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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed 4/20/2026 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 reply and amendments filed on 3/23/2026 have been entered, per the instructions on the Request for continued examination filed 4/20/2026.
Response to Amendment
Applicant’s remarks and amendments filed 3/23/2026, in response to the final rejection mailed 12/23/2025, are acknowledged and have been fully considered.
Applicant’s amendment to the claims is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Claims 18 and 20-32 are pending and have been examined on the merits.
Any previous rejection or objection not explicitly mentioned herein is withdrawn.
Response to Arguments
Applicant's arguments in the reply filed have been fully considered.
Due to the Applicant’s amendments, the previous rejections under 35 U.S.C. § 112(a) have been withdrawn, as the new claims recite subject matter that is adequately described and supported by the filed specification.
Applicant’s arguments regarding the prior rejections under 35 U.S.C. §§ 112(b) and 101, as far as the arguments pertain to the pending claims, have been fully considered. The rejections under 112(b) have been withdrawn, however, upon further consideration, new and/or modified grounds of rejection are presented herein, as necessitated by Applicant’s amendments.
Claim Interpretation
As discussed in previous communications, the claims are drawn to a product or a composition. Thus, claim limitations regarding intended uses, functional properties, or desired results will be considered to be an intrinsic feature of the provided bacterial strains, and will be afforded the appropriate patentable weight. See e.g. MPEP § 2112.I.
Claim Objections - New
Claims 18 and 20 are objected to because of the following informalities:
There are errant parenthesis markings with no clear partner (i.e. open parenthesis without a corresponding closing marking, et cetera) in both claims 18 and 20. These include:
lines 15, 18, 27, 31, and 47 (last line) of claim 18; and
lines 5, 11, 13, 15, 17, and 19 (two occurrences) of claim 20.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) - New Rejections
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18 and 20-32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As amended, claim 18 recites “NaCl (125 mM/l), KCl (7 mM/l), NaHCO3 (45 mM/l), and pepsin (3 g/l)”, in lines 7-8. The use of parenthesis in the description of the concentrations for the composition of the gastric juice renders the claim scope unclear.
The resulting claims are considered indefinite because there is a question or doubt as to whether the concentrations recited in the parenthesis are (a) merely exemplary and therefore not required, or (b) a required feature of the claims. One would not be reasonably apprised of the scope of the invention, because it is impossible to determine whether these particular concentrations are required of the claim element.
Also, claim 18 recites the phrase “MC8 (L. plantarum DSM33363, DSM33364; L. paracasei DSM33375; L. reuteri DSM33374; B. megaterium DSM33300; and B. pumilus DSM33297”, which lacks the term “consists of” as used in the description of each of the other MC... consortiums. Because the claim limitation includes an open ended parentheses mark, without the use of a transitionary phrase, this alternative does not have a defined scope and the claim is indefinite. It is required to remove the open parenthesis (and also all other errant parentheses marks throughout the claim set, see objections above). This claim element should be amended to “MC8 consists of...”, to accurately recite the claimed subject matter.
Claim 20 recites the composition of claim 18, wherein the consortium comprises a “consortium of MC1, MC2, MC3, MC4, MC5, MC6, MC7, MC8, MC9, or MC16”. It is unclear whether claim 20 is meant to encompass only the individual consortiums of MC1, MC2, MC3, MC4, MC5, MC6, MC7, MC8, MC9, or MC16, each of which is selected separately, or if, because of the use of “comprising”, the claim encompasses all combinations of these consortiums. Because the metes and bounds of the claimed subject matter cannot be determined, the claim is indefinite. Correction is required (i.e. change the word “comprises” in line 2 to “consists of” if this was the intended meaning; but if mixtures of the consortiums were meant to be encompassed, then the claim should include “and combinations thereof” or similar language to remove the ambiguity).
Claim 21 has a similar issue as claim 20 above. Amended claim 21 recites:
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Claim 21 is indefinite because the claim recites that the consortium “comprises a consortium of MC4, MC8, or MC15, wherein MC4 (bacterial strains); MC8 (bacterial strains); or MC15 (bacterial strains).” The claim does not amount to a complete sentence, nor is there any specific requirement for MC4, MC8, or MC15 to have any particular structure or features. The use of parenthesis renders the claim scope indefinite. It is recommended to cancel the claim, or to recite an exact composition of the claims, as in claims 18 and 20.
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
Claim Rejections - 35 USC § 112(d) - Maintained
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 25 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 25 does not recite any limitations that further limit the subject matter regarding the composition of claim 18. There are no structural or functional limitations conveyed by 25. As best interpreted, claim 25 is reciting that gluten exists in the GI tract of certain subjects, which is not by any understanding able to limit the structure of the composition. Even if the claim was amended to be dependent upon one of claims 22-24, claim 25 would still fail to convey any further limits on the composition, as these merely amount to intended uses.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Response to Arguments
Applicant’s arguments, on pages 9-10 of the remarks filed 3/23/2026, with respect to the rejection of claim 25 under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, have been fully considered but they are not persuasive. Applicant states that the rejection is moot in view of the deletion of the term “the” to place the claim in proper dependent form. This argument is not persuasive because the rejection of claim 25 pertains to a lack of further limiting the claimed composition.
Claim 25, as currently presented, depends on claim 18. The composition of claim 18 is a consortium of bacteria strains, which can exist in any form, i.e. in a frozen state, in a test tube, in a food product, et cetera. There is no recitation of the bacteria consortium being in a gastrointestinal tract. The consortium is recited to have certain properties, including survival properties that are tested by the recited survival assay in simulated gastric juice. However, this is not the same as being administered or being present in a gastrointestinal tract.
Claim 25 only recites a general statement of fact, i.e. that gluten is present in the gastrointestinal tract of one of the recited subjects. The limitations of claim 25 have no relevance to the structure of the claimed composition and does not serve to further limit claim 18.
Applicant’s argument does not pertain to how the claim indeed limits the composition.
Claim Rejections - 35 USC § 101 - Maintained
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 18 and 20-30 are rejected under 35 U.S.C. 101 because the claimed invention is directed to natural phenomenon without significantly more. The claims recite a consortia of naturally occurring bacteria strains having functional properties that amount to naturally phenomenon.
For determining subject matter eligibility, the following analysis was considered, per MPEP § 2106.
Patent Eligibility Analysis Step 1: Step 1 requires determining whether the claims are directed to one of the four categories of subject matter recited in 35 U.S.C. 101. In this case, YES, all of the claims are directed to a composition of matter.
Patent Eligibility Analysis Step 2A Prong 1: Prong One requires evaluation of whether the claims recite a judicial exception (i.e., a law of nature, natural phenomenon, or abstract idea) is set forth or described in the claim.
Claim 18 recites a preparation comprising a consortia of at least a first acid and bile resistant Bacillus strain and a second bile and acid resistant Lactobacillus strain; wherein the bacterial strains in the consortia survive with a less than 2 log CFU loss in simulated gastric juice and survive with a less than 2 log CFU loss in intestinal bile acids, and are selected from the particular consortia MCI, MC2, MC3, MC4, MC5, MC6, MC7, MC8, MC9, MC10, MC11, MC12, MC13, MC14, MC15 and MC16, as further defined therein.
The dependent claims recite this composition having natural bacteria and naturally occurring properties. Claim 27 recites additional naturally occurring bacteria, namely Pediococcus sp. and Weissella sp. Claims 28 and 29 recite the presence of naturally occurring microbial proteases, including the microbial-produced proteases subtilisin and/or nattokinase. Claim 30 recites additional naturally occurring materials. Claim 31 and 32 recite naturally occurring matrices including alginate, agar, cellulose, or chitosan (see specification, pg. 8).
The B.R.I. of the claimed preparation thus encompasses naturally occurring strains of Bacillus and Lactobacillus (as well as additional natural products).
Therefore, the claims recite a judicial exception, namely a consortia of naturally occurring bacteria which are products of nature.
In this case, the claims encompass combinations of naturally occurring bacteria strains (as well as compositions including additional naturally occurring products), having functional properties that are natural phenomenon due to the intrinsic properties of the bacteria. No genetic modifications or other manipulations to the strains are disclosed. Therefore the claims recite a judicial exception, a product of nature.
When a claim recites a natural product limitation, the markedly different characteristics (MDC) analysis is used to determine whether the natural product has markedly different characteristics from its natural counterpart (see MPEP 2106.04(c)).
The first step in the MDC analysis requires selecting the appropriate counterpart. In this case, the closest naturally occurring counterpart(s) are natural non-isolated strains of Bacillus and Lactobacillus, occurring as found in nature, such as in human intestines, which has clearly gastric juice and bile salts present too.
The second step in the MDC analysis requires selecting the appropriate characteristics for analysis. The appropriate characteristics for analysis can be expressed as the natural product’s structure, function, and/or other properties, and are evaluated on a case-by-case basis. In this case, the appropriate characteristics to compare the claimed bacterial strains with the closest naturally occurring counterparts include the structure/identity of the strain, as best determined typically using DNA sequencing, and functional characteristics of the strains.
The third step in the MDC analysis requires comparing the characteristics of the claimed natural product to its naturally occurring counterpart in its natural state, in order to determine whether the characteristics of the claimed product are markedly different. In this case, the claimed bacterial strains are to be compared with the bacteria strains as they exist in nature. Here there is no suggestion that the consortium of strains, as claimed, results in any marked difference in structure, function, or other properties. The following references from the art were consulted as evidence regarding the structure and functions of the natural microbiome.
Herrán et al. ("Gluten-degrading bacteria are present in the human small intestine of healthy volunteers and celiac patients." Research in microbiology 168.7 (2017): 673-684., on IDS filed 9/24/2024) characterizes the adult small intestine microbiota involved in gluten hydrolysis (abstract). Herrán states that “114 bacterial strains belonging to 32 species were isolated; 85 strains were able to grow in a medium containing gluten as the sole nitrogen source, 31 strains showed extracellular proteolytic activity against gluten protein and 27 strains showed peptidolytic activity towards the 33-mer peptide, an immunogenic peptide for celiac disease patients”. (Abstract). Herrán discusses that “The upper small intestine is a hostile environment for bacteria due to the presence of bile acids and low pH, among others. In this intestinal site, bacterial density is estimated to be around 104 cells/g of content” (page 679). However, there are clearly still some bacteria, which are naturally occurring, able to grow in this in vivo site.
Herrán describes a number of the bacteria strains occurring in small intestinal samples which include strains of the genus Bacillus including Bacillus licheniformis, B. subtilis/amyloliquefaciens and B. pumilus as well as multiple strains of Lactobacillus, including Lactobacillus brevis, L. casei, L. paracasei, and L. reuteri (Table 1 on pg. 677 and Fig. 1). These bacteria strains were identified by 16S rDNA sequencing (pg. 675, left col: 2.4 Bacterial identification) and were characterized with assays for gluten utilization and 33-mer hydrolysis activity. Strains of the above-described species were identified as having gluten hydrolysis and/or 33-mer peptide hydrolysis activity (Table 1, on pg. 677 and Fig. 2).
Alvarez et al. (WO 2015177366 A1), discloses a bacterial strain, Lactobacillus casei IPLA12038 with deposit number CECT 8590, and its use for the degradation of gluten, gliadin or derivative peptides (Abstract). Alvarez discloses that the strain survives the conditions of gastrointestinal stress, acid pH and high concentrations of bile salts, analyzed in vitro, which guarantees its prolonged persistence and effectiveness in the intestine after oral administration (pg. 5, lines 30-33, Fig. 3). Thus, the ability of certain strains to survival gastric acidic pH conditions and intestinal bile salt concentrations is a matter of natural properties, which are appreciated in certain strains.
Petri et al. (US PGPub No. 20170340683) describes a Bacillus subtilis strain DSM 32315 and its use as a probiotic (Title, Abstract). According to Petri, such a strain has the innate properties of surviving and being able to grow in presence of 2 mM bile, more preferably in presence of 4 mM bile ([0037]), and this strain survived simulated gastric passage ([0117]). Petri discusses that the strains were tested for survival and growth at low pH, indicating growth under stomach conditions ([0116]).
As evidenced as least from Alvarez and Petri, the recited gastric and intestinal survival abilities of a bacteria are innate characteristics, and the testing thereof does not transform or change the properties, just merely characterizes these natural properties.
Further, regarding the functional properties of gluten degradation, Caminero et al. ("Diversity of the cultivable human gut microbiome involved in gluten metabolism: isolation of microorganisms with potential interest for coeliac disease." FEMS Microbiology Ecology 88.2 (2014): 309-319., on IDS filed 9/22/2022) describes the isolation and characterization of human gut bacteria involved in the metabolism of gluten proteins (Abstract). According to Caminero, “144 strains belonging to 35 bacterial species that may be involved in gluten metabolism in the human gut were isolated. Interestingly, 94 strains were able to metabolize gluten, 61 strains showed an extracellular proteolytic activity against gluten proteins, and several strains showed a peptidasic activity towards the 33-mer peptide” (Abstract). The bacteria strains of Caminero were isolated and identified by 16S rDNA sequencing (pg. 310, right col). The strains discussed in Caminero include naturally-occurring strains of Bacillus and Lactobacillus which have varying amounts of proteolytic activity against gluten and gluten-derived peptides (Fig. 2, Table 1, and pg. 313, left col, third paragraph).
The evidence in the art suggests that functional properties such as survival and effects on gluten degradation, including peptide hydrolysis, are natural properties of the bacteria strains, as they exist in nature. The instantly claimed compositions have these same properties, and have been identified via sequencing, and thus are genetical the same as those occurring naturally.
To show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart (see MPEP 2106.04 (C)(II)(c)). The act of isolation does not change a microbial strain; it merely obtains prior naturally-occurring bacteria in a way that allows isolation to a pure colony from the mixture of strains present in nature. The combination of the bacteria strains amounts to no more than a predictable combination of said strains and their functional properties.
No manipulations or changes to the bacteria strains are recited in the claims and no changes to the strains are disclosed in the instant application. The survival under simulated gastric and intestinal conditions is another innate property of the bacteria and the act of selecting strains having favorable properties does not result in any markedly different characteristics.
Because there is no indication in the record that composition of the claimed strains possess a marked difference in structure, function, or other properties compared to the natural counterparts, the claimed consortia is a product of nature exception (claims 18 and 20-32: YES).
Patent Eligibility Analysis Step 2A Prong 2: Prong Two requires evaluating whether the claim recites additional elements that integrate the judicial exception into a practical application.
This judicial exception is not integrated into a practical application because the claims do not require any directed application or practical use of the claimed product of nature.
Claim 18 is drawn to a consortium of bacteria strains, and the B.R.I. of the claim encompasses the strains of bacteria as they exist in nature. The amended claim recites specific groupings of natural bacteria to choose among, as previously recited in the now-canceled claim 19, yet these are all naturally occurring strains, absent any evidence contrary to this fact. The claim recites innate characteristics of these bacterial strains, which are all naturally occurring properties. There is no evidence that combining the strains impart any new characteristics arising from the combination, not due to natural individual properties. No additional elements are present and there is no recited practical application (i.e. a method of administering for a particular treatment). Claims 20 and 21 further limit the strains that comprise the consortia, but do not recite additional elements that implement the exception into any practical application.
A composition having a number of natural products is not a specific application of the ineligible natural products, regardless of how they were “selected” which amounts to an ineligible mental process. Further, large amounts of bacteria species are known to coexist in a subject or a niche (i.e. a microbiota). The coexistence of many different, naturally occurring strains of lactic acid bacteria does not render the natural product eligible subject matter eligible.
Thus, claims 18 and 20-21 do not recite any additional structural elements, or particular methods, other than a consortia of ineligible natural bacteria strains and intrinsic properties of the strains, and these claims do not integrate the natural product into a practical application.
Claims 22-25 recite additional limitations that amount to innate functional properties and intended uses of the preparation. No structural limitations that further limit the preparation are recited. Having a sufficient concentration of something does not change the fact that the properties of the natural substances are also naturally occurring. The claims do not recite any method steps or practical application of the natural product (e.g. administering the consortia), merely, the claims are drawn to the natural product and recite intended uses.
Claim 26 recites that the strains are present in a dormant form or as vegetative cells. This does not amount to a practical application, merely this represents a recitation of a form or status of the naturally occurring bacteria, both forms of which occur in nature. The B.R.I. of the claim encompasses the product of nature exceptions, in natural dormant or growing states, and the additional limitations do not integrate the exception into a practical application.
Claim 27 recites that the preparation may further comprise a strain of Pediococcus sp. or Weissella sp., which are additional products of nature. The ineligible natural product is not implemented into any particular application or practical method. Claims 28-30 recites that the preparation may further comprise a microbial protease or one of the additional substances recited therein, which are each products of nature themselves. Thus, these do not amount to any specific application of the natural product.
Claims 31 and 32 recite that the strains comprising the consortia are immobilized (either together or individually). However, the acts of “immobilizing” as recited does not result in any measurable change or transformation to the bacteria, merely that they are immobilized (i.e. on a solid surfaces such as cellulose, agar, or alginate and thus trapped within a porous matrix). The B.R.I. of the porous matrix includes cellulose, polysaccharides and agar, which are naturally occurring substances, (pg. 8, last ¶ of the specification), and the combination of the claimed elements does not amount to a practical application of the claimed natural product.
Claims 18 and 20-32 do not recite any particular application of the judicial exemption, instead the claims only recite additional elements that amount to functional properties of the bacteria, intended uses, or additional naturally-occurring materials (Claims 18 and 20-32: NO).
Patent Eligibility Analysis Step 2B: Step 2B requires evaluating whether the claims recite additional elements that amount to significantly more than the judicial exception.
As discussed previously, no additional structural elements or transformations to the bacteria are recited for claim 18. The claim only recites ineligible consortia of specific bacterial strains and natural innate properties thereof. The strains are all naturally-occurring unmodified organisms, and the claims do not amount to significantly more than the judicial exception, even if provided as a combination.
The claims also recite functional properties of the strains that amount to naturally occurring properties or intrinsic functional characteristics. These include the amount of degradation of gluten and gluten peptides, a certain amount of enzymatic activity, and properties pertaining to survival under harsh conditions (i.e. in stomach acid or with bile salts). These limitations are not practically transforming a structure of the bacterial strains or the consortia comprising said strains, they do not amount to significantly more than the judicial exception. This amounts to testing the natural products, to find and use characteristics endowed by nature.
Claim 26 recites that the strains are present in a dormant form or as vegetative cells. This does not amount to a practical application, merely this represents a recitation of a form or status of the naturally occurring bacteria, which also occurs in nature under certain conditions, and thus does not amount to significantly more than the natural product.
Regarding claim 27, Caminero et al. (2014, FEMS Microbiology Ecology, of record) discloses a naturally occurring Pediococcus acidilactici strain having gluten hydrolysis activity (Table 1 and pg. 313, left col, third paragraph). The entirety of claim 27 is thus directed to natural products (judicial exceptions) and does not recite any further elements that amount to significantly more than the natural products.
Regarding claims 28-30, the claims do not recite a practical application of the consortium, only additional natural elements that may further comprise the preparation. The compounds includes naturally-occurring enzymes, i.e. bacterial-derived proteases, and other natural products, with no further manipulations or additional elements that would amount to significantly more than the natural product. Claim 28 and 29 recite the presence of “purified proteases” to the composition, however these are all naturally-occurring enzymes, and the purification and use of such proteins represents well-understood, routine, and conventional activity which does not transform the claims into significantly more than a combination of naturally-occurring products. Further, there is no markedly different characteristic between a purified protease and one that is secreted by one of the lactic acid bacteria of the composition.
Of note, Bacillus subtilis is a known source of the proteases subtilisin and/or nattokinase (belonging to E.C. 3.4.21.62), as evidenced from Nguyen et al. (“Cloning and enhancing production of a detergent- and organic-solvent-resistant nattokinase from Bacillus subtilis VTCC-DVN-12-01 by using an eight-protease-gene- deficient Bacillus subtilis WB800.” Microbial cell factories vol. 12 79. 10 Sep. 2013), which states that “most known nattokinases/subtilisins are secreted by various Bacillus species including B. amyloliquefaciens, B. licheniformis, B. subtilis, and B. amylosacchariticus.” (see page 2, left col 1st paragraph). Thus, these are clearly naturally occurring enzymes, with no recited modification or transformation. Further, the claimed bacteria of the instant invention include species known to produce these bacterial proteases. The presence of a bacterial protease in the composition does not differentiate the claimed composition from a naturally occurring mixture.
Claim 31 and 32 recite that the strains comprising the consortia are immobilized, using a porous matrix (includes agar or a polysaccharide matrix) or with cellulose or chitosan (claim 32). The act of “immobilizing” as recited does not result in any measurable change or transformation to the bacteria, merely that they are immobilized (i.e. on a solid surfaces such as cellulose or trapped within a porous matrix including naturally occurring matrices).
No effect on the natural product, as measured by its composition or its functional properties, when compared to the naturally-occurring counterpart would be imparted simply by the process of the immobilization. Further, even if immobilization could be considered an additional element that changes the bacteria strains (i.e. if the immobilization could be considered a structural change), then such immobilization does not amount to anything more than well-known, routine, and conventional activity to the field. See, for example, the review article Mitropoulou et al. (“Immobilization technologies in probiotic food production.” Journal of nutrition and metabolism vol. 2013 (2013): 716861, of record) which discusses in detail well-known and routine methods of immobilizing microbial cells for using in probiotic foods (particularly Abstract, Introduction, and Figure 1 therein).
Therefore, when considered in light of the specification, and when considering the full breadth of the claimed subject matter, claim 18 and 20-32 do not recite any additional elements that are sufficient to amount to significantly more than the judicial exception, when the claims are considered as a whole (claims 18 and 20-32: NO).
Claims 18 and 20-32 are not patent eligible and remain rejected under 35 U.S.C. § 101.
Response to Arguments
Applicant’s remarks on pages 10-12 of the remarks filed 3/23/2026 have been fully considered but are not considered persuasive. The rejections have been modified to address the amended limitations in the claims. The subject matter of the amended claims have been found to be directed to patent-ineligible natural products.
Applicant argues that the specific combinations of bacteria (e.g. those of MC1-16) result in compositions that have markedly different characteristics than the individual bacterial strains. This argument is not convincing. Applicant has not specifically pointed out any characteristic that is markedly changed when compared to the naturally occurring bacteria. In fact, the characteristics that are said to be selected for are natural innate features, e.g. properties of nature.
To show a marked difference, a characteristic must be changed as compared to nature, and cannot be an inherent or innate characteristic of the naturally occurring counterpart or an incidental change in a characteristic of the naturally occurring counterpart (MPEP 2106.04 (C)(ll)(c)).
The combining of bacteria strains amounts to no more than a predictable combination of said strains and their natural properties. No manipulations or changes to the bacteria strains are recited in the claims and no changes to the strains are disclosed in the instant application. Applicant discusses a selection process to arrive at the combinations, however this amounts to only an ineligible mental process, which are also not required of the claim. Survival under simulated gastric and intestinal conditions is an innate property of the bacteria strains and the act of selecting strains having favorable properties does not itself result in any markedly different characteristics to the bacteria.
Applicant argues that no prior art demonstrates these particular bacteria strains together. In response it is noted that subject matter eligibility is distinct from the requirements of an invention to be novel and non-obvious (see MPEP 2106.05: "As made clear by the courts, the '"novelty' of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the§ 101 categories of possibly patentable subject matter." Intellectual Ventures Iv. Symantec Corp., 838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188-89, 209 USPQ at 9). See also Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016)" ).
The Examiner finds that the previously cited NPL references Herran et al. (Research in microbiology, 2017, of record) and Caminero et al. (FEMS Microbiology Ecology, 2014, of record), describe the isolation and characterization of human intestinal bacteria involved in the metabolism of gluten proteins and together provide evidence that the argued features are properties of bacteria which are known inhabitants of intestines. The discovery or recitation of innate properties- themselves natural phenomena- does not render the claimed products markedly distinct from naturally occurring bacteria strains, which also have these characteristics.
Combining natural products does not remove the claims from reading upon a judicial exception (see Funk Brothers Seed Col. V. Kala lnoclulant Col. - 333 U.S. 127 (1948)) because there is no evidence of a marked difference brought about by combining the instantly claimed bacteria strains. See MPEP § 2106.04(b)(II), and 2106.04(c)(ll)(C).
Further, although Applicant argues a particular practical application in degrading gluten, perhaps in the gastrointestinal tract of a subject, this is not recited or required of the claims. The claims at hand only recite that the consortia are capable of the degradation, which does not amount to a practical application. The examined claims are directed to the composition and not to a method including administering the composition. The recitation of an intended use does not practically integrate the ineligible natural product into a specific application.
As previously set forth in the communication mailed on 4/2/2026, to recite a practical application it is suggested that claims 23 and 24 are amended to recite that the composition degrades gluten upon the administration of the composition to a subject (e.g. a specific patient population) in a sufficient amount to achieve the desired degradation. It is suggested that reciting all of these recommended limitations of claims 23 and/or 24 above (i.e. specific administration and an effective amount) together with the limitations of 25 in the independent claim 18 may amount to significantly more than the ineligible product, when considered as a whole.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW TERRY MOEHLMAN whose telephone number is (571)270-0990. The examiner can normally be reached M-F 9am-5pm EST.
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/A.T.M./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
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