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 .
2. Please note that the Patent Examiner of your application has changed. All communications should be directed to Mary Lyons, Art Unit 1645, whose telephone number is (571)272-2966.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on 11/14/25 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 06/03/25, has been entered. Claims 131-137, 159, and 161-162 are pending and under examination. Claims 1-130, 138-158, and 160 are cancelled. Claim 161 is newly added. Claims 131 and 136 are amended.
Withdrawal of Objections/Rejections
5. The following are withdrawn from the Office Action, filed 12/06/24:
The objection to claim 140, found on page 3, is moot in light of Applicant’s cancellation thereof.
The rejection of claims 131-141 and 159 under 35 U.S.C. 112(b) found on page 5, is withdrawn in light of Applicant’s amendments thereto.
The rejection of claims 131-141, and 159 under 35 U.S.C. 103 as being unpatentable over Henn (US Patent No. 8,906,668 B2), found on page 8, is withdrawn in light of Applicant’s amendments thereto.
The rejection of claims 131-134, 136-137, 138, and 140-141 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 25, 34, 46, 78, and 137 of copending Application No. 17/906,060, found on page 14, is withdrawn in light of Applicant’s amendments thereto.
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 131-141, 159 and 161-162 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more.
STEP 1: Is the claim directed to a process, machine, manufacture, or a composition of matter?
YES, the claims are directed to a composition of a matter.
STEP 2A: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
YES, the claims are drawn to products of nature (i.e. natural products; nature-based products including naturally occurring bacteria) which the courts have held that “products of nature” fall under the laws of nature or natural phenomena exceptions (i.e. the judicial exceptions).
Thus, the markedly different characteristics analysis is part of Step 2A, i.e., it helps answer the question of whether a claim is directed to an exception. In particular, under the broadest reasonable interpretation, the claims are drawn to a composition comprising two or more microbes, which appears to be a combination of naturally existing microorganisms. After a review of the specification, there is no indication that the claims have any characteristics that are different from what occurs in nature (i.e. each species is naturally occurring). For example, the specification discloses:
“Microbial consortia disclosed herein are designed to meet one or more than one of the following criteria: … natural prevalence of component microbial species in the GI tract of healthy adults.” (page 75, lines 10-27).
Therefore, the microbial consortia contain naturally occurring microbes found in the GI tract of healthy adults and function to increase the number of the microbes in the GI tract. The specification and claims do not provide if the listed microbes are genetically modified; thus, absent of evidence to the contrary, all the listed microbes are naturally occurring. Additionally, the sequences in claims 132, 137, and 141 are directed to the sequences of naturally occurring bacteria. The specification discloses:
“FB-001 [or Consortia IX] comprises 148 different anaerobic microbial strains that was designed to emulate the metabolic and phylogenetic diversity of the human microbiome (Figure 17) and was split into 7 different drug substances for manufacturing purposes. Table 22 shows the 7 different drug substances. Species were identified by 16S rRNA gene sequencing and whole genome sequencing of RCBs. The species in the consortium span six of the major phyla found in the GI tracts of healthy adults” (page 129, lines 12-18; compare with instant claims 132, 137, 141)
“Following confirmation of uniform colony morphology for each RCB [research cell bank], individual colonies were analyzed by 16S rRNA gene sequencing (see Sequence Listing). RCBs were further characterized using whole-genome sequencing followed by genome assembly. Strain-level identification was performed using both 16S rRNA gene sequences and whole-genome assemblies.” (see page 141, lines 1-5; compare with instant claims 132, 137, and 141).
Given the above, the SEQ ID NOs of claims 132, 137, and 141 are directed to natural occurring strains. Further, the judicial exception is not integrated into a practical application because formulating the composition into a pharmaceutical composition, or kit, or a dose, does not add a meaningful limitation as it is merely a nominal or token extra-solution component of the claim, and is nothing more than attempt to generally link the product of nature to a particular technological environment.
With regards to the concentrations of the naturally occurring bacteria found in newly amended claim 131, it is noted that an otherwise ineligible item (e.g. a unicorn) is not transformed into eligible subject matter by merely aggregating it (i.e. a herd of unicorns would also not be eligible); also see Funk Brothers Seed Co. v. Kalo Inoculant Co. 333 U.S 127 (1948)).
STEP 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
NO, the claimed invention is directed to the judicial exceptions of a law of nature and/or natural phenomena without significantly more. With regards to the “pharmaceutically acceptable carrier” in newly amended claim 131, the carrier encompasses water and there is no indication that this additional element changes any structural of functional feature of the judicial exception per se; thus all components function as they would individually (i.e. each species of naturally occurring bacteria). Therefore, taken alone, the additional element does not amount to significantly more than the above identified judicial exception (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 (i.e. “a pharmaceutically acceptable carrier”) is also recited at a high level of generality and is a well-understood, routine, conventional activities already engaged in by the scientific community. Consequently, the additional element is not sufficient to make the judicial exception eligible for patent protection.
Further, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because merely formulating the composition into a pharmaceutical composition, or kit, or dose, does not add significantly more to the exception. Note that merely because a particularly combination of bacteria or microbes is not found to co-exist together in nature is not the standard for demonstrating a marked difference (MPEP 2106.04; and Funk Brothers Seed Co. v. Kalo Inoculant Co. 333 U.S 127 (1948)).
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 (i.e. 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 as amended, claim 131 recites the amount of viable cells comprised in the claimed composition and thus the instant claims are not directed to natural products (e.g. microbe consortia) because they recite pharmaceutical compositions including a particular amount of the recited cells (e.g., from about 5 X 10⁹ to about 5 X 10¹² viable cells) as well as a pharmaceutically acceptable carrier and these characteristics differ from any alleged corresponding natural product as it appears in nature; see Remarks, page 8; it is again noted that merely collecting (i.e. concentrating) a product of nature (i.e. each naturally occurring bacterial species), does not structurally or functionally change the product of nature per se. Therefore, this argument is not persuasive because each naturally occurring bacterial species appears to be identical to its natural counterpart, in its natural state, as evidenced by the specification (see above) and the claims, which do not require any type of modification thereto. Consequently, there is no evidence of record that there are any markedly different characteristics of the claimed bacterial species and therefore the judicial exception is not integrated into a practical exception. With regards to the additional element of a generically claimed “pharmaceutically acceptable carrier”, it is again noted that this additional element is not sufficient to amount to significantly more than the judicial exception because there is no evidence of record that the carrier changes any structural or functional features of the naturally occurring bacteria (i.e. the JE is not markedly different from its natural counterpart in its natural state) and this additional element is also recited at a high level of generality and is a well-understood and routine. Thus, these arguments are not persuasive because the naturally occurring bacteria are the handiwork of nature and not one of a human-made invention, as set forth above.
With regards to the argument that the claimed compositions have different characteristics than any alleged corresponding natural product as it appears in nature; Remarks, page 8; this argument is not persuasive because Applicant has failed to identify what these characteristics are, again noting that merely collecting the bacteria is not sufficient.
With regards to the argument that the compositions can be used in a manner that the natural product as it appears in nature cannot; see Remarks, page 8; this argument is not persuasive because Applicant’s claims are drawn to products and not methods.
With regards to the argument that the claimed compositions are not "directed to" the natural product at least because certain phyla are excluded; see Remarks, page 8, this argument is not persuasive because it has nothing to do with the phyla that are included. Further, the claims do not exclude Fusarium just because it is not positively recited (i.e. see transitional phrase “comprising”). Thus, it remains the Office’s position that each naturally occurring bacterial species claimed is a product of nature and that merely aggregating naturally occurring bacteria is not sufficient to convert otherwise ineligible subject matter into eligible matter, as set forth above.
With regards to the argument that the claimed compositions inappropriately monopolize any alleged corresponding natural product at least because the claims recite particular amounts that differ from the amounts of cells present in the human gut. In other words, by reciting certain amounts of cells along with additional carriers, the claims as amended do not "monopolize the law of nature itself." See Vanda, 887 F.3d at 1144; see Remarks pages 8-9; it is noted that while preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility. Therefore this argument is not persuasive.
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. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
11. 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.
12. 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.
13. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARY MAILLE LYONS/Examiner, Art Unit 1645
March 9, 2026