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 101, 104-105, 109, 114, 116, 119, 125, and 127-128 have been amended. Claims 102-103 and 123-124 have been canceled. Now, claims 101, 104-122, and 125-128 remain pending and will be examined herein.
Claim Objections
The claim objection of claim 125 is hereby withdrawn pursuant to the amendments filed on July 24, 2025.
Drawings
The drawing objection is hereby withdrawn pursuant to the new replacement drawings submitted on July 24, 2025.
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 101, 104-122, and 125-128 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.
5. Step 1 – Statutory Categories of Invention:
Claims 101, 104-122, 125, and 126 are drawn to a method (process), claim 127 is drawn to a system (machine), and claim 128 is drawn to a non-transitory computer-readable medium (apparatus) which is one of the statutory categories of invention.
6. Step 2A – Judicial Exception Analysis, Prong 1:
Independent claims 101, 127 and 128 recite, in part, a method and/or system and/or non-transitory computer-readable medium comprising the following:
(a) processing at least one biological sample of a subject to generate a set of genomic, phenotype, or diagnostic data;
(b) using ………….. of said first user and ……….of said second user;
(c) ……….., receiving a request ………. to provide said second user access to said set of genomic, phenotype, or diagnostic data;
(d) subsequent to receiving said request in (c), ……………said at least a subset of said set of genomic, phenotype, or diagnostic data to generate a visualization of said at least said subset of said set of genomic, phenotype, or diagnostic data, wherein said visualization comprises a health data graph; and
(e) ……………, transmitting said visualization to …………..of said second user;
(f) providing said visualization to said second user through…….. of said second user, wherein said visualization comprises one or more dashboards comprising one or more of: a user information dashboard, a genomic data dashboard, a health questionnaire dashboard, and an advanced dashboard.
These steps amount to processing a biological sample of a subject and providing a visualization of the results which are functions that are performable in the mind or with pen and paper and are only concepts relating to organizing or analyzing information in a way that can be performed mentally or is analogous to human mental work (MPEP § 2106.04(a)(2)(III)(B) citing the abstract idea grouping for mental processes with or without physical aid).
Dependent claim 104 recites, in part, wherein said set of genomic, phenotype, or diagnostic data is stored in said cloud-based computer system, and further comprising (i) permitting said second user to access said at least said subset of said set of genomic, phenotype, or diagnostic data in said cloud-based computer system, or (ii) transferring said at least said subset of said set of genomic, phenotype, or diagnostic data from said cloud-based computer system to said second computer.
Dependent claim 105 recites, in part, prior to (c), receiving at said cloud- based computer system said set of genomic, phenotype, or diagnostic data from said first digital computer.
Dependent claim 106 recites, in part, further comprising receiving at said cloud-based computer system a second set of genomic, phenotype, or diagnostic data from said second digital computer, which second set of genomic, phenotype, or diagnostic data is generated from at least one biological sample of said subject.
Dependent claim 107 recites, in part, wherein said second set of genomic, phenotype, or diagnostic data is different than said first set of genomic, phenotype, or diagnostic data.
Dependent claim 108 recites, in part, wherein said first user is said subject or said second user is said subject.
Dependent claim 109 recites, in part, further comprising receiving an item of value from said second user in exchange for permitting said second user to access said at least said subset of said set of genomic, phenotype, or diagnostic data.
Dependent claim 110 recites, in part, further comprising providing at least a portion of said item of value to said first user.
Dependent claim 111 recites, in part, wherein said first user is associated with a first company and said second user is associated with a second company different than said first company.
Dependent claim 112 recites, in part, wherein said first user is said subject and said second user is associated with a company.
Dependent claim 113 recites, in part, wherein (b) further comprises using an account of said first user.
Dependent claim 114 recites, in part, wherein said at least said subset of said set of genomic, phenotype, or diagnostic data is configured to be used by said second user or a third user to generate health-related information of said subject.
Dependent claim 115 recites, in part, further comprising communicating said health-related information of said subject to said first user.
Dependent claim 116 recites, in part, further comprising allowing said first user to manage said set of genomic, phenotype, or diagnostic data through said network interface, wherein managing said set of genomic, phenotype, or diagnostic data comprises granting access to one or more additional users, reviewing access by said one or more additional users, or manipulating said set of genomic, phenotype, or diagnostic data.
Dependent claim 117 recites, in part, wherein said network interface comprises a graphical user interface (GUI).
Dependent claim 118 recites, in part, wherein said network interface is provided via a mobile or web application.
Dependent claim 119 recites, in part, wherein said set of genomic, phenotype, or diagnostic data is stored on a private cloud of said first user.
Dependent claim 120 recites, in part, further comprising administering a diagnostic test to said subject based at least in part on said genomic, phenotype, or diagnostic data, to detect a presence or absence of a disease or disorder in said subject.
Dependent claim 121 recites, in part, wherein said disease or disorder is COVID-19.
Dependent claim 122 recites, in part, further comprising recommending a treatment for said subject or treating said subject based at least in part on said detected presence of said disease or disorder in said subject.
Dependent claim 125 recites, in part, further comprising computer processing said at least said subset of said set of genomic, phenotype, or diagnostic data to detect a disease of said subject.
Dependent claim 126 recites, in part, wherein said disease is a rare disease, wherein said rare disease has a prevalence of at most about 6% of a population of individuals.
Each of these steps of the preceding dependent claims 104-122 and 125-126 only serve to further limit or specify the features of independent claims 101, 127, and 128 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.
7. Step 2A – Judicial Exception Analysis, Prong 2:
This judicial exception is not integrated into a practical application because the additional elements within the claims only amount to instructions to implement the judicial exception using a computer [MPEP 2106.05(f)].
Independent Claims 101, 127, and 128 recite, in part, a cloud-based computer system, a network interface establishing a network communication between said first digital computer and said second digital computer, a user interface, computer processing and/or one or more computer processors, and a visualization and/or a non-transitory computer-readable medium. The specification defines a cloud-based computer system as a cloud-based computer system comprising a network interface that is in network communication with the first digital computer of the first user and the second digital computer of the second user (Specification in § 0005), a network interface establishing a network communication between said first digital computer and said second digital computer as a user interface, such as a graphical user interface (GUI) (Specification in § 0006), a user interface as a graphical user interface (GUI) (Specification in § 0006), computer processing and/or one or more computer processors as executing machine code, such as a computer program or algorithm, to enable one or more method steps or operations (Specification in § 0088), and a visualization as various dashboards for analytics and data visualization (Specification in § 0188), and/or a non-transitory computer-readable medium as any medium that participates in providing instructions to a processor for execution (Specification in § 0109). The use of a cloud-based computer system, a network interface establishing a network communication between said first digital computer and said second digital computer, a user interface, computer processing and/or one or more computer processors, and a visualization and/or a non-transitory computer-readable medium are only recited as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2) see case requiring the use of software to tailor information and provide it to the user on a generic computer within the “Other examples.. v.”).
Dependent claims 104 and 106, recite in part, a cloud-based computer system and said second computer. The limitations are only recited as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2) see case requiring the use of software to tailor information and provide it to the user on a generic computer within the “Other examples.. v.”).
Dependent claim 105 recites, in part, said cloud-based computer system and said first digital computer. The limitations are only recited as a tool which only serves to input data for use by the abstract idea (MPEP § 2106.05(g) - insignificant pre/post-solution activity that amounts to mere data gathering to obtain input) and is therefore not a practical application of the recited judicial exception.
Dependent claim 116 recites, in part, said network interface. The limitations are only recited as a tool which only serves to input data for use by the abstract idea (MPEP § 2106.05(g) - insignificant pre/post-solution activity that amounts to mere data gathering to obtain input) and is therefore not a practical application of the recited judicial exception.
Dependent claim 117 recites, in part, a graphical user interface (GUI). The limitations are only recited as a tool which only serves to input data for use by the abstract idea (MPEP § 2106.05(g) - insignificant pre/post-solution activity that amounts to mere data gathering to obtain input) and is therefore not a practical application of the recited judicial exception.
Dependent claim 118 recites, in part, said network interface…via a mobile or web application. The limitations are only recited as a tool which only serves to input data for use by the abstract idea (MPEP § 2106.05(g) - insignificant pre/post-solution activity that amounts to mere data gathering to obtain input) and is therefore not a practical application of the recited judicial exception.
Dependent claim 119 recites, in part, …is stored on a private cloud. The limitations are only recited as a tool which only serves to input data for use by the abstract idea (MPEP § 2106.05(g) - insignificant pre/post-solution activity that amounts to mere data gathering to obtain input) and is therefore not a practical application of the recited judicial exception.
Dependent claim 125 recites, in part, computer processing. The limitations are only recited as a tool which only serves to input data for use by the abstract idea (MPEP § 2106.05(g) - insignificant pre/post-solution activity that amounts to mere data gathering to obtain input) and is therefore not a practical application of the recited judicial exception.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B – Additional Elements that Amount to Significantly More:
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of instructions to implement the abstract idea on a computer.
Independent Claims 101, 127, and 128 recite, in part, a cloud-based computer system, a network interface that is in network communication with said first digital computer, a user interface, a computer processing and/or one or more computer processors, and a visualization and/or a non-transitory computer-readable medium. Each of these elements is only recited as a tool for performing steps of the abstract idea, such as use of the cloud-based computer system to store data, use of the network interface and user interface to input, receive and send data, use of a visualization to display the data and results, and use of the non-transitory computer-readable medium and processor to store and process data. These additional elements therefore only amount to mere instructions to perform the abstract idea using a computer and are not sufficient to amount to significantly more than the abstract idea (MPEP 2016.05(f) see for additional guidance on the “mere instructions to apply an exception’).
Each additional element under Step 2A, Prong 2 is analyzed in light of the specification’s explanation of the additional element’s structure. The claimed invention’s additional elements do not have sufficient structure in the specification to be considered a not well-understood, routine, and conventional use of generic computer components. Note that the specification can support the conventionality of generic computer components if “the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a)” (Berkheimer in III. Impact on Examination Procedure, A. Formulating Rejections, 1. on p. 3).
Dependent claims 104 and 106, recite in part, a cloud-based computer system and said second computer. Each of these elements is only recited as a tool for performing steps of the abstract idea, such as the use of the storage mediums to store data and the computer and data processing devices to apply the algorithm. These additional elements therefore only amount to mere instructions to perform the abstract idea using a computer and are not sufficient to amount to significantly more than the abstract idea (MPEP 2016.05(f) see for additional guidance on the “mere instructions to apply an exception”).
Dependent claim 105 recites, in part, said cloud-based computer system and said first digital computer. Each of these elements is only recited as a tool for performing steps of the abstract idea, such as the use of the storage mediums to store data and the computer and data processing devices to apply the algorithm. These additional elements therefore only amount to mere instructions to perform the abstract idea using a computer and are not sufficient to amount to significantly more than the abstract idea (MPEP 2016.05(f) see for additional guidance on the “mere instructions to apply an exception”).
Dependent claim 116 recites, in part, said network interface. The courts have decided that receiving or transmitting data over a network as well-understood, routine, conventional activity when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (MPEP § 2106.05(d)(II) other types of activities example i. receiving or transmitting data over a network, OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network).
Dependent claim 117 recites, in part, a graphical user interface (GUI). The courts have decided that receiving or transmitting data over a network as well-understood, routine, conventional activity when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (MPEP § 2106.05(d)(II) other types of activities example i. receiving or transmitting data over a network, OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network).
Dependent claim 118 recites, in part, said network interface…via a mobile or web application. The courts have decided that receiving or transmitting data over a network as well-understood, routine, conventional activity when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (MPEP § 2106.05(d)(II) other types of activities example i. receiving or transmitting data over a network, OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network).
Dependent claim 119 recites, in part, …is stored on a private cloud. The courts have decided that storing and retrieving information in memory as well-understood, routine, conventional activity as a computer function when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (MPEP § 2106.05(d)(II)).
Dependent claim 125 recites, in part, computer processing. The courts have decided that storing and retrieving information in memory as well-understood, routine, conventional activity as a computer function when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (MPEP § 2106.05(d)(II)).
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Their collective functions merely provide conventional computer implementation.
Claims 101, 104-122, and 125-128 are therefore rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
6. The 35 U.S.C. 102 rejections of claims 101, 104-120, 122, 125, 127, and 128 as being anticipated by United States Patent Application Publication Number 2015/0227697, Nelson, et al., hereinafter Nelson is hereby withdrawn pursuant to the amendments filed on July 24, 2025. As amended, claim 101 recites, in part, the combination of "wherein said visualization comprises a health data graph" and "wherein said visualization comprises one or more dashboards comprising one or more of: a user information dashboard, a genomic data dashboard, a health questionnaire dashboard, and an advanced dashboard". Nelson does not teach or suggest all of the elements of amended claim 101. For example, Nelson is silent on generating a visualization of genomic, phenotype, or diagnostic data that comprises a health data graph. As another example, Nelson is silent on generating a visualization of genomic, phenotype, or diagnostic data that comprises one or more dashboards.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
7. The 35 U.S.C. 103 rejections of claims 121 and 126 as being unpatentable over United States Patent Application Publication Number 2015/0227697, Nelson, et al., hereinafter Nelson in view of WIPO International Publication Number WO 2015/153102 A1, Mata-Fink, et al., hereinafter Mata-Fink is hereby withdrawn pursuant to the amendments file don July 24, 2025. Mata-Fink fails to cure the above-mentioned deficiencies of Nelson with respect to claim 101. For example, Mata-Fink is silent on generating a visualization of genomic, phenotype, or diagnostic data that comprises a health data graph. As another example, Mata-Fink is silent on generating a visualization of genomic, phenotype, or diagnostic data that comprises one or more dashboards.
Response to Arguments
8. Applicant's arguments filed July 24, 2025 have been fully considered but they are not persuasive.
A. Applicant argues that the claims do not recite an abstract idea under Step 2A (Prong One), that the claims are directed to a practical application under Step 2A (Prong Two), and that the claims provide an inventive concept under Step 2B.
In response, Examiner respectfully disagrees. Examiner asserts that the claims, as a whole, are directed to merely processing a biological sample to generate a visualization of the resultant data (i.e., processing a biological sample to generate data, generating a visualization of said data, transmitting said visualization, providing said visualization to a user, and transmitting said data), which is, in essence, fundamentally directed to a mental process. The claims are directed to the "mental processes” abstract idea grouping which is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions, such as the processing a biological sample to generate data, generating a visualization of said data, transmitting said visualization, providing said visualization to a user, and transmitting said data.
A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception (see MPEP § 2106.04{d) - Integration of a Judicial Exception Into A Practical Application). The court has provided limitations that are indicative that an additional element (or combination of elements) may have integrated the exception into a practical application and limitations that did not integrate a judicial exception into a practical application (see MPEP §2106.04(d)(1) — Relevant Considerations for Evaluating Whether Additional Elements integrate a Judicial Exception into a Practical Application). The use of a cloud-based computer system, a network interface that is in network communication with said first digital computer, a user interface, a computer processing and/or one or more computer processors, and a visualization and/or a non-transitory computer-readable medium are only recited as a tool to perform an existing process and only amounts to an instruction to implement the abstract idea using a computer (MPEP § 2106.05(f)(2) see case requiring the use of software to tailor information and provide it to the user on a generic computer within the “Other examples.. v.”). Here the instant claims seem more analogous to "apply it" (or an equivalent) with the judicial exception, or merely including instructions to implement an abstract idea on a computer, or merely using a computer as a tool to perform an abstract idea, as discussed in MPEP § 2106.05(f). Accordingly, the claims do not recite additional limitations that integrate the exception into a Practical Application, and the application of the abstract idea is therefore not eligible.
The consideration under Step 2B is if the additional elements, alone or in combination, are well-understood, routine and conventional in the field — the novelty of the abstract idea is not considered relevant under the Step 2B analysis. Here, the additional elements, alone or in combination, amount to instruction to implement the abstract idea using a general purpose computer. Alice Corp. Pty. Ltd. V. CLS Bank Int], 134 S. Ct. 2347, 1357 (2014). Accordingly, it does not amount to significantly more, and the application of the abstract idea is therefore not eligible.
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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Phenotypic Integrated Social Search Database and Method (US 20160110524 A1) teaches generating correlations between human biological phenotype and human behavioral and/or emotional phenotype, and optionally to temporal location, comprising the steps of correlating data on biological phenotype with survey-based data on behavioral and/or emotional phenotype.
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-F 9AM-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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/AMBER A MISIASZEK/Primary Examiner, Art Unit 3682