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 .
Response to Amendment
The amendment filed 03/02/2026 has been entered. Claims 1-2, 4, 6-9, 11-14, 18, 20, 22-25, 28-30, 32-34, and 36-42 are pending in the application.
Oath/Declaration
The affidavit under 37 CFR 1.132 filed 03/02/2026 is insufficient to overcome the rejection of claims 1-2, 4, 6-9, 11-14, 18, 20, 22-25, 28-30, 32-34, and 36-42 based upon 35 USC 101 as set forth in the last Office action because the facts presented are not germane to the rejection at issue. The affidavit states that the claims require “associating metatranscriptomic data derived via metatranscriptomic analysis with biological conditions (gene activities, biochemical activities, chemical pathway activities, or microbial taxa activities”. This is not found persuasive because the affidavit refers only to the system described in the above referenced application and not to the individual claims of the application. As such the declaration does not show that the objective evidence of nonobviousness is commensurate in scope with the claims. See MPEP § 716 . Additionally, the affidavit is not found persuasive because “associating metatranscriptomic data derived via metatranscriptomic analysis with biological conditions (gene activities, biochemical activities, chemical pathway activities, or microbial taxa activities” can be performed in the human mind, or by a human using a pen and paper. The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that the claimed "conversion of binary-coded decimal numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."). In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
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.
The subject matter of a claim must be directed to one of the four patent-eligible subject matter categories: process, machine, manufacture, or composition of matter. If it is not, the claim is not eligible for patent protection. The subject matter which courts have found to be outside of, or exceptions to, the four statutory categories of invention is limited to abstract ideas, laws of nature and natural phenomena (i.e., the judicial exceptions) (See Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. _, 134 S. Ct. 2347, 2354, 110 USPQ2d 1976, 1980 (2014) (citing Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. _, 133 S. Ct. 2107, 2116, 106 USPQ2d 1972, 1979 (2013))). There are two criteria for determining subject matter eligibility under 35 U.S.C. 101 and both must be satisfied. The claimed invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception. The limitations of claims 1-2, 4, 6-9, 11-14, 18, 20, 22-25, 28-30, 32-34, 36-42 are directed to mental processes (concepts performed in the human mind (including an observation, evaluation, judgment, opinion)). The claimed invention is directed to non-statutory subject matter because the claims as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. Based on the subject matter eligibility test for products and processes, claims 1-2, 4, 6-9, 11-14, 18, 20, 22-25, 28-30, 32-34, 36-42 are not eligible for patent protection because:
(Step 1) claims 1-2, 4, 6-9, 11-14, 18, 20, 22-25, 28-30, 32-34, 36-42 are directed to a process, machine, manufacture or composition of matter.
(Step 2A) claims 1-2, 4, 6-9, 11-14, 18, 20, 22-25, 28-30, 32-34, 36-42 are directed to a law of nature, a natural phenomenon, or an abstract idea (a judicially recognized exception) based on the limitations of the claims. The limitations of claims 1-2, 4, 6-9, 11-14, 18, 20, 22-25, 28-30, 32-34, 36-42 fall within the subject matter grouping of abstract ideas and are directed to organizing human activity (managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions)) and mental processes (concepts performed in the human mind (including an observation, evaluation, judgment, opinion)) and . It is noted that the bulk of the claim language is directed to concepts that can be performed in the human mind as the claims are directed to observation of an event and evaluation of the event. The courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). Accordingly, the "mental processes" abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions. The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that the claimed "conversion of binary-coded decimal numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand."). The recitation in claim 1 of “a method comprising: (a) generating metatranscriptomic data from human or from microbiome origin, the metatranscriptomic data comprising metatranscriptomic data; (b) determining, from the metatranscriptomic data, one or more biological conditions in the subject, the one or more biological conditions comprising one or more gene activities, biochemical activities, biochemical pathway activities, or microbial taxa activities;(c) accessing a knowledge base, wherein the knowledge base indicates, for each of a plurality of items selected from foods, supplements and ingredients, a desirability rating of consuming the item for the one or more biological conditions, thereby generating a plurality of desirability ratings associated with the plurality of items; (d) for each item, implementing computer logic to determine a final recommendation for the item, wherein the final recommendation is based on the plurality of desirability ratings; (e) generating functional activity scores by: determining, from the metatranscriptomic data: (1) gene activity scores; (2) taxa activity scores; (3) biochemical activity scores; (4) biochemical pathway activity scores; (f) generating a glycemic response score for each of a plurality of food items by: executing logic that determines a glycemic response score for a subject based on macronutrient content of the food and the subject's gene activity scores and taxa activity scores, and based on the final recommendations and the glycemic response scores, providing a food recommendation to the subject” (and additional limitations of claims 2, 4, 6-9, 11-14, 18, 20, 22-25, 28-30, 32-34, 36-42) are directed to organizing human activity and mental processes. If a claim recites a judicial exception (an abstract idea), the claim is evaluated as to whether the judicial exception is integrated into a practical application. Integration into a practical application is evaluated by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application. The additional elements or combination of elements in the claims other than the abstract idea per se amounts to no more than: a knowledge base that indicates ratings for a plurality of items selected from foods, supplements and ingredients; computer logic/ computer memory. The recited judicial exception has not been integrated into a practical application because the additional elements do no more than generally link the use of the judicial exception to a particular technological environment or field of use.
(Step 2B) claims 1-2, 4, 6-9, 11-14, 18, 20, 22-25, 28-30, 32-34, 36-42 do not recite provide an inventive concept because the additional elements do not amount to significantly more than the judicial exception (See: Mayo Collaborative Serv. v. Prometheus Labs., Inc., 566 U.S. _, 132 S. Ct. 1289, 1293-94, 101 USPQ2d 1961, 1965-66 (2012)). The examiner takes official notice that the additional elements (a knowledge that indicates ratings for a plurality of items selected from foods, supplements and ingredients; computer logic/ computer memory) are well-understood, routine, and conventional and are widely prevalent and in common use in the relevant field (See for example: Apte (20180286520)), comparable to the types of activity or elements that are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. 112(a).
Therefore, claims 1-2, 4, 6-9, 11-14, 18, 20, 22-25, 28-30, 32-34, 36-42 are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Arguments
Applicant's arguments filed 03/02/2026 have been fully considered but they are not persuasive.
Applicant argues that the claims are not directed to an abstract idea, this is not found persuasive because the limitations of claims 1-2, 4, 6-9, 11-14, 18, 20, 22-25, 28-30, 32-34, 36-42 fall within the subject matter grouping of abstract ideas and are directed to organizing human activity (managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions)) and mental processes (concepts performed in the human mind (including an observation, evaluation, judgment, opinion)) and . It is noted that the bulk of the claim language is directed to concepts that can be performed in the human mind as the claims are directed to observation of an event and evaluation of the event. The courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). Accordingly, the "mental processes" abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions. The courts do not distinguish between mental processes that are performed entirely in the human mind and mental processes that require a human to use a physical aid (e.g., pen and paper or a slide rule) to perform the claim limitation. See, e.g., Benson, 409 U.S. at 67, 65, 175 USPQ at 674-75, 674 (noting that the claimed "conversion of [binary-coded decimal] numerals to pure binary numerals can be done mentally," i.e., "as a person would do it by head and hand.").
Applicant argues that the claims include an inventive concept, this is not found persuasive because the additional elements do not amount to significantly more than the judicial exception (See: Mayo Collaborative Serv. v. Prometheus Labs., Inc., 566 U.S. _, 132 S. Ct. 1289, 1293-94, 101 USPQ2d 1961, 1965-66 (2012)). The examiner takes official notice that the additional elements (a knowledge that indicates ratings for a plurality of items selected from foods, supplements and ingredients; computer logic/ computer memory) are well-understood, routine, and conventional and are widely prevalent and in common use in the relevant field (See for example: Apte (20180286520)), comparable to the types of activity or elements that are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. 112(a).
Conclusion
THIS ACTION IS MADE FINAL. 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 CHRISTOPHER GLENN whose telephone number is (571)272-1277. The examiner can normally be reached 9:00 a.m. - 5:00 p.m..
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/C.G./Examiner, Art Unit 3711
/JOSEPH B BALDORI/Primary Examiner, Art Unit 3711
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