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 .
Notice to Applicant
Claims 1-20 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/29/2025 and 7/24/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Double Patenting
3. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7-10, 14, and 20-32 of U.S. Patent No. 12,354,725. Although the claims at issue are not identical, they are not patentably distinct from each other because they are both directed to genetic efficacy testing with regard to dispensing a prescription.
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.
4. Claims 1-20 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.
Claims 1-20 are directed to providing automated prior authorization for genetic efficacy testing, which is considered managing personal behaviors. Managing personal behaviors fall within a subject matter grouping of abstract ideas which the Courts have considered ineligible (Certain methods of organizing human activity). The claims do not integrate the abstract idea into a practical application, and do not include additional elements that provide an inventive concept (are sufficient to amount to significantly more than the abstract idea).
Under step 1 of the Alice/Mayo framework, it must be considered whether the claims are directed to one of the four statutory classes of invention. In the instant case, claims 1-20 recite a system comprising a database and processor. Therefore, the claims are each directed to one of the four statutory categories of invention (manufacture).
5. Under step 2A of the Alice/Mayo framework, it must be considered whether the claims are “directed to” an abstract idea. That is, whether the claims recite an abstract idea and fail to integrate the abstract idea into a practical application.
Regarding independent claim 1, the claim sets forth a system, in the following limitations:
genetic efficacy testing results; and
receive coverage requests for medications for patients, each coverage request comprising identifying information for a patient and at least one medication;
automatically perform a query with identifying information for a patient to determine if genetic efficacy testing results are available for said patient;
where said query indicates that the genetic efficacy testing results are available for said patient, further determine, as part of a contraindication analysis, if the medication is contraindicated for said patient based on said genetic efficacy testing results; and
where said contraindication analysis indicates that a medication is contraindicated for said patient, automatically send, in substantially real time, indicating the medication contraindicated for said patient;
wherein to alert users of patient-specific medication contraindication.
The above-recited limitations providing automated prior authorization for genetic efficacy testing, which is considered managing personal behaviors. Such concepts have been considered ineligible certain methods of organizing human activity by the Courts (See MPEP 2106.04(a)).
Claim 1 does recite additional elements:
one or more databases
one or more non-transitory electronic storage devices comprising software instructions, which when executed, configure one or more processors
over a wide area computer network
an electronic message over the wide area computer network
the electronic message is processable by a plurality of computers in the wide area computer network,
said network.
These additional elements merely amount to the general application of the abstract idea to a technological environment (“one or more databases”, “one or more non-transitory electronic storage devices comprising software instructions, which when executed, configure one or more processors”, “over a wide area computer network”, “an electronic message over the wide area computer network”, “the electronic message is processable by a plurality of computers in the wide area computer network”, “said network”) and insignificant pre-and-post solution activity (receiving, querying, analyzing, processing). The specification makes clear the general-purpose nature of the technological environment. Paragraphs 68, 71, 96, 98, 101, 102, 116, 138, 143-145, 152 indicate that while exemplary general purpose systems may be specific for descriptive purposes, any elements or combinations of elements capable of implementing the claimed invention are acceptable. That is, the technology used to implement the invention is not specific or integral to the claim.
Therefore, considered both individually and as an ordered combination, the additional elements do no more than generally link the use of the abstract idea to a particular technological environment or field of use. That is, given the generality with which the additional limitations are recited, the limitations do not implement the abstract idea with, or use the abstract idea in conjunction with, a particular machine or manufacture that is integral to the claim. Additionally, the claims do not reflect an improvement in the functioning of a computer, or an improvement to other technology or technical field, do not apply or use the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition, do not effect a transformation or reduction of a particular article to a different state or thing; and do not apply or use the abstract idea in some other meaningful way beyond generally linking the use of the abstract idea to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the abstract idea. Accordingly, the Examiner concludes that the claim fails to integrate the abstract idea into a practical application, and is therefore “directed to” the abstract idea.
6. Under step 2B of the Alice/Mayo framework, it must finally be considered whether the claim includes any additional element or combination of elements that provide an inventive concept (i.e., whether the additional element or elements are sufficient to amount to significantly more than the abstract idea). As indicated above, considered both individually and as an ordered combination, the additional elements do not implement the abstract idea with, or use the abstract idea in conjunction with, a particular machine or manufacture that is integral to the claim, do not reflect an improvement in the functioning of a computer, or an improvement to other technology or technical field, do not apply or use the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition, do not effect a transformation or reduction of a particular article to a different state or thing, and do not apply or use the abstract idea in some other meaningful way beyond generally linking the use of the abstract idea to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the abstract idea
Further, the additional elements (recited above) simply append well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. Communicating information (i.e., receiving or transmitting data over a network) has been repeatedly considered well-understood, routine, and conventional activity by the Courts (See MPEP 2106.05(d)). Accordingly, the Examiner asserts that the additional elements, considered both individually, and as an ordered combination, do not provide an inventive concept, and the claim is ineligible for patent.
Independent Claims 18 and 19 are parallel in scope to claim 1 and ineligible for similar reasons.
Dependent claims
7. Each of these steps of the dependent claims 2-17 and 20 only serve to further limit or specify the features of independent claims 1, 18, and 19 accordingly, and hence are nonetheless directed towards fundamentally the same abstract idea as the independent claim and utilize the additional elements already analyzed in the expected manner.
Claim 2 sets forth:
comprise genetic efficacy testing availability information for the at least one medication;
where said testing results query indicates that genetic efficacy testing results are not available for said patient, perform a testing availability query to determine if genetic efficacy testing is available for the at least one medication; and
where the testing availability query indicates that genetic efficacy testing is available for said at least one medication, send a second message requesting a genetic efficacy testing kit; and
the second message is to indicate the request to dispense the genetic efficacy testing kit.
Such a recitation merely embellishes the abstract idea of providing automated prior authorization for genetic efficacy testing, which is considered managing personal behaviors. While the claim does set forth the additional limitation of “one or more databases”, “one or more non-transitory electronic storage devices comprise additional software instructions, which when executed, configure said one or more processors”, “one or more databases”, “wide area computer network”, “electronically and automatically recognizable and processable by the computers in the wide area network of computers”, this recitation is similar to the additional limitations in claim 1, as it does no more than generally link the use of the abstract idea to a particular technological environment. As such, it does not integrate the abstract idea into a practical application, and does not provide an inventive concept. Accordingly, the claim does not confer eligibility on the claimed invention and is ineligible for similar reasons to claim 1.
Claim 4 sets forth:
comprise policy rules for the patients;
perform a policy query to retrieve the policy rules associated with the patient;
perform a coverage decision analysis to determine if coverage is otherwise available for the at least one medication in accordance with said policy rules for the patient; and
where said coverage decision analysis indicates that coverage is not otherwise available for the at least one medication, return a third message indicating denial of coverage for the respective medication; and
the third message indicates denial of coverage.
Such a recitation merely embellishes the abstract idea of providing automated prior authorization for genetic efficacy testing, which is considered managing personal behaviors. While the claim does set forth the additional limitation of “one or more databases”, “one or more non-transitory electronic storage devices comprise additional software instructions, which when executed, configure said one or more processors”, “one or more databases”, “the plurality of computers in said network”, this recitation is similar to the additional limitations in claim 1, as it does no more than generally link the use of the abstract idea to a particular technological environment. As such, it does not integrate the abstract idea into a practical application, and does not provide an inventive concept. Accordingly, the claim does not confer eligibility on the claimed invention and is ineligible for similar reasons to claim 1.
Further, Claims 7, 9-12 and 16-17, only serve to further limit or specify the features of independent claims 1, 18, and 19 accordingly. While the claims do set forth the additional limitation of “one or more non-transitory electronic storage devices comprise additional software instructions, which when executed, configure said one or more processors”, and/or “one or more databases”, and/or “the plurality of computers in said network” and/or “wide area computer network”, and/or “computer systems of the wide area computer network are in electronic communication over an internet”, this recitation is similar to the additional limitations in claim 1, as it does no more than generally link the use of the abstract idea to a particular technological environment. As such, it does not integrate the abstract idea into a practical application, and does not provide an inventive concept. Accordingly, the claim does not confer eligibility on the claimed invention and is ineligible for similar reasons to claim 1.
Additionally, claims 14-15, only serve to further limit or specify the features of independent claims 1, 18, and 19 accordingly. While the claims do set forth the additional limitation of “one or more laboratory information systems (“LIS”)”, “one or more genetic sequencing machines, each in electronic communication with at least one of the one or more LIS”, “one or more databases “, “one or more non-transitory electronic storage devices comprise additional software instructions, which when executed, configure said one or more processors of the one or more LIS”, “the electronic network”, “machine interpretable instructions and/or format”, “machine interpretable instructions to one of the one or more genetic sequencing machines”, and “a plurality of the computers over the wide area computer network”, and/or “one or more robots”, and/or “genetic testing devices” and/or “electronic communication”, this recitation is similar to the additional limitations in claim 1, as it does no more than generally link the use of the abstract idea to a particular technological environment. As such, it does not integrate the abstract idea into a practical application, and does not provide an inventive concept. Accordingly, the claim does not confer eligibility on the claimed invention and is ineligible for similar reasons to claim 1.
Allowable Subject Matter
8. Claims 1-20 would be allowed if rewritten to overcome the 35 U.S.C. 101 rejections.
The following is a statement of reasons for the indication of allowable subject matter:
9. The cited references failed to disclose or teach the following limitations of independent claim 1 (exact language used):
one or more databases comprising genetic efficacy testing results; and
one or more non-transitory electronic storage devices comprising software instructions, which when executed, configure one or more processors to:
receive electronically, over a wide area computer network, coverage requests for medications for patients, each coverage request comprising identifying information for a patient and at least one medication;
automatically perform a query of said one or more databases with identifying information for a patient to determine if genetic efficacy testing results are available for said patient;
where said query indicates that the genetic efficacy testing results are available for said patient, further determine, as part of a contraindication analysis, if the medication is contraindicated for said patient based on said genetic efficacy testing results; and
where said contraindication analysis indicates that a medication is contraindicated for said patient, automatically send an electronic message over the wide area computer network, in substantially real time, indicating the medication contraindicated for said patient;
wherein the electronic message is processable by a plurality of computers in the wide area computer network, to alert users of said network to a patient-specific medication contraindication.
The cited references failed to disclose or teach the following limitations of independent claim 18 (exact language used):
databases comprising a first database comprising policy rules for patients, a second database comprising patient-specific genetic efficacy testing results for medications, a third database comprising genetic efficacy testing availability information for the medications, and a fourth database comprising alternative treatment options for the medications; and
one or more non-transitory electronic storage devices forming part of an electronic network comprising internet connected computer nodes, said nodes comprising pharmacy systems, pharmacy benefits manager systems, and electronic health record systems, said electronic network further comprising laboratory information systems, the databases, and one or more processors, wherein said one or more non-transitory electronic storage devices comprise software instructions, which when executed, configure said one or more processors to:
receive a coverage request for at least one medication for an identified patient, from the an originating node of the electronic network, including identifying information for said patient and for said at least one medication, and for said coverage request,
perform a policy query at the first database to retrieve the policy rules associated with the patient;
determine if coverage is available for the at least one medication as part of a coverage decision analysis in accordance with said policy rules for the patient;
where said coverage decision analysis indicates that coverage is not otherwise available for the at least one medication as part of said coverage decision analysis, return a first message to the originating node indicating denial of coverage for the at least one medication;
where said coverage decision analysis indicates that coverage is otherwise available for the at least one medication as part of said coverage decision analysis:
perform a testing results query of the second database with said identifying information for the patient to determine if genetic efficacy testing results are available for said patient;
where said testing results query indicates that genetic efficacy testing results are available for said patient, further determine, as part of a contraindication analysis, if the respective medication is contraindicated for said patient based on said genetic efficacy testing results for said patient analysis provided from said testing results query;
where results of said contraindication analysis indicate that the at least one medication is contraindicated for said patient, return a second message to the originating node indicating genetic efficacy contraindicated for the at least one medication;
where results of said testing results query indicate that genetic efficacy testing results are not available for said patient, perform a testing availability query of the third database to determine if genetic efficacy testing is available for the at least one medication; and
where the results of the testing availability query indicate that genetic efficacy testing is available for the at least one medication, return a third message to the originating node indicating temporary coverage, and generate and transmit an order for a genetic efficacy testing kit to a fulfillment center system for the genetic efficacy testing kit; and
where results of said testing results query indicate that genetic efficacy testing results are not available for said patient, the results of the testing availability query indicate that genetic efficacy testing is not available for said at least one medication, return a fourth message to the originating node indicating coverage approval of the respective coverage request;
wherein the first, second, third, and fourth messages are electronically and automatically processable by the nodes of the electronic network.
The cited references failed to disclose or teach the following limitations of independent claim 19 (exact language used):
a. A wide area computer network of computer servers and databases, comprising a plurality of healthcare provider nodes on said network, said nodes adapted to electronically share patient healthcare data for a plurality of patients across said network with other of said nodes in said network;
b. At least one genetic efficacy testing subsystem adapted to test the respective genomes of said plurality of patients, and automatically compare results of said testing with at least one drug/genome contraindication formulary, and produce an alert on a patient by patient basis, said alerts identifying any drug contraindications on a patient by patient basis based on each of said patients’ respective genomes;
c. At least one medical insurance coverage subsystem in communication with at least one node of said network, said insurance coverage subsystem adapted to analyze whether genetic efficacy testing is available for coverage for a patient of said plurality of patients, and when available to provide an approval message via said node for said genetic efficacy testing;
d. At least one electronic data transmission of said alerts to a node in the network, said alerts stored in at least one database at said node;
e. At least one electronic health record (EHR) subsystem, at one or more of said nodes of said network, said at least one EHR subsystem adapted to maintain healthcare data on each of said plurality of patients; and,
f. Automatically, electronically updating said at least one EHR subsystem with said contraindications on a patient by patient basis for said plurality of patients, such that said plurality of healthcare provider nodes in said network have electronic access to said contraindications.
The most remarkable prior arts of record are as follows:
A. Fey, et al., hereinafter Fey, Method and system for genetic screening data collection, analysis, report generation and access (US 20020052761 A1) teaches collecting genetic screening and demographic data from clients, storing client's data and DNA/genetic material samples, processing and analyzing genetic testing data in conjunction with other relevant health data, generating custom reports, maintaining life-long health records and pre-populating data into user accessible personal health records.
B. Patterson, et al., hereinafter Patterson, Computerized system and methods of adjudicating medical appropriateness (US 20060259325 A1) teaches a method for adjudicating and reimbursing a care provider for services provided for a clinical event is provided. The method includes the step of receiving a transaction having a number of clinical data elements. The method also includes the steps of accessing a data store including payer information and determining whether the transaction is eligible for reimbursement by at least one payer. The method also includes the steps of accessing a first knowledge base comprising evidence-based standards for providing medically appropriate care and selectively performing analysis of the clinical data elements of the transaction against at least one standard to determine if the care provided is medically appropriate. The method further includes the steps of accessing a second knowledge base containing at least one criterion for assessing quality of care and selectively performing analysis of the clinical data elements of the transaction against the at least one criterion to determine if the care provided is medically appropriate. Also, the method includes determining a level of reimbursement based on the medical appropriateness and quality of the care provided and authorizing reimbursement of the care provider from at least one payer.
C. Kenedy, et al., hereainfter Kenedy, Treatment Determination and Impact Analysis (US 20080228824 A1) teaches a method, software, database and system for determining an optimal treatment for an illness in an individual and for determining the impact (e.g., side effects and intended benefits) of the treatment in the individual are presented in which an attribute profile of the individual containing genetic and non-genetic attributes is compared against a database containing combinations of genetic and non-genetic attributes that are statistically associated with successful treatment of the illness in other individuals.
D. Friedlander, et al., hereinafter Friedlander, OPTIMIZING PHARMACEUTICAL TREATMENT PLANS ACROSS MULTIPLE DIMENSIONS (US 20090240523 A1) teaches generating optimized pharmaceutical treatment plans for an individual. A set of known treatments to be used by the target individual over a future period of time is generated. An actual use of the treatments in the set of known treatments by the target individual during the future period of time is substantially certain. A set of probable treatments of the target individual is received. The actual use of the treatments in the set of probable treatments by the target individual during the future period of time is uncertain. An optimized pharmaceutical treatment plan for the target individual is generated. The optimized pharmaceutical treatment plan comprises medications and durable medical goods that are likely to be used by the target individual over the future period of time optimized over a set of dimensions associated with the set of known treatments and the set of probable treatments;
E. Valverde, et al., hereinafter Valverde, Insurance Evaluation Engine (US 20170293722 A1) teaches evaluating a cost of insurance are provided. The method may commence with parsing a text from medical information sources to obtain statistical data associated with a population of patients. The method may further include structuring the statistical data to form structured medical metadata in an intelligent medical database. Based on the structured medical metadata, a causal network may be created. The method may continue with receiving health data associated with a patient from one or more patient data sources. The health data may be parsed to obtain processed patient health data. The method may further include mapping the processed patient health data against the causal network. Based on the mapping, a future health status associated with the patient may be predicted. The method may continue with evaluating the cost of the insurance associated with the patient based on the future health status.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
A. Fey, et al., hereinafter Fey, Method and system for genetic screening data collection, analysis, report generation and access (US 20020052761 A1) teaches collecting genetic screening and demographic data from clients, storing client's data and DNA/genetic material samples, processing and analyzing genetic testing data in conjunction with other relevant health data, generating custom reports, maintaining life-long health records and pre-populating data into user accessible personal health records.
B. Patterson, et al., hereinafter Patterson, Computerized system and methods of adjudicating medical appropriateness (US 20060259325 A1) teaches a method for adjudicating and reimbursing a care provider for services provided for a clinical event is provided. The method includes the step of receiving a transaction having a number of clinical data elements. The method also includes the steps of accessing a data store including payer information and determining whether the transaction is eligible for reimbursement by at least one payer. The method also includes the steps of accessing a first knowledge base comprising evidence-based standards for providing medically appropriate care and selectively performing analysis of the clinical data elements of the transaction against at least one standard to determine if the care provided is medically appropriate. The method further includes the steps of accessing a second knowledge base containing at least one criterion for assessing quality of care and selectively performing analysis of the clinical data elements of the transaction against the at least one criterion to determine if the care provided is medically appropriate. Also, the method includes determining a level of reimbursement based on the medical appropriateness and quality of the care provided and authorizing reimbursement of the care provider from at least one payer.
C. Kenedy, et al., hereainfter Kenedy, Treatment Determination and Impact Analysis (US 20080228824 A1) teaches a method, software, database and system for determining an optimal treatment for an illness in an individual and for determining the impact (e.g., side effects and intended benefits) of the treatment in the individual are presented in which an attribute profile of the individual containing genetic and non-genetic attributes is compared against a database containing combinations of genetic and non-genetic attributes that are statistically associated with successful treatment of the illness in other individuals.
D. Friedlander, et al., hereinafter Friedlander, OPTIMIZING PHARMACEUTICAL TREATMENT PLANS ACROSS MULTIPLE DIMENSIONS (US 20090240523 A1) teaches generating optimized pharmaceutical treatment plans for an individual. A set of known treatments to be used by the target individual over a future period of time is generated. An actual use of the treatments in the set of known treatments by the target individual during the future period of time is substantially certain. A set of probable treatments of the target individual is received. The actual use of the treatments in the set of probable treatments by the target individual during the future period of time is uncertain. An optimized pharmaceutical treatment plan for the target individual is generated. The optimized pharmaceutical treatment plan comprises medications and durable medical goods that are likely to be used by the target individual over the future period of time optimized over a set of dimensions associated with the set of known treatments and the set of probable treatments;
E. Valverde, et al., hereinafter Valverde, Insurance Evaluation Engine (US 20170293722 A1) teaches evaluating a cost of insurance are provided. The method may commence with parsing a text from medical information sources to obtain statistical data associated with a population of patients. The method may further include structuring the statistical data to form structured medical metadata in an intelligent medical database. Based on the structured medical metadata, a causal network may be created. The method may continue with receiving health data associated with a patient from one or more patient data sources. The health data may be parsed to obtain processed patient health data. The method may further include mapping the processed patient health data against the causal network. Based on the mapping, a future health status associated with the patient may be predicted. The method may continue with evaluating the cost of the insurance associated with the patient based on the future health status.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER ALTSCHUL MISIASZEK whose telephone number is (571)270-1362. The examiner can normally be reached M-TH 8AM-6PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached at 571-270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMBER A MISIASZEK/Primary Examiner, Art Unit 3682
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