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 the Claims
The status of the claims as of the response filed 11/20/2025 is as follows: Claims 1-55, 57-58, 70, and 82-83 are cancelled, and all previously given rejections for these claims are considered moot. Claims 56, 59, 67-69, 72, 75, 77, and 79-81 are currently amended. Claims 60-66, 71, 73-74, 76, and 78 are as previously presented. Claims 84-88 are new. Claims 56, 59-69, 71-81, and 84-88 are currently pending in the application and have been considered below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/16/2025 is in accordance with the provisions of 37 CFR 1.97 and is considered by the Examiner.
Response to Amendment
Rejection Under 35 USC 112(b)
Claim 80 has been amended to sufficiently clarify the indefinite element such that the corresponding 35 USC 112(b) rejection is withdrawn.
Rejection Under 35 USC 101
The claims have been amended but the 35 USC 101 rejections are upheld.
Rejection Under 35 USC 102/103
The amendments made to the claims introduce limitations that are not fully addressed in the previous office action, and thus the corresponding 35 USC 102/103 rejections are withdrawn. However, Examiner will consider the amended claims in light of an updated prior art search and address their patentability with respect to prior art below.
Response to Arguments
Rejection Under 35 USC 101
On pages 7-8 of the response filed 11/20/2025 Applicant argues that the amended claims “recite specific elements that are not practical to be performed in the mind, at least because these elements necessitate (1) obtaining and assaying a biological sample from a subject, (2) transmitting an electronic report over a computer network for storage in a cloud database, (3) establishing a user interface on an electronic display of a computer device coupled to the cloud database via the computer network, (4) presenting the electronic report via the user interface, and (5) transmitting the electronic report over the computer network to a remote user, responsive to user input from the subject relating to access control.” Applicant’s arguments are fully considered, but are not persuasive. Examiner first notes that the claims were not characterized as a mental process in the non-final rejection, but a certain method of organizing human activity (see paras. 6-7 of the Office action mailed 5/23/2025), such that arguments about the impracticality of performance of the method in the mind are moot.
Examiner submits that various aspects of (1)-(5) do fit within the “certain methods of organizing human activity” grouping, such as transmitting a report for storage, presenting the report to a user, and transmitting the report to another user responsive to user input from the subject relating to access control. These underlying functions describe clinical data sharing operations among various entities (including at least two human users) such that they fit within the managing personal behavior, relationships, or interactions between people subgrouping of “certain methods of organizing human activity,” as further detailed below. Examiner concedes that various aspects of (1)-(5) do not fit into the abstract idea itself; for example, obtaining and assaying a biological sample from a subject as well as the electronic/ computerized infrastructure (i.e. the computer processor, computer network, cloud database, and GUI) underlying the otherwise-abstract data sharing operations are not part of a certain method of organizing human activity, and are instead considered as additional elements in Steps 2A – Prong 2 and 2B, as detailed below.
On pages 8-9 Applicant argues that the instant claims are similar to those found eligible in CardioNet because they provide “improved methods of connective tissue injury risk reporting for a subject, based on analysis of polygenic pathways based on SNPs that are transmitted over a computer network and presented via a user interface, which provides improvements in health monitoring technology.” Applicant’s arguments are fully considered, but are not persuasive. The claimed features are not analogous to improvements in cardiac monitoring technology as in CardioNet because they do not include specific technical details of signal processing of any specific type of physiological measurement data, and instead broadly recite generation of polygenic pathway scores and a corresponding report without any details about improved technical methods of actually accomplishing these desired functional outcomes. Examiner submits that steps for generating polygenic pathway scores for different types of connective tissue injuries and generating a report indicative of the scores fit within the abstract idea grouping of “certain methods of organizing human activity” because a clinician or other medical professional could observe genetic data like SNP genotypes and make determinations about polygenic pathway scores for connective tissue injuries and write up a report as part of a diagnostic evaluation interaction with a subject or patient. Because these functions are part of the abstract idea itself, they do not provide a technological improvement and thus do not confer eligibility (see MPEP 2106.05(a): “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements.” See also 2106.05(a)(II): “it is important to keep in mind that an improvement in the abstract idea itself… is not an improvement in technology.”)
On pages 9-10 Applicant appears to analogize the claims to those found eligible in Example 42, specifically pointing to the combination of claim features (1)-(5) listed above as being “additional elements [that] recite a specific improvement over prior art systems by allowing a subject to (1) be presented an electronic report indicative of said connective tissue injuries and said polygenic pathways scores for said types of connective tissue injuries of said subject, (2) enter user input relating to access control of the electronic report, and (3) have the electronic report transmitted over a computer network to a remote user (e.g., a clinician or sports-medicine counselor).” Applicant’s arguments are fully considered, but are not persuasive. First, Examiner notes that Applicant has not provided any explanation of why the analysis of the eligible claim in Example 42 would be similar to the analysis for claim 56 of Applicant’s invention. The present claims differ from those of Example 42 at least because they do not provide remote format standardization with updated messaging capabilities; in Example 42, the crux of the invention was a technical improvement related to specific formatting conversions and remote accessibility. In contrast, the crux of the instant claims is analysis of genetic and environmental data of a subject to calculate polygenic pathway scores and generate and distribute a report reflecting the scores, which Examiner maintains fits into the “certain methods of organizing human activity” grouping of abstract idea. The use of high-level computing infrastructure like a computer processor and GUI such that the report is generated and distributed electronically amount to mere instructions to “apply” the otherwise-abstract data analysis, report generation, input solicitation, and report sharing functions of the invention such that they are digitized and/or automated within a computing/electronic environment. Accordingly, the instant claims do not recite a technical improvement over prior systems like in Example 42, and are directed to an abstract idea, as explained in more detail below.
On page 11 Applicant argues that “claim 56 recites physical elements that, when considered as an ordered combination, are not routinely performed by those of skill in the art.” Applicant specifically lists steps (a)-(b) and (e)-(j) of amended claim 56, with emphasis on “obtaining a biological sample,” “assaying said biological sample… wherein said genetic information comprises a single nucleotide polymorphism (SNP) genotype,” “generating, by said computer processor, an electronic report,” “transmitting said electronic report over a computer network,” “a graphical user interface on an electronic display of a computing device,” “via said graphical user interface, said electronic report,” “via said graphical user interface, user input,” and “transmitting said electronic report over said computer network to a remote user.” Applicant’s arguments are fully considered, but are not persuasive. Examiner notes that it is well-understood, routine, and conventional to obtain and assay a biological sample from a subject to provide genetic information to computer infrastructure including a computer processor and electronic user device with a GUI communicating over a network for the purpose of generating and sharing results of a clinical analysis, as evidenced by at least Moore et al. (US 20140172444 A1), Fig. 5, [0002]-[0004], [0030], & [0189]; Jain et al. (US 20210241139 A1) Figs. 1A-C, [0432]-[0435], [0450]-[0455]; and Athey et al. (US 20180330824 A1) Figs. 1A-C, [0050], [0074]-[0083]. Accordingly, Examiner respectfully disagrees that the listed additional elements amount to an unconventional combination.
For the reasons outlined above, the 35 USC 101 rejections are upheld for claims 56, 59-69, and 71-81.
Rejection Under 35 USC 102/103
Applicant’s arguments directed to alleged deficiencies of Jain and Athey with respect to the newly-introduced limitations have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 56, 59-69, 71-81, and 84-88 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 56 recites “(d) processing, by a computer processor, said genetic information and said environmental information to generate polygenic pathway scores for types of connective tissue injuries of said subject.” Applicant’s original specification does not provide sufficient written support for generating polygenic pathway scores for connective tissue injuries by processing genetic information and environmental information in two ways: (1) there is no disclosure of a specific algorithm for generating polygenic pathway scores that would convince one of ordinary skill in the art that Applicant had possession of this feature at the time of filing, and (2) there is no disclosure of processing environmental information in combination with genetic information to generate polygenic pathway scores.
Regarding (1), paras. [0076], [0080], & [0134] of Applicant’s specification disclose that polygenic risk scores or pathway scores for different types of pathways (including various connective tissue injuries) are calculated from SNP genotyping data, but there is no disclosure of a specific algorithm or formula utilized to transform SNP genotyping data into a polygenic pathway score. Para. [0085] further describes that individual injury risk pathway scores are generated (though it is unclear if these pathway scores are intended to be equivalent to the claimed polygenic pathway scores due to the differing nomenclature), but still provides no detailed algorithm for calculating such scores. Examiner notes the following portions of MPEP 2161.01 (emphases added):
Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed.
When examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. An algorithm is defined, for example, as "a finite sequence of steps for solving a logical or mathematical problem or performing a task." Microsoft Computer Dictionary (5th ed., 2002). Applicant may "express that algorithm in any understandable terms including as a mathematical formula, in prose, or as a flow chart, or in any other manner that provides sufficient structure." Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1340, 86 USPQ2d 1609, 1623 (Fed. Cir. 2008) (internal citation omitted). It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015) (reversing and remanding the district court’s grant of summary judgment of invalidity for lack of adequate written description where there were genuine issues of material fact regarding "whether the specification show[ed] possession by the inventor of how accessing disparate databases is achieved"). If the specification does not provide a disclosure of the computer and algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention a rejection under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, for lack of written description must be made.
Regarding (2), paras. [0076], [0080], & [0134] disclose that polygenic risk scores or pathway scores for different types of pathways (including various connective tissue injuries) are calculated from SNP genotyping data, but there is no explanation of how environmental data are also incorporated to calculate the polygenic pathway score. Para. [0132] mentions that polygenic pathway scores may serve as one type of input to sports performance models, in combination with other inputs like physiological and performance data obtained from wearable devices and contextual information and subjective feedback (i.e. environmental data), indicating that the environmental data are only considered after the polygenic pathway scores have been generated, not as part of the calculation of the polygenic pathway scores themselves as recited in claim 56.
Because the specific method of generating polygenic pathway scores for types of connective tissue injuries based on both genetic information and environmental information is not sufficiently supported by the original disclosure as filed, this limitation constitutes new matter and is rejected under 35 U.S.C. 112(a).
Claim 56 further recites “(i) receiving, via said graphical user interface, user input from said subject relating to access control of said electronic report; and (j) responsive to said user input received in (i), transmitting said electronic report over said computer network to a remote user.” Applicant’s original specification does not provide sufficient written support for receiving user input relating to access control of a report at a GUI, nor transmitting the electronic report to a remote user specifically responsive to the user input. Para. [0096] states that “The systems and methods provided herein can include a user portal and/or a user platform that is configured to perform health, fitness, and sports performance analysis, display profiles and reports to a user and/or control access to profiles, reports, and/or data” (emphasis added). This is the only mention of access control in the entire disclosure, and does not provide sufficient support for the GUI actively receiving a user input relating to access control of a specific electronic report as now claimed. Paras. [0015], [0097], [00119], [00121], & [00130] do disclose that a generated electronic report may be transmitted to a remote user via a computer network, but make no mention of the transmission occurring specifically responsive to a user input relating to access control of the report as now claimed. Because these aspects of limitations (i) and (j) are not sufficiently supported by the original disclosure as filed, they constitute new matter and rejected under 35 U.S.C. 112(a).
Claims 59-69, 71-81, and 84-88 are also rejected on these bases because they inherit the unsupported limitations due to their dependence on claim 56.
Claim 59 recites “wherein said genetic information further comprises at least one of: copy number variants (CNVs), insertions or deletions (indels), fusions, and translocations.” Applicant’s original specification does not provide sufficient written support for generating polygenic pathway scores for connective tissue injuries by processing genetic information comprising SNP genotyping data and at least one of CNVs, indels, fusions, and translocations and environmental information. The written description issues with respect to generation of polygenic pathway scores are addressed above, but are also relevant in the context of claim 59 because paras. [0076], [0080], & [0134] disclose that polygenic risk scores or pathway scores for different types of pathways (including various connective tissue injuries) are calculated from SNP genotyping data, but there is no explanation of how additional genetic data comprising at least one of CNVs, indels, fusions, and translocations are also incorporated to calculate the polygenic pathway score as would be the case in claim 59. Because the specific method of generating polygenic pathway scores for types of connective tissue injuries based on both genetic information of the type recited in claim 59 and environmental information is not sufficiently supported by the original disclosure as filed, this limitation constitutes new matter and is rejected under 35 U.S.C. 112(a).
Claim 67 recites “wherein (d) further comprises determining said polygenic pathway scores of said subject based at least in part on one or more of: a diagnosis of a disease or disorder, a prognosis of a disease or disorder, a risk of having a disease or disorder, a risk of sports-related injury, a treatment history of a disease or disorder, a history of previous treatment for a disease or disorder, a history of prescribed medications, a history of prescribed medical devices, age, height, weight, sex, smoking status, injury risk, training load status, fitness level, race or match readiness, and one or more symptoms of said subject.” Applicant’s original specification does not provide sufficient written support for generating polygenic pathway scores based on the listed types of information. The written description issues with respect to generation of polygenic pathway scores are addressed above, but are also relevant in the context of claim 67 because paras. [0076], [0080], & [0134] disclose that polygenic risk scores or pathway scores are calculated from SNP genotyping data, but there is no explanation of how additional data types such as those listed in claim 67 are also incorporated to calculate the polygenic pathway score. Para. [0013] is the only mention of many of these types of data, and they are disclosed as being used to determine “performance or health risk state of the subject,” not polygenic pathway scores. Because use of these types of data to generate the polygenic pathway scores is not sufficiently supported by the original disclosure as filed, this limitation constitutes new matter and is rejected under 35 U.S.C. 112(a).
Claim 72 recites “wherein (d) further comprises processing said genetic information and said environmental information using a trained algorithm to determine said polygenic pathway scores of said subject.” Applicant’s original specification does not provide sufficient written support for generating polygenic pathway scores using a trained algorithm. The written description issues with respect to generation of polygenic pathway scores are addressed above, but are also relevant in the context of claim 72 because paras. [0076], [0080], & [0134] disclose that polygenic risk scores or pathway scores are calculated from SNP genotyping data, but there is no mention of using a trained algorithm to generate these scores. Paras. [0099]-[00117] broadly disclose that trained machine learning classifiers may be used to transform inputs like genetic data and environmental data into outputs, but makes no mention of the specific output being polygenic pathway scores. Para. [00100] even discloses one of the input variables of the classifier as “a set of genes or pathways corresponding to a polygenic risk or pathway score,” indicating that polygenic pathway scores are inputs to the classifier rather than outputs. Because use of a trained algorithm to generate the polygenic pathway scores is not sufficiently supported by the original disclosure as filed, this limitation constitutes new matter and is rejected under 35 U.S.C. 112(a).
Claims 73-74 further specify different types of trained algorithms, and they are each rejected under 35 USC 112(a) both because they inherit the unsupported limitations due to their dependence on claim 72, and because the specification does not support use of these specific types of classifiers to specifically generate polygenic pathway scores.
Claim 75 recites “wherein said graphical representation comprises a time-series graph illustrating polygenic pathway scores of a subject over time.” Applicant’s original specification does not provide sufficient written support for a time-series graph illustrating polygenic pathway scores of a subject over time. Paras. [0017] & [0073] broadly disclose “a graphical representation of a generated report compris[ing] a time-series graph illustrating performance or health risk scores of a subject over time,” while Fig. 19 and paras. [0043] & [00183] provide an example of a time series of an athlete’s injury risk over time. However, nowhere does the specification explain that “injury risk” is the same as “polygenic pathway scores” or that the generic performance or health risk scores specifically illustrated in a time-series graph include polygenic pathway scores. Because illustration of polygenic pathway scores in a time-series graph is not sufficiently supported by the original disclosure as filed, this limitation constitutes new matter and is rejected under 35 U.S.C. 112(a).
Claim 77 recites “(ii) determining said polygenic pathway scores based at least in part on said modified physiological estimation or measurement of said subject.” Applicant’s original specification does not provide sufficient written support for generating polygenic pathway scores based on modified physiological estimation or measurements. The written description issues with respect to generation of polygenic pathway scores are addressed above, but are also relevant in the context of claim 77 because paras. [0076], [0080], & [0134] disclose that polygenic risk scores or pathway scores are calculated from SNP genotyping data, but there is no explanation of how additional data types such as modified physiological estimations or measurements are also incorporated to calculate the polygenic pathway score. Para. [0017] is the only mention of modified physiological estimation or measurement of the subject, and these features are only disclosed as being used to determine “the performance or health risk state of the subject,” not polygenic pathway scores. Because use of these types of data to generate the polygenic pathway scores is not sufficiently supported by the original disclosure as filed, this limitation constitutes new matter and is rejected under 35 U.S.C. 112(a). Claims 78-79 are also rejected on this basis because they inherit the unsupported limitation due to their dependence on claim 77.
Claim 80 recites “generating updated polygenic pathway scores responsive to said subject following a health regimen.” Applicant’s original specification does not provide sufficient written support for generating updated polygenic pathway scores responsive to a subject following a health regimen. The written description issues with respect to generation of polygenic pathway scores are addressed above, but are also relevant in the context of claim 80 because paras. [0076], [0080], & [0134] disclose that polygenic risk scores or pathway scores are calculated from SNP genotyping data, but there is no disclosure of updating these polygenic pathway scores specifically responsive to a subject following a health regimen. Paras. [0017] & [0082] broadly disclose that updated performance or health risk states may be generated continuously and/or responsively to a subject following a health regimen, but there is no mention of “polygenic risk scores” specifically being one of these updated performance or health risk states. Because polygenic risk scores being updated responsive to a subject following a health regimen is not sufficiently supported by the original disclosure as filed, this limitation constitutes new matter and is rejected under 35 U.S.C. 112(a).
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 56, 59-69, 71-81, and 84-88 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 56 recites the limitation "said user" in limitation (g). There is insufficient antecedent basis for this limitation in the claim because there is no previously introduced “user,” merely a “subject.” For purposes of examination, Examiner will interpret “said user” as “said subject.” Claims 59-69, 71-81, and 84-88 are also rejected on this basis because they inherit the indefinite limitation due to their dependence on claim 56.
Claim 77 recites “(i) using said polygenic pathway scores to modify a physiological estimation or measurement of said subject, and (ii) determining said polygenic pathway scores based at least in part on said modified physiological estimation or measurement of said subject.” It is unclear how the polygenic pathway scores could first be used to modify a physiological estimation or measurement, and then that modified estimation or measurement be subsequently used to determine the polygenic pathway scores which have already been used to previously modify the physiological estimation or measurement. For purposes of examination, Examiner will interpret limitation (ii) as indicating that a different health outcome metric separate from the polygenic pathway scores is determined based at least in part on the modified physiological estimation or measurement. Claims 78-79 are also rejected on this basis because they inherit the indefinite language due to their dependence on claim 77.
Claims 84-85 each recite the limitation "the polygenic risk scores.” There is insufficient antecedent basis for this limitation in each claim because there are no previously introduced “polygenic risk scores” in parent claim 56, merely “polygenic pathway scores.” For purposes of examination, Examiner will interpret “the polygenic risk scores” as “the polygenic pathway scores.”
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 56, 59-69, 71-81, and 84-88 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
In the instant case, claims 56, 59-69, 71-81, and 84-88 are directed to a method (i.e. a process), and thus each of the claims falls within one of the four statutory categories. Nevertheless, the claims fall within the judicial exception of an abstract idea.
Step 2A – Prong 1
Independent claim 56 recites steps that, under their broadest reasonable interpretations, cover certain methods of organizing human activity, e.g. managing personal behavior, relationships, or interactions between people. Specifically, claim 56 recites:
A method for determining a risk of connective tissue injury of a subject, comprising:
(a) obtaining a biological sample from said subject;
(b) assaying said biological sample to generate genetic information of said subject, wherein said genetic information comprises a single nucleotide polymorphism (SNP) genotype of said subject;
(c) receiving environmental information of said subject, wherein said environmental information comprises contextual data, activities, or physiological measurements of said subject;
(d) processing, by a computer processor, said genetic information and said environmental information to generate polygenic pathway scores for types of connective tissue injuries of said subject;
(e) generating, by said computer processor, an electronic report comprising a graphical depiction of (1) said types of connective tissue injuries and (2) said polygenic pathway scores for said types of connective tissue injuries of said subject;
(f) transmitting said electronic report over a computer network for storage in a cloud database;
(g) establishing a graphical user interface on an electronic display of a computer device of said user, wherein said computing device is communicatively coupled to said cloud database via said computer network;
(h) presenting to said subject, via said graphical user interface, said electronic report indicative of said polygenic pathway scores for types of said connective tissue injuries of said subject;
(i) receiving, via said graphical user interface, user input from said subject relating to access control of said electronic report; and
(j) responsive to said user input received in (i), transmitting said electronic report over said computer network to a remote user.
But for the recitation of generic computer components like a computer processor, a computer network, a cloud database, and a GUI, the italicized functions, when considered as a whole, describe a diagnostic analysis, report generation, and clinical data sharing/management operation that could be achieved by a clinician or other medical professional managing their personal behavior and/or interactions with other people (e.g. a patient and colleagues). For example, a clinician could access a filing system (e.g. paper medical records) or communicate with a patient, lab personnel, governmental entities, etc. to obtain genetic information (e.g. SNP genotype results from a biological assay) and environmental information (e.g. information about environmental toxins, patient-reported exercise/activities, sensor data, etc.) about a given subject. The clinician could then use their medical expertise to process the received data to determine polygenic pathways scores for different types of connective tissue injuries of the subject and generate a written report graphically depicting each type of injury and their respective scores. The clinician could then send a copy of the report to be stored (e.g. in a filing cabinet, the subject’s chart, etc.) as well as another copy to be presented to the subject for review. Upon presenting the subject with the report, the clinician could ask the subject whether they would like to share the report with any additional people (e.g. family members, friends, caregivers, coaches, employers, etc.) and facilitate sharing of the report with the other authorized people (e.g. sending them a copy in the mail). Thus, claim 56 recites an abstract idea in the form of a certain method of organizing human activity.
Dependent claims 59-69, 71-81, and 84-88 inherit the limitations that recite an abstract idea from their dependence on claim 56, and thus these claims also recite an abstract idea under the Step 2A – Prong 1 analysis. In addition, claims 59-69, 71-72, 75-81, and 84-88 recite additional limitations that further describe the abstract idea identified in the independent claims.
Claims 59-66 further describe the types of data received and processed, each of which are types of data that a clinician would be capable of analyzing when generating an injury risk report.
Claim 67 recites that the polygenic pathway scores are determined based on a variety of data types, each of which are types of data that a clinician would be capable of considering when calculating or otherwise determining polygenic pathways scores for a subject.
Claims 68-69 recite generating a health or training regimen to prevent connective tissue injury based on the polygenic pathway scores, which a clinician would be capable of determining and recommending for a subject by using their medical expertise.
Claim 71 recites transmitting the report to a remote user of various types, which a clinician could accomplish by calling, mailing, or otherwise communicating a report to another human actor like a clinical practitioner, nutrigenetics counselor, sports coach, etc.
Claim 72 specifies that processing the genetic and environmental information occurs by using a trained algorithm to determine the polygenic pathway scores of the subject, which a clinician could achieve by utilizing an initialized/trained algorithm (e.g. an equation, decision tree, or other simple algorithm that has been developed/trained in advance).
Claim 75 specifies that the report includes a time-series graph illustrating polygenic pathway scores of a subject over time, which a clinician could accomplish by drawing or otherwise visually representing a time-series graph of the calculated scores over time.
Claim 76 recites using the report to provide the subject with a drug as a therapeutic intervention, which a clinician could accomplish by including a specific drug recommendation for the subject in their written report.
Claim 77 recites using the polygenic pathway scores to modify a physiological estimation or measurement of the subject and determining the polygenic pathway scores based at least in part on the modified physiological estimation or measurement. A clinician could accomplish these functions by using their medical expertise to determine a risk score, estimating a predicted physiological measurement for a user based on the risk score, and determining an updated/predicted performance or health risk state of the subject based on the estimation.
Claims 78-79 recite generating a health or training regimen to prevent connective tissue injury for based on the modified physiological estimation or measurement, which a clinician could achieve by using their medical expertise to recommend various types of injury-prevent actions for the subject based on predicted physiological measurements.
Claim 80 recites generating polygenic pathway scores responsive to the subject following a health regimen, which a clinician could accomplish by checking in with the subject after they have implemented a recommended health-based action and repeating the analysis to determine updated polygenic pathway scores reflective of the subject’s current state.
Claim 81 specifies that the report includes subject-specific health and fitness recommendations, which are types of recommendations that a clinician would be capable of making and including in a report.
Claims 84-85 specify that the polygenic risk scores are based on various pathways, which a clinician would be capable of considering when calculating or determining the scores.
Claim 86 describes types of connective tissue injuries, each of which are types of injuries that a clinician would be capable of evaluating a subject’s risk for.
Claims 87-88 specify that the report is indicative of recommendations for a subject after training, each of which a clinician would be capable of determining and including in the report.
However, recitation of an abstract idea is not the end of the analysis. Each of the claims must be analyzed for additional elements that indicate the abstract idea is integrated into a practical application to determine whether the claim is considered to be “directed to” an abstract idea.
Step 2A – Prong 2
The judicial exception is not integrated into a practical application. In particular, independent claims 56, 82, and 83 do not include additional elements that integrate the abstract idea into a practical application. The additional elements of claim 56 are underlined in the Step 2A – Prong 1 analysis above, and include:
obtaining a biological sample from said subject;
assaying said biological sample to generate genetic information of said subject, wherein said genetic information comprises a single nucleotide polymorphism (SNP) genotype of said subject;
a computer processor;
specifying that the report is an electronic report;
transmitting said electronic report over a computer network for storage in a cloud database;
establishing a graphical user interface on an electronic display of a computer device of said user, wherein said computing device is communicatively coupled to said cloud database via said computer network;
using the graphical user interface to present the electronic report to the subject and receive user input from the subject; and
transmitting said electronic report over said computer network to a remote user.
The first two elements directed to obtaining and assaying a biological sample from a subject to generate SNP genotype information, when considered in the context of each claim as a whole, appear to be invoked for the purpose of gathering the genetic data necessary for the main data analysis, report generation, and data sharing steps of the invention. Accordingly, these elements amount to insignificant extra-solution activity in the form of mere data gathering (see MPEP 2106.05(g)) and do not provide integration into a practical application.
The computer infrastructure elements (i.e. computer processor, electronic nature of the report, use of a computer network to transmit the report to a cloud database and a remote user, and establishment of a GUI on an electronic display of a computer device of the subject to present the report and receive user input), when considered in the context of each claim as a whole, merely serve to automate personal behavior and/or interactions that could otherwise be achieve by and between human actors (as described above), and thus amount to instructions to “apply” the abstract idea using generic computer components. For example, a clinician can receive and analyze various types of subject data to generate a graphical report indicative of connective tissue injuries and associated polygenic pathway scores and communicate the report to various entities, and use of a computer processor to perform the data analysis and report generation steps as well as computer networking architecture to transmit, store, and present the electronic report to different entities merely digitize and/or automate these otherwise-abstract functions such that they occur in an electronic/digital environment (see MPEP 2106.05(f)). Accordingly, claim 56 as a whole is directed to an abstract idea without integration into a practical application.
The judicial exception recited in dependent claims 59-69, 71-81, and 84-88 is also not integrated into a practical application under a similar analysis as above. The functions of claims 59-69, 71-72, 75-81, and 84-88 are performed with the same additional elements introduced in independent claim 56, without introducing any new additional elements of their own, and accordingly also amount to insignificant extra-solution activity and/or instructions to “apply” the abstract idea. Claims 73 and 74 specify that the trained algorithm used to determine the polygenic pathway scores are various types of supervised or unsupervised machine learning algorithms, which merely invoke high-level, known machine learning model types as tools with which to automate and/or digitize the otherwise-abstract function of calculating or otherwise determining such scores based on subject data, such that these elements also amount to mere instructions to “apply” the exception.
Accordingly, the additional elements of claims 56, 59-69, 71-81, and 84-88 do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Claims 56, 59-69, 71-81, and 84-88 are directed to an abstract idea.
Step 2B
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 into a practical application, the additional elements describing the computer infrastructure of the invention (i.e. computer processor, electronic nature of the report, use of a computer network to transmit the report to a cloud database and a remote user, and establishment of a GUI on an electronic display of a computer device of the subject to present the report and receive user input) amount to mere instructions to “apply” the exception in an electronic/digital environment using generic computer components. As evidence of the generic nature of the above recited additional elements, Examiner notes Fig. 14 and paras. [0094]-[0097] & [00119]-[00129] of Applicant’s specification, where the computer system of the invention is disclosed at a high level in terms of known, exemplary computer, networking, and user interface components such that one of ordinary skill in the art would understand that any client-server-type computer system may be utilized to implement the invention. Similarly, the trained machine learning algorithms as in claims 73-74 amount to instructions to “apply” the exception, and para. [0099] describes the algorithms in terms of a wide variety of known supervised and unsupervised learning techniques such that one of ordinary skill in the art would understand that many high-level types of machine learning algorithm may be utilized to implement the data processing step.
Obtaining and assaying a biological sample to provide the SNP genotype data for the main data analysis, report generation, and data sharing steps of the invention amounts to insignificant extra-solution activity in the form of mere data gathering, as explained above. Examiner notes that it is well-understood, routine, and conventional to obtain and assay a biological sample to generate SNP genotype data for further clinical analysis and reporting, as evidenced by at least Moore et al. (US 20140172444 A1) paras. [0030] & [0033]. Further, MPEP 2106.05(d)(II) outlines various laboratory techniques as being well-understood, routine, and conventional activity when they are claimed in a generic manner and/or as insignificant extra-solution activity, including using polymerase chain reaction to amplify and detect DNA, detecting DNA or enzymes in a sample, analyzing DNA to provide sequence information or detect allelic variants, amplifying and sequencing nucleic acid sequences, etc.
Analyzing these additional elements as an ordered combination also does not provide an inventive concept. Examiner notes that it is well-understood, routine, and conventional to obtain and assay a biological sample from a subject to provide genetic information to computer infrastructure including a computer processor and electronic user device with a GUI communicating over a network for the purpose of generating and sharing results of a clinical analysis, as evidenced by at least Moore Fig. 5, [0002]-[0004], [0030], & [0189]; Jain et al. (US 20210241139 A1) Figs. 1A-C, [0432]-[0435], [0450]-[0455]; and Athey et al. (US 20180330824 A1) Figs. 1A-C, [0050], [0074]-[0083]. Accordingly, when considered as a whole and in combination, claims 56, 59-69, 71-81, and 84-88 are not patent eligible.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 56, 59-63, 65, 67-69, 71-72, 76-81, and 86-88 are rejected under 35 U.S.C. 103 as being unpatentable over Moore et al. (US 20140172444 A1) in view of Vaughn et al. (Reference U on the accompanying PTO-892).
Claims 56
Moore teaches a method for determining a risk of conditions of a subject (Moore [0002]-[0003], [0041], [0057], noting generation of a phenotype profile for a user representing risk, susceptibility, and/or predisposition to different conditions), comprising:
(a) obtaining a biological sample from said subject (Moore [0022], noting a biological sample such as blood, hair, skin, saliva, etc. can be obtained from a user);
(b) assaying said biological sample to generate genetic information of said subject, wherein said genetic information comprises a single nucleotide polymorphism (SNP) genotype of said subject (Moore [0020], [0030], noting the biological sample is assayed to produce a genetic profile including SNP variations of the user);
(c) receiving environmental information of said subject, wherein said environmental information comprises contextual data, activities, or physiological measurements of said subject (Moore [0037], noting additional user-specific factors like demographics (i.e. contextual data), lifestyle/behavior and exercise habits data (i.e. activities), physical measurements like weight, height, cholesterol level, heart rate, blood pressure (i.e. physiological measurements), etc. are received);
(d) processing, by a computer processor, said genetic information and said environmental information to generate polygenic pathway scores for types of conditions of said subject (Moore [0039]-[0041], [0057]-[0058], [0067]-[0070], noting the genetic profile and additional patient-specific data (i.e. the environmental information as in [0037]) is analyzed to determine a phenotype profile that includes genetic composite index scores for each of a plurality of conditions; these scores are considered equivalent to ‘polygenic pathway’ scores because they represent the risk or susceptibility of developing each condition based on the user’s combined genetic and environmental data. See also [0189], noting the functions of the invention are achieved via a computer system with a CPU);
(e) generating, by said computer processor, an electronic report comprising a graphical depiction of (1) said types of conditions and (2) said polygenic pathway scores for saidconditions of said subject (Moore [0069]-[0070], [0180], noting the GCI scores for each respective condition are visually indicated in an electronic report);
(f) transmitting said electronic report over a computer network for storage in a cloud database (Moore [0069], noting “the GCI scores may be stored digitally so that they are readily accessible at any point of time”; see also [0189], noting the functions of the invention may be achieved via a computer system connected to a local or remote server. Taken together, one of ordinary skill in the art would understand that these disclosures indicate that the electronic report with the GCI scores may be transmitted to a remote server (i.e. cloud database) for storage and retrieval at a later time);
(g) establishing a graphical user interface on an electronic display of a computer device of said user, wherein said computing device is communicatively coupled to said cloud database via said computer network (Moore Fig. 5, [0180], [0189], noting a display device of the computer system establishes a graphical user interface for visualizing the report and other system data);
(h) presenting to said subject, via said graphical user interface, said electronic report indicative of said polygenic pathway scores for types of said conditions of said subject (Moore [0180], noting the report of the GCI scores for the various conditions is displayed at the GUI);
(i) (Moore [0172]-[0173], [0188], noting the user may use an online portal to choose who has access to their phenotype profile and/or report); and
(j) responsive to said user input received in (i), transmitting said electronic report over said computer network to a remote user (Moore [0173], [0189], noting friends and family of the user may access the report in accordance with the user’s access control choices, indicating that the report is transmitted over the computer network to a remote user as in [0189] responsive to the received user input).
In summary, Moore teaches a computerized method by which a user’s genetic SNPs and environmental data can be processed together to generate scores indicative of risk or susceptibility to various phenotypes or conditions for the purpose of providing a personalized action plan to the user. Though [0041] further shows that such phenotypes/conditions can include “any measurable trait or characteristic” including physical traits like susceptibility to sunburn (i.e. a type of injury), Moore fails to explicitly disclose that the types of conditions scored for risk/susceptibility include connective tissue injuries. However, Vaughn teaches that various types of tendon (i.e. connective tissue) injuries are common and depend on both intrinsic (i.e. genetic) and extrinsic (i.e. environmental) factors, and that recognition of individuals at risk for such injuries would be beneficial for targeting interventions to prevent or reduce instances of the injuries (Vaughn abstract, Pgs 1-2). It therefore would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the conditions for which GCI scores are calculated as in Moore to include different types of connective tissue injuries as in Vaughn in order to identify users at risk for these common types of injury conditions so that appropriate preventative interventions may be facilitated (as suggested by Vaughn Pgs 1-2).
Claim 59
Moore in view of Vaughn teaches the method of claim 56, and the combination further teaches wherein said genetic information further comprises at least one of: copy number variants (CNVs), insertions or deletions (indels), fusions, and translocations (Moore [0002], [0020], [0046], noting genetic data can include features like copy number variations, insertions, deletions, and translocations).
Claim 60
Moore in view of Vaughn teaches the method of claim 56, and the combination further teaches wherein said biological sample is selected from the group consisting of saliva, cheek swab, blood, plasma, serum, urine, and a combination thereof (Moore [0022], noting the biological sample can include saliva, blood, urine, etc.).
Claim 61
Moore in view of Vaughn teaches the method of claim 56, and the combination further teaches wherein said assaying comprises at least one of: a single nucleotide polymorphism (SNP) panel assay, a pharmacology genetics assay, an ancestry genetics assay, a medical genetics assay, a pharmacogenetics assay, a sports performance genetics assay, a health screening, a test for a specific disease risk, a migraine test, a thyroid test, an eczema test, and a cancer genetics assay (Moore [0030], noting use of various commercially available SNP panel assays).
Claim 62
Note: claim 62 further limits an optional element of claim 56; because claim 56 recites “wherein said environmental information comprises contextual data, activities, or physiological measurements of said subject,” the broadest reasonable interpretation of that claim does not require activities. Per MPEP 2111.04(I): “Claim scope is note limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure.” Accordingly, the more specific types of the optional activities recited in claim 62 need not be taught by the prior art under the BRI of the claim. However, in the interest of compact prosecution, this limitation is addressed with prior art below.
Moore in view of Vaughn teaches the method of claim 56, and the combination further teaches wherein said activities comprise at least one of: exercising, playing a sport, walking, running, sitting, standing, lying down, and sleeping (Moore [0037], noting data includes exercise habits, i.e. the activities comprise exercising).
Claim 63
Note: claim 63 further limits an optional element of claim 56; because claim 56 recites “wherein said environmental information comprises contextual data, activities, or physiological measurements of said subject,” the broadest reasonable interpretation of that claim does not require physiological measurements. Per MPEP 2111.04(I): “Claim scope is note limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure.” Accordingly, the more specific types of the optional physiological measurements recited in claim 63 need not be taught by the prior art under the BRI of the claim. However, in the interest of compact prosecution, this limitation is addressed with prior art below.
Moore in view of Vaughn teaches the method of claim 56, and the combination further teaches wherein said physiological measurements comprise vital sign measurements of said subject, and wherein said vital sign measurements comprise at least one of: heart rate, heart rate variability, systolic blood pressure, diastolic blood pressure, respiratory rate, blood oxygen concentration (SpO2), carbon dioxide concentration in respiratory gases, a hormone level, sweat analysis, blood glucose, body temperature, impedance, conductivity, capacitance, resistivity, electromyography, galvanic skin response, neurological signals, and immunology markers (Moore [0037], noting physical measurements such as heart rate, blood pressure, glucose level, etc.).
Claim 65
Note: claim 65 further limits an optional element of claim 56; because claim 56 recites “wherein said environmental information comprises contextual data, activities, or physiological measurements of said subject,” the broadest reasonable interpretation of that claim does not require physiological measurements. Per MPEP 2111.04(I): “Claim scope is note limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure.” Accordingly, the more specific types of the optional physiological measurements recited in claim 65 need not be taught by the prior art under the BRI of the claim. However, in the interest of compact prosecution, this limitation is addressed with prior art below.
Moore in view of Vaughn teaches the method of claim 56, and the combination further teaches wherein said physiological measurements comprise a physiological metric that measures an effect of an external influence on a human body (Moore [0037], noting physical measurements such as weight, cholesterol level, heart rate, blood pressure, glucose level, etc., which are each metrics known to be affected by external influences on a human body like nutritional intake, drugs, stress, exercise equipment, etc. and thus are considered equivalent to physiological metrics that measure an effect of an external influence on a human body).
Claim 67
Moore in view of Vaughn teaches the method of claim 56, and the combination further teaches wherein (d) further comprises determining said polygenic pathway scores of said subject based at least in part on one or more of: a diagnosis of a disease or disorder, a prognosis of a disease or disorder, a risk of having a disease or disorder, a risk of sports-related injury, a treatment history of a disease or disorder, a history of previous treatment for a disease or disorder, a history of prescribed medications, a history of prescribed medical devices, age, height, weight, sex, smoking status, injury risk, training load status, fitness level, race or match readiness, and one or more symptoms of said subject (Moore [0037], noting the additional data upon which the risk determinations may be based include known health conditions (i.e. a diagnosis of a disease or disorder), age, height, weight, gender, etc.).
Claim 68
Moore in view of Vaughn teaches the method of claim 56, and the combination further teaches generating a health regimen or a training regimen for said subject based at least in part on said polygenic pathway scores determined in (d) (Moore [0009], [0151], [0155], noting the scores can be used to generate a personalized action plan with health and/or exercise/training recommendations for the user).
Claim 69
Moore in view of Vaughn teaches the method of claim 68, and the combination further teaches wherein said health regimen comprises recommendations to prevent connective tissue injury (Moore [0151], noting the action plan can include dietary and exercise prevention strategies to reduce risks of the evaluated conditions; see also Vaughn Pgs 1-2, noting individuals at risk for connective tissue injuries can be identified to prompt behavioral and sport modifications to prevent injury. Taken together in the context of the combination, these disclosures suggest that the preventative strategies as in Moore would encompass recommendations to prevent the specific condition of connective tissue injury as in Vaughn).
Claim 71
Moore in view of Vaughn teaches the method of claim 56, and the combination further teaches transmitting said electronic report to a remote user, wherein said remote user is a clinical practitioner, a nutrigenetics counselor, a sports coach, a team manager, or an individual (Moore [0173], [0189], noting the report can be accessed by / transmitted to a party such as a health care provider, a health care manager, a friend, a family member, etc.).
Claim 72
Moore in view of Vaughn teaches the method of claim 56, and the combination further teaches wherein (d) further comprises processing said genetic information and said environmental information using a trained algorithm to determine said polygenic pathway scores said subject (Moore [0079], noting the GCI scores are typically calculated via mathematical models, i.e. algorithms trained/fitted with prior knowledge).
Claim 76
Moore in view of Vaughn teaches the method of claim 56, and the combination further teaches using said electronic report to provide said subject with a therapeutic intervention, wherein said therapeutic intervention comprises a drug (Moore [0156], [0184], noting the report gives the user information about drug-based treatment options).
Claim 77
Moore in view of Vaughn teaches the method of claim 56, and the combination further teaches (i) using said polygenic pathway scores to modify a physiological estimation or measurement of said subject, and (ii) determining said polygenic pathway scores based at least in part on said modified physiological estimation or measurement of said subject (Moore [0069], [0153], noting predicted changes in a physiological metric due to an initial risk-based action plan (e.g. predicted calcium levels due to increased calcium intake as recommended from an initial osteoporosis risk score) may be used to update predicted susceptibility risks (e.g. predicting a reduced risk of osteoporosis)).
Claim 78
Moore in view of Vaughn teaches the method of claim 77, and the combination further teaches generating a health regimen or a training regimen for said subject to decrease risk or improve performance, based at least in part on said modified physiological estimation or measurement of said subject (Moore [0009], [0151], [0155], noting the scores can be used to generate a personalized action plan with health and/or exercise/training recommendations for the user; the action plan include future predicted recommendations based on predicted changes in user data as in [0069] & [0153]).
Claim 79
Moore in view of Vaughn teaches the method of claim 78, and the combination further teaches wherein said health regimen comprises recommendations to prevent connective tissue injury (Moore [0151], noting the action plan can include dietary and exercise prevention strategies to reduce risks of the evaluated conditions; see also Vaughn Pgs 1-2, noting individuals at risk for connective tissue injuries can be identified to prompt behavioral and sport modifications to prevent injury. Taken together in the context of the combination, these disclosures suggest that the preventative strategies as in Moore would encompass recommendations to prevent the specific condition of connective tissue injury as in Vaughn).
Claim 80
Moore in view of Vaughn teaches the method of claim 56, and the combination further teaches generating updated polygenic pathway scores responsive to said subject following a health regimen (Moore [0064]-[0066], [0152], noting phenotype profiles containing GCI scores and associated action plans may be updated based on updated data from a user following a suggested health regimen).
Claim 81
Moore in view of Vaughn teaches the method of claim 56, and the combination further teaches wherein said electronic report further comprises subject-specific health and fitness recommendations, and wherein said subject-specific health and fitness recommendations comprise recommendations to improve polygenic pathway scores of said subject (Moore [0151], noting the action plan can include dietary and exercise prevention strategies to reduce risks of the evaluated conditions, i.e. to improve the polygenic pathway scores).
Claim 86
Moore in view of Vaughn teaches the method of claim 56, and the combination further teaches wherein the types of connective tissue injuries comprise an ACL injury, a Hamstring injury, an Achilles tendon injury, a rotator cuff injury, or any combination thereof (Vaughn Pg 1, Table 2 on Pgs 3-4, noting different types of tendon injuries include Achilles rupture, rotator cuff tear, ACL issues, etc.).
Claim 87
Moore in view of Vaughn teaches the method of claim 56, and the combination further teaches wherein the electronic report is further indicative of a recommended recovery time of said subject after training (Moore [0161], noting an action plan can include recommendations for frequency and length of time for exercising in a given timeframe, indicating a recovery time is recommended in the time between exercise sessions).
Claim 88
Moore in view of Vaughn teaches the method of claim 56, and the combination further teaches wherein the electronic report is further indicative of a recommended nutritional intake of said subject after training (Moore [0166], noting an action plan can include recommendations for a timeline or schedule varying dietary plan based on completing earlier portions of the plan, considered equivalent to recommended nutritional intake after a training session).
Claims 64, 66, and 75 are rejected under 35 U.S.C. 103 as being unpatentable over Moore and Vaughn as applied to claim 56 above, and further in view of Jain et al. (US 20210241139 A1).
Claim 64
Note: claim 64 further limits an optional element of claim 56; because claim 56 recites “wherein said environmental information comprises contextual data, activities, or physiological measurements of said subject,” the broadest reasonable interpretation of that claim does not require physiological measurements. Per MPEP 2111.04(I): “Claim scope is note limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure.” Accordingly, the more specific types of the optional physiological measurements recited in claim 64 need not be taught by the prior art under the BRI of the claim. However, in the interest of compact prosecution, this limitation is addressed with prior art below.
Moore in view of Vaughn teaches the method of claim 56, showing consideration of physiological measurements like exercise habits, cholesterol, heart rate, blood pressure, “and other measurements known in the art” (Moore [0037]) as well as measurable information like metabolite levels, ion levels, vitamins, blood cell counts, protein levels, etc. that “can be determined by methods readily available” (Moore [0066] & [0170]). However, the present combination fails to explicitly disclose wherein said physiological measurements comprise sports performance measurements of said subject, and wherein said sports performance measurements comprise at least one of: VO2max, blood lactate, lactate threshold, training load, training stress scores, times spent in aerobic and anaerobic heart rate zones, pace, power, distance, and time. However, Jain teaches that physiological measurements for genetic- and environmental-based user health predictions can include sports performance measurements such as VO2max, training load, distance, and time (Jain [0321], [0443]-[0444], noting exercise and physical activity data such as VO2 max, exercise distance that a subject ran or walked, exercise intensity (i.e. training load), exercise duration, etc.). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the physiological measurement data of the combination to include sports performance data of the types disclosed by Jain because Jain shows that these are types of measurements known in the art that may be readily determined and useful for personalized user risk determinations and action planning.
Claim 66
Note: claim 66 further limits an optional element of claim 56; because claim 56 recites “wherein said environmental information comprises contextual data, activities, or physiological measurements of said subject,” the broadest reasonable interpretation of that claim does not require activities or physiological measurements. Per MPEP 2111.04(I): “Claim scope is note limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure.” Accordingly, the more specific origin of the optional activities or physiological measurements recited in claim 66 need not be taught by the prior art under the BRI of the claim. However, in the interest of compact prosecution, this limitation is addressed with prior art below.
Moore in view of Vaughn teaches the method of claim 56, showing consideration of physiological measurements like exercise habits, cholesterol, heart rate, blood pressure, etc. (Moore [0037]) as well as measurable information like metabolite levels, ion levels, vitamins, blood cell counts, protein levels, etc. that “can be determined by methods readily available… such as by real time monitoring” (Moore [0170]). However, the present combination fails to explicitly disclose wherein said activities or said physiological measurements are obtained using an electronic device, and wherein said electronic device comprises a wearable device. However, Jain teaches that physiological measurements for genetic- and environmental-based user health predictions can be obtained from wearable electronic devices (Jain [0130], [0233], noting sensing devices can include wearable devices for collecting physiological and activity data). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the physiological measurement data collected by “methods readily available” as in the combination to specifically include data obtained from wearable electronic devices as in Jain because Jain shows that these are types of physiological measurement collection devices readily available in the art.
Claim 75
Moore in view of Vaughn teaches the method of claim 56, and the combination further teaches that the report may allow users to track their progress or changes in GCI scores over time (Moore [0173]). However, the present combination fails to explicitly disclose wherein said graphical representation comprises a time-series graph illustrating polygenic pathway scores of a subject over time. However, Jain teaches that a health-based prediction for a user may be displayed via a chart, graph, timeline, scatterplot, etc. showing past, present, and future predictions of the subject (Jain Fig. 1C, [0162], [0351]), considered equivalent to a time-series graph. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the report showing changes in GCI scores over time as in the combination to specifically include a time-series graph of one of the types disclosed by Jain in order to convey the past, present, and/or future scores of the user in a visual manner (as suggested by Jain Fig. 1C) so that changes over time may be more easily tracked.
Claims 73-74 are rejected under 35 U.S.C. 103 as being unpatentable over Moore and Vaughn as applied to claim 72 above, and further in view of Athey et al. (US 20180330824 A1).
Claim 73
Moore in view of Vaughn teaches the method of claim 72, but the combination fails to explicitly disclose wherein said trained algorithm comprises a supervised machine learning algorithm, and wherein said supervised machine learning algorithm comprises a deep learning algorithm, a support vector machine (SVM), a neural network, a Gaussian naive Bayes model, a naive Bayes model, or a Random Forest. However, Athey teaches that a model for generating health-based phenotype predictions using genetic and environmental data of a user can include a supervised machine learning algorithm such as deep learning, neural networks, Gaussian naïve Bayes, naïve Bayes, random decision forest, etc. (Athey abstract, [0069], [0095], [0140], [0203]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the mathematical scoring models of the combination to include supervised machine learning algorithms such as those disclosed by Athey in order to utilize machine learning techniques so that the models are trained to adapt to changes in patient data over time, thereby improving performance of the models over non-learning models (as suggested by Athey [0005]).
Claim 74
Moore in view of Vaughn teaches the method of claim 72, but the combination fails to explicitly disclose wherein said trained algorithm comprises an unsupervised machine learning algorithm, and wherein said unsupervised machine learning algorithm comprises a k-means clustering model or principal component analysis. However, Athey teaches that a model for generating health-based phenotype predictions using genetic and environmental data of a user can include an unsupervised machine learning algorithm such as k-means clustering or principal component analysis (Athey abstract, [0069], [0095], [0203]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the mathematical scoring models of the combination to include unsupervised machine learning algorithms such as those disclosed by Athey in order to utilize machine learning techniques so that the models are trained to adapt to changes in patient data over time, thereby improving performance of the models over non-learning models (as suggested by Athey [0005]).
Claims 84-85 are rejected under 35 U.S.C. 103 as being unpatentable over Moore and Vaughn as applied to claim 56 above, and further in view of Rose et al. (US 20210050086 A1).
Claim 84
Moore in view of Vaughn teaches the method of claim 56, but the combination fails to explicitly disclose wherein the polygenic risk scores are based on a power pathway. However, Rose teaches an analogous method of calculating a polygenic pathway score for a trait such as susceptibility to injury by using genetic and environmental data of a user (Rose [0067], [0071]-[0073], [0139]-[0140], [0161], noting genetic and environmental data are analyzed to calculate trait scores for each trait, which can include susceptibility to injury as in [0161], analogous to the connective tissue injury risk evaluation of the combination), wherein the polygenic risk scores are based on a power pathway (Rose [0362], [0380]-[0383], noting genetic and environmental factors indicative of a user’s power capacity are considered when generating the trait profile scores). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the calculation of polygenic risk scores as in the combination to further be based on a power pathway as in Rose in order to incorporate the user’s personalized genetic and environmental indicators of muscle power which are known to influence wellness traits like susceptibility to injury (as suggested by Rose [0161] & [0381]-[0383]) so that improved and more accurate estimations of the user’s susceptibility to connective tissue injuries may be calculated.
Claim 85
Moore in view of Vaughn teaches the method of claim 56, and the combination further contemplates consideration of endurance (Moore [0053], noting phenotypes consideration of stamina and endurance as phenotypes). However, the present combination fails to explicitly disclose wherein the polygenic risk scores are based on an endurance pathway. However, Rose teaches an analogous method of calculating a polygenic pathway score for a trait such as susceptibility to injury by using genetic and environmental data of a user (Rose [0067], [0071]-[0073], [0139]-[0140], [0161], noting genetic and environmental data are analyzed to calculate trait scores for each trait, which can include susceptibility to injury as in [0161], analogous to the connective tissue injury risk evaluation of the combination), wherein the polygenic risk scores are based on an endurance pathway (Rose [0362], [0384]-[0387], noting genetic and environmental factors indicative of a user’s endurance capacity are considered when generating the trait profile scores). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the calculation of polygenic risk scores as in the combination to further be based on an endurance pathway as in Rose in order to incorporate the user’s personalized genetic and environmental indicators of muscle endurance which are known to influence wellness traits like susceptibility to injury (as suggested by Rose [0161] & [0381]-[0383]) so that improved and more accurate estimations of the user’s susceptibility to connective tissue injuries may be calculated.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sellers, II et al. (US 20060247503 A1), Kovach (US 20130080182 A1), Turner (US 9269278 B1), Giordano et al. (US 20220205040 A1) describe systems and methods for determining the probability or risk of an injury to a person based on genetic and/or environmental factors.
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 KAREN A HRANEK whose telephone number is (571)272-1679. The examiner can normally be reached M-F 8:00-4:00 ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shahid Merchant can be reached at 571-270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KAREN A HRANEK/ Primary Examiner, Art Unit 3684