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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 17, 2026 has been entered.
Detailed Action
This office action is a response to applicant’s communication submitted March 17, 2026 wherein claims 10, 15, and 19 are amended and new claims 20-26 are introduced. 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 priority to foreign application EP16186533.2, 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.
Withdrawn Rejections
Applicant’s amendment, submitted March 17, 2026, with respect to the rejection of claim 15 under 35 USC 112(d) for failing to further limit the base claim, has been fully considered and found to be persuasive to remove the rejection as claims 15 has been amended to limit the population of calves being treated. Therefore the rejection is withdrawn.
Applicant’s amendment, submitted March 17, 2026, with respect to the rejection of claims 10, 11, and 15-19 under 35 USC 103 for being obvious over Morrow et al. in view of Diwakar et al., has been fully considered and found to be persuasive to remove the rejection as the claims have been amended so as to require that the composition contain a specific level of protein. Therefore the rejection is withdrawn.
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 10, 11 and 15-26 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 included with PTO-892)
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 form 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.
Regarding claims 20-26, these claims further require administering the composition during the 12th week after birth. Looking to the disclosure of Diwakar et al., the fecal samples being analyzed were from calves having an age of 3-6 months. Therefore as an age of 3 months is about 12 weeks, and animals of this age are shown to harbor pathogenic enterobacteria that can cause diarrhea, it would have been obvious to one of ordinary skill in the art at the time of the invention to administer the human milk oligosaccharide containing compositions described by Morrow to animals aged 12 weeks suffering from diarrhea, as these animals would be expected to be in need of such treatment.
Therefore the invention taken as a whole is prima facie obvious.
Conclusion
No claims are allowed in this action.
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/ANDREA OLSON/ Primary Examiner, Art Unit 1693 3/31/2026