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, 4-9, 12-13, 15-19, 21, 24, and 26-31 are currently pending and claims 2-3, 5, 10-11, 14, 20, 22-23, and 25 are cancelled.
Claims 12-13 and 15-19 are under consideration, as claims 1, 4-9, 21, 24, and 26-31 are withdrawn.
Priority
The present application claims status as a 371 (National Stage) of PCT/SE2022/050245 filed on March 11, 2022 and claims priority to EP application 21162450.7 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Withdrawn Objections
In view of Applicant’s amendments, the objection to claim 15 is hereby withdrawn.
Withdrawn Rejections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different from its naturally occurring counterpart, rejections of claims 12-13 and 15-19 under 35 USC § 101 are hereby withdrawn.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availability under the conditions specified in 37 CFR 1.808, rejection of claim 18 under 35 USC § 112(a) is hereby withdrawn.
In view of Applicant’s amendments, rejections of claims 12 and 17 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 are hereby withdrawn.
In view of Applicant’s filing of a Terminal Disclaimer on 01/09/2026, all double patenting rejections are hereby withdrawn.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.
Claims 12-13 and 17-18 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 12 and 18, the limitation that requires “cultivating a L. reuteri strain in a growth medium comprising 0.75 wt% to 8 wt% galacto-oligosaccharides (GOS)” 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). Bergonzelli et al. further teaches the composition further comprising prebiotics, such as galacto-oligosaccharides (GOS) (pg. 6-7, para 0043). An exemplary composition of an infant formula comprising the strain and GOS is disclosed in Example 2 (Specification, pg. 14-15).
Regarding claim 13, 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 17, 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 12-13 and 17-18 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 12 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, enhanced mineral solubility and epithelial protection relative to the Lactobacillus reuteri DSM 17938 strain disclosed in Bergonzelli. These arguments have been fully considered but are not persuasive.
Claim 12 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, and an effective amount of GOS. 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 GOS and 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 12. 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 12, notwithstanding the recited cultivation conditions. The rejection of claims 12-13 and 17-18 under 35 U.S.C. §102 by Bergonzelli is therefore 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 12-13, 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Ritter et al. (WO2015153841, cited in a previous office action) and Kumar et al. (WO2020163398, cited in a previous office action).
Regarding claim 12, 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 in various proportions (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, during comparative growth studies, 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). This also demonstrates that GOS supports the growth of Lactobacillus species generally, suggesting that pre-culturing L. reuteri in GOS-containing media would promote its viability and functional properties. 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. However, Ritter et al. does not explicitly teach a composition comprising GOS with a pre-conditioned L. reuteri.
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). Additionally, Kumar et al. also teaches “wherein administered comprises administration of galacto-oligosaccharides (GOS)” in claim 37. Although unclear whether the GOS is co-formulated or administered separately, Kumar et al. teaches co-administration of L. reuteri and GOS, reinforcing their functional compatibility in probiotic compositions.
Regarding claim 13, Ritter et al. further 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 15, Ritter et al. further teaches numerous embodiments, with respect to the amount of GOS in the composition, expressed as a percentage by weight (pg. 27-29), as well as in grams. Specifically, Ritter et al. teaches an amount of GOS ranging from 0.01 to 20 g (pg. 29, para 0111). 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 16, Ritter et al. further 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 17, Ritter et al. further 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, it would have been obvious to one of ordinary skill in the art to prepare the composition of Ritter et al. using L. reuteri strains that has been preconditioned by growth in GOS, as taught by Kumar et al., to enhance the viability or functional activity of the probiotic strain. Moreover, said practitioner would have a reasonable expectation of success in co-formulating the preconditioned L. reuteri with an effective amount of GOS, as both references demonstrate the ability of GOS to enhance Lactobacillus growth and function, with Kumar et al. explicitly teaching the growth of Lactobacillus reuteri in media comprising GOS, and its co-administration with GOS. Therefore, the invention as a whole would have been prima facie obvious at the time of the claimed invention.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Ritter et al. and Kumar et al., as applied to claim 12 above, and further in view of Bergonzelli et al. (EP2609813, cited in a previous office action).
The teachings of Ritter and Kumar as they apply to claim 12 have already been discussed above. Briefly, Ritter and Kumar make obvious a composition comprising GOS and pre-conditioned L. reuteri, with Ritter et al. teaching compositions comprising galacto-oligosaccharide (GOS) and at least one probiotic bacteria, and specifically disclosing Lactobacillus grown in media comprising 2% GOS. Kumar et al. further discloses the use of L. reuteri strains 3630 and 3632 and Ritter et al. discloses the use of L. reuteri ATTC 55730, but neither specifically teach other strains, including those recited in instant claim 18.
Regarding claim 18, 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. and Ritter 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 Ritter and Kumar, 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 Ritter and Kumar. 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 Ritter and 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.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al. and Ritter et al., as applied to claim 12 above, and further in view of Bogicevic et al. (WO2019025637, cited in the IDS).
The teachings of Ritter and Kumar as they apply to claim 12 have already been discussed above. Briefly, Ritter and Kumar make obvious a composition comprising GOS and pre-conditioned L. reuteri, with Ritter et al. teaching compositions comprising galacto-oligosaccharide (GOS) and at least one probiotic bacteria, and specifically disclosing Lactobacillus grown in media comprising 2% GOS. However, neither reference teaches wherein the pre-conditioned L. reuteri strain is freeze dried.
Bogicevic et al. teaches “compositions comprising galactooligosaccharides (GOS) and probiotic bacteria obtained by a process comprising the step of growing the bacteria in a medium comprising GOS, such composition having the effect of boosting the synbiotic effect of the probiotic bacteria with the GOS” (Abstract). The process for obtaining pre-conditioned probiotic, as taught by Bogicevic et al., comprises fermenting the bacteria in a growth medium that comprises GOS, followed by harvesting the cultured bacteria (Specification, pg. 3, lines 11-13). Specifically, GOS is provided in growth medium in an amount of 0.2% to 3% (pg. 13, lines 6-13), which falls within the claimed range. Bogicevic et al. further teaches a drying step after the harvesting step, wherein the drying step may be carried out by freeze drying (pg. 15, lines 26-28).
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, it would have been obvious to a person of ordinary skill in the art to modify the composition made obvious by Ritter and Kumar, to include a freeze-dried, pre-conditioned L. reuteri strain, as Bogicevic et al. teaches that preconditioned probiotics may be obtained by growing probiotic bacteria in GOS-containing media (e.g., 3% GOS) followed by a drying step, which may be carried out by freeze drying. Said practitioner would have recognized freeze drying as a well-known technique for preserving the viability and enhancing shelf life of probiotic bacteria, and would have had a reasonable expectation of success in applying it to a GOS-preconditioned L. reuteri strain for use in a probiotic composition. 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.
Response to Arguments for Rejections under 35 USC § 103
In the response filed on 01/09/2026, Applicant argues that the cited references fail to disclose or suggest cultivating Lactobacillus reuteri in a growth medium comprising 0.75 wt% to 8 wt% galacto-oligosaccharides (GOS) as recited in claim 12. Applicant’s arguments have been fully considered but are not persuasive.
As set forth in the rejection, Ritter et al. teaches probiotic compositions comprising GOS and probiotic bacteria including Lactobacillus reuteri. Ritter et al. further discloses comparative growth studies in which Lactobacillus species are cultivated in media supplemented with 2% GOS. The disclosed 2% GOS concentration falls squarely within the claimed range of 0.75 wt% to 8 wt% GOS. Additionally, Kumar et al. teaches probiotic compositions comprising L. reuteri and further teaches the cultivation of L. reuteri in the presence of GOS, demonstrating that GOS enhances the growth and functional performance of the probiotic strain. Kumar et al. therefore evidences that GOS is a suitable substrate for cultivating, specifically, L. reuteri and improving probiotic viability and activity. Accordingly, a person of ordinary skill in the art would have been motivated to cultivate L. reuteri in GOS-containing media, as taught by Ritter and Kumar, using concentrations known in the art such as those disclosed by Ritter et al., including 2% GOS. Adjusting the concentration of GOS in the growth medium to enhance probiotic growth and functionality represents no more than routine optimization of a result-effective variable, particularly where the prior art demonstrates that GOS promotes the growth and metabolic activity of probiotic Lactobacillus species.
Therefore, the combination of Ritter et al. and of Kumar et al. would have rendered the composition of claim 12 obvious to a person of ordinary skill in the art at the time of the invention. Thus, the rejections under 35 U.S.C. §103 are therefore 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