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 .
Prosecution History Summary
Claims 8, 14, 17, and 19-27 are cancelled.
Claims 1-5, 9, 11-12, and 15-16 are amended.
Claims 1-7, 9-13, 15-16, and 18 are pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7, 9-13, 15-16, and 18 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.
Subject Matter Eligibility Criteria – Step 1:
The claims recite subject matter within a statutory category as a process (claims 11-13, 15-16, and 18), machine (claims 1-7 and 9-10). Accordingly, claims 1-7, 9-13, 15-16, and 18 are all within at least one of the four statutory categories.
Subject Matter Eligibility Criteria – Step 2A – Prong One:
Regarding Prong One of Step 2A of the Alice/Mayo test, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. MPEP 2106.04(II)(A)(1). An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts. MPEP 2106.04(a).
Claim 1
A system comprising:
-a healthcare provider computing system comprising one or more processors associated with a healthcare provider and configured with computer-executable instructions to:
-receive, from a clinician computing device, a prescription comprising an identifier of a specified type of user-administered test prescribed by a clinician, a consultation identifier identifying a consultation at which the type of user-administered test was prescribed, and a medical record number associated with a patient;
-transmit, to a pharmacy interface, prescription information corresponding to the prescription, wherein transmission of the prescription information causes the pharmacy to provide a user-administered test of the specified type to the patient;
-generate an order identifier uniquely identifying the prescription; and
-cause transmission of a notification to a user application associated with a provider of the user-administered test and installed on a user device associated with the patient, the notification comprising the order identifier, the identifier of the specified type of user-administered test, and the consultation identifier; and
-the user device, the user device comprising one or more processors, the one or more processors and memory storing the medical record number associated with the patient, the one or more processors configured with processor-executable instructions included in the user application to:
-receive the notification;
-in response to receiving the notification, cause a display of the user device to display one or more instructions for administering the user-administered test;
-obtain a test result corresponding to the user-administered test;
-automatically retrieve, from the memory, the medical record number associated with the patient;
-associate the test result with the received order identifier and the medical record number associated with the patient; and
-send a test result communication to the healthcare provider computing system, the test result communication comprising the test result, the order identifier and the medical record number associated with the patient;
-wherein the one or more processors of the healthcare provider computing system are further configured to receive the test result communication and, in response to receiving the test result communication:
-create an order within the healthcare provider computing system using an order creation workflow, the order specifying at least one of the consultation identifier and the medical record number;
-associate the test result with the order; and
-send, to the clinician computing device or to another computing device associated with the clinician, a notification comprising the test result and an identifier of the patient.
Examiner states submits that the foregoing underlined limitations constitute: a “mental process” because associating prescription and a user-administered test and its results along with associating creation of an order and their results can all be performed in the human mind.
Accordingly, the claim recites at least one abstract idea.
Subject Matter Eligibility Criteria – Step 2A – Prong Two:
Regarding Prong Two of Step 2A of the Alice/Mayo test, it must be determined whether
the claim as a whole integrates the abstract idea into a practical application. As noted at MPEP
§$2106.04(1D(A)(2), it must be determined whether any additional elements in the claim beyond
the abstract idea integrate the exception into a practical application in a manner that imposes a
meaningful limit on the judicial exception. The courts have indicated that additional elements
merely using a computer to implement an abstract idea, adding insignificant extra solution
activity, or generally linking use of a judicial exception to a particular technological environment
or field of use do not integrate a judicial exception into a “practical application.” MPEP
§2106.05(1(A).
In the present case, the additional limitations beyond the above-noted at least one abstract
idea recited in the claim are as follows (where the bolded portions are the “additional
limitations” while the underlined portions continue to represent the at least one “abstract idea”):
Claim 1
A system comprising:
-a healthcare provider computing system comprising one or more processors associated with a healthcare provider and configured with computer-executable instructions to (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 63):
-receive, from a clinician computing device (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 30), a prescription comprising an identifier of a specified type of user-administered test prescribed by a clinician, a consultation identifier identifying a consultation at which the type of user-administered test was prescribed, and a medical record number associated with a patient;
-transmit, to a pharmacy interface, prescription information corresponding to the prescription, wherein transmission of the prescription information causes the pharmacy to provide a user-administered test of the specified type to the patient (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 30);
-generate an order identifier uniquely identifying the prescription; and
-cause transmission of a notification to a user application associated with a provider of the user-administered test and installed on a user device associated with the patient, the notification comprising the order identifier, the identifier of the specified type of user-administered test, and the consultation identifier (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 30-31); and
-the user device, the user device comprising one or more processors, the one or more processors and memory storing the medical record number associated with the patient, the one or more processors configured with processor-executable instructions included in the user application (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 30-31) to:
-receive the notification;
-in response to receiving the notification, cause a display of the user device to display one or more instructions for administering the user-administered test (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 29);
-obtain a test result corresponding to the user-administered test;
-automatically retrieve, from the memory (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 30-31), the medical record number associated with the patient;
-associate the test result with the received order identifier and the medical record number associated with the patient; and
-send a test result communication to the healthcare provider computing system, the test result communication comprising the test result, the order identifier and the medical record number associated with the patient (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 33);
-wherein the one or more processors of the healthcare provider computing system are further configured to receive the test result communication and, in response to receiving the test result communication (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 30-33):
-create an order within the healthcare provider computing system (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 30-31) using an order creation workflow, the order specifying at least one of the consultation identifier and the medical record number;
-associate the test result with the order; and
-send, to the clinician computing device or to another computing device associated with the clinician, a notification comprising the test result and an identifier of the patient (using computers as mere tools to perform the abstract idea, see MPEP 2106.05(f); para. 30-31).
Thus, taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole with the limitations reciting the at least one abstract idea, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole does not integrate the abstract idea into a practical application of the abstract idea. MPEP §2106.05(I)(A) and §2106.04(IID(A)(2).
The remaining dependent claim limitations not addressed above fail to integrate the
abstract idea into a practical application as set forth below:
Claim 2: The claim specifies the healthcare provider computer system to receive test results and store in a medical record database, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 3: The claim specifies the healthcare provider computer system to send a notification to clinician computing device, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 4: The claim specifies the healthcare provider computer system cause transmission of a notification to install an application, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 5: The claim specifies notification to install an application, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 6: The claim specifies obtaining test result by receiving an image of the test device and determining test result based on the image data, which further narrows the abstract idea.
Claim 7: The claim specifies the test device comprising a lateral flow assay test strip and determining test result to detect lines on flow assay test strip, which further narrows the abstract idea.
Claim 9: The claim specifies the user application to provide instructions for the user-administered test, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 10: The claim specifies the user-administered test, which further narrows the abstract idea.
Claim 12: The claim specifies sending a notification to install the user application, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 13: The claim specifies the type of notification, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 15: The claim specifies providing on the user application instructions for the user-administered test, which uses the computer as a tool to perform an abstract idea (see MPEP 2106.05(f)).
Claim 16: The claim specifies the identifier corresponding to a lateral flow assay test, which narrows the abstract idea.
Claim 18: The claim specifies the user-administered test, which further narrows the abstract idea.
Thus, when the above additional limitations are considered as a whole along with the limitations directed to the at least one abstract idea, the at least one abstract idea is not integrated into a practical application. Therefore, the claims are directed to at least one abstract idea.
Subject Matter Eligibility Criteria – Step 2B:
Regarding Step 2B of the Alice/Mayo test, representative independent claims 1 and 11 do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
Claim 1
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as receive prescription, transmit prescription, transmit notification to user application, receive notification, receive instructions, sent a test result, send a notification comprising the test result, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); obtain test result, retrieve the medical record number, e.g., storing and retrieving information in memory, Versata Dev. Group, MPEP 2106.05(d)(II)(iv)); associate test result with order identifier and medical record number of the patient, associate the test result with the order, e.g., electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii)).
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2-4, 6, 9, 12-13, and 15, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, claims 2 (receive test result), 3 (send notification), 4, 13 (transmit notification), 6 (receive image), 9, 12 (transmission), 15 (providing instructions on user application), e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); claims 2 (store test result), e.g., electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii)). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 1-7, 9-13, 15-16, and 18 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Arguments
Applicant's arguments filed for claims 1-7, 9-13, 15-16, and 18 under 35 U.S.C. 101 have been fully considered but they are not persuasive.
Applicant argues that the use of a user application provides a technological solution to the problem of integrating user-administered tests within electronic health record systems. Examiner disagrees. While the claimed method purports to accelerate the process of integrating user-administered tests within EMRs, the speed increase comes from the capabilities of a general-purpose computer, rather than the patented method itself. See Bancorp Servs., L.L.C. v. Sun Life Assur. Co. of Can. (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012) (“[The fact that the required calculations could be performed more efficiently via a computer does not materially alter the patent eligibility of the claimed subject matter.”). The Applicant seems to be saying that it “improves” computer technology because independent claims recite features that can provide for efficient integration. Insofar as the Applicant is contending that a computer can integrate information faster than a human administrator, Examiner does not necessarily disagree with this contention. However, using a computer to perform a task “more quickly or more accurately” is not, in and of itself, a ticket into patent-eligible territory (OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363 (Fed. Cir. 2015).). Additionally, although the claimed process of integrating user-administered tests into an EMR may be done more quickly using computer components, Applicant’s arguments that the claimed process is more efficient are not persuasive because the claimed process does not lead to the increased efficiency, rather that is due to the use of generic computers. See FairWarning IP, LLC v. latric Sys., Inc., 839 F.3d 1089, 1095 (2016) (“While the claimed system and method certainly purport to accelerate the process of analyzing audit log data, the speed increase comes from the capabilities of a general-purpose computer, rather than the patented method itself’); Bancorp Servs., L.L.C. v. Sun Life Assurance Co. of Can. (U.S.), 687 F.3d 1266, 1278 (Fed. Cir. 2012) (“[T]he fact that the required calculations could be performed more efficiently via a computer does not materially alter the patent eligibility of the claimed subject matter”). Furthermore, the present invention solves the problem associated with integrating data, which is not a problem of technical nature, but an administrative problem solved by a scheme. The present application does not involve more than a generic utilization of well-known functions of a computer, including the particular arrangement/combination of functions, and therefore does not involve any invention or ingenuity in any program or operation of a computer, or implementation by a computer to operate the method.
Applicant’s amendments and arguments, filed 3/20/2026, with respect to 35 U.S.C. 102 and 35 U.S.C. 103 have been fully considered and are persuasive. The 35 U.S.C. 102 and 35 U.S.C. 103 rejections of claims 1-7, 9-13, 15-16, and 18 has been withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ferro et al. – U.S. Publication No. 2022/0310250 – Teaches a system for facilitating self-administered diagnostic tests.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHEETAL R. PAULSON whose telephone number is (571)270-1368. The examiner can normally be reached M-F 8am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Marc Jimenez can be reached at 571-272-4530. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHEETAL R PAULSON/Primary Examiner, Art Unit 3681
Prosecution Insights