DETAILED ACTION
Status of claim rejections
The 35 U.S.C. 112(a) rejection of record is withdrawn in view of Applicant’s Affidavit in the response filed 01/09/2026.
The 35 U.S.C. 101 rejection of record is maintained in view of Applicant’s amendments/arguments in the response filed 01/09/2026.
The 35 U.S.C. 102/103 rejection of record is maintained and modified in view of Applicant’s amendments/arguments in the response filed 01/09/2026.
This Action is Final, as necessitated by Applicant’s amendments.
Maintained/Modified 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.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (natural product) without significantly more. This judicial exception is not integrated into a practical application and the claim(s) do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
Step 1 (Statutory Category): This part of the eligibility analysis evaluates whether the claim falls within any statutory category. Here, the claims recite a compound microbial inoculum. This is a composition of matter, therefore the claim falls within a statutory category of invention. [Step 1: YES]
Step 2A (Judicial Exceptions), Prong 1: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. A claim “recites” a judicial exception when the exception is “set forth” or “described” in the claim (see MPEP 2106.04(II)). Because the claim recites a nature-based product limitation, the markedly different characteristics analysis is used to determine if the nature-based product limitations are a product of nature exception (see MPEP 2106.04(c)(I)). This analysis is performed by comparing the nature-based product limitations in the claims to its naturally occurring counterparts to determine if it has markedly different characteristics (see MPEP 2106.04(c)(II)).
Claim 1 requires, inter alia, “a compound microbial inoculum with bacteriostatic effect, wherein the compound microbial inoculum comprises Lacticaseibacillus rhamnosus FMBL L23004 CNN and Lactiplantibacillus plantarum FMBL L23036 CNN . . . mixed together in a ratio of 1:1” (aka Lactobacillus rhamnosus and Lactobacillus plantarum, respectively). The specification does not indicate where the strains were isolated from (e.g., the intestine). However, absent evidence to the contrary, the examiner is interpreting the instantly claimed strains to encompass the naturally occurring forms. The term “inoculum” has been interpreted under broadest reasonable interpretation (BRI) to mean a population of microorganisms or cells (i.e., that is introduced in a fermentation medium or any other suitable medium. The appropriate natural counterpart to the microbial inoculum composition is naturally occurring Lactobacillus rhamnosus and Lactobacillus plantarum bacterial cells. The second step in the analysis requires identifying appropriate characteristics to compare. In this case, the appropriate characteristics pertain to the physical, structural, and functional characteristics of the bacterium.
de Vries et al (Lactobacillus plantarum—survival, functional and potential probiotic properties in the human intestinal tract. International Dairy Journal 16 (2006) 1018–1028) evidences “L. plantarum is a versatile lactic acid bacterium, that is encountered in a range of environmental niches including dairy, meat and many vegetable fermentations (Table 1). Moreover, it is commonly found in the human gastrointestinal-tract (GI-tract). Furthermore, . . . L. plantarum has the coding capacity for the uptake and utilization of many different sugars, uptake of peptides, and formation of most amino acids. The large number of surface-anchored proteins suggests that L. plantarum has the potential to associate with many different surfaces and potential substrates for growth. In addition, the relatively high number of genes encoding regulatory functions indicated the ability to adapt to many different conditions.” (see pg. 1019, col 2). Thus, the Lactobacillus plantarum as claimed contains no markedly different characteristics from the naturally produced occurring Lactobacillus plantarum bacterial cells with respect to structure, function, or any other characteristic that would distinguish it from its naturally occurring counterpart.
Mathipa et al (Lacticaseibacillus rhamnosus: A Suitable Candidate for the Construction of Novel Bioengineered Probiotic Strains for Targeted Pathogen Control. Foods. 2022 Mar 8;11(6):785) evidences that “Lacticaseibacillus rhamnosus, formerly known as Lactobacillus rhamnosus, has been widely studied. Selected strains belonging to L. rhamnosus species are extensively used as probiotics in food formulations, health, and functional foods. The L. rhamnosus strain GG (Gorbach–Goldin), one of the most well-documented probiotic microorganisms, originally isolated from faecal samples of a healthy human adult, has been identified as a potential probiotic strain. It has been deemed a probiotic because of its resistance to acid and bile as well as its good growth characteristics that allow it to survive and persist within the gastrointestinal tract. It has also been reported to be highly resistant to technological processes and has a great adhesion capacity to the intestinal epithelial layer to subsequently inhibit the growth and adherence of several pathogens. Lacticaseibacillus rhamnosus can survive and thrive through the gastrointestinal tract while adhering to the intestinal epithelial cells. This strain has been displayed as an excellent mucus-adhering Lactobacillus strain when compared to related strains such as Lactobacillus johnsonii LJ1 and Lacticaseibacillus casei Shirota. Additionally, Martín et al. reported that it is able to form biofilms, enhancing its ability to protect and strengthen the cytoskeleton integrity to inhibit pathogen colonization.” (see pg. 1-2).
The specification (see paragraph 0006) further recognizes Lacticaseibacillus rhamnosus LGG (i.e., the same genus and species of the claimed L. rhamnosus) can regulate the maturation and differentiation of dendritic cells and the secretion of inflammatory factors. Thus, the inoculum composition as claimed contains no markedly different characteristics from the naturally produced occurring Lactobacillus rhamnosus and Lactobacillus plantarum bacterial cells with respect to structure, function, or any other characteristic that would distinguish it from its naturally occurring counterpart. The structure and function of the claimed occurring Lactobacillus rhamnosus and Lactobacillus plantarum bacterial cells are the same as the naturally occurring counterpart.
Furthermore, the claimed “bacteriostatic effect” recited I claim 1 is, absent evidence to the contrary, inherent to each of the strains individually, as nothing in the instantly filed specification suggests that the bacteriostatic effect occurred when the strains were combined together or any synergy. Nothing new flows from the “hand of man” action of combining the two naturally occurring strains. [STEP 2A, Prong 1: YES]
Thus, the claim recites a judicial exception, a natural product. Therefore, the analysis proceeds to Step 2A Prong 2.
Step 2A (Judicial Exceptions), Prong 2: This part of the eligibility analysis evaluates whether the claims as a whole integrate the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claims beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claims as a whole integrate the exception into a practical application. Claim 1 is limited to only the judicial exception (naturally occurring Lactobacillus rhamnosus and Lactobacillus plantarum). In this regard, the claims fail to recite any additional elements that integrate the judicial exception natural product into a practical application. [Step 2A, Prong 2: NO]
Step 2B (Significantly More): This part of the eligibility analysis evaluates whether the claims as a whole amount to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (MPEP 2106.05). The claimed composition does not add a meaningful limitation or extra-solution activity to the claimed product, and the product as a whole is nothing more than an attempt to generically link the product of nature to a particular technological environment (e.g., culturing or fermentation of bacterial cells). Furthermore, the claimed ratio of bacteria fail to add anything more to the judicial exception because nothing new flows from the “hand of man” action of combining the two naturally occurring strains in a ratio of 1:1.
Thus, the claims fail to recite any additional elements that are sufficient to amount to significantly more than the judicial exception. [Step 2B: NO]
Therefore, the claims do not qualify as eligible subject matter under 35 U.S.C. 101.
Response to Arguments
Applicant's arguments filed 01/09/2026 have been fully considered but they are not persuasive.
On pg. 4, Applicant argues that one of ordinary skill would have understood a microbial inoculum containing the claimed species at the ratio claimed did not exist in nature. Applicant argues that the claimed inoculum exhibits properties different from their natural counterparts, such that the differences “demonstrate that the claimed inoculum constitutes an application of the referenced biological materials”. Applicant further urges that the inclusion of the 1:1 ratio introduces structural and functional characteristics that do not exist in nature, rendering the inoculum as significantly different from the natural counterpart.
In response, the examiner disagrees. As set forth above, nothing in the specification indicates that isolation and subsequent combination of the claimed strains have conferred the claimed bacteriostatic effect. Second, the inoculum composition as claimed contains no markedly different characteristics from the naturally produced occurring Lactobacillus rhamnosus and Lactobacillus plantarum bacterial cells with respect to structure, function, or any other characteristic that would distinguish it from its naturally occurring counterpart (see rejection above). The structure and function of the claimed occurring Lactobacillus rhamnosus and Lactobacillus plantarum bacterial cells are the same as the naturally occurring counterpart. Furthermore, the claimed “bacteriostatic effect” recited in claim 1 is, absent evidence to the contrary, inherent to each of the strains individually, as nothing in the instantly filed specification suggests that the bacteriostatic effect occurred when the strains were combined together or any synergy. Nothing new flows from the “hand of man” action of combining the two naturally occurring strains in a 1:1 ratio. Arguments presented by applicant cannot take the place of evidence in the record. See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984); In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). Applicant must substantiate arguments about “introduc[ing] structural and functional differences” conferred by the combination with empirical evidence on the record. Thus, the rejection is maintained as set forth above.
Maintained/Modified Claim Rejections - 35 USC § 102/103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Fernández et al. (Characterization of Lactobacillus rhamnosus MP01 and Lactobacillus plantarum MP02 and Assessment of Their Potential for the Prevention of Gastrointestinal Infections in an Experimental Canine Model. Front Microbiol. 2019 May 24;10:1117; hereinafter “Fernandez”).
Fernandez teaches microbial inoculums of Lactobacillus rhamnosus MP01 and Lactobacillus plantarum MP02, which were evaluated for probiotic potential for production of antimicrobial compounds, adherence to intestinal mucin, degradation of mucin, and antibiotic sensitivity in experimental canine models (see abstract; pg. 2, col 1-2; Table 1). The microorganisms in the reference appear to be identical to the claimed strains and it considered to anticipate the claimed microorganisms, as they belong to the same bacterial species and are shown to produce antimicrobial compounds (e.g., bacteriocins against Clostridium perfringens MP24, Enterococcus faecalis MP33, Staphylococcus aureus MP29, Escherichia coli MP07 (O157:H7), MP11 and MP17, Salmonella enterica MP46, Campylobacter jejuni MP42, Proteus vulgaris MP48, and Klebsiella pneumoniae MP68; see pg. 3, col 1). Thus, the prior art strains have bacteriostatic activity, absent evidence to the contrary, as instantly claimed.
In the alternative, even if the claimed microorganisms are not identical to the referenced strains with regard to some unidentified characteristics, one of ordinary skill in the art would have understood the claimed strains to be an obvious variant of the prior art Lacticaseibacillus rhamnosus FMBL L23004 CNN and Lactiplantibacillus plantarum FMBL L23036 CNN since the prior art L. rhamnosus and L. plantarum exhibit the same characteristics as disclosed by Applicant (see paragraphs 0042-43; Table 2 of the specification as instantly filed), and is capable of similar biological effects. As such, in view of the clear, close relationship between the claimed strains and the prior art Lacticaseibacillus rhamnosus and Lactiplantibacillus plantarum, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to have combined and used the claimed strains with a reasonable expectation of successfully producing of antimicrobial compounds. Please note that simply depositing a bacterial strain in another depositary that is identical to the prior art does not, by itself, impart any patentable distinction over the prior art. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06).
Furthermore, Fernandez teaches providing puppies a dose of each bacterium of 109 cfu/day for an 8-week period, starting at weaning (5 weeks of age) (see pg. 5, col 1). One of ordinary skill would have been motivated to combine 109 cfu of each bacteria (i.e., a 1:1 ratio as instantly claimed, to successfully produce antimicrobial compounds with a reasonable expectation of success (see MPEP 2144.06).
Response to Arguments
On pg. 5-8 of the Remarks, Applicant argues that the strains of Fernandez are different strains of the same species, each having its own unique genetic, phenotypic, and functional characteristics, such that the prior art does not teach, suggest, or render obvious the claimed strains. Applicant argues that the combined claimed strains exhibit antibacterial activity and provide a synergistic antibacterial effect, pointing to Table 2 of the specification, comparing each of the single strains to the combined preparation against various bacteria, and promotion of metabolism and use of carbon sources in Table 1. Applicant argues that different strains, even within the same species exhibit different distinct physiological effects, growth profiles, metabolic properties, stability, etc. Applicant also argues that “it is well understood that a specific biological strain is patentably distinct from other strains of the same species, such that Fernandez provides no teaching to replace the disclosed strains with Applicant’s newly isolated, deposited, and distinct strains, nor any motivation to combine in a 1:1 ratio.” Applicant further argues technicalities achieved in the instant case, including use of the strains for yogurt preparations, the fragrance, flavor, and texture of the yogurt, the survival rate of the bacteria in the yogurt, etc. Applicant further urges that the citation of Fernandez against the claimed strains constitutes hindsight reconstruction.
In response, the examiner disagrees. First, regarding Applicant’s arguments about the strain of Fernandez having “unique genetic, phenotypic, and functional characteristics” compared to the claimed strains, [a]rguments presented by applicant cannot take the place of evidence in the record. See In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984); In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997). Fernandez explicitly discloses that microbial inoculums of Lactobacillus rhamnosus MP01 and Lactobacillus plantarum MP02 are shown to produce antimicrobial compounds (e.g., bacteriocins against Clostridium perfringens MP24, Enterococcus faecalis MP33, Staphylococcus aureus MP29, Escherichia coli MP07 (O157:H7), MP11 and MP17, Salmonella enterica MP46, Campylobacter jejuni MP42, Proteus vulgaris MP48, and Klebsiella pneumoniae MP68; see pg. 3, col 1). As noted in Table 2 and paragraph 037, the claimed strains have bacteriostatic effect against some of the same strains as the ones disclosed by Fernandez (e.g., E. coli, S. enterica). Even if the claimed microorganisms are not identical to the referenced strains with regard to some unidentified characteristics, one of ordinary skill in the art would have understood the claimed strains to be an obvious variant of the prior art Lacticaseibacillus rhamnosus FMBL L23004 CNN and Lactiplantibacillus plantarum FMBL L23036 CNN since the prior art L. rhamnosus and L. plantarum exhibit the same characteristics as disclosed by Applicant and is capable of similar biological effects. Thus, absent evidence to the contrary, the strains of Fernandez and the strains as instantly claimed have similar physiological effects, metabolic properties, etc.
Second, as conceded by Applicant, the claimed strains are strains that have only been isolated and deposited. Please note that simply depositing a bacterial strain in another depositary that is identical to the prior art does not, by itself, impart any patentable distinction over the prior art. Furthermore, regarding Applicant’s arguments on the combination of the bacteria to produce a synergistic effect, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991). In the instant case, the teachings of Fernandez lead to a general expectation of greater than additive effect of the antimicrobial/bacteriostatic properties of the bacteria alone because each strain is taught in the prior art to have substantial bacteriostatic activity. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06).
Third, the claims are drawn to a microbial inoculum of the mixed bacterial strains, not to a yogurt preparation with any of the technical properties as instantly argued. The microbial inoculum is taught by the prior art, anticipating, or in the alternative, rendering obvious the instantly claimed invention. Furthermore, in response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, Fernandez provides the teaching, suggestion, and motivation to use and combine microbial inoculums of L. rhamnosus and L. plantarum for successful production of antimicrobial/bacteriostatic activity. As this teaching for the use of these particular strains was taught in the prior art before filing of the claimed invention, hindsight from Applicant’s disclosure was not required to anticipate, or alternatively, render obvious the claimed inoculum. Thus, the rejection is maintained as set forth above.
Conclusion
NO CLAIMS ALLOWED.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/G.C.R./Examiner, Art Unit 1651
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672