DETAILED ACTION
This office action is based on the claim set filed on 02/12/2025.
Claims 1-4 are currently pending and have been examined.
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 .
Claim Objections
Claim 1 is objected to due to the following informalities:
Claim 1 recited “providing a checklist or digital display tracking and recording on digital storage media the subject's progress along the paths, ...”, however the specification ([0216], [0235]) describes checkboxes but does not describe a checklist for tracking and recording the subject progress along the paths. Appropriate correction is needed.
Claim Rejections - 35 USC § 112(a)
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.
Claim(s) 1 and 4 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
In order to satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See MPEP 2161.01(1). However, generic claim language in the original disclosure does not satisfy the written description requirement if it fails to support the scope of the genus claimed, and even original claims may fail to satisfy the written description requirement when the invention is claimed and described in functional language but the specification does not sufficiently identify how the invention achieves the claimed function, See MPEP 2161.01(1) citing in part Ariad, 598 F.3d at 1349 ("[A]n adequate written description of a claimed genus requires more than a generic statement of an invention's boundaries.").
Specifically, with regard to computer-implemented functional claims, the specification must provide a disclosure of the computer and the algorithm in sufficient detail to demonstrate to one of ordinary skill in the art that the inventor possessed the invention, including how to program the disclosed computer to perform the claimed function. MPEP 2161.01(1).
Claim 1, recites “performing a real time periodontal analysis and dental diagnosis, …”, and Claim 4 recites “stored results from dental diagnostic tests and a real time current periodontal analysis” for which the subject matter of the limitation 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, at the time the application was filed, had possession of the claimed invention. As best understood, it appears that there is no support for the underlined recitation in the original disclosure of the present application for this limitation. As described in applicant’s specification [0140], the description discloses “the device further comprises environmental information stored in the data store, the environmental information based on an actual real-time user environment”, and [0201] discloses “the user may enter current, real time weight and height data, medical testing results (e.g., blood work, genetics), current medications (prescription and/or over-the-counter) and their respective amounts and dosages, current dental status and conditions, current oral care products and habits (e.g., kinds of toothpaste and/or rinses, frequency of brushing, flossing, use of air flosser, use of perio protect trays, etc.), current use of vitamin and minerals supplements and probiotics, current habits (smoking packs per day, drug use, alcohol drinks per week and what kind), and/or family history into the user's computer or smartphone”. There is not explicit disclosure as filed describing the feature “a real time periodontal analysis” as claimed.
The examiner takes the position that with respect to these limitations or features of the claims, the specification fails to provide an adequate written description of the invention to an extent that would sufficiently show that applicant was in possession of an invention that could operate as claimed. Simply disclosing a vague description, without actually explaining how to perform the function(s) claimed, results in a written description problem under 112(a). The examiner has no idea how applicant actually contemplated doing these steps because nothing is disclosed other than the broad disclosure of the specification as mentioned above.
Therefore, applicant has failed to show the actual subject matter in their possession at the time of the invention in a way sufficient to reasonably convey to one skilled in the relevant art that applicant had possession of the claimed invention at the time the application was filed. Therefore, these limitations of the claims are considered to be new matter. Appropriate correction is required.
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.
Claim 1-4 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 1-2 are drawn to a method and Claims 3-4 are directed to a system, and each of which is within the four statutory categories (i.e., a machine and a process). Claims 1-4 are further directed to an abstract idea on the grounds set out in detail below.
Under Step 2A, Prong 1, the steps of the claim for the invention represents an abstract idea of a series of steps that recite a process for analyzing a subject health data, provide and monitor treatment plan to improve subject’s health. Collecting dental, medical and genetic records to be analyzed are steps that could have been performed by a human performing the steps following instruction to collect and analyze subject data to provide a treatment plan but for the fact that the claims recite a general-purpose computer processor to implement the abstract idea for which both the instant claims and the abstract idea are defined as Methods of Organizing Human Activity.
Independent Claim 1 recites the steps of:
“(i) obtaining dental, medical and genetic records from the subject;
(ii) performing a real time periodontal analysis and dental diagnosis, and taking an oral sample from the subject;
(iii) assaying the oral sample for indication of:(a) pathogenic microorganisms;(b) endogenous genetic biomarkers of inflammation or disease; and/or (c) specific hormones or lipids;
(iv) using a computer program to compare the dental, medical and genetic records of (i), the real time periodontal analysis and dental diagnosis of (ii), and the results of the assay of (iii) to a reference set of ideal wellness target endpoints and to generate an initial untreated digital landscape of data points;
(v) based on the comparison, computing paths according to a minimum step criterion, each path beginning a data point in the initial untreated digital landscape and ending at corresponding ideal wellness target endpoint;
(vi) quantifying the distance of each path and dividing it into intermediate steps for the patient to take in order to progress toward the ideal wellness endpoint;
(vii) transferring the computed paths as a treatment plan to a user interface for the subject to follow to achieve improved global wellness; and
(viii) optionally, providing a checklist or digital display tracking and recording on digital storage media the subject's progress along the paths; wherein, when the subject follows the treatment plan, the subject progresses toward the ideal wellness target endpoints and the method thereby treats and improves global wellness in the subject”.
Independent Claim 3 recites the steps of:
“(i) a computer-readable storage medium comprising recorded medical and dental history data points from the subject;
(ii) a sample-collection and measuring apparatus for obtaining an oral sample from the subject, comprising a plurality of analyte detection regions in direct or indirect fluid communication with said sample-collection and measuring apparatus, wherein the analyte detection regions test for the presence of and measure current levels of: (a) proteins and nucleic acids from bacteria, viruses or other pathogens; and (b) endogenous genetic biomarkers of inflammation, infection, and autoimmune disease; and/or (c) specific hormones or lipids;
(iii) results from a current periodontal analysis;
(iv) a computer program that compares the medical and dental history data points of (i), the current levels from the analyte detection regions of (ii), and the results from the current periodontal analysis of (iii) to a reference set of desired health and wellness goals, identifies oral-systemic links, generates an initial digital wellness landscape and a restored wellness landscape, and calculates, in silico, a plan comprising a series of behavioral steps according to a minimum step criterion, such that, when the behavioral steps are performed by the subject, the subject is treated and improves in global systemic wellness”
Independent Claim 4 recites the steps of:
“(i) a computer-readable storage medium comprising stored medical and dental history from a subject and stored results from dental diagnostic tests and a real time current periodontal analysis;
(ii) a database comprising a reference set of target indices representing ideal dental and medical health and wellness endpoints in a computer-readable storage medium;
(iii) a sample-collection component for obtaining an oral sample from the subject, and testing for: (a) pathogenic microorganisms;(b) endogenous genetic and polypeptide biomarkers indicative or predictive of disease or inflammation; and/or (c) levels of specific hormones or lipids; and
(iv) a receiver of inputted data from (iii)(a)-(c) for execution of a computer program for:
identifying an oral-systemic link between at least one indicator of disease in the oral cavity and at least one pathogen, biomarker, hormone or lipid level tested in (iii)(a)-(c);
generating an initial digital wellness landscape and a restored digital wellness landscape, and optionally, an intermediate digital wellness landscape;
aligning the initial digital wellness landscape with the restored digital wellness landscape and optional intermediate digital wellness landscape, and simulating a movement path between them; and
computing, according to a minimum step criterion, a treatment plan of steps to move the subject from an initial state to a restored state of wellness”.
These limitations, as drafted, given the broadest reasonable interpretation, cover performance of the limitations by a human user/actor interacting with a computing system and apparatus that constitute Certain Methods of Organizing Human activity (following instructions to determine recommended treatment) along with Mental Process/Mathematical concepts, but for the recitation of generic computer components. The limitations encompass a user the ability to collect a subject dental, medical and genetic records, analyzing the data and compare it against a reference to identify oral link to a systemic condition and provide a treatment plan, which are steps that could be performed by a human actor interacting with other user(s) and/or a machine as such identifying an abstract idea. This abstract idea could have been performed by a human actor but for the fact that the claims recite a general-purpose computer processor to implement the abstract idea for generating a treatment plan to improve health of a subject. If a claim limitation(s), under its broadest reasonable interpretation, covers performance of the limitation(s) by a human actor but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” (following instructions to determine recommended treatment), grouping of abstract ideas. Accordingly, the claim limitations (in BOLD) recite an abstract idea. Any limitations not identified above as part of methods of organizing human activity are deemed "additional elements," and will be discussed in further detail below.
Under Step 2A, Prong 2, this judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract ideas, linking the abstract idea to a particular technological environment. In particular, the claims recite the additional elements such as “processor, digital storage media, computer-readable storage medium, sample-collection measuring apparatus, component, database, computer program, digital landscape” to perform the noted steps that iteratively takes input data and analyzes said data to determine an output to performing generic computer functions, for determining a recommended treatment such that it amounts no more than adding the words "apply it" (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea, see MPEP 2106.05(f), adding insignificant extra-solution activity to the judicial exception, (i.e. “obtaining an oral sample from the subject, measuring and testing/ assaying for...”), and mere data gathering that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.05(d)-(g). As set forth in the 2019 Eligibility Guidance, 84 Fed. Reg. at 55 "merely include[ing] instructions to implement an abstract idea on a computer" is an example of when an abstract idea has not been integrated into a practical application. Accordingly, looking at the claim as a whole, individually and in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
Under step 2B, the claims do not include additional elements that are sufficient to amount to "significantly more" than the judicial exception because as mentioned above, the additional elements amount to no more than generic computing components, recited at a high level of generality, do not present improvements to another technology or technical field, nor do they affect an improvement to the functioning of the computer itself, that amount to no more than mere instruction to perform the abstract idea such that it amounts no more than adding the words "apply it" (or an equivalent) to apply the exception using generic computer component, see MPEP 2106.05(f) and adding insignificant extra-solution activity to the judicial exception, (i.e., “obtaining an oral sample from the subject, measuring and testing/ assaying for...”), and mere data gathering that does not add a meaningful limitation to the above abstract idea, see MPEP 2106.05(d)-(g) and Exergen Corp.; Sequenom, 788 F.3d at 1377-78, 115 USPQ2d at 1157); and Cleveland Clinic Foundation 859 F.3d at 1362, 123 USPQ2d at 1088. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and mere instructions to apply an exception using a generic computer component cannot provide an inventive concept, See Alice, 573 U.S. at 223 ("mere recitation of a generic computer cannot transform a patent-ineligible abstract idea into a patent-eligible invention."). The claims as a whole are therefore directed to an abstract idea and are not patent eligible.
Dependent Claim 2 include all of the limitations of claim(s) 1, and therefore likewise incorporate the above-described abstract idea. While the depending claims add additional limitations, such as
As for claims 2, the claim(s) recite limitations that are under the broadest reasonable interpretation, further define the abstract idea noted in the independent claim(s) that covers a performing the steps by a human actor arranging/organizing patient data, which is a certain methods of organizing human activity along with mathematical concepts, but for, the recitation of the generic computer components which are similarly rejected because, neither of the claims, further, defined the abstract idea and do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept ("significantly more").
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Gizewski (US 20080162352 A1) in view of Denny et al. (US 2003/0040009 A1 – “Denny”)
Regarding Claim 1, Gizewski teaches a method for treating and improving global wellness in a subject (Gizewski: [Abs]; Disclosed is a health maintenance system for comprehensive health assessment, abnormality detection, health monitoring, health pattern and trend detection, health strategy development, and health history archiving, [0041]; determine the effectiveness and adequacy, of the health maintenance system 100, and to make continuous improvements), comprising the steps of:
(i) obtaining dental, medical and genetic records from the subject Gizewski disclosing a personal data acquisition unit (PDAU) and collection of the subject history data and that includes medical, physiological, physical characteristics (e.g., teeth and gum condition), stored at a combined database (Gizewski: [Fig. 1], [0042], [0058], [0112], [0202])
(iv) using a computer program to compare the dental, medical and genetic records of (i), the real time periodontal analysis and dental diagnosis of (ii), and the results of the assay of (iii) to a reference set of ideal wellness target endpoints and to generate an initial untreated digital landscape of data points; Gizewski discloses using the analysis and history data collected to compare the subscriber's current health characteristics against their historical characteristics in order to detect changes and compare to different references such as history, medical research, group of patients, scientific and medical knowledge, authoritative standards and comparative assessments, to similar population groups normal criteria to calculate the statistical probability that a situation or condition will improve, degrade, or remain static and generate a wellness or treatment strategies in order to achieve final objective(s) (Gizewski: [0118], [0122], [0131], [0237]; [claim 77]),
(v) based on the comparison, computing paths according to a minimum step criterion, each path beginning a data point in the initial untreated digital landscape and ending at corresponding ideal wellness target endpoint Gizewski discloses defining the pattern of the current patient status and the expected results being measured at different steps that beings at initial phase to end phase tailoring a user health wellness program using the current patient status and the expected results which are being measured at different steps that beings at initial phase, multiple intermediate phases, and end phase and considering the different elements such as historical recovery rate used in combination with references and other factors in determining minimum steps (Gizewski: [0112], [0131], [0189], [0231], [0237])
(vi) quantifying the distance of each path and dividing it into intermediate steps for the patient to take in order to progress toward the ideal wellness endpoint; Gizewski discloses implementing and monitoring special wellness programs that is/are divided into segments or phases which include the program initiation phase, several intermediate progress assessment phases, and a program termination phase (Gizewski: [0189], [0231], [0237])
(vii) transferring the computed paths as a treatment plan to a user interface for the subject to follow to achieve improved global wellness; Gizewski discloses the (PDAU) comprises a test interface module and facilitates subscriber interface and control and display module (CDM) for displaying changes in condition, direction of change and rate of change where the probable values are recorded and subjected to various types of analysis and tracking and prompting to the subscriber and/or the physician (Gizewski: [Fig. 3], [0043], [0067], [0094], [0156], [0159])
(viii) optionally, providing a checklist or digital display tracking and recording on digital storage media the subject's progress along the paths; wherein, when the subject follows the treatment plan, the subject progresses toward the ideal wellness target endpoints and the method thereby treats and improves global wellness in the subject Gizewski discloses a patterns trends and abnormality detection module (PTADM) that may incorporate several sets of three similar straight-forward questions into various segments of the data acquisition process presented over a relatively short period of time where the subscriber input surveillance and data-acquisition
activities used to systematically collect subscriber data pertaining to the behavioral, psychological, and other information, wherein prescribing a health product/service to the subscriber and treatment strategy that is based on recommendation and measuring the subscriber history and adherence to follow orders and instructions will determine the success probabilities of the treatment plan as such customizing at least one health product for the subscriber and monitor and track the treatment effectiveness of a prescribed treatment or the progression toward a goal or objective and determine whether adequate progress being made or adjustments or modifications is/are needed that would further enhance the subscriber's probability of success (Gizewski: [0013], [0069], [0104], [0123], [0150], [0233], [0241], [0234], [claim 62]).
Gizewski discloses analyzing a saliva (oral cavity sample) using analyzer (Gizewski: [0093], [claim 21]), however, Gizewski does not expressly disclose:
performing a real time periodontal analysis and dental diagnosis, and taking an oral sample from the subject
assaying the oral sample for indication of:(a) pathogenic microorganisms;(b) endogenous genetic biomarkers of inflammation or disease; and/or (c) specific hormones or lipids;
Denny teaches
(ii) performing a real time periodontal analysis and dental diagnosis, and taking an oral sample from the subject Denny discloses a diagnostic kit for obtaining patient oral sample and measuring the amount of component(s) in the sample for analyzing and assessing a subject target condition (Denny: [0063], [0069], [0116], [0143], [0168], [claim 3])
(iii) assaying the oral sample for indication of:(a) pathogenic microorganisms;(b) endogenous genetic biomarkers of inflammation or disease; and/or (c) specific hormones or lipids; (Denny: [0035], [0055-0057], [0070-0071], [0091-0092], [0109], [0111-0112], [0120], [0145], [0155], [0165])
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the system of the combination of Gizewski for identifying treatment for improving a subject wellness to incorporate the sample collection and compare it, as taught by Denny to prevent treatment complication and cost (Denny: [0130]).
Regarding Claim 2, the combination of Gizewski and Denny teaches the method of claim 1, further comprising repeating one or more of steps (ii)-(viii) and recalculating the computed paths in the treatment plan based on the subject's achieved intermediate stepped results
Examiner interprets interpret repeating the steps (ii)-(viii) as disclosed in claim 1 which are disclosed by the combination as such the motivations to combine the above-mentioned references are discussed in the rejection of claim 1, and incorporated herein.
Gizewski calculate probability of success (condition will improve) or failure of the program based on evaluating the steps taken by the individual and may continuously assess this feedback and may introduce product modifications or updates that further enhance product effectiveness whereas computing each of the intermediate progress assessment phases data through different decision-gates that lead down different paths culminating in a highly personalized special diet solution that flexes as changes or unanticipated situations occur as such each progress is audited to achieve the prescribed objective and tailor the treatment (Gizewski: [0065], [0116], [0131], [0141], [0189], [0230-0233]).
Claim 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Lindskog et al. (US 2012/0116799 Al – “Lindskog”) in view of Gizewski (US 20080162352 A1) in view of Denny et al. (US 2003/0040009 A1 – “Denny”)
Regarding Claim 3, Lindskog teaches a system for identifying an oral-systemic link and improving global systemic wellness in a subject Lindskog discloses a system for assessing risk of developing periodontitis [oral-systemic link] and relation of a systemic disease and periodontal conditions and developing a chronic periodontitis and actions or modifications for controlling condition and reducing impact on periodontitis where efficient preventive measures may be taken compared to only knowing the risk level for periodontal disease progression or development for the patient as a whole thus increasing the quality of life for the patient (Lindskog: [Table 1.1], [0045], [0093], [0217]-[0221], [0230]), said system comprising:
(i) a computer-readable storage medium comprising recorded medical and dental history data points from the subject Lindskog discloses a readable storage medium storing a patient health and dental records to include age of the patient in relation to history of periodontitis, history of systemic disease and related diagnoses [history data points], and outcomes from dental/tooth test assessment that includes assessment and progress of periodontitis (Lindskog: [Table 1.3], [0035], [0036], [0058], [0119], [0124]-[0125], [0182], [0192])
(iii) results from a current periodontal analysis (Lindskog discloses using a tool and algorithm providing analysis tool with risk predictors for assessing risk and prognosis of chronic periodontitis the result of saliva sample test [results from dental diagnostics test including...] of the patient to a test with a control patient (patient without a specific disease) or a reference and with oral fluid standard to determine difference between subject test (Lindskog: [Table 2.3], [Fig. 3], [0125], [0181]-[0182], [0250]).
Lindskog does not expressly discloses:
Sample collection apparatus to obtain oral sample comprising plurality of analyte
Compare the data points to a reference.
Generate a wellness plan and calculate steps such as behavioral steps improve wellness.
Denny teaches
(ii) a sample-collection and measuring apparatus for obtaining an oral sample from the subject, comprising a plurality of analyte detection regions in direct or indirect fluid communication with said sample-collection and measuring apparatus, Denny discloses a diagnostic kit for obtaining patient oral sample and measuring the amount of component(s) in the sample for assessing a subject target condition (Denny: [0063], [0069], [0143], [0168], [claim 3])
wherein the analyte detection regions test for the presence of and measure current levels of: (a) proteins and nucleic acids from bacteria, viruses or other pathogens; and (b) endogenous genetic biomarkers of inflammation, infection, and autoimmune disease; and/or (c) specific hormones or lipids; (Denny: [0035], [0055-0057], [0070-0071], [0091-0092], [0109], [0111-0112], [0120], [0145], [0155], [0165])
(iv) a computer program that compares the medical and dental history data points of (i), the current levels from the analyte detection regions of (ii), and the results from the current periodontal analysis of (iii) to a reference set of desired health and wellness goals, identifies oral-systemic links Denny discloses a computer based comprising a biomarker database and a program probability of acquiring the specified biological condition within the specified time period or age interval and diagnostic kit for detecting a disease using the collected sample information and amount of component in the sample and comparing the amount to determine the presence of a target condition such as gingivitis or periodontitis where the comparison is reference to the biomarker database used to compare the collected sample component (e.g., amount of component for the presence of pathogens) to biomarkers of a control patient without the disease and predicting disease associated with oral disease such as periodontal disorders (e.g., cardiovascular disease, respiratory diseases, etc.), diabetes, autoimmune disorders, etc. (Denny: [0064], [0069-0071], [0116], [0134], [0137], [0140], [0168-0169], [0173], [0191-0197], [0261]):
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the system of the combination of Lindskog for identifying periodontal disease and systematic condition to incorporate the sample collection and compare it, as taught by Denny to prevent treatment complication and cost (Denny: [0130]).
Gizewski teaches
generates an initial digital wellness landscape and a restored wellness landscape, and calculates, in silico, a plan comprising a series of behavioral steps according to a minimum step criterion, such that, when the behavioral steps are performed by the subject, the subject is treated and improves in global systemic wellness Gizewski discloses analysis and assessment of data collected to calculate, using central data processing unit (CDPU) [in silico], probability of success (condition will improve) or failure of the program based on evaluating the steps taken by the individual [according to a minimum step criterion] that determines his/her progress to achieve the prescribed objective and tailor the treatment [moving the subject from a systemic diseased state toward a state of restored wellness] (Gizewski: [0069], [0112], [0122]-[0123], [0131], [0184], [0189], [0230], [0233], [0237], [0241], [0247], [claim 60]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have Lindskog association of periodontal disease and a systematic condition and to incorporate the process for using a reference set to compare to a patient health and dental (gum and teeth) data and identifying wellness target and steps to achieve it, as taught by Gizewski which may help establishing intervention strategies that may prevent or mitigate the effects of different conditions (Gizewski: [0130]).
Regarding Claim 4, Lindskog teaches a system for developing a treatment plan to improve systemic disease in a subject Lindskog discloses a system for assessing risk of developing periodontitis [oral-systemic link] and relation of a systemic disease and periodontal conditions and developing a chronic periodontitis and actions or modifications for controlling condition and reducing impact on periodontitis where efficient preventive measures may be taken compared to only knowing the risk level for periodontal disease progression or development for the patient as a whole thus increasing the quality of life for the patient (Lindskog: [Table 1.1], [0036], [0045], [0093], [0141], [0217]-[0221], [0230]), said system comprising:
(i) a computer-readable storage medium comprising stored medical and dental history from a subject and stored results from dental diagnostic tests and a real time current periodontal analysis Lindskog discloses a readable storage medium storing a patient health and dental records to include age of the patient in relation to history of periodontitis, history of systemic disease and related diagnoses [history data points], prognosis of chronic periodontitis the result of saliva sample test [results from dental diagnostics test including...] of the patient to a test with a control patient (patient without a specific disease) or a reference and with oral fluid standard to determine difference between subject test and outcomes from dental/tooth test assessment that includes assessment and progress of periodontitis (Lindskog: [Table 1.3, 2.3], [Fig. 3], [0035-0036], [0058], [0119], [0124-0125], [0141], [0181-0182], [0192], [0250])
(ii) a database comprising a reference set of target indices representing ideal dental and medical health and wellness endpoints in a computer-readable storage medium (Lindskog discloses a database stores the result of saliva sample test [results from dental diagnostics test including...] of the patient to a test with a control patient (patient without a specific disease) or a reference and with oral fluid standard to determine difference between subject test (Lindskog: [Table 1.1, 2.3], [Fig. 3], [0040], [0059], [0092], [0125], [0181]-[0182], [0250]).
Lindskog does not expressly discloses:
Sample collection apparatus to obtain oral sample comprising plurality of analyte
identifying an oral-systemic link between at least one indicator of disease in the oral cavity and at least one pathogen, biomarker, hormone or lipid level tested
generating and aligning an initial digital wellness landscape and a restored digital wellness and calculating treatment plan.
Denny teaches
(iii) a sample-collection component for obtaining an oral sample from the subject, and testing for: (a) pathogenic microorganisms; (b) endogenous genetic and polypeptide biomarkers indicative or predictive of disease or inflammation; and/or (c) levels of specific hormones or lipids; Denny discloses a diagnostic kit for obtaining patient oral sample and measuring the amount of component(s) in the sample for assessing a subject target condition (Denny: [0035], [0055-0057], [0063], [0069], [0143], [0070-0071], [0091-0092], [0109], [0111-0112], [0120], [0145], [0155], [0165], [0168], [claim 3])
(iv) a receiver of inputted data from (iii)(a)-(c) for execution of a computer program for:
identifying an oral-systemic link between at least one indicator of disease in the oral cavity and at least one pathogen, biomarker, hormone or lipid level tested in (iii)(a)-(c) Denny discloses association between tested oral sample and a disease such as link between findings of the tested oral sample and oral cancer (Denny: [0005], [0021], [0042], [0064], [0071], [0101], [0116]),
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the system of the combination of Lindskog for identifying periodontal disease and systematic condition to incorporate the sample collection and compare it, as taught by Denny to prevent treatment complication and cost (Denny: [0130]).
Gizewski teaches
generating an initial digital wellness landscape and a restored digital wellness landscape, and optionally, an intermediate digital wellness landscape Gizewski discloses tailoring a user health wellness program using the current patient status and the expected results which are being measured at different steps that beings at initial phase, multiple intermediate phases, and end phase [restored/ intermediate digital landscape] and implementing and monitoring special wellness programs that is/are divided into segments or phases which include the program initiation phase, several intermediate progress assessment phases, and a program termination phase (Gizewski: [0069] [0112], [0189], [0231]);
aligning the initial digital wellness landscape with the restored digital wellness landscape and optional intermediate digital wellness landscape, and simulating a movement path between them Gizewski discloses implementing and monitoring special wellness programs that is/are divided into segments or phases which include the program initiation phase, several intermediate progress assessment phases, and a program termination phase where an audit progress is performed during each intermediate assessment phase to determine complying with the progress at each phase as such lead to different paths concluding in a highly customized program of the different phases (Gizewski: [0189], [0231], [0242]);
computing, according to a minimum step criterion, a treatment plan of steps to move the subject from an initial state to a restored state of wellness Gizewski discloses analysis and assessment of data collected to calculate probability of success (condition will improve) or failure of the program based on evaluating the steps taken by the individual [according to a minimum step criterion] that determines his/her progress to achieve the prescribed objective and tailor the treatment [move the subject from an initial state to a restored state of wellness] (Gizewski: [0069], [0112], [0122]-[0123], [0131], [0189], [0230], [0233], [0237], [0241], [0247], [claim 60]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have Lindskog association of periodontal disease and a systematic condition and to incorporate the process for using a reference set to compare to a patient health and dental (gum and teeth) data and identifying wellness target and steps to achieve it, as taught by Gizewski which may help establishing intervention strategies that may prevent or mitigate the effects of different conditions (Gizewski: [0130]).
Prior Art Cited but not Applied
The following document(s) were found relevant to the disclosure but not applied:
US 2015/0329908 “Al-Murrani” discloses pattern recognition receptor expression as a measure of systemic health in a subject afflicted with an oral health condition.
US 2002/0004725 “Martin” discloses predicting the likelihood of an entity entering a degraded future state by computing a risk value that reflects that likelihood by evaluation of a function that considers a variety of historic, environmental, and systemic behaviors and conditions.
US 2017/0146532 “SREENIVASAN” discloses determining the presence or severity of oral inflammation, such as gingivitis or periodontitis based on oral sample analysis.
US 2012/0197534 “Kavusi” discloses a portable wellness device including a detector configured to detect at least one biomarker in a biologic sample.
The references are relevant since it discloses analyzing biological sample to determine association with a disease.
Conclusion
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/ALAAELDIN M. ELSHAER/Primary Examiner, Art Unit 3687