DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Request for Continued Examination
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/24/26 has been entered.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 02/24/26 was filed and entered. The submission is in compliance with the provisions of 37 CFR 1.97 and has been considered by the Examiner.
Claim Status
4. The amendment, filed 02/24/26, has been entered. Claims 63-71 and 85-95 are pending and under examination. Claims 1-62 and 72-84 are cancelled. Claim 63 is amended.
Withdrawal of Objections/Rejections
5. The following are withdrawn from the Office Action, filed 10/24/25:
The rejection of claims 63-71 and 85-95 under 35 U.S.C. 102(a)(1) as being anticipated by Von Malzahn et al. 2018 (US 10,064,900), found on page 7 at paragraph 11, is withdrawn in light of Applicant’s amendments thereto; specifically limiting the composition to a plurality of microbial strains “consisting of” the naturally occurring bacteria.
Maintained Rejection: Claim Rejections - 35 USC § 101
6. 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.
7. Claims 63-71 and 85-95 rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e. nature-based products: naturally occurring bacteria) without significantly more.
Instant claims are directed to an ingestible item comprising a plurality of microbial strains, wherein the plurality of microbial strains consists of six to ten microbial strains from different genera of Gluconacetobacter sp., Terrisporobacter glycolicus, Coprococcus sp., Lactobacillus plantarum, Clostridium butyricum, Paenibacillus sp., Veillonella sp., Bifidobacterium sp., Bacillus subtilis, and Acidaminococcus sp. and wherein the ingestible item is a food, beverage, or pharmaceutical composition suitable for human consumption; which encompasses naturally occurring bacteria each of which may be isolated from, for example, naturally occurring microbiomes (e.g. see specification at [0087-0090]). Thus, step 1 of the Subject Matter Eligibility test is yes.
However, these judicial exception(s) are not integrated into a practical application because the naturally occurring bacteria do not appear to be markedly different from their naturally occurring counterparts, in their natural states, since they are not required to be modified in any way. With regards to the naturally occurring bacteria being formulated as an “ingestible item” in general and/or as “a food, beverage, or pharmaceutical composition” in particular, it is noted that the claim does not actually require any particular additional component; and the broadest reasonable interpretation encompasses additional nature-based products (e.g. water, juice, and/or milk; see instant specification at [0112, 0114]); and/or there is nothing that would preclude the naturally occurring bacteria from being ingested. Therefore, although the product claims are directed to a statutory category, they are also directed to one or more judicial exceptions (i.e. nature-based products; thus, Step 2A prong 1 is also yes) that is/are not integrated into a practical application (i.e. Step 2A, prong 2 is no).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no additional elements in claims 63-71 and 85-95 as each of these dependent claims merely specify which and/or how many naturally occurring bacterial genera/species are included in the composition.
With regards to the specific combinations of bacteria in dependent claims 88-95, the courts have determined that mixtures of naturally occurring bacteria, even those that do not naturally co-occur, were found to be ineligible as an unpatentable arrangement of existing natural phenomenon; see Funk Brothers Seed Co. v. Kalo Inoculant Co. 333 U.S 127 (1948). Furthermore, there is nothing of record to show that the particular combinations of bacteria structurally or functionally change any of the individual bacteria from what already exists in nature. Further, with regards to concentrations claimed in dependent claims 88 to 95, it is noted that if one item is not eligible (e.g. a unicorn), a mere grouping of those items is not sufficient to make the item eligible (e.g. a herd of unicorns). Thus, these additional elements are not sufficient to amount to significantly more than the judicial exception because there is no indication that any of these additional element(s) changes any structural or functional features of the judicial exception per se. Therefore, all the components in the composition function as they would individually, and a mere mixture or aggregation of products, natural or not, does not structurally and/or functionally change the nature-based product from what exists in the environment and that in order to be eligible, every embodiment within the broadest reasonable interpretation of the claim must be eligible.
Thus, taken alone, the additional elements do not amount to significantly more than the above identified judicial exceptions (i.e. naturally occurring bacteria). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually because the additional element(s) are recited at a high level of generality and are well-understood, routine, conventional activities engaged in by the scientific community, as evidenced by, for example, Von Malzahn et al. 2018 (US 10,064,900; see Table 1; also teaches each of the claimed bacteria and teaches “ingestible items”). Consequently, the additional element(s) are not sufficient to make the judicial exception eligible for patent protection (Step 2B is no).
Therefore, based upon consideration of all of the relevant factors with respect to the claim as a whole, the claims are held to claim a law of nature and natural products, and are consequently rejected as ineligible subject matter under 35 U.S.C. 101.
Applicant’s Arguments and Response to Arguments
8. All of Applicant’s arguments have been considered but were not deemed persuasive; accordingly, the rejection is maintained for reasons of record. For example:
With regards to the argument that a mixture comprising (or consisting of) six to ten microbial strains is not a product of nature, let alone an ingestible item (i.e. a food, beverage, or pharmaceutical composition) comprising six to ten microbial strains, each microbial strain belonging to a different recited genus; and the Office has not provided any evidence of such an ingestible item comprising at least six to ten of the recited microbial strains being available in nature (see Remarks, page 7); the Office again notes that Applicant’s own specification describes the bacteria as part of natural microbiomes (e.g. see [0087-0091]). In addition, the art recognizes each species claimed as a member of naturally occurring microbiomes (e.g. see Von Malzahn et al. 2018; US 10,064,900; column 11; Table 1; Figure 12). Finally, there is no requirement for the Office to show evidence that the combination occurs in nature, but rather only that the individual judicial exceptions do, which the Office has done on multiple occasions. Therefore, it remains the Office’s position that each of the claimed bacteria are products of nature (i.e. each is not markedly different from its natural counterpart in its natural state) and the merely combining them into a mixture is not sufficient to convert the otherwise ineligible nature-based products into eligible subject matter because there is no evidence of record that members of the combination are structurally or functionally different from their natural counterparts (i.e. not markedly different); see Funk Brothers Seed Co. v. Kalo Inoculant Co. 333 U.S 127 (1948)). Consequently, these arguments are not persuasive because the claims are directed to nature-based products (i.e. a combination of individual species of naturally occurring bacteria) that are (a) each not markedly different from their natural counterparts; (b) not integrated into a practical application; and (c) do not include additional elements that are sufficient to amount to significantly more than the judicial exception per se, as set forth above.
Therefore, all of Applicant’s arguments have been considered but were not deemed persuasive; accordingly, the rejection is maintained for reasons of record.
Conclusion
9. No claims are allowed.
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY MAILLE LYONS whose telephone number is (571)272-2966. The examiner can normally be reached on Monday-Friday 8 am to 5 pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http: //www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dan Kolker can be reached on (571)-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARY MAILLE LYONS/Examiner, Art Unit 1645
March 3, 2026