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 .
Detailed Action
This office action is a response to applicant’s communication submitted July 6, 2026, wherein claims 18 and 20 are amended. This application is a continuation of US application 16/328850, now abandoned, filed February 27, 2019, which is a national stage application of PCT/EP2017/071606, filed August 29, 2017, which claims benefit of foreign application EP16186544.2, filed August 31, 2016.
Claims 10, 11, and 15-26 are pending in this application.
Claims 10, 11, and 15-26 as amended are examined on the merits herein.
The following rejections of record in the previous action are maintained:
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.
Claims 10, 11 and 15-19 are rejected under 35 U.S.C. 103 as being unpatentable over Morrow et al. (PCT international publication WO2010/120682, of record in previous action) in view of Diwakar et al. (Reference of record in previous action) in view of Tikofsky et al. (Reference of record in previous action)
Independent claim 10, and dependent claims 11 and 15 claim a method of treating diarrhea in calves, lambkins, kids, or foals, comprising feeding said animals with 2’-fucosyllactose. The claims further require that the method consist of administering 2’- fucosyllactose or a composition containing 2’- fucosyllactose as the only human milk oligosaccharide to the subject. This limitation excludes methods wherein the subject receives additional human milk oligosaccharides. Still further, the claims require that the composition has a carbohydrate content of no more than 50% by weight and a protein content of at least 18% by weight.
Morrow et al. discloses a food composition for an animal comprising an oligosaccharide derived from human milk containing a first sugar unit which can be fucose. (p. 1 lines 19-24) The composition can be administered to either a young or an adult animal to treat infections, wherein the animal is selected from a number of species including a cow, and can include young animals as well as adult ones. (p. 2, lines 8-19) In one embodiment the oligosaccharide is 2’-fucosyllactose. (p. 3 table 1) The oligosaccharide can be obtained from conventional sources including production in a microorganism. (p. 5 lines 4-7)
While Morrow et al. does not specifically disclose a method of 2’-fucosyllactose to a calf to prevent infection, one of ordinary skill in the art would have found it to be obvious to choose this specific oligosaccharide and this specific animal form among the various oligosaccharides and animal subjects listed by Morrow et al. One of ordinary skill in the art would have recognized this embodiment as among the various embodiments suggested by the art. While the reference further describes an embodiment wherein the composition comprises two or more milk-derived oligosaccharides, (p. 1 line 32) this is only one alternative embodiment, and the reference clearly does not require that the composition comprise two or more milk-derived oligosaccharides. Furthermore the reference states that the oligosaccharides can be synthesized chemically, purified from milk, or produced in a microorganism. (p. 5 lines 4-5) Therefore one of ordinary skill in the art would be in possession of methods of obtaining this oligosaccharide that did not necessarily require it to be isolated as a heterogeneous mixture from a biological source. (e.g. chemical synthesis)
While Morrow et al. does not specifically describe a method of treating diarrhea, Morrow et al. does disclose methods of treating infections caused by a wide variety of different agents including for examples Escherichia, Salmonella, Shigella, Klebisella, and Proteus. (p. 8 lines 16-31) Diwakar et al. further discloses isolation of pathogenic bacteria from fecal samples of calves suffering from diarrhea. (p. 43 left column last paragraph – right column last paragraph) These isolates included E. coli, Shigella, Salmonella, Klebisella, and Proteus. (p. 44 table 1) It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to administer the oligosaccharide described by Morrow et al. to a calf suffering from bacterial diarrhea of the type described by Diwakar et al. One of ordinary skill in the art would have found this to be obvious because Morrow et al. includes these types of bacterial infections among those treatable by their therapeutic method.
Claim 10 further requires that the composition has a content of carbohydrate excluding human milk oligosaccharides of no more than 50% w/w and a protein content of at least 18%. However, Morrow et al. describes that the composition can be provided together with the animal’s regular food. (p. 9 lines 11-15) Furthermore Tikofsky et al. discloses an experiment regarding the protein and fat content of milk replacers fed to calves. (p. 2260 left column third paragraph) These include a medium fat composition containing 24.8% protein and 46.69% lactose, and a high fat composition comprising 27% protein and 35.36% lactose, which meet the limitations recited in the present claims (p. 2261 right column table 1) Medium and high fat milk replacers resulted in increased gain in body weight and fat. (p. 2263) While the reference describes this result as not beneficial for the rearing of dairy calves, it does mention that calves raised for beef or veal would benefit from this increased weight gain. (p. 2263 right column “Discussion”) Therefore it would have been obvious to one of ordinary skill in the art at the time of the invention to administer the 2’- fucosyllactose as part of a milk replacer composition having greater than 18% protein and less than 50% lactose, in view of the suggestion by Tikofsky that such a regimen would be beneficial for calves being fattened for meat production, and by Morrow that the fucosyllactose could be mixed into an animal’s regular feed.
Regarding claim 15, because Tikofsky describes increased fat gain (fattening) as being the goal of rearing calves for beef or veal, it would have been one of ordinary skill in the art at the time of the invention to administer the composition specifically to calves undergoing fattening for meat production, as this would be expected to lead to a beneficial increase in weight gain.
With respect to claims 16-18, these claims require that the 2’-fucosyllactose comprise a specific percent by weight of the composition. However, in order to actually carry out a therapeutic method according to the prior art reference, one of ordinary skill in the art would necessarily have to prepare some sort of pharmaceutical dosage form (e.g. a solution or suspension as described above) and determine what amount of active agent to include. Doing so would necessarily require selecting an appropriate amount of active agent and carrier to include. As the amount of active agent would be regarded as a result-effective variable, determining the appropriate amount would be seen to be prima facie obvious.
Therefore the invention taken as a whole is prima facie obvious.
Response to Arguments
Applicant’s arguments, submitted July 6, 2026, with respect to the above ground of rejection, have been fully considered and not found to be persuasive to remove the rejection. Applicant argues that Morrow does not disclose which individual oligosaccharides are responsible for the antimicrobial effects of human milk oligosaccharides, and that in vitro activity is not the same as in vivo effectiveness at treating disease. Applicant further argues that the declaration of Sabrina Wemhoff under 37 CFR 1.132 demonstrates that administration of 2’-FL to calves resulted in a higher weight gain and a reduction in populations of Peptidoclostridium. This allegedly demonstrates an unexpected result for the claimed invention compared to the cited prior art such as Morrow et al. The declarant further argues that the disclosure of Morrow et al. is specifically directed to methods of treating an infection rather than to methods of preventing an infection or increasing weight gain of a young animal.
Firstly, looking at the experimental protocol described in the declaration of Wemhoff, the experimental animals were calves having a mean age of 42.3 days and not suffering from any particular disease. The therapeutic outcome observed involved an increasing weight gain and a change in fecal microbiota populations. This is not a method of treating a particular disease. By contrast, independent claim 10 is directed to a method of treating a gastrointestinal disease, which is different form a method directed to increasing the weight gain or altering the microbiome of a putatively healthy animal. Therefore the results of record in the declaration are not directly relevant to the presently claimed method.
Secondly, the experimental results described by the declaration do not compare treatment with 2’-FL individually to any of the other treatments described or suggested by Morrow. Morrow’s disclosure is described as a foodstuff comprising “a milk-derived oligosaccharide,” or a combination of such oligosaccharides. 2’-FL is described as one of a large number of milk-derived oligosaccharides that can be used as the active ingredient. Furthermore figure 1 of Morrow discloses an experimental result demonstrating that total human milk oligosaccharides have an inhibitory effect on the growth of C. perfringens in culture. The experiment documented by the declaration, while it established that 2’-FL has an inhibitory activity against a different potential pathogen in healthy calves, does not demonstrate that this effect is greater than that which would be observed from feeding an equivalent dose of total human milk oligosaccahrides, or a different one of the oligosaccahrides specifically noted in tables 1-3 of Morrow. Rather the comparison in the declaration is to a control group receiving no human milk oligosaccharides. In the absence of such a comparison to the actual disclosure of the closest prior art, the declaration does not serve to demonstrate any finding of unexpected results sufficient to overcome a finding of prima facie obviousness.
For these reasons the rejection is deemed proper and maintained.
Applicant’s amendment necessitates the following new grounds of rejection:
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.
Claims 20-26 are rejected under 35 U.S.C. 103 as being unpatentable over Morrow et al. in view of Diwakar et al. in view of Tikofsky et al. as applied to claims 10-11 and 15-19 above, and further in view of Constable. (Reference included with PTO-892)
The disclosures of Morrow, Diwakar, and Tikofsky are discussed above. Morrow in view of Diwakar in view of Tikofsky does not specifically suggest treating a subject aged eight weeks. Rather, Diwakar discloses the presence of pathogenic bacteria in the feces of calves aged 3-6 months, or about 12 weeks at least. However, Constable discloses a review of the occurrence of diarrhea in calves and its treatment with antibiotics. (p. 8 left column last paragraph – p. 9 left column second paragraph) Bacteremia and diarrhea are observed in calves as early as eight or nine days of life. (p. 9 left column third paragraph) It would therefore have been obvious to one of ordinary skill in the art at the time of the invention to administer the oligosaccharide treatment described by Morrow et al. to a calf suffering from bacterial diarrhea at an age of less than 12 weeks, for example 8 weeks. One of ordinary skill in the art would have been motivated to do so because it is known that younger calves can suffer from this condition, from practically the first week of life, and are also in need of treatment.
Therefore the invention taken as a whole is prima facie obvious.
Conclusion
No claims are allowed in this action. 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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/ANDREA OLSON/ Primary Examiner, Art Unit 1693 8/24/2026
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