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 .
Claim Amendment
2. The amendment filed January 15, 2026 has been entered. Claims 1, 10, and 22 were amended. Claims 26, 28, 30-31, 33-36 were withdrawn. Claims 4-9, 11-12, 15, 18, 20-21, 23-24, and 29 are canceled. New claim 37 was added. Claims 1-3, 10, 13-14, 16-17, 19, 22, 25, 27, 32 and 37 are pending in this Office Action.
Election/Restrictions
3. Claims 26, 28, 30-31 and 33-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Information Disclosure Statement
4. The information disclosure statement (IDS) submitted on Jan 15, 2026 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Claim Rejections
5. The rejection of claim 22 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of applicants amendment.
6. The rejection of claims 1, 10, 13-14, 16-17, 19, 22, 25 and 27 under 35 U.S.C. 102(a)(2) as being anticipated by Allen-Vercoe are withdrawn in view of applicants amendment.
7. The rejection of claims 1, 10, 13-14, 16-17, 19, 22, 25 and 27 under 35 U.S.C. 102(a)(2) as being anticipated by Ford et al., are withdrawn in view of applicants amendment.
8. The rejection of claims 1-3, 10, 13-14, 16-17, 19, 22, 25, 27 and 32 under 35 U.S.C. 103 as being unpatentable over Million et al., in view of Henn et al., are withdrawn in view of applicants amendment.
Maintained Grounds of Rejection
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.
9. Claims 1-3, 10, 13-14, 16-17, 19, 25, 27, 32 and 37 are rejected under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claims 1-3, 10, 13-14, 16-17, 19, 25, 27, 32 and 37 are determined to be directed to natural products and do not recite something “significantly different” than the natural product. Natural products are “judicial exemptions”. The rationale for this determination is explained below:
Claims 1-3, 10, 13-14, 16-17, 19, 25, 27, 32 and 37 are drawn to a composition comprising isolated bacteria from at least four bacterial species wherein the bacteria from the first species comprise a 16S rDNA sequence having at least 98.7% sequence identity with a nucleic acid sequence according to SEQ ID NO: 1, the bacteria from the second species comprise a 16S rDNA sequence having at least 98.7% sequence identity with a nucleic acid sequence according to SEQ ID NO: 2, the bacteria from the third species comprise a 16S rDNA sequence having at least 98.7% sequence identity with a nucleic acid sequence according to SEQ ID NO:3 and the bacteria from the fourth species comprise a 16S rDNA sequence having at least 98.7% sequence identity with a nucleic acid sequence according to SEQ ID NO: 5 wherein the composition is formulated for oral or rectal administration.
Bifidobacterium adolescentis is the strain of SEQ ID NO:1, Christensenellaceae R-7 group is the strain of the SEQ ID NO:2, Senegalimassilia anaerobia JC110 is the strain of SEQ ID NO:3 and Bifidobacterium pseudocatenulatum is the strain of SEQ ID NO:5. Each bacteria and sequence is naturally occurring. The Bifidobacterium adolescentis and Bifidobacterium pseudocatenulatum are closely related species of Bifidobacterium that are common in the human gut and feces. Senegalimassilia anaerobia JC110 is an obligate anaerobe, mesophilic bacterium isolated from human feces of a healthy patient. Christensenellaceae R-7 group is a collection of bacteria consistently within the human gut microbiome and human feces, associated with positive health outcomes. All of the recited bacteria strains are not “markedly different” in structure than naturally occurring Bifidobacterium adolescentis, Bifidobacterium pseudocatenulatum, Senegalimassilia anaerobia JC110, and Christensenellaceae R-7 group.
The dependent claims includes SEQ ID NO:4 which is Prevotella copri, SEQ ID NO:10 which is Slackia isoflavoniconvertens, and SEQ ID NO: 11 which is Bifidobacterium adolescentis. All of these bacteria are naturally found in human feces.
Thus the bacterial strains are all naturally occurring and naturally found together. Therefore, all of the ingredients of the instantly claimed composition are therefore not markedly different from their counterparts found in nature.
These claims fail to satisfy the non-naturally occurring requirement. Furthermore, there is no structural difference because of the mere aggregation of the natural occurring Bifidobacterium adolescentis, Bifidobacterium pseudocatenulatum, Senegalimassilia anaerobia JC110 and Christensenellaceae R-7 group. Combining the components together as a composition does not change the structure of the naturally occurring ingredients. The composition being formulated for oral or rectal administration does not add any additional components to the composition. An isolated bacteria does not change the structural identity of Bifidobacterium adolescentis, Bifidobacterium pseudocatenulatum, Senegalimassilia anaerobia JC110, and Christensenellaceae R-7 group.
Additionally, the product claims as a whole do not recite something significantly different from the judicial exceptions because the additional components do not impose meaningful limits on the claim scope therefore substantially all practical applications of the judicial exception are covered. Moreover, the additional elements in dependent claims such as pharmaceutical carrier are recited at a high level of generality, and/or are well-understood, purely conventional and routine in the field, and/or are merely appended to the judicial exception without a significant change in the structure of the judicial exception itself as evidenced by the prior art recited within the rejections. Naturally occurring pharmaceutical carriers are biocompatible, biodegradable, and low-toxicity materials derived from plants, animals, or microorganisms that transport active compounds. Key examples include exosomes, albumin, lipids (cocoa butter), and polysaccharides (chitosan, starch).
If the applicant chooses to amend the instant claims, the examiner recommends that applicant consider the U.S. Supreme Court ruling that the additional steps should consist of more than well-understood, routine, conventional activity already engaged in by the scientific community. Such putative additional steps, when viewed as a whole, might add nothing significant beyond the sum of their parts taken separately. The Court has made clear that to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words "apply it." Essentially, appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patent-eligible.
The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). The unpatentability of natural products was confirmed by the U.S. Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U. S. (June 13, 2013). Also see the December 4, 2014 and May 4, 2016 Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena, & Natural Products (the Guidance).
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 therefore rejected as ineligible subject matter under 35 U.S.C. 101.
Response to Arguments
10. Applicant's arguments filed January 15, 2026 have been fully considered but they are not persuasive.
Applicants argue that the Office failed to establish that bacteria are directed to natural products and do not recite something “significantly different” than the natural product. Natural products are “judicial exemptions”. In this case, Senegalimassilia anaerobia JC110 is an obligate anaerobe, mesophilic bacterium isolated from human feces of a healthy patient. Christensenellaceae R-7 group is a collection of bacteria consistently within the human gut microbiome and human feces, associated with positive health outcomes. Bifidobacterium adolescentis is a naturally occurring, anaerobic bacterium, considered a core member of the healthy human adult gut microbiota, particularly in the large intestine where it plays a crucial role in gut-brain axis interactions by producing GABA and is recognized for its beneficial impact on gut health. Bifidobacterium pseudocatenulatum is a beneficial, gram-positive, anaerobic bacterium that naturally resides in the human gastrointestinal tract. This is the dominant Bifidobacterium species found in the feces of both healthy infants and adults, and is known for its role in maintaining gut health.
Applicants argue that the bacteria are 1) isolated 2) rectal administration in combination with a pharmaceutically acceptable excipient and 3) the composition is formulated for oral and rectal administration. However, isolation of bacteria does not recite something “significantly different” than the natural bacterial product. The structural characteristics of the bacteria are exactly the same. Next applicants assets rectal administration in combination with a pharmaceutically acceptable excipient changes the bacterial to something structural different that the natural bacteria strain. Rectal administration is not a requirement of the composition claim. Claim 1 does not recite the inclusion of any pharmaceutically acceptable excipient. At best only claim 19, recites the inclusion of a pharmaceutical carrier. Furthermore, naturally occurring pharmaceutical carriers do not change the structure of the bacteria. Key examples include exosomes, albumin, lipids (cocoa butter), and polysaccharides (chitosan, starch); none of these carriers recite something which changes the bacteria to a “significantly different” form than the natural bacterial product. Therefore this argument is not persuasive.
Applicants point to the pomelo juice example. Applicants attention is directed to the Pomelo Juice example where the composition comprises pomelo juice and an effective amount of an added preservative. The instant claims do not comprise any preservatives. The example clearly teaches the preservative affects the juice so that it spoils much more slowly (spoils in a few weeks) than the naturally occurring juice by itself (spoils in a few days). This property (slower spoiling) of the claimed combination is markedly different from properties of the juice by itself in nature. Accordingly, the instant claims do not include any natural or non-natural preservatives that change any properties of the naturally occurring bacteria. Thus the instantly claimed composition does not have markedly different characteristics, and is a “product of nature”.
It is suggested that Applicants review the “Bacterial Mixtures” Example. In this case, there is no indication in the specification that the claimed mixture of bacteria has any characteristics (structural, functional, or otherwise) that are different from the naturally occurring bacteria. Thus, the mixture does not have markedly different characteristics from what occurs in nature, and is a “product of nature” exception. Accordingly, the claim is directed to an exception (Step 2A: YES). Because the claims do not include any additional features that could add significantly more to the exception (Step 2B: NO), the claims do not qualify as eligible subject matter, and remain rejected under 35 U.S.C. § 101.
Applicants point to the amended claim language “…formulated for oral or rectal administration.” However this language does not add include any additional components nor does it incorporate any non-naturally occurring structure to the composition. For instance, dried formulation does not change the structural or functional characteristics of any of the bacterial strains. Applicants point out that the composition can be used to treatment UC or Crohn’s Disease. However, the intended use of the composition does not change or affect the structure or function of the bacterial species. Applicant’s examples points to how the composition can affect a recipient of the composition. The affects of recipients does not change the naturally occurring bacterial strains.
Finally, Applicants urge that the present claims are directed to an inventive concept that is significantly more than any judicial exception. In response, because the claims do not include any additional features that could add significantly more to the exception (Step 2B: NO), the claims do not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101. The inoculant of claim 1 was held to be ineligible subject matter in Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 131 (1948): Discovery of the fact that certain strains of each species of these bacteria can be mixed without harmful effect to the properties of either is a discovery of their qualities of noninhibition. It is no more than the discovery of some of the handiwork of nature and hence is not patentable. The aggregation of select strains of the several species into one product is an application of that newly-discovered natural principle. But however ingenious the discovery of that natural principle may have been, the application of it is hardly more than an advance in the packaging of the inoculants. Each of the species of root-nodule bacteria contained in the package infects the same group of leguminous plants which it always infected. No species acquires a different use. The combination of species produces no new bacteria, no change in the six species of bacteria, and no enlargement of the range of their utility. Each species has the same effect it always had. The bacteria perform in their natural way. Their use in combination does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee. The Supreme Court looked back to this claim as an example of ineligible subject matter, stating that “the composition was not patent eligible because the patent holder did not alter the bacteria in any way.” Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. __, 133 S. Ct. 2107, 2117 (2013) (“Myriad”).
With respect to a citation/publication that demonstrates the well understood conventional nature of the additional elements to known in the art. Specifically, Henn et al., (US20140199281 published July 2014; priority to Nov 2013) teach bacterial composition comprises at least about 3, 4, 5, 6, 7, 8, 9, or 10 types of isolated bacteria [para 8]. Using well known techniques, in order to determine the full 16S sequence or the sequence of any hypervariable region of the 16S sequence, genomic DNA is extracted from a bacterial sample, the 16S rDNA (full region or specific hypervariable regions) amplified using polymerase chain reaction (PCR), the PCR products cleaned, and nucleotide sequences delineated to determine the genetic composition of 16S gene or subdomain of the gene [para 68]. Specifically, the patient is administered a bacterial composition containing two bacterial types from Table 1 or Table 3, or a combination from Table 2, at a dose of 108 bacteria total in a lyophilized form formulated in an enteric coated capsule [para 220]. The combination composition is for oral and rectal administration Table 1 recites Bifidobacterium adolescentis, Bifidobacterium pseudocatenulatum, Christensenellaceae, Prevotella copri, Slackia isoflavoniconvertens, Eubacterium ventriosum, Barnesiella intestinihominis and Bacteroides stercoris thus teaching the claimed species. Therefore, Henn et al., clearly and specifically teach the well understood conventional nature of the combining multiple species of isolated bacterial species, with known sequences, into a composition for oral or rectal administration.
Therefore, none of applicants arguments are found persuasive and the rejection is maintained.
Pertinent Art
11. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Yatsunenko et al., (Nature 486, 222-227 (2012).
Yatsunenko et al., teach the human gut microbiome which differs among human populations and characterized the bacterial species in fecal samples from 531 individuals, plus the gene content.
Hutkins et al., (US20210069266 pub 2021-03-11; priority to 2020-04-17) teach 99.3% to SEQ ID NO:5
Conclusion
12. No claims allowed.
13. 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.
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JA-NA A HINES whose telephone number is (571)272-0859. The examiner can normally be reached Monday thru Thursday.
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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/JANA A HINES/Primary Examiner, Art Unit 1645