DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Response to Amendment
In the amendment dated 8/13/2026, the following has occurred: Claims 1, 8 and 10 have been amended.
Claims 2 – 4, 7, 9, and 11 – 17 have been previously canceled.
Claims 1, 5, 6, 8, and 10 are 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, 5, 6, 8, and 10 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.
The claim(s) recite(s) subject matter within a statutory category as a process (claims 10), machine (claims 1, 5, and 6) which recite steps abstract idea steps of
receiving sequenced nucleic acids obtained from a fecal sample collected from an animal selected from dog and cat,,
classifying the bacterial composition data of intestinal flora of the animal using operational taxonomic unity analysis,
calculate, from the taxonomically classified bacterial composition data
(1) a diversity index of the microbiota in the animal samples,
(2) the occupancy rate of each bacterial family, including one or more occupancy rates selected from the group consisting of the occupancy rate of the Coprobacillaceae family, the occupancy rate of the Enterococcaceae family, and the occupancy rate of the Peptostreptococcaceae family, and
using the calculated diversity index of (1) and the occupancy rate of (2), predict and determine whether the animal will be afflicted in future with a disease urological, hepatic, biliary tract, and pancreatic, cardiovascular, neurological, endocrine or blood and hematopoietic disease within one year from a time of acquisition of the diversity index of (1) and the occupancy rate of (2);
a diversity index of intestinal flora samples of the animal other than humans or label set based on thereof,
occupancy rate of each bacterial family, including one or more occupancy rates selected from the group consisting of the occupancy rate of the Coprobacillaceae family, the occupancy rate of the Enterococcaceae family, and the occupancy rate of the Peptostreptococcaceae family in the intestinal flora of the animal or label set based on thereof, and
a presence or absence of disease affliction within a predetermined period of time from a time of acquisition of the occupancy rate data and diversity data of the intestinal flora,
outputting a suggestion for a life improving method according to the disease prediction result selected from the group consisting of disease-preventing meals, supplements containing bacteria that reduce susceptibility to disease, low-salt and low-calorie meals, low-carbohydrate meals and diet menus.
These steps of claims 1, 5, 6, 8, and 10, as drafted, under the broadest reasonable interpretation, includes mathematical concepts. The claims recite the steps of first inputting data or acquiring data. Second, the claims that process that data using an algorithm. The algorithm and the training of the algorithm are mathematical processes. The step of determining an insurance premium is using the predictive results as input into another algorithm.
It should be emphasized that there is no practical application. The result of the invention is data. Even if that data is later claimed to be displayed, although not currently done, then that would be considered an extra solution activity.
Dependent claims recite additional subject matter which further narrows or defines the abstract idea embodied in the claims (such as claims 5 and 6, reciting particular aspects of how insurance premium calculation may be performed in the mind but for recitation of generic computer components).
This judicial exception is not integrated into a practical application. In particular, the additional elements do not integrate the abstract idea into a practical application, other than the abstract idea per se, because the additional elements amount to no more than limitations which:
amount to mere instructions to apply an exception (such as recitation of causing a computer amounts to invoking computers as a tool to perform the abstract idea, see MPEP 2106.05(f))
add insignificant extra-solution activity to the abstract idea (such as recitation of receiving or acquiring occupancy rate data amounts to mere data gathering, see MPEP 2106.05(g))
Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 5 and 6, additional limitations which amount to invoking computers as a tool to perform the abstract idea, claims). 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 and do not impose a meaningful limit to integrate the abstract idea into a practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to discussion of integration of the abstract idea into a practical application, the additional elements amount to no more than mere instructions to apply an exception, add insignificant extra-solution activity to the abstract idea, and generally link the abstract idea to a particular technological environment or field of use. Additionally, the additional limitations, other than the abstract idea per se, amount to no more than limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields (such as claims 1, 5, 6, 8, and 10; training, predicting, and determining, e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii))
Additional Elements
Computer or system including processor – page 17, lines 9 – 14 “a personal computer, a tablet terminal, and the like are mentioned”
Machine learning – page 11, lines 9 – 15, “Artificial intelligence may be either a general-purpose type or a specialized type, may be any of a deep neural network, a convolutional neural network, or the like, and published software can be used” page 18, lines 16 – 25 XGBoost, CatBoost, a deep neural network… and page 12, lines 2 – 6, “As published machine learning algorithms, for example, XGBoost, CatBoost, and LightGBM are mentioned.”
Training – page 11, line 21 – page 12, line 1 For example, the Deep Learning GPU Training System (DIGITS) published by NVIDIA can be used.”
DNA Sequencer – page 8, lines 11, 12 or page 9, lines 18 “ a sequencer such as NGS” page 10, lines 4, 5, “An example of amplicon analysis (bacterial flora analysis) of the 16S rRNA gene using NGS (next-generation sequencer) is specifically described.”
processor for calculating the below (1) and (2), page 9, lines 16 – 25 “Occupancy rate data and diversity data of intestinal flora can be measured using a known metagenomic analysis method or bacterial flora analysis method, such as amplicon sequencing using a sequencer such as NGS. For example, there is mentioned a method in which a sample such as feces is collected from an animal, and DNA and RNA base sequence information of any organisms contained in the sample is analyzed using a next-generation sequencer to identify the organisms contained in the sample.”
Dependent claims recite additional subject matter which, as discussed above with respect to integration of the abstract idea into a practical application, amount to invoking computers as a tool to perform the abstract idea. Dependent claims recite additional subject matter which amount to limitations consistent with the additional elements in the independent claims (such as claims 5 and 6, additional limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, determining insurance premiums or calculating occupancy rate, e.g., performing repetitive calculations, Flook, MPEP 2106.05(d)(II)(ii)). 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.
Response to Arguments
Applicant's arguments filed 8/13/2026 have been fully considered but they are not persuasive.
Rejection under 35 U.S.C. § 101
The Applicant states, “Thus, the amended invention is a system comprising a physical device, namely a DNA sequencer, as a constituent element, and is not directed merely at mathematical operations.” The claimed device is extra-solution activity. The amendments don’t change the utility in because it provides input to the rest of the claim. Replacing the DNA sequencer with a database of sequenced data produces the same output.
The Applicant states, “The amended invention is a system involving specific inputs-namely, predicting whether dogs or cats will develop specific diseases within one year based on a given sample-and specific predictive outputs; it does not amount to a mere abstract idea or mathematical operation.” Most mathematical equations use specific inputs. Explicitly labeling the data as cat or dog only changes the data labels.
The Applicant states, “As stated above, the DNA sequencer is one of the components of the claimed invention, and the claimed invention comprises a DNA sequencer as a component. The inventors of the present application have invented a system and method incorporating a physical device known as a DNA sequencer.” Exactly that a DNA sequencer is incorporated into a claim to provide inputs. The invention is not directed towards a DNA sequencer.
The Applicant states, “The results showed that the claimed diseases (such as urological disease,), the predictive performance was rated 'A', confirming that it demonstrated superior predictive performance compared to the 'B' rating for other diseases. This clearly substantiates that the claimed invention of the present application brings about a technical improvement in the predictive performance for specific diseases based on fecal samples.” The result shows that by applying newer mathematical tools to existing data provides better results. The Specification does not show that the invention provides a technological improvement. The Specifications shows that applying technology improves results.
The Applicant states, “Further, the Office is reminded that an Appeals Review Panel including Director Squires recently reversed an Examiner's eligibility rejection of a claim directed to an artificial intelligence system. Ex parte Desjardins…” The Examiner is aware that Desjardins is directed towards an improved AI model. That improvement is absent from the instant invention. All further arguments directed towards Desjardins are considered moot.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Neal R Sereboff whose telephone number is (571)270-1373. The examiner can normally be reached M - T, M - F 8AM - 6PM.
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/NEAL SEREBOFF/
Primary Examiner
Art Unit 3626
Prosecution Insights