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 .
DETAILED ACTION
Response to Amendment
In the amendment dated 05/29/2026, the following occurred: Claims 1, 3, 6, 8, 10, 12, 14 and 19 have been amended. Claims 2, 4, 5, 7, 9, 11, 13, 15-18 and 20 have been canceled.
Claims 1, 3, 6, 8, 10, 12, 14 and 19 are currently pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 3, 6, 8, 10, 12, 14 and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1 and 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claim recites a system and a method for managing oral health data, which are within a statutory category.
Step 2A1
Regarding claims 1 and 12, the limitation of (claim 1 being representative) receive oral health data of one or more users associated with one or more dental activities performed using a saliva testing kit; generate brushing data including brushing habits of the one or more users; generate, by the saliva testing kit, saliva data including pathogenic-bacteria information or oral-health-risk information; generate plaque scoring data indicating the effectiveness of a brushing technique of the one or more users; analyze the brushing data, the saliva data and the plaque scoring data to generate a custom dental health score for each of the one or more users; determine a schedule for one or more hygiene appointments based on the custom dental health score; obtain during the one or more hygiene appointments, clinical-grade data of the one or more users, wherein the clinical-grade data comprises at least one of intraoral radiographs, cone beam computed tomography (CBCT) scans, and three-dimensional (3D) intraoral scans; store the oral health data, the clinical-grade data, and the custom dental health score as time-stamped data records, encrypted, secured, and tamper-proof and that provides hierarchical levels of access to the time-stamped data records; provide access and store subscriber data and allow the one or more users to control, manage, and share the oral health data and the clinical-grade data; display oral health progress and compliance history of the one or more users; restrict access to the oral health data, the clinical-grade data, and the custom dental health score using private keys so that only authorized users or authorized personnel are permitted to view or modify the time-stamped data records; and validate authenticity and integrity of the oral health data, the clinical-grade data, or the custom dental health score using public keys without compromising privacy of the one or more users as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for the recitation of generic computer components. . The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to receive oral health data, generate brushing data, generate saliva data, generate plaque scoring data, analyze the data to generate a custom dental health score, determine a schedule for one or more hygiene appointments, obtain clinical-grade data, store the data as time-stamped data records, provide access and store subscriber data and allow the one or more users to control, manage, and share the data, display oral health progress and compliance history, restrict access to the data and the custom dental health score using private keys and validate authenticity and integrity of the data, or the custom dental health score using public keys in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “receive … generate … generate … generate … analyze … determine … obtain … store … provide … display … restrict … and validate authenticity and integrity…” as indicated supra.
Other than reciting generic computer components (discussed infra), i.e., a blockchain based platform, a computing device, a processor, a memory, a server, one or more databases, a network and at least one blockchain enabled database (in claim 1), and a blockchain based platform and at least one blockchain enabled database (in claim 12), the claimed invention amounts to managing personal behavior or interaction between people (i.e., rules or instructions). The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people, but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity – Managing Personal Behavior Relationships, Interactions Between People (e.g. social activities, teaching, following rules or instructions)” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, claim 1 recites the additional elements of a blockchain based platform, a computing device, a processor, a memory, a server, one or more databases, a network and at least one blockchain enabled database. Claim 12 recites the additional element of a blockchain based platform and at least one blockchain enabled database. These additional elements are not exclusively defined by the applicant and are recited at a high-level of generality (i.e., a generic server or generic computer component for enabling access to medical information or for performing generic computer functions. See Spec. at para. [0032] and [0033] that teach this additional elements as being generic.) such that they amounts to no more than mere instructions to apply the exception using a generic computer component. As set forth in MPEP 2106.04(d) “merely including 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, even 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.
Claims 1 and 12 further recite the additional elements of a data collection module, a clinical data collection module, one or more dental devices comprising a smart toothbrush attachment and a plague scoring unit, a subscriber-controlled digital wallet and a visualization dashboard. These additional element generally linking the abstract idea to a practical technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Also, claims 1 and 12 further recite the additional element of an artificial intelligence (AI) module to generate a health score and equates to saying “apply it.” MPEP 2106.04(d)(I) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide a practical application. Accordingly, even in combination, this additional element does not integrate the abstract idea into a practical application.
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 of a blockchain based platform, a computing device, a processor, a memory, a server, one or more databases, a network and at least one blockchain enabled database to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”). Moreover, using generic computer components to perform abstract ideas does not provide a necessary 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”). Therefore, whether considered alone or in combination, these additional elements do not amount to significantly more than the abstract idea.
Also as discussed with respect to integration of the abstract idea into a practical application, the additional elements of the data collection module, a clinical data collection module, one or more dental devices comprising a smart toothbrush attachment and a plague scoring unit, a subscriber-controlled digital wallet and a visualization dashboard were considered to generally linking the abstract idea to a practical technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. Accordingly, even in combination, these additional elements do not provide significantly more. As such the claim is not patent eligible.
Also as discussed with respect to integration of the abstract idea into a practical application, the additional element of an artificial intelligence (AI) module to generate a health score was determined to be “apply it.” This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP2106.05(I)(A) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide an inventive concept (“significantly more”). Accordingly, even in combination, this additional element does not provide significantly more. As such the claim is not patent eligible.
The examiner notes that: A well-known, general-purpose computer has been determined by the courts to be a well-understood, routine and conventional element (see, e.g., Alice Corp. v. CLS Bank; see also MPEP 2106.05(d)); MPEP 2016.05(d)(II) indicates that receiving and/or transmitting data over a network has been held by the courts to be well-understood, routine, conventional activity (citing Symantec, TLI Communications, OIP Techs., and buySAFE). and Performing repetitive calculations is/are also well-understood, routine and conventional computer functions when they are claimed in a merely generic manner (see, e.g., Parker v. Flook; MPEP 2016.05(d)).
Claims 3, 6, 8, 10, 14 and 19 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination. Claim(s) 3 and 14 further merely describe(s) the brushing data, the saliva data and the plaque scoring data. Claim(s) 6 and 19 further merely describe(s) a reward module configured to generate one or more tokens based on compliance with dental plan and enable trading of the one or more tokens. Claims 6 and 19 further recites the additional element of a reward module which is interpreted as “apply it” to the abstract idea and does not provide practical application or significantly more. MPEP 2106.04(d)(I) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide a practical application and MPEP2106.05(I)(A) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide an inventive concept (“significantly more”). Claim(s) 8 further merely describe(s) the server is configured to execute gamified compliance programs awarding the one or more tokens to the one or more users for maintaining healthy dental metrics. Claim(s) 10 further merely describe(s) the one or more tokens are configured to be used for discounts on dental care and related products. Claims 3, 6, 8, 10, 14 and 19 further define the abstract idea and are rejected for the same reason presented above with respect to claims 1 and 12.
Subject Matter Free of Prior Art
The cited prior art of record fails to expressly teach or suggest, either alone or in combination, the features found within claims 1, 3, 6, 8, 10, 12, 14 and 19. In particular, the cited prior art of record fails to expressly teach or suggest the combination of: each of the following conditions, using the corresponding method: a system for securely managing oral health data on a blockchain-based platform, comprising: a computing device having a processor and a memory for storing one or more instructions executable by the processor, wherein the computing device is in communication with a server and one or more databases via a network, wherein the one or more instructions, when executed by the processor, cause the processor to: receive, by a data collection module, oral health data of one or more users associated with one or more dental activities performed using one or more dental devices, wherein the one or more dental devices comprises a smart toothbrush attachment, a saliva testing kit and a plague scoring unit; generate, by the smart toothbrush attachment, brushing data including brushing habits of the one or more users; generate, by the saliva testing kit, saliva data including pathogenic-bacteria information or oral-health-risk information: generate, by the plaque scoring unit, plaque scoring data indicating effectiveness of a brushing technique of the one or more users; analyze, by an artificial intelligence (AI) module, the brushing data, the saliva data, and the plaque scoring data to generate a custom dental health score for each of the one or more users the oral health; determine, by the AI module, a schedule for one or more hygiene appointments based on the custom dental health score; Obtain, by a clinical data collection module during one or more hygiene appointments, clinical-grade data of the one or more users, wherein the clinical-grade data comprises at least one of intraoral radiographs, cone beam computed tomography (CBCT) scans, and three-dimensional (3D) intraoral scans; store the oral health data, the clinical grade data, and the custom dental health score as time-stamped data records in the one or more databases, wherein the one or more databases comprise at least one blockchain-enabled database that is encrypted, secured, and tamper-proof and that provides hierarchical levels of access to the time-stamped data records; provide access to the one or more databases through a subscriber-controlled digital wallet configured to store subscriber data and allow the one or more users to control, manage, and share the oral health data and the clinical-grade data; display, through a visualization dashboard integrated with the subscriber-controlled digital wallet, oral health progress and compliance history of the one or more users; restrict access to the oral health data, the clinical-grade data, and the custom dental health score using private keys so that only authorized users or authorized personnel are permitted to view or modify the time-stamped data records; and validate authenticity and integrity of the oral health data, the clinical-grade data, or the custom dental health score using public keys without compromising privacy of the one or more users. The system for securely managing the oral health data of claim 1, wherein brushing data includes brushing frequency, the saliva data includes microbiome results or indicators of pathogenic bacteria or oral health risks, and the plaque scoring data includes plaque scores indicating plaque levels or brushing-technique effectiveness. The system for securely managing the oral health data of claim 1, further comprising a reward module configured to generate one or more tokens based on compliance with the dental plan, and enable trading of the one or more tokens on a cryptocurrency exchange, providing liquidity to the one or more users. The system for securely managing the oral health data of claim 1, wherein the server is configured to execute gamified compliance programs, awarding the one or more tokens to the one or more users for maintaining healthy dental metrics. The system for securely managing the oral health data of claim 1, wherein the one or more tokens are configured to be used for discounts on dental care and related products within the blockchain-based platform.
Response to Arguments
Rejection under 35 U.S.C. § 101
Regarding the rejection of claims 1, 3, 6, 8, 10, 12, 14 and 19, the Examiner has considered the Applicant’s arguments, but does not find them persuasive. Applicant argues:
The Office Action characterized the claims as directed to organizing human activity. This characterization is incorrect. The claims do not recite a fundamental economic practice, method of organizing human activity, or mental process that can be performed by humans alone.
Regarding 1, The Examiner respectfully disagrees. The claims under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for the recitation of generic computer components. . The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to receive oral health data, generate brushing data, generate saliva data, generate plaque scoring data, analyze the data to generate a custom dental health score, determine a schedule for one or more hygiene appointments, obtain clinical-grade data, store the data as time-stamped data records, provide access and store subscriber data and allow the one or more users to control, manage, and share the data, display oral health progress and compliance history, restrict access to the data and the custom dental health score using private keys and validate authenticity and integrity of the data, or the custom dental health score using public keys in the manner described in the identified abstract idea, supra.
The claimed invention solves this computer-centric technical problem through a specific technical architecture that: (1) Integrates three distinct sensing devices (smart toothbrush attachment, saliva testing kit, plaque scoring unit), each performing hardware-level data capture operations that generate structured data streams of different types (brushing data, pathogenic-bacteria information, plaque scoring data). (2) Performs automated Al-driven multi-factor analysis of the three data types to compute a dental health score, which then serves as a control input to automatically determine an appointment schedule. This creates a closed-loop system where the computed score automatically configures downstream clinical data collection timing, replacing manual scheduling with algorithmic determination based on individualized risk assessment. (3) Obtains clinical-grade imaging data (intraoral radiographs, CBCT scans, or 3D intraoral scans) during the Al-scheduled appointments… (4) Stores all data as time-stamped records in a blockchain-enabled database that is encrypted, secured, tamper-proof, and provides hierarchical levels of access. This is not generic data storage; it is a specific cryptographic data structure that creates immutable audit trails while enabling differential access control. (5) Implements dual-key cryptographic access control: private keys restrict record access to authorized subscribers or authorized personnel (solving the access control problem), while public keys enable external validation of record authenticity and integrity without exposing underlying data (solving the validation-without-exposure problem). (6) Provides subscriber-controlled access through a digital wallet with integrated visualization dashboard, enabling subscribers to control, manage, and share their data while viewing their oral health progress and compliance history. None of these operations can be performed through human activity alone… Importantly, the claims do not merely apply generic blockchain, AI, and cryptography to the field of dentistry. They recite a specific ordered combination that solves a specific technical problem in distributed health data systems: how to enable external validation of data authenticity while preserving privacy and enabling subscriber-controlled access. This technical problem did not exist before electronic health records, and the solution requires specific technical architecture.
Regarding 2, The Examiner respectfully disagrees. A human can follow a set of rules or instructions with or without the aid of a computer to perform said functions above. Moreover, the smart toothbrush attachment, saliva testing kit, plaque scoring unit were analyze as additional elements generally linking the abstract idea to a technological environment. They are nor more than tools used to gather information, which is an abstract idea. Also, the artificial intelligence (AI) module to generate a health score was interpreted as an additional element and equates to saying “apply it.” This is the application of mathematics to generate/output data (score), which is an abstract idea. Obtaining and storing data is also an abstract idea. Moreover, the use of blockchain, private and public keys to control access and share data is also an additional elements that merely generally links the abstract idea to a technological environment or field of use and this cannot provide practical application/technical improvements. Whether considering these additional elements alone or in combination, they do not remove the claim from being directed to an abstract idea. Applicants specification does not support technical improvements. The specification at para. [0002] states improvements in access to personalized care and at para. [0048] states improvements in the overall patient experience.
The claimed system provides a specific technological improvement in how distributed health data systems authenticate data integrity while preserving privacy. The technical advancement is the dual-key cryptographic architecture combined with blockchain-enabled hierarchical access control… This combination solves a specific technical problem in distributed health data architectures that prior art systems could not solve: enabling external parties to validate data authenticity without accessing the underlying private health information… Here, the claims produce a new cryptographic data structure (blockchain-enabled, time-stamped, hierarchically accessible dental records with dual-key access control) that enables a new technical function (external validation without privacy compromise)
Regarding 3, The Examiner respectfully disagrees. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application. The claims leverage generic cryptographic techniques to safeguard data. There are no technical improvements to the technology that is used in the claim.
Under Berkheimer V. HP Inc., 881 F.3d 1360, 1368 (Fed. Cir. 2018), whether claim elements or combinations thereof are well-understood, routine, or conventional is a question of fact. The Office Action contains no factual findings or evidentiary support for the proposition that the claimed combination is well-understood, routine, or conventional.
Regarding 4, The Examiner respectfully submits that the additional elements are either recited to generally link the abstract idea to a technological environment or field of use or as “apply it”. that MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more and MPEP2106.05(I)(A) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide an inventive concept (“significantly more”).
Enfish, LLC V. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016): Claims to a self-referential database structure that improved computer functionality were patent-eligible as directed to an improvement in computer technology, not an abstract idea. The present claims similarly recite a specific data architecture (blockchain-enabled, encrypted, tamper-proof, time-stamped, hierarchically accessible records with dual-key access control) that improves how distributed health data systems authenticate data while preserving privacy. Finjan, Inc. V. Blue Coat Systems, Inc., 879 F.3d 1299 (Fed. Cir. 2018): Claims to virus scanning using behavior-based profiles were patent-eligible because they produced a new data structure enabling a new technical function. The present claims produce a new cryptographic data structure (dual-key controlled blockchain records) enabling a new technical function (external validation without privacy exposure). DDR Holdings, LLC V. Hotels.com, L.P., 773 F.3d 1245 (Fed. Cir. 2014): Claims solving a technology-specific problem (retaining website visitors while displaying third- party content) with a particular technical solution were patent-eligible. The present claims solve a technology-specific problem (authenticating distributed health data while preserving privacy) with a particular technical solution (dual-key blockchain architecture). BASCOM Global Internet Services, Inc. V. AT&T Mobility LLC, 827 F.3d 1341 (Fed. Cir. 2016): An inventive concept can be found in the non-conventional and non-generic arrangement of known elements. The present claims arrange sensing devices, AI processing, clinical imaging, blockchain storage, and cryptographic access control in a specific technical pipeline that creates new functionality through component interplay. McRO, Inc. V. Bandai Namco Games Am. Inc., 837 F.3d 1299 (Fed. Cir. 2016): Claims to a specific technological process that improved computer animation were patent-eligible because they automated a previously manual process through a specific implementation. The present claims automate appointment scheduling through Al-driven score computation, replacing manual scheduling with algorithmic determination based on multi-factor risk assessment.
Regarding 4, The Examiner respectfully disagrees. The claims are unlike that of Enfish, LLC V. Microsoft Corp., Finjan, Inc. V. Blue Coat Systems, Inc., DDR holdings, BASCOM Global Internet Services, Inc. and McRO, Inc. V. Bandai Namco Games Am. Inc. As explained above the claims do not provide a technical solution to a technical problem. The claims merely recite system and method for managing healthcare data. And the additional elements recited in the claim do not integrate the abstract idea into a practical application nor provide significantly more.
Rejection under 35 U.S.C. § 103
Regarding the rejection of claims 1, 3, 6, 8, 10, 12, 14 and 19, the Examiner has considered the Applicant’s arguments, and finds them persuasive.
Conclusion
Applicant’s amendment necessitated the new grounds of rejection presented in this Office action. THIS ACTION IS MADE FINAL. See MPEP §706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
The prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Lecharny (US 2003/0049210) discloses oral composition. Smitherman (US 2006/0129435) discloses system and method for providing community health data services. Ferguson (US 2009/0326984) discloses apparatus and method for improved oral healthcare.
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/L.T.K./Examiner, Art Unit 3683
/ROBERT W MORGAN/Supervisory Patent Examiner, Art Unit 3683
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