DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
. 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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant's submission filed on 11/10/2025 has been entered.
Claims 21-31 and 34-42 are pending in the instant application.
Claim Rejections - 35 U.S.C. § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 21-31 and 34-42 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. The claim recite a naturally occurring protein that is a product of nature. This judicial exception is not integrated into a practical application because no other meaningful limitations are recited in the claims. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons stated below.
Choi et al. (Regul Toxicol Pharmacol . 2015 Jun;72(1):39-48; PTO 892) teach that L-fucose is natural monosaccharide that is present in free form in human breast milk (human milk monosaccharide, see abstract), and that lactose is one of the largest constituents of human breast milk (~70g/L) (see page 40 second paragraph on left). Thus, the claims encompass naturally occurring L-fucose and other carbohydrates.
The claim does not recite any additional elements other than a naturally-occurring protein that may be purified or in aqueous solution in some embodiments. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed protein are not markedly different form the naturally occurring counterpart because it conveys the same structural and functional information and the claim do not recite any additional features that could add significantly more to the exception. Accordingly, the claims do not qualify as eligible subject matter.
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 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.
Claim 21 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Choi et al. (Regul Toxicol Pharmacol . 2015 Jun;72(1):39-48; PTO 892).
Choi et al. teach that L-fucose is natural monosaccharide that is present in free form in human breast milk (human milk monosaccharide, see abstract), and that lactose is one of the largest constituents of human breast milk (~70g/L) (see page 40 second paragraph on left).
Thus, the reference teachings anticipate the claimed invention.
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 of this title, 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.
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 21-31 and 34-42 are rejected under 35 U.S.C. 103 as being unpatentable over
Choi et al. (Regul Toxicol Pharmacol . 2015 Jun;72(1):39-48; PTO 892) in view of WO2012112777 (08/23/2012; IDS filed 10/10/2023), WO2008040717 (04/10/2008; IDS filed 10/10/2023), US20160024543 (01/28/2016; reference of record)
Choi et al. teach that L-fucose is natural monosaccharide that is present in free form in human breast milk (human milk monosaccharide, see abstract), and that lactose is one of the largest constituents of human breast milk (~70g/L) (see entire publication especially page 40 second paragraph on left).
The teachings of the reference differ from the claims in that the reference does not teach the food composition comprising L-fucose and at least one other carbohydrate selected from galactooligosaccharides (GOSs), fructooligosaccharides (FOSs), inulin, lactulose, isomaltose, maltodextrin, lactose, and human milk oligosaccharides (HMOs).
WO2012112777 teaches a process for the purification of 2'-fucosyllactose (2'-FL) which is the same HMO that is purified in the instant application, comprising purification of 2'-fucosyllactose from E. coli fermentation broth, where passage of the 2'-FLcontaining fraction through anion-exchange and cation exchange columns can remove excess protein/DNA/caramel body contaminants, and where WO2012112777 lists some resins tested successfully for this purpose. WO2012112777 teaches that the oligosaccharides are purified and used in a number of products for consumption by humans as well as animals, such as companion animals (dogs, cats) as well as livestock (bovine, equine, ovine, caprine, or porcine animals, as well as poultry). For example, a pharmaceutical composition comprising purified 2'-fucosyllactose (2'-FL), 3-fucosyllactose (3FL), lactodifucotetraose (LDFT), or 3'-sialyl-3-fucosyllactose (3'- S3FL) and an excipient is suitable for oral administration. See entire publication and claims especially claims 1-10, Example 4, and page 29, lines 3-6.
WO2008040717 teaches methods for the purification of N-acetylneuraminic acid (Neu5Ac) from a fermentation broth obtained by microbial fermentation of a microorganism which is capable of producing Neu5Ac and secreting said Neu5Ac into the fermentation broth, the fermentation broth containing Neu5Ac, the microorganisms, other medium components and contaminants, as well as preparations of Neu5Ac, which have been purified from such a fermentation broth. See entire publication and claims especially claims 1-13.
US20160024543 teaches compositions and methods for engineering bacteria to produce sialylated and N-acetylglucosamine-containing oligosaccharides (see entire publication and claims especially paragraphs [0004]- [0043]. US20160024543 teaches in the claims:
1. A method for producing a sialylated oligosaccharide in a bacterium comprising: providing a bacterium, said bacterium comprising an exogenous sialyl-transferase, a deficient sialic acid catabolic pathway, a sialic acid synthetic capability, and a functional lactose permease gene; and culturing said bacterium in the presence of lactose.
10. The method of claim 1, wherein said sialylated oligosaccharide comprises 3′-sialyllactose (3′-SL) or 6′-sialyllactose (6′-SL).
US20160024543 teaches in Example 4 the production of 6′-sialyllactose (6′-SL) by engineered E. coli (ΔnanRATEK) which was engineered with a set of mutations that cause cytoplasmic accumulation of non-acetylated lactose precursor and prevent the degradation of N-acetyl-5-neuraminic acid (FIG. 3). US20160024543 teaches in paragraphs [0031] - [0034] a method of treating, preventing, or reducing the risk of infection in a subject comprising administering to said subject a composition comprising a human milk oligosaccharide, purified from a culture of a recombinant strain of the current invention, wherein the hMOS binds to a pathogen and wherein the subject is infected with or at risk of infection with the pathogen.
US20160024543 teaches the compositions are formulated into animal feed (e.g., pellets, kibble, mash) or animal food supplements for companion animals, e.g., dogs or cats, as well as livestock or animals grown for food consumption, e.g., cattle, sheep, pigs, chickens, and goats. US20160024543 teaches the purified human milk oligosaccharides (hMOS) is formulated into a powder (e.g., infant formula powder or adult nutritional supplement powder, each of which is mixed with a liquid such as water or juice prior to consumption) or in the form of tablets, capsules or pastes or is incorporated as a component in dairy products such as milk, cream, cheese, yogurt or kefir, or as a component in any beverage, or combined in a preparation containing live microbial cultures intended to serve as probiotics, or in prebiotic preparations intended to enhance the growth of beneficial microorganisms either in vitro or in vivo. US20160024543 teaches the purified sugar (e.g., LNnT or 6′-SL) can be mixed with a Bifidobacterium or Lactobacillus in a probiotic nutritional composition. (i.e. Bifidobacteria are beneficial components of a normal human gut flora and are also known to utilize hMOS for growth.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify and/or combine the reference teachings to arrive at the claimed the invention by making the food composition comprising the L-fucose of Choi et al., the 2’-fucosyllactose of US20160333042 or WO2012112777, the 3′-sialyllactose (3′-SL) or 6′-sialyllactose (6′-SL) of US20160024543, the N-acetylneuraminic acid of WO2008040717, and the Bifidobacterium or Lactobacillus of US20160024543. One of ordinary skill in the art would have been motivated to do this in order to obtain a beneficial food composition comprising the human milk oligosaccharide 2’-fucosyllactose composition for human consumption. It would have been obvious to adjust the amounts of L-fucose in the food composition recited in the claims as routine optimization and/or as desired to make a beneficial food composition for human consumption. It would have been obvious to add any of the other recited components including protein, vitamin, amylase or other enzymes, galactooligosaccharides (GOSs), fructooligosaccharides (FOSs), inulin, lactulose, isomaltose, maltodextrin, lactose, oil, and other human milk oligosaccharides (HMOs) as routine optimization and/or as desired to make a beneficial food composition for human consumption. It would have been obvious to formulate the food composition as a medical food composition, a dietary supplement, a sachet product, a liquid ready-to-use infant nutrition product, a liquid ready-to-use toddler nutrition product, a granulated product, a spray-dried infant formula product, a premix thereof, or combinations thereof as routine optimization and/or as desired. One of ordinary skill in the art would have had a reasonable expectation of success because making compositions comprising HMOs, L-fucose, sialic acid, and other components are known as shown by the reference teachings. Thus, the claimed invention was within the ordinary skill in the art to make and use at the time the invention was made, and was as a whole clearly prima facie obvious.
Conclusion
No claim is allowed.
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/CHRISTIAN L FRONDA/Primary Examiner, Art Unit 1652