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 .
Claims 21-31 and 34-42 are pending and under consideration in the instant application.
In view of the claim amendment and arguments the previous rejection of the claims under 35 U.S.C. 101 and 35 U.S.C. 102(a)(1) have been withdrawn.
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)
The arguments filed 07/14/2026 have been considered but are not persuasive. Although teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention is an appropriate method for determining obviousness; however, it is just one of a number of valid rationales for doing so. The Supreme Court in KSR identified several exemplary rationales to support a conclusion of obviousness which are consistent with the proper functional approach to the determination of obviousness as laid down in Graham, which is stated in MPEP 2143, I. EXAMPLES OF RATIONALES:
“Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield
predictable results;
(B) Simple substitution of one known element for another to obtain predictable
results;
(C) Use of known technique to improve similar devices (methods, or products)
in the same way;
(D) Applying a known technique to a known device (method, or product) ready
for improvement to yield predictable results;
(E) “ Obvious to try ” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in
either the same field or a different one based on design incentives or other market
forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art
reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.”
As previously stated 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. 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.
Hence, 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; where 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. 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.
The reference teachings and rejection of record have been restated below.
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.
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 extension fee 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Christian L Fronda whose telephone number is (571)272 0929. The examiner can normally be reached Monday-Thursday and alternate Fridays between 9:00AM-5:00PM.
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/CHRISTIAN L FRONDA/Primary Examiner, Art Unit 1652
