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
Claims 1-17 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 1-17 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.
Step 1
Claims 1-17 are within the four statutory categories. Claims 1-8 are drawn to a system for generating an oral care plan, which is within the four statutory categories (i.e. machine). Claims 9-17 are drawn to a method for generating an oral care plan, which is within the four statutory categories (i.e. process).
Prong 1 of Step 2A
Claim 1, which is representative of the inventive concept, recites: A system for enhanced oral health and disease prevention, comprising:
a computing device having a processor and a memory to store one or more instructions executable by said processor,
wherein said computing device is configured to execute a plurality of modules, wherein the plurality of modules includes:
a tooth-brushing data module configured to collect data related to brushing frequency and duration from at least one smart toothbrush used by a user;
an oral microbiome analysis module configured to collect data related to microbiological characteristics and pathogenic bacteria analyzed from a saliva sample of the user;
a plaque assessment module configured to collect data related to plaque scoring generated through a digital application;
a breath analysis module configured to collect data related to oral odor of the user by detecting volatile sulfur compounds (VSCs) and other biomarkers using a breath analyzer;
a data triangulation module configured to gather and process the data from said tooth-brushing data module, oral microbiome analysis module, plaque assessment module, and breath analysis module to generate an oral health scorecard for the user that provides insights into the user's oral health status; and
a preventive care recommendation module configured to generate a personalized oral care plan based on the oral health scorecard of the user, wherein the personalized oral care plan includes a tailored schedule of professional cleaning appointments with dental hygienists, thereby enhancing oral health and disease prevention.
The underlined limitations as shown above recite the abstract idea of a mental process and/or a certain method of organizing human activity because they recite a process that could be practically performed in the human mind (i.e. observations, evaluations, judgments, and/or opinions – in this case, the steps of collecting the brushing data, the microbiological and pathogenic data, the plaque data, and the oral odor data, gathering and processing the collected data to generate an oral health scorecard, and generating an oral care plan based on the oral health scorecard recite observations and evaluations, and/or collecting data, analyzing it, and displaying certain results of the collection and analysis) or using a pen and paper, but for the recitation of generic computer components (i.e. the computing device, the memory, the processor, the various modules, the smart toothbrush, the digital application, the breath analyzer) to perform the mental process, and/or managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions – in this case, the steps of collecting the brushing data, the microbiological and pathogenic data, the plaque data, and the oral odor data, gathering and processing the collected data to generate an oral health scorecard, and generating an oral care plan based on the oral health scorecard recite at following rules or instructions to organize a patient/provider appointment schedule), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements,” and will be discussed in further detail below.
Furthermore, the abstract idea for Claim 9 is identical as the abstract idea for Claim 1, because the only difference between Claims 1 and 9 is that Claim 1 recites a system, whereas Claim 9 recites a method, and Claim 9 does not require that the oral care plan include a tailored schedule of dental cleaning appointments.
Dependent Claims 2-8 and 10-17 include other limitations, for example Claims 2 and 11 recites a particular source for the brushing data, Claims 3 and 12 recite a process for collecting saliva data, Claims 4-5 and 13-14 recite a process for collecting plaque data, Claims 6 and 15 recite monitoring user compliance with the submission of the various types of data, Claims 7 and 16 recite adjusting cost of the care plan based on the compliance, Claims 8 and 17 recite communications between various devices, and Claim 10 recites that the oral care plan include a tailored schedule of dental cleaning appointments, but these only serve to further narrow the abstract idea, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g. see MPEP 2106.04, and/or do not further narrow the abstract idea and instead only recite additional elements, which will be further addressed below. Hence dependent Claims 2-8 and 10-17 nonetheless recite the same abstract idea as independent Claims 1 and 9.
Hence Claims 1-17 recite the aforementioned abstract idea.
Prong 2 of Step 2A
Claims 1 and 9 are not integrated into a practical application because the additional elements (i.e. the non-underlined limitations above – in this case, the computing device including the various modules, the smart toothbrush, the digital application, and the breath analyzer) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of the computing device, the memory, the processor, the various modules, the smart toothbrush, the digital application, and the breath analyzer, which amounts to merely invoking a computer as a tool to perform the abstract idea, and/or recites additional elements at such a high level of generality so as to not provide meaningful limitations that integrate the judicial exception into a practical application, e.g. see [0013], [0017], [0035], and [0041] of the as-filed Specification, and see MPEP 2106.05(f); and/or
generally link the abstract idea to a particular technological environment or field of use – for example, the claim limitations reciting the various type of data collected, which amounts to limiting the abstract idea to the field of oral healthcare, e.g. see MPEP 2106.05(h).
Additionally, dependent Claims 2-8 and 10-17 include other limitations, but these limitations also amount to no more than mere instructions to apply an exception (e.g. the types of hardware devices recited in dependent Claims 2-3, 5, 8, 11-12, 14, and 17), generally linking the abstract idea to a particular technological environment or field of use (e.g. the artificial intelligence recited in dependent Claims 4 and 13, the cost and compliance data recited in dependent Claims 6-7 and 15-16, the dental cleaning appointments recited in dependent Claim 10), and/or do not include any additional elements beyond those already recited in independent Claims 1 and 8, and hence also do not integrate the aforementioned abstract idea into a practical application.
Hence Claims 1-17 do not include additional elements that integrate the judicial exception into a practical application.
Step 2B
Claims 1 and 9 do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the non-underlined limitations above – in this case, the computing device including the various modules, the smart toothbrush, the digital application, and the breath analyzer), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, generally link the abstract idea to a particular technological environment or field of use, and/or add insignificant extra-solution activity to the abstract idea, wherein the additional elements comprise limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The present Specification expressly disclosing that the structural additional elements are well-understood, routine, and conventional in nature:
[0013], [0017], [0035], and [0041] of the as-filed Specification discloses that the additional elements (i.e. the computing device, the memory, the processor, the various modules, the smart toothbrush, the digital application, and the breath analyzer) comprise a plurality of different types of generic computing systems;
Relevant court decisions: The functional limitations interpreted as additional elements are analogized to the following examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the additional elements recite receiving and transmitting the data over a network, e.g. see [0035] of the as-filed Specification;
Storing and retrieving information in memory, e.g. see Versata Dev. Group, Inc. v. SAP Am., Inc. – similarly, the additional elements recite storing the collected data, and retrieving the collected data from storage in order to ultimately generate the personalized oral health scorecard and the oral care plan;
Determining the level of a biomarker in blood by any means, e.g. see Cleveland Clinic Foundation v. True Health Diagnostics, LLC – similarly, the additional elements recite estimating a patient’s level of microbiological characteristics and pathogenic bacteria, plaque, VSCs, and biomarkers via the various modules;
Dependent Claims 2-8 and 10-17 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because the additional elements recited in the aforementioned dependent claims similarly amount to mere instructions to apply the exception (e.g. the types of hardware devices recited in dependent Claims 2-3, 5, 8, 11-12, 14, and 17), generally linking the abstract idea to a particular technological environment or field of use (e.g. the artificial intelligence recited in dependent Claims 4 and 13, the cost and compliance data recited in dependent Claims 6-7 and 15-16, the dental cleaning appointments recited in dependent Claim 10), and/or the limitations recited by the dependent claims do not recite any additional elements not already recited in independent Claims 1 and 9, and hence do not amount to “significantly more” than the abstract idea.
Hence, Claims 1-17 do not include any additional elements that amount to “significantly more” than the judicial exception.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, Claims 1-17 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4-5, 8-10, 13-14, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Bundsgaard (US 2023/0026220) in view of Tagg (US 2006/0171901).
Regarding Claim 1, Bundsgaard teaches the following: A system for enhanced oral health and disease prevention, comprising:
a computing device having a processor and a memory to store one or more instructions executable by said processor (The system includes a client device (i.e. a computing device) including one or more processors and a computer-readable storage medium (i.e. a memory) storing a computer program (i.e. instructions) that are executed by the one or more processors, e.g. see Bundsgaard [0069]-[0075] and [0278].),
wherein said computing device is configured to execute a plurality of modules (The computer program performs a plurality of functions (i.e. modules), e.g. see Bundsgaard [0074] and [0278].), wherein the plurality of modules includes:
a tooth-brushing data module configured to collect data related to brushing frequency and duration from at least one smart toothbrush used by a user (The system collects non-plan specific input and additional activities for a patient regarding dental habits including how often the user brushes their teeth, e.g. see Bundsgaard [0107], [0226]-[0231], and [0263]-[0269].);
an oral microbiome analysis module configured to collect data related to microbiological characteristics and pathogenic bacteria (The system obtains data regarding dental conditions, wherein the dental conditions include pericoronitis, periodontitis, and tonsillitis (i.e. each of the aforementioned conditions are conditions related to microbiological characteristics and pathogenic bacteria), e.g. see Bundsgaard [0124]-[0125].);
a plaque assessment module configured to collect data related to plaque scoring generated through a digital application (The system collects dental health indicators for a patient including the presence of plaque, e.g. see Bundsgaard [0118], [0125], and [0133].);
a data triangulation module configured to gather and process the data from said tooth-brushing data module, oral microbiome analysis module, plaque assessment module, to generate an oral health scorecard for the user that provides insights into the user's oral health status (The system tracks user actions and input regarding topics and assigns values (i.e. an oral health scorecard) for the actions and topics, e.g. see Bundsgaard [0158]-[0159].); and
a preventive care recommendation module configured to generate a personalized oral care plan based on the oral health scorecard of the user, wherein the personalized oral care plan includes a tailored schedule of professional cleaning appointments with dental hygienists, thereby enhancing oral health and disease prevention (The system generates a dental treatment plan for a patient based on the actions and topics (i.e. the oral health scorecard), e.g. see Bundsgaard [0137]-[0141], wherein the treatment plan includes actions comprising a visit to the dentist (i.e. a tailored schedule of professional cleaning appointments with dental hygenists), e.g. see Bundsgaard [0238].).
But Bundsgaard does not teach and Tagg teaches the following:
wherein the data collected by the oral microbiome analysis module is analyzed from a saliva sample of the user (The system obtains saliva samples from users, and analyzes the samples to determine the presence of various bacteria, e.g. see Tagg [0101].);
a breath analysis module configured to collect data related to oral odor of the user by detecting volatile sulfur compounds (VSCs) and other biomarkers using a breath analyzer (The system includes measuring VSC readings for users utilizing a halimeter (i.e. a breath analyzer), e.g. see Tagg [0098].); and
wherein the data triangulation module is further configured to process the data from the breath analysis module to generate the oral health scorecard for the user (The system scores the patient VSC readings in order to determine which patients should be recruited for a study for a treatment protocol, e.g. see Tagg [0098].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify Bundsgaard to incorporate the saliva sample and breath analysis as taught by Tagg in order to inhibit the growth of various bacteria and to evaluate the effectiveness of treatments, e.g. see Tagg [0007] and [0099]-[0100].
Regarding Claim 4, the combination of Bundsgaard and Tagg teaches the limitations of Claim 1, and Bundsgaard further teaches the following:
The system for enhanced oral health and disease prevention of claim 1, wherein said digital application uses one or more advanced artificial intelligence (AI)-based image processing models that are configured to analyze one or more images or videos of the user's teeth captured by at least one capturing unit to generate the plaque scoring, which evaluates effectiveness of the user's tooth-brushing technique (The system obtains digital images of the patient’s teeth, e.g. see Bundsgaard [0099], Fig. 1, analyzes the digital images to determine dental health indicators such as the presence of plaque, e.g. see Bundsgaard [0113]-[0118], wherein the system may utilize deep learning algorithms and neural networks (i.e. advanced AI-based image processing models) to perform the image analysis, e.g. see Bundsgaard [0018]-[0021], [0115], and [0123].).
Regarding Claim 5, the combination of Bundsgaard and Tagg teaches the limitations of Claim 1, and Bundsgaard further teaches the following:
The system for enhanced oral health and disease prevention of claim 4, wherein said at least one capturing unit includes a camera, a smartphone, a webcam, an intraoral camera, an intraoral scanner, a handheld imaging device and thereof (The system obtains digital images of the patient’s teeth via a digital camera of a mobile device such as a smartphone, e.g. see Bundsgaard [0099] and [0272].).
Regarding Claim 8, the combination of Bundsgaard and Tagg teaches the limitations of Claim 1, and Bundsgaard further teaches the following:
The system for enhanced oral health and disease prevention of claim 1, wherein said computing device is configured to communicate with a server and a user device via a network, wherein said computing device and said user device include at least one of a computer, a smartphone, a laptop, a tablet, and thereof (The system includes a client device in communications with a server device over a network, wherein the client device includes a personal computing device, a portable computing device, a tablet computer, or a smartphone, e.g. see Bundsgaard [0272], [0275], and [0278].).
Regarding Claim 9, the limitations of Claim 9 are substantially similar to those claimed in Claim 1, with the sole difference being that Claim 1 recites a system, whereas Claim 9 recites a method. Specifically pertaining to Claim 9, Examiner notes that Bundsgaard teaches a system and method, e.g. see Bundsgaard [0007], and hence the grounds of rejection provided above for Claim 1 are similarly applied to Claim 9.
Regarding Claim 10, the combination of Bundsgaard and Tagg teaches the limitations of Claim 1, and Bundsgaard further teaches the following:
The method of claim 9, wherein the personalized oral care plan includes a tailored schedule of professional cleaning appointments with dental hygienists for enhanced oral health and disease prevention (The system generates a dental treatment plan for a patient based on the actions and topics (i.e. the oral health scorecard), e.g. see Bundsgaard [0137]-[0141], wherein the treatment plan includes actions comprising a visit to the dentist (i.e. a tailored schedule of professional cleaning appointments with dental hygenists), e.g. see Bundsgaard [0238].).
Regarding Claims 13-14 and 17, the limitations of Claims 13-14 and 17 are substantially similar to those claimed in Claim 4-5 and 8 respectively, with the sole difference being that Claim 4-5 and 8 recite a system, whereas Claims 13-14 and 17 recite a method. Specifically pertaining to Claims 13-15 and 17, Examiner notes that Bundsgaard teaches a system and method, e.g. see Bundsgaard [0007], and hence the grounds of rejection provided above for Claims 4-5 and 8 are similarly applied to Claims 13-14 and 17.
Claims 2 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Bundsgaard and Tagg in view of Huang (US 2021/0289271).
Regarding Claim 2, the combination of Bundsgaard and Tagg teaches the limitations of Claim 1, but does not teach and Huang teaches the following:
The system for enhanced oral health and disease prevention of claim 1, wherein said at least one smart toothbrush is a manually operated toothbrush equipped with a clip-on attachment that monitors and records the brushing frequency and duration (The system includes a brushing tracker in the form of a clip attached to a toothbrush, e.g. see Huang [0047]-[0050], Figs. 1 and 5. Furthermore, the tracker records a brushing timestamp, duration, quality indices, and counts over a period of time (i.e. a frequency), e.g. see Huang [0013], [0109], and [0113], Fig. 28.).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Bundsgaard and Tagg to incorporate the clip on attachment tracking the brushing metrics as taught by Huang in order to provide patients with suggestions for areas of improvement in a convenient manner, e.g. see Huang [0009] and [0013]-[0014].
Regarding Claim 11, the limitations of Claim 11 are substantially similar to those claimed in Claim 2, with the sole difference being that Claim 2 recites a system, whereas Claim 11 recites a method. Specifically pertaining to Claim 11, Examiner notes that Bundsgaard teaches a system and method, e.g. see Bundsgaard [0007], and hence the grounds of rejection provided above for Claim 2 are similarly applied to Claim 11.
Claims 3 and 12 rejected under 35 U.S.C. 103 as being unpatentable over the combination of Bundsgaard and Tagg in view of Vojdani (US 2003/0087320).
Regarding Claim 3, the combination of Bundsgaard and Tagg teaches the limitations of Claim 1, but does not teach and Vojdani teaches the following:
The system for enhanced oral health and disease prevention of claim 1, wherein the saliva sample is collected by the user in a vial provided by a saliva testing device and subsequently analyzed in a laboratory to identify microbiological characteristics and detect the presence of pathogenic bacteria (The system includes a sample of patient saliva that is collected in a sterile tube (i.e. a vial), and stored at a laboratory for testing, for example the Microflora Immune Competency Test (MIT) which detects various microbiological data and bacteria, e.g. see Vojdani [0072]-[0077].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Bundsgaard and Tagg to incorporate the vial and laboratory testing for the saliva sample as taught by Vojdani in order to observe the usefulness of treatment for various clinical conditions, e.g. see Vojdani [0072]-[0077].
Regarding Claim 12, the limitations of Claim 12 are substantially similar to those claimed in Claim 3, with the sole difference being that Claim 3 recites a system, whereas Claim 12 recites a method. Specifically pertaining to Claim 12, Examiner notes that Bundsgaard teaches a system and method, e.g. see Bundsgaard [0007], and hence the grounds of rejection provided above for Claim 3 are similarly applied to Claim 12.
Claims 6-7 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Bundsgaard and Tagg in view of Kutzko (US 2021/0241918).
Regarding Claim 6, the combination of Bundsgaard and Tagg teaches the limitations of Claim 1, but does not teach and Kutzko teaches the following:
The system for enhanced oral health and disease prevention of claim 1, wherein said plurality of modules further comprises a smart contract module that is configured to enforce user's compliance with the personalized oral care plan by automatically monitoring and verifying the user's submission of data from said at least one smart toothbrush, the at least one saliva testing device, the digital application, the breath analyzer and user's attendance percentage at scheduled professional cleaning appointments (The system includes a compliance record for a patient including various data such as an attendance percentage at appointments with healthcare providers, e.g. see Kutzko [0123] and [0127], wherein a healthcare provider includes an orthodontist or dentist providing dental care, e.g. see Kutzko [0057] and [0117]. Additionally, the system includes a smart contract for execution of a selected therapy, e.g. see Kutzko [0051]-[0052] and [0134], wherein the therapy may be selected from a plurality of possible therapies that are based on the user’s compliance record, e.g. see Kutzko [0131]-[0135], Fig. 6.).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Bundsgaard and Tagg to incorporate the smart contract to enforce patient compliance with treatment as taught by Kutzko in order to incentivize individuals to improve their health, e.g. see Kutzko [0029].
Regarding Claim 7, the combination of Bundsgaard, Tagg, and Kutzko teaches the limitations of Claim 6, and Kutzko further teaches the following:
The system for enhanced oral health and disease prevention of claim 6, wherein said smart contract module is further configured to adjust cost of the personalized oral care plan based on the user's compliance (The system enables patients to gain or access financial incentives through following or complying with treatments and therapies, for example by rewarding a patient with cryptocurrency tokens for reducing a drug bill, e.g. see Kutzko [0121] and [0145].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Bundsgaard and Tagg to incorporate the financial incentive for the patient as taught by Kutzko in order to incentivize individuals to improve their health, e.g. see Kutzko [0029].
Regarding Claims 15-16, the limitations of Claims 15-16 are substantially similar to those claimed in Claim 6-7 respectively, with the sole difference being that Claim 6-7 recite a system, whereas Claims 15-16 recite a method. Specifically pertaining to Claims 15-16, Examiner notes that Bundsgaard teaches a system and method, e.g. see Bundsgaard [0007], and hence the grounds of rejection provided above for Claims 6-7 are similarly applied to Claims 15-16.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure is as follows:
Saliman (US 2020/0005912) – teaches a system including a smart contract for facilitating patient compliance with a treatment regimen.
Cheng (US 2017/0211131) – teaches collecting saliva in a vial and a laboratory scientist extracting DNA from the saliva.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN P GO whose telephone number is (703)756-1965. The examiner can normally be reached Monday-Friday 9am-6pm Pacific.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, PETER H CHOI can be reached at (469)295-9171. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN P GO/Primary Examiner, Art Unit 3681
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