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 .
Status of Claims
In the amendment filed 05/06/2026 the following occurred: Claims 1, 18, and 35 were amended. Claims 1-51 are presented for examination.
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 1-51 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 1-51 are drawn to a system, method, and tangible, non-transitory computer-readable medium, which is/are statutory categories of invention (Step 1: YES).
Independent claim 1 recites a genetic risk model stored, the genetic risk model configured to output a classification defining respective risks of respective users developing the disease, wherein the classification as output by the genetic risk model is selected from a predetermined set of risk categories comprising: (a) an Increased Risk Category, (b) a Slightly Increased Risk Category, (c) a Not Likely at Increased Risk Category, and (d) an Unknown Risk Category, wherein the risk categories are ordinal with respect to one another ordered based on respective percentage risk values or ranges of contracting the disease, wherein the Increased Risk Category is assigned an upper percentage risk value or range, wherein the Not Likely at Increased Risk Category is assigned a lower percentage risk value or range, wherein the Slightly Increased Risk Category comprises a middle percentage risk value or range that is less than the upper percentage risk value or range but greater than the lower percentage risk value or range, and wherein the Unknown Risk Category has an undetermined percentage risk value or range; and a user application (app) implementing a user interface and comprising computing instructions , the user app configured to send to and receive data: obtain user specific data of a user for detecting a likelihood of occurrence of a user-specific disease, generate a profile of the user comprising the user specific data receive lab-based genetic analysis output based on the genomic DNA of the user, wherein generation of the lab-based genetic analysis output comprises determination of one or more alleles of the user selected from one or more clinically relevant allelic variant genotypes, wherein the lab-based generic analysis output comprises a first set of data, input, into the genetic risk model, the lab-based genetic analysis output, reduce, by the genetic risk model, the lab-based genetic analysis output to a classification, wherein the classification is stored and comprises a reduced dataset compared to the first set of data, output classification for the user, based on the lab-based genetic analysis output, by the genetic risk model, the classification defining a user-specific risk of the user to develop the disease based on the one or more alleles as selected for the user, wherein outputting the classification comprises accessing the classification , the accessing requiring reduced processing compared to analysis of the first set of data of the lab-based generic analysis output to generate the user-specific risk, wherein the classification is stored as a reduced memory classification-based data selected from predetermined set of risk categories, generate a user-specific genetic health risk determination for the user based on the classification of the user and the lab-based genetic analysis output, and transmit, to the user app, the user-specific genetic health risk determination on the user interface.
Independent claim 18 recites obtaining user specific data of a user for detecting a likelihood of occurrence of a user-specific disease; generating a profile of the user comprising the user specific data; receiving lab-based genetic analysis output based on the genomic DNA of the user, wherein generation of the lab-based genetic analysis output comprises determination of one or more alleles of the user selected from one or more clinically relevant allelic variant genotypes, wherein the lab-based genetic analysis output comprises a first set of data; inputting, into the genetic risk model, the lab-based genetic analysis output; reducing, by the genetic risk model, the lab-based genetic analysis output to a classification; wherein the classification is stored and comprises a reduced dataset compared to the first set of data; outputting a classification for the user, based on the lab-based genetic analysis output, by the classification by the genetic risk model, the classification defining a user-specific risk of the user to develop the disease based on the one or more alleles as selected for the user, wherein outputting the classification comprises accessing the classification , the accessing requiring reduced processing compared to analysis of the first set of data of the lab-based genetic analysis output to generate the user-specific risk, wherein the classification is stored as a reduced memory classification-based data selected from predetermined set of risk categories, wherein the genetic risk model is configured to output a classification defining respective risks of respective users developing the disease, wherein the classification as output by the genetic risk model is selected from a predetermined set of risk categories comprising: (a) an Increased Risk Category, (b) a Slightly Increased Risk Category, (c) a Not Likely at Increased Risk Category, and (d) an Unknown Risk Category, wherein the risk categories are ordinal with respect to one another ordered based on respective percentage risk values or ranges of contracting the disease, wherein the Increased Risk Category is assigned an upper percentage risk value or range, wherein the Not Likely at Increased Risk Category is assigned a lower percentage risk value or range, wherein the Slightly Increased Risk Category comprises a middle percentage risk value or range that is less than the upper percentage risk value or range but greater than the lower percentage risk value or range, and wherein the Unknown Risk Category has an undetermined percentage risk value or range; generating a user-specific genetic health risk determination for the user based on the classification of the user and the lab-based genetic analysis output; and providing to the user the user-specific genetic health risk determination.
Independent claim 35 recites obtain user specific data of a user for detecting a likelihood of occurrence of a user-specific disease; generate a profile of the user comprising the user specific data; receive lab-based genetic analysis output based on the genomic DNA of the user, wherein generation of the lab-based genetic analysis output comprises determination of one or more alleles of the user selected from one or more clinically relevant allelic variant genotypes, wherein the lab-based genetic analysis output comprises a first set of data; input, into the genetic risk model, the lab-based genetic analysis output; reduce, by the genetic risk model, the lab-based genetic analysis output to a classification; wherein the classification is stored and comprises a reduced dataset compared to the first set of data; output a classification for the user, based on the lab-based genetic analysis output, by the classification by the genetic risk model, the classification defining a user-specific risk of the user to develop the disease based on the one or more alleles as selected for the user, wherein outputting the classification comprises accessing the classification, the accessing requiring reduced processing compared to analysis of the first set of data of the lab-based genetic analysis output to generate the user-specific risk, wherein the classification is stored as a reduced memory classification-based data selected from predetermined set of risk categories, wherein the genetic risk model is configured to output a classification defining respective risks of respective users developing the disease, wherein the classification as output by the genetic risk model is selected from a predetermined set of risk categories comprising: (a) an Increased Risk Category, (b) a Slightly Increased Risk Category, (c) a Not Likely at Increased Risk Category, and (d) an Unknown Risk Category, wherein the risk categories are ordinal with respect to one another ordered based on respective percentage risk values or ranges of contracting the disease, wherein the Increased Risk Category is assigned an upper percentage risk value or range, wherein the Not Likely at Increased Risk Category is assigned a lower percentage risk value or range, wherein the Slightly Increased Risk Category comprises a middle percentage risk value or range that is less than the upper percentage risk value or range but greater than the lower percentage risk value or range, and wherein the Unknown Risk Category has an undetermined percentage risk value or range; generate a user-specific genetic health risk determination for the user based on the classification of the user and the lab-based genetic analysis output; and provide to the user the user-specific genetic health risk determination.
The respective dependent claims 2-17, 19-34, and 36-51, but for the inclusion of the additional elements specifically addressed below, provide recitations further limiting the invention of the independent claim(s).
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity, as reflected in the specification, which states that the invention “relates to genetic-based biological sample analysis…for detecting a user-specific genetic health risk related to a disease, e.g., lung disease or liver disease” (see: specification paragraph 1). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The present claims cover certain methods of organizing human activity because they address a problem where “[i]ndividuals typically fail to test for individual genetic health risk, which can lead to life threating conditions…even if an individual does test for individual genetic health risk, a problem arises in accurately determining a specific risk type of a specific individual…there are too few clinical cases associated with a given disease…existing genetic health risk tests often focus on over use of data and/or can be erroneous due to overlapping ranges and/or insufficient data” (see: specification paragraph 2-4), which are problems addressed by “detecting a user-specific genetic health risk related to a disease, e.g., lung disease, liver disease, or thrombophilia disease…implemented not only at the doctor's office and under the prescription of a Health Care Professional, but also suitable for over-the-counter use” (see: specification paragraph 5). Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including an “a server comprising one or more processors and server computing instructions configured for execution by the one or more processors of the server, the server communicatively coupled to a computer network…in one or more memories communicatively coupled to the server and accessible by the one or more processors of the server…configured for execution on a computing device…from the server, wherein the server computing instructions, when executed by the one or more processors of the server, cause the one or more processors of the server to…from a display of the computing device…on the one or more memories accessible by the server…from the memory…on the one or more memories of the server…for display” (claim 1), “by one or more processors…by the one or more processors…at the one or more processors…on one or more memories…by the one or more processors…from the memory…on the one or more memories…by the one or more processors…by the one or more processors…” (claim 18), and “A tangible, non-transitory computer-readable medium storing instructions for detecting a user-specific genetic health risk related to a disease, that when executed by one or more processors, cause the one or more processors to:…by one or more processors…by the one or more processors…at the one or more processors…on one or more memories…by the one or more processors…from the memory…on the one or more memories…by the one or more processors…by the one or more processors…” (claim 35), which are additional elements that are recited at a high level of generality (e.g., the “server comprising one or more processors” performs functions through no more than a statement than that said functions are “configured for execution” according to “server computing instructions” such that said one or more processors “cause” said functions to be performed “when executed”; the “computer network” is configured though no more than a statement than that it is “communicatively coupled to” the server; the “memory” is configured though no more than a statement than that it is “communicatively coupled to” the server such that it is “accessible by” the one or more processors of said server; the “display of the computing device” is configured though no more than a statement than that data is obtained “from” said display and data is output “for” said display; the “one or more processors” is configured through no more than a statement than that functions are performed “by” said one or more processors; the “tangible, non-transitory computer-readable medium” causes one or more processors to perform functions though no more than a statement than that it stores “instructions” for doing so “when executed by” said one or more processors) such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The claims recite the additional elements of “wherein generation of the profile initiates physical shipment of a user test kit to the user, wherein the user test kit is configured to collect a biological sample of the user, the biological sample comprising genomic deoxyribonucleic acid (DNA) of the user as extracted from the biological sample…” (claim 1), “wherein generation of the profile initiates physical shipment of a user test kit to the user, wherein the user test kit is configured to collect a biological sample of the user, the biological sample comprising genomic deoxyribonucleic acid (DNA) of the user as extracted from the biological sample…” (claim 18), and “wherein generation of the profile initiates physical shipment of a user test kit to the user, wherein the user test kit is configured to collect a biological sample of the user, the biological sample comprising genomic deoxyribonucleic acid (DNA) of the user as extracted from the biological sample…” (claim 35), which are nominal or tangential addition to the abstract idea(s) and amount to extra-solution activity concerning mere data gathering. The addition of an insignificant extra-solution activity limitation does not impose meaningful limits on the claim such that is it not nominally or tangentially related to the invention. In the claimed context, these claimed additional elements are incidental to the performance of the recited abstract idea(s) as outlined in the recitations above. See: MPEP 2106.05(g).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components and limitations directed toward extra-solution activity. Accordingly, even in combination, these additional elements do not integrate the abstract idea(s) into a practical application because they do not impose any meaningful limits on practicing the abstract idea(s). Accordingly, the claims are directed to an abstract idea(s) (Step 2A Prong Two: NO).
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 integration of the abstract idea(s) into a practical application, using the additional elements to perform the abstract idea(s) amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using generic components cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea(s). The originally filed specification supports this conclusion:
Paragraph 39, where “With reference to Figure 1, user 160 may provide, from a display of a computing device (e.g., user computing device 11 le) user specific data of the user, which may include the user's name, address, or other information for ordering a user test kit for detecting a likelihood of occurrence of a user-specific disease. Provision of the user specific data may cause server 102 to generate a profile for the user, where the profile may comprise the user specific data. Generation of the profile may cause a user test kit 132 to be delivered (122) to the user. The user test kit may be provided by a user test kit provider 130, which may receive information regarding user including the user specific data (e.g., address information) for shipping the user test kit to the user. In the example of Figure 1, the user test kit is a AIA T based kit, but it should be understood that other test kits associated for testing different diseases or related genes are also contemplated herein.
Paragraph 40, where “In various aspects, user test kit 132 comprises is configured to collect a biological sample (e.g., saliva data) of the user. The biological sample may comprise saliva, hair, skin, or other such biological sample comprising genomic deoxyribonucleic acid (DNA) of the user as may be extracted from the biological sample. The user test kit 132 may comprise a container, which may include a preservative, for stabilizing or preserving the biological sample of the user, e.g., during transit. User test kit 132 may further comprise a unique identifier (e.g., a UPC code) that may be linked to the profile of the user, and which may be used to link the biological sample of the user to the user's data (e.g., genomic DNA).”
Paragraph 45, where “…Generation of the profile causes a user test kit (e.g., user test kit 132) to be delivered to the user, such as a home address of the user as provided or indicated by the user. In various aspects, the user test kit may be configured, or may otherwise include equipment, to collect a biological sample (e.g., saliva, hair, skin, or otherwise) of the user. More generally, the biological sample comprises genomic deoxyribonucleic acid (DNA) of the user as extracted from the biological sample. For example, a generated profile of a user, e.g., based on information provided by the user, may comprise the disease the user wants to be tested for (e.g., alphal-antitrypsin deficiency (AIA TD) associated with lung disease, AIA TD associated with liver disease), the user's age (e.g., 35 years old), the user's sex (e.g., female), and whether the user has ever smoked (e.g., nonsmoking). Upon generation of the profile, the user may receive a test kit configured to collect the saliva of the user. The saliva may comprise genomic DNA, which may be extracted from the saliva. It is to be understood that the invention may comprise kits that may collect DNA samples for other, different, or additional respective genes and/or related diseases.”
The claims recite the additional elements directed to pre-solution, as recited and indicated above, each of which amount to extra-solution activity. The specification (e.g., as excerpted above) does not indicate that the additional element(s) provide anything other than well‐understood, routine, and conventional functions when claimed in a merely generic manner (as they are presently). See: MPEP 2106.05(g).
Further, the concepts of receiving or transmitting data over a network, such as using the Internet to gather data, storing and retrieving information in memory, and analyzing DNA to provide sequence information or detect allelic variants have been identified by the courts as well-understood, routine, and conventional activities. See: MPEP 2106.05(d)(II).
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea(s) with routine, conventional activity specified at a high level of generality in a particular technological environment. Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea(s) (Step 2B: NO).
Dependent claim(s) 2-17, 19-34, and 36-51, when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea(s) without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Response to Arguments
Applicant’s arguments from the response filed on 05/06/2026 have been fully considered and will be addressed below in the order in which they appeared.
In the remarks, Applicant argues in substance that (1) the 35 U.S.C. 101 rejections should be withdrawn because “[t]he claims recite specific technical limitations that integrate any alleged abstract idea into a practical application. Specifically, claim 1 recites "reduce, by the genetic risk model, the lab-based genetic analysis output to a classification, wherein the classification is stored on the one or more memories accessible by the server and comprises a reduced dataset compared to the first set of data." Claim 1 as amended further recites "wherein outputting the classification comprises accessing the classification from the memory, the accessing requiring reduced processing compared to analysis of the first set of data of the lab-based generic analysis output to generate the user-specific risk" and "wherein the classification is stored on the one or more memories of the server as a reduced memory classification-based data selected from predetermined set of risk categories." These limitations describe concrete technical improvements to computer functionality. The specification confirms that the claims recite improvements in computer functionality because the claims recite use of a genetic risk model which streamlines output and reduces storage of user specific data by implementing a classifier. As explained in the specification, "the genetic risk model inputs for analysis thereby a user's genomic DNA, as identified in a large set of data defined by a lab-based genetic analysis output and reduces such data into a classification output selected from predetermined set of risk categories." As Filed Specification, paragraph [0010]. The specification further explains that "[s]uch data reduction can reduce data memory needed for a specific user, and, even more so across an entire database system, which may store data for hundreds or thousands of users" and that "[s]uch implementation reduces data storage for the system as a whole, and, thereby improves it." As-Filed Specification, paragraph [0010]...The claims recite a specific technical solution-the genetic risk model that reduces lab-based genetic analysis output to classification-based data-that provides concrete improvements to computer functionality through reduced data storage requirements and reduced processing overhead. This is not merely applying an abstract idea using generic computer components, but rather recites a specific technical implementation that improves the functioning of the computer system itself…The Examiner's characterization of the additional elements as merely "generic computer components" fails to account for the specific technical functionality recited in the claims. The claims do not merely recite using a computer to perform an abstract idea; rather, they recite a specific technical implementation-the genetic risk model's classification-based data reduction-that provides concrete improvements to computer functionality through reduced memory requirements and reduced processing overhead.”
The Examiner respectfully disagrees. Applicant’s arguments are not persuasive.
The claims are constructed such that genetic analysis output is classified in order to be stored on a memory “as a reduced dataset compared to the first set of data” so that when the one or more processors access the stored classifications, “the accessing require[es] reduced processing compared to analysis of the first set of data”. Providing a categorization workflow that reduces the amount of data stored does not, for example, result in a specific type of data structure designed to improve the way a computer stores and retrieves data in memory (e.g., Enfish). It follows that if fewer actions are taken by the one or more processors, the power consumption required for those actions is not altered by the invention, it is simply performing fewer actions because it is processing less data. Even in instances where data processing is reduced, “reducing the amount of calculations in known and established computations”, for example, is known to be an abstract idea (see for example the USPTO IEG July 2015 Quick Ref Sheet, page 2). The claims are not directed to a computer memory and/or processor(s) performing more efficiently. A high-level functioning of the additional elements is applied with the abstract idea, including categorization of data, and does not alter the manner in which the one or more processors and memory functions, but instead merely dictates that categorized data is to be operated upon by said additional elements. The claims here are not directed to a specific improvement to computer functionality that amount to a practical application. Rather, they are directed to the use of conventional or generic technology in a well-known environment, without any claim that the invention reflects an inventive solution to a technical problem presented by combining the two. In the present case, the claims fail to recite any elements that individually or as an ordered combination transform the identified abstract idea(s) in the rejection into a patent-eligible application of that idea.
In the remarks, Applicant argues in substance that (2) the 35 U.S.C. 112 rejections should be withdrawn in view of the amendments.
The rejections are withdrawn.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ROBERT A SOREY whose telephone number is (571)270-3606. The examiner can normally be reached Monday through Friday, 8am to 5pm.
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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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/ROBERT A SOREY/Primary Examiner, Art Unit 3682
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