DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of claims
Claims 1, 2, 4-6, 8 and 9 as filed on 12/15/2025 are pending and under examination.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1, 2, 4-6, 8 and 9 remain rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over WO 2011/096809 (Van Neerven et al), Timmerman et al (“Monostrain, multistrain and multispecies probiotics. A comparison of functionality and efficacy”. International Journal of Food Microbiology. 2004, 96, pages 219-233), US 2010/0247489 (Saur-Brosch), Musa et al (“The Potential Benefits of Probiotics in Animal Production and Health”. Journal of Animal and Veterinary Advances, 2009, 8 (2), pages 313-321) and Lucas et al (“Postnatal Development of Bacterial Population in the Gastrointestinal Tract of Calves”, Folia Microbiol, 2007, 52 (1), pages 99-104).
The cited document WO 2011/096809 (Van Neerven et al) teaches a composition for oral administration to animals (page 5, line 26), wherein the composition comprises:
1) probiotics bacteria belonging to the biological species of Faecalibacterium prausnitzii (page 5, lines 23-26; page 11, lines 10-20; page 14, lines 18-21; page 19, lines 10-12);
2) at least a second organism or probiotics that belong to biological species of Lactobacillus acidophilus, L. lactis, L. plantarum, Bifidobacterium longum, B. bifidum. B. thermophilus (see from line 22 on page 12 to page 13, line 25); and
3) milk protein such as casein or whey proteins (page 17, lines 25-28; page 11, line 10-11).
The cited document WO 2011/096809 (Van Neerven et al) teaches that probiotic organisms are provided in effective amounts about 105 CFU to 1013 CFU per g of the composition (page 12, lines 19-21) as intended to improve and to develop immune system, to inhibit pathogens, to assist in maintenance of well-being (page 12, lines 17-18; page 11, lines 17-20; page 19, line 4), thereby, for improving feed efficiency or weight gain within the broadest reasonable meaning of the claims. The cited document WO 2011/096809 (Van Neerven et al) teaches that probiotic-containing compositions are provided in oral delivery vehicles including power, gel, suspensions, solutions (page 18, line 23).
Thus, the cited document WO 2011/096809 (Van Neerven et al) teaches incorporation of the same major component (F. prausnitzii ) as encompassed by the pending claim 1.
The cited document WO 2011/096809 (Van Neerven et al) teaches incorporation of the same 2 major components (F. prausnitzii plus milk protein) as encompassed by the pending claim 5.
The cited document WO 2011/096809 (Van Neerven et al) teaches incorporation of incorporation of the same 3 major components (F. prausnitzii plus milk protein plus Lactobacillus, Bifidobacterium) as encompassed by the pending claim 8.
However, the cited document WO 2011/096809 (Van Neerven et al) is silent with regard whether or not the “freeze-dried” cells of bacterial probiotics are used for providing nutritional compositions, however it is well known that probiotic-containing nutritional compositions are made with “freeze-dried” bacterial cells that are preserved by lyophilization for stabilization of live and biologically active bacterial cells. For example: see Timmerman at page 221, col. 2, lines 4-5). For example see par. 0202 of the cited US 2010/0247489 (Saur-Brosch), which discloses probiotic-containing nutritional compositions for oral administration to animals including Faecalibacterium (par. 0103) and including bovine animals or cattle (par. 0108).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to incorporate in the nutritional composition the “freeze-dried” probiotic bacteria including “freeze-dried” Faecalibacterium because it is a common practice in the prior art as intended to provide for viability and stabilization of biological activities of beneficial bacterial cells.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Further with regard to limitation “bovine”: in the composition for oral administration to animals of the cited document WO 2011/096809 (Van Neerven et al) probiotics are “commensal” bacteria (page 2, last line) including “commensal” Faecalibacterium prausnitzii (page 4, last line); but in the particular embodiment the probiotics appear to be are sourced from human subjects. However, the prior art clearly acknowledges, recognizes and teaches that the potential beneficial probiotic strains are normal inhabitants of the target host species; for example: see reference by Musa et al at page 314, col. 1, par. 3). Faecalibacterium is commonly present in bovine animals including neonatal calves (see abstract of the cited reference by Lucas).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to incorporate into animal nutritional composition the probiotic bacteria derived from the same animal species for which the nutritional composition is intended. Thus, one of skill in the art would obviously select “bovine” bacteria including bovine Faecalibacterium for incorporation into nutritional composition if intended for “bovine” animals because prior art clearly teaches selection of potential probiotics from normal inhabitants of the target host species (reference by Musa) and because Faecalibacterium is commonly present in bovine animals including neonatal calves (see abstract of the cited reference by Lucas).
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Response to Arguments
Applicant's arguments filed on 12/15/2025 have been fully considered but they are not found persuasive.
With regard to claim rejection under 35 USC § 103 Applicants’ main argument is that the cited document WO 2011/096809 (Van Neerven et al) does not teach or suggest “amount effective to improve weigh gain or feed efficiency” for Faecalibacterium prausnitzii in a composition with Faecalibacterium prausnitzii because the disclosure on page 12, which is cited in the office action, is applied to amounts of probiotics that are Lactobacillus which are listed on this page 12.
This argument is not found persuasive because disclosure on page 12, lines 19-21, of the cited document WO 2011/096809 (Van Neerven et al) refers to probiotics in the probiotic-containing composition, wherein the probiotics are not only Lactobacillus (following paragraph on page 12) but also Faecalibacterium prausnitzii (see following page 14, lines 19-21). By employing language “typically the probiotics are added in amount” (page 12, line 19) the cited WO 2011/096809 (Van Neerven et al) clearly signals to one of skill in the art what effective amounts to be used in order to populate GI of animal, thereby, providing beneficial probiotic effects including improving immune function, thereby, improving health and weight of animals.
No claims are allowed.
Conclusion
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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Vera Afremova
March 24, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653
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