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 .
Claim status
Claims 1-8 and 11-15 are pending in the application. Claims 1 and 8 are currently amended. Claims 2-7, 11 and 13-14 are previously presented. Claims 9-10 are newly cancelled. Claim 12 and 15 are withdrawn with traverse in response to the restriction requirement. Claims 1-8, 11 and 13-14 are hereby examined on the merits.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in EP on 12/15/2022. It is noted, however, that applicant has not filed a certified copy of the EP22213935.4 application as required by 37 CFR 1.55.
Examiner Note
Any objections and/or rejections that are made in the previous actions and are not repeated below, are hereby withdrawn.
Claim Rejections - 35 USC § 102
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, 5-7, 11 and 13-14 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hougee US Patent Application Publication No. 2010/0278781 A1 (hereinafter referred to as Hougee).
Regarding claims 1-3, 11 and 13-14, Hougee teaches an infant and/or toddler nutrition comprising, inter alia, non-viable Bifidobacterium breve, a non-digestible oligosaccharide and a protein (0014; 0053), wherein the non-digestible oligosaccharide is selected from group consisting of beta-GOS, alpha-GOS, FOS, MOS, and a mixture thereof (0029), and wherein the protein is selected from the group consisting of casein, whey protein, soy protein, potato protein and pea protein (0053). Hougee teaches that the infant and/or toddler nutrition is a liquid (0060). The infant and/or toddler nutrition reads on the food supplement or the animal nutritional composition as recited in claims 13-14.
Regarding the newly amened limitation about a prebiotic formulation that consists of the protein and the oligosaccharide, the combination of protein and non-digestible oligosaccharide as disclosed by Hougee reads on the prebiotic formulation as recited in the claim 1. Note that claims 13-14 recite that the prebiotic formulation is part of a food supplement or animal nutritional composition.
Claims 5-6 are interpreted to be met by Hougee, given that alpha-GOS or FOS is in alternative form with the beta-GOS as disclosed by Hougee.
Regarding claim 7, Hougee teaches MOS, which is known to derive from yeast cell wall, or is materially indistinguishable from a MOS that is obtained from yeast cell wall.
Claim 4 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hougee as applied to claim 1 above, and evidenced by Jeurink US Patent Application Publication No. 2017/0209472 A1 (hereinafter referred to as Jeurink).
Regarding claim 4, Hougee teaches that the GOS is Vivinal® GOS (0036). As evidenced by Jeurink (para. 0118), Vivinal® GOS is obtained from by transgalactosylation of lactose by beta-galactosidase.
Claims 1-3, 5, 7, 11 and 13-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gibson US Patent Application Publication No. 2004/0131659 A1 (hereinafter referred to as Gibson).
Regarding claims 1-2, 11 and 13-14, Gibson teaches a composition such as a nutritional composition for mammals such as human (0075) comprising, inter alia, GOS and FOS (0001; 0014; 0016), a protein such as milk protein (0062; 0112, note that 0112 teaches milk powder), oil, cocoa aroma, flavoring, etc. (0112). Gibson teaches that the nutritional composition is in powder or liquid form (0112; 0068). Gibson teaches that GOS is Vivinal® GOS (0029), which is known to be beta-GOS derived from dairy product. The nutritional composition as disclosed by Gibson reads on the food supplement or the animal nutritional composition as recited in claims 13-14.
Regarding the newly amened limitation about a prebiotic formulation that consists of the protein and the oligosaccharide, the combination of milk protein, FOS and GOS as disclosed by Gibson reads on the prebiotic formulation as recited in the claim 1. Note that claims 13-14 recite that the prebiotic formulation is part of a food supplement or animal nutritional composition.
Regarding claims 3, 5 and 7, it is noted that claim 3 further limits the plant protein of claim 1, which is in alternative form with the milk protein. By meeting the milk protein, Gibson is interpreted to read on claim 3.
For the same reason, claims 5 and 7 are also interpreted to be met by Gibson, given that Gibson teaches FOS and beta-GOS, which are in alternative form with alpha-GOS or MOS.
Claim 4 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gibson as applied to claim 1 above, and evidenced by Jeurink US Patent Application Publication No. 2017/0209472 A1 (hereinafter referred to as Jeurink).
Regarding claim 4, Gibson teaches that the GOS is Vivinal® GOS (0029). As evidenced by Jeurink (para. 0118), Vivinal® GOS is obtained from by transgalactosylation of lactose by beta-galactosidase.
Claims 1-7, 11 and 13-14 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kobayashi EP0323201 B1 (hereinafter referred to as Kobayashi).
Regarding claims 1, 2 and 4, Kobayashi teaches a method of preparing a processed milk containing GOS, the method comprising treating an animal milk product (e.g., milk powder, page 4, line 4-9) with beta-galactosidase to convert lactose present in the milk product into GOS (page 2, line 49-54). Since lactose in the milk product is treated with beta-galactosidase, the GOS formed is necessarily in beta form (see instant specification para. 0016, which evidences that treating lactose with beta-galactosidase will result in a GOS in beta form). The processed milk necessarily contains milk protein. Kobayashi teaches that the processed milk can be served as beverage, or can be used to prepare baby milks, LAB beverages, fermented milks, ice creams, breads, sweets, pet-food and calf starters (page 4, line 43-48) thus reading claims 13-14.
Regarding the newly amened limitation about a prebiotic formulation that consists of the protein and the oligosaccharide, the combination of milk protein and GOS as disclosed by Kobayashi reads on the prebiotic formulation as recited in the claim 1. Note that claims 13-14 recite that the prebiotic formulation is part of a food supplement or animal nutritional composition.
Regarding claims 3, 5, 6 and 7, it is noted that the claim 3 further limits the plant protein of claim 1, which is in alternative form with the milk protein. By meeting the milk protein, Kobayashi is interpreted to read on claim 3.
For the same reason claims 5, 6 and 7 are also interpreted to be met by Kobayashi, given that Kobayashi teaches beta-GOS, which are in alternative form with alpha-GOS, FOS or MOS.
Regarding claim 11, Kobayashi teaches that the processed milk is in the form of an aqueous solution/dispersion (Example 1; Example 2).
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hougee as applied to claim 1 above.
Regarding claim 8, Hougee teaches that the DP of the oligosaccharide is 2-200 (0028). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Gibson as applied to claim 1 above.
Regarding claim 8, Gibson teaches that the DP of the FOS is 2-20, and the DP of GOS is 2-10 (0025; 0027). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kobayashi as applied to claim 1 above.
Regarding claim 8, Kobayashi teaches that the DP of the GOS is 3-6 (page 2, line 51). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I).
Claims 1-3, 5, 7, 8, 11 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Gibson US Patent Application Publication No. 2004/0131659 A1 (hereinafter referred to as Gibson).
Regarding claims 1-2, 11 and 13-14, Gibson teaches a prebiotic formulation (e.g., a composition such as a nutritional composition) for mammals such as human (0075) comprising, inter alia, GOS and FOS (0001; 0014; 0016), a protein such as milk protein (0062; 0112, note that 0112 teaches milk powder), oil, cocoa aroma, flavoring, etc. (0112). Gibson teaches that the nutritional composition is in powder or liquid form (0112; 0068). Gibson teaches that GOS is Vivinal® GOS (0029), which is known to be beta-GOS derived from dairy product. The nutritional composition as disclosed by Gibson reads on the food supplement or the animal nutritional composition as recited in claims 13-14.
Gibson teaches a prebiotic formulation that comprises milk protein, oligosaccharide (e.g., GOS and FOS), and other ingredients such as oil thus being silent regarding a prebiotic formulation that consists of the protein and the oligosaccharide only. However, each of the claimed ingredients (e.g., protein and oligosaccharides including FOS and GOS) and their functions are known in the art (for example, the Abstract of Gibson teaches that the GOS and FOS are prebiotics for controlling inflammatory bowel disease and related disorder; and the function a protein in building, repairing, and regulating the body's tissues is also well known) that one of the ordinary skill in the art could have used any combination of the ingredients including the combinations as claimed by known method with no change in their respective functions, and the combination would have yielded nothing more than predictable results to a skilled in the art, absent a clear showing of the contrary.
Further, attention is invited to In re Levin, 84 USPQ 232 and the cases cited therein, which are considered in point in fact situation of the instant case. At page 234, the Court stated as follows:
This court has taken the position that new recipes or formulas for cooking food which involve the addition or elimination of common ingredients, or for treating them in ways which differ from the former practice, do not amount to invention, merely because it is not disclosed that, in the constantly developing art of preparing food, no one else ever did the particular thing upon which the applicant asserts his right to a patent. In all such cases, there is nothing patentable unless the applicant by a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected and useful function. In re Benjamin D. White, 17 C.C.P.A. (Patents) 956, 39 F.2d 974, 5 USPQ 267; In re Mason et al., 33 C.C.P.A. (Patents) 1144, 156 F.2d 189, 70 USPQ 221.
Regarding claims 3, 5 and 7, it is noted that claim 3 further limits the plant protein of claim 1, which is in alternative form with the milk protein. By meeting the milk protein, Gibson is interpreted to read on claim 3.
For the same reason, claims 5 and 7 are also interpreted to be met by Gibson, given that Gibson teaches FOS and beta-GOS, which are in alternative form with alpha-GOS or MOS.
Regarding claim 8, Gibson teaches that the DP of the FOS is 2-20, and the DP of GOS is 2-10 (0025; 0027). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Gibson as applied to claim 1 above, and evidenced by Jeurink US Patent Application Publication No. 2017/0209472 A1 (hereinafter referred to as Jeurink).
Regarding claim 4, Gibson teaches that the GOS is Vivinal® GOS (0029). As evidenced by Jeurink (para. 0118), Vivinal® GOS is obtained from by transgalactosylation of lactose by beta-galactosidase.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Gibson as applied to claim 1 above, and further in view of Young US Patent Application Publication No. 2010/0150870 A1 (hereinafter referred to as Young).
Regarding claim 6, Gibson as recited above teaches fructo-oligosaccharides as a prebiotic but is silent regarding that the fructo-oligosaccharides are obtained by enzymatic processes or hydrolysis of inulin.
Young discloses that FOS obtained from hydrolysis of inulin can be used as prebiotic (0027).
Both Gibson and Young are directed FOS. It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified Gibson by obtaining FOS through hydrolysis of inulin with reasonable expectation of success, for the reason that prior art has established that FOS obtained from hydrolysis of inulin can be used as prebiotic.
Response to Arguments
Applicant's arguments filed 06/23/2026 have been fully considered but they are not persuasive.
Applicant argues on page 4 of the Remarks that the infant and/or toddler nutritional composition comprises non-viable Bifidobacterium besides protein and oligosaccharides thus failing to teach a prebiotic formulation that consists of the protein and the oligosaccharides.
The arguments are considered. However, as set forth in the instant office action (see para. 8), the combination of protein and non-digestible oligosaccharide as disclosed by Hougee reads on the prebiotic formulation that consists of protein and oligosaccharides only as recited in the claim 1. Note that claims 13-14 recite that the prebiotic formulation is part of a food supplement or animal nutritional composition.
For the same ongoing reason, applicant’s arguments on pages 4-5 of the Remarks regarding Gibson, and Kobayashi are not persuasive, either (see para.15 and 22 of the instant office action).
Conclusion
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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/CHANGQING LI/Primary Examiner, Art Unit 1791
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