DETAILED ACTION
This application is made in response to the amendments/remarks filed on June 11, 2026. This action is made final.
Claims 1-4 and 9 are pending. Claims 5-8 have been cancelled. Claim 9 is newly added. Claims 1 and 4 have been amended. Claim 1 is the sole independent claims.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s argument with respect to the previous 101 rejection has been fully considered but is not persuasive.
Applicant’s arguments that the claims cannot be practically performed in the human mind are moot as the claims are directed towards a method of organizing human activity.
Applicant further argues the claims are integrated into a practical application in that they provide an improvement to a technical field of neurodegenerative disease detection. However, the Examiner respectfully disagrees.
MPEP 2106.04(d)(1) states “the word ‘improvements’ in the context of this consideration is limited to improvements to the functioning of a computer or any other technology/technical field, whether in Step 2A Prong Two or in Step 2B.” Here, there is no improvement to the computer nor is there an improvement to another technology. Because neither type of improvement is present in the claims, an improvement to technology is not present and there is no practical application.
Applicant’s argument that the field of neurodegenerative disease detection is a technology and the claimed invention improves this field is not reflected in the claimed invention. Rather, the claims are confined to a general-purpose computer. Moreover, the entire field of neurodegenerative disease detection is not reasonably understood to be a problem arising in technology, as it is instead a problem arising in health management/detection. The claimed invention is using a computer as a tool and any improvement present is an improvement to the abstract idea of, to paraphrase, diagnosing/detecting a disease.
Applicant’s argument that the claims are not well-understood, routine, and convention (WURC) because the art of record does not teach the claimed invention, is not persuasive.
MPEP 2106.05(d) states: “Another consideration when determining whether a claim recites significantly more than a judicial exception is whether the additional element(s) are well-understood, routine, conventional activities previously known to the industry (emphasis added).” Further, MPEP 2106.05(I) states: “As made clear by the courts, the novelty of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter (internal quotations omitted, emphasis original).” As such, it is only the additional elements identified by the Examiner to not be part of the abstract idea that are analyzed to determine whether they represent well-understood, routine, conventional activities in the field of the invention.
In that regard, MPEP 2106.05(d)(I) indicates that in determining whether the additional elements represent are well-understood, routine, conventional activities, the Examiner should consider whether the additional elements (1) provide an improvement to the technological environment to which the claim is confined, (2) whether the additional elements are mere instructions to apply the judicial exception, or (3) whether the additional elements represent insignificant extra-solution activity. The additional elements of the claims do not provide significantly more based on this inquiry.
Taking these in turn, whether the additional elements of the claim provide an improvement was analyzed/addressed in the 2A2 analysis and no improvement to the functioning of a computer, technology, or technical field was identified. Furthermore, the technological environment to which the claims are confined is a general-purpose computer performing generic computer functions (see Spec [0009], [0032]) and is recited at a high level of generality and has been found by the courts to be insufficient to provide a practical application (see MPEP 2106.05(d)(II); Alice Corp.). None of the additional elements of the claim were found to represent extra-solution activity and thus no well-understood, routine, conventional analysis is required. As such, when viewed either individually or as an ordered combination, the additional elements do not provide significantly more to the abstract idea and the claims are not subject matter eligible.
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 1-4 and 9 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 1-4 and 9 recite a method of diagnosing a disease, which is within the statutory category of a process.
Claims are eligible for patent protection under § 101 if they are in one of the four statutory categories and not directed to a judicial exception to patentability. Alice Corp. v. CLS Bank Int'l, 573 U.S. ___ (2014). Claims 1-4 and 9, each considered as a whole and as an ordered combination, are directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
MPEP 2106 Step 2A – Prong 1:
The bolded limitations of:
Claim 1
A method of risk determination which estimates risks of neurodegenerative diseases through stratification which differentiates multiple diseases, wherein the method comprises: a set of obtaining a saliva sample form a test subject; a step of amplifying 16S rRNA genes from the saliva sample by a polymerase chain reaction (PCR); a step of determining nucleobase sequences of the amplified 16S rRNA genes by a sequencer to generate sequencing reads of multiple bacteria types; a step of clustering the sequencing reads according to a sequence similarity to provide Operational Taxonomic Units (OTUs); a step of acquiring representation abundances of multiple types of bacteria from an analysis of salivary microbiota of the test subject, wherein the representation abundances are identified based on the sequencing read counts of the OTUs; and a step of inputting the acquired representation abundances of multiple types of bacteria into a prediction model, wherein the prediction model estimates risks of neurodegenerative diseases occurring in the test subject through stratification which differentiates multiple diseases, wherein steps (d) to (f) of the method are each performed by a computer program executed by a computer processor, wherein the prediction model has been generated by machine learning which entails obtaining an algorithm using, as explanatory variables, representation abundances of the multiple types of bacteria acquired from an analysis of salivary microbiota of healthy subjects and patients of multiple diseases belonging to the neurodegenerative diseases, and the disease states of the healthy subjects and the patients stratified across the multiple diseases belonging to neurodegenerative diseases, output as target variables, as training data, wherein said multiple types of bacteria include bacteria types having high representation abundances in the analysis of the salivary microbiota of the patients stratified, and/or bacteria types showing significant differences in the representation abundances between patients of different diseases in the analysis of the salivary microbiota of the patients stratified.
as presently drafted, under the broadest reasonable interpretation, covers a method of organizing human activity (i.e., managing personal behavior including following rules or instructions). For example, but for the noted computer elements, the claim encompasses a person following rules or instructions to retrieve and analyze data in the manner described in the abstract idea, such as a person collecting patient saliva to predict a risk of a neurodegenerative disease. The examiner further notes that “methods of organizing human activity” includes a person’s interaction with a computer (see October 2019 Update: Subject Matter Eligibility at Pg. 5). If the claim limitation, under its broadest reasonable interpretation, covers managing persona behavior or interactions between people but for the recitation of generic computer components, then it falls within the “method of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
MPEP 2106 Step 2A – Prong 2:
This judicial exception is not integrated into a practical application because there are no meaningful limitations that transform the exception into a patent eligible application. The additional elements merely amount to instructions to apply the exception using generic computer components (“a processor”, "a computer program”—all recited at a high level of generality). Although they have and execute instructions to perform the abstract idea itself, this also does not serve to integrate the abstract idea into a practical application as it merely amounts to instructions to "apply it." (See MPEP 2106.04(d)(I) indicating mere instructions to apply an abstract idea does not amount to integrating the abstract idea into a practical application). Accordingly, the additional elements do not integrate the abstract idea into a practical application because they do not impose meaningful limits on practicing the abstract idea. Therefore, the claims are directed to an abstract idea.
The claim further recites the additional elements of use of a prediction model generated by machine learning and trained with bacteria and patient stratification data. When given the broadest reasonable interpretation in light of the nonexistent description of model training in the disclosure, training of a machine learning model with the noted data amounts to a mathematical concept that creates data associations. As such, this training of the model is interpreted to be subsumed within the identified abstract idea and the use of the trained model provides nothing more than mere instructions to implement the abstract idea, supra. July 2024 Subject Matter Eligibility Examples, Example 47, Claim 2, discussion of item (c) at Pgs. 7-9. Furthermore, the use of the trained model provides nothing more than mere instructions to implement an abstract idea on a generic computer (“apply it”). See MPEP 2106.05(f). MPEP 2106.05(f); July 2024 Subject Matter Eligibility Examples, Example 47, Claim 2, discussion of items (d) and (e) at Pgs. 8-9.
The claims only manipulate abstract data elements as part of performing the abstract idea. They do not set forth improvements to another technological field or the functioning of the computer itself and instead use computer elements as tools in a conventional way to improve the functioning of the abstract idea identified above. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. 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. None of the additional elements recited "offers a meaningful limitation beyond generally linking 'the use of the [method] to a particular technological environment,' that is, implementation via computers." Alice Corp., slip op. at 16 (citing Bilski v. Kappos, 561 U.S. 610, 611 (U.S. 2010)).
At the levels of abstraction described above, the claims do not readily lend themselves to a finding that they are directed to a nonabstract idea. Therefore, the analysis proceeds to step 2B. See BASCOM Global Internet v. AT&T Mobility LLC, 827 F.3d 1341, 1349 (Fed. Cir. 2016) ("The Enfish claims, understood in light of their specific limitations, were unambiguously directed to an improvement in computer capabilities. Here, in contrast, the claims and their specific limitations do not readily lend themselves to a step-one finding that they are directed to a nonabstract idea. We therefore defer our consideration of the specific claim limitations’ narrowing effect for step two.") (citations omitted).
MPEP 2106 Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the same reasons as presented in Step 2A Prong 2. Moreover, the additional elements recited are known and conventional generic computing elements (“a processor”, "a computer program”—see Specification Fig. 2, [0032] describing the various components as general purpose, common, standard, known to one of ordinary skill, and at a high level of generality, and in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy the statutory disclosure requirements). Therefore, these additional elements amount 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 that amounts to significantly more. See MPEP 2106.05(f).
The Federal Circuit has recognized that "an invocation of already-available computers that are not themselves plausibly asserted to be an advance, for use in carrying out improved mathematical calculations, amounts to a recitation of what is 'well-understood, routine, [and] conventional.'" SAP Am., Inc. v. InvestPic, LLC, 890 F.3d 1016, 1023 (Fed. Cir. 2018) (alteration in original) (citing Mayo v. Prometheus, 566 U.S. 66, 73 (2012)). Apart from the instructions to implement the abstract idea, they only serve to perform well-understood functions (e.g., receiving, translating, and displaying data—see Specification above as well as Alice Corp.; Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307 (Fed. Cir. 2016); and Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334 (Fed. Cir. 2015) covering the well-known nature of these computer functions).
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of the use of a prediction model generated by machine learning and trained with bacteria and patient stratification data to make predictions were considered to be part of the abstract idea and “apply it,” respectively. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. Regarding the training of the model is considered part of the abstract idea and thus cannot provide a practical application. Regarding the use of the trained model represented saying “apply it.” Using the trained model has been revaluated under the “significantly more” analysis and does not provide “significantly more” to the abstract idea. MPEP 2106.05(A) indicates also indicates that merely adding the words “apply it” or equivalent use cannot provide significantly more. Accordingly, even in combination, this additional element does not provide significantly more. As such the claim is not patent eligible.
Dependent Claims
The limitations of dependent but for those addressed below merely set forth further refinements of the abstract idea without changing the analysis already presented. Claims 2-4 merely recites the types of diseases predicted and the types of bacteria used in the prediction, and claim 9 merely recites which regions are amplified by PCR, which covers a method of organizing human activity (i.e., managing personal behavior including following rules or instructions).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STELLA HIGGS whose telephone number is (571)270-5891. The examiner can normally be reached Monday-Friday: 9-5PM.
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/STELLA HIGGS/Primary Examiner, Art Unit 3681
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