DETAILED ACTION
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 .
This application is the national stage entry of PCT/KR2022/001168, filed 21 Jan 2022; and claims benefit of foreign priority document REPUBLIC OF KOREA 10-2022-0002842, filed 07 Jan 2022. This foreign priority document is not in English.
Claims 1-8 are pending in the current application and are examined on the merits herein.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claims 1, 3, and 5-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gibson et al. (US 2004/0131659 A1, published 08 July 2004, cited in PTO-892).
Gibson et al. discloses a nutritional prebiotic compositions comprising of soluble fibres, in particular fructo-oligosaccharides (FOS) and galacto-oligosaccharides (GOS), and their use in the treatment or prevention of gastrointestinal tract disorders, such as inflammatory bowel disease (IBD) (abstract; page 1, paragraph 1). The inventors have found that the prebiotic properties of fructo-oligosaccharides (FOS) are significantly improved by the presence of galacto-oligosaccharides (GOS) and that the effects of FOS and GOS are more than additive, i.e. a synergistic effect in promoting the growth of beneficial bacteria, such as bifidobacteria and lactobacilli, has been observed (page 1, paragraph 12). Accordingly, in one aspect the present invention provides compositions comprising FOS and GOS. In another aspect of the invention there is provided a use of the compositions according to the invention in the manufacture of a medicament or nutritional composition for the prevention or treatment of chronic gut disorder, e.g. IBD and/or for prolonging the remission periods or ameliorating symptoms or conditions associated with this disorder, such as ulcerative colitis, Crohn's disease and/or colon cancer (page 2, paragraphs 14-17), meeting limitations of claims 1 and 5. The term “soluble fibres” pertains to fibres which are able to undergo fermentation in the colon to produce short chain fatty acids (SCFA) (page 2, paragraph 22), implying that the soluble fibres FOS and GOS of the composition promotes the production of short chain fatty acids in the gut and meeting limitations of claim 6. The compositions of the invention, e.g. pharmaceutical or nutritional compositions, e.g. food or beverage incorporating compositions according to the invention can be safely-consumed by anyone, and are especially recommended for mammals, such as humans (page 6, paragraph 75), meeting limitations of claims 7-8. The composition is for controlling inflammatory bowel disease, implying the composition is anti-inflammatory or inflammation-reducing, and a nutritional composition for a mammal is reasonably interpreted as a feed composition, meeting limitations of claim 8.
Regarding claim 3, claim 1 recites a “pharmaceutical composition comprising a galacto-oligosaccharide composition as an active ingredient” (emphasis added) and claim 3 recites “wherein the galacto-oligosaccharide composition has a purity of 70% to 95%”. MPEP 2111.03 at I. provides the transitional phrase “comprising” is inclusive or open-ended and does not exclude additional, unrecited elements, and cites Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) providing that “comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”. In this case Gibson et al. discloses the amount of GOS in the compositions of the invention may be comprised between about 0.3 g to about 20 g, or the amount of GOS in the compositions of the invention may be comprised between about 0.1 to about 40% by weight based on the total weight of the composition (page 3, paragraph 32 and 34). In this case, the claimed pharmaceutical composition is open to the inclusion of unspecified ingredients which include the same components which may be considered as impurities of the “galacto-oligosaccharide composition”, even in major amounts. In the absence of clear definition of how the purity of “the galacto-oligosaccharide composition” limits the claimed “pharmaceutical composition comprising a galacto-oligosaccharide composition”, the composition disclosed in Gibson et al. is interpreted to meet the limitations of claim 3 because the amount of GOS in the compositions of Gibson et al. can be interpreted as the same structural limitations as a pharmaceutical composition comprising galacto-oligosaccharide composition having a purity of 70% to 95% as claimed.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim 3-4 is rejected under 35 U.S.C. 103 as being unpatentable over Gibson et al. (US 2004/0131659 A1, published 08 July 2004, cited in PTO-892).
Gibson et al. teaches as above.
Gibson et al. does not specifically teach the galacto-oligosaccharide composition has a purity of 70% to 95% (claim 3). Gibson et al. does not specifically teach the galacto-oligosaccharide composition comprises monosaccharides in an amount of 5% by weight or less, based on the total weight thereof (claim 4).
Gibson et al. further teaches according to the invention, GOS may comprise between 2 and 15 saccharide units, preferably between 2 to 10 saccharide units, more preferably between 2 to 7 saccharide units and even more preferably between 2 to 6 saccharide units. In one embodiment of the invention, GOS may contain about 0 to about 45% of weight disaccharides, preferably about 33% of weight disaccharides, based of the total weight of GOS. According to the invention, GOS may contain about 0 to about 50% of weight trisaccharides, preferably about 39% of weight trisaccharides, based on the total weight of GOS. According to the invention, GOS may contain about 0 to about 50% of weight tetrasaccharides, preferably about 18% of weight tetrasaccharides, based of the total weight of GOS. According to the invention, GOS may contain about 0 to about 30% of weight pentasaccharides, preferably about 7% of weight pentasaccharides, based of the total weight of GOS (paragraph 27 spanning pages 2-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Gibson et al. in order to select the components of the galacto-oligosaccharide composition. Regarding the amount of monosaccharides, Gibson et al. provides guidance for selecting the GOS to comprise disaccharides through pentasaccharides, preferably about 97% by weight based of the total weight of GOS, suggesting that any monosaccharides would be present in an amount of 0-3% by weight based of the total weight of GOS, addressing limitations of claim 4. Regarding claim 3, insofar as the purity of galacto-oligosaccharide composition is interpreted to reference components that are not the desired disaccharides through pentasaccharides as impurities, Gibson et al. provides guidance for selecting the GOS composition to comprise mainly the desired disaccharides through pentasaccharides, with the 97% by weight based of the total weight of GOS as a starting point. MPEP 2144.05 at II.A. provides “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.” In this case Gibson et al. teaches the general conditions regarding the amount of the desired disaccharides through pentasaccharides in the GOS and provides the preferred value of 97% by weight based of the total weight of GOS as a starting point, suggesting it would have been routine experimentation to discover the optimum or workable ranges for the amount of components that are not the desired disaccharides through pentasaccharides interpreted as impurities.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Gibson et al. (US 2004/0131659 A1, published 08 July 2004, cited in PTO-892) as applied to claims 1 and 3-8 above, and further in view of Ohtsuka et al. (J. Nutr. Sci. Vitaminol., 1990, 36, p265-276, cited in PTO-892).
Gibson et al. discloses and teaches as above. Gibson et al. further teaches the compositions for stimulating the growth and/or the metabolism of beneficial gut bacteria, such as bifidobacteria and/or lactobacilli, and/or in inhibiting the growth and/or the metabolism of nonbeneficial gut bacteria such as Bacteroides (page 2, paragraph 18).
Gibson et al. does not specifically disclose the galacto-oligosaccharide composition comprises 4’-galactosyllactose in an amount of 12% to 25% by weight, based on the total weight thereof (claim 2).
Ohtsuka et al. teaches investigation of the influence of chronic ingestion of 4’-galactosyllactose (4’GL) on body weight gain, organ weight, serum lipids, and liver lipids in rats (page 265, abstract). The administration of 4'GL to healthy adult men induced a significant increase in the number of fecal Bifidobacteria and a decrease in Bacteroidaceae and Enterobacteriaceae. Furthermore, 4'GL feeding by constipated elderly patients improved the constipation and the intestinal microflora without causing any side effects (paragraph spanning pages 265-266). These observations, which are similar to dietary fiber, suggest that a large portion of 4'GL ingested reached the colon without being hydrolyzed by human digestive enzymes in the gastrointestinal tract (page 266, paragraph 2). Ohtsuka et al. teaches working examples in which the experimental diet comprises 5% or 10% 4'GL (page 266, table 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Gibson et al. in view of Ohtsuka et al. in order to select the GOS of Gibson et al. to comprise 4’GL and to select the amount of this component. One of ordinary skill in the art would have been motivated to combine Gibson et al. in view of Ohtsuka et al. with a reasonable expectation of success because both Gibson et al. and Ohtsuka et al. are drawn to a galacto-oligosaccharide for use to increase beneficial gut bacteria such as bifidobacteria and/or decrease nonbeneficial gut bacteria such as Bacteroides, Gibson et al. teaches the GOS may contain about 0 to about 50% of weight trisaccharides, and Ohtsuka et al. teaches examples of an experimental diet that comprises 5% or 10% 4'GL, suggesting it would have been obvious to select the GOS trisaccharides of Gibson et al. to include the 4’GL of Ohtsuka et al., and to select the amount of 4’GL from within the general range taught by Gibson et al. based on the teaching of Ohtsuka et al. of selecting the amount of 4'GL in order to affect the result.
Conclusion
No claim is found to be allowable.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693
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