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 . 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.
Priority
The instant application is a 371 of PCT/EP2022/053678 filed on 02/15/2022 and claims domestic benefit to US provisional application no. 63/149,812 filed on 02/16/2021.
Status of the Claims
The claim amendments and remarks filed on 03/26/2026 is acknowledged. Claims 1, 9, 11, 19, 23, 27-28, 30, and 34 are amended. Claims 4-5, 8, 10, 12-18, 20, 24-26, 29, 31-33, and 35-36 are cancelled.
Accordingly, claims 1-3, 6-7, 9, 11, 19, 21-23, 27-28, 30, and 34 are pending and being examined on the merits herein.
Withdrawn Objections/Rejections
The cancellation of claim 35 renders the 35 USC 112 (b), 35 USC 101, and 35 USC 103 rejections over this claim moot.
The objection to claim 19 and 28 is withdrawn because these claims now start with the capital letter “A”.
The 35 USC 112(b) rejection over claims 1-3, 6-7, 9, 11, 28, 30, and 34 is withdrawn for the following reasons:
Claims 1 and 28 now recite that each n integer is greater than or equal to 2, making it clear that “the n is an integer greater than or equal to 2” is referring to both the “at least n fractions of oligosaccharides” and the “distinct degree of polymerization selected from 1 to n (DP1 to DPn fractions)”.
Claims 1 and 28 have been amended such that the exemplary parenthetical broader range for the fraction % were removed, making it clear what fraction percentage range is required.
Claims 9, and 34 have been amended such that the exemplary parenthetical PPM values were removed, making it clear what PPM value is required.
Claims 1 and 28 have been amended such that there is now sufficient antecedent basis for the limitation “feed additives”.
Claims 9 and 34 have been amended such that there is now sufficient antecedent basis for the limitation “feed”.
Claim 30 has been amended such that there is now sufficient antecedent basis for the limitation “fecal sample”.
The 35 USC 103 rejection over Murphy in view of Geremia, Goodman, Shoaf, Ding, and Murphy for claims 1-3, 6-7, 9, 11, 19, 21-23, 27-28, 30, and 34 are withdrawn because the previous rejections were applied based on each fraction of the oligosaccharide preparation comprising from 0.5% to 90% anhydro-subunit containing oligosaccharides. However, Applicant has amended the 0.5% to 90% anhydro-subunit containing oligosaccharides to 0.5% to 15%, which was not previously rejected.
All of the nonstatutory double patenting rejections are withdrawn in view of the Terminal Disclaimer that was filed and approved on 04/08/2026.
The following grounds of rejection are maintained and new as necessitated by Applicant' s amendments.
Claim Rejections - 35 USC § 112(b)
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 19, 21-23, and 27 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.
Claim 19 recites “… wherein said synthetic oligosaccharide preparation comprises at least n fractions of oligosaccharides each having a distinct degree of polymerization selected from 1 to n (DP1 to DPn fractions), wherein n is an integer greater than or equal to 2 … “
Claim 19 is indefinite because these claims recite two “n” variables and therefore it is unclear if the “n is an integer greater than or equal to 2” is referring to the “at least n fractions of oligosaccharides” or the “distinct degree of polymerization selected from 1 to n (DP1 to DPn fractions)”.
Claims 21-23 and 27 depend from claim 19 but do not overcome the described indefinite issue.
Response to Arguments
Applicant’s arguments filed on 03/26/2026 have been fully considered but were not persuasive.
Applicant states that claim 19 has been amended to clarify that “each” n is an integer greater than or equal 2.
However, Applicant has not amended claim 19 as such in the latest claim set filed on 03/26/2026. Therefore, the 35 USC 112(b) rejection for claims 19, 21-23, and 27 are maintained. It is noted that the other 35 USC 112(b) issues that were raised for claims 19, 23, and 27 have been amended accordingly and overcomes the indefinite issues.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-3, 6-7, 9, 11, 19, 21-23, 27-28, 30, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over WO2020097454A1 (in PTO-892, published 05/14/2020 and effective filing date of date of 11/08/2019) in view of Goodman et al. (US20170209504A1 in PTO-892 dated 02/10/2026), Shoaf et al. (Infection and Immunity, 2006 in PTO-892 dated 02/10/2026), and Ding et al. (Plos One, 2019 in PTO-892 dated 02/10/2026).
WO’454 discloses a method of manufacturing a nutritional composition comprising: a. combining a base nutritional composition with a synthetic oligosaccharide preparation that comprises at least n fractions of oligosaccharides each having a distinct degree of polymerization selected from 1 to n (DP1 to DPn fractions), wherein n is an integer greater than or equal to 3; and wherein the DP1 and DP2 fractions each independently comprises from about 0.1% to about 15% of anhydro-subunit containing oligosaccharides by relative abundance as measured by mass spectrometry (MS) (Claims 126-127).
WO’454 discloses that the oligosaccharide preparation comprises several types of oligosaccharides including galacto-oligosaccharides, fructo-oligosaccharides, and others (paragraph 0141).
WO’454 discloses the nutritional composition can be provided as an animal feed (Abstract), and that the concentration of oligosaccharide preparation can be greater than 500 ppm relative to the composition (paragraph 0007).
WO’454 discloses that the animal feed is administered to animals including humans, cattle, chickens, and others (paragraph 00231).
WO’454 discloses that the chemical composition of the oligosaccharide preparation can affect the manner in which it is utilized by the microflora of the animal, in particular by the gut microbiome, which can further affect the health and performance of the animal as a whole (paragraph 0067). WO’454 discloses that such effects include modulation of the abundance of the various members of the gut microflora (e.g., suppression of pathogenic species, augmentation of beneficial commensal species), and others (paragraph 0067). WO’454 discloses that accordingly, the oligosaccharide preparations can be added to nutritional compositions such as animal feed to act as prebiotics (paragraph 0067).
WO’454 teaches the recited animal feed composition comprising the recited oligosaccharide composition in the recited amounts as described above, and while WO’454 suggests that their animal feed composition can be administered to animals to modulate the abundance of gut microflora species such as suppressing pathogenic species, WO’454 does not specifically disclose their compositions will reduce the pathogenic E. coli populations or the LEE/non-LEE genes of EHEC, EPEC, APEC in the GI tract and/or reduce systemic inflammation caused by these pathogenic E. coli infections.
Goodman teaches probiotic formulations comprising a biocompatible microsphere, a biofilm-generating probiotic bacterium, a prebiotic, and/or a prebiofilmic (see Abstract).
Goodman teaches that probiotics are live microbes that have the capacity to enhance immune system activity with few probiotic microbes also having anti-inflammatory effects (paragraph 0009-0010). Goodman discloses that Lactobacillus reuteri (L. reuteri) is a commonly used probiotic that has been shown to regulate mammalian and avian intestinal immune system (paragraph 0010). Goodman further teaches that L. reuteri can down-regulate both cytokine and chemokine production by colonic epithelial cells stimulated with a pathogenic Citrobacter rodentium (C. rodentium) as well as reduce colonic inflammation in both juvenile and adult animals (paragraph 0010-0012). Goodman teaches that L. reuteri also attenuates the exacerbating effects of stress on C. rodentium-induced colitis as marked by reductions in colonic cytokines and chemokines, inflammatory cell infiltration, colonic epithelial cell defects, and pathogen translocation from the colon to the spleen (paragraph 0012).
Goodman teaches that C. rodentium is a closely related pathogen to human enteropathogenic E. coli (EPEC) and enterohemorrhagic E. coli (EHEC) infection and is widely used as a model to these pathogens (paragraph 0005). Goodman teaches that C. rodentium results in colonic pathology that is nearly indistinguishable from that produced by EPEC and EHEC in humans, and that C. rodentium possesses a homologue of the locus of enterocyte effacement (LEE) pathogenicity island carried by EPEC and EHEC that encodes for the effector proteins necessary for the development of attaching and effacing (A/E) lesions (paragraph 0005).
Goodman teaches that their probiotic formulations comprise the probiotic bacterium Lactobacillus reuteri (L. reuteri) (claim 8). Goodman discloses that the probiotic bacterium provides one or more of supporting anti-bacterial immunity, enhancing or supporting the gastrointestinal barrier, treating dysbiosis, treating or preventing gut pathogenesis, supporting gastrointestinal health, a chronic and/or a recurrent disease that is caused by pathogenic bacteria displacing healthy bacteria or antagonizing disease-related bacterial infections (claim 9). Goodman discloses that the probiotic bacterium also prevents pathogen colonization and/or limits excessive inflammatory responses by down-regulating cytokine and chemokine production (claim 10). Goodman teaches that the subject for treatment can be non-human animals such as livestock (paragraph 0060).
Goodman teaches that their probiotic formulations also comprise a prebiotic which comprises water-soluble carbohydrates such as inulin, oligofructose, fructo-oligosaccharide, galacto-oligosaccharide, glucose, maltose, maltodextrins, polydextrose, sucrose, fructose, lactose, isomaltulose, polyols, glycerol, and combination thereof (claim 5). Goodman teaches that the prebiotic is a nutritional supplement for the probiotic bacterium and helps stimulates the growth of beneficial bacteria while also inhibiting the growth of pathogenic bacteria (paragraph 0041). Goodman discloses that inulin, fructo-oligosaccharides, and galacto-oligosaccharides support lactobacilli growth (paragraph 0129).
Goodman demonstrates in Example 2 (paragraphs 0106-0107) that colony-forming unites reduced for C. rodentium in an vitro model when in the presence of their L. reuteri formulations (see Table 1 paragraph 0107). Goodman also demonstrates in Example 3 that there was a 10-fold reduction in C. rodentium penetration to the spleen in an in vivo mouse model when treated with L. reuteri biofilm (paragraph 0108 and FIG. 4). Goodman discloses in Example 4.1 (paragraphs 0110-0112) that in their in vivo experiments, each mouse is assessed by counting total lactobacilli levels in fecal samples daily for 12 days (paragraph 0111). Goodman discloses in addition, real-time PCR method is used to assess 16S rRNA gene sequence copy numbers for the Lactobacillus genus, and that the gene copy numbers are determined in the feces daily for 12 days, as well as in the colon, cecum, small intestine using real-time PCR on specified days (paragraph 0112).
Shoaf discloses prebiotic galacto-oligosaccharides that reduce adherence of enteropathogenic E. coli to tissue culture cells (see Abstract). Shoaf discloses that prebiotic oligosaccharides may confer health benefits via their antiadhesive activity by directly inhibiting infections by enteric pathogens due to their ability to act as structural mimics of the pathogen binding sites that coat the surface of gastrointestinal epithelial cells (see Abstract). Shoaf discloses that by acting as binding site decoys for pathogenic bacteria, this would then displace or flush these pathogenic bacteria from the GI tract (last paragraph left column through first paragraph right column page 6920). Shoaf demonstrates the adherence of EPEC strain E2348/69 on HEp-2 and Caco-2 cells, in the presence of fructooligosaccharides, inulin, galactooligosaccharides (GOS), lactulose, and raffinose was determined by cultural enumeration and microscopy (see Abstract and Fig. 1). Shoaf discloses that galacto-oligosaccharides exhibited the greatest adherence inhibition on both HEp-2 and Caco-2 cells, reducing the adherence of EPEC by 65 and 70%, respectively (see Abstract and Fig. 2). Shoaf concludes that some prebiotic oligosaccharides may have antiadhesive activity and directly inhibit the adherence of pathogens to the host epithelial cell surface (see Abstract).
Ding discloses the effects of Lactobacillus plantarum 15-1 and fructo-oligosaccharides on the response of chicken broilers to pathogenic E. coli O78 (APEC) challenge (see Abstract). Ding discloses that the administration of prebiotics including fructo- oligosaccharides can regulate the intestinal microbiota by increasing population of probiotic bacteria while competing with pathogenic bacteria for attachment sites, thereby reducing the number of pathogenic bacteria in the intestinal tract (third paragraph page 2). Ding further discloses that dietary supplement with fructo-oligosaccharides reduced E. coli population and increased lactobacilli population (third paragraph page 2).
Ding discloses that one-day-old broiler chicken were randomly allocated to five treatment groups: basal diet and orally administered sterile saline (negative control, n-control); basal diet challenged with E. coli O78 (positive control, p-control); basal diet supplemented with 1×108 CFU/kg L. plantarum 15–1 and challenged with E. coli O78 (LP); basal diet supplemented with 5 g/kg fructo-oligosaccharides (FOS) and challenged with E. coli O78 (FOS); and basal diet supplemented with both L. plantarum 15–1 and FOS and challenged with E. coli O78 (LP+FOS) (see Abstract). Ding demonstrates in Fig. 1-4 (pages 7-9) that broilers in the LP, FOS, and LP+FOS groups displayed a decrease of crypt depth at day 14 compared with the control groups. Furthermore, at days 14 and 21, the broilers in the LP group exhibited reduced serum levels of diamine oxidase (DAO) compared with the p-control group (p<0.05), and the broilers in the LP+FOS group showed increased serum concentrations of IgA and IgG relative to both control groups and decreased DAO levels compared with the p-control group (p<0.05). Moreover, the LP group displayed higher levels of acetic acid and total short-chain fatty acids (SCFAs) compared with the p-control group at day 14 (p<0.05), and the FOS group showed higher levels of valeric acid and total SCFAs at day 21 (p<0.05). The LP+FOS group also displayed a higher level of butyric acid at day 14 (p<0.05) (see Abstract). Ding concludes that dietary supplementation with L. plantarum 15–1 and FOS may ameliorate the negative effects of E. coli O78 (see last paragraph page 11), as the supplementation improved intestinal health by increasing the levels of SCFAs and mitigating the damage caused by E. coli O78, thus preventing intestinal damage and enhancing the immune response (see Abstract)
It would have been prima facie obvious before the effective filing date of the claimed invention to have administered to an animal such as chickens the animal feed compositions of WO’454 comprising oligosaccharide preparations such as galacto-oligosaccharides and fructo-oligosaccharides at a concentration of at least 500 ppm as disclosed in WO’454 to inhibit the growth of pathogenic bacteria and reduce inflammation caused by pathogenic bacteria such as EPEC or EHEC in the GI tract of an animal as suggested in Goodman and disclosed by Shoaf as well as ameliorate the negative effects of E.coli O78 (APEC) as disclosed in Ding to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make these modifications because Goodman suggests compositions that include prebiotics such as oligosaccharides to help promote beneficial bacteria while inhibiting and/or reducing inflammation caused by pathogenic bacteria including EPEC and EHEC in animals, Shoaf provides guidance that galacto-oligosaccharides exhibited the greatest adherence inhibition of enteropathogenic E. coli (EPEC) to tissue culture cells, and Ding provides guidance that fructo-oligosaccharide supplementation in broiler chickens improved intestinal health by increasing the levels of SCFAs and mitigating the damage caused by E. coli O78, thus preventing intestinal damage and enhancing the immune response.
One of ordinary skill in the art would have a reasonable expectation of success because WO’454 discloses animal feed compositions that include oligosaccharides preparations such as galacto-oligosaccharides and fructo-oligosaccharides and further suggests that these oligosaccharides can act as prebiotics to help promote beneficial bacteria while inhibiting pathogenic bacteria.
Lastly, the combined references do not teach a method of reducing LEE and non-LEE gene from EPEC, EHEC, and APEC wherein a 10% reduction of LEE and non-LEE gene populations occurs as recited in instant claims 1-3 and 35. Furthermore, the combined references also do not teach a method wherein a 10% inflammation reduction occurs as recited in instant claims 19, 22-23, 28, 30, and 35.
However, these limitations would flow naturally from the combined references described above because the combined references teach treating an animal such as chickens to reduce pathogenic EPEC, EHEC, and APEC comprising feeding the animal the same oligosaccharide feed composition at least 500 ppm, and as evidenced in paragraph 0127 of the instant specification, a 500 ppm test material comprising the recited oligosaccharide preparation was used which resulted in the recited method limitations (also see paragraphs 0150-0151 of the instant specification).
MPEP 2145 II recites “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter.m 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
Response to Arguments
Applicant’s arguments filed on 03/26/2026 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant presents arguments against the teachings of Geremia that the oligosaccharides disclosed do no teach anhydro-content of the DP1/DP2 fractions being 0.5-15%.
However, the new rejection above does not cite Geremia, rendering Applicant’s arguments moot. Rather, the teachings of WO’454 are relied upon as discussed above for the recited oligosaccharide preparation.
Applicant states that Goodman, Shoaf, and Ding do not disclose or suggest any effect on LEE and non-LEE pathogenic genes of EHEC/EPEC/APEC.
Applicant’s arguments described above were not found persuasive because even though these teachings do not disclose any effects on LEE and non-LEE pathogenic genes of EHEC/EPEC/APEC, as discussed above, the claimed effects would flow naturally from the combined teachings described above because the combined teachings of WO’454, Goodman, Shoaf, and Ding provide guidance of treating an animal such as chickens to reduce pathogenic EPEC, EHEC, and APEC comprising feeding the animal the same oligosaccharide feed composition at least 500 ppm, and as evidenced in paragraph 0127 of the instant specification, a 500 ppm test material comprising the recited oligosaccharide preparation was used which resulted in the recited method limitations (also see paragraphs 0150-0151 of the instant specification).
Applicant states that Goodman does not disclose or suggest any such effects would be achievable by an oligosaccharide preparation because Goodman teaches the disclosed effects stems from their probiotic and not the additional prebiotic that include oligosaccharides. Applicant further states that Shoaf only teaches that certain oligosaccharides affect EPEC adherence to epithelial cells but does not teach the EPEC abundance is affected in a microbiome. Applicant states that Ding only discloses effects of L. plantarum and/or fructo- oligosaccharides to improve intestinal health but does not disclose nor suggest any effect on pathogenic microbes.
Applicant’s arguments described above were not found persuasive because Goodman does disclose that the prebiotics which include oligosaccharides such as fructo-oligosaccharides, galacto-oligosaccharide, and others can help stimulate the growth of beneficial bacteria while also inhibiting the growth of pathogenic bacteria, which suggests that the prebiotics can further aid alongside the probiotics in reducing the disclosed C. rodentium pathogenic bacteria and its associated inflammation. Goodman also discloses that C. rodentium bacteria is a model pathogen for EPEC/EHEC and that its colonic pathology is nearly indistinguishable from that produced by EPEC and EHEC, which suggests that the described effects using their compositions against C. rodentium would also work similarly against the EPEC and EHEC pathogens.
Furthermore, while Shoaf may not explicitly teach that the disclosed galacto-oligosaccharides reduces the abundance of EPEC, Shoaf discloses that the galacto-oligosaccharides act as binding site decoys for pathogenic bacteria, which would then displace or flush these pathogenic bacteria from the GI tract (last paragraph left column through first paragraph right column page 6920). Therefore, an ordinary skilled artisan would have recognized that by reducing the adherence of EPEC bacteria using the disclosed galacto-oligosaccharides, the abundance of the EPEC bacteria would also be reduced in the GI tract.
Additionally, Ding discloses that the administration of prebiotics including fructo- oligosaccharides can regulate the intestinal microbiota by increasing population of probiotic bacteria while competing with pathogenic bacteria for attachment sites, thereby reducing the number of pathogenic bacteria in the intestinal tract (third paragraph page 2). Ding further discloses that dietary supplement with fructo- oligosaccharides reduced E. coli population and increased lactobacilli population (third paragraph page 2).
Therefore, when viewing the combination of Goodman, Shoaf, and Ding as well as WO’454, the ordinary skilled artisan would have a reasonable expectation that the oligosaccharide preparations of WO’454 such as the galacto-oligosaccharides and fructo-oligosaccharides preparations can reduce EPEC/EHEC/APEC pathogenic bacteria in the GI tract as well as its associated inflammation.
Conclusion
No claim is found allowable.
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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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner
Art Unit 1693
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