol, Diabetes, Sexually Transmitted Diseases (STDs), Carpal Tunnel and Cancers, such as, Breast, Prostate, Colon and Skin cancer [0022].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the method for testing a user for a predetermined medical condition with a unique access code, and connecting a user device with communication devices to provide the test results as taught by Quattrocchi to incorporate the testing for a multitude of health conditions as taught by Calabrese. Although Calabrese does not explicitly teach the limitation of a disease being SARS-CoV-2, this is known work in the field of endeavor and would have been the use of a simple substitution of one known element for another to obtain predictable results. This modification would create a system and methods which can provide the user with different kinds of tests depending upon their medical condition and ensure the proper test is used (see Calabrese, ¶ 0007).
Regarding Claim 28, Quattrocchi, Katz, Dieben, and Pulitzer teach the limitations as shown in the rejection of claim 18 above. Quattrocchi further teaches the following limitations:
wherein, after establishing consultation, the method further comprises scheduling an appointment for the user with a medical entity, …to an appointment booking system of the medical entity for identification of the user. (Quattrocchi discloses if the test results reported by the laboratory are positive, the computer program 84 shifts the program to Step 134 whereat a counselor informs the caller of the test results. At Step 134, the counselor further takes the opportunity to counsel the person being tested about how to get proper medical attention, face-to-face counseling and to determine if there are any people that the user should inform about the test results because they might also be infected with the HIV [0092].)
…the user communication device (Quattrocchi discloses the person taking the test proceeds by creating or activating a personal electronic file through a software program in a computer system that can be both created and subsequently accessed anonymously and remotely from a telephone [0017]. The user communication device is the subject’s phone.)
Quattrocchi and Katz do not teach the following limitations met by Dieben:
wherein the unique identifier is transmitted by the…device (Dieben teaches at least two or more communication devices scan said machine readable code and send a first message comprising at least said machine readable code to a server [0012]. The first messages may comprise a machine readable code and a (generated) unique identifier [0029]. The unique identifiers may comprise the communication address (for instance IP address) of the communication device [0005]. The Examiner interprets communication address being associated with the communication device.)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate scanning the access code and generating a unique identifier as taught by Dieben. This modification would create a system and method which enables communication between a plurality of communication devices while identifying the correct device (see Dieben, ¶ 0001-0002).
Regarding Claim 29, Quattrocchi, Katz, Dieben, and Pulitzer teach the limitations as shown in the rejection of claim 18 above. Quattrocchi further discloses:
…the user communication device, (Quattrocchi discloses the person taking the test proceeds by creating or activating a personal electronic file through a software program in a computer system that can be both created and subsequently accessed anonymously and remotely from a telephone [0017]. The user communication device is the subject’s phone.)
Quattrocchi and Katz do not teach the following limitations met by Dieben:
addressed by using the unique identifier to…(Dieben teaches the first messages may comprise a machine readable code and a (generated) unique identifier [0029].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate scanning the access code and generating a unique identifier as taught by Dieben. This modification would create a system and method which enables communication between a plurality of communication devices while identifying the correct device (see Dieben, ¶ 0001-0002).
Quattrocchi, Katz, Dieben, and Pulitzer do not teach the following limitations met by Calabrese:
wherein the method further comprises, by the laboratory entity, sending of a message …informing the user about at least one of (i) receipt of the sample, (ii) testing of the sample, and (iii) that testing has been completed. (Calabrese teaches upon receipt of the test specimen, the test facility matches the specimen with the PIN. Once the analysis is completed, the results are connected to an electronic file identified by the PIN that corresponds to the PIN of the test specimen [0034]. If the test results are negative for the presence of a human malady, the patient may simply be informed of the results. However, additional information may also be provided to the patient regarding, for example, further testing [0037].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate a second test in the situation that the first test result is positive as taught by Katz, and further to incorporate providing the user with updates regarding the status of their test as taught by Calabrese. This modification would create a system and methods which can connect all of the communication devices for efficient information sharing and interaction (see Calabrese, ¶ 0006-0008).
Regarding Claim 32, Quattrocchi, Katz, Dieben, and Pulitzer teach the limitations as shown in the rejection of claim 18 above. Quattrocchi, Katz, Dieben, and Pulitzer do not teach the following limitations met by Calabrese:
a computer program comprising instructions, (Calabrese teaches the test results and PIN may be linked by creating or activating a personal electronic file through a software program in a computer system that can be both created and subsequently accessed anonymously and remotely from a telephone or through the internet [0029].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the system which provides the user with instructions for properly preparing their sample as disclosed by Quattrocchi to incorporate the instructions being provided via the user communication device as taught by Sobti. This modification would have been the use of one known technique to improve similar devices/methods in the same way. This modification would create a system and methods which are capable of providing the user with the information they require to properly take the medical test (see Quattrocchi, ¶ 0006-0007).
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Quattrocchi, Katz, Dieben, and Pulitzer in view of Calabrese et al. (US 20050075543 A1) and further in view of Goldhaber et al. (US 20090089079 A1).
Regarding Claim 30, Quattrocchi, Katz, Dieben, and Pulitzer teach the limitations as shown in the rejection of claim 18 above. Quattrocchi further discloses:
by the user communication device (Quattrocchi discloses the person taking the test proceeds by creating or activating a personal electronic file through a software program in a computer system that can be both created and subsequently accessed anonymously and remotely from a telephone [0017]. The user communication device is the subject’s phone.)
Quattrocchi, Katz, Dieben, and Pulitzer do not teach the following limitations met by Calabrese:
wherein the method further comprises,… when a message indicating a negative test result has been received, the step of obtaining user input indicating whether the user belongs to a high risk group for the predetermined medical condition, (Calabrese teaches a testing facility should receive a sufficient quantity of a sample to perform the desired test at least twice, thereby allowing for verification of the test accuracy. The invention also provides for a testing facility to receive sufficient sample to perform additional tests, thus, the testing facility may maintain the sample and identify the same in relation with the PIN. The patient may then contact, the IGC or the testing facility to order additional tests to be performed on the sample [0042]. The reporting system may initially provide a series of automated messages to patients who have tested negative, to repeat patients who have previously accessed information regarding a positive test result and who were previous flagged to receive counseling or announcements, and to patients for whom test results are not available [0061].)
Quattrocchi, Katz, Dieben, and Pulitzer and Calabrese do not teach the following limitations met by Goldhaber:
wherein in the case the user belongs to a high risk group, performing at least one of: by the user communication device, generating a reminder for the user to repeat the test after a predetermined time has passed; and by the user communication device, offering further testing in order to assess whether the user is eligible for a prophylaxis treatment relating to the predetermined medical condition. (Goldhaber teaches a system and method for determining whether to issue an alert to consider prophylaxis. One or more sources of patient information are queried to retrieve patient information for a set of patients. From this retrieved patient information, it is determined whether any risk factors of a set of risk factors are satisfied for each such patient. For each patient for which one or more risk factors are satisfied, a respective value and/or classification is assigned to each risk factor. If the patient has the risk condition, an alert is issued (e.g., on a display screen) to a health care provider for consideration of prophylaxis (abstract). Ninety-day follow-up was performed in all study patients by medical record review using the patient database of the hospital. Clinical events were identified using information from the index hospitalization, recurrent hospitalizations, and office visits, including discharge summaries, physician notes, blood test results, vascular laboratory reports, nuclear medicine reports, or radiology reports [0287].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for identifying when a patient is high risk based upon their input as taught by Goldhaber and further recommending prophylaxis treatments with the integration of continuous testing as taught by Calabrese. This modification would have been the use of a known technique to improve similar devices/methods ready for improvement to yield predictable results. It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate providing the user with reminders for continuously testing if they are deemed high risk taught by Calabrese and Goldhaber. This modification would create a system and methods which can provide continued support and recommendations to the user if they are at a high risk (see Calabrese, ¶ 0006-0008, Goldhaber, ¶ 0006).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Quattrocchi, Katz, Dieben, and Pulitzer in view of Rapaport et al. (US 20060161457 A1).
Regarding Claim 37, Quattrocchi, Katz, Dieben, and Pulitzer teach the limitations as shown in the rejection of claim 18 above. Quattrocchi further discloses:
wherein sending the message informing the user about the first negative test result… (Quattrocchi discloses if the test results are negative, the telephone-operated computer program or software 84 of the computer system 48 will inform the person being tested of the negative results [0081].)
Quattrocchi, Katz, Dieben, and Pulitzer do not teach the message being triggered to notify the patient of the negative result which is met by Rapaport:
is triggered by the first negative test result (Rapaport teaches an introductory announcement to the Patient, which is followed by information of the results of the test given by lines 73 to 84. One of the three possible results, "POSITIVE," "NEGATIVE," or "INDETERMINATE," is assigned together with a corresponding explanation statement. Lines 86 to 90 are activated if the Interview Dialog delivery is not acknowledged or successful and cause the Dialog delivery to cease. In an embodiment, a Retrieval Alert may be automatically sent [0650].)
It would have been obvious to a person having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the systems and methods for testing a user for a predetermined medical condition by using a unique access code, and connecting with the user to provide the test results via communication devices as taught by Quattrocchi to incorporate the message being sent to the patient being automatically triggered in the event of a negative result as taught by Rapaport. This modification would create a system and methods which can immediately inform patients of developments in their health and therefore improve their overall experience (see Rapaport, ¶ 0019).
Relevant Prior Art of Record Not Currently Being Applied
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Michon et al. (US 20090299767 A1) teaches medical testing with proteins and nucleic acids, as well as methods for obtaining information of maladies caused by fungal and parasitic diseases.
Foley et al. (US 20210233627 A1) teaches a system in which a patient can self-sample medical tests and remotely view their test results as well as consult remotely with a physician.
Response to Arguments
Regarding the rejection under 35 USC 112(d) to Claim 31, Applicant’s arguments have been considered and are persuasive in light of the amendments. Therefore, the rejection has been withdrawn.
Regarding rejections under 35 USC 101 to Claims 18-37, Applicant’s arguments have considered but are not persuasive. The rejection has been updated in light of the amendments.
Applicant argues that the Office has not met its burden under MPEP 2106.07(a) and relevant case law which require that a rejection under Step 2A Prong 1 must include a reasoned explanation as to why each claim limitation falls within a judicial exception. The Office’s rejection does not provide a specific explanation as to how each step in representative Claim 18 recites “managing person al behavior or interactions between people”. After identifying the elements that allegedly recite the judicial exception, the Office does not provide any explanation as to why each element falls within the judicial exception (see Applicant’s Remarks, p. 10)
Regarding (a), Examiner respectfully disagrees. MPEP 2106.07(a) states “the rejection should identify the judicial exception by referring to what is recited (i.e., set forth or described) in the claim and explain why it is considered an exception. For example, if the claim is directed to an abstract idea, the rejection should identify the abstract idea as it is recited (i.e., set forth or described) in the claim and explain why it is an abstract idea.” In following with the guidelines for formulating a rejection, the action has underlined every part of independent Claim 18 to identify the abstract idea and explained why they recite certain method of organizing human activity.
Furthermore, the court does not require "evidence" that a claimed concept is a judicial exception, and generally decides the legal conclusion of eligibility without resolving any factual issues (see MPEP 2106.07(a)(III)). Thus, it is not the Examiner’s burden to provide caselaw or any other “evidence” as to why the claims recite a judicial exception, but rather the identification of the judicial exception and an explanation.
Applicant argues the office alleges that “the abstract steps of the claims are all a series of steps a lab technician would follow to perform a medical test [on] a patient and inform them about their medical test results." This is not a correct application of the law. For example, the performing of a medical test does not relate to interactions between people as is evidenced by the examples "social activities, teaching, and following rules or instructions" being completely different. And MPEP 2106 counsels that this list of enumerated subgroupings is "not to be expanded beyond these enumerated sub-groupings except in rare circumstances as explained in MPEP § 2106.04(a)(3)." Applicant submits the Examiner is improperly expanding.
Regarding (b), Examiner respectfully disagrees. The claims do not recite a tentative abstract idea as Applicant insinuates. The claims are directed to certain methods of organizing human activity because they recite steps that a doctor could reasonably follow to perform a medical test and inform a patient about their results. MPEP 2106.04(a)(2)(II)(C) shows examples of managing personal behavior or relationships or interactions between people including iii. a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982). The claims are similar to example iii. provided and are not expanded beyond the enumerated sub-groupings. The step of receiving a medical sample from a user to test it and then provide the results to the patient can all be carried out by a doctor.
Applicant argues the Office’s interpretation of Claim 18 is taken with the broadest possible interpretation and ignores the claim language requiring device-executed operations. The claims, when read in light of the specification, clearly require a technical protocol for privacy-preserving, distributed sample management and communication that is implemented by computing and laboratory devices, and not by a human acting alone or by conventional interpersonal behavior (p. 11).
Regarding (c), Examiner respectfully disagrees. The additional elements are not considered when evaluating whether there is a judicial exception present. Instead, the additional elements are omitted, and the limitations that remain are evaluated for the presence of a judicial exception, and in this case, the limitations are steps that could be reasonably carried out by a person behind a generic computer. It is important to note that the text within the parentheses stating social activities, teaching, and following rules or instructions are provided as examples and not an exclusive listing and that the October 2019 Update: Subject Matter Eligibility on p. 5 states certain activity between a person and a computer may fall within the “certain methods of organizing human activity” grouping. Because it is not specified, it is assumed that the step of analyzing the medical sample is conducted by a technician following instructions. The transmission of messages containing technical results/test outcomes is a regularly performed task done by medical professionals. The steps of sending messages are all steps that could be done by a laboratory, practitioner, and a patient/user with the implementation of a generic computer, face-to-face, or via the mail and describes social activities or interactions between people as it is simply providing different groups with information as required.
Applicant argues that steps in Claim 18 do not recite "managing personal behavior or interactions between people. For example, the scanning and verification of the access code by a user communication device involves the use of a user communication device to authenticate and initiate the workflow. The requirement that a user communication device (e.g., smartphone or RFID-enabled system) scans and verifies an access code as an entry point to a distributed diagnostic process is not an interaction between people, but a computer-implemented protocol for secure access (see, e.g., [0049]-[0051]).
Regarding (d), Examiner respectfully disagrees. Examiner does agree that scanning the code is not a part of the abstract idea and the 101 rejection has been updated to reflect this in light of the amendments. However, verifying an access code is not something that has to be conducted by a computer and using BRI can be completed by a person. Because there is no additional element in the limitation, it is a part of the abstract idea and grouped under certain methods of organizing human activity by considering the claims as a whole.
Applicant argues the generation of a unique identifier by the user communication device in response to scanning the access code is a technical operation performed by software or hardware, not a human or a social process. The unique identifier is specifically generated to enable privacy- preserving, anonymous routing of electronic communications and sample tracking. This action cannot be performed by unaided human effort, and does not constitute organizing human interactions, but rather implements a technical means of unlinking identity from workflow in a distributed system (see, e.g., [0042]-[0043]). If a human is involved in the process, the privacy- preserving purpose of the unique identifier would be defeated, since a human would necessarily have access to or knowledge of the user's identity. In contrast, the automated generation of the unique identifier by the user communication device enables secure, anonymous communication and sample handling that cannot be achieved by manual or social processes (p. 12).
Regarding (e), Examiner respectfully disagrees. Regardless of the consideration of privacy, as recited in claim 18 any person could also generate a unique identifier because the term is not claimed specifically enough to eliminate a human from carrying out the same process. Since the medical sample is (physically) obtained from the user, presumably by shipping the medical sample, various people would, such as the mail carrier, would “have access to or knowledge of the user’s identity” based on the sender’s address of the shipping package.
Applicant argues the step of receiving the medical sample and analyzing the received medical sample are technical operations performed by devices and laboratory systems. These steps define automated sample intake, identification, and laboratory analysis, thus do not recite managing personal behavior or interpersonal interactions. The subsequent steps involving sending messages to the user communication device addressed by the unique identifier, and, in the event of a positive result, initiating further analysis and practitioner consultation, are likewise technical communications between devices. The claim requires that all such messaging is performed through the use of technical identifiers and device- based communication protocols, not through direct human interaction. The establishment of consultation via practitioner communication device configured to contact the user device by unique identifier is an automated, privacy-preserving routing step, not an organization of social relationships or behavior as contemplated by the "managing personal behavior or interactions. Therefore, none of the steps recited in representative Claim 18 is not directed to organizing human activity as described in MPEP 2106.04(a) (p. 12-13).
Regarding (f), Examiner respectfully disagrees. Examiner notes that the claims do not recite the use of the laboratory systems or devices when receiving the medical sample or for testing/analyzing the received medical sample. The only involvement of the laboratory device in the claims is the use of the laboratory communication device to send a message to inform the user about a first and second negative test result. With regards to Applicant’s argument that the claim requires technical involvement and not human interaction, Examiner notes that the claims do not preclude human involvement. A person operating the laboratory communication device does not need to know the identity of the medical sample to send a test result. The laboratory communication device is simply a mechanism used to facilitate the communicating of the result, which is akin to “apply it” and/or generally linking the device to the abstract idea.
Furthermore, the devices and laboratory systems are not a part of the abstract idea. However, the limitation of sending messages based upon the result of the test and using the unique identifier are a part of the abstract idea as there is nothing technical about them. MPEP 2106.04(a)(2)(II)(C) states the sub-grouping "managing personal behavior or relationships or interactions between people" include social activities, teaching, and following rules or instructions. An example of a claim reciting managing personal behavior is Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 115 USPQ2d 1636 (Fed. Cir. 2015). The patentee in this case claimed methods comprising storing user-selected pre-set limits on spending in a database, and when one of the limits is reached, communicating a notification to the user via a device. 792 F.3d. at 1367, 115 USPQ2d at 1639-40. The Federal Circuit determined that the claims were directed to the abstract idea of "tracking financial transactions to determine whether they exceed a pre-set spending limit (i.e., budgeting)", which "is not meaningfully different from the ideas found to be abstract in other cases before the Supreme Court and our court involving methods of organizing human activity." 792 F.3d. at 1367-68, 115 USPQ2d at 1640.
The act of automating a message does not change this fact and it is still an abstract limitation.
Assuming, arguendo, that the limitations were not a part of the abstract idea, the court have recognized the following computer functions as well-understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as an insignificant extra solution activity: i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network).
Applicant argues the Office’s analysis overlooks the specific, non-conventional arrangement and sequence of steps recited in the claims, and fails to address several critical limitations that are central to the claimed invention. The Office does not discuss or analyze the requirement that the user communication device generates a unique identifier in direct response to access code scanning, that the medical sample is labeled and tracked via this unique identifier, or that all subsequent messaging and multi-stage analysis are routed using this identifier in a manner that preserves privacy and anonymity. These limitations are not mere instructions to use generic components, but instead define a particular, technical workflow unique to distributed, computer-enabled medical testing. The Examiner's analysis ignores these specific device-driven steps, which are essential to the privacy-preserving, automated, and distributed architecture claimed. By failing to consider these substantive limitations, the Office's analysis does not properly evaluate whether the claims as a whole are integrated into a practical application (p. 13).
Regarding (g), Examiner respectfully disagrees. The concept of a unique identifier associated with patient data is not new, nor is it a technology related concept. The remarks argue the identifier ensures privacy and safety of patient data; however, there is no personally identifiable information present in the claims, just a generic sample. An improvement to the abstract ideas of generating an access code and messaging and multi-stage analysis with said identifier does not amount to an improvement to technology or a technical field (see MPEP § 2106.05(a)(III) stating “it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019), the court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology.”). There is no indication in the instant disclosure that the involvement of a computer assists in improving the technology for the outlined problem statement. Here, the improvement is to ‘managing information dealing with a medical test’ which does not provide any improvement to a computer or any other technology. The instant application and claim language fail to detail how a computer aids the method, the extent to which the computer aids the method, or the significance of a computer to the performance of the method. Merely adding generic computer components to perform the method is not sufficient.
The specification does not provide any evidence as to how the unique identifier is generated in response to scanning a code or how the messaging through the identifier takes place. MPEP 2106.05(f) states when determining whether a claim simply recites a judicial exception with the words "apply it" (or an equivalent), such as mere instructions to implement an abstract idea on a computer, examiners may consider the following: (1) Whether the claim recites only the idea of a solution or outcome i.e., the claim fails to recite details of how a solution to a problem is accomplished. The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words “apply it”. See Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1356, 119 USPQ2d 1739, 1743-44 (Fed. Cir. 2016); Intellectual Ventures I v. Symantec, 838 F.3d 1307, 1327, 120 USPQ2d 1353, 1366 (Fed. Cir. 2016); Internet Patents Corp. v. Active Network, Inc., 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1417 (Fed. Cir. 2015).
Additionally, Examiner notes that the medical testing is not claimed as involving any computing system or any sort of laboratory device. The argued “technical workflow” is for preserving privacy and anonymity of the individual who submitted the medical sample. However, this does not have any impact or effect on the testing or analysis of the medical sample. The knowledge (or lack thereof) of the identity of the individual whose medical sample is being tested does not make the testing faster or slower, does not dictate what testing protocols are used or not used.
Applicant argues this claim structure is directly analogous to the claims found eligible in DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245 (Fed. Cir. 2014). In DDR Holdings, the Federal Circuit held that claims that solved a specific problem in website functionality were "necessarily rooted in computer technology in order to overcome a problem specifically arising in the realm of computer networks." The Court found the claims patent eligible because they did not merely recite the automation of a longstanding business practice using generic computer components. Rather, the claims recited a specific, non-conventional solution to a technical problem unique to the Internet: how to retain website visitors after clicking on a third-party merchant link by dynamically generating a hybrid web page that preserved the "look and feel" of the host website. This was not a business solution that could be performed by a human; it was a technical architecture that fundamentally altered how web navigation operated to achieve a computer-centric privacy and branding goal.
Similarly, the claimed method recites a specific, device-driven workflow that is necessarily rooted in computer and laboratory technology to overcome problems unique to distributed, digital medical testing environments. The claims require that the user communication device generates a unique identifier in response to access code scanning, and that all sample labeling, sample/result tracking, and cross-entity messaging are performed using this unique identifier in a way that breaks any link to personal identity. This structure is not a conventional use of generic computers to automate existing manual processes; rather, it is a technical protocol for preserving privacy and enabling secure, anonymous communication across multiple entities in a distributed digital health system. As in DDR Holdings, the solution set forth in the claims is not one that could be achieved by manual means, but only through a particular, non-conventional arrangement of computing and laboratory devices, and a precise sequence of technical steps (p. 14).)
Regarding (h), Examiner respectfully disagrees. First, there is nothing in the claims that recites that the testing environments themselves are digital – the tests are still completed by a patient and sent to a lab for testing. Furthermore, the claims are not analogous to those of DDR Holdings because they do not recite a technical solution to a technical problem. DDR Holdings provided a solution to a problem necessarily rooted in computer technology which is not the case in the instant invention. That is, the concept of providing medical test kits and/or generating a unique identifier for patient/sample information have existed since long before the advent of computer technology, and thus, cannot properly be considered a technological improvement and/or an improvement to the computer itself.
Additionally, Examiner notes that the medical testing is not claimed as involving any computing system or any sort of laboratory device. The argued “technical workflow” is for preserving privacy and anonymity of the individual who submitted the medical sample. However, this does not have any impact or effect on the testing or analysis of the medical sample. The knowledge (or lack thereof) of the identity of the individual whose medical sample is being tested does not make the testing faster or slower, does not dictate what testing protocols are used or not used.
Applicant argues Office's assertion that the use of a unique identifier is not a technical solution because such identifiers are "well known in the art" overlooks both the context of the claimed invention and the specific improvement it provides over existing systems. In conventional distributed medical testing workflows, there is a persistent technical problem: identity is often directly or indirectly linked to medical samples and result data at multiple stages, such as during laboratory processing, result reporting, or practitioner notification. This linkage exposes systems to risks of privacy breaches, unauthorized access, and re-identification, particularly as data moves between different entities or is stored on centralized servers. The claimed invention addresses this problem by requiring that the user communication device itself generates a unique identifier in response to secure access code scanning, and by mandating that all subsequent sample labeling, communication, and multi-stage workflow steps be routed and managed using this unique identifier and without reference to any information that personally identifies the user. This claimed method effectively decouples personal identity from sample and result data throughout the distributed system, thereby preventing identity exposure even in the event of server, laboratory, or practitioner compromise. The claimed workflow provides a specific technical improvement to the operation and security of distributed digital health systems, enabling secure, anonymous, and privacy-preserving sample management and communication, which is an improvement not attainable by merely using known identifiers in generic or unrelated contexts (p. 14-15).
Regarding (i), Examiner respectfully disagrees. The claimed invention does not provide a technical solution to a technical problem because there is no technological problem present. The distributed nature of the claimed invention is not, in itself, dispositive in determining whether the claimed invention recites an abstract idea because the concept of managing information associated with medical testing is not a technological solution to a technological problem – that is, the concept of providing medical test kits and/or generating a unique identifier for patient/sample information have existed since long before the advent of computer technology, and thus, cannot properly be considered a technological improvement and/or an improvement to the computer itself.
Furthermore, there is no indication in the claims that the unique identifier comprises any private patient identification information as is argued by Applicant. As claimed, the invention only indicates the unique identifier is associated with a generic sample.
Applicant argues The Office alleges that the claims, individually or in combination, do not recite additional elements that amount to "significantly more" than the judicial exception. The Office states that the elements are limited to generic computer components and the general linking of a medical test kit, and that, even in combination, these components do not meaningfully limit the practice of the alleged abstract idea. Applicant submits that the Office has not shown, with evidence or reasoned explanation, that the claimed arrangement of elements is well-understood, routine, or conventional in the field. As set forth in MPEP 2106.07(a)(III), a finding that an additional element is well-understood, routine, or conventional must be supported by one or more of the following: (A) a citation to an express statement in the specification or to a statement made by Applicant during prosecution; (B) a citation to one or more court decisions stating, or to a publication demonstrating, that the element is well-understood, routine, conventional; (C) a citation to a publication that describes the element and states it is well- understood, routine, conventional; or (D) a statement that the examiner is taking official notice, with an appropriate explanation. No such evidence or explanation has been provided in this case (p. 15-16).
Regarding (j), Examiner notes that if it was asserted in the office action that the additional elements of the claims were well-understood, routine, conventional, then the Examiner would have to provide Berkheimer evidence to support this statement. However, the Office Action groups the additional elements of the claims as generic computer components and generally linking which do not require any evidence as support.
MPEP 2106.07(a)(III) states the courts consider the determination of whether a claim is eligible (which involves identifying whether an exception such as an abstract idea is being claimed) to be a question of law. Rapid Litig. Mgmt. v. CellzDirect, 827 F.3d 1042, 1047, 119 USPQ2d 1370, 1372 (Fed. Cir. 2016); OIP Techs. v. Amazon.com, 788 F.3d 1359, 1362, 115 USPQ2d 1090, 1092 (Fed. Cir. 2015); DDR Holdings v. Hotels.com, 773 F.3d 1245, 1255, 113 USPQ2d 1097, 1104 (Fed. Cir. 2014); In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1335, 110 USPQ2d 1668, 1670 (Fed. Cir. 2014); In re Bilski, 545 F.3d 943, 951, 88 USPQ2d 1385, 1388 (Fed. Cir. 2008) (en banc), aff’d by Bilski v. Kappos, 561 U.S. 593, 95 USPQ2d 1001 (2010). Thus, the court does not require "evidence" that a claimed concept is a judicial exception, and generally decides the legal conclusion of eligibility without resolving any factual issues. FairWarning IP, LLC v. Iatric Sys., 839 F.3d 1089, 1097, 120 USPQ2d 1293, 1298 (Fed. Cir. 2016) (citing Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1373, 118 USPQ2d 1541, 1544 (Fed. Cir. 2016)); OIP Techs., 788 F.3d at 1362, 115 USPQ2d at 1092; Content Extraction & Transmission LLC v. Wells Fargo Bank, N.A., 776 F.3d 1343, 1349, 113 USPQ2d 1354, 1359 (Fed. Cir. 2014). In some cases, however, the courts have characterized the issue of whether additional elements are well-understood, routine, conventional activity as an underlying factual issue upon which the legal conclusion of eligibility may be based. See, e.g., Interval Licensing LLC v. AOL, Inc., 896 F.3d. 1335, 1342, 127 USPQ2d 1553, 1557 (Fed. Cir. 2018) (patent eligibility is a question of law that may contain underlying issues of fact), Berkheimer v. HP, Inc., 881 F.3d 1360, 1368, 125 USPQ2d 1649, 1654 (Fed. Cir. 2018) (issue of whether additional elements are well-understood, routine, conventional activity is factual).
Furthermore, this section of the MPEP states at Step 2A Prong Two or Step 2B, there is no requirement for evidence to support a finding that the exception is not integrated into a practical application or that the additional elements do not amount to significantly more than the exception unless the examiner asserts that additional limitations are well-understood, routine, conventional activities in Step 2B. The Examiner has not asserted the limitations as well-understood, routine, conventional activities and because of this, does not need to provide Berkheimer evidence.
Applicant argues The Office's reliance on an example in MPEP 2106.05(a) that "generally linking the use of the judicial exception to a particular technological environment or field of use" is not enough to qualify as "significantly more" is also misplaced as the example does not control the present case. Claim 18 does not merely recite the use of a judicial exception in a generic technological field. At least the ordered combination of the additional elements in Claim 18 provides a specific, non-conventional technological solution that requires "generating, in response to the scanning, a unique identifier by the user communication device," "sending a message addressed by using the unique identifier to the user communication device," "sending, by the laboratory communication device or the second laboratory communication device, a message to a practitioner communication device, the message comprising an indication of the unique identifier and at least one of the first positive test result and the second positive test result," and "establishing, by the practitioner communication device, a communication with the user, wherein the practitioner communication device is configured to contact the user communication device identified by using the unique identifier." The unconventionality of the claimed method in representative Claim 18 is also evidenced by the cited art (p. 16).
Regarding (k), Examiner respectfully disagrees. The consideration under Step 2B is if the additional elements, alone or in combination, are well-understood, routine and conventional in the field – the novelty of the abstract idea is not considered relevant under the Step 2B analysis. Here, the additional elements, alone or in combination, amount to instruction to implement the abstract idea using a general purpose computer. Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 134 S. Ct. 2347, 1357 (2014). These generic computer components of a user communication device, laboratory communication device, and practitioner communication device are merely generic computers which carry out, at best, a novel abstract idea (see Applicant’s specification which states that “the user communication device, the laboratory communication device, if present the further laboratory communication device and/or the further practitioner communication device is a smart device such as a smartphone or a tablet, or is an internet enabled PC.” (p. 6, lines 11-15). There is no evidence that the communication devices provide any improvement to the functioning of the devices or an improvement to the scanning of access codes or furthermore an unconventional use. There is no indication in the instant disclosure that the involvement of a computer assists in improving the technology for the outlined problem statement. Here, the improvement is to structurally and automatically alert a user of a positive test result. The instant application and claim language fail to detail how a computer aids the method, the extent to which the computer aids the method, or the significance of a computer to the performance of the method. Merely adding generic computer components to perform the method is not sufficient.
Furthermore, Examiner notes that the courts have decided that receiving or transmitting data over a network as well-understood, routine, conventional activity when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (MPEP § 2106.05(d)(II) other types of activities example i. receiving or transmitting data over a network, OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network).
Regarding the rejection under 35 USC 103 to Claims 18-37, Applicant’s arguments have been considered, and are persuasive regarding the newly added limitations not being met by Quattrocchi and Katz; however, the arguments are moot because, upon further consideration, a new grounds for rejection necessitated by Applicant’s amendments has been made, rejecting the claims over Quattrocchi in view of Katz, Dieben, and Pulitzer.
Applicant argues the office’s analysis is fundamentally flawed because it improperly evaluates the claim elements in isolation, rather than considering the claim as an ordered combination as required by controlling precedent.
Regarding (l), Examiner respectfully disagrees. The claims are evaluated individually and as an ordered combination, as stated in the rejection.
Applicant argues The Office's approach, which attempts to map each claim limitation to a separate reference or isolated disclosure, fails to address whether the specific arrangement and interplay of elements in the present claims would have been obvious to one of ordinary skill in the art, and specifically how and why each modification would be made ("We must still be careful not to allow hindsight reconstruction of references to reach the claimed invention without any explanation as to how or why the references would be combined to produce the claimed invention." Innogenetics, NV v. Abbott Labs, 85 USPQ2d 1641, 1648 n. 3 (Fed. Cir. 2008)).
When properly considered as an ordered combination, the claimed invention recites a non-conventional, privacy-preserving architecture for distributed medical testing and communication that is not taught or suggested by the cited art. In particular, Claim 18 requires that, after two stages of laboratory analysis, a laboratory communication device sends a message to a practitioner communication device, the message comprising an indication of a unique identifier, and that the practitioner device is then configured to contact the user device identified by using only that unique identifier. This protocol ensures that all subsequent electronic communications, including practitioner follow-up, are routed through the unique identifier, thereby preserving user anonymity and unlinkability throughout the workflow. The prior art does not disclose or suggest this structure, nor do the references provide any motivation or rationale for combining their teachings to arrive at the claimed privacy-centric, cross-entity messaging protocol.
Simply alleging that one could combine elements from the cited references to arrive at the claimed invention does not fulfill the Office's burden. A proper obviousness rejection requires a reasoned rationale supported by the prior art, not mere assertion or hindsight reconstruction. The proposed combination is insufficient and improperly uses hindsight to assemble disparate teachings in a way not suggested or motivated by the references themselves. Absent these teachings and rationale, the claimed invention as a whole is nonobvious and patentable under 35 U.S.C. § 103 (p. 19).
Regarding (m), Examiner respectfully disagrees. Firstly, Examiner notes that the office action does not fail to address the obviousness and reasons to combine for each claim, as it is clearly stated in each rejection above. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the unique identifier being anonymous and preserving user anonymity and unlinkability throughout the workflow) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues the Bessette reference As discussed during the interview, Bessette teaches use of a "account identifier" in a message, albeit solely for internal routing within the Human-Centric EHR system 102 (see, e.g., Bessette, [0122], [0138], [0175], [0191], [0196]). However, as reflected in the cited paragraphs, Bessette's identifier is used exclusively for internal account management, authentication, and message routing between system components, and not for sending messages to or establishing communications with external devices outside the EHR system. There is no teaching or suggestion in Bessette of transmitting a message containing the unique identifier to an external communication device, such as a practitioner device distinct from the EHR system, nor is there any suggestion of using the identifier as the basis for establishing a direct, privacy- preserving communication channel between distributed entities as required by the claims (p. 20).
Regarding (n), the Bessette reference is no longer in the office action, and therefore, this argument is moot.
Applicant argues the Bosch reference is not analogous art and even if it were analogous it does not teach the limitations "generating, in response to the scanning, a unique identifier by the user communication device" and "wherein the medical sample is labeled with a sample identifier associated with the unique identifier, wherein the sample identifier is ... associated with the unique identifier during the scanning and verification of the access code by a database linking the access code to the sample identifier." (p. 20-21).
Regarding (o), the Bosch reference is no longer in the office action, and therefore, this argument is moot.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA R GEDRA whose telephone number is (571)270-0944. The examiner can normally be reached Monday - Friday 8:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter H Choi can be reached at (469)295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA R. GEDRA/Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
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