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 .
Amendments Received
Amendments to the claims were received and entered on January 9, 2026.
Status of Claims
Claims 1, 4-8, 10-14, 16-18, and 20-24 are currently pending
Claims 10-14 and 16 are under consideration, as claims 1, 4-8, 16-18, and 20-24 are withdrawn.
Priority
The present application claims status as a 371 (National Stage) of PCT/SE2022/050247 filed on March 11, 2022 and claims priority to EP application 21162451.5 filed on March 12, 2021. Acknowledgment is made of applicant’s claim for foreign priority and papers submitted under 35 U.S.C. 119 (a)-(d). In future actions, the effective filing date may change due to amendments or further review of priority documents.
Withdrawn Rejections
In view of Applicant’s amendments and arguments, including evidence indicating that the pre-conditioned L. reuteri strain exhibits functional properties that are markedly different from its naturally occurring counterpart, rejections of claims 10-14 and 16 under 35 USC § 101 are hereby withdrawn.
In view of Applicant's statement, filed on 01/09/2026, confirming compliance with the deposit requirements under 37 CFR 1.801-1.809, including assurances regarding public availability under the conditions specified in 37 CFR 1.808, rejection of claim 14 under 35 USC § 112(a) is hereby withdrawn.
In view of Applicant’s amendments, rejections of claims 10 and 13 under 35 USC § 102 by Kumar et al. are hereby withdrawn.
In view of Applicant’s filing of a Terminal Disclaimer on 01/09/2026, all double patenting rejections are hereby withdrawn.
Claim Rejections - 35 USC § 102
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.
Claim 16 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kumar et al. (WO2020163398, cited in a previous office action).
Regarding claim 16, Kumar et al. teaches probiotic compositions for increasing animal health, comprising L. reuteri (Specification, pg. 5, lines 19-21). Kumar et al. specifically discloses the growth of L. reuteri strains 3630 and 3632 in the presence of galacto-oligosaccharides (GOS), wherein GOS demonstrated increased growth compared to other oligosaccharides (pg. 27, Example 4 and Fig 10). Kumar et al. further discloses that the strains were grown individually and in combination and “various molecules were analyzed in the cell pellet and the supernatant of the cultures”, wherein the strains were grown in AOF-MRS media control with no glucose but 0.5% GOS (pg. 29, Example 7). Kumar et al. inherently teaches the harvesting of the L. reuteri strain, as evidenced by the reference to the analysis of various molecules in the cell pellet and supernatant. The presence of a cell pellet indicates that the cultured bacteria were subjected to centrifugation or another separation technique, which necessarily involves harvesting of the biomass from the culture. Accordingly, Kumar et al. teaches cultivating L. reuteri in the presence of GOS, thereby pre-conditioning the L. reuteri strain, as recited in claim 1, and then harvesting the strain. The teachings of Kumar et al. thereby anticipate all of the claimed subject matter in 16.
Thus, claim 16 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kumar et al. (WO2020163398, cited in a previous office action).
Claims 10-11 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bergonzelli et al. (EP2609813, cited in a previous office action).
Regarding claims 10 and 14, the limitation that requires “cultivating a L. reuteri strain in the presence of galacto-oligosaccharides (GOS) in a growth medium” is a product by process limitation that is given little patentable weight because determination of patentability is based on the characteristics of the product itself. Pursuant to MPEP 2113, "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.” Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009). See also Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016). Bergonzelli et al. teaches compositions comprising Lactobacillus reuteri DSM 17938, for promoting the healthy development and/or repair of the enteric nervous system in mammals (Abstract). An exemplary composition of an infant formula comprising the strain is disclosed in Example 2 (Specification, pg. 14-15).
Regarding claim 11, Bergonzelli et al. specifically teaches the probiotic (i.e., L. reuteri) may be administered as a single dose in the form of a composition ranging between 1x10³ cfu to 1x10¹² cfu (pg. 5, para 0038 and claim 15).
Regarding claim 13, as indicated above, the composition comprising L. reuteri taught by Bergonzelli et al. is used for repair of the enteric nervous system in mammals (i.e., a pharmaceutical formulation). Additionally, Bergonzelli et al. also teaches that L. reuteri may be administered as a nutritional supplements, diluted in milk (i.e., a functional food and/or beverage product) and a nutritional supplement (pg. 6, para 0042 and claims 12 and 14). As mentioned above, Bergonzelli et al. discloses a composition of an infant formula comprising L. reuteri DSM 17938 (pg. 14-15, Example 2).
Thus, claims 10-11 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bergonzelli et al. (EP2609813, cited in a previous office action).
Response to Arguments for Rejections under 35 USC § 102
In the response filed on 01/09/2026, Applicant argues that claim 10 is not anticipated by Bergonzelli because the recited preconditioning “results in a product with demonstrably different and unexpected functional properties,” including improved acid and bile tolerance and enhanced mineral solubility relative to the Lactobacillus reuteri DSM 17938 strain disclosed in Bergonzelli. These arguments have been fully considered but are not persuasive.
Claim 10 recites a composition comprising an effective amount of a preconditioned probiotic Lactobacillus reuteri strain wherein the preconditioned probiotic L. reuteri strain has been prepared by cultivating a L. reuteri strain in a growth medium comprising 0.75 wt% to 8 wt% galactooligosaccharides. The claim therefore defines the bacterial product, at least in part, by the manner in which it is made. Such language is interpreted as a product-by-process limitation. As discussed in the 102 rejection above, under MPEP §2113, product-by-process claims are limited by the product itself rather than by the recited method of manufacture. Thus, a prior art reference that discloses the same or substantially identical product anticipates a product-by-process claim even if the prior art product was made by a different process. Bergonzelli discloses compositions comprising Lactobacillus reuteri DSM 17938, the same strain recited by applicant as the starting strain for the claimed composition. Accordingly, Bergonzelli describes the same bacterial product as recited in claim 10. Where a prior art product appears to be substantially identical to the product recited in a product by process claim, the burden shifts to the applicant to demonstrate that the claimed product is structurally or otherwise materially different from the prior-art product. See MPEP §2113.
Applicant relies on experimental data in the specification showing that DSM 17938 grown under certain preconditioning conditions exhibits improved acid and bile tolerance and increased mineral solubility relative to a non-preconditioned control. However, these data do not establish that the claimed preconditioned DSM 17938 strain constitutes a different product from the DSM 17938 strain disclosed in Bergonzelli. Rather, the data indicate that the same known bacterial strain performs differently when cultivated under particular growth conditions. Applicant has not demonstrated that the claimed strain possesses structural, genetic, or other inherent characteristics that distinguish it from the DSM 17938 strain described by Bergonzelli. The evidence therefore reflects differences attributable to cultivation conditions applied to the same known strain, rather than demonstrating that the claimed strain is a different product from that disclosed in Bergonzelli.
Accordingly, Bergonzelli’s disclosure of compositions comprising Lactobacillus reuteri DSM 17938 is considered to disclose the same product as recited in claim 10, notwithstanding the recited cultivation conditions. The rejection of claims 10-11 and 13-14 under 35 U.S.C. §102 by Bergonzelli is therefore maintained.
Applicant’s arguments regarding Kumar et al. have also been considered. Applicant argued that Kumar et al. fails to disclose the recited concentration of GOS in the growth medium. These arguments are persuasive with respect to claims 10–11 because those claims require cultivation in a growth medium comprising 0.75 wt% to 8 wt% GOS, whereas Kumar et al. teaches cultivation in 0.5% GOS. Accordingly, the rejection of claims 10–11 under 35 U.S.C. §102 based on Kumar et al. has been withdrawn. However, these arguments are not persuasive with respect to claim 16. Claim 16 recites a composition comprising a probiotic Lactobacillus reuteri strain produced by the method of claim 1. Claim 1 requires cultivating a probiotic L. reuteri strain in the presence of GOS and harvesting the strain but does not limit the concentration of GOS in the growth medium. As described above, Kumar et al. teaches cultivation of L. reuteri strains in media containing 0.5% GOS followed by harvesting of the bacteria. Therefore, Kumar et al. teaches a strain produced by the method of claim 1, and the rejection of claim 16 under 35 U.S.C. §102 is maintained.
Claim Rejections - 35 USC § 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 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.
Claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al. (WO2020163398, cited in a previous office action) and Ritter et al. (WO2015153841, cited in a previous office action).
Regarding claim 10, Kumar et al. teaches probiotic compositions for increasing animal health, comprising L. reuteri (Specification, pg. 5, lines 19-21). Kumar et al. specifically discloses the growth of L. reuteri strains 3630 and 3632 in the presence of galacto-oligosaccharides (GOS), wherein GOS demonstrated increased growth compared to other oligosaccharides (pg. 27, Example 4 and Fig 10). Kumar et al. further discloses that the strains were grown individually and in combination and “various molecules were analyzed in the cell pellet and the supernatant of the cultures”, wherein the strains were grown in AOF-MRS media control with no glucose but 0.5% GOS (pg. 29, Example 7). Kumar et al. inherently teaches the harvesting of the L. reuteri strain, as evidenced by the reference to the analysis of various molecules in the cell pellet and supernatant. The presence of a cell pellet indicates that the cultured bacteria were subjected to centrifugation or another separation technique, which necessarily involves harvesting of the biomass from the culture. Ritter et al. does not teach wherein the growth medium comprises 0.75 wt% to 8 wt% GOS.
Ritter et al. discloses methods to improve gastrointestinal health by colonic microbiome alteration, the methods comprising to a subject in need thereof an effective amount of a composition comprising one or more indigestible oligosaccharides (Abstract). Ritter et al. teaches compositions comprising galacto-oligosaccharide (GOS) and at least one probiotic bacteria (pg. 55, para 0181) and discloses L. reuteri as a “probiotic bacteria that can be used in the methods and compositions described…”, more preferably L. reuteri ATTC 55730 (pg. 48, para 0169-0170). Additionally, Ritter et al. teaches the growth of Lactobacillus and Bifidobacterium in the presence of GOS (pg. 141-142, Example 6), disclosing the ability of Lactobacillus to effectively grow in media comprising GOS (pg. 143, para 0398). Specifically, Lactobacillus was evaluated in scratch MRS supplemented with 2% (20 g/L) of a carbohydrate solution, including GOS (see Table 16). The disclosed 2% GOS concentration falls within the claimed range of 0.75 wt%-8 wt% GOS, thereby demonstrating that cultivation of Lactobacillus in media containing GOS concentrations within the claimed range was known in the art.
Regarding claim 11, Ritter et al. teaches “in one embodiment, one or more strains of probiotic bacteria are ingested in an amount of about 1x10⁶ to 1x10⁹ cfu” (Specification, pg. 50-51, para 0173). Pursuant to MPEP 2144.05, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Regarding claim 12, Ritter et al. teaches that the composition discussed above can be in the form of a powder or sachet, and in liquid forms (pg. 63, para 0188). Ritter et al. further teaches the composition in the form of an emulsion, tablets, and capsules (pg. 65-66, para 0192-0195).
Regarding claim 13, Kumar et al. teaches the composition disclosed above formulated as animal feed, feed additive, food ingredient, water additive, water-mixed additive, consumable solution, consumable spray additive, consumable solid, consumable gel, injection, or combinations thereof (claim 10). Additionally, Ritter et al. teaches the composition discussed above in candy form (i.e., a functional food product) and as a pharmaceutical preparation (pg. 77, para 0233-0235 and pg. 78, para 0237).
An invention would have been obvious to a person of ordinary skill in the art if some teaching in the prior art would have led that person to combine prior art reference teachings to arrive at the claimed invention. Before the effective filing date of the claimed invention, Kumar et al. teaches that L. reuteri grown in the presence of GOS demonstrate increased growth and discloses a probiotic composition comprising Lactobacillus reuteri cultivated in the presence of 0.5% GOS, which may be in the form of powder/sachet/liquid. Ritter et al. teaches that compositions comprising Lactobacillus species may be cultivated in media containing 2% GOS, and further teaches pharmaceutical preparations with dosages ranging from about 10⁶ to 10⁹ CFU. A person of ordinary skill in the art would have recognized that the concentration of GOS in the growth medium of Kumar et al. represents a result-effective variable that can be adjusted to support the growth and metabolic activity of probiotic Lactobacillus species. Ritter et al. demonstrates successful cultivation of Lactobacillus species in media containing 2% GOS, which falls within the claimed range. Accordingly, it would have been obvious to a person of ordinary skill in the art to adjust or optimize the GOS concentration in the culture medium of Kumar et al. in view of the disclosure of Ritter et al. and teachings of Kumar et al. that GOS facilitates L. reuteri growth. There is a reasonable expectation of success because Ritter et al. demonstrate the successful cultivation of Lactobacillus in media comprising 2% GOS. Said practitioner would have also been motivated to select a known and acceptable dosage amount, as taught by Ritter et al., for the probiotic composition disclosed in Kumar et al. These represent routine optimization of a result-effective variable (amount of GOS in growth media) and administration (dose), particularly since Ritter et al. discloses the same or similar types of probiotic-GOS combinations for promoting gastrointestinal health. Therefore, the invention as a whole would have been prima facie obvious at the time of the claimed invention.
Thus, claims 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al. (WO2020163398, cited in a previous office action) and Ritter et al. (WO2015153841, cited in a previous office action).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al. and Ritter et al., as applied to claim 10 above, and further in view of Bergonzelli et al. (EP2609813, cited in a previous office action).
The teachings of Kumar and Ritter as they apply to claim 10 have already been discussed above. Briefly, Kumar et al. discloses a composition comprising L. reuteri grown in media comprising 0.5% GOS, and Ritter et al. demonstrates the successful cultivation of Lactobacillus species in media comprising 2% GOS, thereby making a composition comprising “pre-conditioned” L. reuteri obvious. Kumar et al. further discloses the use of L. reuteri strains 3630 and 3632 but does not expressly teach specific other strains, including those recited in instant claim 14.
Regarding claim 14, Bergonzelli et al. provides compositions comprising Lactobacillus reuteri DSM 17938 for promoting healthy development of the enteric nervous system in neonates and infants (Specification, pg. 3, para 0017).
An invention would have been obvious to a person of ordinary skill in the art if some teaching in the prior art would have led that person to combine prior art reference teachings to arrive at the claimed invention. The invention would have been obvious to a person of ordinary skill in the art at the time of the invention in view of Kumar et al., which teaches that Lactobacillus reuteri strains grown in the presence of galactooligosaccharides (GOS) demonstrate increased growth and potential probiotic benefits. A person of ordinary skill in the art, seeking to apply the teachings of Kumar and Rittert, would have found it obvious to substitute a known and widely used L. reuteri strain such as DSM 17938 into the composition made obvious by Kumar and Ritter. DSM 17938 was readily available before the effective filing date of the present application and was known in the art to provide beneficial health effects. Given its availability and prior use as a probiotic, one of ordinary skill would have had a reasonable expectation of success in substituting DSM 17938 for the L. reuteri strains used in Kumar, with the expectation that similar benefits would result (see MPEP 2144.06, “Substituting equivalents known for the same purpose”). Such a substitution represents the predictable use of a known alternative in the same field. Furthermore, the substitution of a known strain with documented probiotic properties into a formulation that is already shown to enhance L. reuteri growth via GOS would have been a routine optimization of strain selection, well within the level of ordinary skill in the art. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Thus, claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al. and Ritter et al., as applied to claim 10 above, and further in view of Bergonzelli et al. (EP2609813, cited in a previous office action).
Response to Arguments for Rejections under 35 USC § 103
In the response filed on 01/09/2026, Applicant argues that the claimed “pre-conditioned probiotic Lactobacillus reuteri strain,” prepared by cultivating L. reuteri in a growth medium comprising 0.75 wt% to 8 wt% galactooligosaccharides (GOS), possesses different and unexpected properties, including enhanced mineral bioavailability and improved acid tolerance. Applicant relies on the specification’s experimental data, including the mineral solubility data and acid challenge results, as evidence of such unexpected results. The arguments and cited data have been fully considered but are not persuasive for the reasons set forth below.
The closest prior art embodiment is Kumar’s disclosure of cultivating L. reuteri in a growth medium comprising 0.5 wt% GOS. Ritter teaches cultivating probiotic Lactobacillus species in a medium comprising 2 wt% GOS. The concentration of GOS in the growth medium constitutes a variable affecting probiotic growth and metabolic activity and therefore represents a recognized result-effective variable. It would have been obvious to a person of ordinary skill in the art to adjust the concentration of a known growth substrate (GOS) within a conventional culture medium to optimize probiotic growth and metabolic activity. See MPEP § 2144.05 (optimization of result-effective variables).
To rebut a prima facie case of obviousness with unexpected results, applicant must show that the claimed range produces results that are unexpected over the closest prior art and that are commensurate in scope with the claims. See MPEP §§ 716.02(a), 716.02(d), and 2145. The claims recite a broad GOS concentration range of 0.75 wt% to 8 wt%. The closest prior art teaches 0.5 wt% GOS. However, the specification’s preconditioning embodiment (Example 1) does not evaluate multiple concentrations across the claimed range. Rather, Example 1 describes cultivation in a fermentation medium containing 6% BMOS as carbon source, wherein the BMOS mixture is composed of 48% GOS. Thus, the effective GOS concentration in Example 1 is: 6% × 48% = 2.88 wt% GOS. The record does not contain comparative data that directly compare L. reuteri preconditioned at or near the prior art 0.5 wt% GOS concentration with L. reuteri preconditioned at concentrations within the claimed 0.75–8 wt% range.
The specification data cited by applicant show that L. reuteri preconditioned at approximately 2.88 wt% GOS exhibits higher survival under acid challenge and increased magnesium, calcium, and iron solubility compared to a non-preconditioned strain. However, these results represent quantitative improvements in known probiotic properties. GOS is a recognized prebiotic substrate that supports probiotic growth and metabolic activity. Increasing the concentration of a known growth substrate would reasonably be expected to influence metabolic output and related functional effects. The evidence does not demonstrate a new property or a difference in kind relative to the prior art, but rather reflects a difference in degree. Evidence of a mere difference in degree of a known property is generally insufficient to establish unexpected results sufficient to overcome a prima facie case of obviousness. See MPEP § 716.02(a). Furthermore, because the data are limited to a single concentration (approximately 2.88 wt% GOS), the evidence is not commensurate in scope with the full claimed range of 0.75 wt% to 8 wt%. See MPEP § 716.02(d).
Accordingly, applicant’s arguments and cited data do not sufficiently rebut the prima facie case of obviousness, and the rejection under 35 U.S.C. § 103 is maintained.
Conclusion
No claim is in condition for allowance.
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.
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/NAGHMEH NINA MOAZZAMI/Examiner, Art Unit 1652
/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652