DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after appeal to the Patent Trial and Appeal Board, but prior to a decision on the appeal. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 10/31/2025 has been entered.
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 .
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.
Response to Amendment
In the amendment dated 10/31/2025, the following has occurred: Claims 1 – 9, 20, and 21 have been amended.
Claims 10 – 19 have been previously canceled.
Claims 1 – 9, 20, and 21 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 – 9, 20, and 21 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.
The claims, understood as a whole, recite(s) subject matter within a statutory category as a process (claims 1 – 9, 20, and 21) which recite the abstract idea steps of
Claim 1:
receiving orders and associated patient data from the healthcare provider systems, each of said orders comprising a patient identifier, insurance information, and genetic testing to be performed for a patient, and said patient data comprising active medications and diagnoses associated with the patient identifiers;
analyzing the orders and the patient data to generate prior authorization requests;
sending to the prior authorization provider associated with the insurance information, the prior authorization requests;
receiving from the prior authorization providers, a reference identifier and patient responsibility amount for each of the prior authorization request;
for each of the orders,
in at least one instance where the patient responsibility amount is above a predetermined threshold:
initiating contacting the patient and requesting payment of the patient responsibility amount;
in at least one other instance where no payment is received,
generating and transmitting a notification to destroy a specimen associated with the electronic order;
in at least one other where an indication of payment is received or the patient responsibility amount is below the predetermined threshold:
providing instructions to a genetic sequencing machine to perform the genetic testing on the specimen; and
integrate results from the genetic testing into the health record associated with the patient.
Claim 20:
patient health records, each patient record comprising diagnoses and active medications for a number of patients;
a database comprising medications known to be wholly or partially ineffective in persons having particular genetic markers;
wherein, for each of a number of received orders:
query the patient record associated with an ordering healthcare provider office to retrieve all of the active medications and diagnoses associated with a patient identifier provided in the order;
parse the patient identifier, insurance information, and ordered testing information from the order and the diagnoses and active medications from the patient record to generate a prior authorization request;
deliver, from the laboratory to the prior authorization provider, the prior authorization request;
receive, from the prior authorization provider at the laboratory, a patient responsibility amount for the prior authorization request;
for each of the number of received orders where the patient responsibility amount is above the predetermined threshold:
deliver a message comprising patient contact information and the patient responsibility amount to the delivery department;
contact the patent contact information by way of the delivery department to request payment for the patient responsibility amount;
in at least one other instance where payment is not received from the patient, provide a notification to the laboratory to destroy a specimen for the respective order; and
in at least one instance where the patient responsibility amount is below a predetermined threshold or in at least one other instance where payment is received for the patient responsibility amount:
providing instructions to a genetic sequencing machine to perform the genetic testing on the specimen; and
query the database to retrieve any of the medications known to be wholly or partially ineffective in persons having a same relevant portion of genetic makeup as the patient;
determine, if one or more of the active medications retrieved from the patient record match the retrieved medications from the database;
integrate testing results into the patient record of the ordering healthcare provider office by flagging the ineffective mediations as allergies.
These steps of claims 1 – 9, 20, and 21, as drafted, under the broadest reasonable interpretation, includes methods of organizing human activity. Although not required, the sub-category is both commercial or legal interactions as healthcare is a business and also managing personal behavior or relationships or interactions between people. As the Court has shown, the claims are interpreted in light of the Specification including paragraphs 11, 19, and 23
[0011] The disclosed systems and methods may streamline the ordering and eligibility process. The system may be configured to determine whether identified tests fit certain billing parameters. For example, the system may be configured to determine whether the identified tests are coved by the user's insurance. If the test for one or more markers does not fit the billing parameters, then the next genetic marker(s) may be considered. If the test does fit the billing parameters then the option to order testing may be presented to the healthcare provider. If selected, the appropriate marker(s) may be added to a testing device and the genetic testing may be performed. In exemplary embodiments, diagnostic and treatment codes may be entered by the healthcare provider into their system. A determination may be made as to whether certain genetic efficacy testing meets various insurance eligibility criteria, such as but not limited to, medically necessary criteria. If so, the respective genomic tests may be automatically added to an order list. In this way, all available testing for which the patient is eligible may be automatically added to an ordering list, thereby increasing the availability of potentially relevant information to the healthcare provider. The order list may be subsequently displayed to the healthcare provider for confirmation, though in other exemplary embodiments the order list may be automatically processed.
[0019] Systems and methods for automatically providing laboratory-based authorization of genetic testing are provided. An order may be generated at a healthcare provider's EHR or other system. The order may be initiated by a healthcare provider and may be based on suggested orders from the laboratory. A specimen for testing may be sent from the healthcare provider to the laboratory. The order information may be sent electronically from the healthcare provider's office system or EHR to a laboratory information system ("LIS") associated with a laboratory. The LIS may automatically parse information from the order. The LIS may be in electronic communication with the EHR and electronically retrieve certain patient health information.
[0023] The disclosed systems and methods may reduce the number of human interactions required, thereby improving data processing times and/or accuracy. The electronic automation may result in faster, more accurate, and more consistent data processing. The disclosed systems and methods may reduce the amount of paper transferred, data faxed, telephone calls made, voicemails recorded, and the like, all of which may serve as additional points to data intrusion. In this way, the communication pipeline may be streamlined to reduce the number of access points and improve data security. The disclosed systems and methods may reduce the need for resources at the healthcare provider office reducing business costs and complexity.
The Examiner notes that it is the Specification that describes the Applicant’s invention. It is the Specification that describes the invention as something other than a technological improvement and other than a practical application. The result of the invention is data.
Regarding the genetic sequencing device, the Examiner notes a few things. First, the device is used to provide input to the invention. Therefore, the Examiner believes that the operation of the genetic sequencing device is extra-solution activity.
However, the Examiner also points to the Specification, paragraph 44.
[0044] The genetic sequencing device 20 may comprise any kind of device configured to sequence genetic material. In exemplary embodiments, the genetic sequencing device 20 may comprise a loading area 22 and a control panel 24. The loading area 22 may be configured to accept one or more testing devices 30. The control panel 24 may be integrally formed with the genetic sequencing device 20 or may be a separate electronic device in communication with the genetic sequencing device 20. The control panel 24 may be configured to accept user input comprising instructions for carrying out various genetic tests on the testing device 30. The control panel 24 may be configured to display the results of such testing. Such instructions may, alternatively or additionally, be accepted from a remote device, which may comprise the control panel 24 or another device. Testing results may be transmitted to one or more remote devices and/or systems as further described herein.
The Examiner understands that these instructions are being entered by a user either at a control panel or remotely. Therefore, the genetic sequencing device function is outside the claimed invention.
The invention represents an abstract idea applied to technology. As shown above, the various claimed systems including EHR, LIS, HIE are various devices used to apply the abstract idea to technology to achieve all the benefits of applying technology to the abstract idea. These systems are generic as shown in paragraph 101.
[00101] Certain operations described herein may be performed by one or more electronic devices. Each electronic device may comprise one or more processors, electronic storage devices, executable software instructions, and the like configured to perform the operations described herein. The electronic devices may be general purpose computers of specialized computing device. The electronic devices may be personal computers, smartphone, tablets, databases, servers, or the like. The electronic connections described herein may be accomplished by wired or wireless means. The computerized hardware, software, components, systems, steps, methods, and/or processes described herein may serve to improve the speed of the computerized hardware, software, systems, steps, methods, and/or processes described herein.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 2 – 9 and 21, reciting particular aspects of how genetic testing authorization may be performed but for recitation of generic computer components).
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception (such as recitation of a system for amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of receiving an order, amounts to mere data gathering, recitation of query the EHR amounts to selecting a particular data source or type of data to be manipulated, recitation of the various transmitting steps and the genetic sequencing machine amounts to insignificant application, see MPEP 2106.05(g))
Although “genetic sequencing machine” does not appear within the Specification, “genetic sequencing device” does appear 29 times. There is description of the genetic sequencing device including paragraph 44 that includes, “The genetic sequencing device 20 may comprise any kind of device configured to sequence genetic material…. Such instructions may, alternatively or additionally, be accepted from a remote device, which may comprise the control panel 24 or another device. Testing results may be transmitted to one or more remote devices and/or systems as further described herein.” The invention is directed toward automated authorization for genetic testing and not directed towards the genetic testing device.
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 2 – 9 and 21). 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 and do not impose a meaningful limit to integrate the abstract idea into a practical application.
It should be emphasized that as the abstract idea is applied to technology, various technology options can be claimed. These claimed options, such as transmitting via HL7 or describing the message as encrypted, do not change the abstract idea. Rather, these are specific technology that the abstract idea is applied to. For example, the invention is not directed toward an encryption scheme or a transmission method.
The claim(s) does/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:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as claims 1 – 9, 20, and 21; receiving and transmitting, e.g., receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i); electronically integrate results … into EHR, e.g., electronic recordkeeping, Alice Corp., MPEP 2106.05(d)(II)(iii))
Additional elements:
electronic communications network -paragraph 47 internet
systems - healthcare provider systems, electronic communication system, prior authorization provider system, laboratory system comprising a laboratory information system – paragraphs 80,81, 101
payment processing system – paragraph 92 including a bank
electronic health records (EHR) – paragraphs 46, 80
electronic storage - paragraphs 50, 101
Robot – paragraph 45 – it should be emphasized that the Specification does not state what a “robot” must be or should be. As another example of a potential robot, see Van Der Zaag, as listed on the PTO-892, paragraphs 45 – 48 testing apparatus
genetic sequencing device – paragraph 44 any type of device
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 – 9 and 21, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields including receiving or transmitting data over a network, Symantec, MPEP 2106.05(d)(II)(i) and also 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.
Regarding the question of technological improvement, paragraph 34 states:
[0023] The disclosed systems and methods may reduce the number of human interactions required, thereby improving data processing times and/or accuracy. The electronic automation may result in faster, more accurate, and more consistent data processing. The disclosed systems and methods may reduce the amount of paper transferred, data faxed, telephone calls made, voicemails recorded, and the like, all of which may serve as additional points to data intrusion. In this way, the communication pipeline may be streamlined to reduce the number of access points and improve data security. The disclosed systems and methods may reduce the need for resources at the healthcare provider office reducing business costs and complexity.
These improvements are all achieved by automating the abstract idea. These are not obtained by technological improvements. The improvements are the result of the abstract idea being applied to technology and not the invention focus.
Response to Arguments
Applicant's arguments filed 10/31/2025 have been fully considered but they are not persuasive.
Claim Rejection under 35 USC§ 101
The Applicants states, “Applicant respectfully maintains its position, but takes the opportunity to reply to Examiner's remarks in response. OA of 7/22/24 at pg. 10-12” The Applicant is responding to the Office Action and not the Appeal Brief.
The Applicants states, “Examiner contends that Applicant has not shown "that the invention must be performed within technology. Rather any tests performed are outside the claimed invention" While this is arguably true insofar that claims to a programmed piece of electronic equipment does not literally require performance of the claimed functionality it is programmed to carry out, those programming limitations still carry weight, otherwise literally all possible functions of a programmed computer would be swallowed by the existence of a computer as prior art.” The Examiner was responding to a particular question about the operation of the devices understanding the claimed invention as a whole.
The invention as stated in the abstract provides “System and methods for providing laboratory-based authorization of genetic testing are disclosed.” That abstract idea is applied to technology to obtain all the benefits of applying the abstract idea to technology. The claimed invention, as currently amended, uses technology but is not directed towards a technological improvement to overcome a problem of technology.
As mentioned above, the devices are used to provide input into the invention. Whether that input comes from a user, a device, or a database the instant invention would operate the same. Just the source of the data would differ.
The Applicants states, “Notably here, the claimed invention requires that the instructions be provided for carrying out testing in certain circumstances, and that the genetic sequencing device be configured to carry out those instructions by performing testing following receipt. The claims go on to further require integration of testing results into an EHR. This effectively requires carrying out of the testing.” Genetic testing must occur to provide input into the invention. The Specification describes this function as a manual activity. However, even if that function were automated the Examiner believes that it would still just be providing input into the invention.
The Applicants states, “Furthermore, contrary to Examiner's position, the§ 103 analysis of a system claim requires also considering the limitations regarding capability of performing the testing. Id. at pg. 12.” The Examiner is trying to reject the invention using compact prosecution. If the Examiner can find the most difficult option within the art then the easier cases are moot. The Applicant’s conclusion is therefore different from the Examiner’s intent.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Judson et al Pub. No.: US 2005/0026117 A system and method is disclosed for managing users' genomic data, including providing and offering access to genomic-based services, routing genomic data to providers of genomic-based services, brokering financial transactions related to the management of genomic data, securing for users best prices for genomic-based services, allowing users to earn money for the use of their genomic and other data, and using genomic data for marketing and developing products in particular geographic regions or for particular populations.
Francois Pub. No.: US 2014/0244309 In certain embodiments, a EMR comprises at least one active diagnosis module (ADM). In some embodiments, the database is searchable based on at least some ADM content.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Neal R Sereboff whose telephone number is (571)270-1373. The examiner can normally be reached M - T, M - F 8AM - 6PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached on (571)272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEAL SEREBOFF/
Primary Examiner
Art Unit 3626